SEC Comment Letter for ACORDA THERAPEUTICS INC (CIK 0001008848) — Nov 10, 2005
ACORDA THERAPEUTICS INC (CIK 0001008848)
Date: Nov. 10, 2005 · CIK: 0001008848 · Accession: 0000000000-05-057309
AI Filing Summary & Sentiment
File numbers found in text: 333-128807
Referenced dates: October 26, 2005
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Mail Stop 6010
November 10, 2005
Ron Cohen
Chief Executive Officer
Acorda Therapeutics, inc.
15 Skyline Drive
Hawthorne, New York 10532
Re: Acorda Therapeutics, Inc.
Form S-1 Registration Statement
File No. 333-128807
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.
Comments applicable to the entire filing
1. We note that your filing contains numerous omissions throughout
the prospectus which relate to the offering price range or the
number
of shares you will sell. These omissions include but are not
limited
to:
* Summary Financial Data
* Use Of Proceeds
* Capitalization
* Dilution
* The Option Grants Table
* Shares Eligible For Future Sale
* The Principal Stockholders Table
* Description of Capital Stock
Rule 430A requires you to include this information in your filing
based upon an estimate of the offering price within a bona fide
range
you disclose on the cover page and based upon an estimate of the
number of shares you will sell. We consider a bona fide range to
be
$2 if the price is under $20 and 10% if it is above $20. You
should
include the required information in an amendment prior to
circulating
a "red herring" prospectus.
2. Provide us with copies of all the graphic, photographic or
artistic materials you intend to include in the prospectus prior
to
its printing and use. Please note that we may have comments.
Please
also note that all textual information in the graphic material
should
be brief and comply with the plain English guidelines regarding
jargon and technical language.
3. Comments on your application for confidential treatment will be
provided in a separate letter when they are available. Please
note
that we will not be in a position to accelerate effectiveness
until
all issues relating to your confidential treatment request have
been
resolved.
Summary - page 1
4. On page 3, under "Preclinical programs," please explain what
the
term "first-in-class therapies" refers to.
Summary Consolidated Financial Data - page 7
5. Please include an explanatory note to your summary statements
of
operations data to clarify your presentation of the "pro forma"
net
loss per share information for the periods ended December 31, 2004
and June 30, 2005.
Risk Factors - page 8
If our Phase 3 clinical trials of Fampridine-SR are unsuccessful,
or
if we are unable to obtain regulatory approval for this product
candidate or any approval is unduly limited in scope, our business
prospects will be adversely affected. - page 10
6. In the third paragraph of the risk factor you use an acronym,
"SPA," that will likely not be familiar to your readers. Please
replace it with the term it stands for.
Our products and product candidates may not gain market acceptance
among physicians, patients and the medical community, thereby
limiting our potential to generate revenue. - page 12
7. If there is a risk that physicians may not believe that the
benefits of your Zanaflex Capsules do not outweigh the higher cost
of
the capsules in relation to Zanaflex tablets or the generic
equivalent of the Zanaflex tablets, then include this information
in
the risk factor to illustrate the risk.
The loss of our key management and scientific personnel may hinder
our ability to execute our business plan. - page 14
8. Do you maintain key person life insurance?
We face an inherent risk of liability in the event that the use of
misuse of our products results in personal injury or death. - page
15
9. Please expand the risk factor to disclose the amount of
insurance
coverage you have.
If we use biological and hazardous materials in a manner that
causes
injury, we may be liable for damages. - page 17
10. Please identify the types of hazardous materials you use. If
you
have experienced adverse consequences in the past related to the
use
of these materials, please discuss the circumstances briefly here.
11. Also, disclose whether you maintain insurance for these types
of
damages and any limitations on this insurance.
As a new investor, you will experience immediate and substantial
dilution in the net tangible book value of your investment and
experience further dilution in the future. - page 21
12. Please revise this risk factor to explain that investors who
purchase shares will:
* Pay a price per share that substantially exceeds the value of
your
assets after subtracting its liabilities; and
* Contribute __% of the total amount to fund the company but will
own
only __% of the shares outstanding.
