As filed with the Securitiesand Exchange Commission on September 6, 2024
RegistrationNo. 333-____
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,DC 20549
FormF-1
REGISTRATIONSTATEMENT UNDER THE SECURITIES ACT OF 1933
NEWGENIVFGROUP LIMITED
(Exactname of registrant as specified in its charter)
British Virgin Islands | | 8090 | | Not Applicable |
(State or other jurisdiction of incorporation or organization) | | (Primary Standard Industrial Classification Code Number) | | (I.R.S. Employer Identification Number) |
WingFung Alfred Siu
ChiefExecutive Officer
1/F,Pier 2, Central
HongKong, 999077
Tel:+1 (212) 537-4406
(Address,including zip code, and telephone number,
includingarea code, of registrant’s principal executive offices)
CogencyGlobal Inc.
122 East 42nd Street,18th Floor
New York, NY 10168
(212) 947-7200
(Name, address, includingzip code, and telephone number, including area code, of agent for service)
Copies to:
Darrin M. Ocasio, Esq.
Matthew Siracusa, Esq.
Sichenzia Ross Ference Carmel LLP
1185 Avenue of the America, 31st Fl.
New York, NY 10036
Telephone: +1-212-930-9700
Approximate date of commencement of proposedsale to the public: As soon as practicable after the effective date hereof.
If any of the securities being registered onthis form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, check the following box.☒
If this form is filed to register additionalsecurities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registrationstatement number of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filedpursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number ofthe earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filedpursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number ofthe earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrantis an emerging growth company as defined in Rule 405 of the Securities Act of 1933.
Emerging growth company ☒
If an emerging growth company that prepares itsfinancial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transitionperiod for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the SecuritiesAct. ☐
The registrant hereby amends this registrationstatement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment whichspecifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the SecuritiesAct or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a),may determine.
The information inthis prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with theSecurities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and is not soliciting an offerto buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY PROSPECTUS | SUBJECT TO COMPLETION | DATED SEPTEMBER 6, 2024 |
5,912,281 Class A Ordinary Shares
NewGenIvf Group Limited
This prospectus relates tothe resale by the selling shareholders identified in this prospectus (“Selling Shareholders”) of up to 5,912,281 Class A OrdinaryShares, no par value per share (“Ordinary Shares”).
The Selling Shareholdersare identified in the table commencing on page 60. No Ordinary Shares are being registered hereunder for sale by us. We will not receiveany proceeds from the sale of the Ordinary Shares by the Selling Shareholders. All net proceeds from the sale of the Ordinary Sharescovered by this prospectus will go to the Selling Shareholders (see “Use of Proceeds”). The Selling Shareholders areoffering their securities to further enhance liquidity in the public trading market for our equity securities in the United States. Unlikean initial public offering, any sale by the Selling Shareholders of the Ordinary Shares is not being underwritten by any investment bank.The Selling Shareholders may sell all or a portion of the Ordinary Shares from time to time in market transactions through any marketon which our Ordinary Shares are then traded, in negotiated transactions or otherwise, and at prices and on terms that will be determinedby the then prevailing market price or at negotiated prices directly or through a broker or brokers, who may act as agent or as principalor by a combination of such methods of sale (see “Plan of Distribution”).
Our Ordinary Shares currentlytrade on The Nasdaq Global Market under the symbol “NIVF.” The last reported closing price of our Ordinary Shares on August30, 2024 was $0.86.
We are not a “controlledcompany” as defined under the Listing Rules of The Nasdaq Stock Market LLC (“Nasdaq”), but we qualify as a “foreignprivate issuer,” as defined in Rule 405 under the U.S. Securities Act of 1933, as amended, or the Securities Act, and are eligiblefor reduced public company reporting requirements.
NewGenIvf Group Limited(“NewGenIvf,” “Company,” “our,” “we,” or “us”) is a British Virgin Islandsholding company with our operations conducted through our subsidiaries in the Cayman Islands (our wholly-owned subsidiary, NewGenIvfLimited) and in Asia (Hong Kong, Thailand, Kyrgyzstan, and the Kingdom of Cambodia). Under this holding company structure, investorsare purchasing equity interests in NewGenIvf, a British Virgin Islands holding company, and obtaining indirect ownership interests inour Cayman Islands and Asian operating subsidiaries. Substantially all of NewGenIvf’s operations and assets are based in Thailand,Cambodia and Kyrgyzstan. As a result, its businesses and operations are subject to the changing economic conditions prevailing fromtime to time in such countries.
Investing in our OrdinaryShares involves a high degree of risk, including the risk of losing your entire investment. See “Risk Factors” startingon page 20 to read about the factors you should consider before buying the Ordinary Shares.
Neither the Securitiesand Exchange Commission, or the SEC, nor any state or other foreign securities commission has approved nor disapproved these securitiesor determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2024
TABLE OF CONTENTS
You should rely only onthe information contained in this prospectus and any free writing prospectus prepared by or on behalf of us or to which we have referredyou. Neither we nor any of the Selling Shareholders have authorized anyone to provide you with different information. Neither we norany of the Selling Shareholders are making an offer of these securities in any jurisdiction where the offer is not permitted. You shouldnot assume that the information in this prospectus or any applicable prospectus supplement is accurate as of any date other than thedate of the applicable document. Since the date of this prospectus, our business, financial condition, results of operations and prospectsmay have changed.
For investors outside ofthe United States: Neither we nor any of the Selling Shareholders have done anything that would permit this offering or possession ordistribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You arerequired to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.
In this prospectus, “we,”“us,” “our” and the “Company” refer to NewGenIvf Group Limited and its wholly owned subsidiary, NewGenIvfLimited, a Cayman Islands company.
Our reporting currency isthe U.S. dollar. Unless otherwise expressly stated or the context otherwise requires, references in this prospectus to “dollars”or “$” are to U.S. dollars.
This prospectus includesstatistical, market and industry data and forecasts which we obtained from publicly available information and independent industry publicationsand reports that we believe to be reliable sources. These publicly available industry publications and reports generally state that theyobtain their information from sources that they believe to be reliable, but they do not guarantee the accuracy or completeness of theinformation. Although we believe that these sources are reliable, we have not independently verified the information contained in suchpublications.
Our consolidated financialstatements are prepared and presented in accordance with accounting principles generally accepted in the United States of America, orU.S. GAAP.
The number of Ordinary Sharescurrently issued and outstanding was 10,149,386 as of September 4, 2024. No new shares are being issued by the Company pursuant to thisoffering.
ABOUT THIS PROSPECTUS
This prospectus describesthe general manner in which the Selling Shareholders identified in this prospectus may offer from time to time up to 5,912,281 OrdinaryShares. If necessary, the specific manner in which the Ordinary Shares may be offered and sold will be described in a supplement to thisprospectus, which supplement may also add, update or change any of the information contained in this prospectus. To the extent there isa conflict between the information contained in this prospectus and the prospectus supplement, you should rely on the information in theprospectus supplement, provided that if any statement in one of these documents is inconsistent with a statement in another document havinga later date—for example, any prospectus supplement—the statement in the document having the later date modifies or supersedesthe earlier statement.
GLOSSARY OF DEFINED TERMS
In this prospectus, unless otherwise indicatedor the context otherwise requires, references to:
“ASCA” meansA SPAC I Acquisition Corp., a British Virgin Islands business company.
“A SPAC IMini Acquisition Corp.” means A SPAC I Mini Acquisition Corp., a British Virgin Islands business company.
“Business Combination”means the transactions contemplated by the Merger Agreement, pursuant to which (i) ASCA reincorporated to the British Virgin Islandsby merging with and into the Company; and (ii) Merger Sub merged with and into Legacy NewGenIvf, resulting in Legacy NewGenIvf beinga wholly-owned subsidiary of the Company.
“BVI” meansBritish Virgin Islands.
“BVI Act”means BVI Business Companies Act (As Revised).
“Class A OrdinaryShare” means Class A ordinary shares of the Company, no par value per share.
“Class B OrdinaryShare” means (x) the Company’s Class B ordinary shares with no par value per share, and (y) any shares into which such ordinaryshares shall have been changed or any shares resulting from a reclassification of such ordinary shares.
“Closing”means the consummation of the Business Combination, which occurred on April 3, 2024.
“Company”means NewGenIvf Group Limited, a British Virgin Islands business company, the surviving entity of the Business Combination.
“Legacy NewGenIvf”means NewGenIvf Limited, a Cayman Islands exempted company, which became a wholly owned subsidiary of ASCA upon the Closing.
“Merger Agreement”means the Merger Agreement entered into on February 15, 2023, and as amended on June 12, 2023 and December 6, 2023, between ASCA, A SPAC IMini Acquisition Corp., Merger Sub, Legacy NewGenIvf, and certain shareholders of Legacy NewGenIvf, pursuant to which the ReincorporationMerger and Acquisition Merger were consummated.
“Merger Sub”means A SPAC I Mini Sub Acquisition Corp., a Cayman Islands exempted company and former wholly-owned subsidiary of A SPAC IMini Acquisition Corp.
“Memorandum and Articlesof Association” means the Company’s Amended and Restated Memorandum and Articles of Association, as amended on April 3, 2024.
“NewGenIvf”means NewGenIvf Group Limited, a British Virgin Islands business company, the surviving entity of the Business Combination, unless thecontext so requires.
“Ordinary Shares”means the Class A Ordinary Shares.
“Preferred Shares”means preferred shares of the Company, no par value per share.
“ReincorporationMerger” means the first step of the Business Combination which occurred pursuant to the Merger Agreement, in which ASCA reincorporatedto the British Virgin Islands by merging with and into A SPAC I Mini Acquisition Corp.
PROSPECTUS SUMMARY
This summary highlightsinformation contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investingin our securities. Before you decide to invest in our securities, you should read the entire prospectus carefully, including the “RiskFactors” section and the financial statements and related notes appearing at the end of this prospectus.
Unless the context otherwiserequires, all references in this Prospectus Summary to “NewGenIvf,” “we,” “our,” and “us”refer to Legacy NewGenIvf and its subsidiaries as they existed prior to the Closing if described in relation to a date prior to April3, 2024. Any references to “NewGenIvf,” “we,” “our,” and “us” with respect to the presenttime, a future time, or a date after April 3, 2024 refers to NewGenIvf, a British Virgin Islands company, and its subsidiaries, whoseexistence continued after the Closing.
Overview
We are an assisted reproductiveservices (“ARS”) provider in Asia-Pacific. Since the opening of our first clinic in Thailand in 2014, we have establishedourself as a long-standing ARS provider in this region. Our strategic presence in Thailand, Cambodia, and Kyrgyzstan positions us totake advantage of opportunities across Asia-Pacific. According to China Insights Consultancy (“CIC”), from 2014 to 2022,there was a rising number of women in the key ARS-targeted age group (ages 15 to 49) in Asia Pacific and a growing trend towards latermaternal age. The number of married women of reproductive age in Asia Pacific has risen from 816.4 million in 2014 to 833.2 millionin 2022. Additionally, according to CIC, there was increasing social acceptance of ARS use in Asia Pacific countries such as China, India,and Thailand during the same period. For example, the number of ARS users in China has risen from 136.8 thousand in 2017 to 184.9 thousandin 2022 approximately and that in Japan has risen from 98.0 thousand in 2017 to 128.5 thousand in 2022.
According to CIC, the prevalenceof infertility in Asia-Pacific developing countries is substantial. For example, the infertility rate in Thailand, India and China wasabout 15.4%, 13.8% and 17.8%, respectively, in 2022. In India, the infertility rate in 2020 was approximately 13.1%, representing anannual growth of 2.6%. The infertility rate in China was around 17.6% in 2020, representing an annual growth of 0.6%. Infertility isincreasingly gaining society’s attention as individuals are more openly discussing their struggles. Despite the prevalence of infertility,access to treatment is often limited in the Asia Pacific region. According to CIC, financial challenges, costs of treatment, and limitedavailability or capacity of fertility medical care are some of the main challenges in the fertility marketplace in Asia-Pacific region.Religious, social and cultural roadblocks can also prevent hopeful couples from realizing their dream to have children. We believe thatwe can help address some of these key challenges of Asia-Pacific fertility industry.
History and Development of the Company
Prior to the Business Combination,on April 29, 2021, A SPAC I Acquisition Corp. (“ASCA”), was incorporated as a British Virgin Islands business company,specifically a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, recapitalization,reorganization or similar business combination with one or more target businesses.
The Business Combination
On February 15, 2023,ASCA entered into the Merger Agreement (as amended on June 12, 2023 and December 6, 2023, the “Merger Agreement,” and thetransactions contemplated thereunder, the “Business Combination”) with A SPAC I Mini Acquisition Corp., Merger Sub,NewGenIvf Limited, a Cayman Islands exempted company (“Legacy NewGenIvf”) and certain shareholders of Legacy NewGenIvf. Pursuantto the Merger Agreement, the Business Combination was effected in two steps: (i) ASCA was reincorporated to the British Virgin Islandsby merging with and into A SPAC I Mini Acquisition Corp. (such transaction, the “Reincorporation Merger”); and (ii) MergerSub merged with and into Legacy NewGenIvf, resulting in Legacy NewGenIvf being a wholly-owned subsidiary of the Company (such secondstep in isolation, the “Acquisition Merger”). The surviving entity of the Business Combination, together with its subsidiariesis referred to in this prospectus as “NewGenIvf,” the “Company,” “we,” “our,” or “us,”unless the context otherwise requires.
On June 12, 2023, theparties to the Merger Agreement entered into the First Amendment to Merger Agreement (the “First Amendment”), pursuant towhich Legacy NewGenIvf agreed to provide non-interest bearing loans in an aggregate principal amount of up to $560,000 (the “Loan”)to ASCA to fund any amount that would be required in order to further extend the period of time available for ASCA to consummate a businesscombination and for ASCA’s working capital, payment of professional, administrative and operational fees and expenses, and otherpurposes as mutually agreed by ASCA and Legacy NewGenIvf. Such loans were to become repayable upon the closing of the Acquisition Merger.In addition, pursuant to the First Amendment, subject to receipt of at least $140,000 as part of the Loan from NewGenIvf, ASCA agreedto waive its termination rights and the right to receive any break-up fee due to Legacy NewGenIvf’s failure to deliver auditedfinancial statements by no later than February 28, 2023.
On December 6, 2023, theparties to the Merger Agreement entered into the Second Amendment to the Merger Agreement (the “Second Amendment”) whichamended and modified the Merger Agreement to, among other things, (i) reduce the size of NewGenIvf’s board of directors followingthe consummation of the Business Combination to five (5) directors, two (2) of whom would be executive directors designated by NewGenIvfand three (3) of whom will be designated by NewGenIvf to serve as independent directors in accordance with Nasdaq requirements, (ii)provide for the conversion of NewGenIvf shares issued by NewGenIvf following the original date of the Merger Agreement into Class A OrdinaryShares in connection with the Acquisition Merger, and (iii) remove the condition that ASCA have in excess of $5,000,000 in net tangibleassets immediately after the consummation of the Business Combination.
On April 3, 2024, the BusinessCombination was consummated with the Company as the surviving entity.
NewGenIvf’s Business
With a focus on providingfertility treatments to fulfil the dreams of building families, NewGenIvf mainly offers two services, namely: (i) in vitro fertilization(“IVF”) treatment service, comprising traditional IVF and egg donation; and (ii) surrogacy and ancillary caring services.Currently, we have three clinics: one clinic in Thailand, one clinic in Cambodia, and one clinic in Kyrgyzstan.
| ● | IVF treatment service: For the years ended December 31, 2023 and 2022, we generated approximately 78.3% and 47.4%, of its revenue from IVF treatments services. We primarily provide our clients with conventional IVF/intracytoplasmic sperm injection (“ICSI”) and embryo transfer services. As technology has progressively advanced, we have been able to, through technologies and facilities provided by MicroSort technology, help fulfill the family-balancing dreams of its clients and avoiding certain gender-related hereditary diseases. IVF treatment involves the performance of a series of medical treatment and procedures that are not separately distinct and only brings benefits to clients when embryo is successfully implanted, therefore revenue from IVF treatment is recognized at a point in time when it is completed in clinic. The completion of this treatment is evidenced by a written IVF report indicating successful embryo implantation. |
| ● | Surrogacy and ancillary caring services: We also generate revenue from surrogacy services and related ancillary caring services in Kyrgyzstan. For the years ended December 31, 2023 and 2022, we generated approximately 21.7% and 52.6%, of our revenue from surrogacy and ancillary caring services. For surrogacy services, NewGenIvf conducts implantation of embryos from biological parents in surrogate mothers. In addition, NewGenIvf provides a “success guarantee” program for egg donation services in Cambodia and surrogacy services in Kyrgyzstan. Under this optional program, patients pay additional fees of approximately 40% of the original price and can have repeated attempts of IVF cycles, egg donation services and/or surrogacy services until the procedures are successful. The additional costs to NewGenIvf are generally limited and amount to approximately 30% of the original costs because NewGenIvf’s clinics, together with the patients, can choose suitable egg donors and surrogate mothers to limit the additional costs. During the pregnancy period, NewGenIvf provides ancillary caring services including regular body check and provision of vitamins, supplements and medicines to surrogate mothers. Revenue from surrogacy and ancillary caring services is recognized at a point in time when the surrogate mother gives birth. Surrogacy services provide infertile couples with an alternative method of having children. |
For the years endedDecember 31, 2023 and 2022, NewGenIvf’s revenue was US$5,136,153 and US$5,944,190, and its net income was US$108,418 andUS$135,847, respectively.
Market Opportunity
According to CIC, NewGenIvf’score market for fertility services is substantial and growing rapidly, driven by, among other things, societal and cultural shifts, suchas people starting families later in life and other health-related challenges which could impact couples’ and individuals’ability to have children. In addition, NewGenIvf believes that continued overall de-stigmatization of infertility will help drive betteraccess to, and stronger demand for, fertility treatment services, thereby further enabling the expansion of NewGenIvf’s addressablemarket. According to CIC, the market size of fertility treatments in Asia Pacific was increasing steadily and the potential size of theAsia fertility market is expected to reach US$37.4 billion by 2030. NewGenIvf believes its market opportunity is substantial andis continuing to grow as a result of the rising demand for fertility services, the lack of adequate offerings in the market and the increasingawareness of the challenges of infertility.
Competitive Strengths
NewGenIvf believes thatthe following competitive strengths have positioned it to meet growing opportunities in the fertility market across Asia-Pacific, andhave differentiated it from its competitors:
Broad-range ARS Provider Offering ComprehensiveFertility Treatment Services
With almost a decade ofexperience in the fertility market, NewGenIvf has built a reputation in the IVF industry in Asia-Pacific. NewGenIvf has reinforced itslong-standing position through expanding its service offerings and locations to address the evolving clients’ needs or requests.
NewGenIvf’s comprehensivefertility treatment offerings in Thailand, Cambodia, and Kyrgyzstan, primarily including IVF, egg donation (in Cambodia) and surrogacyservices (in Kyrgyzstan), make it convenient for clients in Asia-Pacific market to have access to various fertility services but witha relatively low cost, as compared with the US market. According to CIC, the average cost per IVF cycle in the US is around US$12,000(excluding medication), which is 65% higher than that of Asia-Pacific market. Meanwhile, the average cost per IVF cycle by NewGenIvfis around US$7,000 (excluding medication). Each of NewGenIvf’s clinics in Thailand, Cambodia, and Kyrgyzstan has its own specialty,and together, NewGenIvf is able to provide more flexibility and options to its patients. For example, NewGenIvf’s Thailand clinicfocus on IVF and related ancillary services including HIV sperm washing, egg freezing, and chromosome screening. The clinic in Cambodiaspecializes in providing both IVF services and egg donation services. NewGenIvf opened the clinic in Kyrgyzstan in 2019, which broadenedNewGenIvf’s services by being legally qualified/received approval letter from The Ministry of Health of Kyrgyzstan to offer surrogacyservices. As of December 31, 2023, NewGenIvf was the one of the few ARS providers in Kyrgyzstan and one of the few companies in Kyrgyzstanthat is licensed to offer surrogacy services in Kyrgyzstan.
NewGenIvf attributes itstrack record of success to its experienced physicians and its ability to provide comprehensive ARS services, allowing it to meet patients’increasing demand for advanced, high-end, and sophisticated ARS, a higher standard and a wider range of advanced services.
NewGenIvf has extensiveexperience serving Asia-Pacific patients and a deep understanding of their general profiles. In particular, NewGenIvf has personnel speakingmultiple languages, including nurses, facilitators, and translators, who are familiar with the health condition and culture of Asia-Pacificpatients from different countries in the region. NewGenIvf believes that it is therefore well-positioned to benefit from market growthdriven by Asia-Pacific patients travelling to its clinics for treatment.
Attractive Market with Significant Demandand Fast Growth
NewGenIvf operates in theARS market in Asia Pacific, positioning it to leverage on an attractive market with compelling underlying growth potential. Accordingto CIC, during the years ended December 31, 2021 and 2022, the ARS market in Asia Pacific has experienced growth underpinnedby long-term demographic and social trends. These trends include a rising demand for fertility services, the lack of adequate offeringsin the market and the increasing awareness of the challenges of infertility, according to CIC.
According to CIC, the AsiaPacific ARS market is a large, multi-billion dollar industry growing at a strong pace of approximately 15% in 2022 as increased awarenessand acceptance of IVF and surrogacy services continue to drive demand. Additionally, according to CIC, the market is underserved as asubstantial percentage of patients in need of ARS treatments go untreated. The industry also remains constrained in capacity, therebycreating challenges in providing access to ARS to the volume of patients in need. According to CIC, as of December 31, 2022, therewere more than 213 million infertile couples in Asia Pacific. While there have been substantial increases in the use of ARS, accordingto CIC, only approximately 1.47 million ARS cycles, including IVF, and other fertility treatments, were performed in Asia Pacificin 2022. This amounts to less than 1.1% of the infertile couples in Asia Pacific being treated and only 0.7% having a child though ARSin 2022, indicating significant unmet demand for ARS.
Asia-Pacific fertility markets,in particular India and China, present a vast opportunity for ARS providers in the region. China’s ARS market has been driven byan increasing rate of infertility, the implementation of the Three-Child Policy in May 2021, a decreasing number of couples at childbearingage and increasing affordability and awareness of ARS, according to CIC. China’s ARS market size in 2021 and 2022 was US$2,105 millionand US$2,069 million, respectively, and is expected to further grow to US$2.3 billion in 2023, according to CIC. India’sARS market size increased from US$1.2 billion in 2021 to US$1.5 billion in 2022, and is expected to grow further to US$1.6 billionin 2023, according to CIC. NewGenIvf believes that its existing market presence and reputation in Thailand, Cambodia, and Kyrgyzstanwell positions it to capitalize on the fast-growing Asia-Pacific fertility market.
According to CIC, the significantentry barriers in Asia-Pacific ARS industry are expected to continue to constrain supply in the industry. The industry is heavily regulatedand a significant number of stringent requirements must be satisfied in order to obtain relevant licenses to conduct IVF, egg donationand surrogacy procedures in the relevant countries. NewGenIvf believes that such barriers to entry can help it maintain its market positionin Asia Pacific as the fertility market in the region continues to expand.
Built on years of experience,NewGenIvf has established a strong reputation in its industry, which in turn attracted potential business partners to approach NewGenIvfto negotiate cooperations and referrals. Over the years, NewGenIvf sends representatives to medical expos mostly held in the PRC to approachpotential business partners and establish new partnerships by entering into agency agreements with each agent. NewGenIvf has become asignificant partner with approximately 90 fertility service agents in China as well as in India. Normally, each agency agreement hasa maximum term of one year, which is renewable upon mutual agreement. Agents typically market and promote NewGenIvf’s servicesby word-to-mouth referrals and other measures and NewGenIvf pays the agents commission at a range of 10% to 25% of the treatment feesupon the completion of client’s treatment. Normally, agents provide potential clients’ contact information to the sales teamof NewGenIvf, who then approach potential clients and provide consultation on services. Overall, approximately 50% of NewGenIvf’spatients are referrals from agents, among which approximately 80% are referrals from China and the remaining 20% from India, whereasthe remaining 50% of NewGenIvf’s patients are patients who contact NewGenIvf directly through its websites from social media promotions.With its partnerships in various countries, NewGenIvf believes it is able to better benefit from the growing market opportunities.
Exclusively Licensed Technology for Family Planning and Accessto Mature Fertility Technologies
NewGenIvf believes thatits licenses and/or access to mature technologies contribute to its ability to identify and tailor ARS services to individual patient’sneeds. These technologies include:
| ● | MicroSort Technology: NewGenIvf holds an exclusive license granted by a division of the Genetics and IVF Institute, to use MicroSort technology in Thailand and Cambodia, which is a form of pre-conception gender selection technology for humans. MicroSort technology aims to separate male sperm cells based on which gender chromosome they contain, which results in separated semen samples that contain a higher percentage of sperm cells that carry the same gender chromosome. The technology ultimately helps couples choose the gender of their future child by choosing semen samples that predominately contain sperm with the X chromosome for a female or Y chromosome for a male. Traditionally and naturally, gender selection occurs after conception, meaning after the eggs are fertilized. As a result, some fertilized eggs will go unused. However, with MicroSort technology, NewGenIvf is able to increase the ratio of male or female embryos, based on the patient’s preference. Eggs are more likely to be fertilized according to the preferences of the parents. Other improvements that MicroSort treatment could help achieve include prevention of certain gender-related hereditary diseases. As of December 31, 2023, NewGenIvf was one of the only seven exclusive license holders of MicroSort technology world-wide. |
| ● | Preimplantation Genetic Screening (“PGS”): PGS is used in parallel with an IVF treatment cycle. PGS is the practice of determining the presence of aneuploidy (either too many or too few chromosomes) in a developing embryo. PGS improves success rates of in vitro fertilization by ensuring the transfer of euploid embryos that have a higher chance of implantation and resulting in a live birth. PGS has improved clinical outcomes for NewGenIvf by achieving a higher implantation rate of 70.9% and reducing miscarriage rates by 26.6%. |
| ● | Next-Generation Sequencing (“NGS”): NGS is a high-throughput technology for determining the sequence of deoxyribonucleic acid (“DNA”) or ribonucleic acid (“RNA”) to study genetic variation associated with diseases or other biological phenomena. NGS determines the sequence of a sample all at once by using parallel sequencing. Traditional Sanger sequencing determines the sequence of a sample one section at a time. Sequencing thousands of gene fragments simultaneously with NGS reduces time and cost associated with sequencing and increases the coverage quality and data output. |
| ● | Preimplantation Genetic Diagnosis (“PGD”): Similar to PGS, PGD is also used in parallel with an IVF treatment cycle. But PGD is a process more enhanced than PGS since it scans for individual genes. PGD is the practice of evaluating embryos for specific genetic abnormalities, such as sickle cell disease or cystic fibrosis, where carrier status has been documented in each of the parents. By using this technique, physicians are able to check the genes or chromosomes for a specific genetic condition. PGD can decrease the risk of miscarriage and this technology can help women better achieve a healthy pregnancy. Individuals who suspect or know they carry genes for serious medical conditions may opt to screen for healthy embryos ahead of time. |
Well Established Brand with Reliable Reputation
The founders of NewGenIvfentered the fertility market as agents in 2011 by introducing patients in need to a Thailand clinic for fertility treatments. The foundersof NewGenIvf started to operate their own clinic in Thailand in 2014 and subsequently added clinics in Cambodia and Kyrgyzstan. Sincethen, NewGenIvf has attracted clients from countries throughout Asia-Pacific, including Mainland China, Hong Kong, India, Thailand,Australia and Taiwan.
NewGenIvf benefits fromthe favourable geographic locations of its clinics, especially its clinic in Thailand. Located in central Bangkok and situated in oneof the biggest shopping malls of the city, the clinic is located in close proximity to various transportation facilities and populartourist attractions, such as the Erawan Shrine. In this regard, NewGenIvf believes that its business has benefited from, and will continueto benefit from, the convenience of its locations.
NewGenIvf has developeda relatively replicable and scalable operating model that supports high productivity at its assisted reproductive medical facilitiesin Asia. Under this model, NewGenIvf’s medical facilities have established standardized operating procedures to select the treatmentprocess according to each patient’s profile. NewGenIvf’s medical and operational personnel are organized into specializedteams according to the different stages of the treatment process and different patient profiles. When patients are initially admittedor would like to seek additional medical services later on, they are assigned to one of the optimal medical teams, which NewGenIvf believesis better suited after taking into account the patient’s diagnosis and preferences. NewGenIvf believes that this model allows eachteam to improve its efficiency and arrange suitable physicians for patients.
The physicians of NewGenIvfhave also developed and employed an operating model that seeks to increase the effectiveness of physicians by utilizing standardizedworkflows and operating procedures with teams of supporting nurses and medical assistants. This helps to increase the number of IVF treatmentcycles that physicians can perform while providing treatment customized based on patient conditions.
With its established clientservice history, accumulated experience as well as its continuous upgrades and development of treatment models, NewGenIvf believes thatit will be able to better monetize its brands through its business.
Experienced Management Team
The NewGenIvf managementteam has considerable experience in the ARS market and the broader healthcare industry. A considerable number of NewGenIvf’s managementare physicians or laboratory technicians who possess extensive experience in the ARS industry and are experts in their respective fields.NewGenIvf’s Chief Executive Officer, Mr. Alfred Siu, has more than 13 years of experience in the fertility service market.Dr. Wiphawee Luangtangvarodom had over 8 years of experience as an obstetrician and gynecologist. NewGenIvf’s two labsupervisors, Ms. Anussara Phinyong, and Ms. Araya Boonchaisitthipong, each had over eight years of experience in the embryologistfield. These individuals have extensive experience in managing assisted reproductive medical facilities. NewGenIvf is also led by othermembers of the professional management team, who are intimately involved in the operational and financial management of NewGenIvf’sGroup. Leveraging their experience, NewGenIvf believes that it is well positioned to expand its network and aims to become a leader inthe Asia Pacific ARS market.
Strategies
NewGenIvf’s visionis to provide tailored ARS solutions to fulfil patients’ dreams of becoming a parent. To realize this vision, NewGenIvf plans toadopt the following strategies:
Offer Broad Fertility Services for FertilityTourists across Asia Pacific
NewGenIvf intends to providebroad fertility services for fertility tourists seeking high quality, cost effective and comprehensive fertility solutions. Accordingto CIC, the demand for fertility tourism is driven by a variety of factors including the prevalence of infertility, the introductionof the Three-Child policy in China, the improved understanding of assisted reproductive technology and increased affordability of ARS. Toaddress these needs, NewGenIvf plans to offer its customers a “hassle-free”, seamless and integrated ARS and hospitalityarrangement experience. To complement its fertility services, NewGenIvf intends to integrate its offerings with additional services fortraveling patients, most of whom are first-time fertility tourists, such as translation service, hotel arrangement and airport pickupservices. NewGenIvf plans to enhance its customers’ experience by entering into exclusive cooperation arrangements with local premiumhospitality providers.
Furthermore, NewGenIvf expectsthe easing of COVID-19 travel restrictions to contribute to an increase in tourists seeking fertility services. According to CIC, theCOVID-19 pandemic led to a delay in many patients’ plans for fertility treatments, with travel restrictions and border closuresimpacting their ability to access care. On May 5, 2023, the WHO Director-General Dr. Tedros Adhanom Ghebreyesus announced thatCOVID-19 no longer constituted a public health emergency of international concern. The pent-up demand for these services is expectedto be released with the lifting of the travel restrictions, leading to a surge in patients seeking fertility treatment. NewGenIvf’sbelieves that its strategy of offering a comprehensive approach to fertility treatments will help it capture a share of the growing marketfor fertility tourism in Asia Pacific.
Continue to Invest in Laboratories and Facilities
NewGenIvf believes laboratoriesand treatment facilities are critical to supporting its future research, development and clients experience. NewGenIvf currently operatestwo laboratories that offer IVF services, one in Thailand and one in Cambodia, and plans to continue to scale up its existing laboratories.NewGenIvf plans to continue to invest in upgrading its laboratories and facilities to complement its growth and expansion, which it believeswill help NewGenIvf maintain an edge over its competitors with regard to technology, operational efficiency, scalability, and clientexperience.
NewGenIvf intends to developadvanced facilities for its existing laboratories, which will be conducting research on ARS related basic science and experiments relatingto emerging technologies to improve ARS success rates and lower costs. NewGenIvf also plans to correlate its data on patient treatmentprotocols to the embryo physiologic data and the pregnancy success rate-related data to identify better treatment protocols to increaseARS success rates. NewGenIvf intends to continue to actively promote technological cooperation with tertiary institutions to discoverways to improve its IVF success rates. Furthermore, NewGenIvf seeks to actively deploy the technology that it possesses to expand theservices it provides.
NewGenIvf has accumulatedexperience in treating patients over 40 years old with premature ovarian failure and patients who have had recurrent ARS implementationfailure, by, for the example, injecting platelet rich plasma into the ovaries to stimulate and support growth of the follicles. NewGenIvfis also implementing certain technological advancements relevant to the ARS industry, including microfluidics, automated sperm analysers,time lapsed incubators, non-invasive preimplantation genetic testing (“PGT”) of cell-free DNA in spent media, automated systemsfor oocyte/embryo vitrification to reduce reagent consumption and decrease labor intensity, mitochondria replacement therapy to reconstructoocytes by nuclear transfer of polar body genome from an MII oocyte into an enucleated donor MII cytoplasm, to increase the number ofoocytes available for the treatment of infertile women, preimplantation methylome screening. There are also breakthrough developmentsin science including organ culture systems, induced pluripotent stem cells, embryonic stem cells, spermatogonial stem cells for creationof functional gametes, but these techniques are not yet ready for human clinical trials.
NewGenIvf also intends todevelop clinically customised interior design concepts for its medical facilities, including improved service rooms, consultation rooms,reception areas, nutrition food areas, and traditional Chinese medicine (such as acupuncture) facilities.
Increase Brand Awareness and Market Share
NewGenIvf intends to maintainand strengthen its brand awareness and market share in Asia Pacific. In order to expand its reach and increase patient numbers, NewGenIvfplans to collaborate with local hospitals, companies, premium hospitality providers and other key players in the ARS industry in AsiaPacific. Additionally, NewGenIvf intends to increase brand awareness through social media promotions and marketing initiatives, and establishingits business development team with the goal of attracting new patients and partners across Asia Pacific. Meanwhile, NewGenIvf intendsto provide innovative treatment services to attract more clients. For example, NewGenIvf plans to introduce IVF mental health services,which allows clients who fail in IVF treatments to access online consultation for further treatment plans such as egg donation and surrogacy.These new treatments services aim to enable NewGenIvf to attract potential clients. By adopting a comprehensive strategy to expand itsmarket share, NewGenIvf aims to strengthen its reputation as a long-standing ARS provider and capture additional market share of thegrowingly ARS market in Asia-Pacific.
Expand Service Reach Through Acquisitions and Partnerships
Leveraging its reputationand footprint in its current markets, NewGenIvf intends to expand its reach, services offering and client base through strategic acquisitionsand/or partnerships in Asia Pacific. Acquisitions of or by companies offering similar services could not only allow NewGenIvf to diversifyits client base, but also allow it to benefit from potential economies of scale and increasing efficiency through consolidation. NewGenIvfcould also leverage the acquired or acquiring company’s customer base, reputation and expertise to further improve its offeringsand operations. NewGenIvf intends to focus on ARS providers in Asia Pacific which possess all conventional licenses and locally recognizedbrands. For the global market beyond Asia Pacific, NewGenIvf intends to expand its footprint through partnerships with other IVF clinics.
