STOCKHOLM, Jan. 8, 2024 /PRNewswire/ -- Calliditas
Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas"),
a commercial biopharma company focused on rare diseases today
provided a business update for the fourth quarter of 2023 and
certain preliminary, unaudited key financial information for the
fourth quarter and full year 2023, as follows:
- Strong Q4 preliminary product revenue growth with net TARPEYO
revenues of $31 – 33m for the quarter, representing significant
growth over Q3.
- Preliminary Net TARPEYO revenues of $100 – 102m for
2023, representing over 170% year over year growth compared to
2022.
- Preliminary Total revenues reaching $110 – 113m for
2023, as a result of milestone payments and royalty income from the
Nefecon franchise outside the US.
- Record quarter in terms of enrollments with 555 new TARPEYO
prescriptions in the 4th quarter.
The information above reflects our preliminary estimates with
respect to such results based on currently available information.
We have provided ranges, rather than specific amounts, for the
preliminary results described above primarily because our financial
closing procedures are not yet complete and, as a result, our final
results may vary from the preliminary estimates.
"We are very pleased with the preliminary outcome of the 2023
fiscal year, generating product sales in excess of $100 million in our second year of
commercialisation. This is a very strong result and we are very
excited about 2024 based on the recent full approval of TARPEYO in
the US, strengthened product protection and the record growth
seen in enrollments in Q4. This result, in combination with our
successful debt refinancing and strengthening our US leadership
team, puts us in an optimal position to drive growth and
profitability in 2024 and build a high growth, durable franchise in
the rare disease space." said CEO Renée Aguiar-Lucander.
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 persons set out above, on January 8, 2024 at 8.15 am
CET.
The above unaudited, estimated results for the
quarter and year ended December
31, 2023 are preliminary financial information, remain
subject to completion, and were prepared by management based upon
estimates, a number of assumptions and currently available
information, and are subject to revision based upon, among other
things, quarter-end closing procedures and/or adjustments, the
completion of our financial statements and other operational
procedures. Our actual results could be materially different from
this preliminary financial information, which should not be
regarded as a representation by us as to our actual
results for the quarter and year ended December 31, 2023. In addition, our independent
registered public accounting firm has not audited, reviewed,
compiled or performed any procedures with respect to this
preliminary financial information and does not express an opinion
or any other form of assurance with respect to this preliminary
financial information. During the course of the preparation of our
financial statements and related notes as of and for the
quarter and year ended December
31, 2023, we may identify items that would require us to
make material adjustments to this preliminary financial
information.
About Calliditas
Calliditas Therapeutics is a biopharma company headquartered in
Stockholm, Sweden, focused on
identifying, developing, and commercializing novel treatments in
orphan indications with significant unmet medical needs.
Calliditas' common shares are listed on Nasdaq Stockholm (ticker:
CALTX) and its American Depositary Shares are listed on the Nasdaq
Global Select Market (ticker: CALT). Visit Calliditas.com for
further information.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding the development of Calliditas' pipeline. The words "may,"
"will," "could," "would," "should," "expect," "plan," "anticipate,"
"intend," "believe," "estimate," "predict," "project," "potential,"
"continue," "target," and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based on
management's current expectations and beliefs and are subject to a
number of risks, uncertainties, and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, any related to
Calliditas' business, operations, clinical trials, intellectual
property of the NEFECON franchise globally, competition from other
companies, pipeline development, revenue and product sales
projections or forecasts, 2023 revenue guidance and other
risks identified in the section entitled "Risk Factors" in
Calliditas' reports filed with the Securities and Exchange
Commission. Calliditas cautions you not to place undue reliance on
any forward-looking statements, which speak only as of the date
they are made. Calliditas disclaims any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions, or circumstances on which
any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent Calliditas' views only as
of the date hereof and should not be relied upon as representing
its views as of any subsequent date.
The following files are available for download:
https://mb.cision.com/Main/16574/3905241/2525263.pdf
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