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Kurs & Likviditet
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Mid Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX):
Target market expansion following full approval in the US
- 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 KEY EVENTS AFTER THE REPORTING PERIOD
FROM Q1, 2024 · Preliminary net sales from TARPEYO for the second quarter
- Calliditas to date amounts to USD 25.5 million.
quarter with · Positive read out of the Nefecon Open label Phase 3
705 extension trial.
enrollments,
representing a · Positive topline results from the setanaxib Phase 2 trial
27% increase in head and neck cancer.
over Q4.
- Commercial launch of Nefecon in China by partner Everest
- In Medicines.
United States · European Commission decision regarding a potential full
Patent and approval for Kinpeygo for Calliditas' partner STADA.
Trademark
Office (USPTO) · Full data read out of Phase 2 trial in Primary Biliary
issued patent Cholangitis.
no. 11896719,
entitled "New · Updated KDIGO guidelines expected in 2024.
Pharmaceutical
Compositions".
This was
Calliditas'
second patent
for TARPEYO in
the United
States and
provides
product
protection
until 2043.
- In March,
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
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.
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) (https://ir.financialhearings.com/calliditas-therapeutics-q1-report-2024)
To participate via conference call register via this link: Call Access (financialhearings.com) (https://conference.financialhearings.com/teleconference/?id=50047214)