Date
2023-02-01- Full-Year 2022 net revenue of KRW 110 billion, up 8% over 2021 reaching a record high
- Strong R&D momentum to continue with batoclimab entering multiple pivotal studies with the first Phase 3 data readout in China expected in 2022
- Top-line data from tanfanercept’s Phase 3 dry eye study expected in H1 2023
HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for 2022 and provided business updates.
Total revenues for 2022 were 110 billion won, an 8% increase
year-on-year, mainly driven by continued strong sales from the key products and
milestone revenues from the licensed partners, including $10 million milestone
payment from Immunovant for the initiation of the MG Phase 3 trial. Net income for
the year was 2 billion won, offset by increased R&D expenses.
“HanAll continued to transform into innovative global
biopharma in 2022 by strengthening clinical development capability and expanding
open collaboration network while continuing to deliver solid sales performance.
We were able to launch a share buyback program to return value to our
stakeholders,” said Sean Jeong, M.D., CEO of HanAll Biopharma.
“Moving into the 50th years since our foundation,
2023 will be a pivotal year for HanAll with top-line data readout of
tanfanercept and progress in anti-FcRn programs. We will continue to make our
best efforts to contribute to the patients,” he added.
Full-Year 2022 BUSINESS
UPDATE
Pipeline Development
Highlights
A
comprehensive update on HanAll’s pipeline development below includes an
overview of HanAll’s research along with the list of compounds, targeted
indications, and developmental phase.
Autoimmune Diseases
Programs
Batoclimab (Code
name: HL161BKN)
A novel, fully human, subcutaneously
administered antibody targeting FcRn, with the potential to address multiple
IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to and inhibit
FcRn, which plays a role in recycling IgG, thus leading to a reduction in IgG
antibodies.
l In the
second half of 2022, HanAll Biopharma received approval from the
Pharmaceuticals and Medical Devices Agency to initiate a Phase 3 study of
batoclimab in myasthenia gravis (MG) in Japan, and plan to initiate the study
in the first half of 2023. HanAll is exploring the options of developing
batoclimab in thyroid eye disease (TED) in Japan.
l HanAll’s
licensed partner, Immunovant is conducting global Phase 3 trials with
batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED). The initial results for the pivotal Phase 2b trial in chronic inflammatory
demyelinating polyneuropathy (CIDP) are expected in the first half of 2024. In Graves’
disease (GD), a Phase 2 trial is planned to be initiated in early 2023.
Immunovant will finalize the trial design in warm autoimmune hemolytic anemia (WAIHA)
in early 2023, based on recent FDA interaction.
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 2022. Under the agreement, CSPC was granted the rights to develop and
commercialize batoclimab in Greater China. The company is developing batoclimab
in an array of autoimmune disorders including myasthenia gravis (MG), chronic
inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenia
(ITP). The top-line data for the ongoing Phase 3 study in MG are expected in
the first half of 2023.
HL161ANS (Immunovant
code name: IMVT-1402)
A second novel, fully
human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of
IgG, designed to deliver maximum lgG reductions while minimizing interference
with albumin binding.
l In September
2022, Immunovant unveiled a new FcRn inhibitor HL161ANS (Immunovant code name:
IMVT-1402), originally discovered and developed by HanAll. Immunovant plans to start
a Phase 1 trial for HL161ANS in early 2023 with the initial data read out
expected in in mid-2023.
Eye Disease Programs
Tanfanercept (Code name:
HL036)
A novel, topical
biologic therapy for eye diseases including dry eye disease (DED) by inhibiting
TNF alpha, which is a key mediator of ocular inflammation.
l HanAll
Biopharma and Daewoong Pharmaceutical are progressing with the second Phase 3
VELOS-3 study in patients with moderate to severe DED to examine the safety and
efficacy of tanfanercept, at nine clinical sites in the US. The study
enrollment is complete and the top-line results from the VELOS-3 study are
expected in the first half of 2023.
l Harbour BioMed,
HanAll’s licensed partner in China, announced in October 2022, that they
decided to close its Phase 3 study in DED without enrolling additional patients
to the study, following the recommendation from the Independent Data Monitoring
Committee (IDMC) upon review of the insufficient efficacy trend observed during
the second interim analysis. The study in China is different from the ongoing US
study (VELOS-3) in key inclusion criteria, primary endpoints, and patient
demographics reflecting different medical practices and regulatory requirements.
HanAll is in discussion with Harbour BioMed regarding the next steps for the
development of tanfanercept in China.
Oncology Programs
HL187/ HL186
Monoclonal antibodies
that respectively target TIM-3 and TIGIT, for the potential treatment of cancer,
being developed in collaboration with Daewoong Pharmaceutical Co.
l HanAll
is continuing with the pre-clinical development of HL187 and is preparing for
IND submission in 2023. HL186 is currently in the discovery phase.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights
(KRW in billion) |
2022 |
2021 |
% change |
Sales |
110 |
102 |
+8% |
Gross
Profit |
62 |
60 |
+3% |
Selling,
marketing and administrative expenses |
44 |
40 |
+11% |
Research
and development expenses |
16 |
10 |
+58% |
Operating
income |
2 |
10 |
-85% |
Net Income |
2 |
9 |
-78% |
l Sales recorded 110 billion won
in 2022, an 8.3% increase compared to 2021. The sales in the pharmaceutical division
remained strong with its major products including Normix, Eligard, and Biotop.
l R&D expenses showed a 58% increase
compared to 2021, with a record of 16 billion won.
l
Net income was 2 billion
won, a 78% decrease, compared to the same period in the year of 2021, mainly
due to increased investments in R&D.
About
HanAll Biopharma
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 50 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.
Connect with us on linkedin
to connect with us. For any media inquiries, please contact HanAll PR/IR
(pr@hanall.com,
ir@hanall.com).
Disclaimer
statement