ABVC BioPharma, Inc. Reports Q3 2024 Financial Results and Operational Milestones
ABVC BioPharma reported significant Q3 2024 financial improvements, achieving its first operational profit. Revenue increased to $389,276 from $15,884 in Q3 2023. Net loss decreased to $134,272 from $3.37 million, with EPS improving to $(0.02) from $(0.82). The company secured multiple licensing agreements, including partnerships with ForSeeCon Eye for Vitargus®, potentially generating $187 million. Clinical developments include completed Phase II trials for ABV-1504 in Major Depressive Disorder and ongoing Phase IIb trials for ADHD. Cash position improved to $137,344, with shareholders' equity at $7.98 million.
ABVC BioPharma ha riportato significativi miglioramenti finanziari nel terzo trimestre del 2024, raggiungendo il suo primo profitto operativo. I ricavi sono aumentati a $389,276 rispetto a $15,884 nel terzo trimestre del 2023. La perdita netta è diminuita a $134,272 da $3,37 milioni, con l'EPS che è migliorato a $(0.02) da $(0.82). L'azienda ha concluso diversi accordi di licenza, inclusi partenariati con ForSeeCon Eye per Vitargus®, generando potenzialmente $187 milioni. Gli sviluppi clinici includono il completamento della fase II dei trial per ABV-1504 nel Disturbo Depressivo Maggiore e prove in corso della fase IIb per l'ADHD. La posizione di cassa è migliorata a $137,344, con il patrimonio netto degli azionisti pari a $7,98 milioni.
ABVC BioPharma reportó mejoras financieras significativas en el tercer trimestre de 2024, logrando su primer beneficio operativo. Los ingresos aumentaron a $389,276 desde $15,884 en el tercer trimestre de 2023. La pérdida neta se redujo a $134,272 desde $3,37 millones, con un EPS que mejoró a $(0.02) de $(0.82). La empresa aseguró múltiples acuerdos de licencia, incluyendo asociaciones con ForSeeCon Eye para Vitargus®, generando potencialmente $187 millones. Los desarrollos clínicos incluyen ensayos de fase II completados para ABV-1504 en el Trastorno Depresivo Mayor y ensayos en curso de fase IIb para el TDAH. La posición de efectivo mejoró a $137,344, con un capital contable de $7.98 millones.
ABVC BioPharma는 2024년 3분기 재정 개선을 보고하며 최초의 운영 이익을 달성했습니다. 매출은 2023년 3분기의 $15,884에서 $389,276로 증가했습니다. 순손실은 $3.37 백만에서 $134,272로 감소했으며, 주당순이익(EPS)은 $(0.02)에서 $(0.82)로 개선되었습니다. 회사는 Vitargus®를 위한 ForSeeCon Eye와의 파트너십을 포함하여 여러 라이선스 계약을 체결하여 잠재적으로 $187 백만을 생성할 수 있습니다. 임상 개발에는 주요 우울 장애에 대한 ABV-1504의 2상 시험 완료와 ADHD에 대한 2b상 시험이 포함됩니다. 현금 상태는 $137,344로 개선되었으며, 주주 지분은 $7.98 백만입니다.
ABVC BioPharma a rapporté d'importantes améliorations financières pour le troisième trimestre 2024, atteignant son premier bénéfice opérationnel. Les revenus ont augmenté, passant de $15,884 au troisième trimestre 2023 à $389,276. La perte nette a diminué, atteignant $134,272 contre $3,37 millions, avec un bénéfice par action (EPS) amélioré à $(0.02) par rapport à $(0.82). L'entreprise a signé plusieurs accords de licence, y compris des partenariats avec ForSeeCon Eye pour le Vitargus®, générant potentiellement $187 millions. Les développements cliniques incluent l'achèvement des essais de phase II pour ABV-1504 dans le cadre du Trouble Dépressif Majeur et des essais de phase IIb en cours pour le TDAH. La position de liquidités s'est améliorée à $137,344, avec des capitaux propres s'élevant à $7,98 millions.
