Release Date: July 25, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Idorsia Ltd (IDRSF, Financial) announced a collaboration with Viatris for selatogrel and cenerimod, which could retain long-term shareholder value through potential milestones and royalties.
- Approval of aprocitentan (TRYVIO) in the US and EU, with launch preparations underway, indicating potential for addressing resistant hypertension.
- QUVIVIQ has shown global progress, with significant prescription and healthcare professional engagement, and ongoing efforts to increase sales.
- Restructuring of the convertible bond extended the cash runway, providing financial stability.
- New compound entering clinical development, a synthetic glycan vaccine for Clostridium Difficile infection, showcasing continued innovation.
Negative Points
- Despite progress, Idorsia Ltd (IDRSF) still faces the challenge of extending its cash runway, which is crucial for future operations.
- Salesforce downsizing for QUVIVIQ in the US, which may impact market penetration and sales growth.
- Ongoing negotiations and uncertainties around the AMNOG process in Germany, which could affect pricing and reimbursement for QUVIVIQ.
- Significant operating loss reported, despite reductions in R&D and SG&A costs, indicating financial pressures.
- Dependence on securing a favorable deal for aprocitentan to ensure financial stability and future growth, which remains uncertain.
Q & A Highlights
Q: What kind of field force do you expect to need for aprocitentan in the US? And what kind of data will help payer discussions in the US for aprocitentan? Also, what would you consider the optimal deal for aprocitentan in Europe?
A: (Tosh Butt, President & General Manager, Idorsia Pharmaceuticals US Inc.) We are still analyzing the prescribers for uncontrolled resistant hypertension patients and will share details about our field force size closer to the commercial launch. We will cover high-prescribing cardiologists, nephrologists, and primary care physicians. (André Muller, CEO) We aim to get the best possible deal for Europe, focusing on selecting the right partner and structure.
Q: Is it definite that you will commercialize aprocitentan in the US yourself? Can you share more details about the synthetic glycan vaccine that has entered clinical phase?
A: (André Muller, CEO) We are preparing for the US launch while exploring collaboration structures like joint ventures or profit-sharing to avoid delays. In Europe, we are engaging with potential partners for a regional deal. (Andrew Weiss, SVP, Head of Investor Relations and Corporate Communications) The synthetic glycan vaccine targets Clostridium Difficile, addressing a significant unmet medical need in gut health.
Q: Will you continue to add earlier-stage assets to your pipeline while out-licensing or looking for partners for later-stage assets?
A: (André Muller, CEO) Our portfolio review will determine R&D priorities based on our funding situation. We aim to secure the long-term future of Idorsia by discovering, developing, and commercializing additional assets ourselves, while remaining open to partnerships for certain assets.
Q: Can you share high-level timelines on next inflection points for the clinical pipeline? Do you expect any further repayments due to the AMNOG discussions in Germany?
A: (André Muller, CEO) We are evaluating resources for promising assets to reach their next milestones, with the aprocitentan deal being a key factor. (Benjamin Limal, President, Europe & Canada) The AMNOG 2 negotiation will end in March 2025, and we are confident in maintaining the current price levels in Germany.
Q: What are the next steps for the launch of TRYVIO in the US and Europe?
A: (André Muller, CEO) We are on track to make TRYVIO commercially available in early Q4 2024, with a full commercial launch planned for early 2025. We are preparing the commercial supply, REMS program, distribution network, and MSL team.
Q: How is QUVIVIQ performing in the US and other markets?
A: (André Muller, CEO) QUVIVIQ has treated over 155,000 US patients with nearly 450,000 prescriptions dispensed. Sales have grown despite a reduced salesforce. In Europe and Canada, sales are increasing, with significant progress in Germany, France, and other markets.
Q: What are the financial highlights for the first half of 2024?
A: (Arno Groenewoud, CFO) Revenue increased to CHF26 million, mainly due to QUVIVIQ sales. R&D and SG&A costs were significantly reduced, resulting in a non-GAAP operating loss of CHF170 million, a reduction of over 50% compared to the first half of 2023.
Q: What is the cash position and outlook for 2024?
A: (Arno Groenewoud, CFO) We ended June 2024 with CHF237 million in cash. We expect a US GAAP operating loss of CHF320 million for 2024, including a one-off benefit from the Viatris deal, and a non-GAAP operating loss of around CHF400 million.
Q: What are the strategic priorities for the second half of 2024?
A: (André Muller, CEO) We aim to extend the cash runway, close a collaboration for aprocitentan, prepare for the launch of TRYVIO, increase QUVIVIQ sales, and continue innovating.
Q: How is the restructuring of the convertible bond progressing?
A: (André Muller, CEO) We have restructured the convertible bond, extending our cash runway. We are awaiting final confirmation, expected by the end of August.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
