HANALL BIOPHARMA

Ÿ Q3’21 sales of KRW 25.5 billion increased 15% from the same period last year

Ÿ Q3’21 operating profit of KRW 2.2 billion grew by 120% compared to Q3’20

Ÿ Nine months sales of KRW 76.7 billion and operating profit of KRW 9.2 billion rose by 15% and 67% YoY, repectively

 

[Business Performance and Financial Status]

 

HanAll Biopharma (KRX: 009420.KS)​ announced today that the company had achieved sales of 25.5 billion won, an operating profit of 2.2 billion won, and a net profit of 2.1 billion won in the third quarter of 2021.

 

In the first nine months of the year, net sales were 76.7 billion won, a 15% increase compared to the same period last year, and the operating profit increased by 67% to 9.2 billion won. Increased sales were largely due to strong revenues with double digit growth from major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product.

 

As of the end of the third quarter, HanAll Biopharma maintained a stable financial status with net cash of 87.6 billion won and reported assets of 203.0 billion won, an equity of 163.9 billion won, and liabilities of 39.1 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 HanAll’s partners, Immunovant and Harbor BioMed.

 

The licensed partner in the US and Europe, Immunovant, is preparing to resume clinical trials, which were put on hold in February of this year due to an issue related to increased cholesterol. Program-wide data review suggests that HL161 has a broader therapeutic window than previously anticipated and that lipid elevations are predictable, manageable, and appear to be driven by reductions in albumin. Immunovant announced its plan

1)     to return to the clinic and initiate a pivotal Phase 3 myasthenia gravis (MG) trial and Phase 2 in warm autoimmune hemolytic anemia (WAIHA) in the first half of 2022 following meetings with regulators including the FDA,

2)     to communicate with the FDA and other authorities to discuss future plans for Phase 2 trials for thyroid eye disease or other thyroid related disease and  

3)     to initiate new studies in two additional indications in 2022.

 

The licensed partner in greater China, Harbour BioMed, is currently conducting clinical trials in myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica (NMO), and thyroid eye disease (TED) in China. In September, Harbour BioMed released that the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a Phase 2 trial of batoclimab in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

 

Harbor BioMed reported the first dosing of the first patient in registrational Phase 3 trial of batoclimab in myasthenia gravis in China in September and expects BLA submission for the disease next year.

 

In Japan, HanAll Biopharma is preparing a Phase 3 trial for myasthenia gravis (MG) 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. The first Phase 3 clinical trial (VELOS-2) for dry eye disease was completed last year.

 

HanAll submitted the IND for the second Phase 3 clinical trial (study name: VELOS-3) to the US FDA on July 22, and is expected to begin the study in the fourth quarter this year and have topline results next year. Due to the recent COVID related delays of global transportation, there was a delay in the investigational drug transportation.  Accordingly clinical study initiation was rescheduled from the third quarter to the fourth quarter.  

 

The VELOS-3 study is a Phase 3, multicenter, randomized, double-blind, and placebo-controlled study evaluating the efficacy and safety of tanfanercept ophthalmic solution 0.25% compared to placebo in subjects with dry eye disease.

 

Harbor BioMed, the license holder for the Chinese market, started a pivotal Phase 3 trial in dry eye disease in the first half of the year, and plans to file a biologics license application (BLA) with NMPA in 2022 after the study ends.

 

- 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 decide on new indications development plan in 2022.

 

- HL186/HL187 (novel immune-oncology therapies)

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

 

 

Third Quarter 2021 Financial Highlights (consolidated, KRW billion)

 

	3Q 2021	3Q 2020	% change	9M 2021	9M 2020	% change
Sales	25.5	22.1	+15%	76.7	66.8	+15%
Gross Profit	14.8	12.1	+22%	46.3	38.4	+21%
Gross Margin	58%	55%		60%	50%
Operating Profit	2.2	1.0	+120%	9.2	5.5	+67%
Operating Margin	9%	5%		12%	7%
Net Income	2.1	3.7	-43%	9.8	13.5	-27%
Net Margin	8%	17%		13%	18%

 

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.

 

For further information, please contact: 

​

HanAll IR team (ir@hanall.co.kr) or

Daewoong IR team (t_797rx@daewoong.co.kr)

 

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 2020 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, including the effects of the COVID-19 pandemic, 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.