Release Date: February 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Camurus AB (FRA:7CA, Financial) achieved a total revenue of SEK553 million in Q4 2024, marking a 48% growth compared to the same period last year.
- The company reported a strong gross margin of 94% for the quarter, an improvement of 267 basis points from the previous year.
- Buvidal sales showed significant growth, with a 28% increase year-over-year and an 11% increase from the previous quarter.
- Camurus successfully established a fully operational US commercial organization, preparing for the launch of Oakla in Acromegaly.
- The company maintained a strong cash position, ending the quarter with SEK2.85 billion and no debt.
Negative Points
- Camurus received a complete response letter from the FDA due to issues at a third-party manufacturing facility, delaying the approval process for CAM2029 in the US.
- The company faced a temporary setback in the US regulatory review process, impacting the timeline for CAM2029's market entry.
- Operating expenses reached SEK357 million, representing a 4% decrease, but still indicating significant investment requirements.
- The estimated time for reaching the target of 194 events for the Soreto trial's primary results was updated to late 2025 or early 2026, indicating potential delays.
- The company incurred one-time expenses of SEK8 million related to a potential transaction, impacting the financial results.
Q & A Highlights
Q: Can you provide more details on the revenue guidance for 2025, particularly regarding Buvidal and any specific markets driving growth?
A: Fredrik Tiberg, President and CEO, mentioned that growth is expected in large European countries such as Germany, the UK, Spain, and France. The focus remains on these areas for geographical expansion and market penetration.
Q: What are the next steps for CAM2029 in polycystic liver disease if the study reads out well?
A: Fredrik Tiberg explained that the current study is a phase two/three trial. In the US, a single study may not suffice, but in Europe, it might. The company plans to use the data from the Positano trial to design a phase three trial, which is currently being planned.
Q: Could you elaborate on the regulatory situation and the reasons for the OAI classification?
A: Fredrik Tiberg stated that the company is awaiting the establishment inspection report (EIR) to clarify any outstanding issues. The manufacturer has addressed the 483 observations, and there are no concerns related to CAM2029's safety, efficacy, or chemistry.
Q: What is the company's M&A strategy, and what kind of assets are you looking for?
A: Fredrik Tiberg confirmed that the M&A strategy remains focused on acquiring commercial or pre-commercial assets that are synergistic with Camurus' current pipeline and commercial operations. The preference is for late-stage assets, but phase two assets may also be considered.
Q: Can you provide some granularity on Buvidal's market share in major European markets?
A: Richard Jameson, Chief Commercial Officer, noted that market share varies, with some markets reaching up to 30% and others in high single digits. In larger countries, market share is in the low double-digit range, while in Nordic markets, it can be as high as 60-70%.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
