Key Updates
Commercial highlights
- QUVIVIQ™ (daridorexant) acceleration in volume and number of patients treated after the start of the consumer campaign – poised to become the leading branded insomnia medication in the US in new-to-brand prescriptions
- QUVIVIQ™ (daridorexant) Net sales of CHF 2.3 million since launch in May 2022, do not reflect the volume as broad commercial coverage is under negotiation
- PIVLAZ™ (clazosentan) strong performance in Japan with net sales of CHF 25.1 million since launch in April 2022, with approximately 20% of aSAH patients treated in September
Pipeline highlights
- QUVIVIQ (daridorexant) – 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, approval in Switzerland anticipated in the coming months
- Daridorexant – Positive Phase 3 study of Japanese patients with insomnia paves way to regulatory submission in H1 2023
- Aprocitentan – Data from the positive Phase 3 study, PRECISION, will be presented as a Late-Breaking Science presentation during the American Heart Association (AHA) Scientific Sessions 2022. Activities to submit a New Drug Application to the US FDA are on track for filing by the end of the year.
- Clazosentan – Market registration, based on Japanese data, requested in Republic of Korea
- Clazosentan – Results from global Phase 3 study, REACT, expected in the first quarter 2023
- Cenerimod – Data from the Phase 2b study, CARE, will be presented at the American College of Rheumatology (ACR) Convergence 2022
Financial highlights
- Net revenue 9M 2022 at CHF 43 million
- US GAAP operating expenses 9M 2022 at CHF 653 million
- Non-GAAP operating expenses 9M 2022 at CHF 621 million
- Sale & leaseback – Idorsia entered into an agreement generating proceeds of CHF 164 million
- Guidance for 2022: US GAAP operating loss of around CHF 840 million and non-GAAP operating loss of around CHF 785 million confirmed – barring unforeseen events
Financial Results as of September 30, 2022
US GAAP results
|
Nine Months |
Third Quarter |
|||
|
in CHF millions, except EPS (CHF) and number of shares (millions) |
2022 |
2021 |
2022 |
2021 |
|
Net revenues |
43 |
30 |
21 |
17 |
|
Operating expenses |
(653) |
(415) |
(227) |
(150) |
|
Operating income (loss) |
(610) |
(385) |
(206) |
(133) |
|
Net income (loss) |
(635) |
(383) |
(216) |
(140) |
|
Basic EPS |
(3.58) |
(2.29) |
(1.22) |
(0.83) |
|
Basic weighted average number of shares |
177.4 |
167.0 |
177.5 |
167.3 |
|
Diluted EPS |
(3.58) |
(2.29) |
(1.22) |
(0.83) |
|
Diluted weighted average number of shares |
177.4 |
167.0 |
177.5 |
167.3 |
US GAAP net revenue of CHF 43 million in the first nine months of 2022 (CHF 30 million in the first nine months of 2021) consisted of product sales of QUVIVIQ (CHF 2.3 million) and PIVLAZ (CHF 25.1 million), contract revenue recognized in connection with the collaboration agreements with Janssen Biotech, Inc. (CHF 8 million), Mochida Pharmaceutical Co., Ltd (CHF 4 million) and Neurocrine Biosciences, Inc. (CHF 3 million), and revenue share from J&J (CHF 1.3 million).
US GAAP operating expenses in the first nine months of 2022 amounted to CHF 653 million (CHF 415 million in the first nine months of 2021), of which CHF 4 million relates to cost of sales, CHF 278 million to R&D expenses (CHF 288 million in the first nine months of 2021) and CHF 372 million to SG&A expenses (CHF 127 million in the first nine months of 2021).
US GAAP net loss in the first nine months of 2022 amounted to CHF 635 million (CHF 383 million in the first nine months of 2021). The increase of the net loss was mainly driven by higher operating expenses, largely in the commercial functions, and a negative financial result, partially offset by higher net revenues.
The US GAAP net loss resulted in a net loss per share of CHF 3.58 (basic and diluted) in the first nine months of 2022, compared to a net loss per share of CHF 2.29 (basic and diluted) in the first nine months of 2021.
Non-GAAP* measures
|
Nine Months |
Third Quarter |
|||
|
in CHF millions, except EPS (CHF) and number of shares (millions) |
2022 |
2021 |
2022 |
2021 |
|
Net revenues |
43 |
30 |
21 |
17 |
|
Operating expenses |
(621) |
(388) |
(214) |
(139) |
|
Operating income (loss) |
(577) |
(357) |
(193) |
(123) |
|
Net income (loss) |
(597) |
(347) |
(202) |
(124) |
|
Basic EPS |
(3.36) |
(2.08) |
(1.14) |
(0.74) |
|
Basic weighted average number of shares |
177.4 |
167.0 |
177.5 |
167.3 |
|
Diluted EPS |
(3.36) |
(2.08) |
(1.14) |
(0.74) |
|
Diluted weighted average number of shares |
177.4 |
167.0 |
177.5 |
167.3 |
* 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 2022 amounted to CHF 597 million: the CHF 38 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 13 million), share-based compensation (CHF 19 million) and a negative non-cash financial result (CHF 6 million).
The non-GAAP net loss resulted in a net loss per share of CHF 3.36 (basic and diluted) in the first nine months of 2022, compared to a net loss per share of CHF 2.08 (basic and diluted) in the first nine months of 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.