In addition, NewGenIvf plansto explore expanding its client base by offering its fertility services as part of corporate benefit programs in Asia. NewGenIvf believesthat there is potential in Asia in offering fertility treatments as a benefit for employees, particularly in companies with a large numberof female employees of childbearing age. By partnering with corporate clients to provide fertility benefits, NewGenIvf can increase itsmarket reach, enhance its brand reputation, and drive client growth. NewGenIvf’s broad range of fertility services, including IVFand egg freezing, can help corporate partners differentiate their employee benefits in the competitive employment landscape, which couldmake them more attractive to potential employees. Additionally, by offering these services, companies can help address the growing concernof delayed childbearing, which is becoming more common among women according to CIC. NewGenIvf plans to collaborate with potentialcorporate clients to develop customized fertility benefit programs that cater to their specific needs, and to provide comprehensive supportand counselling throughout the process.
Meanwhile, NewGenIvf alsointends to attract more clients by establishing its “home country gynecologist partnership program”. Under the program, NewGenIvfmay, subject to its discretion and screening process, offer treatment services to clients with reduced time requirements to be spentoverseas. Depending on local laws, the potential clients may be able to complete their treatments with gynecologists NewGenIvf partnerswith, in their home countries.
Business Model
With a focus on providingfertility treatments to fulfil couples and individuals’ dreams of raising children, NewGenIvf offers mainly two services, namely:(i) IVF treatment service, comprising traditional IVF and egg donation; and (ii) surrogacy and ancillary caring services. Thefollowing table sets forth NewGenIvf’s revenue by service offerings and as a percentage of total revenue for the periods indicated:
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | | | % | | | US$ | | | % | |
IVF Treatment Service | | | 4,021,696 | | | | 78.3 | | | | 2,819,163 | | | | 47.4 | |
Surrogacy and Ancillary Caring Services | | | 1,114,457 | | | | 21.7 | | | | 3,125,027 | | | | 52.6 | |
Total Revenue | | | 5,136,153 | | | | 100.0 | | | | 5,944,190 | | | | 100.0 | |
IVF Treatment Service
NewGenIvf primarily providesits clients with conventional IVF/ICSI and embryo transfer services. NewGenIvf is also able to, through MicroSort technology, help fulfillthe family-balancing dreams of its clients and avoiding certain gender-related hereditary diseases.
IVF treatments that NewGenIvfprovides address tubal factor, ovulatory dysfunction, diminished ovarian reserve, endometriosis, uterine factor, male factor, unexplainedinfertility and other causes. IVF bypasses the function of the fallopian tube by achieving fertilization within a laboratory environment.Ovarian hyper-stimulation is common with IVF treatments to recruit numerous follicles to increase the chances for success. Folliclesare retrieved trans-vaginally using a vaginal probe and ultrasound guidance. Anaesthesia is frequently used due to the number of folliclesretrieved and the resulting discomfort experienced by the patient. The eggs are identified in the follicular fluid and combined withsperm and culture medium in culture dishes, which are placed in an incubator with a temperature and gas environment designed to mimicthe condition of the fallopian tubes. Once the embryos develop, typically over a 3-to-5-day period, they are transferred to the uterinecavity. According to CIC, the average clinical pregnancy success rates, using 5-day incubation, averaged approximately 64.6% (with noPGT) for IVF, with live birth rate at approximately 28.7%.
As a long-standing IVF treatmentsprovider in Asia-Pacific, NewGenIvf had completed over 4,000 cycles of IVF treatments from 2014 to 2023. For the years ended December 31,2023 and 2022, the revenue from NewGenIvf’s IVF treatments was US$4,021,696 and US$2,819,163, respectively, representing 78.3%and 47.4% of its total revenue in the corresponding periods.
IVF Treatments Process
A typical IVF treatmentprocess mainly includes two stages, the pre-IVF treatment stage and the IVF treatment stage. During the IVF treatment process, NewGenIvfalso provides support services such as nutrition guidance and psychological counselling. The flow chart below shows the stages involvedin a typical IVF treatment process:
At the pre-IVF treatmentstage, clients attend an initial consultation, undergo pre-IVF tests, and undergo treatment for gynaecological and andrological diseases,if needed. At the initial consultation, a physician reviews the clients’ detailed medical history to collect more information relatingto the potential cause of their infertility. The client then undergoes various pre-IVF tests, which may include, among other things,blood pressure, hormone level, ultrasound, infectious disease screening, uterine evaluation and male fertility test. The physician willthen design treatment plans based on the client’s medical history and results of the tests. If the client is satisfied with treatmentplan and the test results are acceptable to the physician, the physician will prescribe medications and start stimulation treatment.
The first step of the cycleis to boost egg production through injecting synthetic hormones. Over about one week of ovarian stimulation, clients are monitored ona regular basis with blood test and transvaginal ultrasound. If follicles have reached at least 10 mm in size, an additional antagonistdrug will be added into the daily injection schedule. This is used to prevent ovulation before ovum pickup time. After another few daysof ovarian simulation, if follicle growth is consistent and majority of follicles are around 16 mm to 17 mm, the final injection of ahuman chorionic gonadotropin will be administered. The trigger injection is the final step of the stimulation process and is for thematuration of the eggs in the follicles before they are collected. The next major step is to retrieve the eggs with a minor surgicalprocedure called Trans Vaginal Follicle Aspiration conducted under anaesthesia. At the same time the male partner collects the spermsfor fertilizing the eggs in the laboratory by a process known as intracytoplasmic sperm injection. The fertilized embryos are culturedin the laboratory for two to six days. Embryos that grow well are biopsied and tested by PGT to detect potential genetic diseases.
The final step is to transferthe embryos into the uterus using a catheter. Within eight days after the embryo transfer, a blood test can be conducted to detectwhether the implantation was successful.
MicroSort Technology
MicroSort technology isa preconception process developed by the Genetics and IVF Institute, Inc. that aims to improve the chances that the baby to be conceivedwill be of the desired gender and prevents certain gender-related hereditary diseases.
Semen samples usually containequal amounts of sperm carrying the Y chromosome (which will produce a boy), and sperm carrying the X chromosome (which will producea girl). During the MicroSort process, the sperm sample is washed to remove seminal liquid and nonmotile cells. After the washing, thesample is stained with a special fluorescent material that attaches to the DNA contained in the sperm. The stained sperm cells are analyzedone by one by a flow cytometer, in which cells pass through a laser to make the stain attach to the DNA fluoresce. The sperm containingthe X chromosome (which have more DNA and therefore more stain) will shine brighter than the sperm containing the Y chromosome.The flow cytometer uses a special software to identify X and Y chromosome sperm based on their fluorescence signature. Thesperm carrying the chromosome that will produce the desired gender are separated from the rest of the sample -resulting in an enrichedsperm sample ready for use.
NewGenIvf holds an exclusivelicense granted by a division of the Genetics and IVF Institute, MicroSort International, to use the MicroSort technology in Thailandand Cambodia. MicroSort licenses for NewGenIvf’s operation in Thailand and Cambodia are each provided under a lease and serviceagreement. In April 2019, First Fertility PGS entered into a Lease and Services Agreement with MicroSort International to use MicroSortequipment in Thailand and in March 2019, Phnom Penh Center entered into a Lease and Services Agreement with MicroSort International touse MicroSort equipment in Cambodia (together, the “Lease and Services Agreements”). Pursuant to the Lease and Services Agreements,First Fertility PGS and Phnom Penh Center each has the exclusive right to utilize the MicroSort equipment and to market and sell MicroSortsperm sorting services in Thailand and Cambodia, respectively. MicroSort International is responsible for the maintenance of MicroSortequipment and technical and engineering support. The term of each Lease and Service Agreements is initially from 2019 to 2024, whichshall be automatically renewed for one year unless a written notice of at least 180 days prior to the intended termination dateis provided. The consideration under each of the Lease and Services Agreements is US$9,000 per month after six months from the effectivedate of the agreements. MicroSort International was entitled to a down payment of US$15,000 per agreement and the aggregated amountsreceived by it under the agreements was US$328,500. During the term of each lease and service agreement, MicroSort grants NewGenIvf theexclusive right in that country to utilize the MicroSort equipment and market MicroSort services. The term of each lease and serviceagreement is initially from 2019 to 2024, which shall be automatically renewed for one year unless a written notice at least 180 daysprior to the intended termination date is provided. The flow chart below shows the process involved in MicroSort:
Preimplantation Genetic Screening
PGS is used in parallelwith an IVF treatment cycle. PGS is the practice of determining the presence of aneuploidy (either too many or too few chromosomes) ina developing embryo. PGS improves success rates of in vitro fertilization by ensuring the transfer of euploid embryos that have a higherchance of implantation and resulting in a live birth. PGS has improved clinical outcomes for NewGenIvf by achieving a higher implantationrate of 70.9% and reducing miscarriage rates by 26.6%.
Next-Generation Sequencing
NGS is a high-throughputtechnology for determining the sequence of deoxyribonucleic acid DNA or RNA to study genetic variation associated with diseases or otherbiological phenomena. NGS determines the sequence of a sample all at once by using parallel sequencing. Traditional Sanger sequencingdetermines the sequence of a sample one section at a time. Sequencing thousands of gene fragments simultaneously with NGS reduces timeand cost associated with sequencing and increases the coverage quality and data output.
Preimplantation Genetic Diagnosis
Similar to PGS, PGD is alsoused in parallel with an IVF treatment cycle. But PGD is a more enhanced process than PGS since it scans for individual genes. PGD isthe practice of evaluating embryos for specific genetic abnormalities, such as sickle cell disease or cystic fibrosis, where carrierstatus has been documented in each of the parents. By using this technique, physicians are able to check the genes or chromosomes fora specific genetic condition. PGD can decrease the risk of miscarriage and this technology can help women achieve a healthy pregnancy.Individuals who suspect or know they carry genes for serious medical conditions may opt to screen for healthy embryos ahead of time.
Surrogacy and Ancillary Caring Services
NewGenIvf also generatedrevenue from surrogacy services and related ancillary caring services in Kyrgyzstan. NewGenIvf conducts implantation of embryos frombiological parents in surrogate mothers. During the pregnancy period, NewGenIvf provides ancillary caring services including regularbody check and provision of vitamins, supplements and medicines to surrogate mothers. Revenue from surrogacy and ancillary caring servicesis recognized when the surrogate mother gives birth. Surrogacy services provide infertile couples with an alternative method of havingchildren. In general, NewGenIvf provides certain discount to clients if they wish to pursue additional services such as egg donationand surrogacy, after several cycles of IVF treatments failures due to medical reasons including, but not limited to, the poor egg qualityof aged female clients.
As compared to other countries,Kyrgyzstan has the following features that allow NewGenIvf to operates its surrogacy services: (i) surrogacy is legal and regulated,which means that there are less restrictions on either intended parents or surrogate mothers, and a parent-child relationship can berequested before the child’s birth; and (ii) the costs of operation and surrogate mother is favourable, given the cost ofliving in Kyrgyzstan is relatively low.
In addition to the regularsurrogacy services, NewGenIvf is also able to assist the clients with birth certificate applications and facilitate the application ofinfants’ passports and visas as supplemental services.
For the years endedDecember 31, 2023 and 2022, the revenue from NewGenIvf’s surrogacy and ancillary caring services was US$1,114,457 and US$3,125,027,respectively, representing 21.7% and 52.6% of its total revenue in the corresponding periods.
The flow chart below showsthe stages involved in a typical surrogacy process:
In Kyrgyzstan, NewGenIvfalso provides ancillary fertility services when carrying out surrogacy services. These ancillary fertility services include: (i) maternitycaring service, and (ii) documentation service.
Network of Facilities
As of December 31, 2023,NewGenIvf had one marketing and sales support office located in Hong Kong and three clinics located in Thailand, in Cambodia, andin Kyrgyzstan, respectively. The integration of the medical facilities in Thailand help NewGenIvf provide a more seamless one-stop experienceto its clients. Set out below is an illustration of the locations of NewGenIvf’s clinics and marketing and sales office:
The following table setsforth the approximate aggregate average gross floor area (“G.F.A.”) of each of NewGenIvf’s clinics that wereunder lease and actively used for client service as of December 31, 2023:
| | As of December 31, 2023 | |
| | (Square Feet) | |
Thailand | | | |
First Fertility PGS Center Co., Ltd. (“First Fertility PGS Center”) | | | 14,750 | |
| | | | |
Cambodia | | | | |
First Fertility Phnom Penh Center (“Phnom Penh Center”) | | | 18,567 | |
| | | | |
Kyrgyzstan | | | | |
First Fertility Bishkek Limited Liability Company (“First Fertility Bishkek”) | | | 2,368 | |
| | | | |
Aggregate G.F.A | | | 35,685 | |
To increase the scale ofNewGenIvf’s operations, NewGenIvf expanded its Thailand fertility services by leasing a new property for its second clinic ErawanConsultation Clinic in May 2023. Consisting of approximately 2,500 sq. ft., Erawan Consultation Clinic is expected to open in 2024.
Currently, IVF treatmentsare performed in its Thailand and Cambodia clinics, egg donation services are provided in its Cambodia clinic, and surrogacy servicesare provided in its Kyrgyzstan clinic. The following table summarises the services available at NewGenIvf’s clinics:
| | IVF Treatments | | Surrogacy Services |
Thailand | | | | |
First Fertility PGS Center | | √ | | × |
| | | | |
Cambodia | | | | |
Phnom Penh Center | | √ | | × |
| | | | |
Kyrgyzstan | | | | |
First Fertility Bishkek | | × | | √ |
The following table setsforth a breakdown of revenue from services performed at NewGenIvf’s medical centers for the periods indicated:
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | | | % | | | US$ | | | % | |
HK SAR | | | 34,038 | | | | 0.7 | | | | — | | | | — | |
Thailand | | | 1,356,903 | | | | 26.4 | | | | 505,609 | | | | 8.5 | |
Cambodia | | | 621,619 | | | | 12.1 | | | | 377,608 | | | | 6.4 | |
Kyrgyzstan | | | 3,123,593 | | | | 60.8 | | | | 5,060,973 | | | | 85.1 | |
Total Revenue | | | 5,136,153 | | | | 100.0 | | | | 5,944,190 | | | | 100.0 | |
Thailand Clinic
As of December 31, 2023,NewGenIvf had one clinic in Thailand. At the clinic in Thailand, NewGenIvf offers its clients customized fertility treatment solutionsincluding IVF/ICSI, embryo culture, hormonal blood tests, infectious diseases tests, chromosome screening by PGT, hysteroscopy, spermanalysis, sorting, washing and freezing, and egg freezing. Its medical and operational personnel are organized into specialized teamsaccording to the different stages of the IVF treatment process and different patient profiles. When clients are admitted, they are assignedto a team which NewGenIvf believes is better suited the clients after taking into account the clients’ diagnosis and preferences.Furthermore, NewGenIvf also provides related value-added services such as nutrition guidance, psychological counselling, acupuncture,and translation interpreters to supplement the IVF treatment. NewGenIvf prides itself on providing quality and customized treatment toits clients on a day-to-day basis.
As of December 31, 2023,the clinic in Thailand had six nurses, 8 full time lab physicians and embryologists, 14 administrative staff, totaling 28 staff members.
Cambodia Clinic
NewGenIvf has one clinic,Phnom Penh Center, in Cambodia. Phnom Penh Center is staffed with one Cambodian physician, three embryologists, five nurses and twelveother staff, and offers similar IVF treatments as in Thailand and egg donation services. Phnom Penh Center operates under a license issuedby Cambodia MOH for the Cambodian physician, who has entered into an agreement with Phnom Penh Center for the exclusive use of such license.
After eight years ofdevelopment since its opening in 2015, Phnom Penh Center has become one of the long-standing ARS providers in Cambodia. According toCIC, it was the first to use conventional IVF technology which led to a successful birth in 2016 in Cambodia. Since its establishment,Phnom Penh Center achieved more than 1,600 IVF treatment cycles as of December 31, 2023. As of December 31, 2023, Phnom Penh Center’sIVF philosophy concentrates on three key points in the treatment process: the mother’s wellbeing, the technology used to assistmothers deliver a strong and healthy baby and the medical science used to ensure every chance of success for women in various age spectrums.
Clinic in Kyrgyzstan
NewGenIvf established FirstFertility Bishkek in October 2019 in Kyrgyzstan for its surrogacy services, as Kyrgyzstan has supply of surrogate candidates ata relatively low cost and a more friendly legal environment for surrogacy services. In 2020, First Fertility Bishkek obtained the licenseto provide ARS and surrogacy services, becoming one of the few facilities licensed to offer ARS and one of the facilities licensed tooffer surrogacy services in Kyrgyzstan as of December 31, 2023, according to CIC. In addition, NewGenIvf also provide relatedancillary fertility services when carrying out surrogacy services. These ancillary fertility services include: (i) maternity caringservice, and (ii) documentation service.
Physicians at First FertilityBishkek have expertise in sourcing surrogate mothers, techniques of embryo transfers, prenatal care, baby delivery, and postnatal care.First Fertility Bishkek also collaborates closely with Phnom Penh Center in arranging shipment of frozen embryos. NewGenIvf hires localphysicians and local staff. NewGenIvf also provides training for newly admitted Kyrgyzstan physicians and embryologists in Thailand.Some personnel who had relevant experience in Kyrgyzstan had also been sent from Cambodia to Kyrgyzstan to help manage such operationsfrom time to time.
As of December 31, 2023,First Fertility Bishkek had one full-time physician, one embryologist, two nurses, and ten other staff.
Professionals
Licensed Physicians
As of December 31, 2023,NewGenIvf contracted with five licensed physicians, among which one was based in Cambodia and the other four were based in Thailand.Most of NewGenIvf’s physicians had over 10 years of experience or above. The following table summarises the number and typesof such licensed physicians as of December 31, 2023.
Country | | Licensed physician | | Licenses and Approvals | | Effective Period | | Issuing Authority |
Cambodia | | Mr. Keut Serey | | Decision on permission for beauty treatment operation | | December 14, 2022 – December 14, 2026 | | The Ministry of Health of Cambodia |
Thailand | | Dr Patsama Vichinsartvichai | | Medical Facility Operating License number 288006 | | August 12, 2022 – December 31, 2023 | | The Ministry of Health of Thailand |
| | | | Number 30920 Medical Practitioner License | | April 1, 2004 – Indefinite | | The Ministry of Health of Thailand |
| | | | Number 26443/2556 Reproductive Medicine Diploma | | July 1, 2013 – Indefinite | | Medical Council of Thailand |
| | | | Certificate number obscured OB-Gyn License | | October 13, 2010 – Indefinite | | Medical Council of Thailand |
Thailand | | Dr Keatthisak Boonsimma | | Number 31801 Medical Practitioner License | | April 1, 2005 – Indefinite | | Royal Thai College of Obstetricians and Gynaecologists of Thailand |
| | | | Number 22624/2554 OB-Gyn License | | July 1, 2014 – Indefinite | | Medical Council of Thailand |
| | | | Number 40962/2563 Reproductive Medicine Diploma | | July 1, 2020 – Indefinite | | Medical Council of Thailand |
Country | | Licensed physician | | Licenses and Approvals | | Effective Period | | Issuing Authority |
Thailand | | Dr Seree Teerapong | | Number 15231/2564 Reproductive Medicine License | | July 1, 2021 – Indefinite | | Medical Council of Thailand |
| | | | Number 4576/2533 OB-Gyn License | | July 12, 1990 – Indefinite | | Medical Council of Thailand |
| | | | Number 11544 (replacement) Medical Practitioner License | | April 12, 1984 – Indefinite | | Medical Council of Thailand |
Thailand | | Dr Wiphawee Luangtangvarodom | | Number 38347/2562 OB-Gyn License | | August 1, 2019 – Indefinite | | Medical Council of Thailand |
| | | | Number 43217/2564 Reproductive Medicine License | | July 1, 2021 – Indefinite | | Medical Council of Thailand |
| | | | Number 48510 Medical Practitioner License | | April 1, 2014 – Indefinite | | Medical Council of Thailand |
Agreements with Physicians
NewGenIvf enters into independentphysician agreements or employment contracts with its physicians. The terms and conditions and the format of the agreements NewGenIvfenters into with each of its physicians vary, depending on the physician’s seniority and practise nature.
Customers
For the years endedDecember 31, 2023 and 2022, the majority of NewGenIvf’s clients were from China (including mainland China and Hong Kong). Thenumber of Thai and Cambodian local patients generally increased in 2022 and 2023 compared with earlier years due to the impact of COVID-19on international travel. NewGenIvf enters into a service agreement with each of its customers that outline, among other things, the scopeof services, service fees, payment terms and rights, responsibilities and obligations of each party. Customers are not entitled to enjoythe relevant services until outstanding amounts have been settled pursuant to the relevant contract. Sales to individual consumers didnot vary significantly and none of the customers contribute more than 10% of NewGenIvf’s revenue for the years ended December 31,2023 and 2022.
The following table setsforth a breakdown of NewGenIvf’s total customers by major countries (determined by the passports they provided to NewGenIvf forregistration) and as a percentage of the total customers for the periods indicated(1):
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | First Fertility PGS Center | | | Phnom Penh Center | | | Total | | | % | | | First Fertility PGS Center | | | Phnom Penh Center | | | Total | | | % | |
China(2) | | | 34 | | | | 87 | | | | 121 | | | | 42 | | | | 66 | | | | 117 | | | | 183 | | | | 72 | |
India | | | 16 | | | | — | | | | 16 | | | | 6 | | | | 16 | | | | — | | | | 16 | | | | 6 | |
Thailand | | | 103 | | | | — | | | | 103 | | | | 36 | | | | 25 | | | | 3 | | | | 28 | | | | 11 | |
Cambodia | | | — | | | | 7 | | | | 7 | | | | 2 | | | | — | | | | 22 | | | | 22 | | | | 9 | |
Others(3) | | | 31 | | | | 9 | | | | 40 | | | | 14 | | | | — | | | | 5 | | | | 5 | | | | 2 | |
Total | | | 184 | | | | 103 | | | | 287 | | | | 100 | | | | 107 | | | | 147 | | | | 254 | | | | 100 | |
(1) | Customers of First Fertility Bishkek are the same customers of Phnom Penh Center. |
(2) | Include customers from mainland China and Hong Kong. |
(3) | Include customers from Philippines, Singapore, USA, Korea, Nigeria and UK. |
In addition to significantcustomers using NewGenIvf’s IVF treatment services and surrogacy and ancillary caring services, NewGenIvf also has customers whoonly use its relatively insignificant services, such as check-ups services, blood test services and other minor services (the latter categoryof customers are referred to as “consultation customers”).
Sales and Marketing
For the years endedDecember 31, 2023 and 2022, NewGenIvf promoted brand awareness through its sales teams and, in many cases, through cooperating withthird-party agencies and partners.
NewGenIvf’s sales teamshave broad experience in fertility services and are responsible for identifying potential clients and managing the overall sales process.NewGenIvf’s sales team primarily relies on social media marketing, word-of-mouth referrals, recognition of its brand, printed advertisementsand marketing events. NewGenIvf spends marketing expenses on placing advertisements through popular social media platforms, maintainingthe official website of NewGenIvf and sending information through its official accounts on social media platforms.
Supply and Procurement
NewGenIvf’s procurementis mainly for medications, laboratory media and reagents, laboratory consumables, and blood test reagents. As of December 31, 2023and 2022, one and four suppliers individually contributed more than 10% of the Group’s trade payable, in aggregate accounting for30.6% and 69.8% of the Group’s trade payables, respectively. For the year ended December 31, 2023 and 2022, nil and two vendorscontributed more than 10% of total purchases of the Group, in aggregate accounting for nil and 55.3% of the Group’s total purchases,respectively. NewGenIvf’s procurement team is experienced in selecting cost-effective supplies as well as selecting reliable suppliers.NewGenIvf’s major suppliers are pharmaceutical companies.
Competition
NewGenIvf believes that itis a long-standing provider of ARS in Asia Pacific that competes primarily based on the following competitive factors:
| ● | the value and comprehensivenessof the solutions; |
| ● | treatment that is effectiveand achieves desired outcomes; |
| ● | clients’ experience, includingdedicated patient education, clinical guidance and emotional support; and |
| ● | access to a network of high-qualityfertility specialists. |
NewGenIvf competes primarilywith other regional fertility service providers. While NewGenIvf does not believe any single competitor offers a comparably robust andintegrated fertility solution package as NewGenIvf in the regions that it operates, NewGenIvf’s competitors may compete in a varietyof ways, including by providing better services, having established local connections, fulfilling evolving client needs, as well as conductingbrand promotions and other marketing activities.
As NewGenIvf may introducenew ancillary services and other companies may introduce similar fertility services as NewGenIvf’s, NewGenIvf may become subjectto additional competition.
Facilities
As of December 31, 2023,in addition to its clinics, NewGenIvf leased one property in Hong Kong with an aggregate square footage of approximately 8,000 forits administration support offices. NewGenIvf also operates its medical facilities as described above in “— Network ofFacilities” above. NewGenIvf believes that its existing facilities are suitable and adequate to meet its current needs.
C. Organizational Structure
The following is a list ofour principal subsidiaries and consolidated affiliated entities as of the date of this prospectus:
Name | | Place of Formation | | Relationship |
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Legacy NewGenIvf | | Cayman Islands | | Wholly-owned subsidiary |
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FFPGS (HK) Ltd | | Hong Kong | | Indirect subsidiary, wholly owned by Legacy NewGenIvf |
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First Fertility Bishkek LLC | | Kyrgyzstan | | Indirect subsidiary, wholly owned by Legacy NewGenIvf |
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First Fertility PGS Center Limited | | Thailand | | Indirect subsidiary, wholly owned by Well Image Limited HK |
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First Fertility Phnom Penh Ltd | | Kingdom of Cambodia | | Indirect subsidiary, wholly owned by Legacy NewGenIvf |
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Med Holdings Limited | | Thailand | | Indirect subsidiary, wholly owned by Well Image Limited HK |
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Well Image Limited HK | | Hong Kong | | Indirect subsidiary, wholly owned by Legacy NewGenIvf |
D. Property, Plants and Equipment
The Company leases the premisesfor its principal executive office located at 36/39-36/40, 13th Floor, PS Tower, Sukhumvit 21 Road (Asoke) Khlong Toei Nuea Sub-district,Watthana District, Bangkok 10110, Thailand. This property contains approximately 14,750 square feet. The Company leases one property inHong Kong with an aggregate square footage of approximately 8,000 for its administration support offices.
The Company also leases severalpremises to operate its clinics in various countries. In Kyrgyzstan, the Company operates the First Fertility Bishkek Limited LiabilityCompany, which premises have an aggregate area of 2,368 square feet. In Cambodia, the Company operates the First Fertility Phnom PenhCenter, which premises have an aggregate area of 18,567 square feet. In Thailand, the Company operates a clinic named First FertilityPGS Center Co., Ltd., which premises have an aggregate area of 14,750 square feet.
The Company also leases premiseslocated in Thailand for its anticipated Erawan Consultation Clinic clinic, with an aggregate area of approximately 2,500 square feet.This property is used as the Company’s second clinic in Thailand, which is expected to open in 2024.
Implications of being a “Foreign PrivateIssuer”
We are subject to the informationreporting requirements of the Exchange Act that are applicable to “foreign private issuers,” and under those requirements,we file reports with the SEC. As a foreign private issuer, we are not subject to the same requirements that are imposed upon U.S. domesticissuers by the SEC. Under the Exchange Act, we are subject to reporting obligations that, in certain respects, are less detailed and lessfrequent than those of U.S. domestic reporting companies. For example, we are not required to issue quarterly reports, proxy statementsthat comply with the requirements applicable to U.S. domestic reporting companies or individual executive compensation information thatis as detailed as that required of U.S. domestic reporting companies. We also have four months after the end of each fiscal year to fileour annual report with the SEC and are not required to file current reports as frequently or promptly as U.S. domestic reporting companies.Our officers, directors and principal shareholders are exempt from the requirements to report transactions in our equity securities andfrom the short-swing profit liability provisions contained in Section 16 of the Exchange Act. As a foreign private issuer, we are notsubject to the requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act. In addition, as a foreign private issuer,we are permitted to follow certain home country corporate governance practices instead of those otherwise required under the rules ofNasdaq for domestic U.S. issuers and are not required to be compliant with all Nasdaq rules as of the date of our initial listing on Nasdaqas would domestic U.S. issuers. These exemptions and leniencies will reduce the frequency and scope of information and protections availableto you in comparison to those applicable to a U.S. domestic reporting company. We intend to take advantage of the exemptions availableto us as a foreign private issuer.
Summary of Risk Factors
Investing in our OrdinaryShares involves significant risks. You should carefully consider all of the information in this prospectus before making an investmentin our shares. Below please find a summary of the principal risks we face, organized under relevant headings. These risks are discussedmore fully in the section titled “Risk Factors” and in Part I, Item 3, D. Risk Factors in our most recent Annual Reporton Form 20-F.
Risks Related to NewGenIvf’s Businessand Industry
| ● | We may not be able to continue operating as a going concern. |
| | |
| ● | The fertility market in which NewGenIvf participates is competitive, and if NewGenIvf does not continue to compete effectively, its results of operations could be materially and adversely affected. |
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| ● | NewGenIvf has a limited operating history with its current platform of solutions, which makes it difficult to predict its future prospects, financial performance and results of operations. |
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| ● | NewGenIvf’s marketing efforts depend significantly on its ability to receive positive references from its existing clients. |
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| ● | If NewGenIvf is unable to attract new clients, its business, financial condition and results of operations would be adversely affected. |
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| ● | NewGenIvf’s business depends on its ability to maintain its existing client demographics. Any failure to do so would harm its business, financial condition and results of operations. |
| ● | If NewGenIvf fails to offer high-quality support, its reputation could suffer. |
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| ● | NewGenIvf’s failure to effectively develop and expand its marketing and sales capabilities could harm its ability to increase its client base and achieve broader market acceptance of solutions NewGenIvf provides. |
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| ● | NewGenIvf may experience net losses and may not sustain profitability in the future. |
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| ● | NewGenIvf’s future revenue may not grow at the rates it historically has, or at all. |
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| ● | NewGenIvf’s quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of NewGenIvf’s business. |
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| ● | If the estimates and assumptions NewGenIvf uses to determine the size of the target markets for its services are inaccurate, its future growth rate may be impacted and its business would be harmed. |
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| ● | NewGenIvf may not be able to successfully manage its growth, and if NewGenIvf is not able to grow efficiently, its business, financial condition and results of operations could be harmed. |
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| ● | If NewGenIvf’s new solutions and services are not adopted by its clients, or if it fails to innovate and develop new offerings that are adopted by its clients, its revenue and results of operations may be adversely affected. |
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| ● | If NewGenIvf fails to adapt and respond effectively to the changing medical landscape, changing regulations, changing client needs, requirements or preferences, its offerings may become less competitive. |
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| ● | If NewGenIvf fails to maintain and enhance its brand, its ability to expand its client base will be impaired and its business, financial condition and results of operations may suffer. |
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| ● | If NewGenIvf fails to retain and motivate members of its management team or other key employees, or fails to attract additional qualified personnel to support its operations, its business and future growth prospects could be harmed. |
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| ● | To successfully market and sell its services and products in Asia-Pacific markets, NewGenIvf must address many international business risks with which NewGenIvf has limited experience. |
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| ● | Ethical, legal and social concerns related to the use of assisted reproductive technology could reduce demand for the fertility services provided by the medical facilities in NewGenIvf’s network, and thus may adversely affect the business, financial conditions and results of operations of the medical facilities in its network. |
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| ● | NewGenIvf is reliant on revenue from international clients. |
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| ● | Fluctuations in exchange rates could have a material and adverse effect on NewGenIvf’s results of operations and the value of your investment. |
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| ● | Governmental control of currency conversion may limit NewGenIvf’s ability to utilize NewGenIvf’s net revenue effectively and affect the value of your investment. |
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| ● | Substantially all of NewGenIvf’s assets and operations are located in Thailand, Cambodia and Kyrgyzstan and they are subject to economic, legal and regulatory uncertainties in such countries. |
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| ● | Failure to comply with the terms of future financing arrangements could result in default, which could have an adverse effect on NewGenIvf’s cash flow and liquidity. |
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| ● | NewGenIvf requires a significant amount of capital to fund its operations and growth. If NewGenIvf cannot obtain sufficient capital on acceptable terms, its business, financial condition, and prospects may be materially and adversely affected. |
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| ● | The defects in certain leased property interests and failure to register certain lease agreements may materially and adversely affect NewGenIvf’s business, financial condition, results of operations, and prospects. |
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| ● | NewGenIvf currently has no insurance coverage for its operations. |
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| ● | NewGenIvf may not be successful in adapting to technological developments, which may affect its business and results of operations. |
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| ● | If its computer systems, or those of itsproviders, specialty pharmacies or other downstream vendors lag, fail or suffer security breaches, NewGenIvf may incur a material disruptionof its services, which could materially impact its business and the results of operations. |
Risks Related to NewGenIvf’s Relationships with Third Parties
| ● | NewGenIvf’s business depends on its ability to maintain its network of high-quality fertility specialists and other healthcare providers. If NewGenIvf is unable to do so, its future growth would be limited and its business, financial condition and results of operations would be harmed. |
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| ● | The medical facilities and professionals in NewGenIvf’s network could become the subject of litigation, allegations and other claims, and NewGenIvf is not insured against these liabilities. |
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| ● | The assisted reproductive medical facilities in NewGenIvf’s network have limited control over the quality of the pharmaceuticals, medical equipment, medical consumables and other supplies used in its operations, and cannot guarantee that the products in use are not defective or counterfeit. NewGenIvf also has no control over independent sub-contractors and cannot guarantee the services thereof. |
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| ● | If NewGenIvf loses its relationship with one or more key pharmaceutical manufacturers, its business and results of operations could be adversely affected. |
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| ● | NewGenIvf has engaged in transactions with related parties, and such transactions present potential conflicts of interest that could have an adverse effect on its business and results of operations. |
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| ● | NewGenIvf may be subject to claims and allegations relating to intellectual property and other causes. |
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| ● | Certain data and information in this prospectus relied on by NewGenIvf were obtained from third-party data and polls. These metrics were not independently verified by NewGenIvf and may not be accurate. |
Risks Related to Government Regulation
| ● | NewGenIvf operates in a highly regulated industry and must comply with a significant number of complex and evolving requirements. Any lack of requisite approvals, licenses, or permits applicable to NewGenIvf’s business may have a material and adverse impact on NewGenIvf’s business, financial condition, and results of operations. |
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| ● | Changes in NewGenIvf’s effective tax rate or tax liability may have an adverse effect on its results of operations. |
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| ● | NewGenIvf’s reported financial results may be adversely affected by changes in accounting principles generally accepted in relevant jurisdictions. |
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| ● | NewGenIvf’s reported financial results may be adversely affected by changes in accounting principles generally accepted in relevant jurisdictions. |
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| ● | If NewGenIvf’s estimates or judgments relating to its critical accounting policies prove to be incorrect, its results of operations could be adversely affected. |
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| ● | NewGenIvf is subject to anti-corruption,anti-bribery, anti-money laundering, and similar laws, and non-compliance with such laws can subject it to criminal or civil liabilityand harm its business, financial condition and results of operations. |
THE OFFERING
This prospectus relates tothe resale by the Selling Shareholders identified in this prospectus of up to 5,912,281 Ordinary Shares. All of the Ordinary Shares,when sold, will be sold by these Selling Shareholders. The Selling Shareholders may sell their Ordinary Shares from time to time at prevailingmarket prices. We will not receive any proceeds from the sale of the Ordinary Shares by the Selling Shareholders.
Ordinary Shares currently issued and outstanding | | 10,149,386 Class A Ordinary Shares |
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Ordinary Shares offered by the Selling Shareholders | | Up to 5,912,281 Class A Ordinary Shares |
| | |
Use of proceeds | | We will not receive any proceeds from the sale of the Ordinary Shares by the Selling Shareholders. All net proceeds from the sale of the Ordinary Shares covered by this prospectus will go to the Selling Shareholders (see “Use of Proceeds”). |
| | |
Risk factors | | You should read the “Risk Factors” section starting on page 20 of this prospectus for a discussion of factors to consider carefully before deciding to invest in our securities. |
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Nasdaq symbol | | “NIVF” (Class A Ordinary Shares); “NIVFW” (Warrants to purchase Class A Ordinary Shares). |
Thenumber of Class A Ordinary Shares issued and outstanding is 10,149,386 as of September 4,2024. No new Class A Ordinary Shares will be issued by us under this offering.
