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)
|
Delaware
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94-3023969
|
|
|
(State
or Other Jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
|
|
Incorporation)
|
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:
|
¨
|
Written communications pursuant
to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
¨
|
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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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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|
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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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|
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99.1
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Press Release, dated September 1,
2010
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|
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99.2
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Information Sheet, dated September 1,
2010
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Contacts:
|
|
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Cris
Larson
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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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||||
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Net
sales up to $1.5 billion
|
3.0 | % | ||
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Net
sales between $1.5 billion and $2.5 billion
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2.5 | % | ||
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Net
sales between $2.5 billion and $4.0 billion
|
2.0 | % | ||
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Net
sales exceeding $4.0 billion
|
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:
|
|
—
|
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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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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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.
Reported
Net Sales Revenue by Product ($ in 000's) *
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
1,586,093 | 1,596,892 | 1,594,707 | 4,777,692 | ||||||||||||||||
|
2009
|
1,345,487 | 1,295,536 | 1,439,730 | 1,514,053 | 5,594,806 | |||||||||||||||
|
2008
|
980,715 | 1,084,930 | 1,180,427 | 1,239,382 | 4,485,454 | |||||||||||||||
|
2007
|
678,068 | 746,587 | 797,013 | 875,084 | 3,096,752 | |||||||||||||||
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2006
|
439,318 | 516,052 | 570,551 | 592,897 | 2,118,817 | |||||||||||||||
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Herceptin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
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2010
|
1,337,732 | 1,349,512 | 1,300,934 | 3,988,178 | ||||||||||||||||
|
2009
|
1,210,268 | 1,133,993 | 1,226,435 | 1,278,626 | 4,849,323 | |||||||||||||||
|
2008
|
1,105,426 | 1,195,215 | 1,211,982 | 1,186,806 | 4,699,428 | |||||||||||||||
|
2007
|
891,761 | 949,556 | 979,602 | 1,015,033 | 3,835,952 | |||||||||||||||
|
2006
|
529,585 | 659,719 | 761,099 | 803,576 | 2,753,979 | |||||||||||||||
|
Lucentis
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
759,965 | 698,890 | 745,376 | 2,204,231 | ||||||||||||||||
