Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland - April 25, 2023
Idorsia Ltd (SIX: IDIA) today announced its financial results for the first quarter of 2023.
Commercial highlights
- QUVIVIQ (daridorexant) total net sales of CHF 4.3 million in Q1 2023
- QUVIVIQin the US: Now the leading branded insomnia medicine in new-to-brand prescriptions (NBRx) and total prescriptions (TRx) in the commercial market. Net sales do not reflect the volume as broad commercial coverage is under negotiation.
- QUVIVIQ in Europe: Demand continues to grow in Germany and Italy
- PIVLAZ® (clazosentan): Treated more than 5,000 patients in the first year of availability, with net sales of CHF 13.5 million in Q1 2023, and approximately 27% of aSAH patients treated with PIVLAZ in the month of March.
Pipeline highlights
- Aprocitentan - NDA accepted for review by the US FDA - PDUFA December 19, 2023
- Aprocitentan - MAA submitted to the EMA at the end of January 2023
Financial highlights
- Net revenue Q1 2023 at CHF 21 million
- US GAAP operating expenses Q1 2023 at CHF 219 million and non-GAAP operating expenses Q1 2023 at CHF 202 million
- US GAAP operating loss Q1 2023 of CHF 198 million and non-GAAP operating loss of CHF 181 million
- Guidance for 2023: The company is committed to manage operating expenses in order to deliver US GAAP operating loss of around CHF 735 million and non-GAAP operating loss of around CHF 650 million - unforeseen events excluded
- Fundraising: With a liquidity of CHF 212 million at the end of Q1 2023 and the current guidance for 2023 - the company is pursuing options including non-equity dilutive funding avenues and/or equity raise should it be needed, to extend the cash runway
- Profitability target: The company is committed to become profitable in 2025 with global revenue above CHF 1 billion
Jean-Paul Clozel, MD and Chief Executive Officer, commented:
"The company continues to deliver on the strategic priorities and make progress on many fronts. PIVLAZ has been available in Japan for a year now and more than 5,000 patients have been treated, a great result. QUVIVIQ is approaching one year on the market in the US, and it is already the number one branded insomnia treatment in the commercial market. While there has been a delay in securing reimbursement, progress has been made and the situation is steadily improving. Demand is good and growing, feedback from patients and prescribers is excellent, and refills are accelerating. Uptake in the first markets of Europe is also strong, with more markets set to launch in the coming year. We will adapt our cost-base to accommodate the delay in reimbursement and we are very active on several non-dilutive opportunities to extend the cash runway. For a company based on science, that started from zero less than 6 years ago, and launched two products in the past year, there are many reasons to believe in Idorsia's bright future."
Financial results
| US GAAP results | First Quarter | |||
| in CHF millions, except EPS (CHF) and number of shares (millions) | 2023 | 2022 | ||
| Net revenues | 21 | 5 | ||
| Operating expenses | (219) | (198) | ||
| Operating income (loss) | (198) | (193) | ||
| Net income (loss) | (212) | (198) | ||
| Basic EPS | (1.19) | (1.12) | ||
| Basic weighted average number of shares | 178.0 | 177.1 | ||
| Diluted EPS | (1.19) | (1.12) | ||
| Diluted weighted average number of shares | 178.0 | 177.1 | ||
US GAAP net revenue of CHF 21 million in the first quarter of 2023 (CHF 5 million in the first quarter of 2022) consisted of product sales of QUVIVIQ (CHF 4.3 million) and PIVLAZ (CHF 13.5 million), contract revenue recognized in connection with Mochida Pharmaceutical Co., Ltd (CHF 1 million) and Neurocrine Biosciences, Inc. (CHF 1 million), and revenue share from Johnson & Johnson (CHF 1 million).
US GAAP operating expenses in the first quarter of 2023 amounted to CHF 219 million (CHF 198 million in the first quarter of 2022), of which CHF 1 million related to cost of sales (no cost of sales in the first quarter of 2022), CHF 93 million to R&D expenses (CHF 95 million in the first quarter of 2022) and CHF 125 million to SG&A expenses (CHF 103 million in the first quarter of 2022).
US GAAP net loss in the first quarter of 2023 amounted to CHF 212 million (CHF 198 million in the first quarter of 2022). The increase of the net loss was mainly driven by higher operating expenses, largely in the commercial functions, a negative financial result and partially offset by higher net revenues.
