SEC Comment Letter for NEUROBIOLOGICAL TECHNOLOGIES — Mar 25, 2005
NEUROBIOLOGICAL TECHNOLOGIES INC /CA/ (CIK 0000918112)
Date: March 25, 2005 · CIK: 0000918112 · Accession: 0000000000-05-014083
AI Filing Summary & Sentiment
File numbers found in text: 000-23280, 333-123017
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Mail Stop 3-9 March 25,
2005
Paul Freiman
Chief Executive Officer
Neurobiological Technologies, Inc.
3260 Blume Drive
Suite 500
Richmond, California 94806
Re: Neurobiological Technologies, Inc.
Registration Statement on Form S-3
Filed February 25, 2005
File Number 333-123017
Form 10-K
Form the period ended June 30, 2004
File Number 000-23280
Dear Mr. Freiman:
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 have filed a request for confidential
treatment
in connection with the Form 10-Q filed November 10, 2004. You
will
receive comments relating to that request under separate cover.
Please be advised that all confidential treatment issues must be
resolved before we will consider a request for acceleration of the
registration statement.
2. If you are planning an immediate takedown offering and plan to
use
any graphic, visual or photographic information, you should
provide
us with proofs of that visual material prior to its use in a
prospectus supplement. Please note we may have comments regarding
this material. Additionally, if you are planning an immediate
take
down, please provide us with a supplemental copy of your
prospectus
summary. We may have additional comments after we have had an
opportunity to review it.
3. 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.
4. 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.
5. We note that you have not included the undertaking required by
Item 512(e) of Regulation S-K. Please revise to include the
undertaking.
Form S-3
Cover page
6. Please revise your cover page to refer to the risk factors
discussed in your Form 10-K and Form 10-Qs. In future periodic
reports include the risk factor section in your table of contents
and
title the section "Risk Factors," rather than "Other Factors that
May
Affect Future Results." Revise the "Risk Factors" section in your
registration statement to reference the pages of your periodic
reports where the risk factors are discussed.
About Neurobiological Technologies
7. In the subheading "Memantine," you state that, "we share in
revenues from sales of Memantines for all indications." This
statement appears to conflict with the statement in the Risk
Factors
in your latest 10-Q under the heading "We are dependent on Merz
and
its marketing partners..." In that risk factor, you suggest the
possibility that there are other indications for which you may not
be
entitled to royalty payments. Please revise your disclosure to
clarify the indications for which you are entitled to royalty
payments. Additionally, if you are not entitled to share in the
revenues from sales in all jurisdictions please revise to clarify
which jurisdictions are exempted.
8. Please revise the discussion of your agreement with Merz and
Children`s Medical Center Corporation to more clearly explain each
parties` obligations under the agreement.
9. Revise the description of Mertz`s agreements with Forest
Laboratories, H. Lundbeck and Daiichi Suntory Pharma to explain
how
these agreements affect you and your operations.
10. Please revise your discussion of Xercept to clarify that
Orphan
drug designation provides you with seven years market exclusivity
if
your product is the first FDA approved product that addresses the
specified indications. The disclosure should clarify that if a
competing product with Orphan drug status obtains FDA approval
before
you, the competitor receives seven years of market exclusivity.
11. Please provide more information about your difficulties
obtaining
Xercept. Do you have a supply agreement? Is your supplier a sole
source supplier? What was the cause of the shortage? How are you
addressing the problem? To the extent you rely on any sole source
suppliers, please consider amending your most recent Form 10-Q to
include a risk factor disclosing the reliance and potential
consequences. The discussion should identify the sole source
providers and your product(s) or product candidate(s) that are
dependent on this source.
12. Please revise the discussion of Viprinex to explain the
meaning
of the term "reperfusion therapy."
Use of proceeds, p 4
13. Please confirm that you will provide a detailed "Use of
Proceeds"
section in a prospectus supplement each time you do a take down.
