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United States securities and exchange commission logo
January 5, 2022
Pat Cotroneo
Chief Financial Officer
FIBROGEN INC
409 Illinois Street
San Francisco, CA 94158
Re: FIBROGEN INC
Form 10-K for the
Fiscal Year Ended December 31, 2020
Filed March 1, 2021
File No. 001-36740
Dear Mr. Cotroneo:
We have reviewed your December 16, 2021 response to our comment
letter 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 these comments within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comments apply to your facts and circumstances, please tell us why in
your response.
After reviewing your response to these comments, we may have
additional
comments. Unless we note otherwise, our references to prior comments are
to comments in our
November 8, 2021 letter.
Form 10-K filed March 1, 2021
Cover Page
1. We note your response
to our prior comment 1. At the onset of Part 1, please provide
prominent disclosure
that you are a U.S. holding company that conducts its operations in
China through a
wholly-owned subsidiary and joint venture, as referenced in your
response to comment 1,
and that investors will not hold direct investments in the Chinese
operating companies.
2. We note your response
to our prior comment 2, which we reissue. We note your
disclosure that 42% of
revenue for the fiscal year ended December 31, 2020 was from
roxadustat commercial
sales in China and that you own manufacturing facilities in China
to produce your lead
product. Please expand your disclosure at the onset of Part 1 to
provide prominent
disclosure about the legal and operational risks associated with having
Pat Cotroneo
FirstName LastNamePat Cotroneo
FIBROGEN INC
Comapany
January NameFIBROGEN INC
5, 2022
January
Page 2 5, 2022 Page 2
FirstName LastName
a significant portion of the company's operations in China.
3. We note your response to our prior comment 4 and proposed disclosure
to be provided in
the Management's Discussion and Analysis of Financial Condition and
Results of
Operations and Risk Factors section. Please also provide revised
disclosure at the onset of
Part 1. We will not object to expanded disclosure under the heading
"ROXADUSTAT
FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE IN CHINA,"
as referenced in response to prior comment 3.
4. We note your response to our prior comment 7, which we reissue in
part. We note your
proposed additional risk factor. Please also provide related
disclosure at the onset of Part
1. Additionally, please revise your proposed disclosure to explicitly
address the
consequences to you and your investors if you, your subsidiaries or
Falikang inadvertently
conclude that such permissions or approvals are not required.
5. At the onset of Part 1, please disclose whether your auditor is
subject to the
determinations announced by the PCAOB on December 16, 2021 and whether
and how
the Holding Foreign Companies Accountable Act and related regulations
will affect your
company.
Item 1A. Risk Factors, page 49
6. We note from the audit opinion that you have a U.S. based auditor that
is registered with
the PCAOB and currently subject to PCAOB inspection. Please disclose
any material risks
to the company and investors if it is later determined that the PCAOB
is unable to inspect
or investigate completely your auditor because of a position taken by
an authority in a
foreign jurisdiction. For example, disclose the risk that lack of
inspection could cause
trading in your securities to be prohibited under the Holding Foreign
Companies
Accountable Act and as a result an exchange may determine to delist
your securities.
7. Please expand your risk factors to disclose that the United States
Senate has passed the
Accelerated Holding Foreign Companies Accountable Act, which, if
enacted, would
decrease the number of "non-inspection years" from three years to two
years, and thus,
would reduce the time before your securities may be prohibited from
trading or delisted.
Additionally, disclose that the Commission adopted rules to implement
the HFCAA and
that, pursuant to the HFCAA, the PCAOB has issued its report notifying
the Commission
of its determination that is unable to inspect or investigate
completely accounting firms
headquartered in mainland China or Hong Kong.
You may contact Jane Park at 202-551-7439 or Christine Westbrook at
202-551-
5019 with any questions.
Sincerely,
Pat Cotroneo
FIBROGEN INC
January 5, 2022
FirstName
Page 3 LastNamePat Cotroneo
Comapany NameFIBROGEN INC
Division of Corporation Finance
January 5, 2022 Page 3 Office of Life Sciences
FirstName LastName