RISK FACTORS
Investing in our Class A OrdinaryShares involves a high degree of risk. You should carefully consider the risks described in Part I, Item 3,D. Risk Factors in our most recent Annual Report on Form 20-F, together with the other information set forth in this prospectus, and inthe other documents that we include or incorporate by reference into this prospectus, as updated by our Current Reports on Form 6-K andother filings we make with the SEC, the risk factors described under the caption “Risk Factors” in any applicable prospectussupplement and any risk factors set forth in our other filings with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the SecuritiesExchange Act of 1934, as amended, or the Exchange Act, before making a decision about investing in our Ordinary Shares. The risks anduncertainties we have described are not the only ones we face. Additional risks and uncertainties not presently known to us or that wecurrently deem immaterial may also affect our operations. If any risks actually occur, our business, financial condition and results ofoperations may be materially and adversely affected. In such an event, the trading price of our Ordinary Shares could decline and youcould lose part or all of your investment.
Additionally, we are alsosubject to the following risk factors.
Risks Related to NewGenIvf’s Businessand Industry
We may not be able to continue operatingas a going concern.
As of December 31, 2023,the Company had bank balance of $54,104 and may have challenge to settle its obligations when payment become due. The Company is alwaysclosely monitoring the market opportunities and is currently in the process of exercising various fundraising projects with various potentialinvestors to improve the Company's cash flow position for its operation and short-term payables.
One fundraising project wascompleted on April 3, 2024. As of April 4, 2024, the Company settled $2 million to any payment with respect to accounts payable, but not,directly or indirectly, for (i) except for expenses relating to the Business Combination, the satisfaction of any indebtedness of theCompany or any of its Subsidiaries, (ii) the redemption or repurchase of any securities of the Company or any of its Subsidiaries, or(iii) the settlement of any outstanding litigation as at December 31, 2023. The Company secured funding subsequent to year-end with totalof $2 million, and that the Company received $2 million funding to date.
The Company can make no assurancethat required financings will be available for the amounts needed, or on terms commercially acceptable to the Company, if at all. If oneor all of these events does not occur or subsequent capital raises are insufficient to bridge financial and liquidity shortfall, therewould likely be a material adverse effect on the Company and its financial statements.
The consolidated financialstatements do not reflect adjustments that would be necessary if the going concern basis was not appropriate. If the going concernbasis was not appropriate for these consolidated financial statements, then adjustments would be necessary in the carrying value of theassets and liabilities, the reported revenues and expenses, and the balance sheet classifications used. These adjustments could be material.
The fertility market in which NewGenIvfparticipates is competitive, and if NewGenIvf does not continue to compete effectively, its results of operations could be materiallyand adversely affected.
The market for NewGenIvf’ssolutions is competitive and is likely to attract increased competition, which could make it hard for it to succeed. NewGenIvf faces significantcompetition from other fertility companies and other players in the fertility market. Some of NewGenIvf’s competitors are more established,have a longer operating history and a larger client base, benefit from greater brand recognition and have substantially greater financial,technical and marketing resources than NewGenIvf does. NewGenIvf’s competitors may compete with NewGenIvf in a variety of ways,including seeking to develop or integrating solutions and services that may become more efficient or appealing to NewGenIvf’s existingand potential clients, achieving superior clinical outcomes, having access to a network of more high-quality fertility specialists, establishingmore comprehensive data reporting and sharing systems, conducting brand promotions and other marketing activities, and making investmentsin and acquisitions of NewGenIvf’s business partners. While NewGenIvf believes that one of its key competitive advantages is itsability to provide a broad range of services, and NewGenIvf does not believe any competitors have developed a similar broad range servicesin Asia Pacific at this time, current or future competitors may be successful in doing so in the future. If current or future competitorsare successful at developing a similar broad range of services, NewGenIvf’s financial performance may be negatively impacted.
In addition, NewGenIvf believesthat there is growing awareness of the demand for fertility services. As the fertility services field gains more attention, more competitorsmay be drawn into the market. NewGenIvf also could be adversely affected if NewGenIvf fails to identify or effectively respond to changesin market dynamics. As a result of any of these factors, NewGenIvf may not be able to continue to compete successfully against its currentor future competitors, and this competition could result in the decrease in its clients base and market share and the failure of its platformto continue to maintain market acceptance, which would materially and adversely affect its business, financial condition and results ofoperations.
NewGenIvf has a limited operating historywith its current platform of solutions, which makes it difficult to predict its future prospects, financial performance and results ofoperations.
The predecessor entity ofthe Company prior to the Business Combination in April of 2024, NewGenIvf Limited, a Cayman Islands exempted company, was establishedin 2019, and although it launched its fertility services in 2014, has a limited operating history. As a result of its limited operatinghistory with its current platform of solutions, as well as a limited amount of time serving a majority of its client base, its abilityto accurately forecast its future results of operations, key operating data, net revenue, cash flows, and operating margins is limitedand subject to a number of uncertainties, including its ability to plan for and model future growth. NewGenIvf’s historical revenuegrowth should not be considered indicative of its future performance. Further, in future periods, its revenue growth could slow or declinefor a number of reasons, including risks, challenges and uncertainties that NewGenIvf has encountered and may continue to encounter thatare frequently experienced by companies at an early stage, slowing demand for its solutions and fertility services in general, changesin utilization trends by its clients, general economic slowdown, an increase in unemployment, an increase in competition, changes to healthcare trends and regulations, changes to science relating to the fertility market, a decrease in the growth of the fertility market, orits failure, for any reason, to continue to take advantage of growth opportunities. If NewGenIvf’s assumptions regarding these risksand uncertainties and its future revenue growth are incorrect or change, or if it does not address these risks successfully, its operatingand financial results could differ materially from its expectations, and its business could suffer.
NewGenIvf’s marketing efforts dependsignificantly on its ability to receive positive references from its existing clients.
NewGenIvf’s marketingefforts depend significantly on its ability to call on its current clients to provide positive references to new, potential clients. Givenits limited number of long-term clients, the loss or dissatisfaction of any client could substantially harm its brand and reputation,inhibit the market adoption of its offering and impair its ability to attract new clients and maintain existing clients. Any of theseconsequences could have an adverse effect on its business, financial condition and results of operations.
If NewGenIvf is unable to attract new clients,its business, financial condition and results of operations would be adversely affected.
To increase its revenue,NewGenIvf must continue to attract new clients. NewGenIvf’s ability to do so depends in large part on the success of its sales andmarketing efforts, and the success of references through existing clients. Potential clients may seek out other options; therefore, NewGenIvfmust demonstrate that its solutions are valuable and superior to alternatives. If NewGenIvf fails to provide high-quality solutions andconvince clients of the benefits of its model and value proposition, NewGenIvf may not be able to attract new clients. If the marketsfor NewGenIvf’s solutions decline or grow more slowly than it expects, or if the number of clients that contract with it for itssolutions declines or fails to increase as it expects, its financial results could be harmed. As the markets in which NewGenIvf participatemature, fertility solutions and services evolve and competitors begin to enter into the market and introduce differentiated solutionsor services that are perceived to compete with its solutions, particularly if such competing solutions are adopted by its competitors,its ability to sell its solutions could be impaired. As a result of these and other factors, NewGenIvf may be unable to attract new clients,which would have an adverse effect on its business, financial condition and results of operations.
NewGenIvf’s business depends on itsability to maintain its existing client demographics. Any failure to do so would harm its business, financial condition and results ofoperations.
As part of its growth strategy,NewGenIvf is focused on maintaining its services within its existing client demographics. NewGenIvf mainly competes with mid-level privateclinics and hospitals, which have improved and developed their services and equipment over the years. In addition to private clinicsand hospitals already existing, foreign medical companies may also enter the markets where NewGenIvf operates. Such foreign medical companiesmay be well-placed to compete with NewGenIvf due to their larger network size, reputation as global players and access to more advancedtechnology and financial resources. The expansion of existing competitors in the industry may erode NewGenIvf’s existing marketshare or decrease its traditional client pool. There can be no assurance that NewGenIvf will be able to compete effectively and thereforeits future business growth may suffer.
A significant reduction in the utilizationof NewGenIvf’s solutions could have an adverse effect on its business, financial condition and results of operations.
A significant reduction inthe number of clients using NewGenIvf’s solutions could adversely affect its business, financial condition and results of operations.Factors that could contribute to a reduction in the use of its solutions include: general economic downturn that results in adverse financialconditions; regulatory changes; failure to adapt and respond effectively to changing medical landscape, changing regulations, changingclient needs, requirements or preferences; negative publicity, through social media or otherwise and news coverage.
If NewGenIvf fails to offer high-qualitysupport, its reputation could suffer.
NewGenIvf relies on its clientaccount management personnel and the patient navigators (the “PNs”) to resolve client issues and help clients realize thefull benefits that its solutions and services provide. High-quality support is also important for the renewal and expansion of its servicesto existing clients. The importance of its support functions will increase as NewGenIvf expands its business and pursue new clients. IfNewGenIvf does not help its clients quickly resolve issues and provide effective ongoing supports, its ability to maintain and expandits offerings to existing and new clients could suffer, and its reputation with existing or potential clients could suffer. Further, tothe extent that NewGenIvf is unsuccessful in hiring, training and retaining adequate PNs and client account management personnel, itsability to provide adequate and timely support to its clients would be negatively impacted, and its clients’ satisfaction with itssolutions and services would be adversely affected.
NewGenIvf’s failure to effectivelydevelop and expand its marketing and sales capabilities could harm its ability to increase its client base and achieve broader marketacceptance of solutions NewGenIvf provides.
NewGenIvf’s abilityto increase its client base and achieve broader market acceptance of solutions it provides will depend to a significant extent on itsability to expand its marketing and sales capabilities. NewGenIvf plans to continue expanding its direct sales force and to dedicate significantresources to sales and marketing programs, including direct sales, inside sales, targeted direct marketing, advertising, digital marketing,e-newsletter and conference sponsorships. All of these efforts will require it to invest significant financial and other resources. Itsbusiness and results of operations could be harmed if its sales and marketing efforts do not generate significant increases in revenue.NewGenIvf may not achieve anticipated revenue growth from expanding its sales and marketing efforts if it is unable to hire, develop,integrate and retain talented and effective sales personnel, if its new and existing sales personnel, on the whole, are unable to achievedesired productivity levels in a reasonable period of time, or if its sales and marketing programs are not effective.
NewGenIvf may experience net losses andmay not sustain profitability in the future.
NewGenIvf experienced significantrevenue decrease from 2019 to 2020, due to the impact of COVID-19. NewGenIvf is not certain whether it will obtain sufficient levels ofsales to sustain its growth or maintain profitability in the future. NewGenIvf also expects its costs and expenses to increase in futureperiods, which could negatively affect its future results of operations if its revenue does not increase accordingly. In particular, NewGenIvfintends to continue to incrementally expand its sales and client account management teams to educate potential clients and drive new clientadoption. NewGenIvf also expects to incur additional costs as it introduces new solutions and services to enhance its comprehensive fertilityoffering. NewGenIvf will also face increased compliance costs associated with growth, the expansion of its client base and being a publiccompany. NewGenIvf’s efforts to grow its business may be costlier than it expects, and NewGenIvf may not be able to increase itsrevenue enough to offset its increased operating expenses. NewGenIvf may incur significant losses in the future for a number of reasons,including the other risks described herein, and unforeseen expenses, difficulties, complications and delays, and other unknown events.If NewGenIvf is unable to sustain profitability, the value of its business and common stock may significantly decrease.
NewGenIvf’s future revenue may notgrow at the rates it historically has, or at all.
NewGenIvf has experiencedgrowth since its business operations started in 2014. Revenue and NewGenIvf’s client base may not grow at the same rates they historicallyhave, or they may decline in the future. NewGenIvf’s future growth will depend, in part, on its ability to:
| ● | continue to attract new clientsand/or maintain existing clients; |
| ● | price its solutions and serviceseffectively so that it is able to attract new clients, expand sales to its existing clients and maintain profitability; |
| ● | provide its clients with clientsupport that meets their needs, including through dedicated PNs; |
| ● | maintain successful collection of applicable receivable balances; |
| ● | retain and maintain relationships with high-quality and respected fertility specialists; |
| ● | attract and retain highly qualified personnel to support all clients; and |
| ● | increase awareness of its brand and successfully compete with other competitors. |
NewGenIvf may not successfullyaccomplish all or any of these objectives, which may affect its future revenue, and which makes it difficult for it to forecast its futureresults of operations. In addition, if the assumptions that NewGenIvf uses to plan its business are incorrect or change in reaction tochanges in its market, it may be difficult for it to maintain profitability. NewGenIvf’s shareholders should not rely on its revenuefor any prior quarterly or annual periods as any indication of its future revenue or revenue growth.
In addition, NewGenIvf expectsto continue to expend substantial financial and other resources on:
| ● | technology infrastructure, including systems architecture, scalability, availability, performance and security; and |
| ● | general administration, including increased legal and accounting expenses associated with being a public company. |
These investments may notresult in increased revenue growth in its business. If NewGenIvf is unable to increase its revenue at a rate sufficient to offset theexpected increase in its costs, its business, financial position, and results of operations will be harmed, and NewGenIvf may not be ableto maintain profitability over the long term. Additionally, NewGenIvf may encounter unforeseen operating expenses, difficulties, complications,delays and other unknown factors that may result in losses in future periods.
If its revenue growth doesnot meet its expectations in future periods, NewGenIvf may not maintain profitability in the future, its business, financial positionand results of operations may be harmed.
NewGenIvf’s quarterly and annual resultsmay fluctuate significantly and may not fully reflect the underlying performance of NewGenIvf’s business.
NewGenIvf’s quarterlyand annual results of operations, including the levels of NewGenIvf’s revenues, expenses, net (loss)/income and other key metrics,may vary significantly in the future due to a variety of factors, some of which are outside of NewGenIvf’s control, and period-to-periodcomparisons of NewGenIvf’s operating results may not be meaningful, especially given NewGenIvf’s limited operating history.Accordingly, the results for any one fiscal quarter or any one fiscal year are not necessarily an indication of future performance. Fluctuationsin quarterly and/or annual financial results may adversely affect the price of NewGenIvf’s ordinary shares. Factors that may causefluctuations in NewGenIvf’s quarterly and annual financial results include:
| ● | NewGenIvf’s ability toattract new customers and maintain relationships with existing customers; |
| ● | changes in NewGenIvf’sproducts and services offered and introduction of new services and products; |
| ● | the amount and timing of operatingexpenses related to marketing and the maintenance and expansion of NewGenIvf’s business, operations and infrastructure; |
| ● | general economic, industry andmarket conditions; and |
| ● | the timing of expenses relatedto the development or acquisition of technologies or businesses. |
If the estimates and assumptions NewGenIvfuses to determine the size of the target markets for its services are inaccurate, its future growth rate may be impacted and its businesswould be harmed.
Market opportunity estimatesand growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate.Market opportunity estimates and growth forecasts included in this prospectus, including those NewGenIvf has generated itself, are subjectto significant uncertainty and are based on assumptions and estimates that may not prove to be accurate, including the risks describedin this prospectus. Even if the markets in which NewGenIvf competes achieve the forecasted growth, its business could fail to grow atsimilar rates, if at all.
NewGenIvf’s estimatesof the market opportunity for its services are based on the assumption that the purpose-built, data-driven and disruptive fertility servicesplatform with the plan design NewGenIvf offers will be attractive to clients. Clients may pursue alternatives or may not see the valuein providing enhanced fertility-related services. In addition, NewGenIvf believes that it is expanding the size of the fertility marketas NewGenIvf enhances demand and increase awareness for fertility services. If these assumptions prove inaccurate, or if the increasein awareness of fertility services attracts potential competitors to the market and results in greater competition, NewGenIvf’sbusiness, financial condition and results of operations could be adversely affected.
It is difficult to predictthe demand for NewGenIvf’s solutions, the entry of competitive solutions or the future growth rate and size of the fertility market.The expansion of the fertility market depends on a number of factors, including, but not limited to: the continued trend of individualsstarting families later in life, increase in the number of single mothers by choice, adoption of non-traditional paths to parenthood andcontinued de-stigmatization of infertility.
If there is a reduction indemand caused by a lack of client acceptance, weakening economic conditions, data security or privacy concerns, governmental regulation,competing offerings or otherwise, the market for its solutions and services might not continue to develop or might develop more slowlythan NewGenIvf expects, which would adversely affect its business, financial condition and results of operations.
NewGenIvf may not be able to successfullymanage its growth, and if NewGenIvf is not able to grow efficiently, its business, financial condition and results of operations couldbe harmed.
As usage of its solutionsgrows, NewGenIvf will need to devote additional resources to improving and maintaining its infrastructure. In addition, NewGenIvf willneed to appropriately scale its internal business systems and its client account management and services personnel to serve its growingclient base. Any failure of or delay in these efforts could result in reduced client satisfaction, resulting in decreased sales to newclients and lower renewal and utilization rates by existing clients, which could hurt its revenue growth and its reputation. Even if NewGenIvfis successful in these efforts, they will require the dedication of management time and attention. NewGenIvf could also face inefficienciesor service disruptions as a result of its efforts to scale its internal infrastructure. NewGenIvf cannot be sure that the expansion andimprovements to its internal infrastructure will be effectively implemented on a timely basis, and such failures could harm its business,financial condition and results of operations.
If NewGenIvf’s new solutions and services are not adoptedby its clients, or if it fails to innovate and develop new offerings that are adopted by its clients, its revenue and results of operationsmay be adversely affected.
To date, NewGenIvf has deriveda substantial majority of its revenue from sales of its fertility services. As NewGenIvf operates in an evolving industry, its long-termresults of operations and continued growth will depend on its ability to successfully develop and market new successful solutions andservices to its clients. If its existing clients do not value and/or are not willing to make additional payments for such new solutionsor services, it could adversely affect its business, financial condition and results of operations. If NewGenIvf is unable to predictclients’ preferences, if the markets in which NewGenIvf participates change, including in response to government regulation, orif NewGenIvf is unable to modify its solutions and services on a timely basis, NewGenIvf may lose clients. Its results of operations wouldalso suffer if its innovations were not responsive to the needs of the clients, appropriately timed with market opportunity or effectivelybrought to market.
If NewGenIvf fails to adapt and respondeffectively to the changing medical landscape, changing regulations, changing client needs, requirements or preferences, its offeringsmay become less competitive.
The market in which NewGenIvfcompetes is subject to a changing medical landscape and changing regulations, as well as changing client needs, requirements and preferences.The success of its business will depend, in part, on its ability to adapt and respond effectively to these changes on a timely basis.NewGenIvf’s business strategy may not effectively respond to these changes, and NewGenIvf may fail to recognize and position itselfto capitalize upon market opportunities. NewGenIvf may not have sufficient advance notice and resources to develop and effectively implementan alternative strategy. There may be scientific or clinical changes that require it to change its solutions or that make its solutionsless competitive in the marketplace. If there are sensitivities to its model or its existing competitors and new entrants create new disruptivebusiness models and/or develop new solutions that clients prefer to its solutions, NewGenIvf may lose clients, and its results of operations,cash flows and/or prospects may be adversely affected. The future performance of NewGenIvf’s business will depend in large parton its ability to design and implement market appropriate strategic initiatives, some of which will occur over several years in adynamic industry. If these initiatives of NewGenIvf do not result in met objectives, NewGenIvf’s results of operations could beadversely affected.
If NewGenIvf fails to maintain and enhanceits brand, its ability to expand its client base will be impaired and its business, financial condition and results of operations maysuffer.
The growth of NewGenIvf’sbusiness partially depends on the recognition of NewGenIvf’s brand and reputation. NewGenIvf believes that maintaining and enhancingits brand is important to support the marketing and sale of its existing and future solutions to new clients and expand sales of its solutionsto existing clients. NewGenIvf also believes that the importance of brand recognition will increase as competition in its market increases.Successfully maintaining and enhancing its brand will depend largely on the effectiveness of its marketing efforts, its ability to providereliable services that continue to meet the needs of its clients at competitive prices, its ability to maintain its clients’ trust,its ability to continue to develop new solutions, and its ability to successfully differentiate its platform from competitive solutionsand services. NewGenIvf’s brand promotion activities may not generate client awareness or yield increased revenue, and even if theydo, any increased revenue may not offset the expenses NewGenIvf incurs in building its brand. If NewGenIvf fails to successfully promoteand maintain its brand, its business, financial condition and results of operations may suffer.
If NewGenIvf fails to retain and motivatemembers of its management team or other key employees, or fails to attract additional qualified personnel to support its operations, itsbusiness and future growth prospects could be harmed.
NewGenIvf’s successand future growth depend largely upon the continued services of its management team and its other key employees. From time to time, theremay be changes in its executive management team or other key employees resulting from the hiring or departure of these personnel. Itsexecutive officers and other key employees are employed on an at-will basis, which means that these personnel could terminate their employmentwith it at any time. The loss of one or more of its executive officers, or the failure by its executive team to effectively work withits employees and lead its company, could harm its business.
In addition, to execute itsgrowth plan, NewGenIvf must attract and retain highly qualified personnel. Competition for these personnel is intense, especially forexperienced medical officers and scientific staffs and sales and client account management personnel. There is no guarantee NewGenIvfwill be able to attract such personnel or that competition among potential employers will not result in increased salaries or other benefits.From time to time, NewGenIvf has experienced, and NewGenIvf expects to continue to experience, difficulty in hiring and retaining employeeswith appropriate qualifications. Many of the companies with which NewGenIvf competes for experienced personnel have greater resourcesthan NewGenIvf has. If NewGenIvf hires employees from competitors or other companies, their former employers may attempt to assert thatthese employees or NewGenIvf has breached their legal obligations, resulting in a diversion of its time and resources. In addition, prospectiveand existing employees often consider the value of the equity awards they receive in connection with their contribution to the company.If the perceived value of its equity awards declines, experiences significant volatility, or increases such that prospective employeesbelieve there is limited upside to the value of its equity awards, it may adversely affect its ability to recruit and retain key employees.If NewGenIvf fails to attract new personnel or fails to retain and motivate its current personnel, its business and future growth prospectscould be harmed.
Furthermore, in order toattract and retain key personnel and employees, the compensation amounts for NewGenIvf’s executive officers may change significantlyafter consummation of the Business Combination, although there are currently no agreements in place relating to any such post BusinessCombination compensation arrangements. As a result, NewGenIvf’s expenses associated with the compensation may increase, which mayalso have an adverse effect on its results of operations.
To successfully market and sell its servicesand products in Asia-Pacific markets, NewGenIvf must address many international business risks with which NewGenIvf has limited experience.
NewGenIvf’s businessis subject to risks in connection with changes in international, national and local economic and market conditions, including the effectsof global financial crises, effects of terrorist acts and war and global pandemics. Such economic changes could negatively impact infertilecouples’ abilities to pay for fertility treatments around the world.
NewGenIvf’s strategyis to increase its international presence in Asia-Pacific countries and its international sales are subject to a number of risks, including:
| ● | increased competition as a result of more products and procedures receiving regulatory approval or otherwise free to market in international markets; |
| ● | longer accounts receivable payment cycles and difficulties in collecting accounts receivable; |
| ● | reduced or varied protection for intellectual property rights in some countries; |
| ● | export restrictions, trade regulations, and foreign tax laws; |
| ● | fluctuations in currency exchange rates; |
| ● | foreign certification and regulatory clearance or approval requirements; |
| ● | customs clearance and shipping delays; |
| ● | political, social, and economic instability abroad, terrorist attacks, and security concerns in general; |
| ● | preference for locally provided services; |
| ● | potentially adverse tax consequences, including the complexities of foreign value-added tax systems; |
| ● | the burdens of complying with a wide variety of foreign laws and different legal standards; and |
| ● | increased financial accounting and reporting burdens and complexities. |
If one or more of these risksare realized, its business, financial condition and results of operations could be adversely affected.
Ethical, legal and social concerns relatedto the use of assisted reproductive technology could reduce demand for the fertility services provided by the medical facilities in NewGenIvf’snetwork, and thus may adversely affect the business, financial conditions and results of operations of the medical facilities in its network.
Patient sentiment and distrustof the use of assisted reproductive technology may lead to less demand for fertility services. Assisted reproductive technologies, includinggenetic testing, technologies used for surrogacy and egg donation and gender selection, have raised ethical, legal and social issues regardingprivacy and the appropriate uses of the resulting information. Government authorities could, for social or other purposes, limit or regulatethe use of assisted reproductive technology to certain conditions. Similarly, these concerns may lead patients to refuse to use, or physiciansto be reluctant to order, assisted reproductive services even if permissible. These and other ethical, legal and social concerns may limitmarket acceptance of fertility services or reduce patient demand for such services, either of which could have a material adverse effecton the business, financial condition and results of operations of the medical facilities in NewGenIvf’s network, and NewGenIvf itself.
NewGenIvf is reliant on revenue from internationalclients.
Fertility services revenuefrom international clients are an important part of NewGenIvf’s revenue, though NewGenIvf is expanding rapidly into the local markets.The number of international clients travelling to Thailand, Cambodia and Kyrgyzstan to seek fertility services may, however, be affectedby a number of factors, including the economic status of the foreign client’s country of origin, the relative exchange rate of theclient’s home currency to the relevant authorities, which may affect the cost of treatment, natural disasters, pandemics like COVID-19,and political tension or acts of terrorism in such countries and the region. For example, the COVID-19 has had resulted in a number ofcountries declaring a state of emergency and a number of countries, including the countries in Asian Pacific, imposing extensive travelrestrictions, which in turn caused a decrease in the numbers of internal clients traveling to Thailand, Cambodia or Kyrgyzstan for treatments.
These events could causea postponement or a reduction in the number of clients traveling to Thailand, Cambodia or Kyrgyzstan, and could in turn affect revenuesfrom international clients, which is the significant contributor in terms of volume. A decline in the medical tourism industry may havea material adverse effect on NewGenIvf’s financial condition and results of operations.
Fluctuations in exchange rates could havea material and adverse effect on NewGenIvf’s results of operations and the value of your investment.
NewGenIvf’s reportingcurrency is U.S. dollars. The functional currency of NewGenIvf and its subsidiaries include Hong Kong dollar (“HK$”),Thai baht (“THB”), Cambodian riel (“KHR”) and United States dollar (“USD”). Accordingly, fluctuationsin the value of HK$, THB and KHR relative to the USD could affect its results of operations due to translational remeasurements. As itsinternational operations expand, an increasing portion of its revenue and operating expenses may be denominated in non- HK$, THB or KHRcurrencies. Accordingly, NewGenIvf’s revenue and operating expenses will become increasingly subject to fluctuations due to changesin foreign currency exchange rates. If NewGenIvf is not able to successfully hedge against the risks associated with currency fluctuations,NewGenIvf’s business, financial condition and results of operations could be materially adversely affected.
Governmental control of currency conversionmay limit NewGenIvf’s ability to utilize NewGenIvf’s net revenue effectively and affect the value of your investment.
NewGenIvf’s revenueand expenses for its businesses are substantially denominated in THB, which are currently not freely convertible currencies. A portionof such revenue must be converted into other currencies in order to meet its foreign currency obligations. For example, NewGenIvf’ssubsidiaries will need to obtain foreign currency to make payments of declared dividends, if any, on its shares.
Under the existing foreignexchange regulations in Thailand, NewGenIvf will be able to make current account foreign exchange transactions. However, in the future,governments may take measures, at its discretion, to restrict access to foreign currencies for capital account and current account transactionsunder certain circumstances. If such measures are implemented, NewGenIvf may not be able to pay dividends in foreign currencies to holdersof its shares. Foreign exchange transactions under its capital account are subject to significant foreign exchange controls and requirecertain approvals. These limitations could affect our ability to obtain foreign exchange through offshore financing.
The value of the THB againstthe U.S. dollar and other currencies fluctuates, and is subject to changes resulting from policies of the Thailand and other governments,and depends to a large extent on domestic and international economic and political developments as well as supply and demand in the localmarket. For example, the Bank of Thailand, which is the central bank of Thailand, is responsible for formulating and implementing monetarypolicies in the country to maintain the price stability and promote economic stability and sustainable growth. The Bank of Thailand imposes(four) measures in preventing THB fluctuation. Those are measures to limit THB liquidity, to curb capital inflows, to limit the flowson Non-resident Bank Account and Non-resident Baht for Securities, and to limit the flows on Non-Deliverable Forward transactions. Withan increased floating range of the THB’s value against foreign currencies and a more market-oriented mechanism for determining themid-point exchange rates, the THB may further appreciate or depreciate significantly in value against the U.S. dollar or other foreigncurrencies in the long-term, depending on the fluctuation of the basket of currencies against which it is currently valued, or it maybe permitted to enter into a full float, which may also result in a significant appreciation or depreciation of the THB against the U.S. dollaror other foreign currencies. It cannot be assured that THB will not experience significant appreciation or depreciation against the U.S. dollaror other foreign currencies in the future.
Furthermore, NewGenIvf isalso currently required to obtain approvals before converting significant sums of foreign currencies into THB. All of these factors couldmaterially and adversely affect its business, results of operations, financial condition and prospects, and could reduce the value of,and dividends payable on, its shares in foreign currency terms.
Substantially all of NewGenIvf’s assetsand operations are located in Thailand, Cambodia and Kyrgyzstan and they are subject to economic, legal and regulatory uncertainties insuch countries.
Substantially all of NewGenIvf’soperations and assets are based in Thailand, Cambodia and Kyrgyzstan. As a result, its businesses and operations are subject to thechanging economic conditions prevailing from time to time in such countries. Since 2020, Thailand’s economy has been experiencinga slowdown. According to the National Economic and Social Development Board of Thailand (the “NESDB”) the GDP growth rateof Thailand declined to minus 6.1% in 2020 and slightly recovered to 1.6% in 2021 and 2.6% in 2022. Under such conditions, the NESDB projectedthat Thailand’s economy will only grow by 3.0% to 4.0% in 2023, lower than the previously growth in historical years.Meanwhile, Cambodia’s post-pandemic economic recovery has gained momentum, but remains uneven. Traditional growth drivers, especiallymanufacturing and agricultural commodities exports, have fully recovered. However, while travel and tourism have improved, the sectorremains well below pre-COVID-19 levels. The subsequent impact also caused the vendors and customers preference change, lower the willingnesstravelling to Kyrgyzstan for surrogacy services. The economy is projected to grow, underpinned by merchandise exports and domestic economicactivity. Foreign direct investment, while diversified, remains affected by China’s related COVID-19 policies.
NewGenIvf also derives asubstantial portion of its revenue from Chinese clients and as such, its maintenance of PRC-sourced revenues and access to new and existingclients from the PRC are also subject to the economic conditions of China. However, the near-term growth prospects of the PRC economyare unclear due to the uncertain effects of ongoing economic stress caused by policies to contain the COVID-19 pandemic, trade and nationalsecurity policies, and the elevated levels of private and public indebtedness, among others. According to the National Statistics Bureauof the PRC, growth rate of China’s GDP for the year 2022 slowed down to 3.0% on a year-on-year basis compared to the growth rateof approximately 8.4% for the year 2021. In the second quarter of 2023, China’s GDP grew only 0.8% on a quarter basis, a significantslowdown from the 2.2% quarter growth registered in the first quarter of 2023. A prolonged downturn in the PRC economy generally couldmaterially and adversely affect NewGenIvf’s results of operations.
Factors that may adverselyaffect the economy and conditions in such countries include:
| ● | political instability (e.g., Thailand’s national election in May 2023); |
| ● | global economic conditions; |
| ● | exchange rate fluctuations and the exchange control policy of the banks; |
| ● | a prolonged period of inflation or increase in regional interest rates; |
| ● | changes in government policies affecting import and export volumes; |
| ● | natural disasters, including tsunamis, earthquakes, fires, floods, drought and similar events; |
| ● | a potential recurrence or outbreak of avian influenza, severe acute respiratory syndrome or other infectious or contagious diseases like COVID-19 in Asian countries, and governmental policies to address such outbreak; |
| ● | scarcity of credit or other financing, resulting in lower demand for products and services provided by companies in the region; |
| ● | increases in oil prices and other commodity prices; |
| ● | decreased consumer confidence; |
| ● | other external recessions or potential economic downturns in the United States, Asia or other parts of the world; and |
| ● | other regulatory, political or economic developments in or affecting the countries. |
The economic conditions inThailand, Cambodia, Kyrgyzstan and China are also affected by global economic conditions. The global credit markets have experienced,and may continue to experience, volatility and liquidity disruptions, which have resulted in the consolidation, failure or near failureof a number of institutions in the banking and insurance industries. There remains a concern that a return of the debt crisis in Europe,the political unrest in the Middle East and Eastern Europe as well as rumors or threats or actual terrorist attacks or conflicts in theMiddle East, Southeast Asia, Eastern Europe or other regions will impinge upon the health of the global financial system. These or othersuch events could adversely affect NewGenIvf’s business, financial condition, results of operations and prospects.
There is no assurance thatthe economies and social conditions of Thailand, Cambodia, Kyrgyzstan and China will meet current projections or improve in the future.Any instability or economic downturn could have a material adverse effect on NewGenIvf’s business, financial condition, resultsof operations and prospects.
Failure to comply with the terms of futurefinancing arrangements could result in default, which could have an adverse effect on NewGenIvf’s cash flow and liquidity.
NewGenIvf may from time totime enter into credit facilities and debt financing arrangements containing financial and other covenants that could, among other things,restrict NewGenIvf’s business and operations. If NewGenIvf breaches any of these covenants, including the failure to maintain certainfinancial ratios, NewGenIvf’s lenders may be entitled to accelerate NewGenIvf’s debt obligations. Any default under the creditfacility could result in the repayment of these loans prior to maturity as well as the inability to obtain additional financing, whichin turn may have a material adverse effect on NewGenIvf’s cash flow and liquidity.
NewGenIvf requires a significant amountof capital to fund its operations and growth. If NewGenIvf cannot obtain sufficient capital on acceptable terms, its business, financialcondition, and prospects may be materially and adversely affected.
NewGenIvf requires a significantamount of capital and resources for its operations and continued growth. NewGenIvf expects to make significant investments to fund operations,laboratory upgrades, among other things, which may significantly increase NewGenIvf’s net cash used in operating activities. Inaddition, NewGenIvf will continue to invest in laboratory and facilities which are fundamental to NewGenIvf’s business operationand future growth. However, NewGenIvf cannot assure you that these investments will generate the optimal returns, if at all. To date,NewGenIvf has historically funded its cash requirements primarily through operational, capital contributions from its shareholders andshort-term or long-term borrowings. If these resources are insufficient to satisfy NewGenIvf’s cash requirements, NewGenIvf mayseek to raise funds through additional equity offering or debt financing or additional bank facilities. NewGenIvf’s ability to obtainadditional capital in the future, however, is subject to a number of uncertainties, including those relating to its future business development,financial condition, and results of operations, general market conditions for financing activities by companies in its industry, and macro-economicand other conditions in Thailand, Cambodia, Kyrgyzstan and globally. If NewGenIvf cannot obtain sufficient capital on acceptable termsto meet its capital needs, NewGenIvf may not be able to execute its growth strategies, and NewGenIvf’s business, financial condition,and prospects may be materially and adversely affected.
The defects in certain leased property interestsand failure to register certain lease agreements may materially and adversely affect NewGenIvf’s business, financial condition,results of operations, and prospects.
NewGenIvf leases premisesin Thailand, Cambodia and Kyrgyzstan in various locations. With respect to property leased by First Fertility PGS Center in Thailand,the lessors did not have or provide NewGenIvf with property ownership certificates or other documents evidencing their rights to leasesuch premises to First Fertility PGS Center. Therefore, NewGenIvf cannot assure that it will not be subject to any challenges, lawsuits,or other actions taken against First Fertility PGS Center with respect to its leased premises for which the relevant lessors do not havevalid title or right to lease. If First Fertility PGS Center’s lessors’ right to lease premises is successfully challengedby any third party, First Fertility PGS Center’s lease agreements may not be enforceable and NewGenIvf may be forced to vacate thepremises and relocate to a different location. Under such circumstances, NewGenIvf expects to incur relocation costs of up to THB3 millionand expects that there would not be material business interruption costs, if any.
