F-1: Anbio Biotechnology Files for $8 Million Nasdaq IPO
Registration Statement
Anbio Biotechnology, a Cayman Islands-based medical technology company, is seeking to raise $8 million through an initial public offering on the Nasdaq Global Market.
Summary
- Anbio Biotechnology, a medical technology company specializing in in vitro diagnostics (IVD) products, has filed for an initial public offering (IPO) to raise $8 million.
- The company plans to offer 1,600,000 Class A ordinary shares, with an anticipated initial public offering price between $5.00 and $6.00 per share.
- Anbio's portfolio includes IVD products for infectious diseases, cancer, cardiovascular diseases, and other conditions, catering to over-the-counter, point-of-care, and laboratory applications.
- The company's main sales revenue has been from SARS-CoV-2 and SARS-CoV-2/Flu A/Flu B Antigen Rapid Test Kits.
- For the six months ended June 30, 2024, Anbio generated revenue of $5.85 million, with 44% from respiratory diseases and COVID-19 related products and 63% of revenue generated in the European Union.
- The company intends to use the net proceeds from the IPO primarily for expansion of its sales and distribution network, research and development, and working capital.
- The company faces risks including a short operating history, reliance on third-party suppliers and distributors, and potential delays in regulatory approvals.
Sentiment
Score: 6
Explanation: The document presents a mixed sentiment. While the company is pursuing an IPO and has growth strategies, it also faces significant risks and a decline in revenue from COVID-19 related products. The sentiment is neutral to slightly positive.
Positives
- The company offers a comprehensive range of IVD products to meet the growing demand in the POCT and OTC market.
- The IVD assays developed by the company utilize established and widely used IVD technology platforms and their scientific principles.
- The company has commenced sales of its non-COVID products in countries within the European Union (EU), Americas, APAC, and Africa since 2023.
- The company has a diverse portfolio of IVD instruments and reagents to detect various diseases and abnormalities.
- The company has a dedicated team of experienced quality assurance specialists who ensure that customers globally receive products of the highest quality and reliability.
Negatives
- The company has a relatively short operating history compared to some of its established competitors.
- The company faces significant risks relying on third-party suppliers and distributors.
- A limited number of customers currently represent a substantial portion of the company's revenue.
- The company may face delays or failures during the registration process as it recertifies all of its supplied IVD products under the IVDR 2017/746, which could have an adverse effect on its future growth and business in the EU.
- The company may face intellectual property infringement claims, which could be time-consuming and costly to defend and may result in the loss of significant rights by the company.
Risks
- The company may not succeed in promoting and sustaining its brand, which could have an adverse effect on its future growth and business.
- The company may incur losses or experience disruption of its operations as a result of unforeseen or catastrophic events, including pandemics, terrorist attacks, or natural disasters.
- The company's corporate actions will be substantially controlled by its Class B shareholders, CVC Investment and Northwestern Investment, which will have the ability to control or exert significant influence over important corporate matters that require approval of shareholders.
- There has been no public market for the company's Class A Ordinary Shares prior to this offering, and you may not be able to resell the company's Class A Ordinary Shares at or above the price you paid, or at all.
- There is uncertainty as to the enforceability in the Cayman Islands of judgments predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States.
Future Outlook
The company expects to finance its operations and working capital needs from part of the net proceeds of the initial public offering and cash generated through operations.
Industry Context
The global immunoassays market is projected to reach $43.8 billion by 2032, exhibiting a CAGR of 6.1%. The global ChLIA market is expected to reach more than $15.3 billion in 2032. The global FIA market is expected to reach $6.9 billion in 2032. The global LFIA market is expected to reach nearly $16.2 billion by 2032. The global RT-PCR market is expected to reach $19.6 billion by 2032. The global isothermal nucleic acid amplification technology (INAAT) market is expected to grow at a compound annual growth rate (CAGR) of 12.3% from 2023 to 2030. The global laboratory developed tests market size was valued at USD 10.04 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 6.58% from 2024 to 2030.
Comparison to Industry Standards
- The global immunoassays market is highly fragmented with Abbott Laboratories, Roche, Siemens, QuidelOrtho, Thermo Fisher Scientific, and Danaher Corporation as market leaders and account for more than 60% of the immunoassays market.
- Other significant market players include PerkinElmer, SD Biosensor, Mindray, Randox Laboratories, Abcam Plc, Abnova Corp, and Orasure Technologies.
- Smaller market players include, Werfen, R&D Systems, Maccura Biotechnology Co. Ltd., Diatron, Acon, and DaAn Gene Co. Ltd.
Related Party Transactions
- The company's former CFO, Richard Chen, is one of the partners of CLC LLP, which provided accounting services to the company from late 2021.
Stakeholder Impact
- The company's potential success and growth will impact shareholders, employees, customers, and suppliers.
- The company's ability to obtain regulatory approvals and market acceptance will affect its stakeholders.
Next Steps
- The company plans to apply to list its Class A Ordinary Shares on the Nasdaq Global Market under the symbol NNNN.
- The company intends to use the net proceeds of this offering primarily for expansion of sales and distribution network in the strategically selected markets, research and development, and working capital and general corporate matters.
Key Dates
| Date | Description |
|---|---|
| July 27, 2021 | Anbio Biotechnology was incorporated in the Cayman Islands. |
| November 30, 2021 | Anbio BVI was incorporated in the British Virgin Islands. |
| August 6, 2021 | Anbio HK was incorporated in Hong Kong. |
| September 10, 2021 | Beijing AnBiAo was incorporated in PRC. |
| October 6, 2021 | Anbio Australia was incorporated in Australia. |
| October 22, 2021 | Anbio UK was incorporated in the United Kingdom. |
| October 22, 2021 | AnBiAo Xiamen was incorporated in PRC. |
| November 18, 2021 | Anbio France was incorporated in France. |
| February 21, 2022 | Anbio Australia became a wholly owned subsidiary of Anbio. |
| April 13, 2022 | PharVac BVI was incorporated in the British Virgin Islands. |
| December 28, 2022 | Anbio UK became a wholly owned subsidiary of Anbio. |
| January 18, 2023 | PharVac USA was incorporated in Delaware. |
| February 7, 2023 | AnBai became a wholly owned subsidiary of Beijing AnBiAo. |
| February 22, 2023 | LoviWell BVI was incorporated in the British Virgin Islands. |
| March 28, 2023 | LoviWell USA was incorporated in Delaware. |
| June 30, 2023 | The Company adopted its amended and restated memorandum and articles of association. |
| December 31, 2027 | Anticipated IVDR approval date for high individual risk and high public health risk products (Class D). |
| December 31, 2028 | Anticipated IVDR approval date for high individual risk and/or moderate public health risk products (Class C). |
| December 31, 2029 | Anticipated IVDR approval date for moderate individual risk and/or low public health risk (Class B) and low individual risk and low public health risk products placed on the market in a sterile condition (Class A sterile). |
| December 31, 2024 | Date of the prospectus. |
Keywords
IVD, Biotechnology, Diagnostics, IPO, Anbio, Offering, Class A Ordinary Shares, Medical Technology
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