Calliditas Therapeutics AB (publ) (NASDAQ:CALT) Q4 2023 Earnings Call Transcript
Calliditas Therapeutics AB (publ) (NASDAQ:CALT) Q4 2023 Earnings Call Transcript February 21, 2024
Calliditas Therapeutics AB (publ) isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
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 20th, 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.
In the quarter, there was also initiation of a Phase 2 trial in Alport syndrome and this is being done with Setanaxib. This is the lead compound from our pipeline platform consisting of NOX inhibitors, a novel platform with Setanaxib being the first ever candidate in clinical trials. So Alport syndrome is a rare kidney disease and today there are no approved medications, and so we're very excited about being able to hopefully repeat our success in the IgAN space of being the first company to hopefully bring an approved medication to those patients suffering from this rare disease. Also in the quarter, the USPTO issued a notice of allowance for a new patent covering TARPEYO in the US and that provides a run rate until 2043 and this was issued in December of last year.
We also towards the end of the year refinanced an existing credit line that we had with Athyrium Capital and we added a small amount of additional capital to our balance sheet in terms of just under $20 million. And actually this allowed us to continue to have a interest rate only -- interest payment only kind of period for another several years. So if we can turn the page please. So talking a little bit more about the commercial highlights and this obviously on the commercial side, we saw a very strong quarter from TARPEYO, reflected by strong growth both in terms of enrollments and new prescribers. So actually we saw a 51% increase in enrollments over Q3, and new prescribers also grew by over 50%. And we believe that this is reflecting of the growing familiarity with the Phase 3 data, especially the convincing eGFR data, as well as good results and positive patient experiences from nephrologists using the product in real life.
See also 13 Best Falling Stocks To Buy Right Now and Goldman Sachs Penny Stocks: Top 12 Stock Picks.
To continue reading the Q&A session, please click here.
