Full Press Release Details
ABVC BioPharma Inc. Reports Strong Q2 2024 Financial
and Strategic Achievements
Fremont, CA (August 15, 2024) - ABVC BioPharma,
Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology,
is pleased to announce its financial results and key operational highlights for the second quarter ended June 30, 2024.
Key Financial and Operational Highlights:
1. Significant Global Licensing Agreements:
Vitargus Licensing: Along with our subsidiary,
BioFirst Corporation, we secured licensing agreements with ForSeeCon Eye Corporation that have the potential to provide up to a total
of $187 million in income. The agreements include total upfront payments of $60 million that can be paid in cash or shares of ForSeeCon
stock, milestone cash payments of $7.0 million and potential royalties up to $120 million after the product launches, of which there can
be no guarantee; initial $116,000 milestone payment received in June 2024. This agreement underscores our commitment to advancing innovative
therapies and enhancing shareholder value.
- Oncology Products Licensing: Along with our
subsidiary and affiliate, BioLite, Inc. and Rgene Corporation, we entered into a total of 8 licensing agreements with OncoX BioPharma,
Inc., that have the potential to provide up to an aggregate of $105 million in income. The agreements include total upfront payments of
$55,000,000 that can be paid in cash or shares of OncoX stock and royalties up to a total of $50 million after the product launches, of
which there can be no guarantee. These potential payments and relationships will further solidify our financial foundation and strategic
2. Financial Performance:
- Earnings Per Share (EPS): Demonstrated a remarkable
year-over-year improvement of approximately 86.8%, with EPS improving to -$0.09 in Q2 2024 from -$0.68 in the same period last year. This
significant progress reflects our successful efforts in managing operational expenses and capitalizing on milestone payment revenue from
licensing agreements.
- Revenue Growth: Revenue increased to $117,142
in Q2 2024, a substantial rise from $6,109 in Q2 2023. This growth directly results from our strategic execution of licensing agreements,
which have begun generating meaningful cash inflows.
- Shareholders' Equity: As of June 30, 2024, shareholders'
equity stood at $7.8 million, maintaining a solid financial foundation despite challenging macroeconomic conditions.
3. Strategic Partnerships and Market Positioning:
- ABVC has strategically aligned itself with promising
partners that we believe will ultimately enhance the value of ABVC's equity holdings. These partnerships are pivotal in driving shareholder
value as we believe they will help market valuations grow.
- We believe the Company is poised for significant
market capitalization growth, leveraging its pipeline accomplishments and international partnerships to bring breakthrough therapies to
4. Operational and Regulatory Milestones:
- Patent and FDA Approvals: Received multiple
patents and regulatory approvals across the US, Taiwan, and Australia for treatments targeting major depressive disorder, ADHD, and ophthalmology.
These achievements highlight our continued progress in expanding our intellectual property portfolio and advancing clinical trials.
- Neurology and Oncology Advancements: Completed
Phase II trials for MDD, initiated Phase IIb trials for ADHD, and received FDA approval for multiple IND applications, positioning us
for continued growth and innovation in these critical therapeutic areas.
Management Commentary:
Dr. Uttam Patil, ABVC Chief Executive Officer,
commented, "We are thrilled with the substantial progress we have made in Q2 2024. Our financial performance and strategic licensing
agreements have enhanced our cash reserves and strengthened our position in the biopharmaceutical industry. We remain focused on advancing
our pipeline, expanding our partnerships, and driving sustainable growth for the benefit of our shareholders."
Board of Directors Statement:
"We sincerely thank our shareholders for
their continued support and confidence in ABVC. Our focus remains on advancing our licensing agreements and maximizing the value they
bring. The execution of these agreements provides us with a solid foundation for future growth and stability. We are excited about these
partnerships' prospects and are committed to driving our strategic goals forward."
We believe ABVC BioPharma is on a promising trajectory,
focusing on sustainable growth, innovation, and value creation through strategic partnerships. Our improving financial strength and unwavering
commitment to advancing healthcare solutions prepare us for future success. We sincerely thank our shareholders, partners, and dedicated
team for their continued support and look forward to a prosperous future.
