SEC Company Response from Somaxon Pharmaceuticals, Inc. (CIK 0001339455) — Nov 23, 2005
Somaxon Pharmaceuticals, Inc. (CIK 0001339455)
Date: Nov. 23, 2005 · CIK: 0001339455 · Accession: 0000950137-05-014208
AI Filing Summary & Sentiment
File numbers found in text: 333-128871
Referenced dates: November 18, 2005
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Somaxon Pharmaceuticals, Inc.
12636 High Bluff Drive, Suite 400
San Diego, California 92130-2071
Tel: (858) 523-5400 Fax: (858) 523-5450
www.lw.com
FIRM / AFFILIATE OFFICES
Boston
New York
Brussels
Northern Virginia
Chicago
Orange County
Frankfurt
Paris
Hamburg
San Diego
November 23, 2005
Hong Kong
San Francisco
London
Shanghai
Los Angeles
Silicon Valley
VIA EDGAR AND HAND DELIVERY
Milan
Singapore
Moscow
Tokyo
New Jersey
Washington, D.C.
Jeffrey Riedler
Assistant Director
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Mail Stop 6010
Washington, D.C. 20549
Re:
Somaxon Pharmaceuticals, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Registration No. 333-128871
Dear Mr. Riedler:
We are in receipt of the Staff’s letter dated November 18, 2005 with respect to the
above-referenced Registration Statement. We are responding to the Staff’s comments on behalf of
Somaxon Pharmaceuticals, Inc. (“Somaxon”) as set forth below. Simultaneously with the filing of
this letter, Somaxon is submitting (by EDGAR) Amendment No. 2 to its Registration Statement on Form
S-1 (the “Amendment”), responding to the Staff’s comments. Courtesy copies of this letter and the
Amendment (specifically marked to show the changes thereto) are being submitted to the Staff by
hand delivery.
Somaxon’s responses set forth in this letter are numbered to correspond to the numbered
comments in the Staff’s letter. All terms used but not defined herein have the meanings assigned
to such terms in the Amendment. For ease of reference, we have set forth the Staff’s comments and
Somaxon’s response for each item below.
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.
Somaxon’s Response: Somaxon has revised the first sentence in accordance with the Staff’s
comment and made conforming changes throughout the Amendment. Please refer to pages 1, 2, 32, 36,
39, 40 and F-8 of the Amendment.
Jeffrey Riedler
November 23, 2005
Page 2
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 any
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.
Somaxon’s Response: Somaxon has revised the Amendment in accordance with the Staff’s comment.
Please refer to page 19 of the Amendment.
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.
Somaxon’s Response: Somaxon has revised the Amendment in accordance with the Staff’s comment.
Specifically, the revised disclosure sets forth the mean values relative to placebo, with
associated p-values. Please note that Somaxon has not described the high and low values
experienced by the patient population; because of the cross-over nature of the study design and the
variability of individual patients and individual nights, the high and low values can be misleading
as a measure of variability. Somaxon believes that the presentation of the mean values, with
associated p-values for the comparison relative to placebo, provides all relevant information
necessary for an investor’s understanding of the clinical trial results, in particular because the
p-value can only reach statistical significance when the variation around the mean is not
excessive. Please refer to pages 44 and 45 of the Amendment.
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.
Somaxon’s Response: Somaxon has revised the Amendment in accordance with the Staff’s comment.
Please refer to pages 56, 57 and 58 of the Amendment.
Jeffrey Riedler
November 23, 2005
Page 3
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Liquidity and Capital Resources, p. 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.
Somaxon’s Response: Somaxon has revised the Amendment in accordance with the Staff’s comment.
Please refer to pages 37 and F-14 of the Amendment.
Financial Statements
Notes to Financial Statements
Stock Options, p. 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.
