Recruitment for NefIgArd part A completed on plan and budget
“In the last quarter of 2019, we achieved a major milestone: the full recruitment of 200 patients for Part A of our pivotal Phase 3 study, NefIgArd. We continue to expect to read out top line data in Q4 2020 as projected at the start of the study, based on the 9 months treatment period. Another key event during the quarter was the acceptance by the Chinese authorities, NMPA, of the IND filed in China by Everest Medicines. The acceptance triggered one of several milestones under the agreement, resulting in a USD 5 million milestone providing additional capital for clinical development programs.”
Renée Aguiar-Lucander, CEO
Summary of Q4 2019
October 1 – December 31, 2019
- Net sales for the period amounted to 46.6 (-) million.
- Net income (loss) for the period was SEK -23.1 (-44.2) million.
- Earnings before and after dilution per share totalled SEK -0.60 (-1.26).
- At December 31, 2019, cash and cash equivalents amounted to SEK 753.5 (646.2) million.
Significant events during Q4 2019, in summary
- In October 2019, Calliditas obtained positive advice from the European Medicines Agency (EMA) in which the agency expressed support for a conditional marketing authorization (CMA) of Calliditas lead compound Nefecon, subject as usual to the strength of the full data set presented at the time of filing.
- In December 2019, a USD 5 million milestone payment from Everest Medicines was triggered as part of the licensing agreement pursuant to which Everest will develop and commercialize Calliditas leading drug candidate Nefecon in the Chinese region and Singapore.
- In December 2019, the recruitment of the 200 patients needed for Part A of Calliditas pivotal Phase 3 study NefIgArd was completed. Topline readout of part A of the study is expected in Q4 2020.
Investor presentation February 14, 14:00 CET
Audio cast with teleconference, Q4 2019, February 14, 2020, 14:00 (Europe/Stockholm)
Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q4-2019
Teleconference: SE +46850558355 UK: +443333009034 US: +18446251570
Financial calendar
Publication of the annual report 2019 Week of March 30, 2020
Interim report for the period January 1 – March 31, 2020 May 14, 2020
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 February 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 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.