HANALL BIOPHARMA

- Q2’21 operating profit of KRW 1.6 billion fell slightly by 3% compared to Q2’20

- H1’21 sales of KRW 51.2 billion and operating profit of 6.3 billion grew by 15% and 56% YoY

[Business Performance and Financial Status]

HanAll Biopharma (KRX: 009420.KS)​ announced today that the company had achieved sales of 23.4 billion won, operating profit of 1.6 billion won, and net profit of 3.3 billion won in the second quarter of 2021.

In the first half of this year, cumulative sales were reported as 51.2 billion won, a 15% increase compared to the same period last year, and operating profit increased by 56% to 7 billion. In particular, with increased sales in major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product; operating margin was at 14%, indicating an increase of 362 basis-point in profitability compared to the first half of last year.

As of the end of the first half, HanAll Biopharma maintained a stable financial status with a debt ratio of 25% and assets of 201.9 billion won, equity of 161.2 billion won, and liabilities of 40.6 billion won.

[R&D Pipeline]

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

HL161 (INN: batoclimab), an antibody-drug for autoimmune diseases caused by pathogenic antibodies, is currently undergoing clinical trials in the US, and China through its partners Immunovant and Harbor BioMed.

In early June, global partner Immunovant announced plans to resume clinical trials, which were put on hold in February this year due to an issue related to increased cholesterol. As a result of a detailed analysis of patients participating in the clinical trials, it said lipid elevations are predictable and manageable. It plans to return to the clinic and initiate a pivotal MG trial in late 2021 or early 2022 as well as resume its trial in WAIHA on a similar timeframe. In addition, the company has a plan to initiate at least two additional clinical studies over the next 12 months, including another pivotal trial in 2022.

Meanwhile, HanAll Biopharma is preparing a Phase 3 clinical trial for the treatment of myasthenia gravis in Japan in collaboration with Immunovant.

In China, Harbour BioMed is conducting clinical trials in myasthenia gravis, thrombocytopenia, and neuromyelitis optica. In July, it announced positive topline results from the Phase 2 clinical trial of batoclimab in myasthenia gravis.

Batoclimab demonstrated a statistically significant improvement (p=0.043) compared to placebo in patients with myasthenia gravis on MG-ADL (Myasthenia Gravis Activities of Daily Living), the primary endpoint of the study. In addition, the drug induced rapid, substantial and persistent clinical improvement over placebo as measured by all four predefined clinical efficacy scales - MG-ADL, QMG (Quantitative Myasthenia Gravis), MGC (Myasthenia Gravis Composite) and MG-QoL (Myasthenia Gravis Quality of Life).

Furthermore, batoclimab has shown to be overall safe and well-tolerated, with incidence of adverse events (AE) comparable to placebo, majority of AEs characterized as mild, no serious adverse events (SAE) and no discontinuation due to AEs. Harbor BioMed plans to enter Phase 3 clinical trial of HL161 in myasthenia gravis in China in the second half of this year.

- 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 could cause inflammation in the eye. To target the dry eye disease market in the US, clinical trials are in progress in the US since Phase 2 and the first Phase 3 clinical trial for dry eye disease was completed in the first half of last year.

HanAll Biopharma submitted the IND for the second Phase 3 clinical trial (study name: VELOS-3) to the U.S. FDA on July 22, and is expected to begin clinical trials in the third quarter of this year and have topline results by the first half of next year.

The VELOS-3 study is a Phase 3, multicenter, randomized, double-masked and placebo-controlled study evaluating the efficacy and safety of tanfanercept (HL036) ophthalmic solution 0.25% compared to placebo in subjects with dry eye disease. Following two week screening period, 300 patients with dry eye disease will be randomized into treatment group and placebo. Each group will benefit administration of tanfanercept or placebo twice per day respectively for eight weeks.

Harbor BioMed, a license holder for the Chinese market, started a pivotal Phase 3 trial in dry eye disease in the first half of the year, and is still in progress. The first patient administration was started in March, and the efficacy and safety of tanfanercept will be evaluated in patients with dry eye disease throughout the study.

- HL189 (tanfanercept)

HanAll Biopharma is planning to expand tanfanercept, which is being developed in dry eye disease, with new inflammatory eye disorders including uveitis. The company will make a decision for the asset in the second half to the year.

- HL186/HL187 (novel immune-oncology therapies)

Currently, HanAll Biopharma is jointly developing a novel immune-oncology antibodies that target TIGIT and TIM-3 with Daewoong Pharmaceutical, and will take a step forward to preclinical study.

Second Quarter 2021 Financial Highlights (consolidated,KRW billion)