Idorsia Pharmaceuticals, a leading biopharmaceutical company, has released its financial results for the first nine months of 2024, showcasing a diverse portfolio of innovative drug candidates and strategic partnerships driving its growth. Despite facing headwinds, the company has demonstrated resilience, improved guidance, and made significant strides in commercializing its key products, QUVIVIQ and TRYVIO, across global markets.

Unlocking the Potential of Insomnia and Hypertension Treatments

Navigating the Challenges of QUVIVIQ's Commercialization

Idorsia's flagship product, QUVIVIQ (daridorexant), a dual orexin receptor antagonist for the treatment of adult patients with insomnia, has seen steady progress in its global rollout. The company reported net sales of CHF 39 million for QUVIVIQ in the first nine months of 2024, with strong performance in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, and France.In the US, QUVIVIQ's net sales reached CHF 21 million, a 41% increase compared to the same period in 2023. The product has been prescribed by nearly 50,000 healthcare professionals, with over 165,000 patients treated and 500,000 prescriptions dispensed since its launch in 2022.Despite recent budget constraints leading to a reduction in the US field force, Idorsia's President and General Manager of the US region, Tosh Butt, noted that "the sales are holding-up for now." The company remains focused on the ongoing citizen petition, which aims to review the evidence and potentially lead to the descheduling of the dual orexin receptor antagonist (DORA) class of chronic insomnia medications, a crucial step in unlocking the true value of QUVIVIQ.

Expanding QUVIVIQ's Reach Across Europe and Canada

In the EUCAN region, QUVIVIQ net sales reached CHF 18 million in the first nine months of 2024, with a 46% increase in the third quarter compared to the second quarter. The company has made significant progress in securing reimbursement and expanding access to QUVIVIQ across key European markets.In Germany, QUVIVIQ was launched in November 2022 and has seen a doubling of sales in the first nine months of 2024 compared to the same period in 2023. The lifting of the prescribing limitation for sleep medications in November 2023 has been a game-changer, making QUVIVIQ the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia.In Italy, the company is working to expand the prescriber base and secure reimbursement, with a reimbursement dossier submitted in June 2023 and a hearing expected before the end of 2024. In Switzerland, QUVIVIQ was launched to the self-pay market in June 2023, and reimbursement discussions are ongoing.In Spain, the largest insomnia market in Europe, QUVIVIQ was launched to the self-pay market in September 2023, with a reimbursement dossier submitted to the authorities in July 2024. The UK has recommended QUVIVIQ as a first-line pharmaceutical treatment for chronic insomnia, and the company is focused on securing regional access and raising awareness among general practitioners.In France, QUVIVIQ was included in the hospital and retail formulary lists of reimbursed pharmaceutical specialties in January 2024 and launched in March 2024. To address the need for expanded awareness and adoption, Idorsia has partnered with Menarini, a leading pharmaceutical company in France, to promote QUVIVIQ to general practitioners.Benjamin Limal, President of the Europe and Canada region, emphasized that "securing public access to Europe's only dual orexin receptor antagonist remains our number one priority throughout the EUCAN region – this is the pathway to unlocking the true value of QUVIVIQ."

Advancing TRYVIO for the Treatment of Hypertension

Idorsia's second key product, TRYVIO (aprocitentan), a dual endothelin receptor antagonist for the treatment of hypertension, received FDA approval in the US in March 2024. The company is making robust preparations for the full commercial launch of TRYVIO by the end of the first quarter of 2025, with the REMS program and specialty distribution channel already in place.Tosh Butt, the company's President and General Manager of the US region, stated that "TRYVIO is now available to prescribe to the millions of patients in the US whose high blood pressure is not adequately controlled by other drugs. We have everything in place except a field-force and funding for promotional activities, which is dependent on a partnership deal."In Europe, the European Commission approved JERAYGO (aprocitentan), Idorsia's dual endothelin receptor antagonist for the treatment of resistant hypertension, in June 2024. The company has also submitted marketing authorization applications for JERAYGO in the UK, Canada, and Switzerland.

Strengthening the Pipeline and Partnerships

Idorsia's diversified and balanced portfolio includes a range of assets developed and/or marketed by the company, as well as partner-led programs to maximize the value of its innovation. The company's drug discovery engine has produced a pipeline of promising candidates, including QUVIVIQ, TRYVIO, and JERAYGO, as well as a vaccine platform for the discovery and development of glycoconjugate vaccines.Idorsia's partner-led portfolio includes collaborations with Simcere for the development and commercialization of QUVIVIQ in Greater China, Nxera Pharma for the Asia-Pacific region (excluding China), and Viatris for the development and commercialization of selatogrel and cenerimod.The company's collaboration with Neurocrine Biosciences for the development of ACT-709478, a novel T-type calcium channel blocker, has come to an end after the Phase 2 study did not meet its primary endpoint.

Navigating Financial Challenges and Improving Guidance

Idorsia's financial results for the first nine months of 2024 reflect the company's efforts to navigate challenges and maintain a cost-conscious approach. Net revenue for the period was CHF 53 million, with QUVIVIQ product sales contributing CHF 39 million.The company's US GAAP operating loss for the first nine months of 2024 was CHF 154 million, while the non-GAAP operating loss was CHF 248 million. However, Idorsia has been able to improve its financial guidance for 2024, driven by diligent cost control measures.Arno Groenewoud, Idorsia's Chief Financial Officer, commented, "While closing a deal for TRYVIO is a key focal point, we have also sharpened our cost-conscious approach, which we will increase going forward. Hence, we have been able to stretch the cash runway out to about year-end 2024, which allows us to appropriately plan and execute the next steps of our financial strategy."The company expects QUVIVIQ net sales of around CHF 55 million in 2024, with SG&A expenses of around CHF 265 million and R&D expenses of around CHF 130 million for Idorsia-led pipeline assets. The non-GAAP operating loss is expected to be around CHF 350 million, while the US GAAP operating loss is anticipated to reach CHF 260 million, including a one-off benefit of CHF 125 million from the Viatris deal.

Unlocking Value through Strategic Partnerships

Idorsia's strategic partnerships have played a crucial role in its growth and value creation. In March 2024, the company closed agreements with Viatris Inc. for the global development and commercialization of two Phase 3 assets – selatogrel and cenerimod. Idorsia received an upfront payment of USD 350 million, with the potential for up to USD 300 million in development and regulatory milestone payments, up to USD 2.1 billion in sales milestone payments, and potential tiered royalties.The collaboration with Viatris has allowed Idorsia to focus on its core competencies while leveraging Viatris' global reach and expertise in commercialization. The joint development committee oversees the ongoing Phase 3 programs for selatogrel and cenerimod, with Idorsia contributing up to USD 200 million over the next three years.Additionally, Idorsia has granted Viatris a right of first refusal and first negotiation for certain other pipeline assets, further strengthening the partnership and unlocking the potential of the company's innovative drug candidates.

Navigating the Convertible Bonds Landscape

Idorsia has also proactively managed its convertible bonds, which were due to mature in July 2024. In May 2024, a bondholder meeting was held, where 83.5% of the total outstanding bondholders voted in favor of amendments to the terms of the bonds. The approved bond terms include an amended conversion price of CHF 6.00, an extended maturity date of January 17, 2025, and the option to call the bonds at par, in full or in part, at any time upon giving ten trading days' notice. A consent fee of 8,000 shares per Bond was paid to bondholders on September 5, 2024.These strategic actions have allowed Idorsia to maintain financial flexibility and extend its cash runway, positioning the company to execute its next steps and continue its pursuit of innovative treatments for patients.