Shares of the Calliditas Therapeutics AB (publ) (CALT) stock continue to rise in the premarket trading session today on December 20, 2021. CALT stock price saw an uptrend of 12.89% to reach $26.50 a share at the time of this writing. The stock was also green in the previous trade and went up by 2.38% at closing. Let’s understand the reason behind this bull.
What’s Happening?
CALT stock is enjoying positive momentum in the stock market after Calliditas announced the approval of TARPEYO by the U.S Food & Drug Administration. TARPEYO is the capsule intended for adults with primary immunoglobulin to decrease the proteinuria in IgA Nephropathy. TARPEYO does not demonstrate whether it slows kidney function decline in patients with IgAN. Continued approval for this product is depended on the verification and description of a clinical trial. This approval has made Calliditas a commercial-stage biopharmaceutical company.
FDA approved the TARPEYO product after it achieved the primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study. The study determined the safety and efficacy of the TARPEYO 16 mg in adult patients suffering from IgAN. The results were statistically significant as patients in the trial showed a 34% reduction in proteinuria from baseline vs 5% with RASi alone in nine months period. The adverse reactions were less than 5% in the study.
Financial View of CALT stock:
- According to third-quarter 2021 financial results, CALT reported SEK 198.2 million in net sales in the three months ended September 2021. The company recognized no net sales in the same period of the previous year.
- Operating profit(loss) was SEK 7.9 million in the third quarter of 2021. This compares to $104.9 million in the same tenure of the previous year.
- Earnings per share before dilution of the CALT stock was SEK 0.21 in the third quarter of 2021. In the same quarter of last year, earnings per share for the CALT stock was $2.77.
- By the end of the third quarter of 2021, Calt had SEK 1,163.8 million in cash on hand. The company had SEK 1,396.9 million cash as of September 30, 2020.
Events in the Third Quarter of 2021:
In July, Calliditas entered into the loan agreement with Kreos Capital of up to the EUR equivalent of $75 million. Moreover, it signed the license agreement with STADA Arzneimittel AG for the registration and commercialization of Nefecon in the European Economic Area (EEA) member states, Switzerland, and the UK. In August, FDA granted the fast-track designation to CALT for setanaxib in PBC.
