Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Record quarter in terms of revenues with $46.3 million of net TARPEYO revenues, representing 90% growth over the same quarter last year.
- Positive top line data from Phase 2 proof-of-concept study in head and neck cancer with setanaxib, showing statistically significant impact on both progression-free survival and overall survival.
- Full approval of Kinpeygo in Europe by the European Commission, triggering a EUR10 million milestone payment.
- Achieved operational profitability excluding advisory costs and incentive program provisions.
- Strong cash position with almost neutral cash impact for the quarter, and updated revenue guidance for 2024 to USD165 million to USD185 million.
Negative Points
- Operating loss for the quarter of SEK31.5 million, primarily due to costs related to the Asahi Kasei offer and provisions for incentive programs.
- Increased operating expenses, with total operating expenses for the quarter amounting to SEK537.8 million compared to SEK330.3 million for the same quarter last year.
- Costs for research and development increased by SEK31.7 million in the quarter, primarily due to increased costs for Nefecon manufacturing scale-up.
- Sales and marketing costs increased by SEK61.5 million in the quarter, related to the scale-up of TARPEYO in the US.
- General and administrative costs increased by SEK89.6 million in the quarter, primarily due to provisions for incentive programs and advisory fees related to the Asahi Kasei offer.
Q & A Highlights
Q: Can you provide more details on the financial performance and profitability achieved in Q2?
A: Fredrik Johansson, CFO: We reported SEK559.8 million in net revenues for the quarter, with TARPEYO net product sales amounting to SEK493.4 million, a 90% increase from the same quarter last year. Excluding costs related to the Asahi Kasei offer and provisions for incentive programs, we achieved an adjusted operating profit of SEK70.2 million.
Q: What were the key drivers behind the record revenues for TARPEYO?
A: Maria Törnsén, President of North America: The strong demand for TARPEYO is attributed to its full approval, the new label removing the UPCR criteria, and its recognition as a disease-modifying agent. We saw 750 new enrollments and 343 new prescribers in Q2, contributing to the record $46 million in sales.
Q: Can you elaborate on the positive data from the Phase 2b trial in Primary Biliary Cholangitis (PBC)?
A: Richard Philipson, Chief Medical Officer: The Phase 2b trial of setanaxib in PBC showed statistically significant reductions in alkaline phosphatase levels at both 1,200 mg and 1,600 mg doses compared to placebo. Improvements in liver stiffness were also observed, and setanaxib was generally well-tolerated.
Q: What is the status of the Asahi Kasei offer and its impact on the company?
A: Renee Aguiar-Lucander, CEO: Asahi Kasei announced a public cash offer for all shares in Calliditas at SEK208 per share, valuing the company at approximately SEK1.2 billion. The tender is ongoing, with the last day announced as August 30. The offer is recommended by the Board, and around 45% of shareholders have agreed to accept it.
Q: How is the company positioned in terms of cash flow and future profitability?
A: Fredrik Johansson, CFO: We were almost cash-neutral for the quarter with a cash burn of approximately SEK7 million. We expect to remain profitable on an operating level for the rest of the year, excluding deal-related costs, driven by continued revenue growth from TARPEYO and the Nefecon franchise.
Q: What are the future projections for TARPEYO and the Nefecon franchise?
A: Maria Törnsén, President of North America: We are raising our full-year guidance for the Nefecon franchise to $165 million to $185 million, reflecting the strong demand and positive market reception. We will continue to educate healthcare professionals and payers to ensure broad access and adoption.
Q: Can you discuss the recent patent granted for setanaxib and its implications?
A: Renee Aguiar-Lucander, CEO: We were granted a new patent by the USPTO for the treatment with setanaxib in cancer, with expiry in 2039. This strengthens our intellectual property portfolio and supports the potential long-term value of setanaxib in oncology.
Q: What are the next steps for the company's pipeline and upcoming milestones?
A: Richard Philipson, Chief Medical Officer: We will continue to advance our pipeline, including further development of setanaxib in PBC and other indications. We also look forward to presenting additional data at upcoming scientific congresses and conferences.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
