Attached files
| file | filename |
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| EX-99.2 - PDL BIOPHARMA, INC. | v195765_ex99-2.htm |
| EX-99.1 - PDL BIOPHARMA, INC. | v195765_ex99-1.htm |
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of
Report (Date of Earliest Event Reported): August 27,
2010
PDL
BioPharma, Inc.
(Exact
name of Company as specified in its charter)
000-19756
(Commission
File Number)
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Delaware
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94-3023969
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(State
or Other Jurisdiction of
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(I.R.S.
Employer Identification No.)
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Incorporation)
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932
Southwood Boulevard
Incline
Village, Nevada 89451
(Address
of principal executive offices, with zip code)
(775)
832-8500
(Company’s
telephone number, including area code)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the Company under any of the following
provisions:
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¨
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Written communications pursuant
to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
7.01 Regulation FD Disclosure.
Press
Release
On
September 1, 2010, PDL BioPharma, Inc. (the “Company”) issued a press release
with revenue guidance for the quarter ending September 30, 2010. The
Company notes that the royalty payment it received from Genentech was complete
and without a reservation of rights. A copy of the press release is
attached hereto as Exhibit 99.1.
Detailed
Product Sales, Royalties and Manufacturing
On
September 1, 2010, the Company distributed to analysts covering or interested in
covering the Company’s securities and posted to its website a summary of certain
information underlying the Company’s receipt of royalty payments (the
“Information Sheet”) to assist those analysts and its stockholders in valuing
the Company’s securities. The Information Sheet is based on
information provided to the Company by its licensees and includes reported net
sales revenues by licensed product, royalty revenue by licensed product and
where certain licensed products are manufactured. A copy of the
Information Sheet is attached hereto as Exhibit 99.2.
Limitation
of Incorporation by Reference
In
accordance with General Instruction B.2. of Form 8-K, the information in this
report, including the exhibits, is furnished pursuant to Item 7.01 and shall not
be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange
Act of 1934, as amended, or otherwise subject to the liabilities of that
section. This Current Report will not be deemed an admission as to the
materiality of any information in the report that is required to be disclosed
solely by Regulation FD.
Cautionary
Statements
This
filing, the press release and the Information Sheet include “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we can give no assurance that such expectations will
prove to be correct. Important factors that could impair the Company’s royalty
assets or business are disclosed in the “Risk Factors” contained in the
Company’s 2009 Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 1, 2010. All forward-looking statements are expressly
qualified in their entirety by such factors. We do not undertake any duty to
update any forward-looking statement except as required by law.
Item
8.01 Other Events.
As
previously disclosed, on August 13, 2010, the Company announced that it had
received a facsimile letter from Genentech regarding Avastin®,
Herceptin®,
Lucentis® and
Xolair® (the
“Genentech Products”) sales in Europe. In its letter, Genentech
asserted that the Genentech Products do not infringe the supplementary
protection certificates (“SPCs”) granted to PDL by various countries in Europe
for each of the Genentech Products.
On August
31, 2010, the Company sent its reply to Genentech, stating that Genentech’s
assertions are without merit. In its response, the Company disagreed
fundamentally with Genentech’s assertions of non-infringement with respect to
the Genentech Products and cautioned that, in the 2003 settlement agreement
between PDL and Genentech, Genentech had waived its right to challenge the
validity of PDL’s patent rights, including its SPCs. PDL has
requested a meeting with Genentech to discuss resolving their differences
regarding infringement of the Company’s SPCs by the Genentech
Products.
On August
27, 2010, the Company filed a complaint in the Second Judicial District of
Nevada, Washoe County, to enforce its rights against Genentech under the 2003
settlement agreement and seeking an order from the court declaring that
Genentech is obligated to pay royalties to PDL on international sales of the
Genentech Products. The Company has not yet served its complaint on
Genentech.
The
settlement agreement was entered into as part of a definitive agreement
resolving intellectual property disputes between the two companies at that
time. The 2003 settlement agreement limits Genentech’s ability to
challenge infringement of PDL’s patent rights and waives Genentech’s right to
challenge the validity of PDL’s patent rights, including its
SPCs. Certain breaches of the 2003 settlement agreement would subject
Genentech to substantial liquidated and other damages.
The
Company notes that the royalty payment it received from Genentech on August 27,
2010, was complete and without a reservation of rights.
On
September 1, 2010, the Company issued a press release with the above information
regarding Genentech. A copy of the press release is attached hereto
as Exhibit 99.1, and the section titled “Genentech Update” is incorporated
herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
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Exhibit No.
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Description
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99.1
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Press
Release, dated September 1, 2010
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99.2
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Information
Sheet, dated September 1,
2010
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Company has duly
caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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PDL
BIOPHARMA, INC.
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(Company)
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By:
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/s/ Christine R. Larson
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Christine
R. Larson
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Vice
President and Chief Financial
Officer
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Dated: September
1, 2010
EXHIBIT
INDEX
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Exhibit No.
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Description
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99.1
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Press Release, dated September 1,
2010
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99.2
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Information Sheet, dated September 1,
2010
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