Recent Operational Highlights
Patents and FDA Approvals
The Company received a US patent (US 16/936,032),
valid until September 04, 2040, a Taiwanese (TW I821593) Patent, valid until July 22, 2040, and an Australian (AU2021314052B2) Patent,
valid until April 09, 2041, for Polygala extract for the treatment of major depressive disorder. The Company received a US (US17/120,965),
valid until December 20, 2040, and Taiwanese (TW 110106546), valid until February 24, 2041, Patent for Polygala Extract for treating Attention
Deficit Hyperactive Disorder. A Taiwanese Patent (TW I792427) for Storage Media for the Preservation of Corneal Tissue was obtained on
February 11, 2023, and is valid till July 19, 2041. As we work towards expanding our patent map into global coverage, we eagerly await
the results of patent applications in the European Union, China, Japan, and others.
On December 30, 2022, the Company received US
FDA approval for the IND ABV-1519 to proceed with the Combination therapy for treating Advanced Inoperable or Metastatic EGFR Wild-type
Non-Small Cell Lung Cancer was approved and the study can proceed. The IND was then submitted to the Taiwan FDA, and the approval was
received on January 04, 2024. The United States Food & Drug Administration (US FDA) has approved four INDs, ABV-1501 for Triple Negative
Breast Cancer (TNBC), ABV-1519 for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 for Myelodysplastic Syndrome (MDS), and ABV-1703 for Pancreatic
The MDD Phase II trials for ABV-1504 were completed
successfully with good tolerance to the drug, and no serious adverse effects were reported. The product is ready for an End-of-Phase 2
meeting with the FDA to finalize the protocol for Phase III trials. At the same time, we commenced the ADHD Phase IIb trials at the University
of California, San Francisco (UCSF) and five other sites in Taiwan. The trials are heading for the interim report, which we expect to
complete by the end of Q3 2024. ABV-1601 for MDD in cancer patients has completed Phase I study preparation, including the Site Initiation
Visit (SIV). The study is set to initiate by the end of 2024.
On July 31, 2023, ABVC signed a legally binding
term sheet with a Chinese pharmaceutical company, Xinnovation Therapeutics Co., Ltd, for the exclusive licensing of ABV-1504 for Major
Depressive Disorder (MDD) and ABV-1505 for Attention-Deficit Hyperactivity Disorder in mainland China. Under this agreement, Xinnovation
will hold exclusive rights to develop, manufacture, market, and distribute our innovative drugs for MDD and ADHD in the Chinese market
and shall bear the costs for clinical trials and product registration in China. We are negotiating definitive agreements with Xinnovation
and are excited that the licensing deal carries a possible aggregate income of $20 million for ABVC if all expected sales are made, of
which there can be no guarantee. This transaction remains subject to the negotiation of definitive documents and therefore there is no
guarantee that this transaction will occur.
In November 2023, each of ABVC and one of its
subsidiaries, BioLite, Inc. ("BioLite"), entered a multi-year, global licensing agreement with AIBL for the Company and BioLite's
CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the "Licensed
Products"). The potential license will cover the Licensed Products' clinical trial, registration, manufacturing, supply, and distribution
rights. The Licensed Products for MDD and ADHD, owned by ABVC and BioLite, were valued at $667M by a third-party evaluation. The parties
are determined to collaborate on the global development of Licensed Products. The parties are also working to strengthen new drug development
and business collaboration, including technology, interoperability, and standards development. As per each of the respective agreements,
each of ABVC and BioLite shall receive 23 million shares of AIBL stock that the parties value at $10 per share (not independently validated)
and if certain milestones are met, $3,500,000 and royalties equaling 5% of net sales, up to $100 million, which is not guaranteed.
Vitargus , a vitreous substitute,
is a groundbreaking, advanced-staged R&D product that we believe will be the first biodegradable hydrogel used in retinal detachment
surgery. Vitargus has completed the feasibility study in Australia and was approved by the Australian Therapeutic Goods
Administration (TGA) to initiate the next trial phase in two participating sites. This is vital to obtaining final regulatory approval
for Vitargus in Australia.
The Science Park Administration in Taiwan approved
ABVC's plan to set up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus and to pursue the process
development work for manufacturing optimization. We are undertaking this project, proposed by ABVC's Taiwan affiliate and co-development