SEC Comment Letter for Somaxon Pharmaceuticals, Inc. (CIK 0001339455) — Nov 1, 2005
Somaxon Pharmaceuticals, Inc. (CIK 0001339455)
Date: Nov. 1, 2005 · CIK: 0001339455 · Accession: 0000000000-05-055528
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File numbers found in text: 333-128871
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Mail Stop 6010 November 1, 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
Filed October 7, 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.
General
1. We note that you are submitting a number of documents in a
confidential treatment request. Please note that you will be
receiving comments to the confidential treatment request under
separate cover and that all confidential treatment issues must be
resolved before we will consider a request for acceleration of the
registration statement.
2. Please provide us proofs of all graphic, visual or photographic
information you will provide in the printed prospectus prior to
its
use, for example in a preliminary prospectus. Please note we may
have comments regarding this material.
3. Please note that when you file a pre-effective amendment
containing pricing-related information, we may have additional
comments. As you are likely aware, you must file this amendment
prior to circulating the prospectus.
4. Please note that when you file a pre-effective amendment that
includes your price range, it must be bone fide. We interpret this
to
mean that your range may not exceed $2 if you price below $20 and
10%
if you price above $20.
5. Please file as promptly as possible all exhibits required by
the
Exhibit Table provided in Item 601(a) of Regulation S-K. We note,
for example, that you have not filed the opinion or consent of
your
legal counsel.
6. Please note that where we provide examples to illustrate what
we
mean by our comments, they are examples and not exhaustive lists.
If
our comments are applicable to portions of the filing that we have
not cited as examples, make the appropriate changes in accordance
with our comments.
7. In your response letter, please state our comment and then
explain
each change that has been made in response to a comment. In
addition, you should also reference each page number in which
disclosure has been revised in response to a comment so that we
can
easily place your revised disclosure in its proper context.
8. We note that you are planning to conduct a directed share
offering
to officers, directors, employees and others. Please provide us
with
any material you intend to furnish to potential purchasers such as
a
"friends and family" letter. Tell us when you intend to send this
material to these potential purchasers. Tell us whether the sale
will be handled by you directly or by the underwriting syndicate.
Tell us the procedures you or the underwriter will employ in
making
the offering and how you will assure that this offer will meet the
requirements of Section 5 of the Securities Act and Rule 134.
Also,
as soon as possible, tell us the number of shares or portion of
the
offering that will be reserved for sale under your directed share
plan. We may have further comments.
9. In the registration statement, please be careful when giving
statements of opinion. As one example only, in the Business
section,
you have included an entire section called "Silenor and Its
Advantages." In that section, you include statements of belief
regarding scheduling, improvement in key sleep parameters and
other
similar statements. In light of the fact that your product has
not
received regulatory approval and that your statements of belief
have
not been proven, statements of this type are not appropriate for
the
registration statement and your discussion should be limited to
what
has been observed and measured. Please revise or delete such
statements from the registration statement. We expect substantial
changes to several subsections of and statements made in the
registration statement in response to this comment.
10. You have stated in numerous places that nalmefene
hydrochloride
is in Phase II/II trials. Please explain the basis for the
disclosure that the product candidate is in this phase rather than
Phase II.
Prospectus Summary, page 1
General
11. We note that your disclosure in the first two pages of the
Summary is nearly identical to the disclosure in the forepart of
the
Business section and the first part of MD&A. To the extent you
make
changes to the disclosure in response to our comments to the any
of
these sections of the document, you should make conforming changes
elsewhere in the document where similar disclosure or concepts are
discussed.
12. Since you have not yet commercialized any products, please
delete
the statement in the first sentence and throughout the prospectus
which states that your company "focuses on. . . commercializing"
your
product candidates. We note that in a risk factor on page 6, you
state, "If our Phase III or other clinical trials fail to
demonstrate
that SILENOR is safe and effective, it will not receive regulatory
approval." You also state that the earliest you will receive
results
of the Phase III trial you mention is mid-2006 and that you have
several clinical trials planned for the product candidate that are
not yet enrolled fully. Please delete this statement throughout
your
prospectus as well, including but not limited to, on pages 2
(under
"Strategy"), 30 and 36.