The US GAAP net loss resulted in a net loss per share of CHF 1.19 (basic and diluted) in the first quarter of 2023, compared to a net loss per share of CHF 1.12 (basic and diluted) in the first quarter of 2022.
| Non-GAAP* measures | First Quarter | |||
| in CHF millions, except EPS (CHF) and number of shares (millions) | 2023 | 2022 | ||
| Net revenues | 21 | 5 | ||
| Operating expenses | (202) | (188) | ||
| Operating income (loss) | (181) | (183) | ||
| Net income (loss) | (189) | (189) | ||
| Basic EPS | (1.06) | (1.07) | ||
| Basic weighted average number of shares | 178.0 | 177.1 | ||
| Diluted EPS | (1.06) | (1.07) | ||
| Diluted weighted average number of shares | 178.0 | 177.1 | ||
* 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 quarter of 2023 amounted to CHF 189 million: the CHF 23 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 4 million), and share-based compensation (CHF 12 million) and a loss on marketable securities (CHF 7 million).
The non-GAAP net loss resulted in a net loss per share of CHF 1.06 (basic and diluted) in the first quarter of 2023, compared to a net loss per share of CHF 1.07 (basic and diluted) in the first quarter of 2022.
Creation of Treasury Shares
In January 2023, the Company created 10.0 million treasury shares with a nominal value of CHF 0.05 each, thereby increasing its registered share capital from CHF 8,848,349.75 to CHF 9,348,349.75. The new shares, created on January 6, 2023, out of the Company's authorized share capital, were subscribed at nominal value by Idorsia Pharmaceuticals Ltd, a wholly owned subsidiary, and were listed on the SIX Swiss Exchange on January 9, 2023. With this increase, the Company holds treasury shares that can be used in a cash preservative manner for potential share-based compensation, effective fund raising, or business development purposes.
Financial outlook
PIVLAZ (clazosentan) is available in Japan and QUVIVIQ (daridorexant) in the US, Germany, and Italy, and additional launches are anticipated in Switzerland and the UK during 2023. Regulatory applications for aprocitentan have been filed with the FDA and the EMA. Phase 3 studies with selatogrel and cenerimod are expected to be actively recruiting throughout 2023. The company is prioritizing those projects in drug discovery and early clinical pipeline that are expected to result in the greatest return in the near term, as well as seeking partnership opportunities to share risk and rewards. The company therefore expects US GAAP operating loss of around CHF 735 million and non-GAAP operating loss of around CHF 650 million - unforeseen events excluded.
André C. Muller, Chief Financial Officer, commented:
"Due to the slower than expected speed of payer coverage and resulting uncertainties in the US revenue development, the company is taking steps to manage its operating expenses in order to deliver on our 2023 guidance - unforeseen events excluded. Furthermore, we must address our near-term liquidity needs. Hence, we are pursuing non-equity dilutive funding avenues, while preparing an equity raise should it be needed, to extend the cash runway."
Liquidity and indebtedness
At the end of the first quarter of 2023, Idorsia's liquidity amounted to CHF 212 million.
| (in CHF millions) | Mar 31, 2023 | Dec 31, 2022 | |
| Liquidity | |||
| Cash and cash equivalents | 212 | 146 | |
| Short-term deposits | - | 320 | |
| Long-term deposits | - | - | |
| Total liquidity* | 212 | 466 | |
| Indebtedness | |||
| Convertible loan | 335 | 335 | |
| Convertible bond | 795 | 795 | |
| Other financial debt | 162 | 162 | |
| Total indebtedness | 1,292 | 1,292 |
*rounding differences may occur
Commercial operations
In 2022, Idorsia launched two products in different markets, QUVIVIQ (daridorexant) in the US and the first countries in Europe, and PIVLAZ® (clazosentan) in Japan, generating total product sales of CHF 18 million in Q1 2023.
United States
| Product | Mechanism of action | Indication | Commercially available since |
| Dual orexin receptor antagonist | Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance | May 2022 |
QUVIVIQ (daridorexant) continues to gain traction in the US insomnia market. After just 11 months, QUVIVIQ has surpassed all other branded insomnia medications in new-to-brand prescriptions. Along with this, refills continue to increase - leading to strong growth in total prescriptions in the first quarter, with over 22,000 prescriptions of QUVIVIQ dispensed in March alone.
