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Idorsia announces financial results for the third quarter 2021 – company progressing and launch preparations in key markets well underway

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland – October 26, 2021
Idorsia Ltd (SIX: IDIA) today announced its financial results for the third quarter of 2021.

Business highlights

  • Five Idorsia affiliates in key European markets (France, Germany, Italy, Spain, UK) established
  • Daridorexant for the treatment of insomnia under review with US FDA (Food and Drug Administration), EMA (European Medicines Agency), Swissmedic, and Health Canada
  • Clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) under review with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
  • “SOS-AMI” Phase 3 registration study with selatogrel in suspected acute myocardial infarction (AMI) is recruiting
  • Results for CARE Phase 2b study with cenerimod for systemic lupus erythematosus expected in Q4 2021
  • Decision on the lucerastat for Fabry disease program awaiting interim analysis of the open-label extension study – expected by year-end
  • Issuance of CHF 600 million senior unsecured convertible bonds to fund the development of the company into a leading biopharmaceutical company

Financial highlights

  • US GAAP operating expenses Q3 2021 at CHF 150 million
  • Non-GAAP operating expenses Q3 2021 at CHF 139 million
  • Guidance for 2021: US GAAP operating expenses below CHF 665 million and non-GAAP operating expenses below 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:
“We are steadily advancing toward becoming a leading biopharmaceutical company. For this, we have set ourselves ambitious goals, one of which is to deliver at least three products to the market. Launch preparations for daridorexant, our most valuable asset to date, and clazosentan in Japan, are well under way. We have made a big step towards having a world class commercial organization by setting up affiliates in key markets at a fast pace. In terms of our potential new therapies, we are developing our diversified and balanced clinical portfolio with a scientific, data-driven approach. In summary, we are ready for our important product launches, we are making considerable strides across the entire company, and I am excited about our future.”

Simon Jose, Chief Commercial Officer of Idorsia, commented:
“We continue to focus on preparing for our first expected launches next year with daridorexant in the US and Europe and clazosentan in Japan. I’m delighted with the caliber of the commercial teams we are building in the affiliates and the ambitious launch plans we have developed for these innovative assets. In the US, our medical and market access teams are engaging with key customers to introduce Idorsia and discuss the significant patient needs in the insomnia market. In Europe, our new General Managers are establishing local affiliates in the top 5 markets and bringing on board their lead teams. In Japan, our medical team is engaging with experts in aSAH who are anticipating the first new pharmacological therapy for this life-threatening condition in over 20 years. I look forward to sharing more about our launch plans in the coming months.”

Financial results

US GAAP resultsNine MonthsThird Quarter
in CHF millions, except EPS (CHF) and number of shares (millions)2021202020212020
Operating expenses(415)(354)(150)(118)
Operating income (loss)(385)(288)(133)(110)
Net income (loss)(383)(308)(140)(118)
Basic EPS(2.29)(2.25)(0.83)(0.83)
Basic weighted average number of shares167.0136.8167.3142.6
Diluted EPS(2.29)(2.25)(0.83)(0.83)
Diluted weighted average number of shares167.0136.8167.3142.6

US GAAP revenue of CHF 30 million in the first nine months of 2021 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 3 million), Janssen Biotech, Inc. (CHF 8 million), Roche (CHF 4 million), Mochida Pharmaceutical Co., Ltd (CHF 4 million), settlement of exchangeable note with Santhera (CHF 12 millio...

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