FREMONT, CA, Nov. 16, 2023 (NASDAQ: ABVC) (“Company”), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and oncology/hematology, announced today that it entered into a global licensing definitive agreement with AiBtl BioPharma Inc. (AiBtl) for the Company’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the “Licensed Products”). The agreement has the potential of licensing income worth $467M and royalties up to $200M.
The Licensed Products for MDD and ADHD, owned by ABVC and its subsidiary BioLite, Inc., were valued at $667M by a third-party evaluation. ABVC and AiBtl are determined to work to strengthen their new drug development and business collaboration. This definitive agreement brings licensing revenues for ABVC and its subsidiary BioLite, Inc. as AiBtl stock of 46 million shares worth $460M and milestone cash payments of $7M with the royalties of 5% of net sales, up to $200 million, after the product’s launch.
AiBtl is a US company registered in Delaware. “With ABVC as one of our major shareholders, holding 57% consolidated shares of AiBtl, we are proud to join the family of ABVC BioPharma. We will help ABVC to conduct international business development for the MDD and ADHD markets and to bridge the partnership with international pharmaceutical companies. Meanwhile, we will take advantage of our collaborative project in the Asian Special Economic Zone to develop Good Agricultural Practices for the raw material of botanical new drugs to supply the global markets,” said AiBtl Chief Executive Officer Russman Jaimes. He further emphasizes, “By licensing the strong ABVC pipeline, AiBtl aims to go IPO with stocks of $10 per share and getting listed on NASDAQ in 2024.”
“Utilizing AiBtl’s strong capability in its global business development will allow ABVC to secure partnerships with international pharmaceutical companies to develop the products and subsequently bring the drugs to the market,” said Dr. Uttam Patil, ABVC Chief Executive Officer. “This will allow ABVC to continue to focus on bringing its other proprietary patented products, such as ophthalmology medical devices, Vitargus, and oncology drugs, to the global market.”
We believe the Company’s pipeline products have great market potential. As per the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032 with a CAGR of 2.8% over the forecast period[1]. According to the Polaris market research report, the global ADHD treatment market was valued at $15.23 billion in 2022 and is expected to grow at a CAGR of 7.3% over the forecast period between 2023-2032.[2]
About ABVC BioPharma & Its Industry
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III.
Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company’s securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company’s securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
Contact:
Tom Masterson
Email: tmasterson@allelecomms.com
[1] https://www.futuremarketinsights.com/reports/major-depressive-disorder-treatment-market#:~:text=The%20major%20depressive%20disorder%20(MDD,US%24%2011.51%20billion%20in%202022
[2] https://www.polarismarketresearch.com/industry-analysis/attention-deficit-hyperactivity-disorder-market