ABVC BioPharma berichtete von erheblichen finanziellen Verbesserungen im 3. Quartal 2024 und erzielte den ersten operativen Gewinn. Der Umsatz stieg im 3. Quartal 2023 von $15,884 auf $389,276. Der Nettoverlust verringerte sich von $3,37 Millionen auf $134,272, während sich das EPS von $(0.02) auf $(0.82) verbesserte. Das Unternehmen sicherte sich mehrere Lizenzvereinbarungen, darunter Partnerschaften mit ForSeeCon Eye für Vitargus®, die potenziell $187 Millionen generieren könnten. Zu den klinischen Entwicklungen gehören abgeschlossene Phase-II-Studien für ABV-1504 bei Major Depressive Disorder und laufende Phase-IIb-Studien für ADHS. Die Liquiditätsposition verbesserte sich auf $137,344, während das Eigenkapital der Aktionäre bei $7,98 Millionen liegt.
- First operational profit achieved in company history
- Revenue grew by 2,352% to $389,276 in Q3 2024
- Net loss reduced significantly from $3.37M to $134,272
- EPS improved from $(0.82) to $(0.02)
- Potential revenue of $292M from global licensing agreements
- Successful completion of Phase II trials for ABV-1504
- Still reporting net loss of $134,272
- Low cash position of $137,344
- Higher interest expenses from convertible debt affecting profitability
Insights
The Q3 2024 results show remarkable improvement in ABVC BioPharma's financial position. Revenue surged to
The company's pipeline shows significant progress across multiple therapeutic areas. Key developments include:
- Completed Phase II trials for ABV-1504 in Major Depressive Disorder, advancing to FDA End-of-Phase 2 meeting
- Phase IIb trials for ADHD program at multiple sites with interim report expected Q4 2024
- Vitargus® advancement in Australia for retinal detachment surgery
- Four FDA-approved INDs for various cancer treatments
- ABVC BioPharma Achieved its First Operational Profit, with a
102% Improvement over the Third Quarter of Last Year. - Incremental Payments Received based on Executed Global Licensing Agreements that could provide up to
$292 million in income - Received Cash Milestone Incomes of
$496,000 for the nine months ended September 30, 2024
FREMONT, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2024.
Key Financial and Operational Highlights:
1. Financial Performance:
- Impressive Revenue Growth: ABVC reported a significant increase in revenue, reaching
$389,276 in Q3 2024, from$15,884 in the third quarter of 2023. This growth reflects the growing demand for our CNS and oncology R&D services and highlights the positive potential of our strategic partnerships. - Continued Improvement in Earnings: The Company’s net loss for Q3 2024 decreased substantially to
$134,272 from$3.37 million in Q3 2023. This positive net loss reduction trend results from disciplined financial management and focused R&D investments, underscoring our commitment to building a sustainable growth pathway. - Earnings Per Share (EPS): EPS improved year-over-year, with a basic and diluted net loss per share of
$(0.02) for Q3 2024, a significant advancement from$(0.82) per share in Q3 2023. This achievement demonstrates our effective cost management and operational efficiency gains. - Improved Cash Position: The Company’s cash and cash equivalents reached
$137,344 as of September 30, 2024, up from$60,155 at the end of 2023. Through strategic financing and operational efficiencies, ABVC has strengthened its liquidity to support upcoming anticipated clinical milestones and expansion efforts. - Shareholders' Equity: As of September 30, 2024, shareholders' equity stood at
$7.98 million , maintaining a solid financial foundation despite challenging macroeconomic conditions.
2. Strategic and Operational Milestones:
Advances in Clinical Development:
ABVC completed Phase II trials for ABV-1504 in Major Depressive Disorder (MDD) and is preparing for an FDA End-of-Phase 2 meeting to finalize the Phase III protocol.
Progress continues in our ADHD program with Phase IIb trials at multiple prominent sites. We aim to have an interim report by Q4 2024.