In addition, the failureof the lessor to provide sufficient legal evidence of its right to lease the premises has prevented First Fertility PGS Center from registeringthe clinic with the Bangkok Metropolitan Authority (“BMA”) as required under the Public Health Act B.E. 2535 (1992) (the “PHA”).Under Section 71 of the PHA, First Fertility PGS Center and its directors are subject to imprisonment of up to 6 (six) months and a fineof up to THB50,000, or both. The BMA could also order First Fertility PGS Center to stop operating the clinic which would require relocationof the clinic if First Fertility PGS Center could not make the necessary registration. Under such circumstances, First Fertility PGS Centerexpects to incur relocation costs of up to THB3 million and expects that there would not be material business interruption costs, if any.
Only one of NewGenIvf’sdirectors or officers, namely Ms. Fong, Hei Yue Tina, is also a director of First Fertility PGS Center. NewGenIvf believes that if FirstFertility PGS Center’s directors, including Ms. Fong, are found guilty of the above offence and subject to imprisonment, theresulting impact on NewGenIvf’s business, results of operations and financial conditions would be limited, as Ms. Fong has limitedinvolvement in the day-to-day management of First Fertility PGS Center’s operations and Mr. Siu, Wing Fung Alfred and the otherdirectors and officers of NewGenIvf and its subsidiaries would be able to keep operating the group’s and First Fertility PGS Center’sactivities with limited disruptions.
In addition, NewGenIvf hasnot registered the lease agreements of First Fertility Bishkek in Kyrgyzstan with the relevant government authorities. The enforceabilityof the lease of property may therefore be subject to restrictions under relevant laws and regulations and NewGenIvf may be forced to vacatethe premises and relocate to a different premise. Under such circumstances, NewGenIvf expects to incur relocation costs of up to USD150,000and expects that there would not be material business interruption costs, if any. Meanwhile, First Fertility Bishkek may be required topay a penalty for the late registration of the lease agreement with a lease term of 3 or more years, the maximum amount of which is KGS3060($35).
NewGenIvf currently has no insurance coveragefor its operations.
The assisted reproductivemedical facilities in NewGenIvf’s network are exposed to potential liabilities that are inherent to the provision of services. Medicaland other liabilities may not be fully covered by insurance and the medical facilities may face claims in excess of the insurance coverageor claims which are not covered by insurance due to other policy limitations or exclusions or where the medical facilities in NewGenIvf’snetwork have failed to comply with the terms of the policy. Any uninsured risks may result in substantial costs and the diversion of resources,which could adversely affect its results of operations and financial condition.
The insurance industriesin Thailand, Cambodia and Kyrgyzstan are still at early stages of development, and insurance companies in Thailand, Cambodia and Kyrgyzstancurrently offer limited business-related insurance products. NewGenIvf does not currently maintain insurance. NewGenIvf cannot assureyou that the medical facilities in its network will be able to obtain and/or maintain medical liability insurance on acceptable termsor without substantial premium increases or at all in the future.
In addition, as NewGenIvf’sbusiness expands, the cost for each medical facility in its network and NewGenIvf to maintain an adequate level of insurance may becomeincreasingly high. NewGenIvf cannot ensure that the medical facilities in its network will be able to locate or purchase appropriate insuranceto cover the expanding operations in time, on commercially reasonable terms or at all. Any significant uninsured loss could have materialand adverse effects on the financial condition and results of operations of the medical facilities in NewGenIvf’s network, and thusmay affect its business, results of operations and financial condition.
Moreover, NewGenIvf doesnot currently maintain professional malpractice liability insurance for its physicians and nurses. As a result, NewGenIvf may be subjectto medical disputes and claims arising under relevant laws from time to time, which could cause substantial damage to NewGenIvf if notcovered by professional malpractice liability insurance. Any dispute with clients, or any legal proceeding involving the physicians ofthe medical facilities or medical professionals, regardless of its merit or eventual outcome, could result in significant legal costsand financial and/or reputational damages to the medical facilities and NewGenIvf and materially and adversely affect the business, financialcondition and results of operations of the medical facilities in NewGenIvf’s network, and further affect its business, financialcondition, results of operations and prospects.
NewGenIvf may not be successful in adaptingto technological developments, which may affect its business and results of operations.
It is possible that new technologiescould be developed or scientific advances made by NewGenIvf’s competitors, or elsewhere and licensed to NewGenIvf’s competitors,which cannot be replicated by NewGenIvf without significant capital expenditure or at all, or that replace or reduce the requirement forassisted reproductive services, ultrasound or specialized diagnostics. The consequences for NewGenIvf of the development of new technologiescould include lower or loss of revenues, loss of market position and reduced prospects of NewGenIvf.
If its computer systems, or those of itsproviders, specialty pharmacies or other downstream vendors lag, fail or suffer security breaches, NewGenIvf may incur a material disruptionof its services, which could materially impact its business and the results of operations.
NewGenIvf’s businessesin Thailand, Cambodia and Kyrgyzstan are increasingly dependent on critical, complex and interdependent information technology systemsto support business processes as well as internal and external communications. NewGenIvf’s success is therefore dependent in parton its ability to secure, integrate, develop, redesign and enhance its (or contract with vendors to provide) technology systems that supportits business strategy initiatives and processes in a compliant, secure, and cost and resource efficient manner. If NewGenIvf or its providers,specialty pharmacies or other downstream vendors have an issue with its or their respective technology systems, it may result in a disruptionto its operations or downstream disruption to its relationships with its clients or its selective network of high-quality fertility specialists.Additionally, if NewGenIvf chooses to insource any of the services currently handled by a third party, it may result in technologicalor operational disruptions.
In addition, despite theimplementation of security measures, its internal computer systems, and those of its provider clinics, specialty pharmacies or other downstreamvendors, are potentially vulnerable to damage from malicious intrusion, malware, computer viruses, unauthorized access, natural disasters,terrorism, war and telecommunication and electrical failures. While NewGenIvf is not aware that it has experienced any such system failure,accident or security breach to date, if such an event were to occur and cause interruptions in its operations, it could result in a materialdisruption to its ability to operate and deliver its solutions. In addition, to the extent that any disruption or security breach wereto result in a loss or inappropriate disclosure of confidential information, NewGenIvf could incur liability. See “— RisksRelated to Government Regulation — NewGenIvf operates in a highly regulated industry and must comply with a significantnumber of complex and evolving requirements. Any lack of requisite approvals, licenses, or permits applicable to NewGenIvf’s businessmay have a material and adverse impact on NewGenIvf’s business, financial condition, and results of operations — DataProtection and Breaches.”
Risks Related to NewGenIvf’s Relationships with Third Parties
NewGenIvf’s business depends on itsability to maintain its network of high-quality fertility specialists and other healthcare providers. If NewGenIvf is unable to do so,its future growth would be limited and its business, financial condition and results of operations would be harmed.
NewGenIvf’s performanceand success is dependent upon its continued ability to maintain a credentialed network of high-quality fertility specialists, includingits senior management team, other key employees, as well as research and development and operation maintenance personnel, many of whomare difficult to replace. Fertility specialists could refuse to contract, demand higher payments or take other actions that could resultin higher medical costs, less attractive service for its clients or difficulty meeting regulatory or accreditation requirements. Identifyinghigh-quality fertility specialists, credentialing and negotiating contracts with them and evaluating, monitoring and maintaining its network,requires significant time and resources. Competition in the healthcare industry for qualified employees is intense. NewGenIvf may needto offer higher compensation and other benefits in order to attract and retain key personnel in the future, which could increase NewGenIvf’scompensation expenses, including stock-based compensation. NewGenIvf’s continued ability to compete effectively depends on NewGenIvf’sability to attract new employees and to retain and motivate NewGenIvf’s existing employees. If NewGenIvf is not successful in maintainingits relationships with top fertility specialists, these fertility specialists may refuse to renew their contracts with it, and potentialcompetitors may be effective in onboarding these or other high-quality fertility specialists to create a similarly high-quality network.There may be additional shifts in the fertility specialty provider space as the fertility market matures, and high-quality fertility specialistsmay become more demanding in re-negotiating to remain in its network. Its ability to develop and maintain satisfactory relationships withhigh-quality fertility specialists also may be negatively impacted by other factors not associated with it, such as regulatory changesimpacting providers or consolidation activity among hospitals, physician groups and healthcare providers. In addition, certain organizationsof physicians, such as practice management companies (which group together physician practices for administrative efficiency), may changethe way in which healthcare providers do business with it and may compete directly with it, which could adversely affect its business,financial condition and results of operations. NewGenIvf intends to grant, and may continue to grant, options and other types of awards,which may result in increased share-based compensation expenses.
NewGenIvf’s Share IncentiveAward will allow NewGenIvf to enhance its ability to attract and retain exceptionally qualified individuals and agents and to encouragethem to acquire a proprietary interest in the company’s growth and performance. Competition for highly skilled personnel and agentsis often intense and NewGenIvf may incur significant costs or may not be successful in attracting, integrating, or retaining qualifiedpersonnel and agents to fulfill NewGenIvf’s current or future needs. NewGenIvf believes that the granting of share-based awardsis of significant importance to NewGenIvf’s ability to attract and retain agents, key personnel and employees, and NewGenIvf willcontinue to grant share-based awards in the future. As a result, NewGenIvf’s expenses associated with share-based compensation mayincrease, which may have an adverse effect on NewGenIvf’s results of operations.
Meanwhile, the retirementor loss of certain specialists, scientific staff or other key personnel, the activities of competitors, the introduction of a competingservice that is perceived to be superior to the services provided by NewGenIvf, or other events which impact NewGenIvf’s reputationcould adversely affect NewGenIvf’s relationships with fertility specialists. For example, one specialist who was previously engagedby NewGenIvf brought a lawsuit against NewGenIvf regarding disputed remuneration, which resulted in a settlement for NewGenIvf to compensatethe specialist with a sum of approximately US$98,000. Also, fertility specialists’ relationship with NewGenIvf could affect theirbehaviors in recommending NewGenIvf’s services or referring patients to NewGenIvf, which could in turn adversely impact the numberof patients treated by NewGenIvf and adversely impact on its financial performance, market position and prospects.
In addition, the perceivedvalue of NewGenIvf’s solutions and its reputation may be negatively impacted if the services provided by fertility specialists orother healthcare providers are not satisfactory to NewGenIvf’s clients, including as a result of error that could result in litigation.For example, if fertility specialist or other healthcare provider releases sensitive information of its clients, it could incur additionalexpenses and give rise to litigation against NewGenIvf. Any such issue with one of its providers may expose it to public scrutiny, adverselyaffect its brand and reputation, expose it to litigation or regulatory action, and otherwise make its operations vulnerable. Further,if its services result in less than favorable outcomes, this could cause it to fail to meet its contractually guaranteed specified servicemetrics, and NewGenIvf could be obligated to provide the client with a fee reduction or a second chance for free, depending on their contractterms. The failure to maintain its selective network of high-quality fertility specialists or the failure of those specialists to meetand exceed its clients’ expectation, may result in a loss of or inability to grow or maintain its client base, which could adverselyaffect its business, financial condition and results of operations.
The medical facilities and professionalsin NewGenIvf’s network could become the subject of litigation, allegations and other claims, and NewGenIvf is not insured againstthese liabilities.
NewGenIvf relies on the physiciansand other medical professionals of the assisted reproductive medical facilities in its network to make proper clinical decisions regardingthe diagnosis and treatment of clients. However, NewGenIvf does not have full and direct control over every step of clinical activitiesundertaken at each of the medical facilities. In addition, physicians and medical professionals outside NewGenIvf’s network mayintroduce patients to NewGenIvf and conduct medical treatments and/or procedures for such patients in NewGenIvf’s facilities. NewGenIvfenters into independent contractor agreements with such physicians and medical professionals and treats such patients as NewGenIvf’sown patients. As such, NewGenIvf will have to bear any liabilities arising from their medical treatments and/or procedures conducted inNewGenIvf’s facilities. Any incorrect clinical decision or malpractice on the part of physicians and other medical professionals(including those from outside of its network), or any failure by the medical facilities in its network to properly manage their clinicalactivities may result in unsatisfactory treatment outcomes, patient injury or even death, which could lead to disputes with patients and/ortheir families or the medical professionals, including those from outside its network. In its experience, moreover, clients of fertilitytreatments tend to be more demanding on the medical services received. In addition, the relevant laws governing medical disputes and claimsgrant claimants liberal rights in bringing claims against physicians and other medical professionals practicing in the jurisdiction. Asa result, the medical facilities in its network may be subject to medical disputes and claims arising under relevant laws, from time totime, which could generate substantial damages imposed on such facilities if not covered by professional liability insurance. Any disputewith its patients and/or their families or the medical professionals, including those from outside its network, or any legal proceedinginvolving the physicians of the medical facilities or medical professionals, including those from outside its network, regardless of itsmerit or eventual outcome, could result in significant legal costs and reputational damage to the medical facilities and materially andadversely affect the business, financial condition and results of operations of the medical facilities in its network, and further affectits business, financial condition and results of operations.
The assisted reproductive medical facilitiesin NewGenIvf’s network have limited control over the quality of the pharmaceuticals, medical equipment, medical consumables andother supplies used in its operations, and cannot guarantee that the products in use are not defective or counterfeit. NewGenIvf alsohas no control over independent sub-contractors and cannot guarantee the services thereof.
The assisted reproductivemedical facilities in NewGenIvf’s network procure a variety of pharmaceuticals, medical equipment, consumables and other suppliesin NewGenIvf’s operations from third-party suppliers. As the medical facilities in NewGenIvf’s network do not engage in thedirect manufacture of such supplies, NewGenIvf cannot assure you that such supplies are free of defects and meet relevant quality standardsor, in the case of imported supplies, verify the origin of such products. In addition, there may be counterfeit pharmaceutical productsmanufactured without proper licenses or approvals or fraudulently mislabeled with respect to their content or manufacturer in the pharmaceuticalmarkets. In some cases these products are very similar in appearance to the authentic products. The quality control checks and processesmay not be able to identify all counterfeit pharmaceutical products in the inventory. Any sale of such products by the medical facilitiesin NewGenIvf’s network, regardless of its knowledge as to their authenticity, may subject the medical facilities to administrativesanctions, civil claims, negative publicity or reputational damage. NewGenIvf cannot assure you that the medical facilities in our networkwill be able to successfully claim full indemnity from such manufacturers of counterfeit pharmaceutical products.
NewGenIvf also cannot assureyou that the medical facilities in our network will not encounter incidents relating to defective products, or that such incidents willnot materially and adversely affect our network of medical facilities. If the products provided by NewGenIvf’s suppliers are defective,of poor quality or are otherwise unsafe or ineffective, the medical facilities in NewGenIvf’s network could be subject to liabilityclaims, complaints or adverse publicity, any of which would materially and adversely affect its results of operations and reputation.NewGenIvf cannot assure you that the medical facilities in NewGenIvf’s network will find suitable replacement suppliers on commerciallyacceptable terms or at all.
The suppliers are also subjectto extensive laws, rules and regulations. If any suppliers violate applicable laws, rules and regulations, NewGenIvf’s reputationor procurement may be materially and adversely affected. In addition, the medical facilities in NewGenIvf’s network may be exposedto reputational damages or even liabilities for defective goods provided by the suppliers or negative publicity associated with any suppliers,and the business and results of operations of the medical facilities in NewGenIvf’s network and NewGenIvf could suffer as a result.
Independent sub-contractorsand/or agents that work with NewGenIvf are also subject to extensive laws, rules, and regulations. If any sub-contractor and/or agentviolates any applicable laws, rules, regulations or breaches any agreements, NewGenIvf’s reputation may be materially and adverselyaffected and NewGenIvf may be penalized by regulatory or other parties. In addition, NewgenIvf’s clients may engage Newgen’ssub-contractors and/or agents for ongoing services or additional services following the termination of contracts with NewGenIvf. NewGenIvfhas no control over the services provided by sub-contractors and cannot assure the quality of such services or ensure compliance withapplicable laws, rules and regulations. In addition, the services provided by independent sub-contractors may expose NewGenIvf to publicscrutiny, adversely affect its brand and reputation, expose it to litigation or regulatory action, and otherwise make its operations vulnerableif such independent sub-contractors fail to meet their contractual obligations or to comply with applicable laws or regulations.
If NewGenIvf loses its relationship withone or more key pharmaceutical manufacturers, its business and results of operations could be adversely affected.
NewGenIvf maintains contractualrelationships with select pharmaceutical manufacturers in Thailand, Cambodia and Kyrgyzstan. The consolidation of pharmaceutical manufacturers,the shortages of drugs provided by such manufacturers, the termination or material alteration of its contractual relationships, or itsfailure to renew such contracts could have a material adverse effect on its business and results of operations. Adoption of new laws,rules or regulations or changes in, or new interpretations of, existing laws, rules or regulations, relating to any of these programscould materially adversely affect its business and results of operations.
NewGenIvf has engaged in transactions withrelated parties, and such transactions present potential conflicts of interest that could have an adverse effect on its business and resultsof operations.
NewGenIvf has entered intoa number of transactions with related parties. NewGenIvf may in the future enter into additional transactions with its related parties.Interests of these related parties may not necessarily be aligned with NewGenIvf’s or The Company’s interests and the interestsof its other shareholders. For example, conflicts of interest may arise in connection with decisions regarding the transaction arrangementswhich may be less favorable to NewGenIvf than similar arrangements negotiated with unaffiliated third parties. Conflicts of interest mayalso arise in connection with the exercise of contractual remedies, such as the treatment of events of default. As a result, those relatedparty transactions, individually or in the aggregate, may have an adverse effect on NewGenIvf’s business and results of operations.
NewGenIvf may be subject to claims and allegationsrelating to intellectual property and other causes.
NewGenIvf may from time totime receive claims that NewGenIvf infringes on the intellectual property rights of others. Moreover, NewGenIvf may be subject to claimsby third parties who maintain that NewGenIvf’s service providers’ technology infringes third-party’s intellectual propertyrights. If NewGenIvf fails to successfully defend against such claim or does not prevail in such litigation, it could be required to modify,redesign or cease operating, pay monetary amounts as damages or enter into royalty or licensing arrangements with the valid intellectualproperty holders. Any royalty or licensing arrangements that NewGenIvf may seek in such circumstances may not be available to it on commerciallyreasonable terms or at all. Also, if NewGenIvf acquires technology licenses from third parties, NewGenIvf’s exposure to infringementactions may increase because NewGenIvf must rely upon these third parties to verify the origin and ownership of such technology. Thisexposure to liability could result in disruptions in NewGenIvf’s business that could materially and adversely affect NewGenIvf’sresults of operations.
Some of NewGenIvf’semployees may previously employed at other companies, including NewGenIvf’s competitors. NewGenIvf may hire additional personnelto expand its development team and technical support team as its business grows. To the extent these employees were involved in the developmentof content or technology similar to NewGenIvf’s at their former employers, NewGenIvf may become subject to claims that these employeesor NewGenIvf has appropriated these employees’ former employers’ proprietary information or intellectual properties. If NewGenIvffails to successfully defend such claims against itself, NewGenIvf may be exposed to liabilities which could have a material adverse effecton its business.
NewGenIvf is currently nota party to any material legal or administrative proceedings but may subject to legal or administrative actions for defamation, negligence,copyright and trademark infringement, unfair competition, breach of service terms, or other purported injuries resulting from the contentNewGenIvf provides or the nature of NewGenIvf’s services. Such legal and administrative actions, with or without merits, may beexpensive and time-consuming and may result in significant diversion of resources and management attention from NewGenIvf’s businessoperations. Furthermore, such legal or administrative actions may adversely affect NewGenIvf’s brand image and reputation.
Certain data and information in this prospectusrelied on by NewGenIvf were obtained from third-party data and polls. These metrics were not independently verified by NewGenIvf and maynot be accurate.
Certain numbers and informationin this prospectus were obtained and provided from numerous sources including management data, third-party data or numbers generally estimatedby calculating infertile couples, fertility tourism number, etc. to generally assess potential customer numbers in Asia-Pacific countries.
These metrics were not independentlyverified. Such databases, third-party information, and calculations may not accurately reflect actual statistics or numbers and NewGenIvfdoes not have access to specific rating numbers. Similarly, any statistical data in any third-party publications also include projectionsbased on a number of assumptions. If any one or more of the assumptions underlying the market data is later found to be incorrect, actualresults may differ from the projections based on these assumptions.
Risks Related to Government Regulation
NewGenIvf operates in a highly regulatedindustry and must comply with a significant number of complex and evolving requirements. Any lack of requisite approvals, licenses, orpermits applicable to NewGenIvf’s business may have a material and adverse impact on NewGenIvf’s business, financial condition,and results of operations.
The operations of NewGenIvfare subject to various laws, rules and regulations at the national, regional and local levels in Thailand, Cambodia, Kyrgyzstan and otherapplicable jurisdictions. Such laws and regulations mainly relate to (i) the licensing of local and foreign medical professionals,nursing professionals, medical technology professionals, pharmaceutical professions and other applicable licensing; (ii) the licensing,registration, and accreditation of medical facilities, laboratories, including but not limited to the licensing, registration, and accreditationof persons performing related activities; (iii) the privacy and security of confidential patient medical records; (iv) the corporatepractice of medicine; (v) healthcare fraud and abuse laws; (vi) the donation and transplantation of human cells, tissues andorgans; (vii) potential prohibition on surrogacy or providing intermediary assistance in surrogacy; and (viii) licensing andapproval of the accommodation provided as parts of the services.
NewGenIvf has attempted tostructure its operations to comply with laws, regulations and other requirements applicable to it directly and to its clients and vendors,but there can be no assurance that its operations will not be challenged or impacted by regulatory authorities or enforcement initiatives,or that the relevant authorities in each jurisdiction could impose higher standards or requirements, which NewGenIvf may have difficultyto adhere to, e.g. Medical Facilities Act B.E. 2541 (1998) and Protection of a Child Born by Medically Assisted Reproductive TechnologyAct B.E. 2558 (2015) for Thailand jurisdiction, Law on Reproduction Rights and on Guarantees of Their Realization of July 4,2015 No. 148, Law on status of medical worker of May 28, 2013 No. 81 and Temporary Regulation on Procedure of Licensing Private MedicalActivity approved by the resolution of government of April 4, 2017 No. 203 for Kyrgyz Republic. NewGenIvf in the future may becomeinvolved in governmental investigations, audits, reviews and assessments. Any determination by a court or agency that NewGenIvf’ssolutions or services violate, or cause its clients to violate, applicable laws, regulations or other requirements could subject it orits clients to civil, criminal, or administrative penalties. Such a determination also could require it to change or terminate portionsof its business, disqualify it from serving clients that do business with government entities, or cause it to refund some or all of itsservice fees or otherwise compensate its clients. In addition, failure to satisfy laws, regulations or other requirements could adverselyaffect demand for its solutions and could force it to expend significant capital, research and development and other resources to addressthe failure. Even an unsuccessful challenge by regulatory and other authorities or parties could be expensive and time-consuming, couldresult in loss of business, exposure to adverse publicity, and injury to its reputation and could adversely affect its ability to retainand attract clients. If NewGenIvf fails to comply with applicable laws, regulations and other requirements, its business, financial conditionand results of operations could be adversely affected. Such non-compliance could also require significant investment to address and mayprove costly. There are several additional state statutes, regulations, guidance and contractual provisions related to or impacting thehealthcare industry that may apply to its business activities directly or indirectly, including, but not limited to:
| ● | Licensing and Licensed Personnel. Many countries have licensure or registration requirements for entities acting as a medical services provider. The scope of these laws differs from country to country, and the application of such laws to the activities of fertility treatment is often unclear. Given the nature and scope of the solutions and services that NewGenIvf provides, it is required to maintain the License to Operate Medical Facility Business (Sor.Por.7), the License to Manage Medical Facility Business (Sor.Por.19), License to Certify the Standard of Service relating to Medically Assisted Reproductive Technology (KorThorPhor.9), and personnel licenses, i.e., license of medical professionals, nursing professionals, medical technology professionals, pharmaceutical professions and other applicable licenses in Thailand, Approval on Opening of Medical Clinic, Approval on Opening of Pharmacy and relevant approvals to conduct IVF, embryo implant and/or transfer activities issued by the Ministry of Health of Cambodia (“Cambodia MOH”) in Cambodia and licenses to carry out private medical activities (including diagnostics and treatment gynecological diseases, supervision of pregnant women before childbirth, IVF in outpatient and day hospital conditions (for four (4) beds)) in Kyrgyzstan, respectively, and to ensure that such licenses and registrations are in good standing on an annual basis. NewGenIvf is licensed, has licensure applications pending before appropriate regulatory bodies, is exempt from licensure or registration, or is otherwise authorized under such laws in those countries in which it provides its services. These licenses require it to comply with the rules and regulations of the governmental bodies that issued such licenses. NewGenIvf’s failure to comply with such rules and regulations could result in criminal and/ or administrative penalties, the suspension of a license, or the loss of a license, all of which could negatively impact its business. First Fertility PGS had provided arrangements of accommodation without additional charges for its patients without a tourism license in Thailand, all of which was subsequently ceased in early 2023. Pursuant to the Tourism Business and Guide Act 2551 (2008) of Thailand, a maximum fine of THB500,000 may be imposed on First Fertility PGS as a result of the above activity without a tourism license in Thailand. NewGenIvf is unable to predict, however, how its services may be viewed by regulators over time, how these laws and regulations will be interpreted, or the full extent of their applicable. If a regulatory authority in any country determines that the nature of its business requires that NewGenIvf be licensed under applicable laws, it may need to restructure its business or it may need to comply with any related requirements, such as obtaining relevant license, paying additional regulatory fees and/or penalties for previous non-compliance with relevant licensing requirements, which could adversely affect its results of operation. Additionally, in extreme case, NewGenIvf may need to cease operations until it is able to obtain appropriate licensure, which may adversely affect its revenue for a period of time that it cannot estimate. |
| ● | Patients’ Right Protection. There has been an increased awareness of patients’ rights in Thailand, Cambodia and Kyrgyzstan, especially with the issuance of the Constitution of the Kingdom of Thailand, the Act on Court Proceedings for Consumer Cases B.E. 2551 (2008) (as amended), National Health Act B.E. 2550 (2007), and other applicable laws in Thailand, the Civil Code dated December 8, 2017 as amended by the Law on Implementation of the Civil Code dated May 31, 2011, Law on Management of Donation and Transplantation of Human Cells, Tissues, and Organs (2016) and Sub-Decree No. 61 on the Code of Medical Ethics (2003) in Cambodia and Constitution of Kyrgyzstan of May 5, 2021, Civil Code, Part I of May 8, 1996 No. 15, Law on Health Protection of Civilians of Kyrgyzstan of January 9, 2005 No. 6, Law on Reproduction Rights and on Guarantees of their Realization of July 4, 2015 No. 148, Law on status of medical worker of May 28, 2013 No. 81 and other relevant applicable laws in Kyrgyzstan, which enables consumers and patients to file suits more easily against healthcare service providers. Furthermore, treatment of more complex medical conditions has no guaranteed positive outcome, which subjects it to an increased likelihood of medical malpractice suits. Such lawsuits could result in hefty compensation payments or damage to NewGenIvf’s reputation, which may have a material adverse effect on its business, financial condition, results of operations and prospects. |
Meanwhile, Thailand is considering enactinga Patient Protection Bill (the “Bill”). The Bill, if issued, is intended to alleviate disputes between patients andhealthcare providers, which have an impact on the healthcare system in Thailand as a whole. The compensation outlined in the Bill willassist patients in claiming damages, thereby fostering a positive relationship between patients and healthcare providers. Consequently,the rate of disputes is expected to decrease. The provisions under the Bill would require healthcare providers to compensate patientsin a timely manner, sometimes without requiring proof of wrongdoing. The Bill also contemplates setting up a patient protection fund fordamages to patients pursuant to which healthcare providers have to make mandatory contributions according to the rules determined by apatient protection committee. Failure by it to comply with applicable rules and regulations could result in penalties, the loss of regulatorypermits and damage to NewGenIvf’s business reputation, each of which could have a material adverse effect on its financial conditionand results of operations.
Furthermore, the Protection of A ChildBorn By Medically Assisted Reproductive Technology Act B.E. 2558 (2015) of Thailand was promulgated with the intention to appropriatelydesignate the legitimate parenthood status of a child born using medically assisted reproductive technology and regulate any medical scientificresearch on embryology and medically assisted reproductive technologies to prevent the misuse of medically assisted reproductive technologies.NewGenIvf is therefore under the supervision of a Committee of the Protection for Children Born through Medically Assisted ReproductiveTechnology, which is a committee established to control, inspect, supervise and formulate various policies relating to such acts. In Cambodiaand Kyrgyzstan, all health establishments, including private medical clinics, are under the supervision of the Cambodia MOH and the Ministryof Health of Kyrgyzstan, respectively, which each governs and regulates the operation of medical clinics and activities of medical practitionersin respective countries. In particular, the Medical Council of Cambodia, Cambodian Council of Nurses, Cambodian Midwives Council and thePharmaceutical Council of Cambodia, all assist the Cambodia MOH to supervise and monitor the practice of health professionals in Cambodia.IVF/embryo implant/transfer activities are subject to an approval by the Cambodia MOH.
| ● | Privacy and Security Requirements. There are numerous laws and regulations related to the privacy and security of health information in each country. In particular, regulations promulgated pursuant to the Personal Data Protection Act B.E. 2562 (2019) of Thailand (“PDPA”), Law on Data of Personal Character of April 14, 2008 No. 58 of Kyrgyzstan (“Data Protection Law”), as well as Regulation of Registration of Personal Data Holders (Owners) approved by the Resolution of the Cabinet of Ministers of KR of November 18, 2022, Offences Code No. 128 of October 28, 2021 of Kyrgyzstan establish privacy and security standards in each country that limit the collection, use, and/ or disclosure of certain individually identifiable health information, whether directly or indirectly (excluding the information of the deceased person) and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronic protected health information. The privacy regulations established under the PDPA and Data Protection Law also provide patients with rights related to understanding and controlling how their protected health information is collected, used and/ or disclosed. As a provider of services to entities subject to the PDPA and Data Protection Law, NewGenIvf is directly subject to certain provisions of the regulations. To the extent permitted by applicable privacy regulations and contracts with its clients, NewGenIvf is permitted to use and disclose protected health information to perform its services and for other limited purposes, but other uses and disclosures, such as marketing communications, require written authorization from the patient or must meet an exception specified under the privacy regulations. |
NewGenIvf also has downstream entitieswhich provide it with services and are also subject to applicable regulations. If NewGenIvf or any of its downstream entities are unableto properly protect the privacy and security of protected health information entrusted to it, it could be found to have breached its contractswith its clients and be subject to investigation by the relevant supervision institution, i.e., the Office of the Personal Data ProtectionCommittee of Thailand (the Government Authority under the PDPA), the Cambodia MOH and the State Data Protection Agency under the Cabinetof Ministers of Kyrgyzstan (the “Agency”). In the event the Office of the Personal Data Protection Committee or the Agencyfinds that NewGenIvf has failed to comply with applicable privacy and security standards, it could face civil, criminal, and/ or administrativepenalties. In addition, the Office of the Personal Data Protection Committee performs compliance audits in order to proactively enforcethe privacy and security standards. The Office of the Personal Data Protection Committee has become an increasingly active regulator andhas signaled its intention to continue this trend. The Office of the Personal Data Protection Committee has the discretion to impose penaltiesand may require companies to enter into resolution agreements and corrective action plans which impose ongoing compliance requirements.The Office of the Personal Data Protection Committee’s enforcement activity, or audit related to incident regarding it or its downstreamentity, can result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internalresources. Although NewGenIvf has implemented and maintain policies, processes and compliance program infrastructure to assist it in complyingwith these laws and regulations and its contractual obligations, NewGenIvf cannot provide assurance regarding how these laws and regulationswill be interpreted, enforced or applied to its operations. In associated with enforcement activities and potential contractual liabilities,its ongoing efforts to comply with evolving laws and regulations might also require it to make costly system purchases and/or modificationsor otherwise divert significant resources to compliance initiatives from time to time.
| ● | Other Privacy and Security Requirements. In addition, numerous other laws govern the collection, dissemination, use, access to and confidentiality of personal information. For example, the Law on E-Commerce of Cambodia (2019) places an obligation on those who electronically store private information to use all means to ensure that the information is protected by security safeguards in every reasonable circumstance to avoid the loss, access, use, modification, leakage, or disclosure of the information, except with the consent of the data owner or other lawfully authorized party. The Law on E-Commerce also prohibits individuals from dishonestly accessing, downloading, copying, extracting, leaking, deleting, modifying, or otherwise interfering with data stored by other persons. Applicable laws are contributing to increased enforcement activity and may also be subject to interpretation by various courts and other governmental authorities. |
Certain of NewGenIvf’s solutionsand services involve the transmission and storage of client data in various jurisdictions, which subjects the operation of those solutionsand services to privacy or data protection laws and regulations in those jurisdictions. While NewGenIvf believes those solutions and servicescomply with current regulatory and security requirements in the jurisdictions in which it provides these solutions and services, therecan be no assurance that such requirements will not change or that it will not otherwise be subject to legal or regulatory actions. Thelaws and regulations are rapidly evolving and changing, and could have an adverse impact on its operations. These laws and regulationsare subject to uncertainty in how they may be interpreted and enforced by government authorities and regulators. The costs of compliancewith, and the other burdens imposed by, these and other laws or regulatory actions may increase its operational costs, prevent it fromproviding its solutions, and/or impact its ability to invest in or jointly develop its solutions. NewGenIvf also may face audits or investigationsby one or more government agencies relating to its compliance with these laws and regulations.
