SEC Comment Letter for Somaxon Pharmaceuticals, Inc. (CIK 0001339455) — Nov 18, 2005
Somaxon Pharmaceuticals, Inc. (CIK 0001339455)
Date: Nov. 18, 2005 · CIK: 0001339455 · Accession: 0000000000-05-058627
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File numbers found in text: 333-128871
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Mail Stop 6010 November 18, 2005
Kenneth Cohen
President and Chief Executive Officer
Somaxon Pharmaceuticals, Inc.
12750 High Bluff Drive
Suite 310
San Diego, California 92130
Re: Somaxon Pharmaceuticals, Inc.
Registration Statement on Form S-1/A
Filed November 9, 2005
File Number 333-128871
Dear Mr. Cohen:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
Prospectus Summary, p. 1
1. We note our prior Comment 12 and your response. Eliminate the
word commercialization from the first sentence. Your focus today
appears to be on development and in-licensing. You have not and
may
never commercialize any product candidates.
Risk Factors
"The patent rights that we have in-licensed," p. 17
2. We note your response to prior comment 39, which explains that
you
have an exclusive license until the last patent to expire in 2020.
However, it appears that competitors may begin to utilize the
intellectual property associated with the patents that expire
earlier
before 2020. You should either disclose this fact explicitly in
the
risk factor or provide us with an analysis explaining why this is
not
the case.
Adult Phase II Clinical Trial, p. 44
3. We note our prior Comment 49 and your response. It appears
that
you can provide more quantified information concerning improvement
relative to placebo along the lines of the information we
requested
in our comment. If comparison relative to placebo as opposed to
baseline is more appropriate, provide that information.
Government Regulation, p. 55
4. We note our prior Comment 53 and reissue it. Expand your
disclosure to explain how the referenced regulations apply to you
and
each of your product candidates.
Management`s Discussion and Analysis of Financial Conditions and
Results of Operations
Liquidity and Capital Resources, page 34
5. We have read your response to comment 42. Please disclose here
and in the footnotes to the financial statements the aggregate
milestone payments to be paid for all your research and
development
arrangements. We also note on page F-14 under Note 3, License
Agreements, you disclose that you are obligated to pay $10,960,000
in
milestone and license payments. The $10,960,000 appears to be the
same amount included in the contractual obligation table, but you
disclose the fact that milestone payments are not included in the
table. Please revise your disclosure to correct this
inconsistency.
Financial Statements
Noted to Financial Statements
Stock Options, page F-19
6. We have read your response to comment 68. It is unclear from
your
response what specific factors existed at the time of the option
issuances that caused the increase in fair value. It is also
unclear
how you quantified the qualitative factors mentioned in your
response
to determine the fair value of the options. Please tell us and
revise your disclosure accordingly. Specify the assumed IPO
prices
and when those values were first determined or estimated. Explain
the change in fair value of the common stock from the issuance of
the
Series C Preferred to the date of filing the S-1. Explain the
factors which caused the company to decide to file the S-1 at the
time it was filed.
As appropriate, please amend your filing in response to
these
comments. You may wish to provide us with marked copies of the
amendment to expedite our review. Please furnish a cover letter
with
your amendment that keys your responses to our comments and
provides
any requested supplemental information. Detailed cover letters
greatly facilitate our review. Please file your cover letter on
EDGAR under the form type label CORRESP. Please understand that we
may have additional comments after reviewing your amendment and
responses to our comments.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors require
for
an informed decision. Since the company and its management are in
possession of all facts relating to a company`s disclosure, they
are
responsible for the accuracy and adequacy of the disclosures they
have made.
We will consider a written request for acceleration of the
effective date of the registration statement as a confirmation of
the
fact that those requesting acceleration are aware of their
respective
responsibilities under the Securities Act of 1933 and the
Securities
Exchange Act of 1934 as they relate to the proposed public
offering
of the securities specified in the above registration statement.
We
will act on the request and, pursuant to delegated authority,
grant
acceleration of the effective date.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
You may contact Joe Roessler at (202) 551-3628 or Lisa Van
Joske at (202) 551-3614 if you have questions regarding comments
on
the financial statements and related matters. Please contact Zafar
Hasan at (202) 551-3653 or me at (202) 551-3715 with any other
questions.
Sincerely,
Jeffrey Riedler
Assistant Director
cc: Cheston Larson
Latham & Watkins
12636 High Bluff Drive
Suite 400
San Diego, California 92130-2071
Fax (858) 523-5450
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