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Idorsia announces financial results for the first half 2021 – Building momentum towards becoming a fully-fledged biopharmaceutical company

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 resultsFirst HalfSecond Quarter
in CHF millions, except EPS (CHF) and number of shares (millions)2021202020212020
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 shares166.9133.8167.1136.4
Diluted EPS(1.46)(1.41)(0.83)(0.51)
Diluted weighted average number of shares166.9133.8167.1136.4

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 mill...

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