HanAll Biopharma Reports Full-Year 2022 Results and Provides Business Update

• Full-Year 2022 net revenue of KRW 110 billion, up 8% over 2021 reaching a record high
• Strong R&D momentum to continue with batoclimab entering multiple pivotal studies with the first Phase 3 data readout in China expected in 2023
• Top-line data from tanfanercept's Phase 3 dry eye study expected in H1 2023

SEOUL, South Korea, Feb. 1, 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 2022 and provided business updates.

Total revenues for 2022 were 110 billion won, an 8% increase year-on-year, mainly driven by continued strong sales from the key products and milestone revenues from the licensed partners, including $10 million milestone payment from Immunovant for the initiation of the MG Phase 3 trial. Net income for the year was 2 billion won, offset by increased R&D expenses.

"HanAll continued to transform into innovative global biopharma in 2022 by strengthening clinical development capability and expanding open collaboration network while continuing to deliver solid sales performance. We were able to launch a share buyback program to return value to our stakeholders," said Sean Jeong, M.D., CEO of HanAll Biopharma.

"Moving into the 50^th years since our foundation, 2023 will be a pivotal year for HanAll with top-line data readout of tanfanercept and progress in anti-FcRn programs. We will continue to make our best efforts to contribute to the patients," he added.

Full-Year 2022 BUSINESS UPDATE

Pipeline Development Highlights  

A comprehensive update on HanAll's pipeline development below includes an overview of HanAll's research along with the list of compounds, targeted indications, and developmental phase.

Autoimmune Diseases Programs

Batoclimab (Code name: 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 leading to a reduction in IgG antibodies.

• In the second half of 2022, HanAll Biopharma received approval from the Pharmaceuticals and Medical Devices Agency to initiate a Phase 3 study of batoclimab in myasthenia gravis (MG) in Japan, and plan to initiate the study in the first half of 2023. HanAll is exploring the options of developing batoclimab in thyroid eye disease (TED) in Japan.
• HanAll's licensed partner, Immunovant is conducting global Phase 3 trials with batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED). The top-line results for the pivotal Phase 2b trial in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected in the first half of 2024. In Graves' disease (GD), a Phase 2 trial is planned to be initiated in early 2023. Immunovant will finalize the trial design in warm autoimmune hemolytic anemia (WAIHA) in early 2023, based on recent FDA interaction.
• Harbour BioMed, another licensed partner of HanAll who is developing batoclimab in China, signed a sub-licensing deal with CSPC NBP Pharmaceutical Co., Ltd. in October 2022. Under the agreement, CSPC was granted the rights to develop and commercialize batoclimab in Greater China. The company is developing batoclimab in an array of autoimmune disorders including myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenia (ITP). The top-line data for the ongoing Phase 3 study in MG are expected in the first half of 2023.

HL161ANS (Immunovant code name: IMVT-1402)

A second novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG, designed to deliver maximum lgG reductions while minimizing interference with albumin binding.

• In September 2022, Immunovant unveiled a new FcRn inhibitor HL161ANS (Immunovant code name: IMVT-1402), originally discovered and developed by HanAll. Immunovant plans to start a Phase 1 trial for HL161ANS in early 2023 with the initial data read out expected in in mid-2023.

Eye Disease Programs

Tanfanercept (Code name: HL036)

A novel, topical biologic therapy for eye diseases including dry eye disease (DED) by inhibiting TNF alpha, which is a key mediator of ocular inflammation.

• HanAll Biopharma and Daewoong Pharmaceutical are progressing with the second Phase 3 VELOS-3 study in patients with moderate to severe DED to examine the safety and efficacy of tanfanercept, at nine clinical sites in the US. The study enrollment is complete and the top-line results from the VELOS-3 study are expected in the first half of 2023.
• Harbour BioMed, HanAll's licensed partner in China, announced in October 2022, that they decided to close its Phase 3 study in DED without enrolling additional patients to the study, following the recommendation from the Independent Data Monitoring Committee (IDMC) upon review of the insufficient efficacy trend observed during the second interim analysis. The study in China is different from the ongoing US study (VELOS-3) in key inclusion criteria, primary endpoints, and patient demographics reflecting different medical practices and regulatory requirements. HanAll is in discussion with Harbour BioMed regarding the next steps for the development of tanfanercept in China.

Oncology Programs

HL187/ HL186

Monoclonal antibodies that respectively target TIM-3 and TIGIT, for the potential treatment of cancer, being developed in collaboration with Daewoong Pharmaceutical Co.

• HanAll is continuing with the pre-clinical development of HL187 and is preparing for IND submission in 2023. HL186 is currently in the discovery phase.

FINANCIAL HIGHLIGHTS (CONSOLIDATED)

Key Highlights

• Sales recorded 110 billion won in 2022, an 8.3% increase compared to 2021. The sales in the pharmaceutical division remained strong with its major products including Normix, Eligard, and Biotop.  
• R&D expenses showed a 58% increase compared to 2021, with a record of 16 billion won.
• Net income was 2 billion won, a 78% decrease, compared to the same period in the year of 2021, mainly due to increased investments in R&D.

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973, 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. A leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hemolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease. 

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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 2022 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 as a result of various important factors our expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements, 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 for its technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of its 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.