corresp
|
|
|
|
|
Aastrom Biosciences
Dominos Farms, Lobby K
24 Frank Lloyd Wright Drive
Ann Arbor, MI 48105
T 734 930-5555 F 734 665-0485
www.aastrom.com |
|
|
|
February 18, 2011
VIA EDGAR AND FEDERAL EXPRESS
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jim B. Rosenberg
Re: |
|
Aastrom Biosciences, Inc.
Form 10-K for the Year Ended June 30, 2010
Filed September 7, 2010
File No. 000-22025 |
Ladies and Gentlemen:
This letter is submitted by Aastrom Biosciences, Inc. (the Company) in response to the comments
of the staff of the Division of Corporation Finance (the Staff) of the Securities and Exchange
Commission (the Commission) raised in your letter of January 28, 2011 regarding the Companys
Form 10-K for the fiscal year ended June 30, 2010 filed on September 7, 2010 (the Comment
Letter). For reference purposes, the text of the Comment Letter has been reproduced herein with
responses below each numbered comment.
Cover Page
1. |
|
You have indicated through check marks that you are both an accelerated filer and a smaller
reporting company. In future filings, please only check the correct box. |
|
|
|
Response 1: |
|
|
|
The Company acknowledges the Staffs comment and will check only the correct box in future
filings and in the Amended Reports (as defined below). |
Item 1. Business
Production
2. |
|
You state in your disclosure that you rely on certain third parties to manufacture or supply
certain devices and manufacturing equipment, as well as components and other materials that are
used in your cell manufacturing process. Specifically, you refer to the following third parties:
Sparton Corporation, Ethox, ATEK Medical, Lonza Walkersville, |
U.S. Securities and Exchange Commission
February 18, 2011
Page 2
|
|
Inc., Genpore, BioLife Solutions, Inc., and Invitrogen Corporation. Please provide us with
draft disclosure for future filings that describes the material terms of each of these
agreements, including their payment, duration and termination provisions. Furthermore, you
have not filed most of these agreements as exhibits to your annual report; we request that you
do so. If you believe you are not substantially dependent on any of these arrangements,
please provide us with your analysis. |
|
|
|
Response 2: |
|
|
|
In response to the Staffs comment, we respectfully advise the Staff that the Company is not
substantially dependent on any arrangements with Sparton Corporation, Ethox, Lonza
Walkersville, Inc., Genpore, BioLife Solutions, Inc., and Invitrogen Corporation, as the
Company would experience only a minor disruption in business if any of these arrangements
were to change or terminate, and that these arrangements were made in the ordinary course of
business and are of the type ordinarily accompanying the kind of business conducted by the
Company. Thus, the Company has determined that none of these arrangements is material as
such term is defined under Regulation S-K Item 601(b)(10). The Company further advises the
Staff that, subsequent to the filing of its Annual Report on Form 10-K on November 8, 2010
and as disclosed in the Companys Current Report on Form 8-K filed on November 12, 2010, the
Company finalized the terms of a manufacturing and supply agreement with ATEK Medical, LLC
(the ATEK Agreement). As the Company will be substantially dependent on the ATEK
Agreement, the Company anticipates filing the ATEK Agreement as a material contract with its
upcoming Annual Report on Form 10-K for the fiscal year ended December 31, 2010 along with
the submission of a Confidential Treatment Request for certain pricing information provided
in the ATEK Agreement. |
|
|
|
The Company advises the Staff that it will revise its disclosure in future filings, to the
extent applicable, to read as set forth in Exhibit A hereto. For the Staffs convenience,
this disclosure has been marked against the applicable sections from the Companys Form 10-K
for the fiscal year ended June 30, 2010 and is set forth in Exhibit B hereto. |
Patents and Proprietary Rights, page 7
3. |
|
In future filings, please include the duration of each of your material patents in this
disclosure. Please confirm you will do so. |
|
|
The Company advises the Staff that it will include the duration of each of our material
patents in future filings with the Commission. |
U.S. Securities and Exchange Commission
February 18, 2011
Page 3
Managements Discussion and Analysis of Financial Condition and Results of Operations, page
27
4. |
|
In your July 14, 2005 response to the first comment of our April 15, 2005 letter you
represent that you will disclose, in tabular format, the historical costs incurred on your
research and development projects. Please provide us draft disclosure for inclusion in your
future periodic reports that discloses the costs you incurred during each period presented and
to date on each of your projects. In this regard, it appears that at a minimum you should
separately disclose the costs incurred for your Critical Limb Ischemia and Dilated
Cardiomyopathy projects. |
|
|
The Company advises the Staff that it will revise its disclosure in future filings, to the
