STOCKHOLM, Feb. 24, 2022 /PRNewswire/ -- "The accelerated
approval of TARPEYO was for the indication of reduction of
proteinuria, which was the endpoint of Part A of the trial, in
adult patients with IgA nephropathy with risk of rapid progression,
which is characterized as generally UPCR ≥ 1.5 g/g. It is
well established that patients with higher levels of proteinuria
have a worse outlook and prognosis as they tend to experience a
more rapid decline of their kidney function, as measured by eGFR.
These patients are therefore at considerable risk of progressing to
ESRD, resulting in the need for dialysis or transplantation. We are
obviously thrilled to be able to bring a medication to all these
patients, who before now did not have any approved treatment
options that addressed their illness.
This undertaking has taken well over a decade to reach patients
and is the result of the incredibly hard work and dedication of a
diverse and extraordinary group of people, working as a team
towards a common goal. It has been a privilege to help guide and
participate in this amazing journey over the last 4 years, and I am
confident that this is just the beginning of our evolution into a
broad-based biopharma business with the requisite talent, resources
and science to continue to deliver enduring value to all of our
stakeholders."
Renée Aguiar-Lucander, CEO
Summary of Q4 2021
October 1 - December 31,
2021
- Net sales amounted to SEK 31.2
million and SEK 0.4 million
for the three months ended December 31,
2021 and 2020, respectively.
- Operating loss amounted to SEK 222.1
million and SEK 135.9 million
for the three months ended December 31,
2021 and 2020, respectively.
- Loss per share before and after dilution amounted to
SEK 4.19 and SEK 3.41 for the three months ended December 31, 2021 and 2020, respectively.
- Cash amounted to SEK 955.5
million and SEK 996.3 million
as of December 31, 2021 and 2020,
respectively.
Significant events during Q4 2021, in summary
- In December 2021, Calliditas
announced that the US Food and Drug Administration (FDA) had
granted accelerated approval for TARPEYO (budesonide) delayed
release capsules indicated to reduce proteinuria in adults with
primary immunoglobulin A nephropathy (IgAN) at risk of rapid
disease progression, generally a urine protein-to-creatinine ratio
(UPCR) ≥1.5g/g. TARPEYO is the first and only FDA-approved
treatment for this disease and was designed specifically to target
the origin of IgA nephropathy. This approval marked the successful
transition for Calliditas to a commercial-stage biopharmaceutical
company.
Investor Presentation February 24,
2022, 14:30 CET
Audio cast with teleconference, Q4 2021
Webcast:
https://tv.streamfabriken.com/calliditas-therapeutics-q4-2021
Teleconference: SE: +46850558354 UK: +443333009269 US:
+16467224902
Financial calendar
Publication of the
Annual Report
2021
|
April 27,
2022
|
Interim Report for
the period January 1 - March 31,
2022
|
May 18,
2022
|
Annual General
Meeting 2022
|
May 19,
2022
|
Interim Report for
the period January 1 - June 30,
2022
|
August 18,
2022
|
Interim Report for
the period January 1 - September 30,
2022
|
November 17,
2022
|
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
Mikael Widell, Investor
Relations
Tel: +46 703 11 99 60, email: mikael.widell@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on February 24, 2022 at 07:00
a.m. CET.
About Calliditas
Calliditas Therapeutics is a 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, TARPEYO, has been approved by the FDA as the first and
only treatment of IgA nephropathy (IgAN), indicated for reduction
of proteinuria in adults with primary IgAN at risk of rapid disease
progression, generally a UPCR of ≥1.5g/gram. Calliditas has also
filed a marketing authorization application (MAA) with the European
Medicines Agency (EMA) for this drug product. Additionally,
Calliditas has initiated a clinical trial with NOX inhibitor
product candidate setanaxib in primary biliary cholangitis and
plans to also initiate a study with setanaxib in head and neck
cancer. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX)
and 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 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 forward-looking
statements contained in this press release, including, without
limitation, any related to Calliditas' business, operations,
continued FDA approval for TARPEYO, market acceptance of TARPEYO,
clinical trials, supply chain, strategy, goals and anticipated
timelines, competition from other biopharmaceutical companies, 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.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/calliditas-therapeutics/r/year-end-report--2021,c3513388
The following files are available for download:
https://mb.cision.com/Main/16574/3513388/1540059.pdf
|
Calliditas interim
report Q4 2021_EN - Final
|
https://mb.cision.com/Public/16574/3513388/8a75da51f994e524.pdf
|
Q4 Press Release
EN
|
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SOURCE Calliditas Therapeutics