ABVC BioPharma Announces Strong Q2 2024 Financial Results and Strategic Milestones

ABVC BioPharma, Inc., a clinical-stage biopharmaceutical company specializing in oncology, CNS, and ophthalmology therapies, has disclosed its financial performance and key operational milestones for the second quarter ending June 30, 2024.

Key Financial and Operational Highlights:

1. Global Licensing Agreements:
- Vitargus® Licensing: ABVC and its subsidiary, BioFirst Corporation, have struck a licensing deal with ForSeeCon Eye Corporation, potentially bringing in up to $187 million. This includes upfront payments of $60 million, milestone payments of $7 million, and potential royalties up to $120 million post-product launch. An initial milestone payment of $116,000 was received in June 2024. This agreement accentuates ABVC's focus on pioneering therapies and driving shareholder value.
- Oncology Products Licensing: Alongside its subsidiary and affiliate, BioLite, Inc., and Rgene Corporation, ABVC secured eight licensing agreements with OncoX BioPharma, Inc., with a potential of up to $105 million. This includes $55 million in upfront payments and possible royalties up to $50 million post-launch.

2. Financial Performance:
- Earnings Per Share (EPS): ABVC demonstrated significant improvement with an 86.8% year-over-year change, improving EPS to -$0.09 in Q2 2024 from -$0.68 in the same period last year. This marks their success in managing operational expenses and leveraging milestone revenues.
- Revenue Growth: Revenues surged to $117,142 in Q2 2024 from $6,109 in Q2 2023, driven by executing licensing agreements.
- Shareholders' Equity: As of June 30, 2024, shareholders' equity was $7.8 million, reflecting a robust financial foundation amid challenging economic conditions.

3. Strategic Partnerships and Market Positioning:
- ABVC has formed strategic alliances with promising partners aimed at enhancing equity value and market valuations. These partnerships are crucial for driving shareholder value and market capitalization growth through pipeline accomplishments and international collaborations.

4. Operational and Regulatory Milestones:
- Patents and FDA Approvals: ABVC has received multiple patents and regulatory approvals in the US, Taiwan, and Australia for treatments in major depressive disorder, ADHD, and ophthalmology, demonstrating progress in intellectual property and clinical trials.
- Neurology and Oncology Advancements: The company completed Phase II trials for MDD and commenced Phase IIb trials for ADHD, with multiple FDA approvals for IND applications, paving the way for future growth and innovation.

Recent Operational Highlights:

Patents and FDA Approvals:
ABVC secured several patents for Polygala extract treatments for major depressive disorder and ADHD in the US, Taiwan, and Australia. The company also received US FDA approval for the IND ABV-1519 for treating advanced inoperable or metastatic EGFR wild-type non-small cell lung cancer. This IND was also approved by the Taiwan FDA. Additionally, the US FDA approved INDs for triple-negative breast cancer, myelodysplastic syndromes, and pancreatic cancer therapies.

Neurology:
ABVC completed Phase II trials for ABV-1504 for MDD with no serious adverse effects reported and is preparing for Phase III trials. The ADHD Phase IIb trials are underway at UCSF and other Taiwan sites, with an interim report expected by Q3 2024. ABV-1601 for MDD in cancer patients is set to begin by the end of 2024.

Ophthalmology:
Vitargus®, a novel vitreous substitute, completed feasibility studies in Australia and received approval for further trials. ABVC plans to set up a pilot GMP facility in Taiwan for Vitargus® production, aiming to meet global demand.

Oncology/Hematology:
The US FDA approved the IND for BLEX 404, the active ingredient in ABV-1519, for treating advanced non-small cell lung cancer. This follows previous IND approvals for combination therapies in triple-negative breast cancer, myelodysplastic syndromes, and pancreatic cancer.

CDMO:
BioKey, ABVC’s subsidiary, produces dietary supplements and has entered its second distribution year with Define Biotech Co. Ltd. BioKey also secured a three-year contract worth up to $3 million for clinical development services with Rgene Corporation and aims to evolve into a comprehensive pharmaceutical service provider.

ABVC BioPharma, Inc. is committed to advancing its pipeline and fostering international partnerships to drive growth and innovation in healthcare solutions, ensuring a promising future for the company and its stakeholders.