SEC Comment Letter for ACCENTIA BIOPHARMACEUTICALS INC (CIK 0001310094) — Mar 11, 2005
ACCENTIA BIOPHARMACEUTICALS INC (CIK 0001310094)
Date: March 11, 2005 · CIK: 0001310094 · Accession: 0000000000-05-011729
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File numbers found in text: 333-122769
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Via Facsimile and U.S. Mail
Mail Stop 03-09
March 11, 2005
Samuel S. Duffey
General Counsel
Accentia Biopharmaceuticals, Inc.
5310 Cypress Center Drive #101
Tampa, Florida 33609
Re: Accentia Biopharmaceuticals, Inc.
Registration Statement on Form S-1
Filed February 11, 2005
File Number 333-122769
Dear Mr. Duffey:
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.
FORM S-1
General
1. 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 these materials.
2. Please complete all of the non-pricing blank sections of your
filing prior to filing your next amendment.
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 bona 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 note that where we provide examples to illustrate what
we
mean by our comments, they are examples and not complete lists.
If
our comments are applicable to portions of the filing that we have
not cited as examples, please make the appropriate changes in
accordance with our comments.
6. Provide a currently dated and appropriately signed consent from
your independent accountants in the amendment for which you will
request effectiveness.
Cover Page
7. Please revise the first line where you disclose the number of
shares of common stock to say "up to (blank) shares of our common
stock."
Table of Contents
8. Please relocate the first paragraph at the top of this page and
the paragraphs below the table of contents so that they appear
somewhere after the Risk Factors section in the filing.
Prospectus Summary, page 1
9. Your summary does not present a balanced view of your business.
Currently, your summary is a detailed discussion of only the
positive
aspects of your company`s business and products. Please revise
the
summary to present a balanced picture. The revised discussion
should
include, among other things, your history of losses, accumulated
deficit, that you have no commercially viable products or FDA
approved products, and that you expect to continue incurring
substantial losses for the foreseeable future and may never
achieve
profitability. Please also note that the balancing disclosure you
provide should be no less prominent than your positive disclosure.
This means that you cannot satisfy the comment by merely providing
a
cross-reference to the risk factors section.
10. As you have chosen to include a summary of your strategy,
please
revise to include a discussion of the risks and obstacles you must
address in implementing this strategy.
11. Please eliminate jargon and technical terms from the forepart
of
the prospectus and provide a "plain English" explanation or
substitute. For example, these words and phrases appear in your
summary in other parts of the prospectus:
* "intranasal"
* "oral corticosteroids "
* "antifungals"
* "applied topically"
* "oral suspension"
* "antigen"
* "hybridoma"
* "mammalian"
* "higher fidelity"
If you must include technical terms in the body of your prospectus
that are understood only by industry experts you must make every
effort to concisely explain these terms where you first use them.
Risk Factors
12. Please revise the risk factors where appropriate to replace
generic language with specific disclosure of exactly how these
risks
have affected and will affect your operations, financial condition
or
business, and if practicable to quantify, the specific and
immediate
effects to investors of each risk that you have identified. For
example, you use general phrases such as "material adverse effect"
throughout the risk factor section. These generic phrases are
subject to varying interpretations and, therefore, do not
adequately
explain the risk or concern to which you refer. Please revise to
describe the adverse effect(s) in greater detail.
13. Please include a separate stand alone risk factor to disclose
any
known side effects of your product candidates, in particular, side
effects associated with SinuNase and Biovaxid.
14. Please revise to include a description and caption that
addresses
your material legal proceedings as discussed on page 94.
We are largely dependent on the success of our two most
significant
..., page 9
15. Many of the factors included in this risk factor warrant
separate
disclosure. To the extent they have been discussed as separate
risk
factors, delete them from this discussion, if they have not been
discussed independently, please consider including separate risk
factor disclosure addressing them.
