Calliditas Year-end report, January - December 2023

Calliditas Therapeutics Sweden

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.

 

OUTLOOK FOR 2024

Calliditas expects continued revenue growth:

Total net sales are estimated to be USD 150-180 million for the year ending December 31, 2024

INVESTOR PRESENTATION

February 21, 2024, 14:30 CET

Link to webcast: https://ir.financialhearings.com/calliditas-therapeutics-q4-report-2023

To participate via conference call register via this link: https://conference.financialhearings.com/teleconference/?id=50046870

For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: [phone], Email: [e-mail]

The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact person set out above, on February 21, 2024, at 07:00 a.m. CET.

The following files are available for download:

https://mb.cision.com/Main/16574/3932653/2618214.pdf

Calliditas interim report Q4 2023_ENG

https://mb.cision.com/Public/16574/3932653/b208fe02f5312ac1.pdf

Q4 Press Release - ENG

 

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