Risks Related to Our
Business
We are in the process of seeking
stockholder approval of the proposed acquisition of Avigen by MediciNova, which
if the acquisition does not occur, we will have expended significant resources
for no benefit, and will have delayed a dissolution of Avigen.
We are
pursuing the acquisition of the company by MediciNova, Inc., which has required
that we incur significant legal and other costs. If either our stockholders, or
the MediciNova stockholders do no approve the merger, then the merger will not
occur, and we will need to pursue a dissolution of Avigen. If this were to
occur, we would have incurred significant merger-related costs, as well as
continued operating costs, that we would not have incurred if we had pursued a
dissolution of the company. Further, we will need to hold an annual meeting of
our stockholders as soon as possible if the acquisition does not occur, which
will also require that we incur additional costs. If all of this were to occur,
we will have less cash to return to stockholders than we believe we will have if
the merger with MediciNova is consummated.
We are in the process of pursuing
a monetization of our AV411 product in the event that we are not able to
complete the proposed merger with MediciNova, which we may not be able to do on
terms we believe we should be able to obtain for this product
We are
pursuing the sale of our AV411 product in the event that we are not able to
complete the proposed merger with MediciNova. We believe that this product has
substantial value, but given the current economic climate, we may not be able to
find a buyer that is willing to pay what we believe is the fair value for AV411.
If we are not able to obtain significant value for the sale of AV411, we will
not be able to return to our stockholders the value that we believe we should be
able to obtain for AV411.
We are in the process of pursuing
a monetization of our rights under our Genzyme agreement in the event that we
are not able to complete the proposed merger with MediciNova, which we may not
be able to do on terms we believe we should be able to obtain
We are
pursuing discussions with Genzyme to have Genzyme purchase from Avigen the
rights under our existing agreement with Genzyme or may seek in the alternative
to sell these rights to another party in the event that the merger with
MediciNova does not occur. We believe that these rights have substantial value,
but we may not be able to find a buyer that is willing to pay what we believe is
the fair value for these rights, and Genzyme may not be willing to purchase
these rights for the value that we believe they are worth. If we are not able to
monetize these rights or obtain value for these rights on the terms that we
believe they are worth in the event that we are not able to complete the
proposed merger, we will not be able to return to our stockholders the value
that we believe we should be able to obtain for these rights.
We will incur costs as we pursue
the completion of the proposed merger with MediciNova or possible dissolution of
Avigen, which may be more than we expect, which could result in a return to
Avigen stockholders of less than we expect
We will
continue to incur operating costs as the company pursues the completion of the
proposed merger or, if the merger is not completed, dissolution of the company.
We are being very frugal with respect to the costs we are incurring, but we will
need to continue to incur costs of operations. We have incurred costs in
negotiations with MediciNova regarding the proposed merger and will continue to
incur substantial costs in seeking stockholder approval and defending a law suit
filed against us relating to the proposed merger. If the proposed merger is not
completed and, as a result, we pursue a dissolution, we would need to solicit
stockholder approval of such a dissolution, which would take time and we would
incur costs in such a solicitation. If these costs are more than we expect, we
will decrease the amount that we believe we would be able to return to our
stockholders.
Other persons may assert rights
to our proprietary technology, which could be costly to contest or settle
Third
parties may assert patent or other intellectual property infringement claims
against us with respect to our products, technologies or other matters. Any
claims against us, with or without merit, as well as claims initiated by us
against third parties, can be time-consuming and expensive to defend or
prosecute and resolve. There may be third-party patents and other intellectual
property relevant to our products and technology which are not known to us. We
have not been accused of infringing any third party's patent rights or other
intellectual property, but we cannot assure you that litigation asserting claims
will not be initiated, that we would prevail in any litigation, or that we would
be able to obtain any necessary licenses on reasonable terms, if at all. If our
competitors prepare and file patent applications in the United States that claim
technology also claimed by Avigen, we may have to participate in interference
proceedings declared by the Patent and Trademark Office to determine priority of
invention, which could result in substantial cost to us, even if the outcome is
favorable to us. In addition, to the extent outside collaborators apply
technological information developed independently by them or by others to our
product development programs or apply our technologies to other projects,
disputes may arise as to the ownership of proprietary rights to these
technologies.
27
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
As of
September 30, 2009, in order to increase the liquidity of our investment
portfolio, we sold all of our outstanding available-for-sale marketable
securities and invested all of our excess funds in money market funds or cash
accounts. As a result, as of September 30, 2009, we do not have any material
exposure to fair value fluctuations of our
investment portfolio due to market risk, compared to our estimated exposure of
$341,000 as reported in our market risk disclosures set forth in Item 7A of our
Annual Report on Form 10-K for the year ended December 31, 2008, as filed with
the SEC on March 16, 2009. The market risk exposure associated with our
investment in marketable securities at December 31, 2009 was deemed to be
immaterial and was based on the potential impact if market interest rates were
to increase by 100 basis points, or 1%, from their December 31, 2008
levels.
