Financial overview

Commercial highlights

• QUVIVIQ™ (daridorexant) total net sales of CHF 6.5 million since launch in May 2022 in the US, and in November 2022 in Germany and Italy
• QUVIVIQ in the US: Becoming the leading branded insomnia medicine in new to brand prescriptions (NBRx)– with accelerating continued brand prescriptions (CBRx). Net sales in 2022 do not reflect the volume as broad commercial coverage is under negotiation. 2023 kicks-off with progress in payer coverage
• QUVIVIQ in Europe: Off to a great start in Germany and Italy
• PIVLAZ^® (clazosentan) strong performance in Japan with net sales of CHF 44 million since launch in April 2022, with approximately 25% of aSAH patients in the month of December treated with PIVLAZ

Pipeline highlights

• QUVIVIQ – Europe’s first DORA – granted approval by the European Commission in April 2022 and subsequently by the Medicines and Healthcare products Regulatory Agency in Great Britain; approved in Switzerland in December 2022
• Daridorexant – Positive Phase 3 study of Japanese patients with insomnia paves way to regulatory submission in H2 2023
• Aprocitentan – The Lancet and American Heart Association (AHA) late-breaking science session reported significant and sustained antihypertensive effect of aprocitentan in patients with resistant hypertension. NDA submitted to the US FDA in December 2022. MAA submitted to the EMA at the end of January 2023
• Clazosentan – Market registration, based on Japanese data, requested in Republic of Korea
• Clazosentan – Global Phase 3 study, REACT, did not meet primary endpoint
• Cenerimod – Phase 3 registration program for the treatment of patients with systemic lupus erythematosus initiated in December 2022
• Selatogrel – Phase 3 SOS-AMI study for the treatment of heart attack has now exceeded 3,300 patients and recruitment is expected to ramp up in 2023

Financial highlights

• Net revenue FY 2022 at CHF 97 million
• US GAAP operating expenses FY 2022 at CHF 900 million and Non-GAAP operating expenses FY 2022 at CHF 854 million
• Sale & leaseback – Idorsia entered into an agreement generating gross proceeds of
  CHF 164 million
• Guidance for 2023: Company is committed to manage OPEX in order to deliver US GAAP operating loss of around CHF 735 million and non-GAAP operating loss of around CHF 650 million – unforeseen events excluded
• Fundraising: With a liquidity of CHF 466 million at the end of 2022 and the current guidance for 2023 ­– company expects to raise cash in the near term
• Profitability target: The company is committed to become profitable and expects to reach this goal in 2025 with global revenue above CHF 1 billion

US GAAP results

US GAAP net revenue of CHF 97 million in 2022 (CHF 35 million in 2021) consisted of product sales of QUVIVIQ (CHF 6.5 million) and PIVLAZ (CHF 44.0 million), contract revenue recognized in connection with the licensing agreement with Hainan Simcere Pharmaceutical Co., Ltd. (CHF 28 million), the collaboration agreements with Janssen Biotech, Inc. (CHF 8 million), Mochida Pharmaceutical Co., Ltd (CHF 5 million) and Neurocrine Biosciences, Inc. (CHF 4 million), and revenue share from Johnson & Johnson (CHF 2.0 million).

US GAAP operating expenses in 2022 amounted to CHF 900 million (CHF 648 million in 2021), of which CHF 6 million related to cost of sales, CHF 383 million to R&D expenses (CHF 414 million in 2021) and CHF 509 million to SG&A expenses (CHF 234 million in 2021).

US GAAP net loss in 2022 amounted to CHF 828 million (CHF 635 million in 2021). The increase of the net loss was mainly driven by higher operating expenses, largely in the commercial functions, and partially offset by higher net revenues, including the first commercial product sales.

The US GAAP net loss resulted in a net loss per share of CHF 4.67 (basic and diluted) in 2022, compared to a net loss per share of CHF 3.77 (basic and diluted) in 2021.

Non-GAAP* measures

* 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 2022 amounted to CHF 782 million: the CHF 46 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 19 million) and share-based compensation (CHF 26 million).

The non-GAAP net loss resulted in a net loss per share of CHF 4.41 (basic and diluted) in 2022, compared to a net loss per share of CHF 3.41 (basic and diluted) in 2021.

Sale and leaseback

In September 2022, Idorsia entered into a sale and leaseback agreement with a private Swiss company for Idorsia’s research and development building at its headquarters in Allschwil. The building was sold for CHF 164 million (net proceeds of CHF 162 million) and leased back by Idorsia from October 1, 2022.