An adverse outcome under any such investigationor audit could result in fines, penalties, other liability, or could result in adverse publicity or a loss of reputation, and adverselyaffect NewGenIvf’s business. Any failure or perceived failure by it or by NewGenIvf’s solutions to comply with these lawsand regulations may subject it to legal or regulatory actions, damage its reputation or adversely affect its ability to provide its solutionsin the jurisdiction that has enacted the applicable law or regulation. Moreover, if these laws and regulations change, or are interpretedand applied in a manner that is inconsistent with its policies and processes or the operation of its solutions NewGenIvf may need to expendresources in order to change its business operations, policies and processes or the manner in which it provides its solutions. This couldadversely affect NewGenIvf’s business, financial condition and results of operations.
| ● | Data Protection and Breaches. In recent years, there have been a number of well-publicized data breaches involving the improper dissemination of personal information of individuals both within and outside of the healthcare industry. Pursuant to the applicable data protection law of Thailand, the PDPA requires businesses to notify the data subjects and/or the government authorities upon the occurrence of a data breach. The laws are not consistent, and compliance in the event of a widespread data breach is costly. Each country also constantly amending existing laws, requiring attention to frequently changing regulatory requirements. Most countries require holders of personal information to maintain safeguards and take certain actions in response to a data breach, such as providing prompt notification of the breach to affected individuals. In some countries, these laws are limited to electronic data, but they increasingly are enacting or considering stricter and broader requirements. |
Despite NewGenIvf’s security managementefforts with respect to physical and technological safeguards, employee training, vendor (and sub-vendor) controls and contractual relationships,its infrastructure, data or other operation centers and systems used in its business operations, including the internet and related systemsof its vendors (including vendors to whom NewGenIvf outsources data hosting, storage and processing functions) are vulnerable to, andmay from time to time experience, unauthorized access to data and/or breaches of confidential information due to a variety of causes.Techniques used to obtain unauthorized access to or compromise systems change frequently, are becoming increasingly sophisticated andcomplex, and are often not detected until after an incident has occurred. As a result, NewGenIvf might not be able to anticipate thesetechniques, implement adequate preventive measures, or immediately detect a potential compromise. If its security measures, some of whichare managed by third parties, or the security measures of its service providers or vendors, are breached or fail, it is possible thatunauthorized or illegal access to or acquisition, disclosure, use or processing of personal information, confidential information, orother sensitive client or employee data, including protected health information, may occur. A security breach or failure could resultfrom a variety of circumstances and events, including third-party action, human negligence or error, malfeasance, employee theft or misuse,phishing and other social engineering schemes, computer viruses, attacks by computer hackers, failures during the process of upgradingor replacing software, databases or components thereof, power outages, hardware failures, telecommunication failures, and catastrophicevents. If NewGenIvf’s security measures, or those of its service providers or vendors, were to be breached or fail, its reputationcould be severely damaged, adversely affecting client or investor confidence. As a result, clients may curtail their use of or stop usingits offering and its business may suffer. In addition, NewGenIvf could face litigation, damages for contract breach, penalties and regulatoryactions for violation of laws or regulations applicable to data protection and significant costs for remediation and for measures to preventfuture occurrences. In addition, any potential security breach could result in increased costs associated with liability for stolen assetsor information, repairing system damage that may have been caused by such breaches, incentives offered to clients or other business partnersin an effort to maintain the business relationships after a breach and implementing measures to prevent future occurrences, includingorganizational changes, deploying additional personnel and protection technologies, training employees and engaging third-party expertsand consultants. Negative publicity may also result from real, threatened or perceived security breaches affecting it or its industryor clients, which could cause it to lose clients or partners and adversely affect its operations and future prospects. NewGenIvf may notcarry insurance or maintain coverage sufficient to compensate for all liability and such insurance may not be available for renewal onacceptable terms or at all, and in any event, insurance coverage would not address the reputational damage that could result from a securityincident.
| ● | Fraud and Abuse Laws. NewGenIvf may be impacted directly and indirectly by certain fraud and abuse laws, including the Act Supplementing the Constitution Relating to the Prevention and Suppression of Corruption B.E. 2561 (2018) of Thailand, the Penal Code of Thailand, the Criminal Code of Cambodia, the Offences Code of October 28, 2021 No. 128 of Kyrgyzstan, the Criminal Code of October 28, 2021, No. 17 of Kyrgyzstan and the Law on prevention of corruption of August 8, 2021 No. 153 of Kyrgyzstan. Because the solutions and services NewGenIvf provides are not reimbursed by government healthcare payors, such fraud and abuse laws generally do not directly apply to its business, however, some laws may be applicable. The laws, regulations and other requirements in this area are both broad and vague and judicial interpretation can also be inconsistent. NewGenIvf reviews its practices with regulatory experts in an effort to comply with all applicable laws, regulatory and other requirements. However, NewGenIvf is unable to predict how these laws, regulations and other requirements will be interpreted or the full extent of their application, particularly to services that are not directly reimbursed by healthcare programs. Any determination by a regulatory authority that any of NewGenIvf’s activities or those of its clients or vendors violate any of these laws or regulations could subject NewGenIvf to civil or criminal penalties, require it to enter into corporate integrity agreements or similar agreements with ongoing compliance obligations, disqualify it from providing services to clients and/or have an adverse impact on its business, financial condition and results of operations. Even an unsuccessful challenge by a regulatory authority of NewGenIvf’s activities could result in adverse publicity and could require a costly response from it. |
| ● | Consumer Protection Laws. Consumer protection laws are being applied increasingly by the Office of the Consumer Protection Board in Thailand and by the Cambodia Ministry of Health to regulate the collection, use, storage and disclosure of personal or health information, through websites or otherwise, and, in Cambodia, by the Consumer Protection Competition and Fraud Repression Directorate-General, to regulate the presentation of website content. Courts may also adopt the standards for fair information practices, which concern consumer notice, choice, security and access. |
| ● | Restrictions on Communication. Communications with NewGenIvf’s clients increasingly may be subject to and restricted by laws and regulations governing communications via telephone, fax, text, and email. NewGenIvf also uses email and social media platforms as marketing tools. For example, NewGenIvf maintains social media accounts. As laws and regulations rapidly evolve to govern the use of these platforms and devices, the failure by it, its employees or third parties acting at its direction to abide by applicable laws and regulations in the use of these platforms and devices could adversely impact its business, financial condition and results of operations or subject it to fines or other penalties. |
| ● | Advertisement Laws. NewGenIvf’s advertisement and announcements, in particular, the messages releasing on the Internet related to medical facilities may subject to the laws and regulations of relevant jurisdictions (and potential prohibition in Cambodia on commercial advertisement of private medical services). |
For example, in Thailand, NewGenIvfshall apply for and obtain the approval and/ or pre-approval from the relevant authority for the images, and text used in advertisementsor announcements which shall be in accordance with the Medical Facility Act B.E. 2541 (1998) (and its amendments) and the Notificationof the Department of Health Services Support on Rules, Procedures, Conditions, and Costs of Advertisements or Announcements of HealthcareFacilities B.E. 2562 (2019) (and its amendments) and the Operational Manual for Approval of Advertisements or Announcements relatingto Healthcare Facilities. If such approval was not obtained by NewGenIvf, it could lead to significant liabilities and consequences, whichcould adversely impact NewGenIvf’s business, financial condition and results of operations or subject its sales and marketing directorto personal liabilities.
For Cambodia, Prakas 028 on Advertisementof Private Medical, Paramedical and Medical Aid Practices dated August 23, 2004 issued by the Cambodia MOH prohibits commercial advertisingof private medical services. Advertisement of private health care services is only allowed for any advertisements within the professionalframework not affecting the ethics of private medical services and such advertisement requires a permit from the Cambodia MOH. Inaddition, the Royal Government of Cambodia has recently issued Sub-Decree 232 on the Management of Commercial Advertisements of Goodsand Services on November 4, 2022 to provide the legal framework for the management of commercial advertising of goods and servicesfor all types, forms and means in Cambodia. In light of this Sub-Decree, in addition to the permit requirement of the Cambodia MOH, aperson wishing to advertise their goods and/or services in Cambodia may also apply for a compliance certificate from the Ministry of Commerce,which certifies that advertising text or content complies with the Law on Consumer Protection or other applicable regulations.
For Kyrgyzstan, the Law on Advertisementsof December 24, 1998, No. 155 requires that if the activities of the advertiser subject to licensing, the advertisement of such advertisermust include the license number and the name of the authority that issued the license, except for radio advertising, where it is sufficientto state “licensed activity” on the territory of Kyrgyzstan. In advertising goods (including works and services), and otherobjects of advertising, cost indicators must be stated in the national currency. There are also other requirements established in relationto size, frequency, cost and other features of advertisements via different types of media.
New laws and regulationsrelevant to the fertility services may be introduced in the future, or the current applicable regulations may otherwise be amended orreplaced requiring the assisted reproductive medical facilities in its network to conduct business with additional oversight and regulatorycompliance. If NewGenIvf fails to obtain the necessary licenses, permits and approvals, NewGenIvf may be subject to fines, confiscationof revenues generated from incompliance operations, or the suspension of relevant operations. NewGenIvf may also experience adverse publicityarising from such non-compliance with government regulations that negatively impacts its brand. NewGenIvf may experience difficultiesor failures in obtaining the necessary approvals, licenses, and permits for new spaces or new service offerings. If NewGenIvf fails toobtain the material licenses, NewGenIvf’s business activities could be severely delayed. In addition, there can be no assurancethat NewGenIvf will be able to obtain, renew, and/or convert all of the approvals, licenses, and permits required for its existing businessoperations upon their expiration in a timely manner, in a cost-efficient manner or at all, which could adversely affect NewGenIvf’sbusiness operations and financial condition.
In addition, considerableuncertainties exist in relation to the interpretation and implementation of existing and future laws and regulations governing NewGenIvf’sbusiness activities. NewGenIvf could be found not in compliance with any future laws and regulations or of the laws and regulations currentlyin effect due to changes in the relevant authorities’ interpretation of those laws and regulations. It is possible that differentinterpretations or enforcement of these regulations could subject the current or past practices to allegations of impropriety or illegalityor require the medical facilities in its network to implement changes in the facilities, equipment, personnel or services, or increasecapital expenditure and operating expenses. If NewGenIvf fails to complete, obtain, or maintain any of the required licenses or approvalsor make the necessary filings, NewGenIvf may be subject to various penalties, such as confiscation of unlawful gains, the imposition offines, revocation of licenses, and the discontinuation or restriction of NewGenIvf’s operations. Any such penalties or changes inpolicies, regulations, or enforcement by government authorities may disrupt NewGenIvf’s operations and materially and adverselyaffect NewGenIvf’s business, financial condition, and results of operations.
Legal or regulatory restriction, governmentregulation, industry standards and other requirements create risks and challenges with respect to NewGenIvf’s compliance effortsand its business strategies and could adversely impact NewGenIvf’s business and limited the growth of NewGenIvf’s operations.
The healthcare industry ishighly regulated and subject to frequently changing laws, regulations, industry standards and other requirements. Many healthcare lawsand regulations are complex, and their application to specific solutions, services and relationships may not be clear. In particular,many existing healthcare laws and regulations, when enacted, did not anticipate the solutions and services that NewGenIvf provides, andthese laws and regulations may be applied to its solutions and services in ways that NewGenIvf does not anticipate. Efforts to reformor revise aspects of the healthcare industry or to revise or create additional legal or and regulatory requirements could impact its operations,the use of its solutions and services, and its ability to market new solutions and services, or could create unexpected liabilities forit. NewGenIvf also may be impacted by laws, industry standards and other requirements that are not specific to the healthcare industry,such as consumer protection laws and payment card industry standards. These requirements may impact its operations and, if not followed,could result in fines, penalties and other liabilities and adverse publicity and injury to its reputation.
There is a risk that existingor future laws may be interpreted in a manner that is not consistent with the healthcare industry’s current practices and couldhave an adverse effect on NewGenIvf’s business, financial condition, results of operations and growth prospects.
Any litigation against NewGenIvf could becostly and time-consuming to defend and could harm its business, financial condition and results of operations.
NewGenIvf has in the pastand may in the future become subject to regulatory actions, litigation, disputes, or claims of various types, legal proceedings and claimsthat arise in the ordinary course of business, such as claims brought by its clients or vendors in connection with commercial disputesor employment claims made by its current or former employees, as well as claims brought by relevant regulatory authorities or NewGenIvf’scompetitors, patients, employees, or other third parties against NewGenIvf. NewGenIvf is unable to predict the outcome of any of theselegal proceedings. Such regulatory actions, disputes, allegations, complaints, or legal proceedings may damage NewGenIvf’s reputation,evolve into litigation, or otherwise have a material adverse impact on NewGenIvf’s reputation and business. Such proceedings mightresult in substantial costs, regardless of the outcome, and may significantly divert management’s attention and resources from operatingNewGenIvf’s business, which might seriously harm its business, financial condition and results of operations. Insurance might notcover such claims, might not provide sufficient payments to cover all the costs to resolve one or more such claims, and might not continueto be available on terms acceptable to it. A claim brought against it that is uninsured or underinsured could result in unanticipatedcosts, potentially harming its business, financial condition and results of operations. The outcomes of actions NewGenIvf institutes maynot be successful or favorable to NewGenIvf. Lawsuits against NewGenIvf may also generate negative publicity that significantly harmsNewGenIvf’s reputation, which may adversely affect NewGenIvf’s client base. NewGenIvf may also need to pay damages or settlelawsuits with a substantial amount of cash.
Acquisitions, strategic investments, partnerships,or alliances could be difficult to identify, pose integration challenges, divert the attention of management, disrupt NewGenIvf’sbusiness, dilute stockholder value, and adversely affect its business, financial condition and results of operations.
NewGenIvf may in the futureseek to acquire or invest in businesses, joint ventures, products and services, or technologies that it believes could complement or expandits platform, enhance its technical capabilities, or otherwise offer growth opportunities. Any such acquisition or investment may divertthe attention of management and cause NewGenIvf to incur various expenses in identifying, investigating and pursuing suitable opportunities,whether or not the transactions are completed, and may result in unforeseen operating difficulties and expenditures. In particular, NewGenIvfmay encounter difficulties assimilating or integrating the businesses, technologies, products and services, personnel or operations ofthe acquired companies, particularly if the key personnel of the acquired company choose not to work for it, they are operationally difficultto integrate, or NewGenIvf has difficulty retaining the clients of any acquired business due to changes in ownership, management or otherwise.These transactions may also disrupt its business, divert its resources, and require significant management attention that would otherwisebe available for development of its existing business and may not benefit NewGenIvf’s business strategy, may not generate sufficientrevenues to offset the associated acquisition costs or may not otherwise result in the intended benefits. Any such transactions that NewGenIvfis able to complete may not result in any synergies or other benefits it had expected to achieve, which could result in impairment chargesthat could be substantial. In addition, NewGenIvf may not be able to find and identify desirable acquisition targets or business opportunitiesor be successful in entering into an agreement with any particular strategic partner. These transactions could also result in dilutiveissuances of equity securities or the incurrence of debt, which could adversely affect its results of operations. In addition, if theresulting business from such a transaction fails to meet NewGenIvf’s expectations, or it fails to successfully integrate such businessesinto its own, its business, financial condition and results of operations may be adversely affected or it may be exposed to unknown risksor liabilities. Even when NewGenIvf identifies an appropriate acquisition or investment target, it may not be able to negotiate the termsof the acquisition or investment successfully, obtain financing for the proposed transaction, or integrate the relevant businesses intoits existing business and operations. Strategic investments or acquisitions will involve risks commonly encountered in business relationships,including:
| ● | difficulties in assimilating and integrating the operations, personnel, systems, data, technologies, products and services of the acquired business; |
| ● | inability of the acquired technologies, products or businesses to achieve expected levels of revenue, profitability, productivity or other benefits; |
| ● | difficulties in retaining, training, motivating and integrating key personnel; |
| ● | diversion of management’s time and resources from NewGenIvf’s normal daily operations; |
| ● | difficulties in maintaining uniform standards, controls, procedures and policies within the combined organizations; |
| ● | difficulties in retaining relationships with customers, employees and suppliers of the acquired business; |
| ● | risks of entering markets in which NewGenIvf have limited or no prior experience; |
| ● | regulatory risks, including remaining in good standing with existing regulatory bodies or receiving any necessary pre-closing or post-closing approvals, as well as being subject to new regulators with oversight over an acquired business; |
| ● | assumption of contractual obligations that contain terms that are not beneficial to NewGenIvf, require it to license or waive intellectual property rights or increase its risk for liability; |
| ● | failure to further successfully develop the acquired technology; |
| ● | liability for activities of the acquired business before the acquisition, including intellectual property infringement claims, violations of laws, commercial disputes, tax liabilities and other known and unknown liabilities; |
| ● | potential disruptions to NewGenIvf’s ongoing businesses; and |
| ● | unexpected costs and unknown risks and liabilities associated with strategic investments or acquisitions. |
Even if the transaction isconsummated, NewGenIvf may only have limited control over the companies in which it only has minority stake, it cannot ensure that thesecompanies will always comply with applicable laws and regulations in their business operations. Non-compliance of regulatory requirementsby NewGenIvf’s investees may cause substantial harm to NewGenIvf’s reputations and the value of NewGenIvf’s investment.In addition, if the resulting business from such a transaction fails to meet NewGenIvf’s expectations, or it fails to successfullyintegrate such businesses into its own, its business, financial condition and results of operations may be adversely affected or it maybe exposed to unknown risks or liabilities. If NewGenIvf is unable to effectively address these challenges, its ability to execute acquisitionsas a component of its long-term strategy will be impaired, which could have an adverse effect on its growth. As a result of the above,NewGenIvf’s strategies may not be successfully implemented beyond the current markets.
Any investment might notachieve the synergies, operational or financial benefits it expects and may adversely impact NewGenIvf’s operating results. In addition,NewGenIvf cannot assure you that any future investment in or acquisition of new businesses or technology will lead to the successful developmentof new or enhanced products and services or that any new or enhanced products and services, if developed, will achieve market acceptance,or prove to be profitable.
Changes in NewGenIvf’s effective taxrate or tax liability may have an adverse effect on its results of operations.
NewGenIvf’s effectivetax rate could increase due to several factors, including, but not limited to:
| ● | changes in the relative amounts of income before taxes in the various jurisdictions in which NewGenIvf operates that have differing statutory tax rates; |
| ● | changes in tax laws, tax treaties, and regulations or the interpretation of them; |
| ● | changes to its assessment about its ability to realize its deferred tax assets that are based on estimates of its future results, the prudence and feasibility of possible tax planning strategies, and the economic and political environments in which NewGenIvf does business; |
| ● | the outcome of future tax audits, examinations, or administrative appeals; and |
| ● | limitations or adverse findings regarding its ability to do business in some jurisdictions. |
Any of these developmentscould have an adverse effect on its results of operations.
NewGenIvf’s reported financial resultsmay be adversely affected by changes in accounting principles generally accepted in relevant jurisdictions.
Accounting principles generallyaccepted in Thailand, Cambodia and Kyrgyzstan are subject to interpretation by the relevant supervision institutions, and various bodiesformed to promulgate and interpret appropriate accounting principles. A change in these principles or interpretations could have a significanteffect on NewGenIvf’s reported results of operations and could affect the reporting of transactions already completed before theannouncement of a change. The adoption of new or revised accounting principles may require it to make changes to its systems, processesand control, which could have a significant effect on its reported financial results, cause unexpected financial reporting fluctuations,retroactively affect previously reported results or require it to make costly changes to its operational processes and accounting systemsupon or following the adoption of these standards.
If NewGenIvf’s estimates or judgmentsrelating to its critical accounting policies prove to be incorrect, its results of operations could be adversely affected.
The preparation of financialstatements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported inNewGenIvf’s consolidated financial statements and accompanying notes appearing elsewhere in this prospectus. NewGenIvf bases itsestimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, as providedin the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations of NewGenIvf — CriticalAccounting Policies, Judgments and Estimates.” The results of these estimates form the basis for making judgments about thecarrying values of assets, liabilities and equity, and the amount of revenue and expenses that are not readily apparent from other sources.Significant estimates and judgments used in preparing NewGenIvf’s consolidated financial statements include those related to thedetermination of fair value of its Class A Ordinary Shares and Warrants and revenue recognition relating to services rendered but forwhich no claim has yet been reported, among other things. NewGenIvf’s results of operations may be adversely affected if its assumptionschange or if actual circumstances differ from those in its assumptions, which could cause its results of operations to fall below theexpectations of securities analysts and investors, resulting in a decline in the market price of its Class A Ordinary Shares and Warrants.
NewGenIvf is subject to anti-corruption,anti-bribery, anti-money laundering, and similar laws, and non-compliance with such laws can subject it to criminal or civil liabilityand harm its business, financial condition and results of operations.
NewGenIvf is subject to theAnti-Money Laundering Act B.E. 2542 (1999) of Thailand, the Act Supplementing the Constitution Relating to the Prevention and Suppressionof Corruption B.E. 2561 (2018) of Thailand, and the Penal Code of Thailand, domestic bribery laws, and other anticorruption and anti-moneylaundering laws in the countries in which it conducts activities. Anti-corruption and anti-bribery laws have been enforced aggressivelyin recent years and are interpreted broadly to generally prohibit companies, their employees and their third-party intermediariesfrom authorizing, offering, or providing, directly or indirectly, improper payments or benefits to recipients in the public or privatesector. If NewGenIvf expands its business and sales and to the public sector, it may engage with business partners and third-party intermediariesto market its services and to obtain for it the necessary permits, licenses, and other regulatory approvals. In addition, NewGenIvf orits third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-ownedor affiliated entities. NewGenIvf can be held liable for the corrupt or other illegal activities of these third-party intermediaries,its employees, representatives, contractors, partners and agents, even if it does not explicitly authorize such activities. Detecting,investigating, and resolving actual or alleged violations of anti-corruption laws can require a significant diversion of time, resources,and attention from senior management. In addition, noncompliance with anti-corruption, anti-bribery, or anti-money laundering laws couldsubject it to whistleblower complaints, investigations, prosecution, enforcement actions, sanctions, settlements, fines, damages, othercivil or criminal penalties or injunctions, suspension or debarment from contracting with certain persons, reputational harm, adversemedia coverage, and other collateral consequences. If any subpoenas or investigations are launched, or governmental or other sanctionsare imposed, or if NewGenIvf does not prevail in any possible civil or criminal proceeding, its business, financial condition and resultsof operations could be harmed. In addition, responding to any action will likely result in a materially significant diversion of management’sattention and resources and significant defense costs and other professional fees, which could adversely affect its business, financialcondition and results of operations.
For more information aboutour SEC filings, please see “Where You Can Find More Information” and “Incorporation by Reference.”
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements madeunder “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysisof Financial Condition and Results of Operations,” “Business” and elsewhere in this prospectus constituteforward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,”“should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,”“predicts,” “potential” “intends” or “continue,” or the negative of these terms or othercomparable terminology.
These forward-looking statementsmay include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projectionsof results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development,completion and use of our products, and all statements (other than statements of historical facts) that address activities, events ordevelopments that we intend, expect, project, believe or anticipate will or may occur in the future.
Forward-looking statementsare not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements onassumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions,expected future developments and other factors they believe to be appropriate.
Important factors that couldcause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statementsinclude, among other things:
| ● | our planned level of revenuesand capital expenditures; |
| ● | our ability to market and sell our products and services; |
| ● | our plans to continue to invest in research and development to develop technology for both existing and new products; |
| ● | our ability to maintain our relationships with suppliers, manufacturers and other partners; |
| ● | our ability to maintain or protect the validity of our intellectual property and know-how; |
| ● | our ability to retain key executive members; |
| ● | our ability to internally develop and protect new inventions and intellectual property; |
| ● | our ability to expose and educate the industry about the use of our services and products; |
| ● | our expectations regarding our tax classifications; |
| ● | interpretations of current laws and the passages of future laws; and |
| ● | the impact of the coronavirus (COVID-19) pandemic and resulting government actions on us, our manufacturers, suppliers and facilities. |
These statements are onlycurrent predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’sactual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-lookingstatements. We discuss many of these risks in this prospectus in greater detail under the heading “Risk Factors” andelsewhere in this prospectus. You should not rely upon forward-looking statements as predictions of future events.
Although we believe that theexpectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performanceor achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether asa result of new information, future events or otherwise, after the date of this prospectus.
LISTING DETAILS
Our Ordinary Shares currentlytrade on Nasdaq under the symbol “NIVF.” As of the date of this prospectus, our only listed class of securities are our OrdinaryShares. All of our Ordinary Shares, including those to be offered by the Selling Shareholders pursuant to this prospectus, have the samerights and privileges. For more information, see “Description of Share Capital—Ordinary Shares.”
USE OF PROCEEDS
We will not receive any proceedsfrom the sale of the Ordinary Shares by the Selling Shareholders. All net proceeds from the sale of the Ordinary Shares will go to theSelling Shareholders.
DIVIDEND POLICY
We have not declared or paidany cash dividend on our Ordinary Shares as of the date of this prospectus. We currently intend to retain any future earnings and do notexpect to pay any dividends in the near future. Any further determination to pay dividends on our ordinary shares would be at the discretionof our Board of Directors, subject to applicable laws, and would depend on our financial condition, results of operations, capital requirements,general business conditions, and other factors that our Board of Directors may deem relevant.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION ANDRESULTS OF OPERATIONS
The following discussionand analysis of our results of operations and financial condition should be read together with ou consolidated financial statements andthe notes thereto and other financial information, which are included elsewhere in this registration statement. Our financial statementshave been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). In addition, our financialstatements and the financial information included in this registration statement reflect our organizational transactions and have beenprepared as if our current corporate structure had been in place throughout the relevant periods.
This section containsforward-looking statements. These forward-looking statements are subject to various factors, risks and uncertainties that could causeactual results to differ materially from those reflected in these forward-looking statements. Further, as a result of these factors,risks and uncertainties, the forward-looking events may not occur. Relevant factors, risks and uncertainties include, but are not limitedto, those discussed in the section entitled “Business,” “Risk Factors” and elsewhere in this registration statement.Readers are cautioned not to place undue reliance on forward-looking statements, which reflect management’s beliefs and opinionsas of the date of this registration statement. We are not obligated to publicly update or revise any forward -looking statements, whetheras a result of new information, future events or otherwise. See “Cautionary Note Regarding Forward-Looking Statements.”
Overview
NewGenIvf is an assistedreproductive services (“ARS”) provider in Asia Pacific. Since the establishment of its first clinic in Thailand in 2014, ithas established itself as a long-standing ARS provider in the region. NewGenIvf’s mission is to assist couples and individuals acrossAsia Pacific, regardless of fertility challenges that they may face, to fulfil their dreams of building families and to increase theiraccess to fertility treatments. Its strategic presence in Thailand, Cambodia, and Kyrgyzstan positions the company to take advantage ofopportunities across Asia Pacific.
NewGenIvf is still in theearly stage of materializing its long-term objective of building a comprehensive, sophisticated and high-end ARS platform for its clientsand providing personalized solutions based on NewGenIvf’s brands and client-generated services. NewGenIvf plans to offer full fertilityservices for fertility tourists across Asia Pacific, continue to invest in laboratories and facilities updates, increase its brand awarenessand market share, as well as expand service reach through acquisitions and partnerships, which NewGenIvf believes will help expand itsclient base and enhance expertise attraction, and in turn strengthen NewGenIvf’s monetization capabilities.
Key Factors Affecting NewGenIvf’s Results of Operations
NewGenIvf’s resultsof operation are principally affected by the following factors:
Regulatory environment
The ARS market in Asia-Pacificregion is highly regulated. The implementation and enforcement of laws, regulations and government policies in Thailand, Cambodia, Kyrgyzstanand other applicable jurisdictions significantly impact the design, pricing and sale of fertility services and cost of compliance forclinics across Asia Pacific. Medical facilities providing fertility services generally must be filed and registered with the relevantsupervision institutions and such filing and registration must be renewed periodically. Any change in laws, regulations or policies inrelation to such filing or registration could affect NewGenIvf’s ability and plans to launch new services and renew registrationfor existing services. The regulatory framework for medical facilities and services, especially those involving ARS, is, and will continue,evolving. Any changes in the applicable regulatory frameworks in the jurisdictions where NewGenIvf operates may materially affect itsfinancial condition and results of operations.
Growth and competitive landscape of Asia Pacific’s ARSmarket
NewGenIvf’s revenuehas historically been primarily derived from clients in Asia Pacific. As such, NewGenIvf’s financial performance and future growthdepend primarily on the demand for ARS, as well as changes in its competitive landscape, in Asia Pacific. Population growth, infertilityrates, and demand for facility treatments in the region will ultimately determine the demand for NewGenIvf’s services. Accordingto CIC, infertility is increasingly becoming prevalent globally, primarily driven by increasing average age of first birth, as well asvarious lifestyle and environmental factors. Driven by an increased infertility rate and growing demand for children without birth defects,resulting from improving living standards and improved awareness about birth defects and prevention, the global ARS market is expectedto continue to grow. Furthermore, according to CIC, a growing number of governments around the world has granted legal recognition tosame-sex marriages, which brings more desires for having children to form a complete family. According to CIC, because of the fertilityrate and recent government incentive policies, such as the Three-child Policy of China in 2021, the ARS market increased significantlyin Asia Pacific. Leveraging its status as a long-standing ARS provider in Asia Pacific, NewGenIvf expects to continue to be well positionedto capture the expected growth in the demand for ARS in the area.
To date, NewGenIvf holds an exclusive licensegranted by a division of the Genetics and IVF Institute to use MicroSort technology in Thailand and Cambodia, which is a form of pre-conceptiongender selection technology for humans. While NewGenIvf expects to benefit from first-mover advantages for this technology in the tworegions, market entry by potential competitors or faster-than-expected development of potential competitors may affect its market positionand demand for its services and cause downward pricing pressure on its treatments, which may in turn materially and adversely affectits results of operations. Meanwhile, ARS market could also be affected by the macroeconomic environment and geopolitical events. Uncertaintyin the macroeconomic environment, resulting from a range of events and trends, including the rise in global inflation and interest rates,supply chain disruptions, geopolitical pressures, including the unknown impact of current and future trade regulations, changes in Asian-Pacificrelations, fluctuation in foreign exchange rates, and associated global economic conditions may result in volatility in ARS market andNewGenIvf’s operating performance. For example, NewGenIvf derives a substantial portion of its revenue from Chinese clients andas such, its failure to maintain PRC-sourced revenues and access to new and existing clients from the PRC could materially and adverselyaffect its results of operations and competitive position. However, the near-term growth prospects of the PRC economy are unclear dueto the uncertain effects of ongoing economic stress caused by policies to contain the COVID-19 pandemic, trade and national securitypolicies, and the elevated levels of private and public indebtedness, among others. According to the National Statistics Bureau of thePRC, growth rate of China’s GDP for the year 2022 slowed down to 3.0% on a year-on-year basis compared to the growth rate of approximately8.4% for the year 2021. In the second quarter of 2023, China’s GDP grew only 0.8% on a quarter basis, a significant slowdown fromthe 2.2% quarter growth registered in the first quarter of 2023. A prolonged downturn in the PRC economy generally could materially andadversely affect NewGenIvf’s results of operations and there is a significant likelihood that NewGenIvf’s actual resultsover the time periods and under the scenarios covered by the projections would be different. However, China’s GDP in the thirdquarter of 2023 grew 4.9% on a year-on-year basis and grew 1.3% on a quarter-by-quarter basis. NewGenIvf believes that if there is arecovery of the PRC economy, it might increase the demand for NewgenIvf’s services and therefore in turn affect NewGenIvf’sresults of operations.
Fluctuation of costs
NewGenIvf’s costs primarilyinclude clinic costs, cost of goods sold, selling and marketing expenses and general and administrative expenses, details of which areset out below.
| ● | Clinic costs. NewGenIvf’s clinic costs primarily consisted of sub-contracting charges, office supplies and staff salaries and bonus, most of which are recognized during the provision of surrogacy services. Its clinic costs represented approximately 55.7%, 65.7% of its revenue for the years ended December 31, 2023 and 2022, respectively. As NewGenIvf gradually expands the scale of its operation and presence in Asia Pacific, its clinic costs is expected to increase in the foreseeable future, which will affect its profitability. |
| ● | Cost of goods sold. NewGenIvf’s cost of goods sold primarily consisted of purchase and direct cost for IVF treatment services and surrogacy and ancillary caring services, most of which are recognized during the provision of IVF treatment services. Its cost of goods sold represented approximately 11.6% and 8.5% of the revenue for the years ended December 31, 2023 and 2022, respectively. NewGenIvf expects its cost of goods sold to increase in the foreseeable future as it gradually grows its revenues and expand its sales network. |
| ● | Selling and marketing expenses. NewGenIvf’s selling and marketing expenses primarily consisted of social media expense. Its selling and marketing expenses represented approximately 0.4% and 0.6% of its revenue for the years ended December 31, 2023 and 2022, respectively. NewGenIvf expects its selling and marketing expenses to increase as it plans to expand its sales and scale its operation in Asia-Pacific. |
| ● | General and administrativeexpenses. NewGenIvf’s general and administrative expenses primarily consisted of depreciation in operating lease right-of-use(“ROU”) assets, l and staff salaries anddirector fees. Its general and administrative expenses represented approximately 24.5% and 18.4% of its revenue for the years endedDecember 31, 2023 and 2022, respectively. NewGenIvf expects its general and administrative expenses to increase in line with its expansionplan. |
NewGenIvf expects its coststructure to evolve as it develops and expands its business. As NewGenIvf continues to develop new services and technologies, NewGenIvfexpects to incur additional costs in relation to its raw materials procurement, production and sales and marketing, among other things.Moreover, to support NewGenIvf’s business growth, it expects to increase its headcount, particularly for its lab and nurse team,and incur higher staff costs as a result.
Ability to maintain trust of clients and reputation in the industry
The success of NewGenIvf’sbusiness will depend to a large extent on its ability to gain broad acceptance of its services from clients. Reputation is crucial inkeeping existing clients and attracting new clients. NewGenIvf’s reputation depends on a number of factors, including for examplethe success, effectiveness, quality and pricing of its services, service offerings of its competitors, the effectiveness of its marketingefforts to drive awareness and the demand for fertility services, which eventually will affect its ability to maintain clients and attractnew clients. Therefore, NewGenIvf’s success will depend to a large extent on its ability to maintain its reputation in the industryand its clients’ trust, which would affect the number of its clients and treatment cycles that will in turn affect its revenues.
NewGenIvf believes that themedical facilities in its network are increasingly recognized among clients, for their service quality, technological expertise and patientexperience. NewGenIvf also hopes to keep its clients by providing discounts in treatment services and via the “success guarantee”program for egg donation services in Cambodia and surrogacy services in Kyrgyzstan, which provides treatments to clients until a successis achieved.
Based on its increasinglyrecognized reputation, NewGenIvf believes that there is substantial opportunity to continue to grow its revenue through attracting newclients. NewGenIvf’s addressable market is couples who want to have children, egg freezing patients, LGBT groups and couples withgenetic abnormalities, particularly those in Asia Pacific. NewGenIvf believes that its current client base represents a small percentageof its total market opportunity. NewGenIvf intends to attract new clients by, among other things, making significant investments in salesand marketing to engage, educate and drive awareness of the unmet need of fertility treatment among its potential clients and by its customer-referencediscounts mechanism. Additionally, NewGenIvf believes that its expanding presence has resulted in a heightened awareness of the need tooffer fertility services and the value it provides to its clients, which it believes will help facilitate its growth. In addition, NewGenIvfis continuously utilizing its established client relationships to evaluate other potential services that could benefit its clients andsimultaneously drive its growth.
International traveling conditions
The revenue from internationalclients is a critical component of NewGenIvf’s revenue. International traveling to Thailand, Cambodia and Kyrgyzstan may be affectedby a number of factors, including local and global political, economic and cultural conditions. Furthermore, an outbreak, or threatenedoutbreak, of any severe contagious disease may also in turn significantly reduce the demand of traveling. For example, the COVID-19 pandemichas had resulted in a number of countries declaring a state of emergency and a number of countries, including the countries in Asian Pacific,imposing extensive travel restrictions. NewGenIvf’s revenue in the year 2021 was significantly adversely affected due to the impactfrom COVID-19 travel restrictions. In addition, a Chinese crime thriller, No More Bets, which has grossed more than $500 millionat the international box office since its August 2023 release and which tells the harrowing story of characters being lured and kidnappedinto a violent scam ring in an unnamed Southeast Asian country after accepting lucrative overseas job offers, and the continuing socialmedia coverage may have brought fears and safety concerns to Chinese tourists of being scammed and kidnapped in Thailand and Cambodia.In addition, in October 2023, a 14-year-old with a gun opened fire in a luxury shopping mall in downtown Bangkok, killing two people andinjuring five in one of Thailand’s most popular tourist destinations. These conditions may cause NewGenIvf difficulty in attractingclients from the PRC to travel to Thailand, Cambodia and Kyrgyzstan for NewGenIvf’s services, which could materially and adverselyaffect NewGenIvf’s operations and financial results.
Given the uncertainty ofthe local and global conditions and the countries’ future policy regarding international traveling, all of which are beyond NewGenIvf’scontrol, NewGenIvf’s results of operation may be materially and adversely affected by any changes in international travelling conditions.
Key Components of Results of Operations
NewGenIvf’s revenueswere derived from two types of services: IVF treatment services and surrogacy and ancillary caring services.
Revenue
The following table setsforth a breakdown of NewGenIvf’s revenue by the types of services, in absolute amounts and as percentages of total revenue, forthe periods indicated.
