Full Press Release Details
Year-End Report, 2021
Calliditas became the first Company to receive accelerated approval
"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
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."
Ren e Aguiar-Lucander, CEO
October 1 - December 31, 2021
Significant events during Q4 2021, in summary
Investor Presentation February 24, 2022, 14:30 CET
Audio cast with teleconference, Q4 2021
Teleconference: SE: +46850558354 UK: +443333009269 US: +16467224902
| 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.
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
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.