A quarter of deal making and regulatory review
"Following on from the positive top line read out of Part A our Phase 3 study, we initiated a structured process to select our commercial partner for Nefecon in
In the third quarter, the
We remain ready for commercial launch in the US. Our field medical directors are in dialogue with nephrologists across the country and we are proceeding with market access related conversations as well as other pre-commercial activities. We are excited about our strong US capabilities reflected by the highly experienced and well-prepared team in place."
Summary of Q3 2021
- Net sales amounted to
SEK 198.2 million for the three months endedSeptember 30, 2021 . No net sales were recognized for the three months endedSeptember 30, 2020 . -
Operating profit (loss) amounted to
SEK 7.9 million andSEK (104.9 million) for the three months endedSeptember 30, 2021 and 2020, respectively. -
Earnings (loss) per share before dilution amounted to
SEK 0.21 andSEK (2.77) for the three months endedSeptember 30, 2021 and 2020, respectively. -
Cash amounted to
SEK 1,163.8 million andSEK 1,396.9 million as ofSeptember 30, 2021 and 2020, respectively.
Significant events during Q3 2021, in summary
- In
July 2021 , Calliditas signed a loan agreement of up to the EUR equivalent of$75 million withKreos Capital . -
In
July 2021 ,Calliditas andSTADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states,Switzerland and theUK valued at a total ofEUR 97.5 million (approx.$115m ) in initial upfront and potential milestone payments, plus royalties. -
In
August 2021 , Calliditas received FDA fast track designation for setanaxib in PBC. -
In
August 2021 , Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds ofSEK 324.0 million (approx.$37m ) before transaction costs. -
In
September 2021 , Calliditas announced that the FDA extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon toDecember 15, 2021 . -
In
September 2021 , Calliditas announced that theEuropean Medicine Agency's (EMA)Committee for Human Medicinal Products (CHMP) decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.
Investor presentation
Audio cast with teleconference, Q3 2021,
Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q3-2021
Teleconference: SE: +46856642695 |
Financial calendar
Year-end Report for the period
For further information, please contact:
Email: renee.lucander@calliditas.com
Email: mikael.widell@calliditas.com
Telephone: +46 703 11 99 60
The information was submitted for publication, through the agency of the contact persons set out above, at
About
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, the potential for and timing of FDA approval of its regulatory marketing application for Nefecon, the potential for
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