In
each prospectus supplement the "Use of Proceeds" section should
quantify, to the best of your knowledge, the amount of proceeds
you
anticipate will be used for each of your development projects, the
stage of development that you expect to achieve with the proceeds
and
any other activities you plan to fund using the proceeds.
Incorporation of Certain Information by Reference, page 8
14. We note that the company includes the Form 8-K filed in
relation
to the Empire acquisition. Please revise this Form S-3 to provide
updated financial information and pro forma financial information
related to this acquisition.
Exhibits
15. Please file your exhibits as soon as possible. We may have
further comments once we have had an opportunity to review them.
Form 10-K for the period ending June 30, 2004
Business, p. 3
16. Please revise to address applicable comments issued above.
17. In several places throughout the 10-K, you make references to
the
Company`s products being "safe" or "effective" even for
indications
in which a product has not yet received FDA approval. As one
example
only, in the subsection Xerecept on page 8, you make reference to
"clinical evidence" that Xerecept is safer than sythentic
corticosteroids and the potential to "significantly improve the
quality of life for brain cancer patients." However, in light of
the
fact that Xerecept has not received FDA approval, assertions
relating
to safety and efficacy appear to be premature, unless accompanied
by
appropriate qualification. Specifically, any such statements
should
be introduced with a qualification that makes it clear that safety
and/or efficacy have not yet been established, that subsequent
clinical testing may reveal inefficacy or a lack of safety and
that
no definitive conclusions can be obtained until the FDA approval
process is complete. Please review your statements throughout the
section and include this introductory qualification as applicable.
18. Please revise to provide a detailed description of your
agreements with Merz and Children`s Medical Center and Abbott
Laboratories. These descriptions should include the following
information:
* The obligations of each of the parties;
* Payments made or received to date;
* Aggregate amount of potential payments;
* Expiration date;
* Termination provisions; and
* All other material terms
19. We note that you have received license fees and royalty
payments
of $4,766,000 from August 2002 to June 30, 2004. We note that you
entered into this agreement in 1998. If any fees were received
prior
to August 2002, please revise to provide the aggregate amounts
received to date.
Patents and Proprietary Information, page 11
20. Please disclose the identity of the party licensing patents
disclosed in this section. Additionally, describe the material
terms
of each of the licensing agreements, including:
* Total amounts paid to date;
* Existence of royalty provisions;
* Aggregate amount of potential payments;
* Expiration date;
* Termination provisions; and
* Any other material terms.
If such agreements have not been filed as agreements, please file
them or provide a supplemental analysis supporting your
determination
that each agreement is not required to be filed.
Item 7. Management`s Discussion and Analysis of Financial
Condition
and Results of Operations
Critical Accounting Policies, pages 18-19
21. We note that the discussion provided here seems to be merely a
reiteration of what the company discloses in its accounting policy
note to the financial statements related to each of these policies
identified as critical. Please note that your disclosures should
address material implications of uncertainties associated with the
methods, assumptions and estimates underlying the company`s
critical
accounting measurements. Consistent with Section V of Financial
Reporting Release 72, Commission Guidance Regarding Management`s
Discussion and Analysis of Financial Condition and Results of
Operations, please consider the following disclosures:
a. Disclose your analysis of the uncertainties involved in
applying a
principle at a given time or the variability that is reasonably
likely to result for its application over time.
b. Specifically address why your accounting estimates or
assumptions
bear the risk of change.
c. How the company arrived at the estimates, i.e. are they based
on
invoices or internally generated "best guesses."
d. Analyze, to the extent material, such factors as how accurate
the
estimate/assumption has been in the past, how it has changed in
the
past, and whether it is reasonably likely to change in the future.
e. Analyze the estimate/assumption specific sensitivity to change,
based on other outcomes that are reasonably likely to occur and
would
have a material effect.
Research and Development Expenses, pages 19-20
22. Please disclose period in which material net cash inflows from
significant projects are expected to commence for each of your
major
research and development projects. To the extent that information
is
not known or estimable, please disclose that fact and the reason
why
it is not known.