|
2009
|
462,103 | 469,736 | 555,296 | 615,212 | 2,102,347 | |||||||||||||||
|
2008
|
363,615 | 393,682 | 460,167 | 454,922 | 1,672,386 | |||||||||||||||
|
2007
|
224,820 | 219,579 | 299,995 | 322,300 | 1,066,695 | |||||||||||||||
|
2006
|
- | - | 10,689 | 157,742 | 168,431 | |||||||||||||||
|
Xolair
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
240,904 | 225,878 | 251,055 | 717,836 | ||||||||||||||||
|
2009
|
184,669 | 181,086 | 211,006 | 219,693 | 796,454 | |||||||||||||||
|
2008
|
137,875 | 169,521 | 177,179 | 183,753 | 668,329 | |||||||||||||||
|
2007
|
129,172 | 130,700 | 144,250 | 147,754 | 551,876 | |||||||||||||||
|
2006
|
95,241 | 99,354 | 112,608 | 118,002 | 425,204 | |||||||||||||||
|
Raptiva
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
- | 14,224 | - | 14,224 | ||||||||||||||||
|
2009
|
62,653 | 21,526 | 1,502 | - | 85,681 | |||||||||||||||
|
2008
|
55,541 | 57,601 | 66,992 | 65,216 | 245,349 | |||||||||||||||
|
2007
|
45,134 | 47,401 | 52,914 | 53,885 | 199,333 | |||||||||||||||
|
2006
|
32,672 | 35,458 | 39,610 | 41,353 | 149,093 | |||||||||||||||
|
Synagis
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
- | - | - | - | ||||||||||||||||
|
2009
|
571,486 | 623,951 | 57,271 | 105,314 | 1,358,021 | |||||||||||||||
|
2008
|
542,283 | 574,207 | 80,930 | 141,696 | 1,339,116 | |||||||||||||||
|
2007
|
478,388 | 548,227 | 53,586 | 139,736 | 1,219,936 | |||||||||||||||
|
2006
|
472,362 | 489,634 | 30,185 | 124,629 | 1,116,811 | |||||||||||||||
|
Tysabri
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
293,047 | 287,925 | 293,664 | 874,635 | ||||||||||||||||
|
2009
|
221,854 | 229,993 | 257,240 | 285,481 | 994,569 | |||||||||||||||
|
2008
|
129,430 | 163,076 | 200,783 | 233,070 | 726,359 | |||||||||||||||
|
2007
|
30,468 | 48,715 | 71,972 | 94,521 | 245,675 | |||||||||||||||
|
2006
|
- | - | - | 7,890 | 7,890 | |||||||||||||||
|
Actemra
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
52,908 | 5,405 | 10,493 | 68,806 | ||||||||||||||||
|
2009
|
19,504 | 17,920 | 30,313 | 39,888 | 107,627 | |||||||||||||||
|
2008
|
1,452 | 1,377 | 5,981 | 12,305 | 21,116 | |||||||||||||||
|
2007
|
2,388 | 873 | 1,071 | 1,137 | 5,470 | |||||||||||||||
|
2006
|
- | - | - | - | - | |||||||||||||||
|
Mylotarg
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
8,500 | 8,658 | 8,142 | 25,300 | ||||||||||||||||
|
2009
|
8,367 | 8,406 | 8,813 | 8,654 | 34,240 | |||||||||||||||
|
2008
|
8,978 | 8,050 | 8,225 | 8,140 | 33,393 | |||||||||||||||
|
2007
|
7,879 | 8,202 | 8,345 | 7,878 | 32,304 | |||||||||||||||
|
2006
|
8,832 | 9,084 | 8,874 | 16,081 | 42,871 | |||||||||||||||
* As
reported to PDL by its licensees
Royalty
Revenue by Product ($ in 000's) *
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
16,870 | 44,765 | 29,989 | 91,624 | ||||||||||||||||
|
2009
|
13,605 | 35,161 | 21,060 | 15,141 | 84,966 | |||||||||||||||
|
2008
|
9,957 | 30,480 | 19,574 | 12,394 | 72,405 | |||||||||||||||
|
2007
|
8,990 | 21,842 | 17,478 | 9,549 | 57,859 | |||||||||||||||
|
2006
|
10,438 | 15,572 | 15,405 | 12,536 | 53,952 | |||||||||||||||
|
Herceptin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
23,402 | 38,555 | 27,952 | 89,909 | ||||||||||||||||
|
2009
|
16,003 | 32,331 | 26,830 | 18,615 | 93,779 | |||||||||||||||
|
2008
|
14,092 | 34,383 | 28,122 | 20,282 | 96,880 | |||||||||||||||
|
2007
|
19,035 | 28,188 | 22,582 | 14,802 | 84,608 | |||||||||||||||