Net sales in the first quarter of 2023 reached CHF 3 million. To enable early patient access to QUVIVIQ, Idorsia continues to offer a strong copay program, including a free first 30-day prescription. However, due to this approach, the net sales numbers do not reflect actual dispensed prescriptions or product demand. Today, QUVIVIQ is covered by Express Scripts National Preferred Formulary (NPF) and Tricare Uniform Formulary, which together represent over 32 million lives in the US. The company continues to actively engage with other commercial and Part D payers.
Additionally, earlier this month the company filed a Citizen Petition with the United States Drug Enforcement Administration (DEA) requesting that the DORA class of insomnia medications be de-scheduled and removed from the controlled substance list (they are currently schedule IV medications in the US). The Citizen Petition outlines scientific and medical evidence demonstrating that the DORA class has a negligible abuse profile and potential for abuse, lacks non-medical use in the community, lacks physical and psychological dependence, and therefore, should not be a scheduled class under the Controlled Substances Act. Idorsia is confident that there is a solid and compelling case and hopes the DEA acts expeditiously on the petition. De-scheduling the class would remove many access barriers for patients and prescribing complications for physicians.
For more information about QUVIVIQ in the US, see the Full Prescribing Information (https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf) (PI and Medication Guide).
Simon Jose, Chief Commercial Officer of Idorsia, commented:
"It's great to see QUVIVIQ is now the leading insomnia brand in the US commercial market in terms of prescriptions. Although payer access has been slower than anticipated, we have secured access with ESI and TriCare and are in active discussions with other major payers. As further reimbursement is secured, we expect paid prescriptions to continue to increase, boosting net sales. Equally important to establishing QUVIVIQ as the leading branded treatment for insomnia is transforming and modernizing the entrenched, generic market we have entered."
Europe and Canada region
| Product | Mechanism of action | Indication | Commercially available |
| Dual orexin receptor antagonist | Treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning | Germany: Nov 2022 Italy: Nov 2022 |
In April 2022, marketing authorization for QUVIVIQ was granted by the European Commission and subsequently by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. In November 2022, QUVIVIQ was launched in Italy and Germany. Launch preparations are underway in the UK, with a target launch in the second half of 2023, later followed by Spain and France. For more information about QUVIVIQ in the EU, see the Summary of Product Characteristics (https://www.idorsia.com/documents/com/label/quviviq-smpc.pdf). Marketing authorization for QUVIVIQ was granted by Swissmedic in December 2022, and the company aims to make QUVIVIQ available to patients in Switzerland in June 2023. For more information about QUVIVIQ in Switzerland, see the Patient Information (https://www.idorsia.ch/documents/com/label/quviviq-ch-patient-info.pdf) and Information for Healthcare Professionals (https://www.idorsia.ch/documents/com/label/quviviq-ch-info-for-hcp.pdf). The review of daridorexant by Health Canada is expected to reach its conclusion in the coming weeks.
The launches in Germany and Italy are progressing well with positive feedback from physicians and patients to the differentiated profile of QUVIVIQ, the first and only dual orexin receptor antagonist available in Europe. In addition to educating healthcare professionals on the clinical data for QUVIVIQ, the local teams are raising awareness on the burden of chronic insomnia, as highlighted in the recent publication of the RAND report, "The Societal and Economic Burden of Insomnia in Adults: An International Study. (https://www.idorsia.com/media/news-details?newsId=2955560)" Pricing and reimbursement processes are underway in key European markets to secure access to QUVIVIQ for chronic insomnia patients. Net sales in the first quarter of 2023 in Germany and Italy were CHF 1 million.
Japan
| Product | Mechanism of action | Indication | Commercially available since |
| Endothelin receptor antagonist | Prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) | April 2022 |
PIVLAZ (clazosentan) was launched in Japan in April 2022 for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms in patients suffering from aneurysmal subarachnoid hemorrhage (aSAH). Neurosurgeons in Japan are incorporating PIVLAZ into aSAH treatment protocols and approximately 27% of Japanese aSAH patients were treated with PIVLAZ in March based on the estimated incidence of aSAH. Awareness of PIVLAZ has reached over 95% among target neurosurgeons in Japan as the local customer facing teams continue to share the clinical data demonstrating the efficacy and safety of PIVLAZ in Japanese patients. Net sales in the first quarter of 2023 were CHF 13 million.