Additionally, ABVC’s first-in-class vitreous substitute, Vitargus®, for retinal detachment surgery, is advancing through regulatory stages with approvals for further trials in Australia.
3. Strengthening Partnerships:
ABVC has secured multiple long-term licensing agreements, notably with ForSeeCon Eye Corporation for Vitargus®, which could potentially generate
In Q3, ABVC's continued collaboration with OncoX expanded the oncology pipeline, positioning the Company for strong future growth in partnership-driven revenue streams.
Expanded Intellectual Property Portfolio: ABVC has been granted multiple patents in the U.S., Taiwan, and Australia, covering a range of CNS and ophthalmology treatments. These patents reflect our innovative R&D approach and commitment to protecting our groundbreaking therapies.
ABVC will continue working closely together with its strategic partners, AiBtl BioPharma Inc., ForSeeCon Eye Corporation, and OncoX BioPharma Inc., on international business and clinical developments of CNS new drugs, Ophthalmology products and Oncology new drugs, respectively.
Management Commentary:
Dr. Uttam Patil, ABVC Chief Executive Officer, commented, "Our third-quarter results showcase the impact of our strategic direction and dedicated team. Our strengthened financial position and exciting progress in CNS and oncology programs should enable us to drive future shareholder value. We thank our investors for their continued confidence as we advance ABVC's growth trajectory. For the first time in its history, ABVC BioPharma achieved an operational profit in the third quarter of 2024, marking a transformative milestone for the Company and underscoring the effectiveness of our strategic approach. This significant achievement is a testament to our dedicated focus on operational efficiency, robust cost management, and the strength of our pipeline. The company receiving licensing income has successfully turned an operational loss into operational income for the first time. However, due to higher interest expenses arising from the accounting treatment of amortization expenses related to convertible debt, the EPS stands at -
Board of Directors Statement:
"With a stronger financial foundation, strategic partnerships, and a promising pipeline, we believe that ABVC is well-positioned for continued growth. The Company anticipates further revenue growth through strategic collaborations, ongoing clinical developments, and new market entries. ABVC remains committed to advancing its high-potential CNS, oncology, and ophthalmology programs to bring life-changing therapies to patients worldwide."
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 Cancer Therapy.
Neurology
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
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 potential license will cover the licensed products' clinical trials, registration, manufacturing, supply, and distribution rights. The licensed products for MDD and ADHD, owned by ABVC and BioLite, were valued at
Ophthalmology
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 partner, BioFirst Corporation, to upgrade the Vitargus® manufacturing processes so it can ultimately handle the clinical trial supply. ABVC and BioFirst Corporation expect to complete the facility's upgradation in Hsinchu Biomedical Science Park, Taiwan, in 2024.
Oncology/Hematology
The United States Food & Drug Administration (US FDA) approved the Investigational New Drug (IND) application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR wild-type non-small cell lung cancer. This treatment is being co-developed by BioKey, Inc. ("BioKey") and by the Rgene Corporation, Taiwan. The study received approval from the Taiwan FDA. This is the fourth IND approved by the US FDA for BLEX 404. The previous three INDs are for the combination therapies of triple-negative breast cancer, myelodysplastic syndromes (MDS), and pancreatic cancer.
CDMO
BioKey, a wholly-owned subsidiary of the Company based in Fremont, California, produces dietary supplements derived from the maitake mushroom in tablet and liquid forms. BioKey has entered the second year of the distribution agreement with Define Biotech Co. Ltd. BioKey is currently set to produce an additional
On the regulatory services front for our clients, we received two ANDA approvals from the US FDA. We have a three-year contract, worth up to
About ABVC BioPharma, Inc.
ABVC BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center) and then out-licensing the products to international pharmaceutical companies for pivotal Phase III studies and, eventually, generating global sales. The Company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
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. 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 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 these securities, nor shall there be any sale of these 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 that state or jurisdiction.
Contact:
Uttam Patil
Email: uttam@ambrivis.com
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