Somaxon’s Response: Somaxon completed an historical analysis of the fair value of its stock
prices for financial reporting purposes and determined the corresponding compensation expense from
the issuance of stock options to its employees and directors at a price under the fair value of the
underlying stock. The analysis performed here has the benefit of hindsight. At the time of grant,
the common stock price was established by Somaxon’s Board of Directors in good faith, taking into
consideration: (a) pricing of recent preferred stock issuances to outside investors, (b) Somaxon’s
stage of development, (c) operating developments, (d) underlying market conditions and (e)
characteristics of the preferred stock relative to the common stock which creates a premium for
preferred stock pricing (in particular, the substantial liquidation preferences and the redemption
rights of the preferred stock).
Somaxon performed the following analysis of its common stock price from January 1, 2004 to
date. Based on the results of this analysis, Somaxon established its retrospective fair stock
value and determined the related compensation from stock options issued to employees and directors
deemed to have an intrinsic value under APB25. The following analysis should be read in
conjunction with the related graphical depiction attached as Exhibit A to this letter.
Jeffrey Riedler
November 23, 2005
Page 4
Price Difference Between Somaxon’s Preferred and Common Stock
Somaxon’s preferred stock offerings all involved a significant amount of new investor money
(over half of each round came from new investors), providing an arms-length value of the company
during each financing round. Somaxon’s common stock value is based on the pricing of the preferred
stock, combined with consideration of operational events, market events, and characteristics of the
common and preferred stock. The characteristics of Somaxon’s preferred stock which attribute to
the higher value of the preferred stock relative to the common stock include:
•
Liquidation Preference. In the event that Somaxon is liquidated, dissolved, or has a
change of control, either voluntarily or involuntarily, the preferred stock has preference
in liquidation over the common stock equal to the amount paid for the preferred share, plus
any remaining assets (if any) are split evenly amongst the preferred and common
stockholders on an “as if converted” basis. This preference is null in the event that
Somaxon were merged or acquired at a per share price of at least $3.00 per share for the
Series A and Series B preferred stock, and $4.05 for the Series C preferred stock.
However, in the early stages of Somaxon’s life, coupled with difficult market conditions,
it was unlikely that Somaxon’s value would allow the price to exceed this hurdle amount.
•
Dividends. When and if declared by the Board of Directors, holders of the preferred
stock are entitled to receive non-cumulative dividends at a rate of 8% per annum.
Dividends on the preferred stock are in preference to any dividends on the common stock.
•
Redemption Feature. The Series C preferred stock has a redemption feature whereby after
June 2, 2010, at the election of the majority of the Series C preferred stockholders,
Somaxon is obligated to redeem the Series C preferred stock at
the amount paid for the shares plus any unpaid dividends which may be due.
Timeline of Events and Related Pricing
The following table provides a listing of the equity transactions for Somaxon from January
2004 to date, including the estimated fair values for financial reporting purposes:
Number of
Common
Common
Preferred
Preferred
Month
Event
Shares
Issue Price
Fair Value
Issue Price
Fair Value
Jan 2004
Issue Series A preferred
18,462
$
1.00
$
1.00
Apr 2004
Grant common stock to
504,348
$
0.20
$
0.20
licensor
Apr 2004
Grant stock options
180,000
$
0.20
$
0.20
Apr 2004
Issue Series B preferred
17,000,000
$
1.00
$
1.00
June 2004
Issue Series B preferred
6,000,000
$
1.00
$
1.00
June 2004
Grant stock options
1,505,000
$
0.20
$
0.25
Sept 2004
Grant stock options
292,000
$
0.20
$
0.35
Nov 2004
Grant stock options
10,000
$
0.20
$
0.45
Jan 2005
Grant stock options
30,000
$
0.20
$
0.62
Mar 2005
Grant stock options
848,500
$
0.40
$
0.78
Jeffrey Riedler
November 23, 2005
Page 5
Apr 2005
Grant stock options
325,000
$
0.40
$
0.87
June 2005
Issue Series C preferred
40,741,048
$
1.35
$
1.35
July 2005
Grant stock options
4,030,500
$
0.50
$
1.55
Sept 2005
Grant stock options
26,500
$
1.40
$
2.09
Sept 2005
Issue
Series C preferred from exercise
of Warrant
7,407,407
$
1.35
$
2.20
In addition, the table below provides a chronological depiction of the various stock
prices as determined in the following analysis throughout Somaxon’s life from inception through the
initial public offering contemplated to occur in December 2005. A graphical depiction is attached
to this letter as Exhibit A. Somaxon’s historical analysis of the fair value of its stock
prices utilizes a predominantly linear growth assumption, taking into account significant step-ups
in value upon important developments, eventually increasing to the mid-point of the initial public
offering range. The following table provides a summary of the retrospective fair value of
preferred stock and common stock prices as determined in this analysis.
