logo

- HanAll Biopharma achieved both stability and innovativeness

[Sales Performance and Financial Conditions]

HanAll Biopharma(KRX: 009420.KS) announced today that it recorded 22.6 billion KRW, 1.6 billion KRW, and 2.8 billion KRW in sales, operating profit, and net profit, respectively, for the second quarter of 2020.

With the Phase 2 clinical trials for HL161, a novel antibody drug for autoimmune diseases, beginning in China in the second quarter, a milestone payment has been secured, which led to an increase of 2.3% in the company’s sales from the previous quarter despite the difficult business environment in Korea. Operating profit decreased by 1.2 billion KRW from the previous quarter to 1.6 billion KRW due to a temporary cost increase resulting from the requirement of inventory assets and recall of Glucodown, a drug for diabetes, due to the NDMA issue.

The company’s total sales and operating profit in the first half of 2020 were 44.7 billion KRW and 4.5 billion KRW, respectively. Despite the decrease in the number of patients due to the COVID-19 pandemic, which led to a drop in drug sales, HanAll Biopharma’s profitability has improved as a result of the continuously increasing royalties. Accordingly, the company maintained its operating profit rate at approximately 10%.

HanAll Biopharma is maintaining a stable financial condition with assets, capital, and liabilities of 196.8 billion KRW, 156.8 billion KRW, and 40.1 billion KRW, respectively, as of the end of the second quarter. The company’s quick assets(cash, cash equivalents, short-term financial assets) total 91.3 billion KRW as of the end of the second quarter.

[Status of New Drug Pipeline]

HP161, a novel antibody drug for treatment of autoimmune diseases, is differentiated as a subcutaneous injection product with a pre-filled syringe that can be administered by patients. Immunovant, HanAll Biopharma’s global partner, is conducting Phase 2 clinical trials on HL161 in a number of countries including the U.S. in relation to three types of rare autoimmune diseases. It is expected that the Phase 2 clinical trial top-line results for myasthenia gravis(MG), the results for warm antibody autoimmune hemolytic anemia(WAIHA), and the Phase 2b clinical trial results for thyroid eye disease(TED) will be available by the end of the third quarter or early fourth quarter of this year, the end of this year, and the first half of next year, respectively.

In China, Harbour BioMed, HanAll Biopharma’s Chinese partner, is conducting Phase 2 clinical trials on HL161 for patients with neuromyelitis optica spectrum disorder (NMOSD), idiopathic thrombocytopenic purpura (ITP), and MG, which are rare autoimmune diseases. Additionally, it is preparing for clinical trials in relation to TED with approval on the seamless Phase 2/3 trial IND from the China Food and Drug Administration.

For HL036, a novel, topical anti-TNF biologic dry eye disease, which is being jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, the follow-up Phase 3-2 clinical trial plan is being established by the global advisory board on the basis of the Phase 3-1 clinical result secured in the U.S. during the first half of the year. The clinical development strategy will be finalized through the Type C meeting with the FDA. Separately, in China, Harbour BioMed will prepare for and commence Phase 3 clinical trials in the second half of this year to obtain the permit for HL036.

Over the past two to three years, HanAll Biopharma has been implementing HL186 and HL187, the immunotherapeutic antibody projects with new targets other than PD-1 and PD-L1, jointly with Daewoong Pharmaceutical, and has recently begun efficacy evaluation using an animal model. HanAll Biopharma also implemented the HL189 project, which treats non-infectious uveitis through intraocular injection of tanfanercept, the principal component of the HL036 eye drop, thus verifying the drug effect through animal testing, and is preparing to commence clinical trials for the drug.

Successfully transforming from a “small pharmaceutical company in Korea” into a “global innovative new drug developer” by pursuing “corporate innovation through R&D” over the last decade, HanAll Biopharma is drawing attention as a biopharmaceutical company that is recording a surplus and is consistently maintaining and developing innovativeness and stability.