CALT - Calliditas Therapeutics AB (publ) (CALT) Q4 2023 Earnings Call Transcript
2024-02-21 17:46:07 ET
Calliditas Therapeutics AB (publ) (CALT)
Q4 2023 Earnings Call Transcript
February 21, 2024, 08:30 AM ET
Company Participants
Renee Aguiar-Lucander - CEO
Richard Philipson - CMO
Maria Tornsen - President, North America
Fredrik Johansson - CFO
Conference Call Participants
Maurice Raycroft - Jefferies
Vamil Divan - Guggenheim Securities
Rami Katkhuda - LifeSci Capital
Annabel Samimy - Stifel
Arthur He - HC Wainwright
Christopher Uhde - SEB Enskilda
Johan Unnerus - Redeye
Suzanne van Voorthuizen - VLK
Presentation
Operator
Welcome to the Calliditas Therapeutics Q4 2023 Report. For the first part of the conference call, the participants will be in listen-only mode. [Operator Instructions] Now I will hand the conference over to the speaker, CEO, Renee Aguiar-Lucander; CFO, Fredrik Johansson; Maria Tornsen, President, North America; and Richard Philipson, CMO. Please go ahead.
Renee Aguiar-Lucander
Thank you very much, and welcome to the Q4 2023 presentation. I'd like to draw your attention first of all to the disclaimer notice as usual, which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended, and I refer you to public filings including those containing risk factors.
Next page, please. So with regards to Q4, I'd have to start just with some highlights. So obviously the key event for this quarter was on December 20 th , the FDA granted us full approval of TARPEYO based on the submission of the full Phase 3 data set which we filed in June of 2023. The Phase 3 trial showed a highly statistically significant outcome on the primary endpoint of eGFR with a p value of less than 0.0001. Additional supportive data obviously has been presented on conferences and in other places in terms of slope analysis, 3 mils per minute per year in favor of TARPEYO versus placebo, and statistically significant impact on microhematuria biomarkers such as IgA1.
The new indication that we have received reflects reduction of loss of kidney function and is now also indicated for the entire IgAN population at risk of disease progression. Other things that occurred in the quarter was obviously we also received conditional approval of Nefecon in China, which was granted in November. And this approval, we believe, provides access to a very large market opportunity, as IgAN is not a rare disease in China but actually fairly common with estimates of up to 5 million patients and we're very excited about being able to -- for our partner Everest Medicines to launch commercially this year....
Calliditas Therapeutics AB (publ) (CALT) Q4 2023 Earnings Call Transcript