Liquidity and Capital Resources
Cash Flows from Operating Activities, page 21
23. The discussion of the cash flows from operations is very brief
and seems to address only the factors disclosed in the statement
of
cash flows. Please revise this discussion to include a better
understanding of the actual drivers that resulted in the inflows
and
outflows. For instance we note that the company received a
significant license fee in the current period that generated a
significant inflow. Include discussion of that fact as well as
any
known trends related to this receipt. Similarly provide a more
detailed explanation of the specific uses of cash as evidenced by
the
loss generated from operations.
Financial Statements
Note 1. Description of Business and Summary of Significant
Accounting Policies
Derivative Financial Instruments, pages 35-36
24. We note that the company originally established a liability
related to the warrants based on its analysis of the requirements
of
EITF 00-19. Please explain to us the specific provisions within
the
warrant agreements that required the company to establish this
liability in accordance with this guidance including whether the
warrants could only be settled with registered shares. Further
explain how the apparent reversal of the charges from previous
periods complies with the guidance of paragraph 10 of EITF 00-19.
Note 5. Stockholders` Equity
Convertible Preferred Stock, page 37
25. We note in the disclosure that "each share of the preferred
stock
will be automatically converted into one share of common stock
upon
the election of more than 50% of the Series A preferred stock to
convert into common stock." It appears that such an election was
made in the current period as 620,000 of the then outstanding
1,154,000 shares converted. Explain to us why the provision
described here did not result in the automatic conversion of all
of
these outstanding shares.
Note 7. Collaboration Agreement, page 41
26. We note that the company received certain payments under the
licensing agreement with Merz. Please disclose the nature of the
amounts received in the current periods, a better discussion of
the
events that resulted in the receipt of these payments, and a
discussion of the future events that may result in additional
payments related to the license portion of the agreement.
Disclose
the period over which the company expects to receive payments,
both
license and royalty, under the terms of these agreements.
Form 10-Q for the period ending December 31, 2004
Notes to Condensed Financial Statements
Note 2. Acquisition of Empire Pharmaceuticals, Inc.
Purchase Price Allocation, page 9
27. We note that the company appears to capitalize certain
intangible
assets related to the "snake venom compound and snake venom." In
note 1 of the financial statements for Empire, they seem to
expense
the costs for the snake venom as incurred. Please explain to us
why
it is appropriate for the company to capitalize these items.
Results of Operations
Revenues, page 15
28. We note that the discussion of the royalty revenues focuses
mainly on where these royalties were earned. Please revise the
discussion to provide a better insight into actual factors that
resulted in these increases in royalties including management`s
assessment of the known trends that these increases represent.
In-Process Research and Development, page 16
29. We note that the company anticipates incurring additional in-
process research and development expense should the contingent
purchase price payments be required in the future. It does not
appear that the company will receive any additional technology at
that time, so it is unclear to us why any additional charge is
appropriate. Please provide to us the company`s analysis with
references to the specific paragraphs within the applicable
authoritative literature that supports this treatment.
Management`s Discussion and Analysis, p. 12
30. Currently, your MD&A Overview is quite broad and appears
similar
or identical to the information in the registration statement
under
the heading "About Neurobiological Technologies, Inc."
However, we do not believe that the MD&A overview should provide
the
same information as a description of the company. In a recent
release called Commission Statement about Management`s Discussion
and
Analysis of Financial Condition and Results of Operations," the
staff
stated that "the development of MD&A disclosure should begin with
management`s identification and evaluation of what information,
including the potential effects of known trends, commitments,
events,
and uncertainties, is important to providing investors and others
an
accurate understanding of the company`s current and prospective
financial position and operating results." Release Nos. 33-8056;
34-
45321; FR-61.
If future periodic reports please provide an overview with a
focused
discussion that highlights the key points that are covered in
greater
detail in the MD& A section, with emphasis on the key trend and
analytical points.
31. Please n