Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland – January 9, 2023
Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief Executive Officer of Idorsia, will present at the 41st J.P. Morgan Healthcare Conference on January 9, 2023, at 17:15 Pacific Standard Time / 02:15 Central European Time. The conference will take place at the Westin St. Francis hotel in San Francisco, USA.
Jean-Paul will describe how Idorsia is building momentum to become a leading mid-sized biopharmaceutical company. The presentation will cover the launch of the company’s first products, PIVLAZ™ (clazosentan) in Japan and QUVIVIQ™ (daridorexant) in the US and Europe. He will also present opportunities for future growth coming from the clinical development pipeline, including the recent filing of a new drug application for aprocitentan with the US Food and Drug Administration (FDA), the eagerly anticipated Phase 3 REACT clinical results expected in the near-term, and the progress made with other late-stage assets. Follow this link to access the audio stream and find the presentation available here.
Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
“Our achievements in 2022 provide the foundation for our success in 2023. QUVIVIQ is on track to become the leading global brand in insomnia. The feedback from physicians has been overwhelmingly positive. In the US, the team has done a great job in creating awareness and demand with patients and physicians alike. We now need to conclude the access discussions in 2023 to translate the strong and growing demand into revenue. Meanwhile, Germany and Italy are off to a great start, and we expect to see additional European countries launching QUVIVIQ during 2023, as well as the regulatory decision in Canada. Following the excellent Phase 3 results in Japan, I also expect the filing of the daridorexant Japanese NDA.”
“PIVLAZ has had a great start in Japan with around 95% of the target accounts now ordering and around 25% of patients suffering from an aSAH in November receiving PIVLAZ. I am very eager to see the results for clazosentan in the global REACT study which are expected in the coming weeks.”
Expected highlights in 2023
Secure additional funding through non-equity dilutive instruments to narrow the funding gap
Secure broader payer coverage for QUVIVIQ (daridorexant) in the US – removing an important barrier to prescribing†
Commercial launch of QUVIVIQ (daridorexant) in additional European countries, regulatory decision in Canada, and new drug application for daridorexant in Japan
Results of REACT, the Phase 3 study with clazosentan for the prevention of cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage outside of Japan
Marketing authorization application (MAA) for aprocitentan for difficult-to-treat hypertension
FDA decision for the NDA for aprocitentan for difficult-to-treat hypertension
†Effective January 15, 2023, QUVIVIQ will be covered at parity to the other branded dual orexin receptor antagonist (DORA) products for the Express Scripts National Preferred Formulary (NPF).
Jean-Paul commented on the pipeline:
“The pipeline has also progressed in 2022. The positive results with aprocitentan were rapidly analyzed and documented to achieve the US NDA before the end of 2022. This puts us in a good position for other regulatory filings in the coming months and the decision from the FDA before the end of 2023. Our Phase 3 SOS-AMI study investigating selatogrel for the treatment of heart attack has now exceeded 2,800 patients and recruitment will ramp up in 2023, we are encouraged that the patient education material and device is performing well. Having opened recruitment into the Phase 3 OPUS program investigating cenerimod for lupus in December 2022, I expect great interest from patients to participate and it should take off in 2023.”
“For me, a very important aspect to our long-term success is that our drug discovery engine continues to deliver innovative products to the clinical development pipeline. I’m pleased to have a new compound entering the clinic this year and am very excited by what I see coming through from the drug discovery team. These highlights are perfect examples of how we have created a solid foundation in 2022 to succeed in 2023 and for our team to see the fruits of all our labors.”
Mechanism of action
Cerebral vasospasm assoc. aSAH
Commercially available in Japan; Global Phase 3 complete – results expected Q1 2023
Commercially available in the US, and the first countries in Europe; Approved in the UK and Switzerland; Under review in Canada; Phase 3 in Japan successful – filing expected in H2 2023; Phase 2 in pediatric insomnia – recruiting
NDA under review in US, other country filings in preparation
Phase 3 primary endpoint not met; Open Label Extension ongoing
Phase 3 recruiting
Phase 3 recruiting
ACKR3 / CXCR7
Phase 2 in preparation
Rare lysosomal storage disorders
Phase 1 complete
Recent-onset Type 1
* In collaboration with Janssen Biotech to jointly develop aprocitentan, Janssen Biotech has sole commercialization rights worldwide
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 to determine next steps.
Further details including the current status of each project in our portfolio can be found in our innovation fact sheet.
Creation of Treasury Shares
The Company today reports that it has created 10,000,000 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 are expected to be listed on the SIX Swiss Exchange on or around January 9, 2023. With this increase, the Company now holds treasury shares that can be used in a cash preservative manner for potential share-based compensation, effective fund raising, or business development purposes.
Notes to the editor
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 broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1’200 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
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.