extent applicable, to separately disclose our costs for our Critical Limb Ischemia, Dilated
Cardiomyopathy and other projects in tabular format for each period presented in
Managements Discussion and Analysis of Financial Condition and Results of Operations,
beginning with our Form 10-K for the fiscal year ended December 31, 2010. See Exhibit C for
our draft disclosure. |
Notes to Consolidated Financial Statements
Note 4: Shareholders Equity, page 48
5. |
|
It appears that the warrants issued in conjunction with your January 21, 2010 unit offering
were made pursuant to a shelf registration statement. Please explain to us why you have not
accounted for your Class A warrants issued in this unit offering as derivative liabilities
under either or both of the following scenarios: |
|
|
|
Please explain to us how you overcome the presumption in ASC 815-40-25-14 that these
warrants are net cash settleable. In this regard, although it appears that sections
3(a) and 3(b) of the warrant agreement permit the holder the option to exercise the
warrant on a cashless basis if a valid registration statement for the resale of the
underlying common stock is not effective, the warrant agreement does
not appear to require cashless exercise. It therefore appears that by operation of the
U.S. Securities Laws the warrant holder may demand settlement in registered shares, a
result which is beyond your control, and thereby trigger derivative liability treatment
under ASC 815-40-25-14. |
|
|
|
|
It appears that section 4.4 of your warrant agreement provides the holder price protection whereby
the exercise price is reduced if you issue equity instruments at prices lower than the warrant
exercise price. Please explain to us how this provision does not violate the requirement under ASC
815-40-15-7 to be indexed to your own stock. In this regard, although this provision adjusts the
exercise price of the warrant
|
U.S. Securities and Exchange Commission
February 18, 2011
Page 4
|
|
|
based on a mathematical formula, it does not appear that this formula adjusts the
exercise price solely for the dilutive effect of the future equity issuance being below
the then-current market price. Please see Example 17 at ASC 815-40-55-42 and 55-43. |
|
|
In response to the Staffs comments, the Company reviewed the accounting of its Class A
warrants issued in connection with its January 21, 2010 offering and determined that these
Class A warrants should be reflected as liabilities in its financial statements.
Furthermore, in connection with this determination, the Company reviewed its previously
issued warrants to purchase shares of common stock because these warrants generally provide
(i) that in the event the related registration statement is not available for the issuance
of the warrant shares, the warrants could potentially require cash
settlement, and/or (ii)
the holder with weighted-average anti-dilution price protection in the event the Company
issues securities at a price per share that is less than the exercise price of the warrants.
After the completion of this expanded review, the Audit Committee of the Company, together
with management, determined that the Companys previously issued financial statements for
all periods included in the Companys annual report on Form 10-K for the fiscal year ended
June 30, 2010 and included in the Companys quarterly reports on Form 10-Q for the quarters
ended September 30, 2008 through September 30, 2010 (collectively, the Affected Periods)
should be restated because of a misapplication in the guidance around accounting for
warrants and should no longer be relied upon. Specifically, the
financial statements in the Affected Periods should be restated to
reflect the warrants as
liabilities in accordance with Accounting Standards Codification 815, with subsequent
changes in their estimated fair value recorded as non-cash income or expense in each
Affected Period. Please note that the restatement of the Companys financial statements for
the Affected Periods covers fiscal periods that are broader than the initial scope of the
Staffs comment. Please see the Current Report on Form 8-K filed by the Company on February
14, 2011 for additional information regarding the restatement of the Companys financial
statements for the Affected Periods. |
|
|
The Company anticipates filing an amended Annual Report on Form 10-K/A for the fiscal year
ended June 30, 2010 and amended Quarterly Reports on Form 10-Q/A for the fiscal quarters
ended September 30, 2009, December 31, 2009, March 31, 2010 and September 30, 2010, each
with restated financial statements reflecting reclassification of the warrants. The Company
is presently targeting making these filings by February 28, 2011. |
Item 9A. Controls and Procedures
Managements Report on Internal Control over Financial Reporting, page 53
6. |
|
We note your statement that (m)anagement . . . assessed the effectiveness of our internal control
over financial reporting . . . and concluded that it was effective at a reasonable level. Item
308(a)(3) of Regulation S-K requires you to state whether or not your internal control over
