Calliditas: Filing for full approval of TARPEYO

 April 1 - June 30, 2023

• Net sales amounted to SEK 269.4 million, of which TARPEYO^® net sales amounted to SEK 259.2 million, for the three months ended June 30, 2023. For the three months ended June 30, 2022, net sales amounted to SEK 64.0 million, of which TARPEYO net sales amounted to SEK 63.6 million.
• Operating loss amounted to SEK 75.2 million and SEK 209.8 million for the three months ended June 30, 2023, and 2022, respectively.
• Loss per share before and after dilution amounted to SEK 1.71 and SEK 3.62 for the three months ended June 30, 2023, and 2022, respectively.
• Cash amounted to SEK 866.2 million and SEK 846.8 million as of June 30, 2023, and 2022, respectively.

January 1 - June 30, 2023

• Net sales amounted to SEK 460.7 million, of which TARPEYO net sales amounted to SEK 444.9 million, for the six months ended June 30, 2023. For the six months ended June 30, 2022, net sales amounted to SEK 113.8 million, of which TARPEYO net sales amounted to SEK 81.6 million.
• Operating loss amounted to SEK 255.2 million and SEK 418.2 million for the six months ended June 30, 2023, and 2022, respectively.
• Loss per share before and after dilution amounted to SEK 5.21 and SEK 7.57 for the six months ended June 30, 2023, and 2022, respectively.

Significant Events in Q2 2023, in Summary

• In June 2023, Calliditas had two oral presentations and two abstracts reflecting top line data and analyses from the NeflgArd Phase 3 Study, evaluating Nefecon® (TARPEYO^® (budesonide) delayed release capsules/Kinpeygo^®) in patients with IgA nephropathy (IgAN), at the European Renal Association (ERA) Congress in Milan, Italy.
• In June 2023, Calliditas announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking full approval of TARPEYO (budesonide) delayed release capsules (developed under the project name Nefecon) for the entire study population evaluated in the Phase 3 NeflgArd study. The sNDA submission was based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study which assessed the efficacy and safety of Nefecon dosed at 16 mg once daily versus placebo on a background of optimized RASi therapy in adult patients with primary IgAN. The trial met its primary endpoint of kidney function, with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9 months of treatment with Nefecon or placebo and 15 months of follow-up off drug.

Key Takeaways:

• Late breaking data from the Phase 3 NefIgArd study presented at the ERA EDTA Conference in June 2023.
• sNDA submitted to the FDA in June 2023 for full approval in the entire study population of NefIgArd.
• In August Calliditas Therapeutics announced full results from the NefIgArd Phase 3 trial published in The Lancet.

Updated 2023 Outlook

For 2023, Calliditas expects revenue growth in the US where: Net sales from TARPEYO are estimated to be USD 100-120 million for the year ending December 31, 2023.

Investor Presentation August 17, 2023, 14:30 CET

Audio cast with teleconference, Q2 2023
Webcast: https://ir.financialhearings.com/calliditas-therapeutics-q2-2023
Teleconference: SWE +46 (8) 525 07 003, US +1 774 450 99 00, UK +44 7073 5048

https://www.biospace.com/article/releases/interim-report-q2-2023-calliditas-therapeutics/