Release Date: September 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Successful launch of Agamree in Germany and Austria, with market response exceeding expectations.
- Regulatory progress with approvals in the UK and priority review in China.
- Secured non-dilutive funding of up to CHF69 million, extending cash runway into 2026.
- Strong financial performance with revenue from contracts increasing to CHF14.4 million from CHF3.9 million year-over-year.
- Strategic expansion into additional European markets to maximize margins and leverage commercial infrastructure.
Negative Points
- Operating expenses increased to CHF26.7 million, driven by development and commercialization costs.
- Ongoing delays in market access and pricing negotiations in key European markets like France and the UK.
- Net loss of CHF15.3 million, although reduced from CHF23.3 million in the previous period.
- High dependency on European market uptake to achieve cash flow breakeven by 2026.
- Potential risks related to pricing and market penetration, which could impact financial projections and breakeven timeline.
Q & A Highlights
Q: Can you comment on the pricing outlook for Hainan alone in China and how it might compare to Europe and the US?
A: The pricing in China is still open. We have a price for the early access program in Hainan Province, but our partner has asked us not to disclose it. They now have about 70 patients on vamorolone in Hainan.
Q: Regarding the development of vamorolone in additional indications, does this include Becker muscular dystrophy?
A: No, the Becker muscular dystrophy program is already ongoing. Our partner ReveraGen is executing the pilot phase 2a, which is due to report in the second half of next year.
Q: What are the principal risk factors to achieving cash flow breakeven in 2026?
A: The main driver is European sales. The most obvious variable is the final average price in Europe. If prices are lower than forecasted, we would need to take cost-saving measures. Other variables include dosage, patient weight, and market penetration.
Q: Can you provide insights on the delays in key markets?
A: The delays are due to bureaucratic processes and back-and-forth discussions, not requests for new data. For example, in the UK, we are discussing which burden of illness study to use. In France, political changes have influenced the process.
Q: What are the additional costs for expanding into new countries like the Nordics, Portugal, and Ireland?
A: Ireland will be managed out of the UK, and Portugal may require one additional FTE. The Nordics will need six to eight FTEs eventually, but we are starting slowly. We aim to make this as close to self-financing as possible.
Q: Any learnings from the early access program in Spain?
A: There is significant interest despite the bureaucratic burden. We have about five or six patients on the program already. We are also seeing high levels of interest from other countries like Turkey, Saudi Arabia, and India.
Q: Why did you decide to wait with starting the new indication pivotal trial with Catalyst?
A: Catalyst is investing in additional profiling work at higher dose ranges, which will allow us to look at a broader range of indications. This will provide important information for strategically choosing our next steps.
Q: Can you explain the recent financing agreements with R-bridge and Highbridge?
A: R-bridge will receive 75% of net royalties from the US and China until a cap is reached, after which full royalties revert to us. The Highbridge loan is a senior secured term loan with no equity exchangeable features, unlike previous exchangeable notes.
Q: Are you still confident in reaching EUR150 million from Europe by 2028?
A: Yes, we are confident. We initially assumed 3,000 patients at an average price of EUR50,000 per patient per year. Given the strong uptake in Germany and Austria, we believe we have a buffer even if prices are slightly lower.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