financial reporting was effective during the applicable period. Qualifying this statement as you
have done here is not appropriate. Please amend your
|
U.S. Securities and Exchange Commission
February 18, 2011
Page 5
|
|
annual report to remove this qualification by stating that your internal controls were
either effective or were not effective. |
|
|
The Company advises the Staff that it will re-file its previously filed Annual Report on
Form 10-K for the fiscal year ended June 30, 2010 to incorporate the Staffs comments. As
indicated above, the Company expects to re-file this report by February 28, 2011. |
Signatures, page 56
7. |
|
Please amend your annual report to include the signatures of your principal financial officer
and your principal accounting officer or controller. If any of the current signatories act in
these capacities, please advise us and confirm that you will revise your signature page in the
future to indicate all the capacities in which the signatories have signed the report. |
|
|
The Company advises the Staff that it will re-file its previously filed Annual Report on
Form 10-K for the fiscal year ended June 30, 2010 to incorporate the Staffs comments. As
indicated above, the Company expects to re-file this report by February 28, 2011. |
As requested in the Comment Letter, the Company acknowledges 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 do not
foreclose the Commission from taking any action with respect to the filings; 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. |
* * *
U.S. Securities and Exchange Commission
February 18, 2011
Page 6
If you should have any questions concerning the enclosed matters, please contact the undersigned at
(734) 930-5552.
Very truly yours,
Scott C. Durbin, Chief Financial Officer
cc: |
|
Timothy Mayleben, Aastrom Biosciences, Inc.
Mitchell S. Bloom, Esq., Goodwin Procter LLP
Danielle Lauzon, Esq., Goodwin Procter LLP
Jacqueline Mercier, Esq., Goodwin Procter LLP
Jeff Riedler, U.S. Securities and Exchange Commission
Mark Brunhofer, U.S. Securities and Exchange Commission
Kei Nakada, U.S. Securities and Exchange Commission
Scot Foley, U.S. Securities and Exchange Commission |
Exhibit A
Production
Cell Manufacturing and Cell Production Components
In the United States, we operate a cell manufacturing facility in Ann Arbor, Michigan. The
facility supports the current U.S. clinical trials and has sufficient capacity, with minor
modifications, to supply our early commercialization needs. We may establish and operate larger
commercial-scale cell manufacturing facilities for the U.S. market in the future to accommodate
potential market growth.
We have established relationships with manufacturers that are registered with the FDA as
suppliers of medical products to produce various components of our patented cell manufacturing
system.
We have established relationships with various third parties such who manufacture and/or
supply certain components, equipment, disposable devices and other materials used in our cell
manufacturing process to develop our cell products, as well as our final assemblies, component
parts, subassemblies and associated spare parts used in the instrumentation platform of our cell
production system.
There can be no assurance that we will be able to continue our present arrangements with our
manufacturers and/or suppliers, supplement existing relationships or establish new relationships,
or that we will be able to identify and obtain certain components, equipment, disposable devices,
other materials, including ancillary materials that are necessary to develop our product candidates
or that are used in our cell manufacturing and cell production components processes. Our dependence
upon third parties for the supply and manufacture of such items could adversely affect our ability
to develop and deliver commercially feasible cell products on a timely and competitive basis. See
Risk Factors.
Our Arrangement with ATEK
On November 8, 2010, we entered into a contract manufacturing and supply agreement (the
Supply Agreement) with ATEK Medical, LLC (ATEK) for the manufacture our proprietary cell
cassette for use in our manufacturing process. Pursuant to the terms of the Supply Agreement, we
have granted ATEK the exclusive right to manufacture our proprietary cell cassette and to assemble,
package, label and sterilize the cassettes in ATEKs facilities. ATEK will be responsible for
obtaining all of our approved components pertaining to the cassettes and we are obligated to order
and purchase the cassettes from ATEK on an agreed upon schedule and in agreed upon quantities. In
addition, we will provide ATEK with reasonable engineering support to initiate and ramp up
manufacturing of the cassettes and will supply all manufacturing equipment.
The Supply Agreement has an initial term of four years and will terminate automatically
without notice unless prior to that time the term is extended by mutual written consent delivered
at least six months prior to the termination date. The minimum term extension is generally to be
no less than two years.