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | | | % | | | US$ | | | % | |
IVF treatment services(1) | | | 4,021,696 | | | | 78.3 | | | | 2,819,163 | | | | 47.4 | |
Surrogacy and ancillary caring services | | | 1,114,457 | | | | 21.7 | | | | 3,125,027 | | | | 52.6 | |
Total revenues | | | 5,136,153 | | | | 100.0 | | | | 5,944,190 | | | | 100.0 | |
(1) | Include an insignificant amount of revenue derived from consultation customers who used NewGenIvf’s non-IVF treatment and insignificant services, such as check-ups services, blood test services and other minor services. |
NewGenIvf generated revenuefrom facilities located in various geographic regions. The following table sets forth a breakdown of NewGenIvf’s revenue based onthe locations where the revenue originated, in absolute amounts and as percentages of total revenue, for the periods indicated.
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | | | % | | | US$ | | | % | |
HK SAR | | | 34,038 | | | | 0.7 | | | | — | | | | — | |
Kyrgyzstan | | | 3,123,593 | | | | 60.8 | | | | 5,060,973 | | | | 85.1 | |
Cambodia | | | 621,619 | | | | 12.1 | % | | | 377,608 | | | | 6.4 | |
Thailand | | | 1,356,903 | | | | 26.4 | % | | | 505,609 | | | | 8.5 | |
Total revenues | | | 5,136,153 | | | | 100.0 | | | | 5,944,190 | | | | 100.0 | |
NewGenIvf’s revenueresults are affected by, among others, changes in sales price and the fluctuation of foreign currency rates with US dollars. A 5% changein sales price would cause 5% change in NewGenIvf’s revenue. Based on the breakdown of the revenue contribution in terms of currenciesused by customers for 2023, a 5% change in foreign currency rates with US dollars would cause approximately 1.3% change in NewGenIvf’srevenue. NewGenIvf’s average sales revenue from IVF treatment services per each IVF Customer (as defined below) was approximately US$14,951 in 2023 and average sales revenue from surrogacy and related ancillary caring services per each Surrogacy Customer was approximatelyUS$10,926 in 2023.
For the year ended December31, 2023, NewGenIvf served 357 customers using IVF treatment services and surrogacy and ancillary caring services, and recorded averagerevenue per such significant customer of approximately US$14,386.
IVF treatment services
NewGenIvfgenerated revenue from IVF treatment services provided at facilities that NewGenIvf operated in Thailand and Cambodia. In addition, NewGenIvfalso recognized revenues from IVF treatments included in surrogacy services performed in Kyrgyzstan. NewGenIvf’s revenue from IVFtreatment service amounted to US$2,819,163 and US$4,021,696,representing approximately 78.3% and 47.4% of its total revenues in 2023 and 2022, respectively. The number of IVF treatment service customers(the “IVF Customers”), which includes surrogacy and ancillary caring service customers who also use IVF treatment services,was approximately 269 in 2023, and the average sales revenue from IVF treatment services per each IVF Customer was approximately US$14,951in 2023.
IVF treatment involves theperformance of a series of medical treatment and procedures that are not separately distinct and only brings benefits to client when embryois successfully implanted, either in the client or a surrogate mother. Therefore, revenue from IVF treatment is recognized at a pointin time when it is completed in clinic. The completion of this treatment is evidenced by a written IVF report indicating successful embryoimplantation.
Surrogacy and ancillary caring services
NewGenIvf also generated revenue from surrogacy and related ancillarycaring services provided at facilities that NewGenIvf operated in Kyrgyzstan. NewGenIvf’s revenue from surrogacy and ancillary caringservices amounted to US$1,114,457 and US$3,125,027, representing approximately 21.7% and 52.6% of its total revenues in 2023 and 2022,respectively. The decrease in revenue from 2022 to 2023 was primarily attributed to the departure of an agent in mid-2023, which agenthad who introduced us customers for surrogacy and ancillary caring services, thus less income arising from surrogacy and ancillary caringservices was generated. The number of surrogacy and related ancillary caring service customers (the “Surrogacy Customers”)was approximately 102 in 2023 and the average sales revenue from surrogacy and related ancillary caring services per each Surrogacy Customerwas approximately US$10,926 in 2023.
In surrogacy and ancillarycaring services, embryo from intending parents is implanted in the surrogate mother sub-contracted by NewGenIvf. During the pregnancyperiod of the surrogate mother, NewGenIvf provides ancillary caring services including maternity caring services such as regular bodycheck and provision of vitamins, supplements and medicines to surrogate mothers, documentation service, and hotel accommodation services.Revenue from surrogacy and ancillary caring services is recognized at a point in time when the surrogate mother gives birth.
Cost of revenue
The following table setsforth a breakdown of NewGenIvf’s cost of revenue by the nature of the cost, in absolute amounts and as percentages of total costof revenues, for the periods indicated.
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | | | % | | | US$ | | | % | |
Cost of revenues | | | | | | | | | | | | |
Cost of goods sold | | | 594,984 | | | | 17.2 | | | | 502,969 | | | | 11.4 | |
Clinic costs | | | 2,859,384 | | | | 82.8 | | | | 3,903,452 | | | | 88.6 | |
Total cost of revenues | | | 3,454,368 | | | | 100.0 | | | | 4,406,421 | | | | 100.0 | |
Cost of goods sold. Costof goods sold primarily consisted of purchase and direct cost for IVF treatment services and surrogacy and ancillary caring services.NewGenIvf’s cost of goods was mostly recognized during the provision of IVF treatment services.
Clinic costs. Cliniccosts primarily consisted of sub-contracting charges, office supplies and staff salaries and bonus. The largest portion of clinic costswas sub-contracting charges, representing fees paid to agents who recruited surrogate mothers and assisted in the documentation, consultingand medical treatment arrangement throughout treatment procedure. NewGenIvf’s clinic costs of goods were mostly recognized duringthe provision of surrogacy services.
Gross profit and gross margin
The following table setsforth NewGenIvf’s gross profit in absolute amounts and its gross margin as percentages of total revenues, for the periods indicated.
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | | | % | | | US$ | | | % | |
Gross profit | | | 1,681,785 | | | | 32.7 | % | | | 1,537,769 | | | | 25.9 | |
Revenues | | | 5,136,153 | | | | — | | | | 5,944,190 | | | | — | |
NewGenIvf expects that grossprofit and gross margin will continue to be affected by various factors including the geographic locations where treatments are performed,as well as the pricing with its clients, agent subcontracting charges and the costs of the supplies provided by major pharmaceutical companies,all of which are negotiated separately.
Operating expenses
NewGenIvf’s operatingexpenses consist primarily of selling and marketing expenses and general and administrative expenses. NewGenIvf’s selling and marketingexpenses are primarily social media expenses. NewGenIvf’s general and administrative expenses mainly include depreciation in operatinglease ROU assets, loss on disposal of plant and equipment and staff salaries.
Other income
NewGenIvf’s other incomeconsists primarily of waiver of related party balance.
Interest expense
NewGenIvf’s interestexpense is incurred in relation to its interest-bearing borrowing.
Taxation
Cayman Islands
NewGenIvf is incorporatedin the Cayman Islands and is not subject to tax on income or capital gains under current Cayman Islands law. In addition, upon paymentof dividends to shareholders, no Cayman Islands withholding tax will be imposed.
Hong Kong
Under the two-tiered profitstax rates regime, Hong Kong tax residents are subject to Hong Kong profits tax in respect of profits arising in or derived fromHong Kong at 8.25% for the first HK$2 million of profits of the qualifying group entity, and profits above HK$2 millionwill be taxed at 16.5%. The profits of group entities not qualifying for the two-tiered profits tax rates regime will continue to be taxedat a flat rate of 16.5%.
Accordingly, the Hong Kongprofits tax is calculated at 8.25% on the first HK$2 million of the estimated assessable profits and at 16.5% on the remaining estimatedassessable profits.
Thailand
The companies incorporatedin Thailand are taxed on worldwide income. A company incorporated outside of Thailand is taxed on its profits arising from or in consequenceof the business carried on in Thailand. The Thailand corporate income tax rate is 20%. A foreign company not carrying on business in Thailandis subject to a final withholding tax on certain types of assessable income (e.g., interest, dividends, royalties, rentals, and servicefees) paid from or in Thailand. The rate of tax is generally 15%, except for dividends, which is 10%, while other rates may apply underthe provisions of a double tax treaty.
Cambodia
The standard rate of corporateincome tax for companies and permanent establishments in Cambodia who are classified as medium and large taxpayers is 20%. For companiesand permanent establishments who are classified as small taxpayers, the corporate income tax rates are progressive rates from 0% to 20%.In view of the annual turnover of the company, which ranges from KHR1 billion to KHR6 billion for service and commercial sectors, thecompany is considered a medium-sized company.
Kyrgyzstan
NewGenIvf is subject to acorporate income tax on its aggregate annual income earned worldwide. Non-resident legal entities carrying out business activities througha permanent establishment in Kyrgyzstan are subject to profit tax on the income attributed to the activities of that permanent establishments.Profit tax is calculated at a rate of 10% of aggregate annual income less allowed deductions.
Results of Operations
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | |
Revenues | | | 5,136,153 | | | | 5,944,190 | |
Cost of revenues | | | (3,454,368 | ) | | | (4,406,421 | ) |
Gross profit | | | 1,681,785 | | | | 1,537,769 | |
| | | | | | | | |
Operating expenses | | | | | | | | |
Selling and marketing expenses | | | (18,030 | ) | | | (36,194 | ) |
General and administrative expenses | | | (1,259,364 | ) | | | (1,094,962 | ) |
Auditors fees | | | (362,149 | ) | | | (7,908 | ) |
Total operating expenses | | | (1,639,543 | ) | | | (1,139,064 | ) |
| | | | | | | | |
Operating income | | | 42,242 | | | | 398,705 | |
| | | | | | | | |
Other income (expenses), net | | | | | | | | |
Other income | | | 111,837 | | | | 23,019 | |
Interest income | | | 518 | | | | 21 | |
Interest expense | | | (46,179 | ) | | | (77,757 | ) |
Total other income (expenses), net | | | 66,176 | | | | (54,717 | ) |
| | | | | | | | |
Income before taxes | | | 108,418 | | | | 343,988 | |
Provision for income taxes | | | — | | | | (208,141 | ) |
Net income | | | 108,418 | | | | 135,847 | |
Less: net loss attributable to non-controlling interests | | | (21,775 | ) | | | (322,820 | ) |
Net income attributable to the shareholders of the Company | | | 130,193 | | | | 458,667 | |
Other comprehensive (loss) income | | | | | | | | |
Foreign currency translation adjustment | | | (22,704 | ) | | | (1,920 | ) |
Total comprehensive income | | | 85,714 | | | | 133,927 | |
Less: Total comprehensive loss attributable to non-controlling interests | | | (27,621 | ) | | | (323,458 | ) |
Total comprehensive income attributable to the shareholders of the Company | | | 113,335 | | | | 457,385 | |
| | | | | | | | |
(Loss) earning per share – basic and diluted | | | 0.18 | | | | 0.80 | |
Basic and diluted weighted average shares outstanding | | | 615,135 | | | | 575,930 | |
Year Ended December 31, 2023 Compared with Year Ended December 31,2022
Revenue
NewGenIvf’s revenuedecreased by approximately 13.6% from US$5,944,190 in 2022 to US$5,136,153 in 2023.
IVF treatment services
NewGenIvf’sIVF treatment service revenue increased by approximately 42.7% from US$2,819,163 in 2022 to US$4,021,696 in 2023. This increase was primarilythe result of our continued expansion of clinics in Thailand which focus on IVF services.
Surrogacy and ancillary caring services
NewGenIvf’ssurrogacy and ancillary caring services revenue decreased by approximately 64.3% from US$3,125,027 in 2022 to US$1,114,457 in 2023. Thisdecrease was primarily the result of temporary caesura of surrogacy business.
Cost of revenue
NewGenIvf’scost of revenue decreased by approximately 21.6% from US$4,406,421 in 2022 to US$3,454,368in 2023.
Cost of goods sold
NewGenIvf’scost of goods sold increased by approximately 18.3% from US$502,969 in 2022 to US$594,984 in 2023, primarily attributed to the stockingarrangements prepared for 2023 exceed the original estimated demand, due to the local top management reported on board until in the middleof the year, and the procurement strategy was not immediately carried on time, which also caused procurement costs to double year-on-year.
Clinic costs
NewGenIvf’sclinic costs decreased by approximately 26.7% from US$3,903,452 in 2022 to US$2,859,384 in 2023, primarily due to the relocationarrangement, certain daily operating schedules stopped, resulting in the clinic’s service being temporarily suspended in2023.
Gross profit
NewGenIvf’s gross profitincreased by approximately 9.4% from US$1,537,769 in 2022 to US$1,681,785 in 2023, primarily attributable to a reorganizing of our cooperationmodel with subcontractors and the increased efficiency of our marketing services, resulting in a decrease in unit service costs per customer,directly leading to increases in gross profit margins.
NewGenIvf’s gross marginincreased from 25.9% and 32.7% in 2022 to 2023.
Operating expenses
NewGenIvf’soperating expenses increased by approximately 43.9% from US$1,139,064 in 2022 to US$1,639,543 in 2023, primarily attributable to auditorfees of US$362,149 incurred in 2022 being recognised in 2023 and listing legal and professional fees of US$183,527, other than theseold fees incurred, there is the similar level with last year.
Other income
NewGenIvf’sother income increased from US$23,019 in 2022 to US$111,837 in 2023, primarily attributable to a waiving amount due to director from thecompany which is about US$88,151.
Interest expense
NewGenIvf’s interestexpense decreased by approximately 40.6%, from US$77,757 in 2022 to US$46,179 in 2023 as a result of less interest expenses on bank andother borrowings in 2023.
Provision for income taxes
NewGenIvf’sprovision for income taxes decreased by approximately 100% from US$208,141 in 2022 to US$Nil in 2023 as a result of no assessable incomegenerated from Thailand, Kyrgyzstan and Cambodia.
Net income
NewGenIvf’s net incomedecreased by approximately 20% from US$135,847 in 2022 to US$108,418 in 2023 as a result of a listing project carried out during in 2023and a relocation of our operating clinic in Thailand, to cause the increase cost and salary of recruiting and training loacl talents.There is an additional auditor fees for the year, which is amounting to US$362,149.
Liquidity and Capital Resources
Cash flows and working capital
NewGenIvf’sprincipal sources of liquidity have been cash flows generated from its business operations. As of December 31, 2023 and 2022, NewGenIvfhad US$54,104 and U$27,556, respectively, in cash and cash equivalents. NewGenIvf had working capital (defined as total current assetsdeducted by total current liabilities) of a surplus of US$79,000 and deficit of US$157,027, respectively, as of December 31, 2023and 2022.
Over the years, certain amountof cash provided by operating activities was distributed to NewGenIvf’s primary shareholders, Mr. Siu, Wing Fung Alfred and Ms.Fong, Hei Yue Tina. As of December 31, 2023, NewGenIvf does not owe any amounts to shareholders. Nevertheless, NewGenIvf is able to generatesufficient cash flow from its business operations to operate and grow its business.
NewGenIvf continually seeksto monetize from positive cash flow contracts and increase revenue from its operating activities. NewGenIvf monitors its current and expectedliquidity requirements to help ensure that it maintains sufficient cash balances to meet its existing and reasonably likely long-termliquidity needs.
NewGenIvf intends to financeits future working capital requirements and capital expenditures from cash generated from operating activities, in addition to funds raisedfrom financing activities. NewGenIvf may, however, require additional cash due to changing business conditions or other future developments,including any investments or acquisitions it may decide to pursue. If its existing cash is insufficient to meet its requirements, NewGenIvfmay seek to issue debt or equity securities or obtain additional credit facilities. Financing may be unavailable in the amounts NewGenIvfneeds or on terms acceptable to it, if at all. Issuance of additional equity securities, including convertible debt securities, woulddilute NewGenIvf’s earnings per share. The incurrence of debt would divert cash for working capital and capital expenditures toservice debt obligations and could result in operating and financial covenants that restrict NewGenIvf’s operations and its abilityto pay dividends to its shareholders. If NewGenIvf is unable to obtain additional equity or debt financing as required, its business operationsand prospects may suffer. Please see “Risk Factors — Risks Relating to NewGenIvf’s Business and Industry —NewGenIvf requires a significant amount of capital to fund its operations and growth. If NewGenIvf cannot obtain sufficient capital onacceptable terms, its business, financial condition, and prospects may be materially and adversely affected.”
The following table presentsNewGenIvf’s selected consolidated cash flow data for the periods indicated.
| | For the Year ended December 31, | |
| | 2023 | | | 2022 | |
| | US$ | |
Net cash (used in)/provided by operating activities | | | (1,766,135 | ) | | | 1,710,901 | |
Net cash used in investing activities | | | (69,848 | ) | | | (94,452 | ) |
Net cash provided by/(used in) financing activities | | | 1,881,493 | | | | (1,633,781 | ) |
| | | | | | | | |
Net increase/(decrease) in cash and cash equivalents | | | 45,510 | | | | (17,332 | ) |
Effect of foreign currency translation on cash and cash equivalents | | | (18,962 | ) | | | 16,124 | |
Cash and cash equivalents, beginning of year | | | 27,556 | | | | 28,764 | |
Cash and cash equivalents, end of year | | | 54,104 | | | | 27,556 | |
Operating activities
Net cash used in operatingactivities was US$1,766,135 for the year ended December 31, 2023. The difference between NewGenIvf’s net profit of US$108,418 forthe year ended December 31, 2023 and the net cash used in operating activities was primarily attributable to refund of payment from clientsfrom the contract liabilities and the expenses spent on the legal and professional cost which was capitalized in the book of 2023.
Net cash provided by operatingactivities was US$1,710,901 for the year ended December 31, 2022. The difference between NewGenIvf’s net income of US$135,847for the year ended December 31, 2022 and the net cash provided by operating activities was primarily attributable to (i) adjustmentsfor depreciation and amortization of US$303,944, (ii) changes in contract liabilities of US$548,010 and (iii) changes in directors’remuneration of US$240,000, partially offset by operating lease liabilities of US$175,132.
Investing activities
Net cash used in investingactivities in 2023 was US$69,848, primarily representing purchase of plant and equipment.
Net cash used in investingactivities in 2022 was US$94,452, primarily representing purchase of plant and equipment.
Financing activities
Netcash provided by financing activities in 2023 was US$1,881,493, primarily representing amounts from shareholders.
Net cash used in financingactivities in 2022 was US$1,633,781, primarily representing amounts due from related parties.
Contractual Obligations
The following table setsforth NewGenIvf’s main contractual obligations and commitments as of December 31, 2023.
| | December 31, | |
| | 2023 | | | 2022 | |
| | US$ | | | US$ | |
Lease liabilities – current portion | | | 207,128 | | | | 184,651 | |
Lease liabilities – non-current portion | | | 118,979 | | | | 242,187 | |
Total | | | 326,107 | | | | 426,838 | |
Off-Balance Sheet Commitments and Arrangements
NewGenIvf has not enteredinto any financial guarantees or other commitments to guarantee the payment obligations of any third parties, nor any derivative contractsthat are indexed to its shares and classified as shareholder’s equity or that are not reflected in its consolidated financial statements.Furthermore, NewGenIvf does not have any retained or contingent interest in assets transferred to an unconsolidated entity that servesas credit, liquidity or market risk support to such entity. NewGenIvf does not have any variable interest in any unconsolidated entitythat provides financing, liquidity, market risk or credit support to it or engages in leasing, hedging or product development serviceswith it.
Holding Company Structure
NewGenIvf Group Limited isa holding company with no material operations of its own. NewGenIvf Group Limited conducts all of its operations through its subsidiaries.As a result, NewGenIvf Group Limited’s ability to pay dividends depends upon dividends paid by its subsidiaries. If our subsidiariesor any newly formed subsidiaries incur debt on their own behalf in the future, the instruments governing their debt may restrict theirability to pay dividends to the Company.
NewGenIvf Group Limited ispermitted under BVI law to provide funding to its subsidiaries in Hong Kong, Thailand, Cambodia and Kyrgyzstan through loans or capitalcontributions without restrictions on the amount of the funds.
In addition, the Company’ssubsidiaries are currently permitted to pay dividends to the Company in accordance with relevant laws and regulations. Payment of dividendsrequirements in a company incorporated under the laws of Thailand is governed by the Civil and Commercial Code of Thailand. For example,the company may not declare dividends if the company has incurred losses, the company must appropriate to a reserved fund at each dividendcontribution of dividend of at least one-twentieth of the profits until the fund reaches one-tenth of the capital, or the dividends paymentmust be made to the shareholders within one (1) month from the dividend declaration date. On the capital remittance or payment ofdividends to the shareholders from outside of Thailand, it is regulated by the regulations issued by the Bank of Thailand, including theExchange Control Act B.E. 2485 (1942). The fund remittance from Thailand to a foreign jurisdiction may require an approval from the Bankof Thailand or require notifying the Bank of Thailand for such transfer, depending on the types of the remittance transactions, throughthe commercial bank in the country. For a company incorporated under the laws of Kyrgyzstan, under Kyrgyz regulations of dividends (netprofit), the dividends can be paid once a year depending on the results of the financial year of the company.
Quantitative and Qualitative Disclosure about Market Risk
Accounts receivable
In order to minimize thecredit risk, NewGenIvf’s management team monitors and ensures that follow-up action is taken to recover overdue debts. NewGenIvfconsiders the probability of default upon initial recognition of the asset and whether there has been a significant increase in creditrisk on an ongoing basis throughout each reporting period. To assess whether there is a significant increase in credit risk, NewGenIvfcompares the risk of a default occurring on the asset as at the reporting date with the risk of default as at the date of initial recognition.It considers available reasonable and supportive forwarding-looking information, such as GDP growth rate and nominal GDP per capita. Basedon the impairment assessment performed by NewGenIvf, the directors considered the loss allowance for account receivables as of December 31,2023 and December 31, 2022 is $19 and $26, respectively.
Cashand cash equivalents
NewGenIvf is exposed to concentrationof credit risk on liquid funds which are deposited with several banks with high credit ratings. The credit risk on liquid funds is limitedbecause the counterparties are banks with high credit ratings assigned by international credit-rating agencies.
Deposits and other receivables, amountdue from shareholders and loan to A SPAC I
NewGenIvf assessed the impairmentfor deposits and other receivables, due from shareholders and loan to A SPAC I individually based on internal credit rating and ageingof these debtors which, in the opinion of the directors, have no significant increase in credit risk since initial recognition. Basedon the impairment assessment performed by the Company, the directors consider the loss allowance for deposits and other receivables, duefrom shareholders and loan to A SPAC I as of December 31, 2023 is $14, $17,818 and Nil, respectively. The loss allowance for depositsand other receivables, due from shareholders and loan to A SPAC I as of December 31, 2022 is $141, $17,059 and Nil, respectively.The loss allowance for deposits and other receivables and amount due from shareholders as of December 31, 2021 was $115 and $6,312and Nil, respectively.
Cash flow interest rate risk
NewGenIvf is exposed to cashflow interest rate risk through the changes in interest rates related mainly to its variable-rates bank balances.
NewGenIvf currently doesnot have any interest rate hedging policy in relation to fair value interest rate risk and cash flow interest rate risk. The directorsmonitor NewGenIvf’s exposures on an ongoing basis and will consider hedging the interest rate should the need arises.
Sensitivity analysis
The sensitivity analysisbelow has been determined by assuming that a change in interest rates had occurred at the end of the reporting period and had been appliedto the exposure to interest rates for financial instruments in existence at that date. 1% increase or decrease is used when reportinginterest rate risk internally to key management personnel and represents management’s assessment of the reasonably possible changein interest rates.
Ifinterest rates had been 1% higher or lower and all other variables were held constant, NewGenIvf’s post tax loss forthe years ended December 31, 2023 and 2022 would have increased or decreased by approximately US$122 and US$275,respectively.
Foreign currency risk
Foreign currency risk isthe risk that the holding of foreign currency assets will affect NewGenIvf’s financial position as a result of a change in foreigncurrency exchange rates.
NewGenIvf’s monetaryassets and liabilities are mainly denominated in HK$ and THB which are the same as the functional currencies of the relevant group entities.Hence, in the opinion of the directors of NewGenIvf, the currency risk of US$ is considered insignificant. NewGenIvf currently does nothave a foreign currency hedging policy to eliminate currency exposures. However, the directors monitor the related foreign currency exposureclosely and will consider hedging significant foreign currency exposures should the need arise.
Economic and political risks
NewGenIvf’s operationsare mainly conducted in Thailand, Cambodia and Kyrgyzstan. Accordingly, NewGenIvf’s business, financial condition, and results ofoperations may be influenced by changes in the political, economic, and legal environments in Thailand, Cambodia and Kyrgyzstan.
NewGenIvf’s operationsin Thailand, Cambodia and Kyrgyzstan are subject to special considerations and significant risks not typically associated with companiesin North America and Western Europe. These include risks associated with, among other things, the political, economic and legal environmentand foreign currency exchange. NewGenIvf’s results may be adversely affected by changes in the political and social conditions inThailand, Cambodia and Kyrgyzstan, and by changes in governmental policies with respect to laws and regulations, anti-inflationary measures,currency conversion, remittances abroad, and rates and methods of taxation, among other things.
Travel restriction risk
International clients contributea large portion of NewGenIvf’s revenue. International clients need to travel to Thailand, Cambodia and Kyrgyzstan for treatmentservices, where NewGenIvf’s operations are mainly conducted.
International traveling toThailand, Cambodia and Kyrgyzstan may be affected by a number of factors, including local and global political and economic conditions.Furthermore, an outbreak, or threatened outbreak, of any severe contagious disease may also in turn significantly reduce the demand oftraveling or cause extensive travel restrictions. NewGenIvf’s results may be materially and adversely affected if travel restrictionwas imposed or difficulties in cross-border flow arose.
Inflation risk
Management of NewGenIvf monitorschanges in prices levels. Historically inflation has not materially impacted NewGenIvf’s consolidated financial statements; however,significant increases in the price of labor that cannot be passed to NewGenIvf’s customers could adversely impact its results ofoperations.
Critical Accounting Policies, Judgments and Estimates
NewGenIvf prepares its financialstatements in conformity with U.S. GAAP, which requires NewGenIvf to make judgments, estimates and assumptions. NewGenIvf continuallyevaluates these estimates and assumptions based on the most recently available information, its historical experience and various otherassumptions that NewGenIvf’s management believes to be reasonable under the circumstances. Since the use of estimates is an integralcomponent of the financial reporting process, actual results could differ from its expectations as a result of changes in NewGenIvf’sestimates. Some of NewGenIvf’s accounting policies require a higher degree of judgment than others in their application and requireNewGenIvf to make significant accounting estimates.
The selection of criticalaccounting policies, the judgments and other uncertainties affecting application of those policies and the sensitivity of reported resultsto changes in conditions and assumptions are factors that should be considered when reviewing NewGenIvf’s financial statements.NewGenIvf’s management believes the following accounting policies involve the most significant judgments and estimates used in thepreparation of their financial statements.
Foreign currency translation
NewGenIvf’s consolidatedfinancial statements are presented in United States dollar, which is the reporting currency of NewGenIvf. The functional currencyof NewGenIvf and its subsidiaries, FFPGS (HK) Limited and Well Image Limited, are HK$. Med Holdings and FFC use THB as their functionalcurrencies. First Fertility Phnom Penh Limited uses KHR as its functional currency and First Fertility Bishkek LLC uses USD as its functionalcurrency.
Assets and liabilities denominatedin currencies other than the reporting currency are translated into the reporting currency at the rates of exchange prevailing at thebalance sheet date. Translation gains and losses are recognized in the consolidated statements of operations and comprehensive incomeas other comprehensive income or loss.
Transactions in currenciesother than the reporting currency are measured and recorded in the reporting currency at the exchange rate prevailing on the transactiondate. The cumulative gain or loss from foreign currency transactions is reflected in the consolidated statements of operations and comprehensiveincome as other income (other expenses).
The value of foreign currenciesincluding, the HK$, THB, KHR and RMB, may fluctuate against the United States dollar. Any significant variations of the aforementionedcurrencies relative to the United States dollar may materially affect NewGenIvf’s financial condition in terms of reportingin USD. See “Note 2 — Summary of Significant Accounting Policies” for details.
Revenue recognition
NewGenIvf adopted ASC Topic 606,Revenue from Contracts with Customers, and all subsequent ASUs that modified ASC 606 on April 1, 2017 using the full retrospectivemethod which requires it to present the financial statements for all periods as if Topic 606 had been applied to all prior periods.NewGenIvf derives revenue principally from provision of IVF treatment and surrogacy and ancillary caring services. Revenue from contractswith customers is recognized using the following five steps:
| (1) | identify its contracts with customers; |
| (2) | identify its performance obligations under those contracts; |
| (3) | determine the transaction prices of those contracts; |
| (4) | allocate the transaction prices to its performance obligations in those contracts; and |
| (5) | recognize revenue when each performance obligation under those contracts is satisfied. Revenue is recognized when promised services are transferred to the client in an amount that reflects the consideration expected in exchange for those services. |
NewGenIvf enters into serviceagreements with its customers that outline the rights, responsibilities, and obligations of each party. The agreements also identify thescope of services, service fees and payment terms. Agreements are acknowledged and signed by both parties. All the contracts have commercialsubstance, and it is probable that NewGenIvf will collect considerations from its customers for service component.
NewGenIvf derives its revenuesfrom two types of services: (1) IVF treatment services, and (2) surrogacy and ancillary caring services.
Revenue from IVF treatment services
IVF treatment is an assistedreproductive technique where eggs and sperm are collected and fertilized in laboratory to become embryo. Fertilized embryo is then implantedin the customer or a surrogate mother. IVF treatment involves the performance of a series of medical treatment and procedures that arenot separately distinct and only brings benefits to customer when embryo is successfully implanted, therefore revenue from IVF treatmentis recognized at a point in time when it is completed in clinic. The completion of this treatment is evidenced by a written IVF reportindicating successful embryo implantation. NewGenIvf collects payment from customer in advance for IVF treatment.
Revenue from surrogacy and ancillary caring services
NewGenIvf provides surrogacyand ancillary caring services solely in Kyrgyzstan. Embryo from blood parents is implanted to surrogate mother contracted by NewGenIvf.During pregnancy period, NewGenIvf provides ancillary caring services including regular body check and provision of vitamins, supplementsand medicines to surrogate mothers. The key performance obligation is identified as a single performance obligation where a baby is born,therefore revenue from surrogacy and ancillary caring services is recognized at a point in time when surrogate mother gives birth. NewGenIvfcollects approximately 40% of contract sum upfront, and remaining contract sum is collected in installments across pregnancy period ofsurrogate mother.
Lease
NewGenIvfadopted ASU 2016-02, “Leases” (Topic 842). Lease terms used to calculate the present value of lease payments generally donot include any options to extend, renew, or terminate the lease, as NewGenIvf does not have reasonable certainty at lease inception thatthese options will be exercised. NewGenIvf generally considers the economic life of its operating lease ROU assets to be comparable tothe useful life of similar owned assets. NewGenIvf has elected the short-term lease exception, therefore operating lease ROU assets andliabilities do not include leases with a lease term of twelve months or less. Its leases generally do not provide a residual guarantee.The operating lease ROU asset also excludes lease incentives. Lease expense is recognized on a straight-line basis over the lease term.
Asof December 31, 2022, there were approximately $0.38 millionROU assets and approximately $0.43 million in lease liabilities based on the present value of the future minimum rental payments of leases,respectively. NewGenIvf’s management believes that using an incremental borrowing rate of the Hong Kong Dollar Best Lending Rate(“BLR”) minus 0.125% was the most indicative rate of NewGenIvf’s borrowing cost for the calculation of the present valueof the lease payments; the rate used by NewGenIvf was 5.0%.
Asof December 31, 2023, there were approximately $0.28 millionROU assets and approximately $0.33 million in lease liabilities based on the present value of the future minimum rental payments of leases,respectively. NewGenIvf’s management believes that using an incremental borrowing rate of the Hong Kong Dollar Best Lending Rate(“BLR”) minus 0.125% was the most indicativerate of NewGenIvf’s borrowing cost for the calculation of the present value of the lease payments; the rate used by NewGenIvf was5.0%.
Financialinstruments
NewGenIvf’s financialinstruments, including cash and cash equivalents, accounts and other receivables, accounts and other payables, accrued liabilities andamounts due from (to) shareholders, have carrying amounts that approximate their fair values due to their short maturities. ASC Topic 820,“Fair Value Measurements and Disclosures” requires disclosing the fair value of financial instruments held by NewGenIvf. ASCTopic 825, “Financial Instruments” defines fair value and establishes a three-level valuation hierarchy for disclosuresof fair value measurement that enhances disclosure requirements for fair value measures. The carrying amounts reported in the consolidatedbalance sheets for cash and cash equivalents, accounts and other receivables, accounts and other payables, accrued liabilities and amountsdue from (to) shareholders each qualify as financial instruments and are a reasonable estimate of their fair values because of the shortperiod between the origination of such instruments and their expected realization and their current market rate of interest. NewGenIvfanalyzes all financial instruments with features of both liabilities and equity under ASC 480, “Distinguishing Liabilitiesfrom Equity” and ASC 815. See “Note 2 — Summary of Significant Accounting Policies” for details.
Recent accounting pronouncements
InApril 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivativesand Hedging, and Topic 825, Financial Instruments, which amends and clarifies several provisions of Topic 326. In May 2019, the FASB issuedASU 2019-05, Financial Instruments-Credit Losses (Topic 326) Targeted Transition Relief, which amends Topic 326 to allow the fair valueoption to be elected for certain financial instruments upon adoption. ASU 2019-10 extended the effective date of ASU 2016-13 until December15, 2022. This standard replaces the incurred loss methodology with an expected loss methodology that is referred to as the current expectedcredit loss (“CECL”) methodology. CECL requires an estimate of credit losses for the remaining estimated life of the financialasset using historical experience, current conditions, and reasonable and supportable forecasts and generally applies to financial assetsmeasured at amortized cost, including loan receivables and held-to-maturity debt securities, and some off-balance sheet credit exposuressuch as unfunded commitments to extend credit. Financial assets measured at amortized cost will be presented at the net amount expectedto be collected by using an allowance for expected credit losses. The Company already adopted the new standard and the Company recognizesthe full impact of the new standard in these consolidated balance sheets and makes related disclosures.
SELLING SHAREHOLDERS
The 5,912,281 Ordinary Shares being offered by the Selling Shareholdersare the aggregate of Ordinary Shares previously issued to the Selling Shareholders as a result of various transactions that have occurred,which details are set forth below. We are registering the Ordinary Shares in order to permit the Selling Shareholders to offer the OrdinaryShares for resale from time to time.
Other than the relationshipsdescribed herein, to our knowledge, the Selling Shareholders have not had any material relationship with us within the past three years.
Any Selling Shareholders thatare affiliates of broker-dealers and any participating broker-dealers would be deemed to be “underwriters” within the meaningof the Securities Act, and any commissions or discounts given to any such Selling Shareholders or broker-dealer may be regarded as underwritingcommissions or discounts under the Securities Act. To our knowledge, none of the Selling Shareholders listed below are broker-dealersor affiliates of broker-dealers.
The table below lists theSelling Shareholders and other information regarding the beneficial ownership of the Ordinary Shares by each of the Selling Shareholders.The second column lists the number of Ordinary Shares beneficially owned by each Selling Shareholder, based on its ownership of the OrdinaryShares, as of August 27, 2024.
The fourth column lists theOrdinary Shares being offered by this prospectus by the Selling Shareholders.
Because the number of OrdinaryShares may be adjusted for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions, the numberof Ordinary Shares that will actually be sold may be more or less than the number of Ordinary Shares being offered by this prospectus.The fifth and sixth columns assumes the sale of all of the Ordinary Shares offered by the Selling Shareholders pursuant to this prospectus.
As explained below under “Planof Distribution,” we have agreed with the Selling Shareholders to bear certain expenses (other than broker discounts and commissions,if any) in connection with the registration statement, which includes this prospectus.
The following table sets forth details regarding the offering of certain Selling Shareholders’ Ordinary Shares pursuant to this registration statement.
