Key Updates
Business highlights
- Positive results in the Phase 3 program of daridorexant, demonstrating improved overall sleep and daytime functioning of patients with insomnia
- Daridorexant new drug application (NDA) submitted to the US FDA on January 8, 2021
- Positive results in the Japanese registration program for clazosentan, demonstrating reduction in vasospasm-related morbidity and all-cause mortality
- US commercial operations established, with leadership team in place, and Syneos Health selected as commercialization partner to build the salesforce for the launch of daridorexant in the US
- Neurocrine Biosciences entered into a license agreement for the development and commercialization of Idorsia’s novel T-type calcium channel blocker
- Axovan arbitration claim dismissed by Arbitral Tribunal
Financial highlights
- Successful capital increases secured over CHF 865 million of funding to prepare for the launch of daridorexant and to develop our diversified pipeline
- US GAAP operating expenses 2020 at CHF 482 million
- Non-GAAP operating expenses 2020 at CHF 444 million
- Guidance for 2021: US GAAP operating expenses of ~ CHF 685 million and non-GAAP operating expenses of ~ CHF 640 million (both measures include inventory build of around CHF 35 million and exclude unforeseen events).
Financial Results as of December 31, 2020
US GAAP results
|
|
Full Year |
Fourth Quarter | ||
|
in CHF millions, except EPS (CHF) and number of shares (millions) |
2020 |
2019 |
2020 |
2019 |
|
Revenues |
72 |
24 |
6 |
4 |
|
Operating expenses |
(482) |
(506) |
(128) |
(131) |
|
Operating income (loss) |
(411) |
(482) |
(123) |
(127) |
|
Net income (loss) |
(445) |
(494) |
(137) |
(142) |
|
Basic EPS |
(3.11) |
(3.76) |
(0.85) |
(1.08) |
|
Basic weighted average number of shares |
142.8 |
131.2 |
160.8 |
131.2 |
|
Diluted EPS |
(3.11) |
(3.76) |
(0.85) |
(1.08) |
|
Diluted weighted average number of shares |
142.8 |
131.2 |
160.8 |
131.2 |
US GAAP revenue of CHF 72 million in 2020 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 50 million), Janssen Biotech, Inc. (CHF 11 million), Roche (CHF 6 million), Mochida Pharmaceutical Co., Ltd (CHF 3 million) and Santhera Pharmaceuticals Ltd (CHF 2 million) compared to a revenue of CHF 24 million in 2019.
US GAAP operating expenses in 2020 amounted to CHF 482 million (CHF 506 million in 2019), of which CHF 381 million relates to R&D (CHF 439 million in 2019), which includes a one-off expense of CHF 9 million as explained in the legal update below, and CHF 101 million to SG&A expenses (CHF 68 million in 2019).
US GAAP net loss in 2020 amounted to CHF 445 million compared to CHF 494 million in 2019. The decrease of the net loss was mainly driven by higher contract revenues and lower operating expenses, which was partially offset by higher financial expenses.
The US GAAP net loss resulted in a net loss per share of CHF 3.11 (basic and diluted) in 2020 compared to a net loss per share of CHF 3.76 (basic and diluted) in 2019.
Non-GAAP* measures
|
|
Full Year |
Fourth Quarter | ||
|
in CHF millions, except EPS (CHF) and number of shares (millions) |
2020 |
2019 |
2020 |
2019 |
|
Revenues |
72 |
24 |
6 |
4 |
|
Operating expenses |
(444) |
(470) |
(142) |
(122) |
|
Operating income (loss) |
(372) |
(446) |
(136) |
(118) |
|
Net income (loss) |
(392) |
(448) |
(148) |
(121) |
|
Basic EPS |
(2.75) |
(3.41) |
(0.92) |
(0.92) |
|
Basic weighted average number of shares |
142.8 |
131.2 |
160.8 |
131.2 |
|
Diluted EPS |
(2.75) |
(3.41) |
(0.92) |
(0.92) |
|
Diluted weighted average number of shares |
142.8 |
131.2 |
160.8 |
131.2 |
* 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 2020 amounted to CHF 392 million: the CHF 53 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 19 million), share-based compensation (CHF 16 million) and a negative non-cash financial result (CHF 18 million).
The non-GAAP net loss resulted in a net loss per share of CHF 2.75 (basic and diluted) in 2020 compared to a net loss per share of CHF 3.41 (basic and diluted) in 2019.
Legal update on the Axovan arbitration
As a result of the demerger of Idorsia from Actelion, Idorsia holds a license agreement to develop and commercialize clazosentan from a share purchase agreement between Actelion and Axovan sellers.
Axovan sellers and F. Hoffman-La Roche Ltd are entitled to receive milestone up to CHF 92 million (CHF 21 million at filing, CHF 51 million at approval and CHF 20 million sales milestones). These milestones had been reduced following the acquisition in 2020 of claims from some Axovan sellers for a one-time cash consideration of CHF 9 million.
In 2018, the assignee of 65% of former Axovan shareholders (the “Claimants”) entered into an arbitration against Actelion claiming that the acquisition of Actelion by Johnson & Johnson and/or the Demerger triggers the accelerated payment of all outstanding milestones mainly relating to clazosentan (the “Claim”) plus statutory interest for late payment.
On February 1, 2021, Idorsia was notified in a final award by the arbitral tribunal that the Claim had been dismissed.
In the first half 2020, the company accrued CHF 23 million relating to the Axovan arbitration. Following the final award, this accrual was fully reversed in Q4 2020.
Idorsia remains fully committed to developing and commercializing clazosentan and to paying any milestones, if and when due.
