HanAll Biopharma Reports Full-Year 2021 Results and Provides Business Update

[Business Performance and Financial Status]

HanAll Biopharma (KRX: 009420.KS) announced today that it achieved 101.6 billion won in sales in 2021, a 15% increase from the previous year. It had 10.1 billion won in operating profit, a 70% increase year-on-year, for the 19th consecutive quarter in the black, and the net profit in 2021 was 10 billion won. Both growth and profitability were thus secured.

Strong financial performance was largely due to increasing revenues from R&D activities and double digit percentage sales growth of major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product.

HanAll has been generating stable profits since the licensing agreements with Roivant Sciences and Harbour Biomed in 2017. HanAll has thus established a virtuous investment cycle in which new R&D programs are funded by its own profits.

"While transforming into a global, innovative biopharmaceutical company with a promising pipeline and continuous investments, HanAll continues to produce stable profits. Milestone payments are expected to increase more this year. We will be carrying out more proactive R&D activities in 2022 to develop novel drugs for patients with high unmet medical needs," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.

HanAll's financial status as of the end of 2021 includes 199.7 billion won in assets, 164.7 billion won in equity, and 35 billion won in liabilities, maintaining a stable financial structure.

[R&D Pipeline development status]

- HL161 (a novel, fully human, subcutaneous anti-FcRn antibody therapeutic for autoimmune diseases)

HL161 (INN: batoclimab) is a new antibody drug for the treatment of rare autoimmune diseases caused by pathogenic autoantibodies. It is being developed in the US/Europe and China respectively by global license partners Immunovant and Harbour Biomed.

Immunovant recently announced plans for a Phase 3 trial in myasthenia gravis (MG) as well as for other clinical trial plans for this year. The Phase 3 in MG is planned to be initiated in the first half of the year, and two additional pivotal clinical trials are expected to start in 2022. Moreover, with the addition of two new indication programs, HL161 is planned to be developed in five autoimmune diseases in the US and Europe by Immunovant.

Harbour Biomed, HanAll's partner in China, is developing batoclimab in six autoimmune indications: myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica spectrum disorder (NMOSD), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and pemphigus vulgaris (PV). MG is in Phase 3 and ITP, NMOSD, and TED are in Phase 2. Harbour is planning to submitt a biologics license application (BLA) to the National Medical Products Administration (NMPA) for approval in MG this year.

HanAll Biopharma is preparing a Phase 3 trial for myasthenia gravis (MG) in Japan in collaboration with Immunovant. The study is expected to start in 2022.

- HL036 (a novel, topical anti-TNF biologic therapy for dry eye disease)

HL036 (INN: tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is a novel biologic treatment under development to treat inflammatory eye diseases by inhibiting TNF, which is involved in ocular inflammation.

In November 2021, the first patient first dose in the second Phase 3 clinical trial (study name: VELOS-3) has started in the US and the trial is currently ongoing. The clinical trial's topline results are expected in the second half of 2022. The VELOS-3 clinical trial aims to replicate the efficacy seen in VELOS-2 (the first Phase 3 trial), and is proceeding at 9 clinical sites in the US with patients who have moderate to severe dry eye disease.

Harbour Biomed, who has the rights to develop tanfanercept in China, is carrying out the Phase 3 clinical trial for dry eye disease in China. Harbour is planning to submit a BLA to the NMPA at the end of this year. 

- HL189 (tanfanercept)

HanAll Biopharma is exploring the options to expand the indications of tanfanercept to new inflammatory eye disorders including uveitis.  Preclinical studies on uveitis have been conducted. The company will announce a new indications development plan in 2022.

- HL186/HL187 (novel immune-oncology therapies)

HL186 and HL187 projects are novel immuno-oncology antibodies that respectively target TIM-3 and TIGIT, developed in collaboration with Daewoong Pharmaceutical. Both programs are at the preclinical stage. The companies aim to develop differentiated immune checkpoint inhibitors with better efficacy for patients with cancer.

About HanAll Biopharma Co., Ltd.

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 therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas of endocrine, circulatory, and urologic diseases for more than 48 years. HanAll is now focused on autoimmune disease, ophthalmology, oncology, and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its 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. 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.

Forward-looking Statements

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 2021 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.

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Source: HanAll Biopharma