Date2022-01-21
2021 sales of KRW 101.6 billion for a 15% increase from 2020
2021 operating profit of KRW 10.1 billion grew by 70% from 2020
Increasing milestone payments and revenues from R&D activities are reinvested into new R&D programs
[Business Performance and Financial Status]
HanAll Biopharma (KRX: 009420.KS) announced today that it
achieved 101.6 billion won in sales in 2021, a 15% increase from the previous
year. It had 10.1 billion won in operating profit, a 70% increase year-on-year,
for the 19th consecutive quarter in the black, and the net profit in 2021 was
10 billion won. Both growth and profitability were thus secured.
Strong financial performance was largely due to
increasing revenues from R&D activities and double digit percentage sales growth
of major products such as Normix, an antibiotic for gastrointesinal infection;
Eligard, a prostate cancer treatment; and Biotop, a probiotic product.
HanAll has been generating stable profits since
the licensing agreements with Roivant Sciences and Harbour Biomed in 2017. HanAll
has thus established a virtuous investment cycle in which new R&D programs
are funded by its own profits.
“While transforming into a
global, innovative biopharmaceutical company with a promising pipeline and
continuous investments, HanAll continues to produce stable profits. Milestone
payments are expected to increase more this year. We will be carrying out more
proactive R&D activities in 2022 to develop novel drugs for patients with high
unmet medical needs,” said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.
HanAll’s financial status
as of the end of 2021 includes 199.7 billion won in assets, 164.7 billion won
in equity, and 35 billion
won in liabilities, maintaining a
stable financial structure.
[R&D
Pipeline
development status]
- HL161 (a novel, fully human,
subcutaneous anti-FcRn antibody therapeutic for autoimmune diseases)
HL161
(INN: batoclimab) is a new antibody drug for the treatment of rare autoimmune
diseases caused by pathogenic autoantibodies. It is being developed in the
US/Europe and China respectively by global license partners Immunovant and
Harbour Biomed.
Immunovant
recently announced plans for a Phase 3 trial in myasthenia gravis (MG) as well
as for other clinical trial plans for this year. The Phase 3 in MG is planned
to be initiated in the first half of the year, and two additional pivotal
clinical trials are expected to start in 2022. Moreover, with the addition of
two new indication programs, HL161 is planned to be developed in five autoimmune
diseases in the US and Europe by Immunovant.
Harbour
Biomed, HanAll’s partner in China, is developing batoclimab in six autoimmune indications:
myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica spectrum
disorder (NMOSD), thyroid eye disease (TED), chronic inflammatory demyelinating
polyneuropathy (CIDP), and pemphigus vulgaris (PV). MG is in Phase 3 and ITP,
NMOSD, and TED are in Phase 2. Harbour is planning to submitt a biologics
license application (BLA) to the National Medical Products Administration (NMPA)
for approval in MG this year.
HanAll
Biopharma is preparing a Phase 3 trial for myasthenia gravis (MG) in Japan 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.
In November
2021, the first patient first dose in the second Phase 3 clinical trial (study
name: VELOS-3) has started in the US and the trial is
currently ongoing. The clinical trial’s topline results are expected in the
second half of 2022. The VELOS-3
clinical trial aims to replicate the efficacy seen in VELOS-2 (the first Phase
3 trial), and is proceeding at 9 clinical sites in the US with patients who
have moderate to severe dry eye disease.
Harbour Biomed, who has the rights
to develop tanfanercept in China, is carrying out the Phase 3 clinical trial for
dry eye disease in China. Harbour is planning to submit a BLA to the NMPA at
the end of this year.
- 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 announce a new indications development plan in 2022.
- HL186/HL187 (novel immune-oncology
therapies)
HL186 and HL187 projects are novel immuno-oncology
antibodies that respectively target TIM-3 and TIGIT, developed in collaboration
with Daewoong Pharmaceutical. Both programs are at the preclinical stage. The
companies aim to develop differentiated immune checkpoint inhibitors with
better efficacy for patients with cancer.
Full-Year 2021 Financial Highlights (consolidated, KRW
billion)
|
|
2021 |
2020 |
% change |
|
|
Sales |
101.6 |
88.6 |
+15% |
|
|
Gross Profit |
60.3 |
50.7 |
+19% |
|
|
Gross Margin |
59% |
57% |
||
|
Operating Profit |
10.1 |
5.9 |
+70% |
|
|
Operating Margin |
10% |
7% |
|
|
|
Net Income |
10.0 |
19.8 |
-49% |
|
|
Net Margin |
10% |
22% |
|
|
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
2021 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 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.