On November 18, 2021 Calliditas Therapeutics reported that (Press release, Calliditas Therapeutics, NOV 18, 2021, View Source [SID1234595785])

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"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 Europe. In this case, the result of the process was a partnership with Stada Arzneimittel, which has proven to be an excellent match. We also took the opportunity to complement our predominant source of equity capital with a $75m credit line from Kreos.

In the third quarter, the U.S. Food and Drug Administration (FDA) requested further analyses of data from the NeflgArd clinical trial in connection with our NDA submitted for approval under the FDA’s Accelerated Approval Program. The FDA classified the additional analyses received as a major amendment to the NDA and extended the PDUFA goal date by three months from September 15, 2021 to December 15, 2021. The third quarter also saw the European Medicines Agency (EMA) deciding to revert to standard review timelines for our submission, which we estimate will result in the issuance of an opinion in Q1, 2022. We remain confident that we have presented a compelling data package and look forward to continuing our regulatory interactions with the goal of making an approved treatment available for patients in need.

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."

Renée Aguiar-Lucander, CEO

Summary of Q3 2021
July 1 – September 30, 2021

Net sales amounted to SEK 198.2 million for the three months ended September 30, 2021. No net sales were recognized for the three months ended September 30, 2020.
Operating profit (loss) amounted to SEK 7.9 million and SEK (104.9 million) for the three months ended September 30, 2021 and 2020, respectively.
Earnings (loss) per share before dilution amounted to SEK 0.21 and SEK (2.77) for the three months ended September 30, 2021 and 2020, respectively.
Cash amounted to SEK 1,163.8 million and SEK 1,396.9 million as of September 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 with Kreos Capital.
In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of EUR 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 of SEK 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 to December 15, 2021.
In September 2021, Calliditas announced that the European 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 November 18, 14:30 CET
Audio cast with teleconference, Q3 2021, November 18, 2021, 14:30 (Europe/Stockholm)

Financial calendar
Year-end Report for the period January 1 – December 31, 2021 February 24, 2022