The Supply Agreement provides that we may discontinue the manufacture of the cassettes at our
sole discretion. In such event, we agree to use commercially best efforts to notify ATEK at least
120 days prior to our intention to discontinue manufacture of the cassettes. Failure to provide
such notice will not be a breach of the Supply Agreement, but without such notice, we agree to
purchase from ATEK (i) certain finished goods that are in usable condition and (ii) certain
components or raw materials inventory or work in process in each case to the extent convertible
into finished cassettes.
We or ATEK may terminate the Supply Agreement if the other party materially defaults in the
performance of any provision of the Supply Agreement and, should any such default occur, then the
non-defaulting party may give written notice to the defaulting party that if the default is not
cured within 45 days, the Supply Agreement will be terminated. If the non-defaulting party gives
such notice and the default is not cured during the 45 day period, then the Supply Agreement shall
automatically terminate at the end of such period unless an extension is mutually agreed to by ATEK
and us. In addition to other remedies, either party may terminate the Supply Agreement at any time
if either of us breach our confidentiality obligations under the Supply Agreement, in which case
termination shall be effective immediately upon receipt of notice of the breach and of termination.
Either party may immediately terminate the Supply Agreement by written notice if the other party is
or becomes insolvent, appoints or has appointed a receiver for all or substantially all of its
assets, or makes an assignment for the benefit of its creditors. In addition, either party may
terminate the Supply Agreement by written notice if the other party files a voluntary petition, or
has filed against it an involuntary petition, for bankruptcy and such petition is not dismissed
within 90 days.
Upon termination of the Supply Agreement, ATEK agrees to provide reasonable technical support
at ATEKs published engineering rates for the transfer of manufacturing technology to an
alternative manufacturer chosen by us to conduct final manufacture, package and test of the
cassettes in the event that ATEK, for a period of 150 days from the date of receipt of the
associated purchase order, is unable to manufacture all of our orders for any reason, or if ATEK
fails or refuses to meet our orders for cassettes pursuant to the terms of the Supply Agreement.
There can be no assurance that we will be able to continue our present arrangement with ATEK.
Our dependence upon our arrangement with ATEK for the supply and manufacture of our proprietary
cell cassette could adversely affect our ability to develop and deliver commercially feasible cell
products on a timely and competitive basis. See Risk Factors.
Exhibit B
Production
Cell Manufacturing
and Cell Production Components
In the United States, we operate a cell manufacturing facility in Ann Arbor,
Michigan. The facility supports the current U.S. clinical trials and has sufficient
capacity, with minor modifications, to supply our early commercialization needs. We
may establish and operate larger commercial-scale cell manufacturing facilities for
the U.S. market in the future to accommodate potential market growth.
We have established relationships with manufacturers that are registered
with the FDA as suppliers of medical products to produce various components of our
patented cell manufacturing system.
We have established relationships with
various
third parties such
BioLife Solutions, Inc., Lonza Walkersville, Inc. and Invitrogen Corporation
towho
manufacture and/or supply certain components, equipment, disposable
devices and other materials used in our cell manufacturing process to develop our
cell products
., as well as our final assemblies, component parts, subassemblies
and associated spare parts used in the instrumentation platform of our cell
production system.
There can be no assurance that we will be able to continue our present
arrangements with our
manufacturers and/or
suppliers, supplement existing
relationships or establish new relationships, or that we will be able to identify
and obtain certain components, equipment, disposable devices
and,
other
materials
, including ancillary materials that are necessary to develop our
product candidates or that are
used in our cell manufacturing
processand
cell production components processes
. Our dependence upon third parties for the
supply and manufacture of such items could adversely affect our ability to develop
and deliver commercially feasible cell products on a timely and competitive basis.
See Risk Factors.
Cell Production Components
We have established relationships with manufacturers that are registered with the
FDA as suppliers of medical products to produce various components of our patented
cell manufacturing system.
Our Arrangement with ATEK
On November 8, 2010, we entered into a contract manufacturing and supply
agreement (the Supply Agreement) with ATEK Medical, LLC (ATEK) for the
manufacture our proprietary cell cassette for use in our manufacturing process.
