Financial overview

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).

US GAAP results

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

* 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.