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January 10, 2020
Ren e Aguiar-Lucander
Chief Executive Officer
Calliditas Therapeutics AB
Kungsbron 1, C8
SE-111 22
Stockholm, Sweden
Re: Calliditas Therapeutics AB
Draft Registration Statement on Form F-1
Submitted December 13, 2019
CIK No. 0001795579
Dear Ms. Aguiar-Lucander:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so we may
better
understand your disclosure.
Please respond to this letter by providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances
or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
Draft Registration Statement on Form F-1
Cover Page
1. We note your disclosure of the closing price of your common shares on
Nasdaq
Stockholm in SEK, which will be equal to the disclosed price per ADS in
U.S. dollars
based on the SEK/U.S. dollar exchange rate as of the most recent date.
Additionally, we
note your disclosure on page 161 indicating that the price will be
determined by
negotiations with the underwriters considering results of operations,
current financial
condition, future prospects, markets, economic conditions in and future
prospects for your
industry, management, and currently prevailing general conditions in the
equity security
markets, including current market conditions of comparable companies.
You may use the
Ren e Aguiar-Lucander
Calliditas Therapeutics AB
January 10, 2020
Page 2
most recent home market trading price, converted to U.S. dollars at
the most recent
exchange rate in lieu of a price range, assuming the U.S. IPO price
will be substantially
similar to the home market trading price and you provide clarification
of this intention. If
you expect that the U.S. IPO price will not be substantially similar
to the home market
trading price, please disclose on the prospectus cover page a bona
fide price range of the
offered securities. If you intend to price the securities based on the
Nasdaq Stockholm
market price, you may disclose a percentage range based on that price
(for example, 10%
of the home market price) within which you intend to price the
securities. See, for
example, Item 501(b)(3) of Regulation S-K.
Prospectus Summary, page 1
2. It appears from your disclosure in the first risk factor on page 14
that the FDA, EMA and
comparable regulatory authorities have not determined the required
level of reduction of
proteinuria that you would need to demonstrate in order to obtain
marketing approvals
based on that surrogate biomarker. Please clarify your statement that
Nefecon was
associated with a statistically significant and clinically meaningful
reduction in proteinuria
to clarify that the FDA and EMA have not determined the required
reduction for purposes
of your trials and that the reduction you have observed in your trials
might not be a
sufficiently significant reduction to satisfy the FDA and EMA.
3. Please clarify in the summary that the FDA's accelerated approval
pathway may not lead
to a faster development process or regulatory review and does not
increase the likelihood
that a product candidate will receive approval.
Our Pipeline, page 4
4. Please remove the 2021 anticipated milestone related to filing an NDA.
This appears to
be a prediction that the Phase 3 trial will be successful.
Implications of Being an Emerging Growth Company, page 6
5. Please provide us with copies of all written communications, as
defined in Rule 405 under
the Securities Act, that you, or anyone authorized to do so on your
behalf, present to
potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they
retain copies of the communications.
Our product candidates may have serious adverse, undesirable or unacceptable
side effects ...,
FirstName LastNameRen e Aguiar-Lucander
page 18
Comapany NameCalliditas Therapeutics AB
January 10, 2020 Pagethe two drug-related serious adverse events.
6. Please identify 2
FirstName LastName
Ren e Aguiar-Lucander
FirstNameTherapeutics AB Aguiar-Lucander
Calliditas LastNameRen e
Comapany NameCalliditas Therapeutics AB
January 10, 2020
January 10, 2020 Page 3
Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Warrants, page 85
7. You disclose in Note 8 on page F-19 that warrants are measured at fair
value using the
Black-Scholes model. Revise your disclosure to explain why illiquidity
rebates are used
in the valuation and the impact the illiquidity rebates and negative
risk-free rates factors
have on your estimates of fair value. Please explain to us your basis
for including
illiquidity rebates with the typical assumptions used to employ the
Black-Scholes model
and tell us how you determined the illiquidity rebates of 30% and 15%
are reasonable.
Budenofalk for Autoimmune Hepatitis, page 103
8. Please file the in-licensing agreement with Falk Pharama as an exhibit
or explain the basis
for your determination that it is not required to be filed.
License Agreement with Everest Medicines, page 104
9. Please revise to disclose the tiered royalty ranges within a
ten-percent range (e.g., 5% to
15%, single digit to mid-teens or two tiers ranging up to 20%).
Provide similar disclosure
for the royalty payments that may be required under the license
agreements with
Archimedes and Dr. Falk Pharma indicated on page 83.
Patents, page 106
10. We note your disclosure that you license a patent family that protects
a formulation for the
oral delivery of budesonide and the medicinal use thereof. Please
identify the co-owner of
the patent family, describe the material terms of the license
agreement and file this
agreement as an exhibit in accordance with Regulation S-K Item
601(b)(10)(ii)(B).
11. Please revise to clarify if your patent protection and related license
is limited to the oral
drug delivery composition of budesonide or if other budesonide
delivery mechanisms are
separately licensed to other parties or are protected under different
patents. If you could
be subject to competition from other delivery methods of budesonide,
or other
corticosteroids, that would not be protected by your current patents,
please include
appropriate disclosure, including risk factor disclosure.
Principal Shareholders, page 133
12. Please identify the natural persons who are the beneficial owners of
the shares held by the
5% or greater shareholders identified in your table.
Ren e Aguiar-Lucander
FirstNameTherapeutics AB Aguiar-Lucander
Calliditas LastNameRen e
Comapany NameCalliditas Therapeutics AB
January 10, 2020
Page 4
January 10, 2020 Page 4
FirstName LastName
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm, page F-2
13. We note your disclosures on page F-9 in which you discuss the change
in accounting
principle. Please have your auditor tell us why it did not include an
explanatory paragraph
discussing this change in accounting principle in accordance with
PCAOB AS 3101.18.c.
and AS 2820.
You may contact Sasha Parikh at (202) 551-3627 or Lynn Dicker at (202)
551-3616 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Tim Buchmiller at (202) 551-3635 or Suzanne Hayes at (202) 551-3675
with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Michael Rosenberg, Esq.