ROCKVILLE, Md. and SEOUL, South Korea, Nov. 1, 2024 /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 third quarter of 2024 and provided business updates.
HanAll ended the third quarter with total revenue of 36.8 billion KRW, reflecting an 11.7% increase from the same period in 2023 and an operating profit of 430 million KRW. Pharmaceutical sales reached 34 billion KRW from robust sales of key products.
In the third quarter, HanAll's anti-FcRn assets demonstrated potential as best-in-class treatments for a range of autoimmune diseases, particularly Graves' Disease. Ongoing studies include a Phase 2b trial in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) as well Phase 3 studies in generalized Myasthenia Gravis (gMG) and Thyroid Eye Disease (TED), with topline results expected in the first quarter of 2025 and first half of 2025, respectively.
Additionally, HanAll, in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical, completed the Phase 1 study of HL192 in healthy subjects. Results for the HL192 Phase 1 study are anticipated in November of this year.
"This past quarter, HanAll's focus and agile execution have positioned us for significant growth while allowing us to continue our R&D efforts through strategic, value enhancing cost optimization. Looking ahead, we are committed to expanding our competitive advantage by specializing in key products and strengthening our R&D capabilities as we strive to realize our highest potential as a global company," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.
Third Quarter 2024 BUSINESS UPDATE
Pipeline Development Highlights
A comprehensive update of HanAll's public pipeline development below includes an overview of research along with lists of compounds, targeted indications and developmental phases.
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 FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies
HL161ANS (IMVT-1402)
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 PROGRAM
Tanfanercept (HL036)
A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation
NEUROLOGY PROGRAM
HL192 (ATH-399A)
A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School's Molecular Neurobiology Laboratory) which targets Nurr1, both a master regulator in dopaminergic neuron development and maintenance, as well as an important component in anti-inflammatory functions. HL192 (ATH-399A) is being developed to treat neurodegenerative diseases, including Parkinson's disease (PD).
ONCOLOGY PROGRAMS
HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights
(KRW in billion) | Q3 2024 | Q3 2023 | % change |
Sales | 36.8 | 33 | 11.7 % |
Gross Profit | 19.8 | 17.5 | 13.1 % |
Selling, marketing and administrative expenses | 13.4 | 12.9 | 3.8 % |
Research and development expenses | 5.9 | 4.6 | 28.3 % |
Operating income | 0.4 | 0.09 | 377.8 % |
Net Income | 0.2 | 0.3 | N/A |
About HanAll Biopharma
HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the 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 the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years.
HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline assets, 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 generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is being evaluated in multiple indications including GD.
Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease.
HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease, has completed a Phase 1 study in healthy volunteers, with results to be announced in November 2024.
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 2024 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.