IDORSIA LTD Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland -- July 27, 2021
Idorsia Ltd (SIX: IDIA) today announced its financial results for the first half of 2021.
Business highlights
-- Daridorexant for the treatment of insomnia under review with US FDA, EMA,
and Swissmedic
-- Nine scientific presentations for daridorexant shared at SLEEP 2021
-- Ponesimod to treat relapsing forms of multiple sclerosis was approved by
the US FDA and the European Commission, Idorsia receives first income
from the revenue-sharing agreement in respect to ponesimod
-- Clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal
subarachnoid hemorrhage (aSAH) submitted to the Japanese Pharmaceuticals
and Medical Devices Agency (PMDA) in March 2021
-- "SOS-AMI" Phase 3 registration study with selatogrel in suspected acute
myocardial infarction (AMI) initiated in June 2021
-- Phase 2 study with ACT-539313 for binge eating disorder initiated in
March 2021
-- Results for MODIFY Phase 3 study with lucerastat for Fabry disease
expected in Q4 2021
-- Results for PRECISION Phase 3 study with aprocitentan for resistant
hypertension expected mid-2022
-- Results for CARE Phase 2b study with cenerimod for systemic lupus
erythematosus expected in Q4 2021 Financial highlights
-- US GAAP operating expenses HY 2021 at CHF 265 million
-- Non-GAAP operating expenses HY 2021 at CHF 248 million
-- Guidance for 2021: US GAAP operating expenses around CHF 665 million and
non-GAAP operating expenses around CHF 620 million (both measures include
inventory build of around CHF 35 million and exclude unforeseen events) Jean-Paul Clozel, MD and Chief Executive Officer, commented:
"The company is making great progress with delivering on the strategic priorities we defined on Day 1 of Idorsia. Now, just 4 years after establishing the company, we are on the verge of transformation into the fully-fledged biopharmaceutical company we intended to be. The regulatory review and the commercial preparation for daridorexant are progressing well and the team keeps its focus on this important asset. I'm also particularly proud of our newest advancement in the pipeline as selatogrel entered Phase 3 being evaluated as an emergency intervention for suspected AMI at the onset of symptoms. Yet another exciting innovation to watch for Idorsia."
Simon Jose, Chief Commercial Officer of Idorsia, commented:
"We are progressing very well with our preparations for the anticipated approval and launch of daridorexant. In the US, our new medical team is starting to engage with key experts and the recruitment of our market access team is nearing completion. In Europe, we have made great progress in building our commercial footprint and have appointed General Managers in the major markets. In the second half we will increase our engagement with key stakeholders and begin to raise awareness of the science and burden of insomnia. Similarly, we are on track with our plans for the expected launch of clazosentan in Japan -- where the incidence of aSAH is more than twice as high as in the rest of the world."
Financial results
US GAAP results First Half Second Quarter ------------------------------------------------------- -------------- --------------- in CHF millions, except EPS (CHF) and number of shares (millions) 2021 2020 2021 2020 Revenues 14 58 7 53 ------------------------------------------------------- ------ ------ ------ ------- Operating expenses (265) (236) (137) (120) ------------------------------------------------------- ------ ------ ------ ------- Operating income (loss) (252) (178) (130) (67) ------------------------------------------------------- ------ ------ ------ ------- Net income (loss) (243) (189) (139) (69) ------------------------------------------------------- ------ ------ ------ ------- Basic EPS (1.46) (1.41) (0.83) (0.51) ------------------------------------------------------- ------ ------ ------ ------- Basic weighted average number of shares 166.9 133.8 167.1 136.4 ------------------------------------------------------- ------ ------ ------ ------- Diluted EPS (1.46) (1.41) (0.83) (0.51) ------------------------------------------------------- ------ ------ ------ ------- Diluted weighted average number of shares 166.9 133.8 167.1 136.4 ------------------------------------------------------- ------ ------ ------ -------
US GAAP revenue of CHF 14 million in the first half of 2021 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 2 million), Janssen Biotech, Inc. (CHF 5 million), Roche (CHF 4 million), Mochida Pharmaceutical Co., Ltd (CHF 3 million) and revenue share from J&J (CHF 0.4 million) compared to a revenue of CHF 58 million in the first half of 2020.
US GAAP operating expenses in the first half of 2021 amounted to CHF 265 million (CHF 236 million in the first half of 2020), of which CHF 192 million relates to R&D (CHF 197 million in the first half of 2020) and CHF 74 million to SG&A expenses (CHF 40 million in the first half of 2020).
US GAAP net loss in the first half of 2021 amounted to CHF 243 million compared to CHF 189 million in the first half of 2020. The increase of the net loss was mainly driven by lower contract revenues as well as higher operating expenses mainly in the commercial functions, which was partially offset by a positive contribution from financial income.
The US GAAP net loss resulted in a net loss per share of CHF 1.46 (basic and diluted) in the first half of 2021 compared to a net loss per share of CHF 1.41 (basic and diluted) in the first half of 2020.
Non-GAAP* measures First Half Second Quarter ------------------------------------------------------- -------------- --------------- in CHF millions, except EPS (CHF) and number of shares (millions) 2021 2020 2021 2020 Revenues 14 58 7 53 ------------------------------------------------------- ------ ------ ------ ------- Operating expenses (248) (193) (128) (86) ------------------------------------------------------- ------ ------ ------ ------- Operating income (loss) (234) (134) (121) (33) ------------------------------------------------------- ------ ------ ------ ------- Net income (loss) (223) (138) (128) (36) ------------------------------------------------------- ------ ------ ------ ------- Basic EPS (1.34) (1.03) (0.77) (0.26) ------------------------------------------------------- ------ ------ ------ ------- Basic weighted average number of shares 166.9 133.8 167.1 136.4 ------------------------------------------------------- ------ ------ ------ ------- Diluted EPS (1.34) (1.03) (0.77) (0.26) ------------------------------------------------------- ------ ------ ------ ------- Diluted weighted average number of shares 166.9 133.8 167.1 136.4 ------------------------------------------------------- ------ ------ ------ -------
* 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 half of 2021 amounted to CHF 223 million: the CHF 20 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 8 million), share-based compensation (CHF 8 million) and a negative non-cash financial result (CHF 4 million).
The non-GAAP net loss resulted in a net loss per share of CHF 1.34 (basic and diluted) in the first half of 2021 compared to a net loss per share of CHF 1.03 (basic and diluted) in the first half of 2020.
André C. Muller, Chief Financial Officer, commented:
"I'm pleased to now see a regular income stream, albeit modest, with the revenue-sharing agreement relating to ponesimod, which was launched by J&J in the second quarter following its approval for relapsing forms of multiple sclerosis in the US and EU. With regulatory discussions for daridorexant in the US and Europe, and clazosentan in Japan, progressing well, the investment into our global commercial infrastructure and launch preparations will gradually increase over the next quarters leading to US GAAP operating expenses for the full year 2021 around CHF 665 million and non-GAAP operating expenses around CHF 620 million, both measures include an inventory build of around CHF 35 million and exclude unforeseen events."
Liquidity and indebtedness
(MORE TO FOLLOW) Dow Jones Newswires
July 27, 2021 01:01 ET (05:01 GMT)