Month
Event
Preferred
Common
Aug 2003
Company founded; issue Series A preferred
$
1.00
$
0.0001
Sept 2003
$
1.00
$
0.03
Oct 2003
$
1.00
$
0.05
Nov 2003
Issue Series A preferred
$
1.00
$
0.08
Dec 2003
Issue Series A preferred
$
1.00
$
0.10
Jan 2004
Issue Series A preferred
$
1.00
$
0.13
Feb 2004
$
1.00
$
0.15
Mar 2004
$
1.00
$
0.18
Apr 2004
Issue Series B preferred; grant common stock to licensor
$
1.00
$
0.20
May 2004
$
1.00
$
0.22
June 2004
Issue Series B preferred
$
1.00
$
0.25
July 2004
Start first SILENOR™ Phase II clinical trial; license acamprosate
$
1.02
$
0.28
Aug 2004
$
1.04
$
0.31
Sept 2004
Start second SILENOR™ Phase II clinical trial
$
1.06
$
0.35
Oct 2004
$
1.08
$
0.40
Nov 2004
License nalmefene
$
1.10
$
0.45
Dec 2004
Receive positive data on first SILENOR™ Phase II clinical trial
$
1.25
$
0.55
Jan 2005
$
1.27
$
0.62
Feb 2005
$
1.28
$
0.70
Mar 2005
Receive positive data on second SILENOR™ Phase II clinical trial
$
1.30
$
0.78
Apr 2005
$
1.32
$
0.87
May 2005
Start first SILENOR™ Phase III clinical trial
$
1.33
$
0.98
June 2005
Issue Series C preferred
$
1.35
$
1.10
July 2005
$
1.73
$
1.55
Aug 2005
Conduct organizational meeting for IPO
$
2.12
$
2.01
Sept 2005
Series C Warrant exercised
$
2.17
$
2.09
Oct 2005
$
2.23
$
2.18
Nov 2005
$
2.29
$
2.27
Dec 2005
Earliest time and pricing of IPO (pre-reverse stock split)
$
2.35
$
2.35
The following discussion provides a detailed analysis of the events that occurred over
Somaxon’s life and provides the basis to support the pricing assumptions made by Somaxon as
depicted in the preceding table. The points discussed here correspond with the ranges on the
accompanying graphical depiction found in Exhibit A to this letter.
Jeffrey Riedler
November 23, 2005
Page 6
Point (A) — Period from January 2004 through June 2004
Month
Event
Preferred
Common
Jan 2004
Issue Series A preferred
$
1.00
$
0.13
Feb 2004
$
1.00
$
0.15
Mar 2004
$
1.00
$
0.18
Apr 2004
Issue Series B preferred; grant common stock
$
1.00
$
0.20
to licensor; stock option plan established and
options granted
May 2004
$
1.00
$
0.22
June 2004
Issue Series B preferred; stock options granted
$
1.00
$
0.25
Events:
•
In January 2004, Somaxon completed its Series A preferred stock financing at $1.00
per share.
•
Somaxon issued Series B preferred stock at $1.00 per share, raising $23,000,000 from
April through June 2004.
•
Somaxon issued 504,348 shares of common stock to an outside entity under the terms
of the license agreement for SILENOR™ in April 2004.
•
Somaxon’s Equity Incentive Award Plan was adopted in April 2004 and options were
issued.
Market Perspective: The NASDAQ Biotech Index was approximately 782