Calliditas Therapeutics: Interim Report Q2, 2019

STOCKHOLM, Aug. 15, 2019 /PRNewswire/ -- "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)

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

Investor presentation August 15, 15:00 CET

Audio cast with teleconference, Q2 2019, August 15, 2019, 15:00 (Europe/Stockholm)


Teleconference: Dial-in number SE +46850558369 UK +443333009265 US: +18338230590

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


Telephone: +46-722-52-10-06

Mikael Widell, Head of Communications at Calliditas


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 for further information.

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    Press release Q2 2019

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SOURCE Calliditas Therapeutics