If clinical trials of SinuNase, Biovaxid, or any of our current or
future ..., page 10
16. We note the list of factors that may impede your ability to
initiate and complete clinical trials. If you have experienced
any
of these problems, please revise to describe the situation and the
consequences. It may be necessary to break the discussion into
separate risk factor discussions, addressing each of the factors
separately.
17. If there are clinical trial participants who have experienced
any
adverse side effects, please revise to describe them.
18. Please revise to include a separate stand alone risk factor
addressing the possibility that you might be required to conduct
additional preclinical and phase III clinical studies and the
potential consequences if you are required to perform such
studies.
19. Please include a separate stand alone risk factor that
addresses
the risks associated with conducting clinical trials. Your
disclosure should include the possibility of not enrolling enough
patients, costs, FDA non-approval, etc.
If we fail to obtain FDA approval of SinuNase, Biovaxid, or any of
our other ..., page 10
20. If you intend to seek approval of your product in each of
these
foreign markets, please revise to disclose this information. If
you
can market your product in these countries once you receive FDA
approval, please explain.
Lack of precedent for FDA approval of a patient-specific active
idiotype vaccine ..., page 11
21. Please revise to combine this risk factor with the one
immediately preceding it, as it is discussing the same subject
matter
of FDA approval and does not likely warrant its own risk factor
caption and description.
Delays in clinical testing could result in increased costs to us
...,
page 11
22. Please quantify the estimated costs to complete clinical
trials.
23. We note your statement that you may experience delays in
conducting and completing clinical trials. To the extent
applicable,
please revise to describe any delays you have experienced and the
cause of these delays. It may be necessary to discuss each of the
causes as a separate risk factor.
We have incurred significant costs in our development efforts to
date
..., page 12
24. Please revise the disclosure to indicate that as a result of
continuing losses, you may exhaust your resources and be unable to
complete the development of your products. Additionally, clearly
state that your accumulated deficit will continue to increase as
you
continue to incur losses.
The commercialization of our product candidates may not ..., page
12
25. Please revise your disclosure to state that even if you
receive
additional financing, you may not be able to complete planned
clinical trials, development, manufacturing and marketing of any
or
all of your product candidates.
We may experience difficulties in manufacturing Biovaxid or in
obtaining ..., page 14
26. If you have experienced any of the problems you describe in
this
risk factor, please revise to describe these difficulties and
their
impact on you, if material.
We are dependent on third-party development partners for the
development ..., page 15
27. Please revise your disclosure to indicate you may not find
another suitable source of supply that meets your needs to
manufacture the MD Turbo device or your other products.
We will rely on third-party contract manufacturers for the supply
of
many of our ..., page 16
28. We note you expect to rely on third party suppliers to
develop
the pharmaceutical formulations. Please revise to identify all of
the third party suppliers in addition to Mikart, Inc., on which
you
are substantially dependent, and file your agreements with these
parties. If you have not yet entered into agreements with parties
able to provide these services, revise to disclose this
information.
29. Please combine this risk factor with the risk factor on page
15
with the caption "[w]e are dependent on third-party development
partners for the development..." It seems the subject matter of
the
two discuss similar risks and do not warrant separate disclosure.
If we acquire other complementary technologies or companies, our
financial ..., page 17
30. Please disclose if you have experienced any of difficulties
listed in the bullet points and describe the actual or expected
consequences for the acquisitions you have completed to date.
We are not able to prevent third parties, including potential
competitors, from ..., page 18
31. Please disclose the names of known competitors for Biovaxid
that
you describe on page 79, particularly Genitope and Favrille, and
state these two companies have product candidates in Phase III
clinical trials.
If we are sued for infringing intellectual property rights of
third
parties ..., page 19
32. To the extent you are aware of any intellectual proprietary
rights that are being infringed upon or that you have been
notified a
third party`s belief that you are infringing on their patent(s),
please revise to disclose the situation and potential
consequences.
