Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX)
2023: Full approval for TARPEYO in the US; a year of successes
OCTOBER - JANUARY - DECEMBER 2023(COMPARED TO JANUARY -DECEMBER 2022)
DECEMBER · Net sales amounted to SEK 1,206.9 million, of which TARPEYO
2023(COMPARED net sales amounted to SEK 1,075.8 million, for the year ended
TO OCTOBER - December 31, 2023. For the year ended December 31, 2022, net
DECEMBER sales amounted to SEK 802.9 million, of which TARPEYO net sales
2022) amounted to SEK 372.2 million.
amounted to · Operating loss amounted to SEK 373.1 million and SEK 421.9
SEK 451.6 million for the year ended December 31, 2023, and 2022,
million, of respectively.
which
TARPEYO® net · Loss per share before and after dilution amounted to SEK
sales 8.69 and SEK 7.78 for the year ended December 31, 2023, and
amounted to 2022, respectively.
SEK 347.3
million, for · For the year ended December 31, 2023, no dividend is
the three proposed.
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.income
amounted to
SEK 41.8
million and
SEK 32.5
million for
the three
months ended
December 31,
2023, and
2022,
respectively.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.amounted to
SEK 973.7
million and
SEK 1,249.1
million as of
December 31,
2023, and
2022,
respectively.
"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 EXPECTED KEY EVENTS UPCOMING 6 MONTHS
FROM Q4, 2023 · Read out of the Nefecon Open label Phase 3 extension
- In trial, which will provide data on retreatment with Nefecon.
November,
Calliditas' · The transfer of the Marketing Authorization Holder (MAH)
partner approval to Everest Medicines and commercial launch of Nefecon
Everest in China.
Medicines
announced that · European Commission decision regarding a potential full
China's approval for Kinpeygo for Calliditas' partner STADA.
National
Medical · Full data read out of the setanaxib Phase 2 trial in head
Products and neck cancer.
Administration
(NMPA) had
approved
Nefecon for
the treatment
of primary
immunoglobulin
A nephropathy
(IgAN) in
adults at risk
of disease
progression.November,
Calliditas
announced the
initiation of
a Phase 2
clinical study
to evaluate
setanaxib in
Alport
syndrome.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.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.
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