|
2006
|
15,142 | 19,716 | 21,557 | 20,354 | 76,769 | |||||||||||||||
|
Lucentis
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
7,220 | 19,091 | 10,841 | 37,151 | ||||||||||||||||
|
2009
|
4,621 | 12,863 | 8,123 | 6,152 | 31,759 | |||||||||||||||
|
2008
|
3,636 | 11,060 | 7,631 | 4,549 | 26,876 | |||||||||||||||
|
2007
|
2,931 | 6,543 | 6,579 | 3,517 | 19,570 | |||||||||||||||
|
2006
|
- | - | 289 | 3,335 | 3,624 | |||||||||||||||
|
Xolair
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
3,723 | 6,386 | 4,980 | 15,089 | ||||||||||||||||
|
2009
|
2,665 | 5,082 | 4,085 | 3,722 | 15,553 | |||||||||||||||
|
2008
|
1,488 | 4,866 | 3,569 | 2,927 | 12,850 | |||||||||||||||
|
2007
|
1,684 | 3,942 | 3,332 | 2,184 | 11,142 | |||||||||||||||
|
2006
|
2,263 | 2,969 | 3,041 | 2,495 | 10,768 | |||||||||||||||
|
Raptiva
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
(150 | ) | 142 | - | (8 | ) | ||||||||||||||
|
2009
|
477 | 589 | 22 | 150 | 1,238 | |||||||||||||||
|
2008
|
405 | 1,618 | 1,111 | 802 | 3,937 | |||||||||||||||
|
2007
|
588 | 1,246 | 1,160 | 738 | 3,733 | |||||||||||||||
|
2006
|
776 | 1,060 | 1,069 | 874 | 3,780 | |||||||||||||||
|
Synagis
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
- | - | - | - | ||||||||||||||||
|
2009
|
17,145 | 18,869 | 1,568 | 3,159 | 40,741 | |||||||||||||||
|
2008
|
16,268 | 17,376 | 2,278 | 4,251 | 40,173 | |||||||||||||||
|
2007
|
14,352 | 16,747 | 1,608 | 4,042 | 36,748 | |||||||||||||||
|
2006
|
14,171 | 14,689 | 831 | 3,664 | 33,354 | |||||||||||||||
|
Tysabri
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
8,791 | 8,788 | 8,735 | 26,314 | ||||||||||||||||
|
2009
|
6,656 | 7,050 | 7,642 | 8,564 | 29,912 | |||||||||||||||
|
2008
|
3,883 | 5,042 | 5,949 | 6,992 | 21,866 | |||||||||||||||
|
2007
|
839 | 1,611 | 2,084 | 2,836 | 7,370 | |||||||||||||||
|
2006
|
- | - | - | 237 | 237 | |||||||||||||||
|
Actemra
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
1,587 | 237 | 315 | 2,139 | ||||||||||||||||
|
2009
|
585 | 537 | 909 | 1,197 | 3,228 | |||||||||||||||
|
2008
|
44 | 116 | 179 | 369 | 708 | |||||||||||||||
|
2007
|
32 | 326 | 32 | 34 | 425 | |||||||||||||||
|
2006
|
- | - | - | - | - | |||||||||||||||
|
Mylotarg
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||||||||||||
|
2010
|
366 | 153 | 285 | 804 | ||||||||||||||||
|
2009
|
293 | 370 | 805 | 453 | 1,921 | |||||||||||||||
|
2008
|
314 | 132 | 288 | 209 | 943 | |||||||||||||||
|
2007
|
276 | 137 | 292 | 426 | 1,131 | |||||||||||||||
|
2006
|
309 | 168 | 311 | 568 | 1,355 | |||||||||||||||
* As
reported to PDL by its licensees
|
Avastin
|
2009
- Q1
|
2009
- Q2
|
2009
- Q3
|
2009
- Q4
|
2010
- Q1
|
2010
- Q2
|
2010
- Q3
|
|||||||||||||||||||||
|
US
Made & Sold
|
729,006 | 703,216 | 777,635 | 795,199 | 795,453 | 814,872 | 820,453 | |||||||||||||||||||||
|
US
Made & ex-US Sold
|
616,481 | 592,320 | 662,095 | 718,855 | 703,661 | 355,742 | 338,929 | |||||||||||||||||||||
|
ex-US
Made & Sold
|
- | - | - | - | 86,979 | 426,277 | 435,325 | |||||||||||||||||||||
|
Total
|
1,345,487 | 1,295,536 | 1,439,730 | 1,514,053 | 1,586,093 | 1,596,892 | 1,594,707 | |||||||||||||||||||||
|
US
Made & Sold
|
54 | % | 54 | % | 54 | % | 53 | % | 50 | % | 51 | % | 51 | % | ||||||||||||||
|
US
Made & ex-US Sold
|
46 | % | 46 | % | 46 | % | 47 | % | 44 | % | 22 | % | 21 | % | ||||||||||||||
|
ex-US
Made & Sold
|
0 | % | 0 | % | 0 | % | 0 | % | 5 | % | 27 | % | 27 | % | ||||||||||||||
