Calliditas Year-end report, January - December 2023

OCTOBER – DECEMBER 2023
(COMPARED TO OCTOBER – DECEMBER 2022)                          

• Net sales amounted to SEK 451.6 million, of which TARPEYO® net sales amounted to SEK 347.3 million, for the three months ended December 31, 2023. For the three months ended December 31, 2022, net sales amounted to SEK 429.0 million, of which TARPEYO net sales amounted to SEK 167.3 million.
• Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.
• Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively.
• Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.

JANUARY – DECEMBER 2023
(COMPARED TO JANUARY –DECEMBER 2022)             

• Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023. For the year ended December 31, 2022, net sales amounted to SEK 802.9 million, of which TARPEYO net sales amounted to SEK 372.2 million.
• Operating loss amounted to SEK 373.1 million and SEK 421.9 million for the year ended December 31, 2023, and 2022, respectively.
• Loss per share before and after dilution amounted to SEK 8.69 and SEK 7.78 for the year ended December 31, 2023, and 2022, respectively.
• For the year ended December 31, 2023, no dividend is proposed. 

KEY TAKEAWAYS FROM Q4, 2023

EXPECTED KEY EVENTS UPCOMING 6 MONTHS

• In November, Calliditas' partner Everest Medicines announced that China's National Medical Products Administration (NMPA) had approved Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.
• In November, Calliditas announced the initiation of a Phase 2 clinical study to evaluate setanaxib in Alport syndrome.
• In December, Calliditas received approval (Notice of Allowance) regarding a US patent application for TARPEYO®. In the first quarter of 2024, notice was issued regarding the patent, which provides patent in the US through 2043.
• In December, the United States (US) Food and Drug Administration (FDA) granted Calliditas full approval of TARPEYO® for reduction of kidney loss in adult IgAN patients at risk of disease progression.

• Read out of the Nefecon Open label Phase 3 extension trial, which will provide data on retreatment with Nefecon.
• The transfer of the Marketing Authorization Holder (MAH) approval to Everest Medicines and commercial launch of Nefecon in China.
• European Commission decision regarding a potential full approval for Kinpeygo for Calliditas' partner STADA.
• Full data read out of the setanaxib Phase 2 trial in head and neck cancer.