STOCKHOLM, July 15, 2021 /PRNewswire/ -- Calliditas
Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX)
("Calliditas") today announced that the company has signed a loan
agreement of up to the Euro equivalent of $75 million with Kreos Capital. Proceeds from the
loan will be utilized for the launch of Calliditas' lead product
candidate Nefecon, if approved, as well as to support clinical
development efforts and for general corporate purposes.
The loan facility is divided into three tranches of $25 million each. Drawdown of the first
$25 million tranche can be made until
31 December 2021 and will be
available after the satisfaction of customary closing conditions.
Drawdown of the second tranche of $25
million can be made until 30 June
2022 and will be available subject to accelerated approval
of Nefecon by the U.S Food and Drug Administration (FDA). Drawdown
of the third and final $25 million
tranche can be made until 31 December
2022 and will be available subject to certain revenue
milestones and coverage metrics.
"Signing this loan facility broadens our financing options and
gives us access, on a non-dilutive basis, to significant additional
capital, which bolsters our ability to invest in our commercial
capabilities in the US both on a pre- and post-approval basis,
subject to FDA approval later in the year, as well as in to our
development activities with NOX inhibitors," said CEO Renée
Aguiar-Lucander.
"This is an important time for Calliditas as the company
progresses through the approval process and prepares to
commercialise Nefecon. We are very pleased to support the company
in bringing their innovative new medicines to patients with IgA
nephropathy," commented Aris
Constantinides, General Partner at Kreos.
The loan is denominated in Euro and the loan agreement provides
for interest only payments through December
2024, should certain milestones be achieved. The loan is due
in December 2025, but is prepayable
in full, including the final payment and certain fees, at any time
at the option of Calliditas. The senior, secured loan initially
bears an interest at a rate of 9.00%, which may be reduced to 7.95%
upon reaching certain milestones. The loan is secured by
Calliditas' owned intellectual property in the US. Calliditas will
pay a customary fee to Kreos for the establishment of the loan and
the loan agreement does not contain any financial covenants.
Carnegie and Lazard acted as advisors to Calliditas in this
transaction.
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The information in the press release is information that
Calliditas is obliged to make public pursuant to the EU Market
Abuse Regulation. The information was sent for publication, through
the agency of the contact persons set out above, on July 15, 2021 at 8:20 a.m.
CET.
About Calliditas
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.
About Kreos Capital:
Kreos Capital is the leading growth debt provider in
Europe and Israel, backing high-growth companies through
every stage of their life cycle. Kreos targets investments in all
areas of the Technology and Healthcare sectors and, to date, has
committed in excess of €3.1 billion in more than 630 portfolio
company transactions, across 17 countries. With over $1.5 billion in current funds under management
Kreos can invest between $2 million
and $100 million per transaction in
both public and private companies across stages.
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, regulatory
submissions and focus as well as our plans with respect to the
loan facility and the terms thereof. 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, the potential for FDA acceptance
for and the success and timeline of its regulatory marketing
application for Nefecon, clinical trials, supply chain, strategy,
goals and anticipated timelines, competition from other
biopharmaceutical companies, and other risks identified in the
section entitled "Risk Factors" in 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/calliditas-secures--75-million-term-loan-facility,c3385269
The following files are available for download:
https://mb.cision.com/Main/16574/3385269/1445221.pdf
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Calliditas secures
loan facility
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