Use of Proceeds - page 25
13. Please expand the disclosure to identify the amounts you will
use
for each stated purpose. You should also disclose how far the
proceeds will enable you to get in the development of each
identified
product.
14. We note that you have three potential products that are in
preclinical development, Chondroitinase, Neuregulin and
Remyelinating
Antibody. Do you intend to use any of the proceeds to perform
preclinical studies for these products?
Management`s Discussion and Analysis of Financial Condition and
Results of Operations
Liquidity and Capital Resources, page 45
15. Per Note 2 to your consolidated financial statements, we note
that Novartis intends to discontinue tizanidine production at the
end
of 2005. As you have not yet secured a supply agreement with an
alternate manufacturer, please disclose the expected impact on
your
results of operations, inclusive of the potential expenditures
that
you may incur related to securing alternate suppliers.
Critical Accounting Policies and Estimates, page 51
16. Please provide us with further information to clarify your
revenue recognition policy. Specifically, please address the
factors
that led you to conclude that you do not meet criterion f. of SFAS
No. 48, paragraph 6. Additionally, please provide us with your
analysis of the points outlined in paragraph 8, in particular
point
c, as it would appear that Elan`s sales history with respect to
Zanaflex tablets merits consideration.
17. Given that you recognize revenue based on estimates of end-
user
prescription demand, please provide us with additional information
to
clarify your consideration of the following:
* Your visibility into the distribution channels and how you
monitor
the levels of inventory in your distribution channels;
* The significance, if any, of a particular distributor to your
business;
* The impact of existing generic products and end-user demand for
those products; and
* How you evaluate actual historical prescription user data,
retrospectively, in relation to your estimates and whether
significant adjustments would result based on actual prescription
usage data.
18. Please provide us with further information to clarify your
accounting for product shipments using the "consignment model,"
which
implies that you retain the "risks and rewards of ownership" upon
shipment to the wholesaler. Please address the consignment sale
criteria outlined in SAB 104, Topic 13.A.2, Question 2, as well as
paragraph 6b. of SFAS No. 48.
19. Please clarify your accounting policy for estimating and
recording product returns. It appears that you record estimates
for
product returns upon shipment to the wholesaler, which contradicts
your assertion that you do not recognize revenue upon shipment to
the
wholesaler due to your inability to reasonably estimate related
product returns. Please also clarify your policy of recording
estimates for product returns through cost of sales, as opposed to
contra-revenue.
20. You state that deferred revenue of $3.6 million and $3.0
million
at December 31, 2004 and June 30, 2005 has a high likelihood of
being
returned. Please tell us why such amounts are not recorded as
accrued product returns.
21. Please expand your disclosure to address your accounting
policies
related to other items that reduce your gross revenue, such as
chargebacks, rebates and discounts, referencing the applicable
authoritative literature under GAAP. Please also clarify whether
you
record these amounts when revenue is recognized or at the time of
product shipment to the wholesaler, as your disclosure herein and
in
Note 2 to your consolidated financial statements appears
contradictory to that in your Results of Operations discussion.
Business - page 53
22. Throughout this section you make a number of claims regarding
the
size of the market for your products. See, for example, the
second
paragraph on page 53 and the next to last paragraphs on pages 55
and
56. Please provide us with copies of the documents you are
relying
on to support these claims. Mark the documents to show the
location
of the information you are relying on to support each claim.
Collaborations, Alliances and License Agreements - page 71
23. Please revise the discussions of each of your agreements to
include the following additional information:
* Amounts paid to date, including up front payments, periodic
licensing fees, milestone payments and royalty payments;
* Aggregate potential milestone payments;
* Quantify minimum royalty provisions, if any; and
* Expiration and termination provisions.
Management - page 86
24. Please revise the second table on page 93 to include all of
the
information about the option grants in the last fiscal year
specified
in Item 402(c) of Regulation S-K.
