Year-end report, 2018

A transformational year

“2018 was an exciting and transformational year for Calliditas. We listed on Nasdaq Stockholm and raised sufficient capital to fund our pivotal clinical Phase 3 study NefIgArd through top line data read-out and regulatory filing. We subsequently started the study and announced the recruitment of the first patient in November.”

Renée Aguiar-Lucander, CEO

Significant events during 2018, in summary

  • In June 2018, Calliditas Therapeutics was listed on Nasdaq Stockholm in the Mid Cap segment and shares worth a value of SEK 739 million in total were subscribed for in the IPO.
  • In connection with the listing in June 2018, outstanding bridge loans of SEK 95.2 million were converted.
  • In November 2018, the first patient was enrolled in the company’s pivotal clinical phase 3 study NefIgArd. The study is conducted with the leading drug candidate Nefecon for the treatment of patients with IgA nephropathy (IgAN).
  • At an extraordinary general meeting in Stockholm in December 2018, it was decided to adopt a long-term incentive program.
  • During the second quarter of 2018, the company filed a new patent application.

Events after the reporting period

  • Calliditas was granted orphan drug designation (ODD) for the treatment of Autoimmune hepatitis (AIH) by the US Food and Drug Administration (FDA) in February, 2019.

Summary of Q4 2018

October 1 – December 31, 2018

  •  Net sales for the period amounted to SEK – (-)   million.
  •  Net income (loss) for the period was SEK -44.2 (-40.5) million.
  •  Earnings and diluted earnings per share totaled SEK -1.26 (-2.43).
  •  At December 31, 2018, cash and cash equivalents amounted to SEK 646.2 (57.4) million.

Summary of full-year 2018

January 1 – December 31, 2018

  •  Net sales for the period amounted to SEK – (-)   million.
  •  Net income (loss) for the period was SEK -132.0 (-86.8) million.
  •  Earnings and diluted earnings per share totaled SEK -5.09 (-5.81).

Investor presentation February 7, 15:00 CET

Audio cast with teleconference, Q4 2018, February 7, 2019, 15:00 (Europe/Stockholm)
Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q4-2018
Teleconference: Dial-in number SE: +46850558353 UK: +443333009034 US: +18335268381

Financial calendar

  • Publication of the Annual Report                                                      First week of April, 2019
  • Interim report for the period 1 January – 31 March 2019                                    May 8, 2019
  • 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:

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

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 February 7, 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.