Interim Report Q2, 2019

Large China deal further validates Nefecon market potential

This second quarter of 2019 was very busy and exciting as we concluded a USD 121 million (SEK 1.1 billion) outlicensing deal of Nefecon for Greater China and Singapore. Alongside this, our recruitment efforts for the NefIgArd study have been ongoing and we have seen significant progress across all continents. With virtually all centers being open and recruiting in Q2, we have, as expected, seen an increase in screened patient numbers, and we are on plan to recruit the 200 patients before the end of the year”

Renée Aguiar-Lucander, CEO

Summary of Q2 2019

April 1 – June 30, 2019

  • Net sales for the period amounted to SEK 138.2 (-) million.
  • Net income (loss) for the period was SEK 83.2 (-18.2) million.
  • Earnings per share totaled SEK 2.36 (-1.08).
  • At June 30, 2019, cash and cash equivalents amounted to SEK 534.9 (17.0) million.

Significant events during Q2 2019, in summary

  • Calliditas signed license agreement with Everest Medicines, who will develop and commercialize Calliditas’ leading drug candidate Nefecon in Greater China and Singapore for IgA Nephropathy (IgAN). Potential future milestone payments linked to the agreement amount to a maximum of USD 106 million (approximately SEK 1.0 billion) plus royalty income in addition to the upfront fee of USD 15 million (SEK 138.2 million) which was recognized as revenue in the second quarter of 2019.
  • The Annual General Meeting of Calliditas was held in May, and the meeting decided, among other things, on the election of Elmar Schnee (Chairman) and Diane Parks to the Board of Directors.

Significant events after the end of reporting period, in summary

  • Calliditas completed a directed new share issue of 3.5 million shares in July, thereby raising approximately SEK 210 million with the aim of expanding ongoing research programs and accelerating activities to further develop the project portfolio. The new issue was subscribed by Swedish and international institutional investors, including BVF Partners L.P.
  • Calliditas entered into an exclusive in-licensing agreement of Budenofalk 3mg oral capsule for the US market with Dr Falk Pharma. This positions Calliditas to accelerate its development of the pipeline portfolio related to orphan liver disease, such as Autoimmune hepatitis (AIH).

Investor presentation August 15, 15:00 CET

Financial calendar

  • Interim report for the period January 1 – September 30, 2019; November 14, 2019
  • Year-end report for the period January 1 – December 31, 2019; February 14, 2020
  • Interim report for the period January 1 – March 31, 2020; May 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 August 15, 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.