STOCKHOLM, Aug. 19, 2021 /PRNewswire/ -- "Following the
filing for accelerated approval with the FDA in Q1, we filed our
submission for conditional approval with EMA in May. Both FDA and
EMA applications are being processed on an accelerated basis and in
the U.S our target PDUFA date is September
15th.
During the 2nd quarter we significantly ramped up our pre
commercial activities in the US following the strengthening of the
team announced in Q1. We have added significant internal resources
as well as entered into some key partnerships, in order to ensure
that we are well positioned to initiate commercialization in Q4,
subject to a positive outcome of the FDA approval
process.
During Q2 we also explored avenues to non-dilutive financing by
way of a competitive process in order to provide the company with
access to additional capital in advance of, as well as post a
potential regulatory approval. In parallel we also ran a successful
competitive process focused on securing a strong European
commercial partner for Nefecon. The result of these processes which
was announced in Q3 resulted in over $100m of non- dilutive capital potentially being
available to the company, divided between approximately
$50m available pre-approval with the
remainder becoming available post FDA and EMA approvals and
subsequent US commercialization. These processes, together with the
accelerated book building procedure raising approximately gross
$37m (SEK 324
million) which we completed in Q3, have significantly
enhanced our financial strength after the close of Q2."
Renée Aguiar-Lucander, CEO
Summary of Q2 2021
April 1 – June 30, 2021
- No net sales were recognized for the three months ended
June 30, 2021 and 2020,
respectively.
- Operating loss amounted to SEK 159.4
million and SEK 66.6 million
for the three months ended June 30,
2021 and 2020, respectively.
- Loss before income tax amounted to SEK
165.2 million and SEK 61.3
million for the three months ended June 30, 2021 and 2020, respectively.
- Loss per share before and after dilution amounted to
SEK 3.20 and SEK 1.50 for the three months ended June 30, 2021 and 2020, respectively.
- Cash amounted to SEK 709.3
million and SEK 1,459.6
million as of June 30, 2021
and 2020, respectively.
Significant events during Q2 2021, in summary
- In April 2021, Calliditas was
granted accelerated assessment procedure by the European Medicine
Agency's (EMA) Committee for Human Medicinal Products (CHMP) for
Nefecon, reducing the maximum timeframe for review of the
application for marketing authorization. If approved, Nefecon could
be available to patients in Europe
in first half of 2022.
- In April 2021, Calliditas
announced that the FDA accepted the submission and granted Priority
Review for the NDA for Nefecon. The FDA have set a Prescription
Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this
would enable commercialization of Nefecon in the US in Q4,
2021.
- In May 2021, Calliditas announced
that the company submitted a Marketing Authorisation Application
(MAA) to the European Medicines Agency (EMA) for Nefecon.
Significant events after the end of reporting period, in
summary
- In July 2021, Calliditas signed a
loan facility of up to the EUR equivalent of $75 million with Kreos Capital.
- In July 2021, Calliditas and
STADA Arzneimittel AG entered into a license agreement to register
and commercialize Nefecon in the European Economic Area (EEA)
member states, Switzerland and the
UK valued at a total of 97.5 million
EUR ($115m) in initial upfront
and potential milestone payments, plus royalties.
- In August 2021, Calliditas
received FDA fast track designation for setanaxib in PBC.
- In August 2021, Calliditas
completed an accelerated book building procedure and resolved on a
directed share issue in the amount of 2.4 million shares, raising
proceeds of SEK 324.0 million before
transaction costs.
Investor presentation August
19, 14:30 CET
Audio cast with teleconference, Q2 2021, August 19, 2021, 14:30 (Europe/Stockholm)
Webcast:
https://tv.streamfabriken.com/calliditas-therapeutics-q2-2021
Teleconference: SE: +46850558356 UK: +443333009266 US:
+16467224903
Financial calendar
Interim Report for the period January
1 – September 30,
2021
November 18, 2021
Year-end Report for the period January
1 – December 31,
2021
February 24, 2022
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
Email: renee.lucander@calliditas.com
Mikael Widell, Investor
Relations
Email: mikael.widell@calliditas.com
Telephone: +46 703 11 99 60
The information was submitted for publication, through the
agency of the contact persons set out above, at 07:00 CET on August 19,
2021.
About Calliditas Therapeutics
Calliditas Therapeutics is a biopharma company based in
Stockholm, Sweden focused on
identifying, developing and commercializing novel treatments in
orphan indications, with an initial focus on renal and hepatic
diseases with significant unmet medical needs. Calliditas' lead
product candidate, Nefecon, is a proprietary, novel oral
formulation of budesonide, an established, highly potent local
immunosuppressant, for the treatment of adults with the autoimmune
renal disease primary IgA nephropathy (IgAN), for which there is a
high unmet medical need and there are no approved treatments.
Calliditas has recently read out topline data from Part A of its
global Phase 3 study in IgAN and, if approved, aims to
commercialize Nefecon in the United
States. Calliditas is also planning to start clinical trials
with NOX inhibitors in primary biliary cholangitis and head and
neck cancer. Calliditas is listed on Nasdaq Stockholm (ticker:
CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit
www.calliditas.com for further 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 Calliditas' strategy, business plans and focus. The words
"may," "will," "could," "would," "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. Any forward-looking statements in this press
release are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, any related to Calliditas'' business, operations,
clinical trials, supply chain, strategy, goals and anticipated
timelines, 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
any forward-looking statements, which speak only as of the date
they are made. Calliditas disclaims any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent Calliditas'' views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/calliditas-therapeutics/r/interim-report-q2--2021,c3399327
The following files are available for download:
https://mb.cision.com/Main/16574/3399327/1455932.pdf
|
Interim report
January-June 2021
|
https://mb.cision.com/Public/16574/3399327/a8625db737d3591c.pdf
|
Press release Q2 2021
ENG
|
View original
content:https://www.prnewswire.com/news-releases/calliditas-therapeutics-interim-report-q2-2021-301358607.html
SOURCE Calliditas Therapeutics