Item 4.
Controls and Procedures
Evaluation of disclosure controls and procedures
. With the supervision and with the participation of our
management, including our principal executive officer and principal financial
officer, we have evaluated the effectiveness of our disclosure controls and
procedures (as defined in the Securities Exchange Act of 1934, Rules 13a-15(e)
and 15(d)-15(e)), as of September 30, 2009. Based on that evaluation, the
principal executive officer and principal financial officer have concluded that
these disclosure controls and procedures were effective to ensure, at a
reasonable assurance level, that the information required to be disclosed by us
in reports we file with the SEC is recorded, processed, summarized and reported
within the time periods specified in the SECs rules and instructions for such
reports.
Changes in Internal Control over Financial Reporting
. There were no changes in our internal control over financial
reporting during the quarter ended September 30, 2009, that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
Item 4T.
Controls and Procedures
Not applicable.
28
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
On August
24, 2009, The Pennsylvania Avenue Funds filed a complaint in California Superior
Court for Alameda County entitled
The
Pennsylvania Avenue Funds, v. Avigen, Inc., et al.,
Case No. RG09470224. Plaintiff filed an amended complaint on or about
October 15, 2009. Plaintiff alleges that it is an Avigen stockholder and asserts
claims on behalf of a purported class of all public stockholders of Avigen.
Named as defendants in the amended complaint are Avigen, all of the current
members of Avigens board of directors and MediciNova, Inc. Plaintiff alleges
that the Merger resulted from an unfair process; that the consideration offered
in the Merger is inadequate in light of Avigens prospects, liquidation value,
and potential alternative transactions; and that the public disclosures in
connection with the Merger are inadequate. Plaintiff asserts claims against the
individual defendants for breach of fiduciary duties of good faith, loyalty,
fair dealing and due care; against MediciNova for aiding and abetting the
individual defendants breaches of fiduciary duty; and against all defendants
for breach of a fiduciary duty of disclosure. Plaintiff seeks a judgment
determining that the action is a proper class action and that plaintiff is a
proper class representative, and awarding plaintiff and the purported class
damages, attorneys fees, costs and interest
.
Item 1A.
Risk Factors
We
include in Part I, Item 2. Managements Discussion and Analysis of Financial
Condition and Results of Operations Risks Related to Our Business a
description of risk factors related to our business in order to enable readers
to assess, and be appropriately apprised of, many of the risks and uncertainties
applicable to the forward-looking statements made in this Quarterly Report on
Form 10-Q. We do not claim that the risks and uncertainties set forth in that
section are all of the risks and uncertainties facing our business, but do
believe that they reflect the more important ones.
In March
2009, we announced that we had discontinued strategic merger discussions and
intended to develop a plan of dissolution. In June 2009, we announced that we
had reached an understanding with MediciNova, Inc. on key terms for a proposed
acquisition of Avigen by MediciNova
. On August
20, 2009, we entered into a definitive agreement pursuant to which MediciNovas
wholly-owned subsidiary will merge with and into Avigen. The completion of the
transaction will permit the combination of the companies broad neurological
clinical development programs based on ibudilast (Avigens AV411 and
MediciNovas MN-166).
We believe this has
significantly changed our risk profile, including the risk factors set forth in
Part I, Item 1A of our Annual Report on Form 10-K for the year ended December
31, 2008, as filed with the SEC on March 16, 2009. The risks relating to our
business now relate primarily to preserving the value, and monetizing our assets
as we seek to complete the proposed merger with MediciNova or sell or dissolve
the company. We have updated these risk factors in Part 1, Item 2 of this
Quarterly Report on Form 10-Q under the caption Risks Related to Our Business
to take into account these recent developments.
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3.
Defaults Upon Senior Securities
None.
Item 4.
Submission of Matters to a Vote of Security Holders
None.
29
Item 5.
Other Information
On
November 9, 2009, Avigen amended its Management Transition Plan (the Plan)
to cause the Plan to terminate in connection with the acquisition of Avigen by
MediciNova, Inc., and to cause the scheduled payouts under the Plan to occur
upon termination or shortly thereafter, except to the extent necessary to delay
payouts to avoid adverse tax consequences.
Item 6.
Exhibits
See the
Exhibit Index which follows the signature page of this Quarterly Report on Form
10-Q, which is incorporated herein by reference
SIGNATURES
Pursuant
to the requirements of the Securities and Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
AVIGEN, INC.
