Positive Topline Results from Pivotal Phase 3 NefIgArd Trial
"On
We also concluded the purchase of a controlling block in
Summary of Q4 2020
- Net sales amounted to
SEK 0.4 million andSEK 46.6 million for the three months endedDecember 31, 2020 and 2019, respectively. -
Operating loss amounted to
SEK 135.9 million andSEK 18.0 million for the three months endedDecember 31, 2020 and 2019, respectively. -
Loss before income tax amounted to
SEK 173.3 million andSEK 23.0 million for the three months endedDecember 31, 2020 and 2019, respectively. -
Loss per share before and after dilution amounted to
SEK 3.41 andSEK 0.60 , for the three months endedDecember 31, 2020 and 2019, respectively. -
Cash amounted to
SEK 996.3 million andSEK 753.5 million as ofDecember 31, 2020 and 2019, respectively
Significant events during Q4 2020, in summary
- In
November 2020 , Calliditas announced positive topline results from Part A from the pivotal Phase 3 NefIgArd trial. -
In
November 2020 , Calliditas acquired a controlling interest inGenkyotex SA followed by a simplified mandatory offer to the shareholders ofGenkyotex , after which Calliditas controlled 86.2 percent of the shares inGenkyotex .
Significant events after the end of reporting period, in summary
- In
January 2021 , Calliditas shared the clinical development plan for setanaxib and additional data from Part A of the NefIgArd study at the R&D Day.
Investor Presentation
Audio cast with teleconference, Q4 2020,
Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q4-2020
Teleconference: SE: +46850558356
Financial calendar
Publication of the Annual Report 2020
Interim Report for the period
Interim Report for the period
Interim Report for the period
Year-end Report for the period
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
Email: renee.lucander@calliditas.com
Mikael Widell, Investor Relations
Email: mikael.widell@calliditas.com
Telephone: +46 703 11 99 60
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 submitted for publication, through the agency of the contact persons set out above, at
About Calliditas Therapeutics
Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. 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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" Calliditas' reports filed with the
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