Attached files
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8-K - PDL BIOPHARMA, INC. | v195765_8k.htm |
EX-99.2 - PDL BIOPHARMA, INC. | v195765_ex99-2.htm |
Contacts:
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Cris
Larson
|
Jennifer
Williams
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PDL
BioPharma, Inc.
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Cook
Williams Communications, Inc.
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775-832-8505
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360-668-3701
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Cris.Larson@pdl.com
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jennifer@cwcomm.org
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PDL
BioPharma Provides Third Quarter 2010 Revenue Guidance of
Approximately
$86
Million and Update to its Correspondence with Genentech
INCLINE
VILLAGE, NV, September 1, 2010
– PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced revenue
guidance for the third quarter ended September 30, 2010 of approximately $86
million, as compared with actual results of $71.4 million for the third quarter
of 2009, a 20 percent year-over-year increase. The growth is
primarily driven by increased second quarter 2010 sales of Avastin®, Herceptin®, Lucentis® and Tysabri® for which PDL
receives royalties in the third quarter of 2010. Also included in
third quarter 2010 guidance is $2.9 million earned on Eurodollar foreign
currency hedging contracts that the Company initiated in January
2010. The royalty payment from Genentech included royalties generated
on both U.S. and ex-U.S. manufactured products and sales.
Sales of
Avastin, Herceptin, Xolair and Lucentis are subject to a tiered royalty rate for
product that is made or sold in the United States and a flat royalty rate of
three percent for product that is manufactured and sold outside of the United
States. The net sales thresholds and the applicable royalty rates for
product that is made or sold in the United States are outlined below:
Royalty Rate
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||||
Net
sales up to $1.5 billion
|
3.0 | % | ||
Net
sales between $1.5 billion and $2.5 billion
|
2.5 | % | ||
Net
sales between $2.5 billion and $4.0 billion
|
2.0 | % | ||
Net
sales exceeding $4.0 billion
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1.0 | % |
Reported
sales of Avastin and Herceptin increased 11 percent and six percent,
respectively, in the second quarter of 2010, when compared to the same period
for the prior year. Roche recently reported that global sales of Avastin for
advanced colorectal, breast, lung and kidney cancer, and for relapsed
glioblastoma, rose 14 percent in the first half of 2010 driven by uptake in
colorectal, breast and/or lung cancer. Roche also reported that
global sales of Herceptin for HER2-postive breast cancer and advanced stomach
cancer increased eight percent in the first half of 2010 driven by further
penetration in the early and metastatic breast cancer settings, particularly in
emerging markets. Additionally, first signs of uptake in Europe of
Herceptin in HER2-postive advanced stomach cancer were seen following approval
of this new indication in January of this year. Also contributing to
increased Avastin royalties were sales of Avastin that was both manufactured and
sold outside the United States. Ex-U.S. manufactured and sold Avastin
sales represented 27 percent of total Avastin sales; there were no sales of
ex-U.S. manufactured Avastin prior to the fourth quarter of
2009.
Reported
second quarter 2010 sales of Lucentis increased 34 percent when compared to the
same period for the prior year. Lucentis is approved for the
treatment of age related macular degeneration in the United States and in Europe
and received approval for the treatment of macular edema following retinal vein
occlusion in June 2010 in the United States. Second quarter 2010
sales grew by 30 percent in the United States and by 38 percent
internationally.
Reported
sales of Tysabri increased 14 percent in the second quarter of 2010 when
compared to the same period for the prior year. Elan recently
announced that at the end of June 2010, approximately 52,700 patients were on
therapy worldwide representing an increase of 22 percent over the approximately
43,300 patients who were on the therapy at the end of June
2009. Tysabri royalties are determined at a flat rate as a percent of
sales regardless of location of manufacture or sale.
The sales
information presented above is based on information provided by PDL’s licensees
in their quarterly reports to the Company as well as from public disclosures
made by PDL’s licensees.
Genentech
Update
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.
About
PDL BioPharma
PDL
pioneered the humanization of monoclonal antibodies and, by doing so, enabled
the discovery of a new generation of targeted treatments for cancer and
immunologic diseases. PDL is focused on maximizing the value of its antibody
humanization patents and related assets. The Company receives royalties on sales
of a number of humanized antibody products marketed today based on patents which
expire in late 2014. For more information, please visit
www.pdl.com.
NOTE: PDL
BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma,
Inc.
Forward-looking
Statements
This
press release contains forward-looking statements. Each of these forward-looking
statements involves risks and uncertainties. Actual results may differ
materially from those, express or implied, in these forward-looking statements.
Factors that may cause differences between current expectations and actual
results include, but are not limited to, the following:
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—
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The
expected rate of growth in royalty-bearing product sales by
PDL'sexisting
licensees;
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—
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The
relative mix of royalty-bearing Genentech products manufactured and
soldoutside
the U.S. versus manufactured or sold in the
U.S.;
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|
—
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The
ability of our licensees to receive regulatory approvals to
marketand
launch new royalty-bearing products and whether such products, if
launched,
will be commercially
successful;
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|
—
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Changes
in any of the other assumptions on which PDL's projected
royaltyrevenues
are based;
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—
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The
outcome of pending litigation or disputes;
and
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|
—
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The
failure of licensees to comply with existing license
agreements,including
any failure to pay royalties
due.
|
Other
factors that may cause PDL's actual results to differ materially from those
expressed or implied in the forward-looking statements in this press release are
discussed in PDL's filings with the SEC, including the "Risk Factors" sections
of its annual and quarterly reports filed with the SEC. Copies of PDL's filings
with the SEC may be obtained at the "Investors" section of PDL's website at
www.pdl.com. PDL expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements contained
herein to reflect any change in PDL's expectations with regard thereto or any
change in events, conditions or circumstances on which any such statements are
based for any reason, except as required by law, even as new information becomes
available or other events occur in the future. All forward-looking statements in
this press release are qualified in their entirety by this cautionary
statement.