Calliditas Therapeutics: Q2 2021 Interim Report

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STOCKHOLM, August 19, 2021 / PRNewswire / – “Following an application for expedited approval with the FDA in the first quarter, we filed our request for conditional approval with the EMA in May. FDA and EMA applications are being expedited and in the US our target date for PDUFA is September 15the.

During the second quarter, we significantly intensified our pre-sales activities in the United States following the strengthening of the team announced in Q1. We have added significant internal resources and entered into key partnerships to ensure that we are well positioned to go to market in the fourth quarter, subject to a positive outcome of the FDA approval process.

During the second quarter, we also explored non-dilutive funding opportunities through a competitive process to provide the company with access to additional capital before and after potential regulatory approval. At the same time, we also successfully conducted a competitive process focused on securing a strong European business partner for Nefecon. The outcome of these processes, announced in the third quarter, resulted in more than $ 100 million of non-dilutive capital potentially available to the company, distributed between approximately $ 50 million pre-approval available, the rest becoming available after FDA and EMA approvals and subsequent commercialization in the United States. These processes, as well as the fast-track procedure for building up books generating approximately a gross amount. $ 37 million (324 million Swedish kronor) that we completed in the third quarter, significantly improved our financial strength after the end of the second quarter. “

Renée Aguiar-Lucander, CEO

Summary of Q2 2021

April 1June 30, 2021

  • No revenue was recorded for the three months ended June 30, 2021 and 2020, respectively.
  • The operating loss amounts to 159.4 million Swedish kronor and 66.6 million Swedish kronor for the three months ended June 30, 2021 and 2020, respectively.
  • The loss before income tax is 165.2 million Swedish kronor and SEK 61.3 million for the three months ended June 30, 2021 and 2020, respectively.
  • The loss per share before and after dilution amounts to 3.20 SEK and 1.50 SEK for the three months ended June 30, 2021 and 2020, respectively.
  • The cash amounted to SEK 709.3 million and SEK 1,459.6 million from June 30, 2021 and 2020, respectively.

Highlights of Q2 2021, in summary

  • In April 2021, Calliditas has been granted an expedited assessment procedure by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Nefecon, thereby reducing the maximum time taken to review the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in the first half of 2022.
  • In April 2021, Calliditas announced that the FDA had accepted the submission and granted priority review for the NDA to Nefecon. The FDA has set a deadline for the Prescription Drug User Fee Act (PDUFA) of September 15, 2021. Subject to approval, this would allow the commercialization of Nefecon in the United States in the fourth quarter of 2021.
  • In May 2021, Calliditas announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Nefecon.

Significant events after the end of the reporting period, in summary

  • In July 2021, Calliditas has signed a loan facility of up to the EUR equivalent of $ 75 million with Kreos Capital.
  • In July 2021, Calliditas and STADA Arzneimittel AG have entered into a license agreement to register and market Nefecon in the member states of the European Economic Area (EEA), Swiss and the UK valued at a total of 97.5 million euros ($ 115 million) in upfront and potential milestone payments, plus royalties.
  • In August 2021, Calliditas has received FDA expedited designation for setanaxib in PBC.
  • In August 2021, Calliditas completed a fast-track account formation process and resolved a directed share issue in the amount of 2.4 million shares, raising the proceeds from SEK 324.0 million before transaction fees.

Investor presentation August 19, 2:30 p.m.

Audio cast with teleconference, Q2 2021, August 19, 2021, 2:30 p.m. (Europe/Stockholm)

Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q2-2021

Teleconference: SE: +46850558356 United Kingdom: +443333009266 United States: +16467224903

Financial calendar

Interim report for the period January 1stSeptember 30, 2021 November 18, 2021

Year-end report for the period January 1stthe 31st of December, 2021 February 24, 2022

For more information, please contact:

Renée Aguiar-Lucander, CEO of Calliditas
E-mail: [email protected]

Mikael widell, Investor Relations
E-mail: [email protected]
Telephone: +46 703 11 99 60

The information has been submitted for publication, through the contact persons indicated above, to the address 07h00 CET on August 19, 2021.

About Calliditas Therapeutics

Calliditas Therapeutics is a biopharmaceutical company based in Stockholm, Sweden focused on the identification, development and commercialization of new treatments in orphan indications, with an initial focus on kidney and liver disease with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary new oral formulation of budesonide, an established and very potent topical immunosuppressant, for the treatment of adults with primary IgA nephropathy (IgA) autoimmune kidney disease, in which there is a high rate of unmet medical need and there is no approved treatment. Calliditas recently read the first data from Part A of its global Phase 3 IgAN study and, if approved, aims to commercialize Nefecon in United States. Calliditas also plans to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on the Nasdaq Stockholm (ticker: CALTX) and on the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for more information.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the strategy, business plans and direction of Calliditas. The words “may”, “will”, “could”, “should”, “should”, “expect”, “plan”, “anticipate”, “intend”, “believe”, “estimate” “,” Predict “,” project “,” potential “,” continue “,” target “and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All forward-looking statements contained in this press release are based on the current expectations and beliefs of management and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to occur. differ materially from those expressed or implied by any forward-looking statement. statements contained in this press release, including, without limitation, those relating to Calliditas’ business, operations, clinical trials, supply chain, strategy, objectives and expected timelines, to competition from other biopharmaceutical companies and other risks identified in the section entitled “Risk Factors” Calliditas Reports Filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on forward-looking statements, which speak only as of the date at calliditas disclaims any obligation to publicly update or revise such statements to reflect any change in expectations or in the events, conditions or circumstances on which such statements may be based, or which may affect the likelihood that actual results differ from those stated in forward-looking statements. All forward-looking statements The views contained in this press release represent the views of Calliditas only as of the date hereof and should not be construed as representing its views as of any later date.

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SOURCE Calliditas Therapeutics


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