Date: November
9, 2009
|
|
By:
|
/s/ ANDREW A. SAUTER
|
|
|
|
Andrew
A. Sauter
|
|
|
|
Chief
Executive Officer, President and
|
|
|
|
Chief Financial
Officer
|
30
EXHIBIT INDEX
Exhibit
Number
|
|
Exhibits
|
2
|
.1(5)
|
|
Assignment Agreement, dated December 19, 2005, by and between
Genzyme Corporation and Avigen
|
2
|
.2(10)
|
|
Agreement and Plan of
Merger, dated August 20, 2008, by and among MediciNova, Inc., Absolute
Merger, Inc. and Avigen, Inc.
|
2
|
.2(7)
|
|
Asset
Purchase Agreement, dated December 17, 2008, by and between Baxter
Healthcare Corporation, Baxter International Inc., and Baxter Healthcare
S.A. (collectively Baxter) and Avigen
|
3
|
.1(8)
|
|
Amended and Restated
Certificate of Incorporation
|
3
|
.1.1(2)
|
|
Certificate of Amendment to Certificate of
Incorporation
|
3
|
.1.2(3)
|
|
Certificate of
Amendment to Certificate of Incorporation
|
3
|
.1.3(8)
|
|
Certificate of Designation
|
3
|
.2(6)
|
|
Restated Bylaws of the
Registrant
|
4
|
.1(1)
|
|
Specimen Common Stock Certificate
|
4
|
.2(9)
|
|
Rights Agreement dated
as of November 21, 2008, by and between the Company and American Stock
Transfer & Trust Co. LLC
|
4
|
.3(8)
|
|
Form of
Right Certificate
|
4
|
.3(10)
|
|
Amendment to Rights
Agreement, dated August 20, 2008, by and between
Avigen, Inc. and American Stock Transfer & Trust Co.
LLC
|
10
|
.1(10)
|
|
Amendment to Management Transition Plan, effective as of August 20,
2009
|
10
|
.2
|
|
Amendment to Management
Transition Plan, effective as of November [ ], 2009
|
31
|
.1
|
|
CEO
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
|
31
|
.2
|
|
CFO Certification
required by Rule 13a-14(a) or Rule 15d-14(a)
|
32
|
.1(4)
|
|
Certification required by Rule 13a-14(b) or Rule 15d-14(b) and
Section 1350 of Chapter 63 of Title 18 of the United States Code (18
U.S.C. §1350)
|
____________________
(1)
|
|
Filed as an exhibit to the
Registrants Registration Statement on Form S-1 (No. 333-03220) and
incorporated herein by reference.
|
|
(2)
|
|
Incorporated by reference from
such document filed with the SEC as an exhibit to Avigens Quarterly
Report on Form 10-Q for the quarter ended December 31, 2000, as filed with
the SEC on February 13, 2001 (Commission File No.
000-28272).
|
|
(3)
|
|
Incorporated by reference from
such document filed as an exhibit to Avigens Current Report on Form 8-K
filed with the SEC on June 26, 2007 (Commission File No.
000-28272).
|
|
(4)
|
|
This certification accompanies
the Form 10-Q to which it relates, is not deemed filed with the Securities
and Exchange Commission and is not to be incorporated by reference into
any filing of Avigen under the Securities Act of 1933, as amended, or the
Securities Exchange Act of 1934, as amended (whether made before or after
the date of the Form 10-Q), irrespective of any general incorporation
language contained in such filing.
|
|
(5)
|
|
Incorporated by reference from
such document filed with the SEC as an exhibit to Avigens Annual Report
on Form 10-K for the year ended December 31, 2005, as filed with the SEC
on March 16, 2006 (Commission File No. 000-28272). Portions of this
exhibit have been omitted pursuant to a grant of confidential
treatment.
|
31
(6)
|
|
Incorporated by reference from
such document filed with the SEC as an exhibit to Avigens Quarterly
Report on Form 10-Q for the quarter ended September 30, 2007, as filed
with the SEC on November 8, 2007 (Commission File No.
000-28272).
|
|
(7)
|
|
Incorporated by reference from
such document filed with the SEC as an exhibit to Avigens Annual Report
on Form 10-K for the year ended December 31, 2008, as filed with the SEC
on March 16, 2009 (Commission File No. 000-28272). Portions of this
exhibit have been omitted pursuant to request for confidential
treatment.
|
|
(8)
|
|
Incorporated by reference from
such document filed as an exhibit to Avigens Current Report on Form 8-K
filed with the SEC on November 24, 2008 (Commission File No.
000-28272).
|
|
(9)
|
|
Incorporated by reference from
such document filed as an exhibit to Avigens Current Report on Form 8-K/A
filed with the SEC on November 24, 2008 (Commission File No.
000-28272).
|
|
(10)
|
|
Incorporated by reference from
such document filed as an exhibit to Avigens Current Report on Form 8-K
filed with the SEC on August 25, 2009 (Commission File No.
000-28272).
|
32
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