Principal Stockholders - page 99
25. For each identified stockholder that is not a natural person
or a
public reporting company, identify the natural person or persons
that
have voting and investment control.
Underwriting - page 110
26. Tell us whether any of the lead underwriters or any other
broker
dealers who may participate in the syndicate may offer and/or sell
the shares electronically. If so, identify them in this section
and
disclose that they will be offering the shares electronically.
Tell
us the procedures they will use in their selling effort and how
they
intend to comply with the requirements of Section 5 of the
Securities
Act of 1933 particularly with regard to how offers and final
confirmations will be made and how and when purchasers will fund
their purchases.
27. We note that you intend to do a "directed share offering".
Please disclose in this section the number of shares you will
offer
and to whom you will make the offer. Provide us with any material
you
have sent or intend to send to these potential purchasers such as
a
"friends and family letter". Tell us when you first sent them or
intend to send them 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. We may have further comments.
28. Tell us whether you or the underwriters have any arrangements
with a third party to host or access your preliminary prospectus
on
the internet. Also, tell us who the party is and the address of
the
website. Describe the material terms of the agreement and provide
us
with a copy of any written agreement. Provide us with copies of
all
information concerning your company or the offering that appears
on
the third party website. We may have further comments.
29. Confirm that you have described the nature and extent of any
possible short sales by the underwriters. To the extent
applicable,
address the points enumerated in Section VIII.A.3. of the Division
of
Corporation Finance`s "Current Issues Outline" regarding syndicate
short sales. The June 16, 2000 version is available on the SEC`s
website, www.sec.gov.
Report of Independent Registered Public Accounting Firm, page F-2
30. We note that your independent auditors` report is not final
with
respect to the dual-dating of the financial statements to reflect
the
expected stock split. Prior to requesting acceleration of
effectiveness for your registration statement, please file an
amendment to include a final, dual-dated report from your
independent
auditors, inclusive of an updated consent report. Additionally,
please remove all references in the document that allude to the
fact
that you have not yet finalized the stock split and revise all
related disclosures accordingly.
Notes to Consolidated Financial Statements
Note (2) Summary of Significant Accounting Policies, page F-18
31. Please include the information required by Rule 5-04 of
Regulation S-X, either herein or in a separate schedule, for your
allowance for doubtful accounts as of December 31, 2004 and June
30,
2005.
Note (9) Common Stock Options and Warrants, page F-31
32. Please expand your disclosure to include an itemized
chronological schedule covering all equity instruments issued
since
January 1, 2004 through the date of your response. Please also
provide an analysis of how you determined the fair value of the
underlying common stock and any related stock-based compensation
for
each equity issuance. In addition, please disclose the following
in
the financial statements:
* the date of the transaction;
* the number of shares/options/warrants granted or issued;
* the exercise price or per share amount paid;
* management`s fair market value per share and significant
factors,
assumptions and methodologies used in determining fair value;
* whether the valuation was contemporaneous or retrospective;
* the intrinsic value, if any, per option and warrants;
* the identity of the recipient, indicating if the recipient was a
related party;
* the amount of any compensation expense recognized; and
* significant factors contributing to the difference between the
fair
value as of the date of each grant and your estimated IPO price.
Note (15) Zanaflex Asset Purchase Agreement, page F-41
33. Please clarify your recognition of contra-revenue of $4.1
million
related to Elan`s sales of Zanaflex tablets. Specifically, tell us
if
any deferred revenue was recorded at the time of acquisition and
address your consideration of the obligation as an assumed
liability
at the time of acquisition. Please cite the authoritative
literature
used to support your treatment.
34. We acknowledge your letter dated October 26, 2005. We believe
the Zanaflex asset purchase represents a business under Regulation
S-
X 210.11-01(d)(1). Please furnish the required financial
statements.
* * * * *
As appropriate, please amend your registration statement 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. 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 in