Full Press Release Details
BioPharma Reports Annual 2023 Financials and Provides Fiscal Year 2024 First Quarter Business Update
Fremont, CA (March 14, 2024) -
ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a biotechnology company specializing in botanically based solutions that
deliver high efficacy and low toxicity to improve health outcomes, announced its 2023 annual financial and operating results. These
results, including the financial statements included herein, can be found in the Company's Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 13, 2024.
2023 Annual Financial Results
All comparisons are made on a year-over-year basis.
On November 12, 2023, the Company and one of its
subsidiaries, BioLite, Inc. ("BioLite"), each entered into a multi-year, global licensing agreement (the "AIBL Agreement")
with AiBtl BioPharma Inc. ("AIBL") for the Company and BioLite's CNS drugs with the indications of MDD (Major Depressive Disorder)
and ADHD (Attention Deficit Hyperactivity Disorder) (collectively, the "Licensed Products"). As per the respective agreements,
each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share). As a result, the Company
has a controlling interest in AIBL. If certain milestones are met, the Company and BioLite are each eligible to receive $3,500,000 and
royalties equaling 5% of net sales, up to $100 million.
The Company is hopeful that those licensing incomes
will enable it to start becoming profitable in the near future.
The Company has regained compliance with
Nasdaq Marketplace Rules relating to maintaining a minimum $1.00 bid price and the $2.5 million minimum stockholders' equity
requirements, completed on August 08, 2023, and September 6, 2023, respectively.
Strategic Investments
The Company entered a cooperation agreement on
August 14, 2023, with Zhong Hui Lian He Ji Tuan, Ltd.("Zhonghui"). The Company acquired 20%
of the ownership of a property and the parcel of the land (the "Property") owned by Zhonghui in Leshan, Sichuan, China. In exchange,
the Company issued Zhonghui, an aggregate of 370,000 shares (the "Shares") of the Company's common stock, at a per-share price
of $20.0. The Company and Zhonghui plan to jointly develop the Property into a healthcare center for senior living, long-term care,
and medical care in the areas of ABVC's interests, such as Ophthalmology, Oncology, and Central Nervous Systems. As of today, the Property
is valued at US$37,000,000, based on a third-party estimate.
On February 06, 2024, ABVC acquired an additional
real estate asset via an equity transfer of 703,495 shares at $3.50 per share to develop plant factories for ABVC's botanical pipeline.
ABVC hopes the property will ultimately be used as an integrated platform for the global development of the Asian healthcare business
and the medical, pharmaceutical, and biotechnology industries. The Company believes it may be able to leverage the value of the land (which
the parties estimate at approximately $2,962,232) for additional funding that can used for further property development. In this way,
the Company views real estate acquisitions as a potential alternate revenue source.
that end, on February 16, 2024, the Company executed a definitive agreement to license its healthcare-related expertise ("Know-How")
to Senior Paradise, Inc. ("SPI"), which will also lease certain of the Company's real estate properties. Under the lease, SPI
may build a plant factory based on good agricultural practices (GAP) for ABVC's botanical drug products and dietary supplements. This
deal marks the Company's first step towards generating revenue through its real estate acquisitions. Under the agreement, SPI shall pay
ABVC $3M as the license fee for the Know-How, in cash or stock, and royalties of 2% on SPI's revenues earned from any projects on the
Stockholders' Equity
On February 23, 2023, the Company entered into
a securities purchase agreement with Lind Global Fund II, LP ("Lind"), according to which the Company issued Lind a secured,
convertible note in the principal amount of $3,704,167 (the "Lind Offering") for a purchase price of $3,175,000 (the "Lind
Note"), that is convertible into shares of Common Stock at an initial conversion price of $1.05 per share, subject to adjustment. On
August 24, 2023, the Company started repaying Lind the monthly installments due under the Lind Notes; $308,000 was repaid via the issuance
of 176,678 shares of Common Stock (the "Monthly Shares") at the Redemption Share Price (as defined in the Lind Note) of $1.698
per share. Under the terms of the Lind Note, Lind increased the amount of the next monthly payment to one million dollars, such that as
of September and together with the Monthly Shares, the Company repaid Lind a total of $1M by September 2023.
On July 27, 2023, the Company entered into a certain
securities purchase agreement relating to the offer and sale of 300,000 shares of common stock, par value $0.001 per share, and 200,000
pre-funded warrants, at an exercise price of $0.001 per share, in a registered direct offering. According to the related purchase agreement,
the Company agreed to sell the shares and pre-funded warrants at a per-share purchase price of $3.50 for gross proceeds of $1,750,000
before deducting any estimated offering expenses. On August 1, 2023, the pre-funded warrants were exercised.
On August 14, 2023, the Company entered a cooperation
agreement with Zhonghui. The Company acquired 20% of the ownership of a property and the parcel of the land owned by Zhonghui in Leshan,
Sichuan, China. During the third quarter of 2023, the Company issued to Zhonghui an aggregate of 370,000 shares of the Company's common
stock at a per-share price of $20 for its ownership in the acquired Property. The Company also issued 29,600 common stock to consultants for providing consulting services on the above transaction.
On November 17, 2023, the Company entered into
a securities purchase agreement (the "2nd Lind Securities Purchase Agreement") with Lind, under which the Company
issued Lind a secured, convertible note in the principal amount of $1,200,000 (the "2nd Lind Offering"), for a purchase
price of $1,000,000 (the "2nd Lind Note"), that is convertible into shares of the Company's common stock at a conversion
price equal to $3.50 per share for the first 180 days following the issuance date of the 2nd Lind Note, after which the conversion
price shall be based on a variable price set forth therein (the "Variable Price"). Lind will also receive a 5-year, common stock purchase warrant (the
"2nd Lind Warrant") to purchase up to 1,000,000 shares of the Company's common stock at an initial exercise price of
$2 per share, subject to adjustment.
On January 17, 2024, the Company entered into
a third securities purchase agreement with Lind, under which the Company issued Lind another secured, convertible note in the principal
amount of $1,000,000 for a purchase price of $833,333 (the "3rd Lind Note"), that is convertible into shares of
the Company's common stock at a conversion price equal to $3.50 per share for the first 180 days following the issuance date of
the 3rd Lind Note, after which the conversion price shall be based on a variable price set forth therein (the "Variable
Price"). Lind will also receive a 5-year, common stock purchase warrant to purchase up to 1,000,000 shares of the Company's
common stock at an initial exercise price of $2 per share, subject to adjustment.
The Company and Lind later agreed to a floor price
of $1.00 for the Variable Price of the 2nd Lind Note and 3rd Lind Note and that the Company would compensate Lind
in cash if the Variable Price were less than such floor price at the time of conversion.
31, 2023, the Company achieved a total of stockholders' equity of $8,388,050.
Recent R&D 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 early Q2 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 in Q2 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