Pursuant to the terms of the Supply Agreement, we have granted ATEK the exclusive
right to manufacture our proprietary cell cassette and to assemble, package, label
and sterilize the cassettes in ATEKs facilities. ATEK will be responsible for
obtaining all of our approved components pertaining to the cassettes and we are
obligated to order and purchase the cassettes from ATEK on an agreed upon schedule
and in agreed upon quantities. In addition, we will provide ATEK with reasonable
engineering support to initiate and ramp up manufacturing of the cassettes and will
supply all manufacturing equipment.
The Supply Agreement has an initial term of four years and will terminate
automatically without notice unless prior to that time the term is extended by
mutual written consent delivered at least six months prior to the termination date.
The minimum term extension is generally to be no less than two years.
The Supply Agreement provides that we may discontinue the manufacture of
the cassettes at our sole discretion. In such event, we agree to use commercially
best efforts to notify ATEK at least 120 days prior to our intention to discontinue
manufacture of the cassettes. Failure to provide such notice will not be a breach
of the Supply Agreement, but without such notice, we agree to purchase from ATEK (i)
certain finished goods that are in usable condition and (ii) certain components or
raw materials inventory or work in process in each case to the extent convertible
into finished cassettes.
We or ATEK may terminate the Supply Agreement if the other party materially
defaults in the performance of any provision of the Supply Agreement and, should any
such default occur, then the non-defaulting party may give written notice to the
defaulting party that if the default is not cured within 45 days, the Supply
Agreement will be terminated. If the non-defaulting party gives such notice and the
default is not cured during the 45 day period, then the Supply Agreement shall
automatically terminate at the end of such period unless an extension is mutually
agreed to by ATEK and us. In addition to other remedies, either party may terminate
the Supply Agreement at any time if either of us breach our confidentiality
obligations under the Supply Agreement, in which case termination shall be effective
immediately upon receipt of notice of the breach and of termination. Either party
may immediately terminate the Supply Agreement by written notice if the other party
is or becomes insolvent, appoints or has appointed a receiver for all or
substantially all of its assets, or makes an assignment for the benefit of its
creditors. In addition, either party may terminate the Supply
Agreement by written notice if the other party files a voluntary petition,
or has filed against it an involuntary petition, for bankruptcy and such petition is
not dismissed within 90 days.
Sparton Corporation, formerly Astro Instrumentation, LLC, manufactures our final
assemblies, component parts, subassemblies and associated spare parts used in the
instrumentation platform of our cell production system. This agreement automatically
renews every 12 months unless terminated. We retain all proprietary rights to our
intellectual property that is utilized by Sparton pursuant to this agreement.
Through August 2010, Moll Industries, Inc. (Moll) was our supplier of the cell
culture cassettes used in the production of our products. Moll performed the
manufacturing and assembly of the cassettes while we retained all rights to our
intellectual property that was utilized by Moll pursuant to this agreement. In April
2010, Moll filed for bankruptcy protection in a Delaware court. As a result, we plan
to engage ATEK Medical (ATEK) to manufacture our cell culture cassettes. We are in
the process of finalizing the terms of our agreement with ATEK and expect that the
terms will be substantially similar to those we had previously with Moll, including
retention of all rights to our intellectual property.
Upon termination of the Supply Agreement, ATEK agrees to provide reasonable
technical support at ATEKs published engineering rates for the transfer of
manufacturing technology to an alternative manufacturer chosen by us to conduct
final manufacture, package and test of the cassettes in the event that ATEK, for a
period of 150 days from the date of receipt of the associated purchase order, is
unable to manufacture all of our orders for any reason, or if ATEK fails or refuses
to meet our orders for cassettes pursuant to the terms of the Supply Agreement.
There can be no assurance that we will be able to continue our present
arrangements with
our suppliers, supplement existing relationships or establish new relationships or that we
will be able to identify and obtain the ancillary materials that are necessary to develop
our product candidates in the future. Our dependence upon third partiesarrangement with
ATEK. Our dependence upon our arrangement with ATEK
for the supply and manufacture of
such itemsour proprietary cell cassette
could adversely affect our ability to
develop and deliver commercially feasible
cell
products on a timely and competitive
basis. See Risk Factors.
Exhibit C
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
June 30, |
|
|
December 31, |
|
|
December 31, |
|
Project |
|
2009 |
|
|
2010 |
|
|
2009* |
|
|
2010* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Critical Limb Ischemia |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilated Cardiomyopathy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Research and
Development Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Periods presented reflect the Companys change in year end from June 30 to December 31 as
disclosed in a Form 8-K filed on November 12, 2010. |