Interim Report Q1, 2019

Phase 3 study continues according to plan

“This first quarter of 2019, we were busy ensuring that the recruitment efforts for our pivotal phase 3 study NefIgArd remain on track, focusing on site initiation visits and supporting our CRO in their work to ensure that all sites are brought online on a timely manner. During the quarter we also receive orphan designation (ODD) by the US Food and Drug Administration (FDA) for our pipeline indications, Autoimmune hepatitis (AIH) and Primary biliary cholangitis (PBC), two orphan indications focused on chronic liver disease.”

Renée Aguiar-Lucander, CEO

Significant events during Q1 2019, in summary

  • Calliditas was granted orphan drug designation (ODD) for the treatment of Autoimmune hepatitis (AIH) by the US Food and Drug Administration (FDA).
  • Calliditas was also granted orphan drug designation (ODD) for the treatment of Primary biliary cholangitis (PBC) by the FDA.

Summary of Q1 2019

January 1 – March 31, 2019

  • Net sales for the period amounted to SEK – (-) million.
  • Net income (loss) for the period was SEK -42.6 (-38.2) million.
  • Earnings and diluted earnings per share totalled SEK -1.21 (-2.29).
  • At March 31, 2019, cash and cash equivalents amounted to SEK 596.9 (53.1) million.

Investor presentation May 8, 15:00 CET

Financial calendar

  • Annual General Meeting 2019: May 8, 2019
  • Interim report for the period 1 January – 30 June 2019: August 15, 2019
  • Interim report for the period 1 January – 30 September 2019: November 14, 2019
  • Year-end report for the period 1 January – 31 December 2019: February 14, 2020

For further information, please contact:

This is information that Calliditas Therapeutics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on May 8, 2019.

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.