We currently depend on single source suppliers for critical raw
materials ..., page 21
33. Please revise to identify all sole source suppliers, if you
have
already disclosed all of your single source suppliers, please so
state, and revise the caption to indicate a single supplier.
If we fail to comply with extensive regulations enforced bye the
FDA
..., page 23
34. Please revise this in conjunction with the next two risk
factors
that follow. All of these risk factors deal with governmental
compliance or regulatory oversight by governmental agencies. The
subheadings are duplicative and as a result, the risk factor
disclosure is cumbersome and difficult to read. Please revise to
combine where appropriate risks associated with governmental
regulation and reserve more in depth discussion of this subject
for
the government regulation section on page 80.
We may not be able to maintain sufficient product liability
insurance
..., page 26
35. Please disclose your insurance coverage limitations and
whether
or not you believe your coverage is adequate.
The failure to attract and retain skilled personnel could impair
our
product ..., page 26
36. Please identify the individuals with whom you have employment
agreements, and disclose whether you have key man life insurance
policies for Francis E. O`Donnell, Jr., Martin G. Baum, Steve R.
Arikian, and Alan M. Pearce.
37. Please disclose whether any key personnel has plans to retire
or
leave your company in the near future.
If the ownership of our common stock continues to be highly
concentrated, it may ...,page 30
38. Please revise your caption and the discussion to state that
because of highly concentrated ownership this may also lead to the
entrenchment of management.
A significant portion of our total outstanding shares are
restricted
from immediate ..., page 30
39. Please quantify the number of shares that may be issued upon
the
exercise of outstanding options and warrants.
Use of Proceeds, page 34
40. We note you plan to use some proceeds for continued
development
of SinuNase and Biovaxid. Please disclose the specific amounts
from
your offering proceeds that you intend to allocate for each
project
under development. Please also state your reasonable estimate as
to
which stage of development you expect these proceeds will take you
as
to each project.
41. Please identify with more specificity the uses that you
currently
categorize as "general corporate purposes," and state how much of
the
proceeds you plan to put toward each such use. Also, please
provide
similar detail for the amount of net proceeds that may be utilized
as
described in the third paragraph of this section.
42. Please add a statement to the disclosure in this section,
which
states you will amend the registration statement by post-effective
amendment if there are any material changes to application of your
net proceeds.
Selected Consolidated Financial Data, page 39
43. In accordance with Item 301 of Regulation S-K, please include
predecessor financial information.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations
Critical Accounting Policies and Estimates, page 43
44. Please expand your disclosure to include a robust discussion
of
the unique factors effecting estimation of fair value and both
quantified and narrative disclosure of the impact that reasonably
likely changes in one or more of those factors would have on
reported
results, financial position and liquidity. Quantify changes in
estimates in each period or state that changes in estimate were
not
material, if true, and indicate how you determined the amounts
were
not material.
Purchased In-Process Research and Development, page 45
45. We note that you recorded significant amounts of In-Process
Research and Development costs. Please provide the following
disclosures in the notes to financial statements:
a. Disclose the specific nature and fair value of each significant
in-process research and development project acquired.
b. Disclose the completeness, complexity and uniqueness of the
projects at the acquisition date.
c. Disclose the nature, timing and estimated costs of the efforts
necessary to complete the projects, and the anticipated completion
dates.
d. Explain the risks and uncertainties associated with completing
development on schedule, and consequences if it is not completed
timely.
e. Disclose the significant appraisal assumptions, such as:
i. the period in which material net cash inflows from significant
projects are expected to commence;
ii. material anticipated changes from historical pricing, margins
and
expense levels; and
iii. the risk adjusted discount rate applied to the project`s cash
flows.
Results of Operations
Year Ended September 30, 2003 Compared with Year Ended September
30,
2002, page 51
46. Please note that the results of operations should discuss all
periods presented in the financial statements including
predecessor
operations. It does not appear as though you