Date
2022-11-16- Financial results for Q3 2022 ended with revenue of KRW 29.6 billion with continued growth in the pharmaceutical division driven by product portfolio expansion and strong sales in major products
- R&D expenses for the quarter increased by 63%, reflecting the preparation of a Phase 3 study in myasthenia gravis (MG) in Japan, expected to begin in the Q4 2022
- HanAll’s licensed partner Immunovant unveiled two new indications for batoclimab, and adds a new FcRn inhibitor, originally developed by HanAll, into its pipeline
HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global
biopharmaceutical company developing innovative medicines, today reported
financial results for the third quarter of 2022 and provided recent business
updates. HanAll sustained a strong growth momentum across the sales performance
and progress in the R&D portfolio.
The sales for the third quarter ended with 29.6
billion won, a 16% increase from the previous year, with a net profit of 734
million won. The net cash recorded 66.7 billion won based on the stable cash
flow.
“The third quarter delivered strong top-line growth for
HanAll, driven by continued sales performance with disciplined operation
management. Our late-stage pipeline assets are progressing. Batoclimab Phase 3
study in Myasthenia gravis (MG) is expected to start in Japan later this year. The
enrollment to tanfanercept Phase 3 study has been completed, with the topline
result expected in the first half of 2023. In addition, Immunovant added the
second FcRn molecule developed at HanAll into its pipeline, which is another
demonstration of our antibody development expertise,” said Sean Jeong, M.D.,
CEO of HanAll Biopharma.
“Looking forward to the next quarters, HanAll will continue
investing in our R&D programs by fully utilizing our own cash flow to bring
innovative medicines to patients in need,” he added.
THIRD QUARTER 2022
BUSINESS UPDATE
Pipeline
Development Highlights
A
comprehensive update on HanAll’s pipeline development includes an overview of
HanAll’s research and a list of compounds in development with targeted
indication and the phase of development.
Batoclimab (Project
Code: HL161BKN)
A novel, fully human
monoclonal antibody targeting the FcRn, with the potential to address multiple
IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to and inhibit
FcRn, thus blocking the recycling of IgG antibodies.
l HanAll’s
licensed partner, Immunovant, announced its plans to expand the indication of
batoclimab to Chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’
disease (GD). A Phase 2b study on CIDP to evaluate batoclimab is planned to be
initiated by the end of this year, and a Phase 2 trial on GD is expected to
start in early 2023.
l HanAll
Biopharma received approval from the Pharmaceuticals and Medical Devices Agency
to initiate the Phase 3 study for batoclimab in MG in September 2022. The Phase
3 study to evaluate the safety and efficacy of batoclimab is planned to be
initiated in Q4 of 2022.
l 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. Under the agreement, CSPC will be granted the rights to develop and
commercialize batoclimab in Greater China.
HL161ANS
A second novel, fully
human, monoclonal antibody molecule inhibiting FcRn-mediated recycling of IgG,
designed to deliver maximum lgG reduction while minimizing interference with
albumin binding.
l Immunovant
announced that it will add a new FcRn inhibitor HL161ANS (Immunovant code name:
IMVT-1402), discovered and developed by HanAll, to its pipeline. HL161ANS has
been observed to have minimal or no impact on levels of albumin and LDL in
animal studies. Immunovant plans to develop HL161ANS in a wide range of therapeutic
areas including rheumatology and hematology, with a Phase 1 study
expected to initiate in early 2023. The previously announced programs studying
batoclimab in Myasthenia gravis (MG), Thyroid eye disease (TED), Chronic
inflammatory demyelinating polyneuropathy (CIDP), and Graves’ disease (GD) will
be continued at full speed.
Eye Disease Programs
Tanfanercept (Project
Code: HL036)
A novel, topical
anti-TNF alpha biologic therapy for eye diseases including dry eye disease
(DED) by inhibiting TNF alpha, which is critical in ocular inflammation.
l HanAll
Biopharma and Daewoong Pharmaceutical are continuing to conduct the second Phase
3 VELOS-3 study (NCT05109702) in patients with moderate to severe DED to
examine the safety and efficacy of tanfanercept, at nine clinical sites located
in the U.S. The study enrollment is
completed. The topline results from VELOS-3
study are expected in the first half of 2023.
l Results from
the previous Phase 3 VELOS-2 study (NCT03846453) in DED have been presented at
the World Cornea Congress VIII on Thursday, September 29, 2022 at 10:30 am CDT
in Chicago by Dr. Joseph Tauber, MD.
l Harbour
BioMed, HanAll’s licensed partner in China, announced in early October that
they decided to close their Phase 3 study without enrolling new patients to the
study. As a result of its observed insufficient efficacy trend, the Independent
Data Monitoring Committee recommended to terminate the trial according to the
study protocol. The study in China is different from US study (VELOS-3) in key
inclusion criteria, primary endpoint and patient demographics reflecting
different medical practices and regulatory requirements. HanAll is in
discussion with Harbour BioMed regarding the next steps.
Cancer Programs
HL187/ HL186
Novel monoclonal
antibodies that respectively target TIM-3 and TIGIT, for the treatment of
cancer developed in collaboration with Daewoong Pharmaceutical Co.
l HanAll
is continuing with the pre-clinical development of HL187 and plans to submit
IND for phase 1 in 2023. HL186 is currently in the discovery phase.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights
(KRW in millions) |
Q3 2022 |
Q3 2021 |
% change |
Sales |
29,642 |
25,474 |
16.4% |
Gross Profit |
16,521 |
14,841 |
11.3% |
Selling, marketing and administrative
expenses |
11,669 |
10,044 |
16.2% |
Research and development expenses |
4,230 |
2,589 |
63.4% |
Operating income |
622 |
2,207 |
-71.8% |
Net Income |
734 |
2,060 |
-64.3% |
l Sales recorded 29.6 billion won
in the third quarter, a 16% increase compared to the same period last year. The
sales growth in pharmaceutical division remained strong with additions to the product
portfolio including Glucofree, Biotop forte/dual, Abcito, and other major
products.
l R&D expenses showed a 63% increase
compared to the same period last year, with the record of 4.2 billion won.
l
Operating
income
was 622 million won, a 71% decrease, compared to the same period last year,
mainly due to increased investments in R&D.
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 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 more than 49 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.
For further
information visit our website,
and connect with us on linkedin. For any media inquiries,
please contact HanAll PR/IR (pr@hanall.com,
ir@hanall.com).
Disclaimer
statement