Calliditas Therapeutics - Interim Report Q3, 2018

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01 Nov, 2018, 09:54 GMT

STOCKHOLM, Nov. 1, 2018 /PRNewswire/ --

NefIgArd Phase 3-study initiated according to plan

"This quarter, the company went into execution mode with regards to the preparations related to our clinical Phase 3 study NefIgArd. We were excited to get going after receiving the necessary funds in July. We have been submitting requests for approval to ethic committees, negotiated contracts with clinics and continued to tie up the hundreds of ends required in order to initiate such a large, global study. With 19 countries and 149 sites, we believe that this is one of largest clinical studies to be managed out of Sweden today.

Based on progress to date, we believe that we are on track to dose our first patient in 2H 2018 as planned."

Renée Aguiar-Lucander, CEO

Summary of Q3

July 1 - September 30, 2018

Net sales for the period amounted to SEK - (-) million.
Net income (loss) for the period was SEK -31.4 (-18.4) million.
Earnings and diluted earnings per share totaled SEK -0.91 (-1.21).
At September 30, 2018, cash and cash equivalents amounted to SEK 685.9 (22.0) million.

Significant events during the period July 1 – September 30, 2018, in summary

The liquidity from the rights issue of 650 MSEK, before deduction of issue costs, in connection with the listing was received in early July.
In July, the over-allotment option issued in connection with the listing was utilized, which resulted in the company receiving an additional SEK 88.7 million, before deduction of issue costs.

Key figures

	Jul-Sep		Jan-Sep		Jan-Dec
Amounts in SEK 000s	2018	2017	2018	2017	2017

Expenses relating to research and development	(24,055)	(7,773)	(65,088)	(24,529)	(51,686)
Expenses relating to research and development/operating expenses, %	77%	44%	74%	56%	61%
Operating profit (loss)	(31,273)	(17,474)	(87,737)	(43,970)	(84,509)
Earnings per share before and after dilution, SEK	(0.91)	(1.21)	(2.90)	(3.21)	(5.81)
Total registered shares at the end of period	35,202,347	16,531,500	35,202,347	16,531,500	16,673,000
Equity at the end of the period	659,568	12,067	659,568	12,067	33,176
Equity ratio at the end of the period %	96%	44%	96%	44%	53%
Cash and cash equivalents at the end of the period	685,871	21,952	685,871	21,952	57,352

Investor presentation November 1, 15:00 CET

Audio cast with teleconference, Q3, 2018, November 1, 2018, 15:00 (Europe/Stockholm)

Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q3-2018

Teleconference: Dial-in number UK: +442030089809 SE: +46856642697 US: +18557532237

Financial calendar

Year-end report for the period 1 January – 31 December 2018 February 7, 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 7, 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 November 1, 2018.

About Calliditas Therapeutics

Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden, 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. Calliditas Therapeutics aims to take Nefecon through a global Phase 3 study to commercialization. Visit www.calliditas.com for further information.

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