Name of Selling Shareholders | | Ordinary Shares Beneficially Owned Prior to Offering(1) | | | Percentage of Ordinary Shares Beneficially Owned Prior to Offering(1) | | | Maximum Number of Ordinary Shares to be Sold Pursuant to this Prospectus | | | Ordinary Shares Beneficially Owned Immediately After Sale of Maximum Number of Shares in this Offering(1) | | | Percentage of Ordinary Shares Beneficially Owned Immediately After Sale of Maximum Number of Shares in this Offering(1) | |
JAK Opportunities VI LLC(3) | | | 3,618,791 | | | | 35.66 | % | | | 5,912,281 | | | | - | | | | - | |
| (1) | Beneficialownership is determined in accordance with SEC rules and generally includes voting or investment power with respect to securities. OrdinaryShares subject to options or warrants currently exercisable, or exercisable within 60 days of September 4, 2024, are counted as outstandingfor computing the percentage of the Selling Shareholder holding such options or warrants but are not counted as outstanding for computingthe percentage of any other Selling Shareholder. |
| (2) | Theapplicable percentage of beneficial ownership is calculated based on the total number of Ordinary Shares issued and outstanding, being10,149,386 shares, as of September 4, 2024, together with the additional Ordinary Shares to be issued to the relevant Selling Shareholderupon exercise of warrants respectively held. |
| (3) | Thenumber of Ordinary Shares being registered for JAK Opportunities VI LLC represents the aggregate of (i) the following underlying securitiesin connection with the initial closing on August 12, 2024 of the Company’s debt financing (“2024 Debt Financing”):(A) 1,325,301 Ordinary Shares underlying the Series A Warrants and (B) twice the number of the 1,417,832 Ordinary Shares underlying thesenior convertible promissory note in the principal amount of $1,100,000 issued to JAK Opportunities VI LLC, pursuant to the terms ofthe Registration Rights Agreement between JAK Opportunities VI LLC and the Company (the “Registration Rights Agreement”);and (ii) twice the number of the 875,658 Ordinary Shares underlying the senior convertible promissory note in the principal amount of$500,000 issued to JAK Opportunities VI LLC on August 28, 2024 pursuant to the closing of the second tranche of the 2024 Debt Financingand the terms of the Registration Rights Agreement. The percentage of beneficial ownership is calculated based on a denominator of 10,149,386Ordinary Shares issued and outstanding as of August 27, 2024. The mailing address of JAKOpportunities VI LLC is c/o ATW Partners Opportunities Management, LLC, 1 Pennsylvania Plaza, Suite 4810, New York, NY 10119. |
PLAN OF DISTRIBUTION
We are registering the OrdinaryShares previously issued, to permit the resale of these Ordinary Shares by the holders of these securities from time to time after thedate of this prospectus. We will not receive any of the proceeds from the sale by the Selling Shareholders of the Ordinary Shares. Unlikean initial public offering, any resale by the Selling Shareholders of the Ordinary Shares is not being underwritten by any investmentbank. We will bear all fees and expenses incident to our obligation to register the Selling Shareholders’ Ordinary Shares.
The Selling Shareholders maysell all or a portion of the Ordinary Shares beneficially owned by them and offered hereby from time to time directly or through one ormore underwriters, broker-dealers or agents. If the Ordinary Shares are sold through underwriters or broker-dealers, the Selling Shareholderswill be responsible for underwriting discounts or commissions or agent’s commissions. The Ordinary Shares may be sold in one ormore transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of saleor at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions,
| ● | on any national securities exchangeor quotation service on which the securities may be listed or quoted at the time of sale; |
| ● | in the over-the-counter market; |
| ● | in transactions other than on these exchanges or systems or the over-the-counter market; |
| ● | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| ● | block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
| ● | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| ● | an exchange distribution in accordance with the rules of the applicable exchange; |
| ● | privately negotiated transactions; |
| ● | sales pursuant to Rule 144 under the Securities Act; |
| ● | broker-dealers may agree with the selling securityholders to sell a specified number of such shares at a stipulated price per share; |
| ● | a combination of any such methods of sale; and |
| ● | any other method permitted pursuant to applicable law. |
If the Selling Shareholdersaffect such transactions by selling Ordinary Shares to or through underwriters, broker-dealers or agents, such underwriters, broker-dealersor agents may receive commissions in the form of discounts, concessions or commissions from the Selling Shareholders or commissions frompurchasers of the Ordinary Shares for whom they may act as an agent or to whom they may sell as principal (which discounts, concessionsor commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactionsinvolved).
The Selling Shareholders maypledge or grant a security interest in some or all of the Ordinary Shares owned by them and, if they default in the performance of theirsecured obligations, the pledgees or secured parties may offer and sell the Ordinary Shares from time to time pursuant to this prospectusor any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act, amending, if necessary,the list of Selling Shareholders to include the pledgee, transferee or other successors in interest as selling stockholders under thisprospectus. The Selling Shareholders also may transfer and donate the Ordinary Shares in other circumstances in which case the transferees,donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus. The Selling Shareholdersand any broker-dealer participating in the distribution of the shares may be deemed to be “underwriters” within the meaningof the Securities Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed to beunderwriting commissions or discounts under the Securities Act. At the time a particular offering of the shares is made, a prospectussupplement, if required, will be distributed which will set forth the aggregate amount of Ordinary Shares being offered and the termsof the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constitutingcompensation from the Selling Shareholders and any discounts, commissions or concessions allowed or reallowed or paid to broker-dealers.
Under the securities lawsof some states, the Ordinary Shares may be sold in such states only through registered or licensed brokers or dealers. In addition, insome states, the Ordinary Shares may not be sold unless such shares have been registered or qualified for sale in such state or an exemptionfrom registration or qualification is available and is complied with.
There can be no assurancethat any Selling Shareholder will sell any or all of the Ordinary Shares registered pursuant to the registration statement, of which thisprospectus forms a part.
The Selling Shareholders andany other person participating in such distribution will be subject to applicable provisions of the Exchange Act, and the rules and regulationsthereunder, including, without limitation, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of anyof the shares by the Selling Shareholders and any other participating person. Regulation M may also restrict the ability of any personengaged in the distribution of the Ordinary Shares to engage in market-making activities with respect to the shares. All of the foregoingmay affect the marketability of the Ordinary Shares and the ability of any person or entity to engage in market-making activities withrespect to the Ordinary Shares.
We will pay all expenses ofthe registration of the Ordinary Shares, estimated to be $46,741 in total, including, without limitation, SEC filing fees and expensesof compliance with state securities or “blue sky” laws; provided, however, that a Selling Shareholder will pay all underwritingdiscounts and selling commissions if any. We will indemnify the Selling Shareholders against liabilities, including some liabilities underthe Securities Act, or the Selling Shareholders will be entitled to contribution. We may be indemnified by the Selling Shareholders againstcivil liabilities, including liabilities under the Securities Act, that may arise from any written information furnished to us by theSelling Shareholders specifically for use in this prospectus, or we may be entitled to contribution.
Once sold under the registrationstatement, of which this prospectus forms a part, the Ordinary Shares will be freely tradable in the hands of persons other than our affiliates.
DESCRIPTIONOF SHARE CAPITAL
Class A and Class B Ordinary Shares
General
The Memorandum andArticles of Association authorize the issuance of a maximum of 100,000,000 Class A Ordinary Shares, 100 Class BOrdinary Shares and 1,000,000 preferred shares with no par value (“Preferred Shares”). As of September4, 2024, we have 10,149,386 shares of Class A Ordinary Shares outstanding, no Class B Ordinary Shares outstanding, and no PreferredShares outstanding. All of our outstanding Class A Ordinary Shares at the time of the closing of this offering, will be, validlyissued, and fully paid. Our Class A Ordinary Shares and Class B Ordinary Shares are not redeemable and are not subject to anypreemptive right.
Dividends.
The holders of our Class AOrdinary Shares and Class B Ordinary Shares are entitled to an equal share, for each share held, in any dividend paid by the Company.
Voting Rights.
Subject to the rights of thePreferred Shares’ holders, in respect of all matters subject to a member’s vote, each Class A Ordinary Share and Class B OrdinaryShare is entitled to one vote at a meeting of the members or on any resolution of members.
Distributions.
The holders of the Class AOrdinary Shares and Class B Ordinary Shares each have a right to an equal share with each other in the distribution of the surplus assetsof the Company on the Company’s liquidation.
Preferred Shares
Subject to applicablelaw and the Memorandum and Articles of Association, the Board of Directors may issue Preferred Shares with such preferred rights asthey shall determine. The rights, privileges, restrictions and conditions attaching to the Preferred Shares shall be stated in theMemorandum and Articles of Association, which shall be amended accordingly prior to the issue of such Preferred Shares.
TAXATION
The following is a generalsummary of the material U.S. federal income tax consequences relevant to an investment in our Ordinary Shares. The discussion is not intendedto be, nor should it be construed as, legal or tax advice to any particular prospective purchaser. The discussion is based on laws andrelevant interpretations thereof as of the date of this annual report, all of which are subject to change or different interpretations,possibly with retroactive effect. The discussion does not address U.S. state or local tax laws. You should consult your own tax advisorswith respect to the consequences of acquisition, ownership and disposition of our Ordinary Shares.
This discussion is basedon provisions of the Code, the Treasury Regulations promulgated thereunder (whether final, temporary, or proposed), administrative rulingsof the IRS, and judicial decisions, all as in effect on the date hereof, and all of which are subject to differing interpretations orchange, possibly with retroactive effect. This discussion does not purport to be a complete analysis or listing of all potential U.S. federalincome tax considerations that may apply to a securityholder of the Company as a result of the ownership and disposition of the CompanySecurities. In addition, this discussion does not address all aspects of U.S. federal income taxation that may be relevant to particularholders nor does it take into account the individual facts and circumstances of any particular holder that may affect the U.S. federalincome tax consequences to such holder, and accordingly, is not intended to be, and should not be construed as, tax advice. This discussiondoes not address the U.S. federal 3.8% Medicare tax imposed on certain net investment income or any aspects of U.S. federaltaxation other than those pertaining to the income tax, nor does it address any tax consequences arising under any U.S. state andlocal, or non-U.S. tax laws, or, except as discussed here, any tax reporting obligations of a holder of the Company Securities. Holdersshould consult their own tax advisors regarding such tax consequences in light of their particular circumstances.
No ruling has been requestedor will be obtained from the IRS regarding the U.S. federal income tax consequences discussed below; thus, there can be no assurancethat the IRS will not challenge the U.S. federal income tax treatment described below or that, if challenged, such treatment willbe sustained by a court.
This summary is limited toconsiderations relevant to U.S. Holders that hold the Company Securities as “capital assets” within the meaning of section1221 of the Code (generally, property held for investment). This discussion does not address all aspects of U.S. federal income taxationthat may be important to holders in light of their individual circumstances, including holders subject to special treatment under theU.S. tax laws, such as, for example:
| ● | banks or other financial institutions, underwriters, or insurance companies; |
| ● | traders in securities who elect to apply a mark-to-market method of accounting; |
| ● | real estate investment trusts and regulated investment companies; |
| ● | tax-exempt organizations, qualified retirement plans, individual retirement accounts, or other tax- deferred accounts; |
| ● | expatriates or former citizens or long-term residents of the United States; |
| ● | subchapter S corporations, partnerships or other pass-through entities or investors in such entities; |
| ● | any holder that is not a U.S. Holder; |
| ● | dealers or traders in securities, commodities or currencies; |
| ● | persons subject to the alternative minimum tax; |
| ● | U.S. persons whose “functional currency” is not the U.S. dollar; |
| ● | persons who receive stock of the Company through the issuance of restricted share under an incentive plan or through a tax-qualified retirement plan or otherwise as compensation; |
| ● | U.S. shareholders of controlled foreign corporations, as those terms are defined in Sections 951(b) and 957(a), respectively; |
| ● | persons who own (directly or through attribution) 5% or more (by vote or value) of the outstanding Class A Ordinary Shares (excluding treasury shares); |
| ● | holders holding ASCA securities, or, after the Business Combination, the Company Securities, as a position in a “straddle,” as part of a “synthetic security” or “hedge,” as part of a “conversion transaction,” or other integrated investment or risk reduction transaction. |
As used in this prospectus,the term “U.S. Holder” means a beneficial owner of the Company Securities, that is, for U.S. federal income taxpurposes:
| ● | an individual who is a citizen or resident of the United States; |
| ● | a corporation (or other entity that is classified as a corporation for U.S. federal income tax purposes) that is created or organized in or under the laws of the United States or any State thereof or the District of Columbia; |
| ● | an estate the income of which is subject to U.S. federal income tax regardless of its source; or |
| ● | a trust (i) if a court within the United States is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all substantial decisions of the trust, or (ii) that has a valid election in effect under applicable Treasury Regulations to be treated as a U.S. person for U.S. federal income tax purposes. |
If a partnership, includingfor this purpose any entity or arrangement that is treated as a partnership for U.S. federal income tax purposes, holds the CompanySecurities, the U.S. federal income tax treatment of a partner in such partnership will generally depend on the status of the partnerand the activities of the partnership. A holder that is a partnership and the partners in such partnership should consult their own taxadvisors with regard to the U.S. federal income tax consequences of ownership and disposition of the Company Securities.
THIS SUMMARY DOES NOT PURPORTTO BE A COMPREHENSIVE ANALYSIS OR DESCRIPTION OF ALL POTENTIAL U.S. FEDERAL INCOME TAX CONSEQUENCES OF OWNERSHIP AND DISPOSITIONOF THE COMPANY SECURITIES. IN ADDITION, THE U.S. FEDERAL INCOME TAX TREATMENT OF THE BENEFICIAL OWNERS OF THE COMPANY SECURITIESMAY BE AFFECTED BY MATTERS NOT DISCUSSED HEREIN AND DEPENDS IN SOME INSTANCES ON DETERMINATIONS OF FACT AND INTERPRETATIONS OF COMPLEXPROVISIONS OF U.S. FEDERAL INCOME TAX LAW FOR WHICH NO CLEAR PRECEDENT OR AUTHORITY MAY BE AVAILABLE. HOLDERS OF THE COMPANYSECURITIES SHOULD CONSULT WITH THEIR TAX ADVISORS REGARDING THE PARTICULAR TAX CONSEQUENCES TO THEM OF THE OWNERSHIP AND DISPOSITION OFTHE COMPANY SECURITIES, INCLUDING THE APPLICABILITY AND EFFECTS OF U.S. FEDERAL, STATE, LOCAL, AND OTHER TAX LAWS.
Distribution on the Class A Ordinary Shares
Subject to the PFIC rulesdiscussed below “— Passive Foreign Investment Company Status,” the gross amount of any distribution on the ClassA Ordinary Shares that is made out of the Company’s current and accumulated earnings and profits (as determined for U.S. federalincome tax purposes) will generally be taxable to a U.S. Holder as ordinary dividend income on the date such distribution is actuallyor constructively received by such U.S. Holder. Any such dividends paid to corporate U.S. Holders generally will not qualifyfor the dividends-received deduction that may otherwise be allowed under the Code.
Dividends received by non-corporateU.S. Holders, including individuals, from a “qualified foreign corporation” may be eligible for reduced rates of taxation,provided that certain holding period requirements and other conditions are satisfied. For these purposes, a non-U.S. corporationwill be treated as a qualified foreign corporation with respect to dividends paid by that corporation on shares that are readily tradableon an established securities market in the United States. U.S. Treasury Department guidance indicates that shares listed onNasdaq will be considered readily tradable on an established securities market in the United States. Even if the Class A OrdinaryShares are listed on Nasdaq, there can be no assurance that the Class A Ordinary Shares will be considered readily tradable on an establishedsecurities market in future years. Non-corporate U.S. Holders that do not meet a minimum holding period requirement or thatelect to treat the dividend income as “investment income” pursuant to Section 163(d)(4) of the Code (dealing with thededuction for investment interest expense) will not be eligible for the reduced rates of taxation regardless of the Company’s statusas a qualified foreign corporation. In addition, the rate reduction will not apply to dividends if the recipient of a dividend is obligatedto make related payments with respect to positions in substantially similar or related property. This disallowance applies even if theminimum holding period has been met. Finally, the Company will not constitute a qualified foreign corporation for purposes of these rulesif it is a PFIC for the taxable year in which it pays a dividend or for the preceding taxable year. See the discussion below under “— PassiveForeign Investment Company Status.
The amount of any dividendpaid in foreign currency will be the U.S. dollar value of the foreign currency distributed by the Company, calculated by referenceto the exchange rate in effect on the date the dividend is includible in the U.S. Holder’s income, regardless of whether thepayment is in fact converted into U.S. dollars on the date of receipt. Generally, a U.S. Holder should not recognize any foreigncurrency gain or loss if the foreign currency is converted into U.S. dollars on the date the payment is received. However, any gainor loss resulting from currency exchange fluctuations during the period from the date the U.S. Holder includes the dividend paymentin income to the date such U.S. Holder actually converts the payment into U.S. dollars will be treated as ordinary income orloss. That currency exchange income or loss (if any) generally will be income or loss from U.S. sources for foreign tax credit limitationpurposes.
To the extent that the amountof any distribution made by the Company on the Class A Ordinary Shares exceeds the Company’s current and accumulated earnings andprofits for a taxable year (as determined under U.S. federal income tax principles), the distribution will first be treated as atax-free return of capital, causing a reduction in the adjusted basis of the U.S. Holder’s the Class A Ordinary Shares, andto the extent the amount of the distribution exceeds the U.S. Holder’s tax basis, the excess will be taxed as capital gainrecognized on a sale or exchange as described below under “— Sale, Exchange, Redemption or Other Taxable Dispositionof the Company Securities.”
Sale, Exchange, Redemption or Other Taxable Disposition of the CompanySecurities
Subject to the discussionbelow under “— Passive Foreign Investment Company Status,” a U.S. Holder will generally recognize gain orloss on any sale, exchange, redemption, or other taxable disposition of the Class A Ordinary Shares and the Warrants in an amount equalto the difference between the amount realized on the disposition and such U.S. Holder’s adjusted tax basis in such the ClassA Ordinary Shares or Warrants. Any gain or loss recognized by a U.S. Holder on a taxable disposition of the Class A Ordinary Sharesor Warrants will generally be capital gain or loss and will be long-term capital gain or loss if the holder’s holding period inthe Class A Ordinary Shares or Warrants exceeds one year at the time of the disposition. Preferential tax rates may apply to long-termcapital gains of non-corporate U.S. Holders (including individuals). The deductibility of capital losses is subject to limitations.Any gain or loss recognized by a U.S. Holder on the sale or exchange of the Class A Ordinary Shares or the Warrants will generallybe treated as U.S. source gain or loss.
Exercise or Lapse of a Warrant
Except as discussed belowwith respect to the cashless exercise of a Warrant, a U.S. Holder generally will not recognize gain or loss upon the acquisitionof an ordinary share of the Company on the exercise of a Warrant for cash. A U.S. Holder’s tax basis in an ordinary share receivedupon exercise of the Warrant generally will be an amount equal to the sum of the U.S. Holder’s tax basis in the Warrant exchangedtherefor and the exercise price. The U.S. Holder’s holding period for an ordinary share received upon exercise of the Warrantwill begin on the date following the date of exercise (or possibly the date of exercise) of the Warrants and will not include the periodduring which the U.S. Holder held the Warrants. If a Warrant is allowed to lapse unexercised, a U.S. Holder generally will recognizea capital loss equal to such holder’s tax basis in the Warrant.
The tax consequences of acashless exercise of a warrant are not clear under current tax law. A cashless exercise may be tax-free, either because the exercise isnot a gain realization event or because the exercise is treated as a recapitalization for U.S. federal income tax purposes. In eithertax-free situation, a U.S. Holder’s basis in the Class A Ordinary Shares received would equal the holder’s basis in theWarrant. If the cashless exercise were treated as not being a gain recognition event, a U.S. Holder’s holding period in theClass A Ordinary Shares would be treated as commencing on the date following the date of exercise (or possibly the date of exercise) ofthe Warrant. If the cashless exercise were treated as a recapitalization, the holding period of the Class A Ordinary Share would includethe holding period of the Warrant.
It is also possible thata cashless exercise could be treated in part as a taxable exchange in which gain or loss would be recognized. In such event, a U.S. Holderwould recognize gain or loss with respect to the portion of the exercised Warrants treated as surrendered to pay the exercise price ofthe Warrants (the “surrendered warrants”). The U.S. Holder would recognize capital gain or loss with respect to the surrenderedwarrants in an amount generally equal to the difference between (i) the fair market value of the Class A Ordinary Shares that wouldhave been received with respect to the surrendered warrants in a regular exercise of the Warrants and (ii) the sum of the U.S. Holder’stax basis in the surrendered warrants and the aggregate cash exercise price of such warrants (if they had been exercised in a regularexercise). In this case, a U.S. Holder’s tax basis in the Class A Ordinary Shares received would equal the U.S. Holder’stax basis in the Warrants exercised plus (or minus) the gain (or loss) recognized with respect to the surrendered warrants. A U.S. Holder’sholding period for the Class A Ordinary Shares would commence on the date following the date of exercise (or possibly the date of exercise)of the Warrant.
Due to the absence of authorityon the U.S. federal income tax treatment of a cashless exercise, there can be no assurance which, if any, of the alternative taxconsequences and holding periods described above would be adopted by the IRS or a court of law. Accordingly, U.S. Holders shouldconsult their tax advisors regarding the tax consequences of a cashless exercise.
Passive Foreign Investment Company Status
Certain adverse U.S. federalincome tax consequences could apply to a U.S. Holder if the Company or any of its subsidiaries is treated as a PFIC for any taxableyear during which the U.S. Holder holds the Company Securities. A non-U.S. corporation will be classified as a PFIC for anytaxable year (a) if at least 75% of its gross income in a taxable year, including its pro rata share of the gross income of any entityin which it is considered to own at least 25% of the interest by value, is passive income, or (b) if at least 50% of its assets ina taxable year of the foreign corporation, ordinarily determined based on fair market value and averaged quarterly over the year, includingits pro rata share of the assets of any entity in which it is considered to own at least 25% of the interest by value, are held for theproduction of, or produce, passive income. Passive income generally includes dividends, interest, rents and royalties (other than rentsor royalties derived from the active conduct of a trade or business) and gains from the disposition of passive assets.
If the Company is not a PFICin the 2024 taxable year, such U.S. Holder would likely recognize gain (but not loss if the Reincorporation Merger qualifies as a“reorganization”) upon the exchange of ASCA securities for The Company securities pursuant to the Reincorporation Merger.The gain (or loss) would be computed as described above under “— If the Reincorporation Merger Does Not Qualify as aReorganization.” Any such gain recognized by such U.S. Holder on the exchange of ASCA securities for The Company securitieswould be allocated ratably over the U.S. Holder’s holding period for the ASCA securities. Such amounts allocated for the currenttaxable year and any taxable year prior to the first taxable year in which ASCA was a PFIC would be treated as ordinary income, and notas capital gain, in the U.S. Holder’s taxable year, and such amounts allocated to each other taxable year beginning with theyear that ASCA became a PFIC would be taxed at the highest tax rate in effect for each year to which the gain was allocated, togetherwith a special interest charge on the tax attributable to each such year.
Whether the Company is aPFIC for any taxable year is a factual determination that depends on, among other things, the composition of the Company’s incomeand assets, the market value of its assets, and potentially the composition of the income and assets of one or more of the Company’ssubsidiaries and the market value of their assets in that year. Whether a Company subsidiary is a PFIC for any taxable year is likewisea factual determination that depends on, among other things, the composition of the subsidiary’s income and assets and the marketvalue of such assets in that year. One or more changes in these factors may cause the Company and/or one or more of its subsidiaries tobecome a PFIC for a taxable year even though it has not been a PFIC for one or more prior taxable years. Whether the Company or a subsidiaryis treated as a PFIC for U.S. federal income tax purposes is a factual determination that must be made annually at the close of eachtaxable year and, thus, is subject to significant uncertainty. Moreover, there can be no assurance that the Company will timely providea PFIC annual information statement for 2024 or going forward. The failure to provide such information on an annual basis could precludeU.S. Holders from making or maintaining a “qualified electing fund” election under Section 1295 of the Code.
If the Company were determinedto be a PFIC for any taxable year (or portion thereof) that is included in the holding period of a U.S. Holder of Class A OrdinaryShares, the U.S. Holder did not make a valid “mark-to-market” election, such U.S. Holder generally will be subjectto special rules with respect to:
| ● | any gain recognized by the U.S. Holder on the sale or other disposition of the Company Securities (including a redemption treated as a sale or exchange); and |
| ● | any “excess distribution” made to the U.S. Holder (generally, any distributions to such U.S. Holder during a taxable year of the U.S. Holder that are greater than 125% of the average annual distributions received by such U.S. Holder in respect of the Class A Ordinary Shares during the three preceding taxable years of such U.S. Holder or, if shorter, such U.S. Holder’s holding period for such ordinary shares). |
Under these rules:
| ● | the U.S. Holder’s gain or excess distribution will be allocated ratably over the U.S. Holder’s Company Securities; |
| ● | the amount allocated to the U.S. Holder’s taxable year in which the U.S. holder recognized gain or received the excess distribution, or to the period in the U.S. Holder’s holding period before the first day of the Company’s first taxable year in the Company is a PFIC, will be taxed as ordinary income; |
| ● | the amount allocated to other taxable years (or portions thereof) of the U.S. Holder and included in its holding period will be taxed at the highest tax rate in effect for that year and applicable to the U.S. Holder; and |
| ● | the interest charge generally applicable to underpayments of tax will be imposed in respect of the tax attributable to each such other taxable year of the U.S. Holder. |
Although a determinationas to the Company’s PFIC status will be made annually, an initial determination that the Company is a PFIC will generally applyfor subsequent years to a U.S. Holder who held Company Securities while the Company was a PFIC, whether or not the Company meetsthe test for PFIC status in those subsequent years.
If a U.S. Holder, atthe close of its taxable year, owns shares in a PFIC that are treated as marketable stock, the U.S. Holder may make a mark-to-marketelection with respect to such shares for such taxable year. If the U.S. Holder makes a valid mark-to-market election for the firsttaxable year of the U.S. Holder in which the U.S. Holder holds (or is deemed to hold) the Class A Ordinary Shares and for whichthe Company is determined to be a PFIC, such holder generally will not be subject to the PFIC rules described above in respect tothe Class A Ordinary Shares as long as such shares continue to be treated as marketable stock. Instead, in general, the U.S. Holderwill include as ordinary income each year that the Company is treated as a PFIC the excess, if any, of the fair market value of its ClassA Ordinary Shares at the end of its taxable year over the adjusted basis in its Class A Ordinary Shares. The U.S. Holder also willbe allowed to take an ordinary loss in respect of the excess, if any, of the adjusted basis of its Class A Ordinary Shares over the fairmarket value of its Class A Ordinary Shares at the end of its taxable year (but only to the extent of the net amount of previously recognizedincome as a result of the mark-to-market election). The U.S. Holder’s adjusted tax basis in its Class A Ordinary Shares willbe adjusted to reflect any such income or loss amounts, and any further gain recognized on a sale or other taxable disposition of theClass A Ordinary Shares in a taxable year in which the Company is treated as a PFIC will be treated as ordinary income. Special tax rulesmay also apply if a U.S. Holder makes a mark-to-market election for a taxable year after the first taxable year in which the U.S. Holderholds (or is deemed to hold) its Class A Ordinary Shares and for which the Company is treated as a PFIC. Currently, a mark-to-marketelection may not be made with respect to the Warrants.
The mark-to-market electionis available only for stock that is regularly traded on a national securities exchange that is registered with the SEC, including Nasdaq(on which the Company Securities are traded), or on a foreign exchange or market that the IRS determines has rules sufficient toensure that the market price represents a legitimate and sound fair market value. Such stock generally will be “regularly traded”for any calendar year during which such stock is traded, other than in de minimis quantities, on at least 15 days during each calendarquarter, but no assurances can be given in this regard with respect to the Class A Ordinary Shares. U.S. Holders should consult theirown tax advisors regarding the availability and tax consequences of a mark-to-market election in respect of the Class A Ordinary Sharesunder their particular circumstances.
If the Company is a PFICand, at any time, has a foreign subsidiary that is classified as a PFIC, U.S. Holders generally would be deemed to own a portionof the shares of such lower-tier PFIC, and generally could incur liability for the deferred tax and interest charge described above ifthe Company were to receive a distribution from, or dispose of all or part of the Company’s interest in, the lower-tier PFIC (eventhough such U.S. Holder would not receive the proceeds of those distributions or dispositions) or the U.S. Holders otherwisewere deemed to have disposed of an interest in the lower-tier PFIC. A mark-to-market election generally would not be available withrespect to such lower-tier PFIC. U.S. Holders are urged to consult their own tax advisors regarding the tax issues raised bylower-tier PFICs.
A U.S. Holder that owns(or is deemed to own) shares in a PFIC during any taxable year of the U.S. Holder, may have to file an IRS Form 8621 (whetheror not a mark-to-market election is or has been made) with such U.S. Holder’s U.S. federal income tax return and provideany such other information as may be required by the U.S. Treasury Department. Failure to do so, if required, will extend the statuteof limitations until such required information is furnished to the IRS.
The rules dealing withPFICs and mark-to-market elections are very complex and are affected by various factors in addition to those described above. Accordingly,U.S. Holders of Company Securities should consult their own tax advisors concerning the application of the PFIC rules to theCompany Securities under the U.S. Holders’ particular circumstances.
Information Reporting and Backup Withholding
In general, information reportingrequirements may apply to dividends received by U.S. Holders of the Class A Ordinary Shares (including constructive dividends), andthe proceeds received on sale or other taxable disposition of the Class A Ordinary Shares or Warrants effected within the United States(and, in certain cases, outside the United States), in each case, other than U.S. Holders that are exempt recipients (such ascorporations). Backup withholding (currently at a rate of 24%) may apply to such amounts if the U.S. Holder fails to provide an accuratetaxpayer identification number (generally on an IRS Form W-9 provided to the paying agent or the U.S. Holder’s broker)or is otherwise subject to backup withholding.
Certain U.S. Holdersholding specified foreign financial assets with an aggregate value in excess of the applicable dollar threshold are required to reportinformation to the IRS relating to the Company Securities, subject to certain exceptions (including an exception for the Company Securitiesheld in accounts maintained by U.S. financial institutions), by attaching a complete IRS Form 8938, Statement of Specified ForeignFinancial Assets, with their tax return, for each year in which they hold the Company Securities. In addition to these requirements, U.S. Holdersmay be required to annually file FinCEN Report 114 (Report of Foreign Bank and Financial Accounts) with the U.S. Department of Treasury.U.S. Holders should consult their own tax advisors regarding information reporting requirements relating to their ownership of theCompany Securities.
Backup withholding is notan additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or credit against a holder’sU.S. federal income tax liability, if any, provided the required information is timely furnished to the IRS.
This summary does not contain a detailed descriptionof all the United States federal income tax consequences that may be applicable to you in light of your particular circumstances and,except as set forth below with respect to PRC tax considerations, does not address the effects of any state, local or non-United Statestax laws. If you are considering the purchase, ownership or disposition of our Ordinary Shares, you should consult your own tax advisorsconcerning the United States federal income tax consequences to you in light of your particular situation as well as any consequencesarising under the laws of any other taxing jurisdiction.
LEGAL MATTERS
Certain legal matters as toU.S. federal securities law concerning this offering will be passed upon for us by Sichenzia Ross Ference Carmel LLP, New York, New York.Certain legal matters as to BVI law will be passed upon for us by Ogier. Sichenzia Ross Ference Carmel LLP may rely upon Ogier with respectto matters governed by BVI law.
EXPERTS
The financial statementsof NewGenIvf Limited as of December 31, 2023 and for the year then ended included in this prospectus have been so included inreliance on the report of Onestop Assurance PAC, an independent registered public accounting firm, given on the authority of saidfirm as an expert in auditing and accounting. The financial statements of NewGenIvf Limited as of December 31, 2022 and 2021and forthe years then ended included in this prospectus have been so included in reliance on the report of WWC, P.C., an independentregistered public accounting firm, given on the authority of said firm as an expert in auditing and accounting.
EXPENSES
The following are the estimatedexpenses of the issuance and distribution of the securities being registered under the registration statement of which this prospectusforms a part, all of which will be paid by us. With the exception of the SEC registration fee, all amounts are estimates and may change:
SEC registration fee | | $ | 740.54 | |
Printer fees and expenses | | $ | 1,000 | * |
Legal fees and expenses | | $ | 40,000 | |
Miscellaneous | | $ | 5,000 | * |
Total | | $ | 46,741 | |
ENFORCEABILITY OF CIVIL LIABILITIES
We are incorporated underthe laws of the British Virgin Islands with limited liability. We are incorporated in the British Virgin Islands because of certain benefitsassociated with being a British Virgin Islands company, such as political and economic stability, an effective judicial system, a favorabletax system, the absence of exchange control or currency restrictions and the availability of professional and support services. However,the British Virgin Islands has a less developed body of securities laws as compared to the United States and provides protections forinvestors to a lesser extent. In addition, British Virgin Islands companies may not have standing to sue before the federal courts ofthe United States.
Substantially all of our assetsare located outside the United States. In addition, a majority of our directors and officers are nationals and/or residents of countriesother than the United States, and all or a substantial portion of such persons’ assets are located outside the United States. Asa result, it may be difficult for investors to effect service of process within the United States upon us or such persons or to enforceagainst them or against us, judgments obtained in United States courts, including judgments predicated upon the civil liability provisionsof the securities laws of the United States or any state thereof.
We have appointed CogencyGlobal Inc., as our agent to receive service of process with respect to any action brought against us in the United States District Courtfor districts in the State of New York under the federal securities laws of the United States or of any State of the United States orany action brought against us in the Supreme Court of the State of New York under the securities laws of the State of New York.
There is no statutory enforcementin the British Virgin Islands of judgments obtained in the U.S., however, the courts of the British Virgin Islands will in certain circumstancesrecognize such a foreign judgment and treat it as a cause of action in itself which may be sued upon as a debt at common law so that noretrial of the issues would be necessary, provided that:
| ● | the U.S. court issuing the judgment had jurisdiction in the matter and the company either submitted to such jurisdiction or was resident or carrying on business within such jurisdiction and was duly served with process; |
| | |
| ● | the judgment is final and for a liquidated sum; |
| | |
| ● | the judgment given by the U.S. court was not in respect of penalties, taxes, fines or similar fiscal or revenue obligations of the company; |
| ● | in obtaining judgment there was no fraud on the part of the person in whose favor judgment was given or on the part of the court; |
| ● | recognition or enforcement of the judgment in the British Virgin Islands would not be contrary to public policy; and |
| | |
| ● | the proceedings pursuant to which judgment was obtained were not contrary to natural justice. |
The British Virgin Islands courts are unlikely:
| ● | to recognize or enforce against the Company, judgments of courts of the U.S. based on certain civil liability provisions of U.S. securities laws where that liability is in respect of penalties,taxes, fines or similar fiscal or revenue obligations of the company; and |
| | |
| ● | to impose liabilities against the Company, in original actions brought in the British Virgin Islands, based on certain civil liability provisions of U.S.securities laws that are penal in nature. |
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the SECa registration statement on Form F-1 under the Securities Act relating to this registration of the Ordinary Shares to be sold bythe Selling Shareholders, or the Registration Statement. This prospectus, which is part of the Registration Statement, does not containall of the information contained in the Registration Statement. The rules and regulations of the SEC allow us to omit certain informationfrom this prospectus that is included in the Registration Statement. Statements made in this prospectus concerning the contents of anycontract, agreement or other document are summaries of all material information about the documents summarized, but are not complete descriptionsof all terms of these documents. If we filed any of these documents as an exhibit to the Registration Statement, you may read the documentitself for a complete description of its terms.
The SEC also maintains anInternet website that contains reports and other information regarding issuers that file electronically with the SEC. Our filings withthe SEC are also available to the public through the SEC’s website at www.sec.gov.
