STOCKHOLM, Feb. 21,
2024 /PRNewswire/ -- Calliditas Therapeutics AB
(Nasdaq Stockholm: CALTX)
2023: Full approval for TARPEYO in the US; a year of
successes
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.
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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.
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"In December we were granted full approval by the FDA for
TARPEYO - a crowning achievement after many years of striving to
bring an approved disease modifying treatment to patients with
primary IgAN."
CEO Renée Aguiar-Lucander
KEY TAKEAWAYS FROM Q4,
2023
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EXPECTED KEY EVENTS
UPCOMING 6 MONTHS
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- 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.
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- 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.
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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.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
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
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Calliditas interim
report Q4 2023_ENG
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https://mb.cision.com/Public/16574/3932653/b208fe02f5312ac1.pdf
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Q4 Press Release -
ENG
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SOURCE Calliditas Therapeutics