NefIgArd proceeding according to plan
“In the end of the first quarter of 2020 much of the activity at the company was focused on assessing and mitigating any potential impact Covid-19 might have on NefIgArd and I am happy to report that, due to the fact that the Part A of the study was fully recruited in December 2019, Nefecon is an oral formulation which patients are able to take at home and that the study doesn’t require significant interactions with the healthcare system, the impact to date has been limited and our communicated timeline remain intact”
Renée Aguiar-Lucander, CEO
Summary of Q1 2020
January 1 – March 31, 2020
- Net sales for the period amounted to SEK 0.5 (-) million.
- Loss before income tax for the period was SEK 63.7 (42.6) million.
- Loss per share before and after dilution SEK 1.65 (1.21).
- As of March 31, 2020, cash amounts to SEK 728.6 (596.9) million.
Significant events during Q1 2020, in summary
- In January 2020, the Company’s Board of Directors decided to explore whether there are conditions for a potential offering of the company’s securities in the United States and a press release with the title “Calliditas submits draft registration statement for the listing of ADSs in the U.S.” was published.
- In January 2020, EMA Paediatric Committee (PDCO) adopted a positive opinion on the Paediatric Investigation Plan (PIP) for Nefecon for the treatment of primary IgA nephropathy (IgAN).
- In March 2020, Calliditas held an Extra General Meeting where authorization for the Board of Directors to issue new shares for a potential equity offering and listing of securities in the United States, adoption of new articles of association and adoption of a new incentive program were approved.
Significant events after the end of reporting period, in summary
- In April 2020, Calliditas announced that Dr. Richard Philipson had been appointed as Chief Medical Officer (CMO) and would take up the position in early July.
Investor presentation May 14, 15:30 CET
Audio cast with teleconference, Q1 2020, May 14, 2020, 15:30 (Europe/Stockholm)
Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q1-2020
Teleconference: Dial-in number SE: +46850558350 UK: +443333009034 US: +18335268347
Financial calendar
Interim report for the period January 1 – June 30, 2020 August 13, 2020
Interim report for the period January 1 – September 30, 2020 November 12, 2020
Year-end report for the period January 1 – December 31, 2020 February 18, 2021
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
Email: renee.lucander@calliditas.com
Telephone: +46 722 52 10 06
Mikael Widell, Head of Communications at Calliditas
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 07:00 CET on May 14, 2020.
About Calliditas Therapeutics
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which the Company can partially or completely participate in the commercialization efforts. The Company is focused on the development and commercialization of the product candidate Nefecon, a unique two-step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas Therapeutics is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the US. The company is listed on Nasdaq Stockholm (ticker: CALTX). Visit www.calliditas.com for further information.