STOCKHOLM, Nov. 7, 2023
/PRNewswire/ -- The Lancet publication of full Phase 3 data set
In August we were excited to see the full data set from our
Phase 3 clinical trial, NefIgArd, published in The Lancet and we
are looking forward to a potential full approval of TARPEYO for
treatment of IgA Nephropathy, for which the PDUFA date is
December 20, 2023.
Financial Summary of Q3 2023
July 1 – September 30,
2023
- Net sales amounted to SEK 294.6
million, of which TARPEYO® net sales amounted to
SEK 283.6 million, for the three
months ended September 30, 2023. For
the three months ended September 30,
2022, net sales amounted to SEK 260.1
million, of which TARPEYO® net sales amounted to
SEK 123.4 million.
- Operating loss amounted to SEK 159.6
million and SEK 36.2 million
for the three months ended September 30,
2023, and 2022, respectively.
- Loss per share before and after dilution amounted to
SEK 3.14 and SEK 0.17 for the three months ended September 30, 2023, and 2022, respectively.
- Cash amounted to SEK 786.9
million and SEK 736.2 million
as of September 30, 2023, and 2022,
respectively.
January 1 - September 30,
2023
- Net sales amounted to SEK 755.3
million, of which TARPEYO net sales amounted to SEK 728.5 million, for the nine months ended
September 30, 2023. For the nine
months ended September 30, 2022, net
sales amounted to SEK 373.8 million,
of which TARPEYO net sales amounted to SEK
205.0 million.
- Operating loss amounted to SEK 414.8
million and SEK 454.4 million
for the nine months ended September 30,
2023, and 2022, respectively.
- Loss per share before and after dilution amounted to
SEK 8.34 and SEK 7.72 for the nine months ended September 30, 2023, and 2022, respectively.
"The recent ASN meeting in Philadelphia provided us with numerous
opportunities to meet and engage with nephrologists across the
country, further cementing our belief that the strong long-term
data from our Phase 3 trial, in combination with a potential full
approval, will significantly impact how nephrologists view and use
the product going forward. We reconfirm our guidance for 2023 of
USD 100 – 120m of net sales from TARPEYO and look forward
to an exciting 2024."
Renee Aguiar-Lucander,
CEO
Significant Events in Q3 2023, in Summary
- On July 13 Calliditas announced
supportive interim data from Phase 2 head and neck cancer trial
with lead NOX inhibitor candidate, setanaxib.
- On August 15 Calliditas announced
full results from the NefIgArd Phase 3 trial published in The
Lancet.
- On August 18 FDA granted priority
review for full approval of TARPEYO® for the treatment of IgA
Nephropathy.
- On September 27 Calliditas
granted orphan drug designation by the FDA for the treatment of
Alport syndrome with setanaxib.
- On September 28 STADA and
Calliditas announced the filing for full marketing authorization of
Kinpeygo® in the EU.
- On September 29 Calliditas
presented Data from the NefIgArd Phase 3 trial at the 17th
International Symposium on IgA Nephropathy (IIgANN) Tokyo 2023.
Investor Presentation
Calliditas invites investors, analysts and press to a
presentation of the Quarterly Report 2023 at 14:30 pm. on November
7. Calliditas' CEO Renee
Aguiar-Lucander will present the report together with CFO
Fredrik Johansson, CMO Richard
Philipson and President North America Andrew Udell. The
presentation will be given in
English.
- Time: Tuesday 14:30 pm CET. on
November 7
- Link to webcast https://financialhearings.com/event/46414
- To participate via conference call register via this
link:
https://conference.financialhearings.com/teleconference/?id=2001082
After registration, you will receive a phone number and a
conference ID to log in to the conference call. Via the telephone
conference, there is an opportunity to ask oral questions.
For further information, please contact:
Åsa Hillsten, Head of Investor Relations & Sustainability,
Calliditas'
Phone.: +46 764 03 35 43, E mail:
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 November 7, 2023, at 7:00
a.m. CET.
About Calliditas
Calliditas Therapeutics is a commercial stage biopharma company
based in Stockholm, Sweden focused
on identifying, developing, and commercializing novel treatments in
orphan indications, with an initial focus on renal and hepatic
diseases with significant unmet medical needs. Calliditas' lead
product, developed under the name Nefecon, has been granted
accelerated approval by the FDA under the trade name TARPEYO® and
conditional marketing authorization by the European Commission
under the trade name Kinpeygo®. Kinpeygo is being commercialized in
the European Union Member States by Calliditas' partner, STADA
Arzneimittel AG. Additionally, Calliditas is conducting a Phase
2b clinical trial in primary biliary
cholangitis and a Phase 2 proof-of-concept trial in head and neck
cancer with its NOX inhibitor product candidate, setanaxib.
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).
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 Calliditas' strategy, commercialization efforts, business
plans, regulatory submissions, clinical development plans, revenue
and product sales projections or forecasts and focus. 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 forwardlooking
statements contained in this press release, including, without
limitation, any related to Calliditas' business, operations,
continued and additional regulatory approvals for TARPEYO and
Kinpeygo, market acceptance of TARPEYO and Kinpeygo, clinical
trials, supply chain, strategy, goals and anticipated timelines,
competition from other biopharmaceutical companies, revenue and
product sales projections or forecasts, including 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/16574/3870505/2411424.pdf
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Calliditas interim
report Q3 2023_ENG
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https://mb.cision.com/Public/16574/3870505/a1f32c00c6fbe28f.pdf
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Q3 2023 PR ENG
final
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SOURCE Calliditas Therapeutics