IDORSIA LTD
Allschwil, Switzerland -- April 22, 2021
Idorsia Ltd (SIX: IDIA) today announced its financial results for the
first quarter of 2021.
Business highlights
-- Daridorexant new drug application (NDA) submitted to the US FDA in
January 2021 and has been accepted for review
-- Daridorexant marketing authorisation application (MAA) submitted to the
European Medicines Agency (EMA) in March 2021
-- Daridorexant MAA submitted to Switzerland's health authority, Swissmedic,
in April 2021
-- Daridorexant Phase 3 program has concluded -- supporting the chronic use
of daridorexant in insomnia
-- Ponesimod to treat relapsing forms of multiple sclerosis was approved by
the US FDA and a positive CHMP opinion was received in March 2021,
Idorsia has a revenue-sharing agreement in respect to ponesimod
-- Clazosentan NDA submitted to the Japanese Pharmaceuticals and Medical
Devices Agency (PMDA) in March 2021
-- MODIFY Phase 3 study with lucerastat for Fabry disease fully recruited,
results expected in Q4 2021
-- PRECISION Phase 3 study with aprocitentan for resistant hypertension
fully recruited, results expected mid-2022
-- Recruitment of patients into the CARE Phase 2b study with cenerimod for
systemic lupus erythematosus completed, results expected in Q4 2021
-- Recruitment commenced into Phase 2 study with ACT-539313 for binge eating
disorder in March 2021
Financial highlights
-- US GAAP operating expenses in Q1 2021 at CHF 129 million
-- Non-GAAP operating expenses in Q1 2021 at CHF 121 million
-- Guidance for 2021: US GAAP operating expenses below CHF 685 million and
non-GAAP operating expenses below CHF 640 million (both measures include
inventory build of around CHF 35 million and exclude unforeseen events).
Jean-Paul Clozel, MD and Chief Executive Officer, commented:
"This first quarter of 2021 is loaded with important progress and
milestones; we submitted the marketing registration dossiers for
daridorexant to both the FDA, and the EMA and for clazosentan in Japan,
and now in April the MAA submission for daridorexant to Switzerland's
Swissmedic has also occurred. J&J received the marketing approval for
ponesimod in the US and a positive CHMP opinion in the EU which
represents patients being able to benefit from a drug discovered by our
scientists and the first revenues for Idorsia. We also completed the
recruitment of patients into the pivotal trials for lucerastat and
aprocitentan, as well as the large Phase 2b study with cenerimod. We are
all getting ready for the launch of our first products and the
transformation of Idorsia into a fully-fledged biopharmaceutical company
based on science."
Simon Jose, Chief Commercial Officer of Idorsia, commented:
"It's an exciting time at Idorsia and our growing commercial team
continues to work with a laser focus on preparing for the successful
launches of daridorexant in the US and Europe and clazosentan in Japan.
Following the NDA submission for daridorexant, we continue to build our
US team and engage with the medical community and other key stakeholders
to advance the science and raise awareness about the burden of insomnia
on patients' daily lives. The MAA filing for daridorexant in Europe is
also an important milestone. We see a significant medical need for new
safe and effective treatment options for insomnia in Europe and are
ramping up our activities here following the appointment of Jean-Yves
Chatelan, President, Region Europe and Canada."
Financial results
US GAAP results First Quarter
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in CHF millions, except EPS (CHF) and number of shares
(millions) 2021 2020
Revenues 7 5
------------------------------------------------------------ ------- ------
Operating expenses (129) (116)
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Operating income (loss) (122) (111)
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Net income (loss) (105) (120)
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Basic EPS (0.63) (0.91)
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Basic weighted average number of shares 166.6 131.3
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Diluted EPS (0.63) (0.91)
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Diluted weighted average number of shares 166.6 131.3
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US GAAP revenue of CHF 7 million in the first quarter of 2021 consisted
of contract revenue recognized in connection with the collaboration
agreements with Neurocrine Biosciences, Inc. (CHF 1 million), Janssen
Biotech, Inc. (CHF 3 million), Roche (CHF 2 million) and Mochida
Pharmaceutical Co., Ltd (CHF 1 million) compared to a revenue of CHF 5
million in the first quarter of 2020.
US GAAP operating expenses in the first quarter of 2021 amounted to CHF
129 million (CHF 116 million in the first quarter of 2020), of which CHF
97 million relates to R&D (CHF 97 million in the first quarter of 2020)
and CHF 31 million to SG&A expenses (CHF 19 million in the first quarter
of 2020).
US GAAP net loss in the first quarter of 2021 amounted to CHF 105
million compared to CHF 120 million in the first quarter of 2020. The
decrease of the net loss was mainly driven by a positive contribution
from financial income, which was partially offset by higher operating
expenses.
The US GAAP net loss resulted in a net loss per share of CHF 0.63 (basic
and diluted) in the first quarter of 2021 compared to a net loss per
share of CHF 0.91 (basic and diluted) in the first quarter of 2020.
Non-GAAP* measures First Quarter
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in CHF millions, except EPS (CHF) and number of shares
(millions) 2021 2020
Revenues 7 5
------------------------------------------------------------ ------- ------
Operating expenses (121) (106)
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Operating income (loss) (114) (101)
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Net income (loss) (95) (102)
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Basic EPS (0.57) (0.78)
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Basic weighted average number of shares 166.6 131.3
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Diluted EPS (0.57) (0.78)
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Diluted weighted average number of shares 166.6 131.3
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* Idorsia measures, reports and issues guidance on non-GAAP operating
performance. Idorsia believes that these non-GAAP financial measurements
more accurately reflect the underlying business performance and
therefore provide useful supplementary information to investors. These
non-GAAP measures are reported in addition to, not as a substitute for,
US GAAP financial performance.
Non-GAAP net loss in the first quarter of 2021 amounted to CHF 95
million: the CHF 10 million difference versus US GAAP net loss was
mainly due to depreciation and amortization (CHF 4 million), share-based
compensation (CHF 4 million) and a negative non-cash financial result
(CHF 2 million).
The non-GAAP net loss resulted in a net loss per share of CHF 0.57
(basic and diluted) in the first quarter of 2021 compared to a net loss
per share of CHF 0.78 (basic and diluted) in the first quarter of 2020.
André C. Muller, Chief Financial Officer, commented:
"The whole company is working with a very cost-conscious attitude. We've
hit several important milestones in the first quarter and I'm happy to
report that all this has been achieved on a slightly lower spend than
initially expected. As a result, we now expect US GAAP operating
expenses below CHF 685 million and non-GAAP operating expenses below CHF
640 million for the full year 2021, both measures include an inventory
build of around CHF 35 million and exclude unforeseen events."
Liquidity and indebtedness
At the end of the first quarter of 2021, Idorsia's liquidity (including
cash, cash equivalents, short- and long-term deposits) amounted to CHF
1,065 million.
(in CHF millions) Mar 31, 2021 Dec 31, 2020 Mar 31, 2020
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Liquidity
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Cash and cash equivalents 128 141 95
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Short-term deposits 741 867 357 (MORE TO FOLLOW) Dow Jones Newswires
April 22, 2021 01:00 ET (05:00 GMT)