We are not currently subjectto the information reporting requirements of the Exchange Act. In connection with when the Registration Statement is declared effectiveby the SEC, we will become subject to the information reporting requirements of the Exchange Act that are applicable to foreign privateissuers. Accordingly, we will be required to file or furnish reports and other information with the SEC. Those other reports or otherinformation may be inspected without charge at the locations described above. As a foreign private issuer, we are exempt from the rules underthe Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders areexempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, weare not required under the Exchange Act to file annual, quarterly, and current reports and financial statements with the SEC as frequentlyor as promptly as United States companies whose securities are registered under the Exchange Act. However, we will file with the SEC,within 120 days after the end of each fiscal year, or such applicable time as required by the SEC, an annual report on Form 20-Fcontaining financial statements audited by an independent registered public accounting firm, and intend to submit to the SEC, on Form 6-K,unaudited interim financial information.
We maintain a corporate websiteat www.newgenivf.com. Information contained on, or that can be accessed through, our website does not constitute a part of this prospectus.We have included our website address in this prospectus solely as an inactive textual reference. We will post on our website any materialsrequired to be so posted on such website under applicable corporate or securities laws and regulations, including, posting any XBRL interactivefinancial data required to be filed with the SEC and any notices of general meetings of our shareholders.
MATERIAL CHANGES
Except as otherwise describedin our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, and our current reports on Form 6-K filedor submitted under the Exchange Act and incorporated by reference herein and as disclosed in this prospectus, no reportable material changeshave occurred since December 31, 2023.
INCORPORATION BY REFERENCE
TheSEC allows us to incorporate by reference much of the information that we file with the SEC, which means that we can disclose importantinformation to you by referring you to those publicly available documents. The information that we incorporate by reference in this prospectusis considered to be part of this prospectus. This prospectus incorporates by reference the documents listed below (other than any portionsof such documents that are not deemed “filed” under the Exchange Act in accordance with the Exchange Act and applicable SECrules):
Anyinformation contained in this prospectus or in any document incorporated by reference in this prospectus will be deemed to be modifiedor superseded to the extent that a statement contained in any prospectus supplement or free writing prospectus provided to you by us modifiesor supersedes the original statement.
Thereports and documents incorporated by reference into this prospectus are available to the public free of charge on the investor relationsportion of our website located at www.newgenivf.com. You may also request a copy of these filings, at no cost, by writing to usat the following addresses:
NewGenIvf Group Limited
1/F, Pier 2, Central
Hong Kong, 999077
Tel: +1 (212) 537-4406
Email: alfred.siu@newgenivf.com
5,912,281 Ordinary Shares
NewGenIvf Group Limited
PROSPECTUS
,2024
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 6. Indemnification of Directors, Officersand Employees
British Virgin Islandslaw does not limit the extent to which a company’s memorandum and articles of association may provide for indemnification ofofficers and directors, except to the extent any such provision may be held by the British Virgin Islands courts to be contrary topublic policy, such as to provide indemnification against willful default, civil fraud or the consequences of committing a crime.Under our Memorandum and Articles of Association, we may indemnify its directors, officers and liquidators against all expenses,including legal fees, and against all judgments, fines and amounts paid in settlement and reasonably incurred in connection withcivil, criminal, administrative or investigative proceedings to which they are party or are threatened to be made a party by reasonof their acting as our director, officer or liquidator. To be entitled to indemnification, these persons must have acted honestlyand in good faith with a view to the best interest of the registrant and, in the case of criminal proceedings, they must have had noreasonable cause to believe their conduct was unlawful.
Insofar as indemnification for liabilities arisingunder the Securities Act of 1933 may be permitted to directors, officers or persons controlling the registrant pursuant to theforegoing provisions, the registrant has been informed that in the opinion of the Securities and Exchange Commission such indemnificationis against public policy as expressed in the Securities Act and is therefore unenforceable.
Item 7. Recent Sales of Unregistered Securities
Set forth below are the salesof all securities by the Company since the closing of the Business Combination which were not registered under the Securities Act. TheCompany believes that each of such issuances was exempt from registration under the Securities Act in reliance on Section 4(a)(2) ofthe Securities Act.
On April 3, 2024, the dateof Closing, the Company issued to JAK Opportunities VI LLC 295,000 Ordinary Shares which were converted from the ordinary shares of LegacyNewGenIvf pursuant to the terms of the Securities Purchase Agreement by and between A SPAC I Mini Acquisition Corp. and JAK OpportunitiesVI LLC on February 29, 2024. Pursuant to this Securities Purchase Agreement, A SPAC I Mini Acquisition Corp agreed to issue and sell toJAK Opportunities VI LLC, in a private placement, an aggregate of up to $3,500,000 principal amount of convertible notes, consisting ofone or more tranches: (i) an initial tranche of an aggregate principal amount of promissory notes of up to $1,750,000 and including anoriginal issue discount of up to aggregate $122,500, and (ii) subsequent tranches of an aggregate principal amount of promissory notesof up to $1,750,000 and including an original issue discount of up to aggregate $122,500. The closing of the Initial Tranche took placeon April 3, 2024. The Company also closed on a subsequent tranche of the aforementioned promissory notes in the principal amount of $250,000by issuing and selling to JAK Opportunities VI LLC shortly after the closing of the Business Combination, resulting in an aggregate principalamount of notes of $2,000,000 sold to JAK Opportunities VI LLC. The form of these promissory notes is included as Exhibit 4.2 of the Form6-K filed on April 4, 2024. The aforementioned Securities Purchase Agreement is included as Exhibit 4.1 of the Form 6-K filed on April4, 2024.
2024 Debt Financing
On August 7, 2024, the Companyentered into a Securities Purchase Agreement (“Securities Purchase Agreement”) with certain investors named therein (collectively,the “Buyers”), pursuant to which, amongst other things: (i) the Company agreed to sell, at an initial closing with JAK OpportunitiesVI LLC (and such initial closing, the “Initial Closing”), (a) a senior convertible note (the “Initial Note”) inthe aggregate original principal amount not exceeding $1,100,000 and convertible into a maximum of 1,417,832 Ordinary Shares pursuantto its terms), (b) a warrant to purchase 1,325,301 Ordinary Shares (such warrant, the “Series A Warrant:), and (c) a warrant topurchase 180,722 Class B Ordinary Shares, no par value (the “Series B Warrant,” and the Series B Warrants, together with theSeries A Warrants, the “Warrants”); and (ii) the Company may require each Buyer (or each Buyer may require the Company, asapplicable) to participate in the sale of (a) one or more additional convertible notes (which aggregate original principal amount forall additional convertible notes shall not exceed $9,500,000) (the “Additional Notes,” and, together with the Initial Note,the “Notes”). The Securities Purchase Agreement is filed as Exhibit 4.1 of the Company’s current report on Form 6-Kdated August 16, 2024 and is incorporated by reference herein. The Initial Note is filed as Exhibit 10.25 of this registration statement.
Additionally, in connectionwith the Securities Purchase Agreement, the Company entered into amendment and exchange agreements with certain holders of its convertiblepromissory notes (the “Existing Notes” and each of such amendment and exchange agreements, “Amendment and Exchange Agreement”),pursuant to which the Company exchanged the Existing Notes by issuing, among other things, (i) senior convertible notes in the aggregateprincipal amount of $2,700,000 (the “Exchange Notes”) and (b) a series of warrants to initially acquire up to a certain numberof ordinary shares to the holders of the Existing Notes set forth therein or in the Amendment and Exchange Agreement (the “ExchangeWarrants”). The form of the Amendment and Exchange Agreement, the form of Exchange Notes, and the form of Exchange Warrants arefiled as Exhibits 4.2, 4.3, and 4.4 to the Form 6-K dated August 16, 2024, and are incorporated herein by reference.
Initial Closing
On August 12, 2024, the Companyand JAK Opportunities VI LLC consummated the Initial Closing. The Initial Note sold to JAK in connection with the Securities PurchaseAgreement bears an interest rate of 14.75% per annum and is convertible into the Company’s Ordinary Shares as follows: the ConversionAmount (as defined below) into validly issued, fully paid and non-assessable Class A at the Conversion Rate (as defined below). No fractionalClass A Shares are issuable upon any such conversion. The form of the Initial Note is included as Exhibit A of the Securities PurchaseAgreement filed as Exhibit 4.1 in the Form 6-K dated August 15, 2024.
“Conversion Amount”means 110% of the sum of (A) the portion of the principal of the Initial Note, (B) accrued and unpaid interest with respect to such principalowed on the Initial Note (and as reduced pursuant to the of the Initial Note pursuant to redemption, conversion or otherwise, the “Principal”)(C) the Make-Whole Amount, if any, (D) accrued and unpaid Late Charges (as defined below) with respect to the Principal on the InitialNote, Make-Whole Amount and Interest, and (E) any other unpaid amounts pursuant to the Transaction Documents, as may be amended from timeto time., if any.
“Conversion Rate”means the amount of Ordinary Shares issuable upon conversion of any Conversion Amount pursuant to the Initial Note determined by dividing(x) such Conversion Amount by (y) the Conversion Price.
“Conversion Price” means, as of anyConversion Date or other date of determination, $0.83, subject to adjustment as provided in the Initial Note.
“Late Charge”means a late charge incurred and payable by the Company in an amount equal to interest on such amount at the rate of eighteen percent(18%) per annum from the date such amount was due until the same is paid in full, if “Make-Whole Amount” means, as of anygiven date and as applicable, in connection with any conversion, redemption or other repayment hereunder, an amount equal to the amountof additional interest that would accrue under the Initial Note at the interest rate then in effect assuming for calculation purposesthat the outstanding Principal of the Initial Note as of the closing date remained outstanding through and including the maturity date.
“Make-Whole Amount”means, as of any given date and as applicable, in connection with any conversion, redemption or other repayment under the Initial Note,an amount equal to the amount of additional interest that would accrue under the Initial Note at the interest rate then in effect assumingfor calculation purposes that the outstanding Principal of the Initial Note as of the Closing Date remained outstanding through and includingthe maturity date.
At the Initial Closing, theCompany also sold to JAK Opportunities VI LLC a Series A Warrant to purchase 1,325,301 Class A Shares and a Series B Warrant to purchase180,722 Class B Shares. The form of the Series A Warrant and form of the Series B Warrant are included as Exhibit B of the SecuritiesPurchase Agreement included as Exhibit 4.1 in the Form 6-K filed on August 16, 2024, which is incorporate herein by reference.
Second Tranche
On August 28, 2024, the Companyclosed on the second tranche of the 2024 Debt Financing pursuant to the terms of the Securities Purchase Agreement. Under the second tranche,the Company sold a senior convertible promissory note to JAK Opportunities VI LLC in the principal amount of $500,000. This promissorynote bears an interest rate of 14.75% per annum and is convertible into a maximum of 875,658 Ordinary Shares pursuant to its terms. Thispromissory note is included as Exhibit 4.1 in the Form 6-K filed on August 30, 2024.
Financial Statement Schedules:
All financial statement scheduleshave been omitted because either they are not required, are not applicable or the information required therein is otherwise set forthin the Company’s financial statements and related notes thereto.
Item 8. Exhibits and Financial Statement Schedules
Exhibit No. | | Description |
3.1 | | Amended and Restated Memorandum and Articles of Association of PubCo (incorporated by reference to Annex B of PubCo’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
4.1 | | Specimen Class A Ordinary Share Certificate of the Company (incorporated by reference to Exhibit 2.1 of the report on Form 20-F filed with the Securities and Exchange Commission on April 9, 2024) |
4.2 | | Specimen Warrant Certificate of the Company (incorporated by reference to Exhibit 2.2 of the report on Form 20-F filed with the Securities and Exchange Commission on April 9, 2024) |
4.3 | | Warrant Agreement, dated February 14, 2022, by and between ASCA and Continental Stock Transfer & Trust Company (incorporated by reference to Exhibit 4.2 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on February 18, 2022) |
4.4 | | Form of Assumption of Warrant Agreement (incorporated by reference to Exhibit 4.7 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
5.1** | | Opinion of Ogier |
10.1 | | Merger Agreement, dated as of February 15, 2023, by and among ASCA, NewGenIvf Limited, certain shareholders of NewGenIvf Limited, A SPAC I Mini Acquisition Corp., and A SPAC I Mini Sub Acquisition Corp. (incorporated by reference to Exhibit 2.1 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on February 16, 2023) |
10.2 | | First Amendment to the Merger Agreement, dated June 12, 2023, by and among ASCA, NewGenIvf Limited, Principal Shareholders, A SPAC I Mini Acquisition Corp. and A SPAC I Mini Sub Acquisition Corp. (incorporated by reference to Exhibit 2.1 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on June 13, 2023) |
10.3 | | Second Amendment to the Merger Agreement, dated December 6, 2023, by and among ASCA, NewGenIvf Limited, Principal Shareholders, A SPAC I Mini Acquisition Corp. and A SPAC I Mini Sub Acquisition Corp. (incorporated by reference to Exhibit 2.1 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on December 6, 2023) |
10.4 | | Third Amendment to the Merger Agreement, dated March 1, 2024, by and among ASCA, NewGenIvf Limited, Principal Shareholders, A SPAC I Mini Acquisition Corp. and A SPAC I Mini Sub Acquisition Corp. (incorporated by reference to Exhibit 2.1 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on March 6, 2024) |
10.5 | | Stock Escrow Agreement, dated February 14, 2022 by and between ASCA and Continental Stock Transfer & Trust Company (incorporated by reference to Exhibit 10.5 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on February 18, 2022) |
10.6 | | Voting and Support Agreement, dated as of February 15, 2023, by and among A SPAC I Acquisition Corp., A SPAC I Mini Acquisition Corp., NewGenIvf Limited, and certain shareholders of NewGenIvf Limited (incorporated by reference to Exhibit 10.1 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on February 16, 2023) |
10.7 | | Form of Amended and Restated Registration Rights Agreement (incorporated by reference to Exhibit 10.2 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on February 16, 2023) |
10.8 | | Form of Lock-Up Agreement (incorporated by reference to exhibit 4.8 of the Company’s report on Form 20-F filed with the SEC on April 9, 2024) |
10.9 | | Securities Purchase Agreement, dated February 29, 2024, by and among ASCA, The Company, Legacy NewGenIvf, the Buyers and Merger Sub (incorporated by reference to Exhibit 10.1 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on March 6, 2024) |
10.10 | | Form of Note between The Company and the Buyers (incorporated by reference to Exhibit 10.2 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on March 6, 2024) |
10.11 | | Acknowledgement Agreement, dated March 1, 2024, by and among ASCA, Legacy NewGenIvf and Chardan (incorporated by reference to Exhibit 10.3 to ASCA’s Current Report on Form 6-K filed with the Securities and Exchange Commission on March 6, 2024) |
10.12 | | Power Generator Lease Contract, dated January 10, 2021, between BD & H TECH Co., LTD. and First Fertility Phnom Penh Ltd (English Translation) (incorporated by reference to Exhibit 10.19 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.13 | | Property Lease Contract, dated June 22, 2020, between SOK HEANG and First Fertility Phnom Penh Ltd (English Translation) (incorporated by reference to Exhibit 10.20 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.14 | | MicroSort Lease and Services Agreement, dated March 29, 2019, between First Fertility Phnom Penh Ltd and MicroSort International (incorporated by reference to Exhibit 10.21 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.15 | | Management and Administrative Services Agreement, dated November 1, 2022, between First Fertility PGS Center Ltd and Med Holdings Ltd (incorporated by reference to Exhibit 10.22 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.16 | | MicroSort Lease and Services Agreement, dated April, 8, 2019, between First Fertility PGS Center Ltd. and MicroSort International (incorporated by reference to Exhibit 10.23 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.17 | | Medical Consulting Service Agreement, dated January 1, 2021, between First Fertility PGS Center Ltd and First Fertility Phnom Penh Ltd (incorporated by reference to Exhibit 10.24 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.18 | | Receivables Purchase Agreement, dated December, 28, 2022, between First Fertility PGS Center Ltd and Mr. Siu, Wing Fung Alfred (incorporated by reference to Exhibit 10.25 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.19 | | Master Services Agreement, dated December 21, 2022, between First Fertility PGS Center Ltd and First Fertility Phnom Penh Ltd (incorporated by reference to Exhibit 10.26 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.20 | | Form of Agreement for Storage of Embryos, Eggs, and Sperms Service between First Fertility PGS Center Ltd and Reproductive Expert Co Ltd (incorporated by reference to Exhibit 10.27 to the Company’s registration statement on Form F-4 (File No. 333-275208), filed with the Securities and Exchange Commission on October 27, 2023) |
10.21 | | Form of NewGenIvf Group Limited 2024 Share Incentive Plan (incorporated by reference to exhibit 4.21 of the Company’s report on Form 20-F filed with the SEC on April 9, 2024) |
10.22 | | Securities Purchase Agreement between A SPAC I Mini Acquisition Corp. and JAK Opportunities VI LLC dated February 29, 2024 (incorporated by reference to Exhibit 4.1 of the Company’s current report on Form 6-K filed with the SEC on April 4, 2024) |
10.23 | | Form of Note between A SPAC I Mini Acquisition Corp. and JAK Opportunities VI LLC dated February 29, 2024 (incorporated by reference to Exhibit 4.2 of the Company’s current report on Form 6-K filed with the SEC on April 4, 2024) |
10.24 | | Securities Purchase Agreement between the Company and certain buyers dated August 7, 2024 (incorporated by reference to Exhibit 4.1 of the Company’s current report on Form 6-K filed with the SEC on August 16, 2024) |
10.25 | | Form of Note between the Company and JAK Opportunities VI LLC dated August 7, 2024 |
10.26 | | Form of Note between the Company and JAK Opportunities VI LLC dated August 28, 2024 (incorporated by reference to Exhibit 4.1 of the Company’s current report on Form 6-K filed with the SEC on August 30, 2024) |
16.1 | | Letter from WWC, P.C. regarding Item 16F of Form 20-F (incorporated by reference to Exhibit 16.1 of the Company’s annual report on Form 20-F filed with the SEC on August 20, 2024) |
21.1** | | List of Subsidiaries |
23.1* | | Consent Letter from WWC, P.C. |
23.2* | | Consent Letter from Onestop Assurance PAC |
23.3** | | Consent of Ogier (included in Exhibit 5.1) |
24.1* | | Power of Attorney |
97.1 | | Clawback Policy of the Company. (incorporated by reference to Exhibit 97.1 of the Company’s annual report on Form 20-F filed with the SEC on August 20, 2024) |
101.INS* | | Inline XBRL Instance Document. |
101.SCH* | | Inline XBRL Taxonomy Extension Schema Document. |
101.CAL* | | Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
101.DEF* | | Inline XBRL Taxonomy Extension Definition Linkbase Document. |
101.LAB* | | Inline XBRL Taxonomy Extension Label Linkbase Document. |
101.PRE* | | Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
104* | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
107* | | Fee Table |
* | Filed herewith. |
** | To be filed via an amendment |
Item 9. Undertakings
(a) | The undersigned Registrant hereby undertakes: |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
i. | To include any prospectus required by section 10(a)(3) of the Securities Act of 1933; |
ii. | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; |
iii. | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement. |
(2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act need not be furnished, provided that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph (a)(4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, with respect to registration statements on Form F-3, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Act or Rule 3-19 of this chapter if such financial statements and information are contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the Form F-3. |
(5) | That for purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4), or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective. |
(6) | That for the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(b) | Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the U.S. Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue. |
SIGNATURES
Pursuant to the requirementsof the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirementsfor filing on Form F-1 and has duly caused this registration statement on Form F-1 to be signed on its behalf by the undersigned,thereunto duly authorized, on September 6, 2024.
NEWGENIVF GROUP LIMITED | |
| | |
By: | /s/ Wing Fung Alfred Siu | |
| Wing Fung Alfred Siu | |
| Chief Executive Officer | |
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each personwhose signature appears below constitutes and appoints Wing Fung Alfred Siu his true and lawful attorney-in-fact, with full power ofsubstitution and resubstitution for him and in his name, place and stead, in any and all capacities to sign any and all amendments includingpost-effective amendments to this registration statement, and to file the same, with all exhibits thereto, and other documents in connectiontherewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorney-in-fact or his substitute,each acting alone, may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirementsof the Securities Act of 1933, this amendment to the registration statement on Form F-1 has been signed by the following persons in thecapacities and on the dates indicated.
Signature | | Title | | Date |
| | | | |
/s/ Wing Fung Alfred Siu | | Chief Executive Officer and Director, | | September 6, 2024 |
Wing Fung Alfred Siu | | (Principal Executive Officer) | | |
| | | | |
/s/ Hei Yue Tina Fong | | Director, Chief Marketing Officer | | September 6, 2024 |
Hei Yue Tina Fong | | | | |
| | | | |
/s/ Hok Man Jefferson Au | | Independent Director | | September 6, 2024 |
Hok Man Jefferson Au | | | | |
| | | | |
/s/ Yip Eng Jeremy Foo | | Independent Director | | September 6, 2024 |
Yip Eng Jeremy Foo | | | | |
| | | | |
/s/ Wai Yip Raymond Chiu | | Chief Financial Officer | | September 6, 2024 |
Wai Yip Raymond Chiu | | | | |
SIGNATURE OF AUTHORIZED REPRESENTATIVE IN THEUNITED STATES
Pursuant to the SecuritiesAct of 1933, as amended, the undersigned, the duly authorized representative in the United States of America of NewGenIvf Group Limited,has signed this registration statement in New York, NY on September 6, 2024.
| COGENCY GLOBAL INC. |
| |
| By: | /s/ Colleen A. De Vries |
| Name: | Colleen A. De Vries |
| Title: | Senior Vice President on behalf of Cogency Global Inc. |
NEWGENIVF LIMITED
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTINGFIRM
To: | The Board of Directors and Shareholders of NewGenIvf Limited |
Opinion on the Financial Statements
We have audited the accompanying consolidatedbalance sheets of NewGenIvf Limited and its subsidiaries (collectively the “Company”) as of December 31, 2021 and 2022,and the related consolidated statements of operations and comprehensive income (loss), changes in shareholders’ equity (deficit),and cash flows in each of the years for the two-year period ended December 31, 2022, and the related notes (collectivelyreferred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financialposition of the Company as of December 31, 2021 and 2022, and the results of its operations and its cash flows for each of the yearsin the two-year period ended December 31, 2022, in conformity with accounting principles generally accepted in the United Statesof America.
Restatement of Previously Issued FinancialStatements
As discussed in Note 2, the Company has restatedits consolidated financial statements as of December 31, 2021 and 2022, and for the years then ended.
Correction of errors in the classificationof subscription receivable
The Company had previously erroneously presentedsubscription receivable as an asset; that classification was incorrect. According to Article 5-02.29 of Regulation S-X, subscription receivableshould be presented as a deduction from equity rather than an asset. The Company has reassessed the classification of subscription receivableand has determined that it should be deducted from equity.
Recognition of directors’ remunerationfor principal shareholders
The Company has previously recorded no directors’remuneration to Mr. Siu Wing Fung, Alfred and Ms. Fong Hei Yue, Tina, who are concurrently directors and principal shareholders ofthe Company. The absent of cost recognition was incorrect. According to SAB Topics 1:B and 5.T., principal shareholders not receivingcompensation for their time and effort serving as directors are making a capital contribution to the Company. The Company has reassessedthe fair value of services rendered by these directors and has determined that it should be recorded as an operating expense and additionalpaid-in capital.
Emphasis of Matter — Going Concern
The accompanying financial statements have beenprepared assuming that the Company will continue as a going concern. As of December 31, 2021, the Company had a working capital deficitand shareholders’ deficit, accordingly, these factors gave rise to substantial doubt that the Company would continue as a goingconcern. As of December 31, 2022, the Company had an improvement in its capital position where the Company had net positive shareholders’equity position, but the Company still had a working capital deficit; accordingly, the Company had not alleviated the substantial doubtthat it would continue as a going concern. Management closely monitors the Company’s financial position and result of operationsand has prepared a plan that includes raising additional capital and implementing improvements to increase profitability to address thissubstantial doubt. Details of this plan are also found in Note 1. These financial statements do not include any adjustments that mightresult from the outcome of this uncertainly.
Basis for Opinion
These consolidated financial statements are theresponsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financialstatements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and theapplicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with thestandards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether theconsolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have,nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtainan understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness ofthe Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assessthe risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing proceduresthat respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in theconsolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made bymanagement, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits providea reasonable basis for our opinion.
/s/ WWC, P.C.
WWC, P.C.
Certified Public Accountants
PCAOB ID No.1171
San Mateo, California
September 28, 2023
We have served as the Company’s auditorsince 2022.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTINGFIRM
To: | The Board of Directors and Shareholders of Newgenivf Limited |
Opinion on the Financial Statements
We have audited the accompanyingconsolidated balance sheet of Newgenivf Limited and its subsidiaries (collectively, the “Company”) as of December 31, 2023,the related consolidated statements of operations and comprehensive income, shareholders’ equity, and cash flows for the year endedDecember 31, 2023, and the related notes to the consolidated financial statements and schedule (collectively, the financial statements).In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December31, 2023, and the results of its operations and its cash flows for the year ended December 31, 2023, in conformity with accounting principlesgenerally accepted in the United States of America.
Material Uncertainty relating to Going Concern
Theaccompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1to the financial statements, the Company had bank balance of $54,104 as of December 31, 2023 and for the year ended December 31,2023, the Company had operating cash outflows of $1,766,135. This raises substantial doubt about its ability to continue as agoing concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financialstatements do not include any adjustments that might result from the outcome of this uncertainty. Our opinion is not modified inrespect of this matter.
Basis for Opinion
These financial statements arethe responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB)and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rulesand regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordancewith the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whetherthe financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor werewe engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understandingof internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’sinternal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performingprocedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing proceduresthat respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in thefinancial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management,as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis forour opinion.
/s/ Onestop Assurance PAC
We have served as the Company’s auditor since2024.
Singapore
August 16, 2024
NEWGENIVF LIMITED
CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2023 AND 2022
(Stated in US Dollars)
| | 2023 | | | 2022 | |
ASSETS | | | | | | | | |
Current assets | | | | | | | | |
Cash and cash equivalents | | $ | 54,104 | | | $ | 27,556 | |
Accounts receivable, net | | | 9,374 | | | | 13,000 | |
Inventories | | | 126,264 | | | | 46,910 | |
Deposits, prepayment, other receivables and deferred IPO cost, net | | | 517,429 | | | | 70,285 | |
Loan to A SPAC I | | | 140,000 | | | | — | |
Due from shareholders | | | 354,285 | | | | 2,240,872 | |
Total current assets | | | 1,201,456 | | | | 2,398,623 | |
| | | | | | | | |
Non-current assets | | | | | | | | |
Plant and equipment, net | | | 162,157 | | | | 122,673 | |
Right-of-use assets, net | | | 283,847 | | | | 383,670 | |
Total non-current assets | | | 446,004 | | | | 506,343 | |
| | | | | | | | |
TOTAL ASSETS | | $ | 1,647,460 | | | $ | 2,904,966 | |
| | | | | | | | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
Current liabilities | | | | | | | | |
Accounts payable | | $ | 172,626 | | | $ | 104,651 | |
Accrued liabilities and other payables | | | 241,613 | | | | 289,777 | |
Contract liabilities | | | 7,937 | | | | 1,360,168 | |
Due to a related party | | | — | | | | 110,773 | |
Operating lease liabilities, current | | | 207,128 | | | | 184,651 | |
Finance lease liabilities, current | | | 6,446 | | | | 18,758 | |
Taxes payable | | | 486,706 | | | | 486,872 | |
Total current liabilities | | | 1,122,456 | | | | 2,555,650 | |
| | | | | | | | |
Non-current liabilities | | | | | | | | |
Operating lease liabilities, non-current | | | 118,979 | | | | 242,187 | |
Finance lease liabilities, non-current | | | — | | | | 6,446 | |
Total non-current liabilities | | | 118,979 | | | | 248,633 | |
| | | | | | | | |
Total liabilities | | $ | 1,241,435 | | | $ | 2,804,283 | |
| | | | | | | | |
Shareholders’ equity | | | | | | | | |
Ordinary shares, $0.01 par value, 5,000,000 shares authorized; 698,123 and 601,830 shares issued and outstanding as of December 31, 2023 and 2022, respectively | | $ | 6,981 | | | $ | 6,018 | |
Subscription receivable | | | (2,967,100 | ) | | | (319,872 | ) |
Additional paid-in capital | | | 4,324,834 | | | | 1,458,941 | |
Accumulated deficit | | | (461,351 | ) | | | (591,544 | ) |
Accumulated other comprehensive (loss) income | | | (7,288 | ) | | | 9,570 | |
Equity attributable to the shareholders of the Company | | | 896,076 | | | | 563,113 | |
Non-controlling interests | | | (490,051 | ) | | | (462,430 | ) |
Total shareholders’ equity | | | 406,025 | | | | 100,683 | |
| | | | | | | | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | | $ | 1,647,460 | | | $ | 2,904,966 | |
The accompanying notes are an integral part ofthese consolidated financial statements.
NEWGENIVF LIMITED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
(Stated in US Dollars)
| | 2023 | | | 2022 | | | 2021 | |
Revenues | | $ | 5,136,153 | | | $ | 5,944,190 | | | $ | 4,118,120 | |
Cost of revenues | | | (3,454,368 | ) | | | (4,406,421 | ) | | | (3,093,340 | ) |
Gross profit | | | 1,681,785 | | | | 1,537,769 | | | | 1,024,780 | |
| | | | | | | | | | | | |
Operating expenses | | | | | | | | | | | | |
Selling and marketing expenses | | | (18,030 | ) | | | (36,194 | ) | | | (24,693 | ) |
General and administrative expenses | | | (1,259,364 | ) | | | (1,094,962 | ) | | | (801,329 | ) |
Audit fees | | | (362,149 | ) | | | (7,908 | ) | | | - | |
| | | | | | | | | | | | |
Total operating expenses | | | (1,639,543 | ) | | | (1,139,064 | ) | | | (826,022 | ) |
| | | | | | | | | | | | |
Operating income | | | 42,242 | | | | 398,705 | | | | 198,758 | |
| | | | | | | | | | | | |
Other income (expenses), net | | | | | | | | | | | | |
Other income, net | | | 111,837 | | | | 23,019 | | | | 45,652 | |
Interest income | | | 518 | | | | 21 | | | | 63 | |
Interest expense | | | (46,179 | ) | | | (77,757 | ) | | | (88,289 | ) |
Total other income (expenses), net | | | 66,176 | | | | (54,717 | ) | | | (42,574 | ) |
| | | | | | | | | | | | |
Income before taxes | | | 108,418 | | | | 343,988 | | | | 156,184 | |
Provision for income taxes | | | — | | | | (208,141 | ) | | | (294,716 | ) |
Net income (loss) | | | 108,418 | | | | 135,847 | | | | (138,532 | ) |
Less: net loss attributable to non-controlling interests | | | (21,775 | ) | | | (322,820 | ) | | | (137,999 | ) |
Net income (loss) attributable to the shareholders of the Company | | $ | 130,193 | | | $ | 458,667 | | | | (533 | ) |
| | | | | | | | | | | | |
Other comprehensive income (loss) | | | | | | | | | | | | |
Foreign currency translation adjustment | | | (22,704 | ) | | | (1,920 | ) | | | 7,751 | |
Total comprehensive income (loss) | | | 85,714 | | | | 133,927 | | | | (130,781 | ) |
Less: total comprehensive loss attributable to non-controlling interests | | | (27,621 | ) | | | (323,458 | ) | | | (136,396 | ) |
Total comprehensive income attributable to the shareholders of the Company | | $ | 113,335 | | | $ | 457,385 | | | | 5,615 | |
| | | | | | | | | | | | |
Earning per share – basic and diluted | | $ | 0.18 | | | $ | 0.80 | | | | (0.00 | ) |
Basic and diluted weighted average shares outstanding | | | 615,135 | | | | 575,930 | | | | 560,000 | |
The accompanying notes are an integral part ofthese consolidated financial statements.
NEWGENIVF LIMITED
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)
FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
(Stated in US Dollars)
| | Number of shares | | | Ordinary shares | | | Subscription receivable | | | Additional paid-in capital | | | Accumulated deficit | | | Accumulated other comprehensive income/(loss) | | | Total attributable to the shareholders of the Company | | | Non- controlling interests | | | Total | |
Balance, January 1, 2021 | | | 560,000 | | | $ | 5,600 | | | $ | — | | | $ | 57,821 | | | $ | (1,049,678 | ) | | $ | 4,704 | | | $ | (981,553 | ) | | $ | (2,576 | ) | | $ | (984,129 | ) |
Net loss | | | — | | | | — | | | | — | | | | — | | | | (533 | ) | | | — | | | | (533 | ) | | | (137,999 | ) | | | (138,532 | ) |
Foreign currency translation adjustment | | | — | | | | — | | | | — | | | | — | | | | — | | | | 6,148 | | | | 6,148 | | | | 1,603 | | | | 7,751 | |
Directors’ remuneration | | | — | | | | — | | | | — | | | | 200,000 | | | | — | | | | — | | | | 200,000 | | | | — | | | | 200,000 | |
Balance, December 31, 2021 | | | 560,000 | | | $ | 5,600 | | | $ | — | | | $ | 257,821 | | | $ | (1,050,211 | ) | | $ | 10,852 | | | $ | (775,938 | ) | | $ | (138,972 | ) | | $ | (914,910 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance, January 1, 2022 | | | 560,000 | | | $ | 5,600 | | | $ | — | | | $ | 257,821 | | | $ | (1,050,211 | ) | | $ | 10,852 | | | $ | (775,938 | ) | | $ | (138,972 | ) | | $ | (914,910 | ) |
Net income (loss) | | | — | | | | — | | | | — | | | | — | | | | 458,667 | | | | — | | | | 458,667 | | | | (322,820 | ) | | | 135,847 | |
Foreign currency translation adjustment | | | — | | | | — | | | | — | | | | — | | | | — | | | | (1,282 | ) | | | (1,282 | ) | | | (638 | ) | | | (1,920 | ) |
Directors’ remuneration | | | — | | | | — | | | | — | | | | 240,000 | | | | — | | | | — | | | | 240,000 | | | | — | | | | 240,000 | |
Issuance of shares | | | 41,830 | | | | 418 | | | | (319,872 | ) | | | 961,120 | | | | — | | | | — | | | | 641,666 | | | | — | | | | 641,666 | |
Balance, December 31, 2022 | | | 601,830 | | | $ | 6,018 | | | $ | (319,872 | ) | | $ | 1,458,941 | | | $ | (591,544 | ) | | $ | 9,570 | | | $ | 563,113 | | | $ | (462,430 | ) | | $ | 100,683 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance, January 1, 2023 | | | 601,830 | | | $ | 6,018 | | | $ | (319,872 | ) | | $ | 1,458,941 | | | $ | (591,544 | ) | | $ | 9,570 | | | $ | 563,113 | | | $ | (462,430 | ) | | $ | 100,683 | |
Net (loss) income | | | — | | | | — | | | | — | | | | — | | | | 130,193 | | | | — | | | | 130,193 | | | | (21,775 | ) | | | 108,418 | |
Foreign currency translation adjustment | | | — | | | | — | | | | — | | | | — | | | | — | | | | (16,858 | ) | | | (16,858 | ) | | | (5,846 | ) | | | (22,704 | ) |
Settlement of subscription receivable | | | — | | | | — | | | | 219,628 | | | | — | | | | — | | | | — | | | | 219,628 | | | | — | | | | 219,628 | |
Issuance of shares | | | 96,293 | | | | 963 | | | | (2,866,856 | ) | | | 2,865,893 | | | | — | | | | — | | | | — | | | | — | | | | — | |
Balance, December 31, 2023 | | | 698,123 | | | $ | 6,981 | | | $ | (2,967,100 | ) | | $ | 4,324,834 | | | $ | (461,351 | ) | | $ | (7,288 | ) | | $ | 896,076 | | | $ | (490,051 | ) | | $ | 406,025 | |
The accompanying notes are an integral part ofthese consolidated financial statements.
NEWGENIVF LIMITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021
(Stated in US Dollars)