STOCKHOLM, May 23, 2024 /PRNewswire/ -- Calliditas
Therapeutics AB (NASDAQ: CALTX) (STOCKHOLM: CALTX):
Target market expansion following full approval in the
US
JANUARY - MARCH 2024 (COMPARED TO
JANUARY - MARCH 2023)
- Net sales amounted to SEK 295.5
million, of which TARPEYO® net sales amounted to
SEK 278.3 million, for the three
months ended March 31, 2024. For the
three months ended March 31, 2023,
net sales amounted to SEK 191.4
million, of which TARPEYO net sales amounted to SEK 185.7 million.
- Operating loss amounted to SEK 203.8
million and SEK 180.1 million
for the three months ended March 31,
2024, and 2023, respectively.
- Loss per share before and after dilution amounted to
SEK 4.59 and SEK 3.49 for the three months ended March 31, 2024, and 2023, respectively.
- Cash amounted to SEK 810.3
million and SEK 1,013.6
million as of March 31, 2024,
and 2023, respectively.
"In Q1 we generated another record quarter in terms of
demand with 705 enrollments and 354 new prescribers. We are very
excited over this positive trend, and we continue to see strong
demand in Q2." - CEO Renée Aguiar-Lucander.
KEY TAKEAWAYS FROM Q1, 2024
- Calliditas had a record quarter with 705 enrollments,
representing a 27% increase over Q4.
- In February, the United States Patent and Trademark Office
(USPTO) issued patent no. 11896719, entitled "New Pharmaceutical
Compositions". This was Calliditas' second patent for TARPEYO in
the United States and provides
product protection until 2043.
- In March, the FDA granted an orphan drug exclusivity
period of seven years for TARPEYO®, expiring in December 2030, based on when the company obtained
full approval with a new indication for this drug product.
- There was a negative impact on net TARPEYO revenues in the
quarter of approximately USD 4.7
million due to a cyberattack on Change Health. The revenues
we were not able to record in Q1 because of this technical issue
are not lost, but are expected to roll forward over the next
several months. This is not expected to have any impact on annual
revenues.
KEY EVENTS AFTER THE REPORTING
PERIOD
- Preliminary net sales from TARPEYO for the second quarter to
date amounts to USD 25.5
million.
- Positive read out of the Nefecon Open label Phase 3 extension
trial.
- Positive topline results from the setanaxib Phase 2 trial in
head and neck cancer.
- Commercial launch of Nefecon in China by partner Everest Medicines.
KEY EVENTS UPCOMING 6 MONTHS
- European Commission decision regarding a potential full
approval for Kinpeygo for Calliditas' partner STADA.
- Full data read out of Phase 2 trial in Primary Biliary
Cholangitis.
- Updated KDIGO guidelines expected in 2024.
Outlook for 2024: Unchanged
Calliditas expects continued revenue growth:
Total net sales from the Nefecon franchise, including
milestones, are estimated to be USD
150-180 million for the year ending December 31, 2024.
Investor Presentation:
May 23, 2024 14:30 CET
Link to webcast: Calliditas Therapeutics Q1 Report 2024
(financialhearings.com)
To participate via conference call register via this
link: Call Access (financialhearings.com)
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 report 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 May 23,
2024, at 7:00 a.m. CET.
This information was brought to you by Cision
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https://news.cision.com/calliditas-therapeutics/r/calliditas-q1-report--january---march-2024,c3986496
The following files are available for download:
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Q1 2024 Calliditas
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