ROCKVILLE, Md. and SEOUL, South Korea, July 27, 2023 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the second quarter and provided business updates.
HanAll ended the quarter with total revenue of 41.4 billion won, an increase of 58 percent compared to the same period last year, and an operating profit of 8.1 billion won. Net profit recorded 7.3 billion won due to the continued growth of its pharmaceutical products and milestone revenues from the licensed partner.
"We are pleased to announce another successful quarter with strong sales growth and significant advancements in clinical developments. We achieved a meaningful result from the tanfanercept Phase 3 study for dry eye disease, while batoclimab progressed another step further towards commercialization in China. Our commitment to innovation is evident by portfolio expansion and fruitful collaborations in the neurodegenerative domain," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.
"In the second half 2023, we anticipate the initiation of a Phase 1 clinical study on Parkinson's disease (PD), along with the initial results from the anti-FcRn assets batoclimab in Grave's disease and Phase 1 study of HL161ANS. In addition, we anticipate finalizing the next Phase 3 clinical study design for tanfanercept this year. These upcoming milestones exemplify our dedication to advancing innovative medicines, and we will continue to push the boundaries of science and steadfastly pursue our mission to improve patient outcomes," he added.
SECOND QUARTER 2023 BUSINESS UPDATE
Pipeline Development Highlights
A comprehensive update of HanAll's pipeline development below includes an overview of research along with lists of compounds, targeted indications, and developmental phase.
AUTOIMMUNE DISEASES PROGRAMS
Batoclimab (HL161BKN)
A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to and inhibit FcRn, which plays a role in recycling IgG, thus may reduce harmful IgG antibodies.
HL161ANS
Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.
OPHTHALMIC DISEASE PROGRAMS
Tanfanercept (HL036)
A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF alpha, a key mediator of ocular inflammation
ONCOLOGY PROGRAMS
HL187/ HL186
Monoclonal antibodies that respectively target T cell immunoreceptors with immunoglobulin (Ig) and ITIM (Immunoreceptor tyrosine-based inhibitory moti)} domains (TIGIT) and T cell Ig and mucin domain-3 (TIM-3) are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments
NEUROLOGY PROGRAMS
HL192
A pipeline candidate originated from NurrOn Pharmaceuticals that targets Nurr1, a master regulator in dopaminergic neuron development and maintenance, is being developed to treat neurodegenerative diseases, including Parkinson's disease (PD)
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights
(KRW in billion) |
Q2 2023 |
Q2 2022 |
% change |
Sales |
41.4 |
26.2 |
+58 % |
Gross Profit |
27.2 |
14.9 |
+82 % |
Selling, marketing and administrative expenses |
11.3 |
10.6 |
+7 % |
Research and development expenses |
7.8 |
3.7 |
+111 % |
Operating income |
8.1 |
0.7 |
+1092 % |
Net Income |
7.3 |
(0.1) |
N/A |
Sales recorded 41.4 billion won in the second quarter of 2023, a 58 percent increase compared to the second quarter of 2022. Strong sales growth from pharmaceuticals continued from major products sold under the names of Biotop, Eligard, and Normix, with Biotop recording sales growth of 70% compared to the same period last year.
Research and development expenses for the second quarter ended June 30, 2023, were 7.8 billion won, up 111 percent from 3.7 billion won for the three months ended June 30, 2022.
Net income for the three months ended June 30, 2023, recorded 7.3 billion won, due to an increase in milestone revenue and pharmaceutical sales.
About HanAll Biopharma Co., Ltd.
HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presences in Korea, the USA, Japan, and Indonesia, with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for 50 years.
HanAll has also expanded its focus to ophthalmology, immunology, oncology, and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF-alpha inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and China for the treatment of dry eye disease. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).
Disclaimer Statement
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2023 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.