Q2 2024 Calliditas Therapeutics AB Earnings Call Transcript
Key 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.
- 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.
Thank you very much. Welcome to our Q2 2024 report. My name is Renée Aguiar-Lucander, CEO of Calliditas. And I'm joined today by Richard Philipson, Chief Medical Officer; Fredrik Johansson, our Chief Financial Officer; and Maria Tornsen, President of North America.
Next page, please. I'd like to draw your attention to disclaimer notice, which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended, and I refer to our public filings, including those containing risk factors.
Next page, please. So I'd like to review some of the key events in Q2, which included the conclusion of our Phase 3 study, NefIgArd, with the readout of the open-label extension from which we reported nine months efficacy and safety data, similar to that observed in the active arm of the Phase 3 trial for those patients who are retreated with Nefecon after 15 months of observation.
In April, we reported positive top line data from our Phase 2 proof-of
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