SEC Comment Letter for Advanced Life Sciences Holdings, Inc. (CIK 0001322734) — Jun 21, 2005
Advanced Life Sciences Holdings, Inc. (CIK 0001322734)
Date: June 21, 2005 · CIK: 0001322734 · Accession: 0000000000-05-031530
AI Filing Summary & Sentiment
File numbers found in text: 333-124396
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Mail Stop 6010 June 21, 2005
Michael T. Flavin
Chairman and Chief Executive Officer
Advanced Life Sciences Holdings, Inc.
1440 Davey Road
Woodridge, Illinois 60517
Re: Advanced Life Sciences Holdings, Inc.
Registration Statement on Form S-1/A
Filed June 3, 2005
File Number 333-124396
Dear Mr. Flavin:
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 your response to prior comment 7 regarding support for
your statistics and are reissuing the comment in part. While we
have
received the materials you have provided in support of your data
and
are reviewing those materials at this time, we note that you have
not
disclosed those sources in the registration statement as we had
requested in our prior comment. As one example only, on page 40
you
have provided new disclosure stating that your target market is
36%
of total antibiotic sales in 2003. However, you have not
referenced
any third party statistics to support this figure. If this figure
is
an estimate made by you, disclose the basis of the estimate.
Please
review all statistics used in the registration statement and
revise
your disclosure accordingly.
Risk Factors, p. 6
"We will require additional funding, p. 6"
2. We note your disclosure regarding the need for additional funds
and your going-concern opinion. Please consider separating this
risk
factor into two separate factors, with one describing the need for
additional funding and the second one describing the risks
associated
with your going-concern opinion and the possibility of another
such
opinion.
"Our most advanced product candidate...," p. 12
3. Your disclosure regarding possible generic equivalents for
Biaxin
and Zithromax seems significant enough to warrant a separate risk
factor. Please separate the discussion into a separate factor or
provide us with an analysis explaining why a separate factor is
not
necessary. At a minimum, your discussion of generic equivalents
of
Biaxin and Zithromax, you should state explicitly that generic
equivalents are generally much more cost-effective than products
currently on the market, which places your product a competitive
disadvantage.
Capitalization, page 25
4. Please revise the introductory statement to stipulate that cash
and cash equivalents and capitalization as of March 31, 2005 are
presented.
Management`s Discussion and Analysis
Financial Operations Review
Research and Development Expense, page 29
5. We noted your response to comment number 42 and the revised
disclosure included in your amendment. Please amend your filing
to
differentiate between the amount of in-process research and
development costs attributed to cethromycin apart from the amount
attributed to ABT-210.
Liquidity and Capital Resources, page 34
6. We note your response to comment number 44. Please describe
more
specifically to us and disclose within your filing the
uncertainties
of the regulatory approval process that serve as the basis for
your
decision to exclude the $10 million and $30 million milestone
payments from the table of contractual obligations. It would
appear
that the exclusion of these amounts would indicate that management
does not expect to submit the NDA nor receive regulatory approval
for
cethromycin, the events that trigger the milestone payments. If
this
appearance is correct, please specifically state within your
filing,
management`s assessment of the probability of achieving these
developmental milestones. Explain the expected sources of funding
for
the 2005 payments to Abbott Labs and other costs reflected in the
$18.5 million disclosed in Use of Proceeds, if the planned
offering
does not occur, is delayed or results in a lower amount of
proceeds.
Critical Accounting Policies
Stock-Based Compensation, page 36
7. We have read your response to comment 45. Please explain to us
the
basis for your conclusion that your method for determining the
fair
value of stock options complied with SFAS 123 (R). Additionally,
we
noted your lack of a "bona fide" price range. Please be aware
that
we may have further comments regarding the equity fair market
valuations reflected in your financial statements after you
include
the IPO offering range in the filing.
Business, p. 37
Other collaborations and license agreements, p.56
8. Please revise the last paragraph on page 56 to clarify that you
have not yet discovered any promising drug leads through your
collaboration with the Sarawak Biodiversity Center in Malaysia.
Exhibit 5.1
9. We note you have filed a "Form of" legal opinion. Please note,
that you must file an actual legal opinion prior to effectiveness.
10. Please delete the statement that you assume no obligation to
update or supplement you opinion for facts or circumstances that
hereafter come to your attention. To the extent that you have
relied
on facts that you later discover were not accurate at the time,
you
may be required to update your opinion.
Consolidated Financial Statements
Note 3. Joint Venture, pages F-11 and F-12
11. We have read your response to comment 61. Please discuss in
MD&A
the consequences to your future operations, financial position and
liquidity if this debt is not restructured and the joint venture
is
terminated or becomes inactive. Explain to us the financial
implications of an "equal settlement of liabilities" under the
joint
venture agreement. Based upon your disclosures, it appears that
upon
termination of the joint venture, you would be required to make
non
refundable cash payments to the joint venture to settle
outstanding
liabilities. Please explain to us how this provision in the joint
venture agreement does not constitute a guarantee or further
commits
the company to provide further financial support and thus would
necessitate recognition of losses in excess of your initial
investments and any subsequent advances. Additionally, if such a
contingency to settle joint venture liabilities does not exist,
clarify your disclosure on page 56. If such a contingency does
exist, revise your disclosure in the applicable sections of the
filing and in Note 3 to describe the nature of this contingency
and
provide an estimate of the possible loss or range of loss or state
that such an estimate cannot be made. Expand your disclosure in
Note
3 to cover the termination provisions of the joint venture
agreement
as described on page 56.
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 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 Frank Wyman at (202) 551-3660 or Kevin
Woody,
at (202) 551-3629 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: R. Cabell Morris Jr.
Winston & Strawn
35 West Wacker Drive
Chicago, Illinois 60601
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