SEC Comment Letter for BIODELIVERY SCIENCES INTERNATIONAL INC (CIK 0001103021) — Apr 14, 2005
BIODELIVERY SCIENCES INTERNATIONAL INC (CIK 0001103021)
Date: April 14, 2005 · CIK: 0001103021 · Accession: 0000000000-05-018284
AI Filing Summary & Sentiment
File numbers found in text: 001-31361
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<TYPE>LETTER
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Via Facsimile and U.S. Mail
Mail Stop 03-09
April 14, 2005
Mr. Francis E. O`Donnell, Jr., MD
Chairman, Chief Executive Officer and Director
BioDelivery Sciences International, Inc.
2501 Aerial Center Parkway, Suite 205
Morrisville, NC 27560
Re: BioDelivery Sciences International, Inc.
Form 10-KSB for the fiscal year ended December 31, 2004
File No. 001-31361
Dear Dr. O`Donnell:
We have reviewed your filing and have the following
comments.
We have limited our review of the above referenced filings to only
those issues addressed. Where our comments call for disclosure, we
think you should amend your document in response to these
comments.
In some of our comments, we ask you to provide us with
supplemental
information so we may better understand your disclosure. Please
amend your December 31, 2004 Form 10-KSB and respond to these
comments within fifteen business days or tell us when you will
provide us with a response prior to the expiration of the 15-day
period. If we have requested additional information, as well as an
amendment, or if you disagree with any comment that calls for
disclosure, please provide this letter prior to your amendment.
You
may wish to provide us with marked copies of the amendment to
expedite our review. Your letter should key your responses to our
comments. Detailed letters greatly facilitate our review. Please
file your 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.
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 10-KSB for the fiscal year ended December 31, 2004
Management`s Discussion and Analysis or Plan of Operation, page 54
1. We acknowledge your "Pipeline of Proposed Formulations and
Products" page 5. However, we believe that your disclosures about
historical research and development expenses and estimated future
expenses related to your major research and development projects
could be enhanced for investors. Please refer to the Division of
Corporation Finance "Current Issues and Rulemaking Projects
Quarterly
Update" under section VIII - Industry Specific Issues - Accounting
and Disclosure by Companies Engaged in Research and Development
Activities. You can find it at the following website address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm. Please then
disclose the information that follows below for each of your major
research and development projects.
a. The costs incurred on the project during each period presented
and
to date;
b. The nature, timing and estimated costs of the efforts necessary
to
complete the project;
c. The anticipated completion date;
d. The risks and uncertainties associated with completing
development
on schedule and the consequences to operations, financial position
and liquidity if the project is not completed timely; and, finally
e. The period in which material net cash inflows from each
significant project are expected to commence.
Regarding a., if you do not maintain any research and development
costs by project, please disclose that fact and explain why
management does not maintain and evaluate research and development
costs by project. Provide other quantitative or qualitative
disclosure that indicates the amount of the company`s resources
being
used on the project.
Regarding b. and c., disclose the amount or range of estimated
costs
and timing to complete the phase in process and each future phase.
To
the extent that information is not estimable, disclose those facts
and circumstances indicating the uncertainties that preclude you
from
making a reasonable estimate.
Note 1. Nature of business and summary of significant accounting
policies, page F-8
2. We note that you sold to Accentia the rights to your contingent
royalty stream under the related license agreement filed as
exhibit
10.1, recording revenue pursuant to the transaction of $2.5
million.
In review of your obligation under the supply requirements of
section
9 of the license agreement, please provide to us a thorough
analysis
supporting your revenue recognition policy for this transaction
and
include the specific authoritative literature used in arriving at
your conclusions. Additionally, please disclose your ongoing
obligations pursuant to the underlying license agreement and asset
purchase agreement.
Note 4. Business Acquisition, page F-15
3. As Arius was a development stage enterprise according to your
8-
K/A filed November 5, 2004, please tell us why you recorded
goodwill
of $2.7 million and licenses of $1.9 million and only allocated
$0.2
million to in-process research and development. Your response
should
discuss the nature of the licenses acquired and how you use them
in
your operations. In addition, with respect to the goodwill
recorded,
please reference the specific authoritative literature used in
arriving at your conclusion that this acquisition qualifies as a
business combination, rather than an asset acquisition, under both
SFAS No. 141 and EITF 98-3.
Exhibits
4. We note that your officers` certifications pursuant to Section
906
of the Sarbanes Oxley Act, filed as Exhibits 32.1 and 32.2,
currently
refer to your Annual Report on Form 10-KSB for the year ended
December 31, 2003. Please revise and file both exhibits to reflect
the appropriate date of December 31, 2004. Additionally, it
appears
that the Chief Financial Officer`s signature date is incorrect.
* * * *
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.
Since the company and its management are in possession of all
facts
relating to a company`s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, please
provide,
in writing, a statement from the company acknowledging that:
* the company is responsible for the adequacy and accuracy of the
disclosure in the filings;
* staff comments or changes to disclosure in response to staff
comments in the filings reviewed by the staff do not foreclose the
Commission from taking any action with respect to the filing; and
* the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of
Enforcement has access to all information you provide to the staff
of
the Division of Corporation Finance in our review of your filing
or
in response to our comments on your filing.
You may contact Amy Bruckner, Staff Accountant, at (202)
824-
5548 or Joel Parker, Branch Chief, at (202) 824-5487 if you have
questions regarding the comments. In this regard, do not hesitate
to
contact me, at (202) 942-1803.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
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Francis E. O'Donnell, Jr., MD- Chairman, Chief Executive Officer
and
Director
BioDelivery Sciences International, Inc.
Page 4
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