Key Updates

Commercial highlights

  • QUVIVIQ™ (daridorexant) was launched in the US in May 2022 and is building positive early momentum in the insomnia market. Net sales in the first half of 2022 were CHF 0.4 million
  • PIVLAZ™ (clazosentan) was launched in Japan in April 2022 with strong support from neurosurgeons treating aSAH patients. Net sales in the first half of 2022 were CHF 11.4 million

Pipeline highlights

  • QUVIVIQ (daridorexant) – Europe’s first dual orexin receptor antagonist – granted approval by the European Commission on April 29, 2022
  • Aprocitentan – The Phase 3 study, PRECISION, demonstrated the antihypertensive effect of aprocitentan when added to standard of care in patients with resistant hypertension
  • Clazosentan – Recruitment into the Phase 3 study, REACT, completed with 409 patients randomized
  • Cenerimod – The analysis of the 12-month treatment data of the Phase 2b study has reinforced the decision to pursue cenerimod in a Phase 3 program – plans are being finalized

Financial highlights

  • Net revenue HY 2022 at CHF 22 million
  • US GAAP operating expenses HY 2022 at CHF 427 million
  • Non-GAAP operating expenses HY 2022 at CHF 407 million
  • Guidance for 2022: US GAAP operating loss of around CHF 840 million and non-GAAP operating loss of around CHF 785 million confirmed – unforeseen events excluded

Financial Results as of June 30, 2022

US GAAP results

 

First Half

Second Quarter

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

2022

2021

2022

2021

Net revenues

22

14

17

7

Operating expenses

(427)

(265)

(229)

(137)

Operating income (loss)

(405)

(252)

(212)

(130)

Net income (loss)

(419)

(243)

(222)

(139)

Basic EPS

(2.36)

(1.46)

(1.25)

(0.83)

Basic weighted average number of shares

177.3

166.9

177.5

167.1

Diluted EPS

(2.36)

(1.46)

(1.25)

(0.83)

Diluted weighted average number of shares

177.3

166.9

177.5

167.1

 

US GAAP net revenue of CHF 22 million in the first half of 2022 consisted of product sales of QUVIVIQ (CHF 0.4 million) and PIVLAZ (CHF 11.4 million), contract revenue recognized in connection with the collaboration agreements with Janssen Biotech, Inc. (CHF 5 million), Mochida Pharmaceutical Co., Ltd (CHF 3 million) and Neurocrine Biosciences, Inc. (CHF 2 million) and revenue share from J&J (CHF 0.6 million), compared to a revenue of CHF 14 million in the first half of 2021.

US GAAP operating expenses in the first half of 2022 amounted to CHF 427 million (CHF 265 million in the first half of 2021), of which CHF 1 million relates to cost of sales, CHF 192 million relates to R&D (CHF 192 million in the first half of 2021) and CHF 234 million to SG&A expenses (CHF 74 million in the first half of 2021).

US GAAP net loss in the first half of 2022 amounted to CHF 419 million compared to CHF 243 million in the first half of 2021. The increase of the net loss was mainly driven by higher operating expenses, mainly in the commercial functions and a negative financial result, partially offset by higher net sales.

The US GAAP net loss resulted in a net loss per share of CHF 2.36 (basic and diluted) in the first half of 2022 compared to a net loss per share of CHF 1.46 (basic and diluted) in the first half of 2021.

Non-GAAP* measures

 

First Half

Second Quarter

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

2022

2021

2022

2021

Net revenues

22

14

17

7

Operating expenses

(407)

(248)

(219)

(128)

Operating income (loss)

(384)

(234)

(202)

(121)

Net income (loss)

(395)

(223)

(206)

(128)

Basic EPS

(2.23)

(1.34)

(1.16)

(0.77)

Basic weighted average number of shares

177.3

166.9

177.5

167.1

Diluted EPS

(2.23)

(1.34)

(1.16)

(0.77)

Diluted weighted average number of shares

177.3

166.9

177.5

167.1

* 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 half of 2022 amounted to CHF 395 million: the CHF 23 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 9 million), share-based compensation (CHF 11 million) and a negative non-cash financial result (CHF 4 million).

The non-GAAP net loss resulted in a net loss per share of CHF 2.23 (basic and diluted) in the first half of 2022 compared to a net loss per share of CHF 1.34 (basic and diluted) in the first half of 2021.

Financial outlook

“Idorsia has reached another important milestone by recording its first product sales with the launches of PIVLAZ in Japan and QUVIVIQ in the US. Becoming a commercial stage company is a key milestone to achieve our objective of reaching sustainable profitability by 2025. The positive readout of aprocitentan in June is another key milestone as the royalty entitlement from Janssen will bring us another source of revenue by 2024. All these recent milestones make us confident that we will be able to raise cash with non-equity dilutive instruments in the second half of 2022. The next few months will give us more visibility on the uptake of QUVIVIQ in the US. Irrespective of the net sales numbers that will be achieved for the full year 2022, we are fully committed to delivering our current guidance with a non-GAAP operating loss around CHF 785 million and a US GAAP operating loss around CHF 840 million for the full year 2022.” (July 2022)

André C. Muller
Chief Financial Officer

Financial charts

Financial charts for the first half of 2022 are presented in the webcast presentation.