|
Herceptin
|
2009
- Q1
|
2009
- Q2
|
2009
- Q3
|
2009
- Q4
|
2010
- Q1
|
2010
- Q2
|
2010
- Q3
|
|||||||||||||||||||||
|
US
Made & Sold
|
344,808 | 347,932 | 391,401 | 386,654 | 394,883 | 406,222 | 410,563 | |||||||||||||||||||||
|
US
Made & ex-US Sold
|
670,459 | 440,821 | 256,693 | 608,046 | 372,146 | 312,792 | 306,085 | |||||||||||||||||||||
|
ex-US
Made & Sold
|
195,000 | 345,241 | 578,341 | 283,926 | 570,703 | 630,498 | 584,286 | |||||||||||||||||||||
|
Total
|
1,210,268 | 1,133,993 | 1,226,435 | 1,278,626 | 1,337,732 | 1,349,512 | 1,300,934 | |||||||||||||||||||||
|
US
Made & Sold
|
28 | % | 31 | % | 32 | % | 30 | % | 30 | % | 30 | % | 32 | % | ||||||||||||||
|
US
Made & ex-US Sold
|
55 | % | 39 | % | 21 | % | 48 | % | 28 | % | 23 | % | 24 | % | ||||||||||||||
|
ex-US
Made & Sold
|
16 | % | 30 | % | 47 | % | 22 | % | 43 | % | 47 | % | 45 | % | ||||||||||||||
|
Lucentis
|
2009
- Q1
|
2009
- Q2
|
2009
- Q3
|
2009
- Q4
|
2010
- Q1
|
2010
- Q2
|
2010
- Q3
|
|||||||||||||||||||||
|
US
Made & Sold
|
229,921 | 232,413 | 251,182 | 266,405 | 323,153 | 300,501 | 326,840 | |||||||||||||||||||||
|
US
Made & ex-US Sold
|
232,182 | 237,323 | 304,114 | 348,808 | 436,812 | 398,389 | 418,536 | |||||||||||||||||||||
|
ex-US
Made & Sold
|
- | - | - | - | - | - | - | |||||||||||||||||||||
|
Total
|
462,103 | 469,736 | 555,296 | 615,212 | 759,965 | 698,890 | 745,376 | |||||||||||||||||||||
|
US
Made & Sold
|
50 | % | 49 | % | 45 | % | 43 | % | 43 | % | 43 | % | 44 | % | ||||||||||||||
|
US
Made & ex-US Sold
|
50 | % | 51 | % | 55 | % | 57 | % | 57 | % | 57 | % | 56 | % | ||||||||||||||
|
ex-US
Made & Sold
|
0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||||
|
Xolair
|
2009
- Q1
|
2009
- Q2
|
2009
- Q3
|
2009
- Q4
|
2010
- Q1
|
2010
- Q2
|
2010
- Q3
|
|||||||||||||||||||||
|
US
Made & Sold
|
135,732 | 133,843 | 146,022 | 150,950 | 157,503 | 145,245 | 165,109 | |||||||||||||||||||||
|
US
Made & ex-US Sold
|
531 | 77 | 47 | 10 | - | - | - | |||||||||||||||||||||
|
ex-US
Made & Sold
|
48,406 | 47,166 | 64,937 | 68,733 | 83,401 | 80,632 | 85,945 | |||||||||||||||||||||
|
Total
|
184,669 | 181,086 | 211,006 | 219,693 | 240,904 | 225,878 | 251,055 | |||||||||||||||||||||
|
US
Made & Sold
|
74 | % | 74 | % | 69 | % | 69 | % | 65 | % | 64 | % | 66 | % | ||||||||||||||
|
US
Made & ex-US Sold
|
0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||||
|
ex-US
Made & Sold
|
26 | % | 26 | % | 31 | % | 31 | % | 35 | % | 36 | % | 34 | % | ||||||||||||||
|
Total
|
2009
- Q1
|
2009
- Q2
|
2009
- Q3
|
2009
- Q4
|
2010
- Q1
|
2010
- Q2
|
2010
- Q3
|
|||||||||||||||||||||
|
US
Made & Sold
|
1,464,837 | 1,434,715 | 1,567,742 | 1,599,208 | 1,670,992 | 1,666,840 | 1,722,965 | |||||||||||||||||||||
|
US
Made & ex-US Sold
|
1,556,936 | 1,274,755 | 1,222,949 | 1,675,718 | 1,512,620 | 1,081,147 | 1,063,551 | |||||||||||||||||||||
|
ex-US
Made & Sold
|
243,406 | 392,407 | 643,279 | 352,659 | 741,083 | 1,137,407 | 1,105,556 | |||||||||||||||||||||
|
Total
|
3,265,179 | 3,101,878 | 3,433,970 | 3,627,585 | 3,924,694 | 3,885,394 | 3,892,072 | |||||||||||||||||||||
|
US
Made & Sold
|
45 | % | 46 | % | 46 | % | 44 | % | 43 | % | 43 | % | 44 | % | ||||||||||||||
|
US
Made & ex-US Sold
|
48 | % | 41 | % | 36 | % | 46 | % | 39 | % | 28 | % | 27 | % | ||||||||||||||
|
ex-US
Made & Sold
|
7 | % | 13 | % | 19 | % | 10 | % | 19 | % | 29 | % | 28 | % | ||||||||||||||
* As
reported to PDL by its licensees