13. Likewise, you state later in the first paragraph that you
intend
to continue to build a portfolio of products. You currently have
no
products or derive any revenue from product sales. Therefore, you
should not state or imply that you have a product portfolio.
14. Some of your language is too technical for the forepart of the
prospectus. As one example only, your reference to "potent H-1
receptor antagonist," "GABA receptors," "schedule IV controlled
substance," "non-benzodiazepine" and other technical terms
throughout
the Summary and the Risk Factors. These terms should be explained
in
simple language that investors can easily understand the first
time
they are used. Please revise your Summary and Risk Factors
accordingly.
15. Supplementally, provide us with third-party independent
support
for or source material which supports each of the following
statements.
* One study has found that fewer than 15% of those who suffer from
insomnia are treated with prescription medications. p. 1
* Doxepin has a well-established safety profile... p. 1
* ...health care services and medications used for the treatment
of
insomnia...is likely to increase with the aging of the U.S.
population. p. 38
* We believe that many physicians are uncomfortable prescribing
controlled substances, especially when treating a patient with a
history of addiction or when other effective non-scheduled
treatment
options are available. p. 39
Somaxon Pharmaceuticals, Inc., p. 1
16. Some of the information contained in this section is too
detailed
for a Prospectus Summary, which should highlight the company, its
products and strategy. We note that all of the information below
the
header and above the "Strategy" subsection on page 2 is identical
to
the information provided in the Business section. Please give
careful consideration to the key points in this subsection and
highlight those key points in the summary.
17. As currently written, your prospectus summary focuses only the
positive attributes of the company. In addition, in revising the
disclosure in the prospectus make sure to include a subsection
highlighting the risks and challenges the company faces in
executing
its business plan. Your new disclosure should be at least as
prominent as your discussion of product attributes and strategy.
18. On page 1, you mention for the first time clinical trials.
Throughout the document, wherever you mention a specific clinical
trial, you should also mention, and describe in detail in the
Business section, any side affects or adverse events observed or
that
occurred during the course of the trial.
Risk Factors, p. 6
General
19. In the italicized language under the "Risk Factors" heading,
you
state, "The occurrence of any of the following risks, or other
risks
that are currently unknown or unforeseen by us, could harm our
business, financial condition, results of operations or growth
prospects." You should amend this disclosure to remove the
reference
to risks that are currently unknown or unforeseen and ensure and
state that all known material risks are presented in this section.
20. We note that in several cases, you have included bullet points
describing possible reasons that a potential risk factor may come
to
fruition. However, when disclosing a risk factor, the bullet
points
should be customized with specific facts that may give rise to the
risk factor. As one example only, on page 8 in the disclosure in
"Delays in the commencement...," you have provided a list of
bullet
points that set forth the factors that can delay regulatory
approval.
One bullet you have listed relates to reaching approval with a
CRO.
If you have reason to believe that reaching an agreement will be a
problem for your products, you should disclose your concern and
explain its basis, instead of merely referring to a potential
problem
generically.
Furthermore, you should review all of your bullet points to ensure
that your disclosure is customized and fact-specific for the
Company
as possible. In your response letter, please identify all places
where revisions are made in response to this comment.
21. In addition, even where you are not using bullet points, risk
factors should be customized to reflect the specific facts that
may
give rise to the risk factor disclosed. As one example only, in
"Materials necessary to manufacture..." on page 11, you should
disclose any history of problems obtaining materials or facing
other
problems of the type set forth in the risk factor. Please
customize
your risk factors accordingly and advise us of each place where
revisions have been made.