Clinical development
Idorsia's diversified and balanced clinical development pipeline - covering multiple therapeutic areas, including CNS, cardiovascular and immunological disorders, as well as orphan diseases - is on track and progressing as described in the full year 2022 financial results press release (https://www.idorsia.com/media/news-details?newsId=2926547).
Idorsia's portfolio
Product / compound | Mechanism of action | Therapeutic area | Status |
| PIVLAZ® (clazosentan) | Endothelin receptor antagonist | Cerebral vasospasm assoc. with aneurysmal subarachnoid hemorrhage | Commercially available in Japan |
| QUVIVIQ (daridorexant) | Dual orexin receptor antagonist | Insomnia | Commercially available in the US Germany and Italy; approved in the EU, UK and Switzerland; under review in Canada; Filing in Japan expected in H2 2023; Phase 2 in pediatric insomnia - recruiting |
| Aprocitentan* | Dual endothelin receptor antagonist | Difficult-to-control (resistant) hypertension | NDA under review in the US, MAA under review in the EU, other filings in preparation |
| Lucerastat | Glucosylceramide synthase inhibitor | Fabry disease | Phase 3 primary endpoint not met, OLE ongoing** |
| Selatogrel | P2Y12 inhibitor | Suspected acute myocardial infarction | Phase 3 recruiting |
| Cenerimod | S1P1 receptor modulator | Systemic lupus erythematosus | Phase 3 recruiting |
| ACT-1004-1239 | ACKR3 / CXCR7 antagonist | Multiple sclerosis and other demyelinating diseases | Phase 2 in preparation |
| Sinbaglustat | GBA2/GCS inhibitor | Rare lysosomal storage disorders | Phase 1 complete |
| ACT-1014-6470 | C5aR1 antagonist | Immune-mediated disorders | Phase 1 |
| ACT-777991 | CXCR3 antagonist | Recent-onset Type 1 diabetes | Phase 1 |
| IDOR-1117-2520 | Undisclosed | Immune-mediated disorders | Phase 1 |
* In collaboration with Janssen Biotech to jointly develop aprocitentan, Janssen Biotech has sole commercialization rights worldwide
** Open-label extension study
Neurocrine Biosciences has a global license to develop and commercialize ACT-709478 (NBI-827104), Idorsia's novel T-type calcium channel blocker. ACT-709478 was investigated in a Phase 2 study for the treatment of a rare form of pediatric epilepsy. The study did not meet the primary endpoint. ACT-709478 was generally well tolerated. Neurocrine continues to analyze the data generated in the study.
Further details including the current status of each project in our portfolio can be found in our innovation fact sheet (https://www.idorsia.com/documents/com/fact-sheets-presentations/fs-innovation-portfolio.pdf).
Note to Shareholders
The Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2022, will be held on Thursday, May 4, 2023, at 09.00 CEST at the Congress Center, Messe Basel, Switzerland.
The invitation was published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt) and distributed to Shareholders by post. It is also available, together with the Company's Annual Report and Compensation Report, on www.idorsia.com/agm (http://www.idorsia.com/agm).
In order to attend and vote at the AGM, shareholders must be registered in the company's shareholder register by April 25, 2023, 17:00 CEST, at the latest.
Results Day Center
Investor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center (http://www.idorsia.com/results-day-center).
Upcoming Financial Updates
- Annual General Meeting of Shareholders on May 4, 2023
- Half-Year 2023 Financial Results reporting on July 25, 2023
- Nine-Months 2023 Financial Results reporting on October 24, 2023
- Full-Year 2023 Financial Results reporting on February 6, 2024
Notes to the editor
About Idorsia
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.
Headquartered near Basel, Switzerland - a European biotech-hub - Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 20-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe, Japan, and the US - the ideal constellation for bringing innovative medicines to patients.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,300 highly qualified specialists dedicated to realizing our ambitious targets.
For further information, please contact
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com
media.relations@idorsia.com
www.idorsia.com (http://www.idorsia.com)
The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
Attachment
- Press Release PDF (https://ml-eu.globenewswire.com/Resource/Download/4a97e054-661d-422c-838d-37a4e51a8cee)
