Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Camurus AB (CAMRF, Financial) reported a strong third quarter with a 38% revenue growth year-on-year, reaching SEK 480 million.
- Profit before tax increased by 125% to SEK 165 million, marking the company's best results so far.
- The company raised its full-year 2024 outlook, particularly regarding profit performance.
- Camurus AB (CAMRF) has a strong cash position of SEK 2.75 billion with no debt.
- Positive phase three results were reported from the ACROINNOVA2 study, advancing the R&D pipeline.
Negative Points
- The company received a Complete Response Letter (CRL) from the FDA regarding cGMP inspection issues at a third-party manufacturer.
- There was a noted impact of currency fluctuations, negatively affecting reported figures by two points year-on-year.
- Marketing and distribution expenses saw a sequential drop, raising questions about future spending plans.
- The regulatory review process for some products is delayed, with expected outcomes pushed to late 2025 or early 2026.
- Challenges in addressing reimbursement hurdles in new markets could impact future growth.
Q & A Highlights
Q: Can you provide insights into the US market dynamics during Q3, particularly regarding long-acting injectables versus sublingual treatments?
A: Richard Jameson, Chief Commercial Officer, noted that the third quarter showed a slight slowdown in growth, attributed partly to seasonality. However, there was a pickup in September, and they expect a stronger Q4. The majority of new patients are switching from sublingual treatments rather than from other long-acting injectables.
Q: Why was there a sequential drop in marketing and distribution expenses, and does the CRL affect your SG&A plans for the rest of the year?
A: Jon Alonso, Chief Financial Officer, explained that the drop is due to seasonality and the exercise of stock options in Q2. The CRL has a limited impact on SG&A as the sales force hiring was planned for after a positive outcome, which has been postponed.
Q: Regarding the CRL for CAM2029, have you addressed the manufacturing issues, and what are your expectations for resubmission?
A: Richard Jameson stated that the manufacturer has responded to the FDA's observations, and they expect a classification by early December. If satisfactory, they plan a Class 1 resubmission with a two-month review period.
Q: What are your assumptions for the control arm in the Sorrento study, given the pushout in timelines?
A: Richard Jameson mentioned that the study was powered with an assumption of an 18-month progression-free survival (PFS) in the control group, with a hazard ratio of 0.65. The delay is due to better-than-expected tumor control.
Q: Can you elaborate on the reasons for upgrading your sales guidance despite a softer Q3?
A: The guidance increase is modest and based on strong performance from both Buvidal and Brixadi. The company remains confident in its outlook due to continued market penetration and expansion efforts.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
