Key Updates

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)

Financial Results as of September 30, 2021

US GAAP results

 

Nine Months

Third Quarter

in CHF millions, except EPS (CHF) and number of shares (millions)

2021

2020

2021

2020

Revenues

30

66

17

8

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 shares

167.0

136.8

167.3

142.6

Diluted EPS

(2.29)

(2.25)

(0.83)

(0.83)

Diluted weighted average number of shares

167.0

136.8

167.3

142.6

 

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 million) and revenue share from J&J (CHF 0.4 million), compared to a revenue of CHF 66 million in the first nine months of 2020.

US GAAP operating expenses in the first nine months of 2021 amounted to CHF 415 million (CHF 354 million in the first nine months of 2020), of which CHF 288 million relates to R&D (CHF 290 million in the first nine months of 2020) and CHF 127 million to SG&A expenses (CHF 64 million in the first nine months of 2020).

US GAAP net loss in the first nine months of 2021 amounted to CHF 383 million compared to CHF 308 million in the first nine months 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 2.29 (basic and diluted) in the first nine months of 2021 compared to a net loss per share of CHF 2.25 (basic and diluted) in the first nine months of 2020.

Non-GAAP* measures

 

Nine Months

Third Quarter

in CHF millions, except EPS (CHF) and number of shares (millions)

2021

2020

2021

2020

Revenues

30

66

17

8

Operating expenses

(388)

(302)

(139)

(109)

Operating income (loss)

(357)

(236)

(123)

(102)

Net income (loss)

(347)

(245)

(124)

(107)

Basic EPS

(2.08)

(1.79)

(0.74)

(0.75)

Basic weighted average number of shares

167.0

136.8

167.3

142.6

Diluted EPS

(2.08)

(1.79)

(0.74)

(0.75)

Diluted weighted average number of shares

167.0

136.8

167.3

142.6

* 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 nine months of 2021 amounted to CHF 347 million: the CHF 36 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 13 million), share-based compensation (CHF 13 million) and a negative non-cash financial result (CHF 10 million).

The non-GAAP net loss resulted in a net loss per share of CHF 2.08 (basic and diluted) in the first nine months of 2021 compared to a net loss per share of CHF 1.79 (basic and diluted) in the first nine months of 2020.

Financial Guidance

“With the cash raise of CHF 600 million through the issuance of a 7-year convertible bond, we will enter 2022 with a strong balance sheet to fund the launches of daridorexant in the US and some European markets and clazosentan in Japan. Making a success of these treatments in these territories is the best way for us to reach sustainable profitability in the mid-term. For the full year 2021 we now expect US GAAP operating expenses below CHF 665 million and non-GAAP operating expenses below CHF 620 million, both measures include an inventory build of around CHF 35 million and exclude unforeseen events.” (October 2021)

André C. Muller
Chief Financial Officer

Financial Charts

Financial charts for the first nine months of 2021 are presented in the company presentation.