INCLINE VILLAGE, Nev.,
June 1, 2011 /PRNewswire/ -- PDL
BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced revenue
guidance for the second quarter ending June
30, 2011, of approximately $128
million, as compared with actual results of $120 million for the second quarter of 2010, an
expected seven percent year-over-year increase. The forecasted
growth is primarily driven by increased first quarter 2011 sales of
Herceptin®, Lucentis® and Tysabri® for which PDL received royalties
in the second quarter of 2011. The second quarter royalty payment
received from Genentech included royalties generated on all
worldwide sales.
Sales of Avastin®, Herceptin 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
|
|
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
|
1.0%
|
|
|
|
|
|
Reported sales for Herceptin increased 16 percent in the first
quarter of 2011 when compared to the same period in 2010. Roche
recently reported that sales growth is being driven by increasing
penetration in emerging markets and the ongoing launch of Herceptin
for stomach cancer. Additionally, Roche reported that improvements
in the quality of HER2 testing are expanding the patient population
eligible for treatment with Herceptin. Ex-U.S. manufactured and
sold Herceptin sales declined to 30 percent of total Herceptin
sales in the first quarter of 2011 from 47 percent in the first
quarter of 2010.
Reported sales for Lucentis increased 35 percent in the first
quarter of 2011 when compared to the same period in 2010. Lucentis
is approved for the treatment of age-related macular degeneration
(AMD) in the United States and
Europe. Lucentis received approval
for the treatment of macular edema following retinal vein occlusion
in June 2010 in the United States as well as for diabetic
macular edema in Europe in
January 2011. Roche and Novartis
recently reported that first quarter sales grew by 35 percent in
the United States and 18 percent
internationally due to continued growth in the treatment of AMD and
increased uptake in the new indications. All sales of Lucentis were
from inventory produced in the United
States. The approximately $128
million in revenue guidance for the second quarter is net of
the estimated payment due under our February
2011 settlement agreement with Novartis and is based on net
sales of Lucentis made by Novartis, which are sales outside of
the United States, during the
first quarter of 2011.
Reported sales for Tysabri increased 24 percent in the first
quarter of 2011 when compared to the same period in 2010. Biogen
Idec recently announced that, at the end of March 2011, approximately 58,400 patients were on
therapy worldwide, representing a 16 percent increase over the
approximately 50,300 patients who were on therapy at the end of
March 2010 and that cumulatively
83,300 patients have been treated with Tysabri in the
post-marketing setting. 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.
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 by leading pharmaceutical
and biotechnology companies 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's existing licensees;
- The relative mix of royalty-bearing Genentech products
manufactured and sold outside the U.S. versus made or sold in the
U.S.;
- The ability of our licensees to receive regulatory approvals to
market and launch new royalty-bearing products and whether such
products, if launched, will be commercially successful;
- Changes in any of the other assumptions on which PDL's
projected royalty revenues are based;
- The outcome of pending litigation or disputes;
- The change in foreign currency exchange rates; and
- 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.
SOURCE PDL BioPharma, Inc.