European approval for Kinpeygo®
"On
This is the first time that any drug has achieved approval for this rare disease in
In the US we continue to have significant success in our early commercial efforts. Net revenues from TARPEYO® grew by over 250% when compared to Q1, resulting in net revenues of
We are thrilled to be another step closer to bringing the first approved medication in IgAN to patients around the world, and look forward to continuing to expand access for patients with an unmet medical need for the rest of the year and beyond."
CEO
Summary of Q2 2022
- Net sales amounted to
SEK 64.0 million , whereof TARPEYO net sales amounted toSEK 63.6 million , for the three months endedJune 30, 2022 . No net sales were recognized for the three months endedJune 30, 2021 . -
Operating loss amounted to
SEK 209.8 million andSEK 159.4 million for the three months endedJune 30, 2022 and 2021, respectively. -
Loss per share before and after dilution amounted to
SEK 3.62 andSEK 3.22 for the three months endedJune 30, 2022 and 2021, respectively. -
Cash amounted to
SEK 846.8 million and 709.3 million as ofJune 30, 2022 and 2021 respectively.
Significant events during Q2 2022, in summary
- In
May 2022 , Calliditas announced that the first patient had been randomized in the Group's proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib. -
In
May 2022 , Calliditas announced that the Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of IgA nephropathy. -
In
May 2022 , the Annual General Meeting of Calliditas was held and, among other things, the meeting decided on the election ofHenrik Stenqvist and Elisabeth Björk to the Board of Directors and the establishment of aU.S. At-the-Market framework, pursuant to which Calliditas may, at its option, sell American Depositary Shares ("ADSs") inthe United States .
Significant events after the reporting period
- In
July 2022 , Calliditas announced that theEuropean Commission (EC) granted conditional marketing authorization for Kinpeygo for the treatment of IgA nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. Kinpeygo is an orphan medicinal product and became the first and only approved treatment for IgAN inEurope . Kinpeygo will be marketed in the European Economic Area (EEA) exclusively bySTADA Arzneimittel AG .
Investor Presentation
Audio cast with teleconference, Q2 2022
Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q2-2022
Teleconference: SE: +46856642692
For further information, please contact:
Tel.: +44 79 55 12 98 45, email: marie.galay@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
About Calliditas
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 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, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the
https://news.cision.com/calliditas-therapeutics/r/interim-report-q2--2022,c3615859
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