Risks related to our business, p. 6
"Our near-term success is dependent...," p. 6
22. You state, "[t]he patent protection in the United States for
SILENOR for the treatment of insomnia is limited to certain lower
dosages of its active ingredient, doxepin." Please quantify the
lower doses to which patent protection applies.
"Our clinical trials may fail to demonstrate..., p. 8
23. You state, "To date, we have not successfully completed any
Phase
III clinical trials and we have not completed all planned
preclinical
and Phase I clinical trials for our product candidates." To which
of
your product candidates does the statement concerning not having
completed all planned preclinical and Phase I trials apply? You
should expand the disclosure here and in the table on page 38 to
provide disclosure about all ongoing clinical trials.
"Our product candidates may cause undesirable...," p. 8
24. Instead of referring to "adverse consequences" resulting from
abnormal heart rhythm generically, please disclose with
specificity
the consequences that may follow.
25. Please delete the sentence beginning with "We and our
consultants
believe..." The sentence is not appropriate since the abnormal
heart
rhythm was classified as an adverse event.
26. Please consider including the information relating to the
possibility of a black box warning into a separate risk factor.
In
that risk factor, you should explain the implications of being a
Schedule IV drug so that investors can understand the risk factor.
27. In the Business section, in each instance in which you state
that
doxepin is not a Schedule IV controlled substance and discuss its
advantages, please amend the disclosure to state that SILENOR may
be
classified as Schedule IV controlled substance and discuss the
black
box warning. We note that this disclosure appears necessary
throughout the Business section, particularly in the subsection
entitled "Silenor and Its Advantages." Investors need to
understand
that the advantages you reference may not be realized and are not
assured.
Even if our product candidates..., p. 9
28. Please consider including the disclosure relating to
international regulation and regulatory approvals as a separate
risk
factor.
If the manufacturers upon whom we rely...," p. 10
We rely on third parties to conduct our clinical trials, p. 11
29. Please discuss the alternatives you would face and the
obstacles
you would encounter if you faced problems of the types described
in
these risk factors.
30. Please disclose whether you have had any problems of the types
described in the risk factors.
31. Please discuss the extent to which the third parties upon whom
you rely have failed in the past to perform as you expected them
to.
Our business depends on our ability to accquire..., p. 13
32. Please describe any difficulties you have faced in the past in
acquiring products or companies.
33. Please disclose the existence of any agreements or
understandings
to acquire any new product candidates that are currently at the
letter of intent or similar stage.
We will need to increase the size of our organization..., p. 15
34. To the extent you have had difficulty managing growth in the
past, please disclose the problems you have faced, the efforts you
undertook to resolve the problems, and whether the problems were
resolved satisfactorily.
We may not be able to manage our business effectively..., p. 15
35. To the extent that you have experienced problems attracting
and
retaining key personnel in the recent past, please revise to
describe
these problems. Additionally, if any key employee has plans to
retire or leave your company in the near future, please revise the
discussion to disclose this information.
We have never generated revenues..., p. 16
36. Please update your financial information as of September 30,
2005.
Our quarterly operating results have fluctuated..., p. 17
The use of our net operating loss..., p. 17
37. Please disclose how the information contained in these factors
poses a risk to investors.
"The patent rights that we have in-licensed...," p. 17
38. Please disclose any problems you have faced in this section
that
are of the type described in this risk factor.
39. Please disclose when your patent for SILENOR expires. We note
that you have indicated that it expires in 2013 in the Business
section. However, if you believe obtaining regulatory approval
for
your product will take two years, then this would mean that the
limited patent protection you have is further limited by
protection
of only 5 years. If applicable, you should consider including
this
information in the risk factor as well.
Use of Proceeds, p. 24
40. You have allocated proceeds by percentage. Please revise the
percentages to allocate proceeds by dollar amount. Please expand
your disclosure to disclose the proceeds that will be allocated in
each of these four activities. Also, provide disclosure regarding
how much of the proceeds you will allocate for each of your three
development programs and state how far the allocated proceeds will
take each program or