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| PDLI > SEC Filings for PDLI > Form 10-Q on 9-Nov-2009 | All Recent SEC Filings |
9-Nov-2009
Quarterly Report
This report includes "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. All statements other than
statements of historical facts are "forward looking statements" for purposes of
these provisions, including any projections of earnings, revenues or other
financial items, any statements of the plans and objectives of management for
future operations, any statements concerning new products or licensing, any
statements regarding future economic conditions or performance, and any
statement of assumptions underlying any of the foregoing. In some cases,
forward-looking statements can be identified by the use of terminology such as
"believes," "may," "will," "expects," "plans," "anticipates," "estimates,"
"potential," or "continue" or the negative thereof or other comparable
terminology. Although we believe that the expectations reflected in the
forward-looking statements contained in this report are reasonable, there can be
no assurance that such expectations or any of the forward-looking statements
will prove to be correct, and actual results could differ materially from those
projected or assumed in the forward-looking statements. Our future financial
condition and results of operations, as well as any forward-looking statements,
are subject to inherent risks and uncertainties, including but not limited to
the risk factors set forth below, and for the reasons described elsewhere in
this report. All forward-looking statements and reasons why results may differ
included in this report are made as of the date hereof, and we assume no
obligation to update these forward-looking statements or reasons why actual
results might differ.
OVERVIEW
Our business is the management of antibody humanization patents and royalty assets which consist of our Queen et al. patents and our license agreements with numerous biotechnology and pharmaceutical companies. We receive royalties based on sales of humanized antibody products marketed today pursuant to certain rights we have licensed under our patents and may also receive royalty payments on additional humanized antibody products launched before final patent expiry in 2014. Generally, our license agreements cover humanized antibodies targeting antigens specified in the license agreements.
Under most of our licensing agreements, we are entitled to receive a flat-rate royalty based upon our licensees' net sales of covered antibodies. These licensing agreements have contributed to the development of nine marketed products by our licensees. Eight of these products are currently approved for use by the U.S. Food and Drug Administration (FDA) and nine are approved for use by other regulatory agencies outside the United States. We have also entered into licensing agreements pursuant to which we have licensed certain rights under our patents for development stage products that have not yet reached commercialization including products that are currently in Phase 3 clinical trials.
Until December 2008, our business included biotechnology operations which were focused on the discovery and development of novel antibodies and which we spun off (the Spin-Off) to Facet Biotech Corporation (Facet). From March 2005 until March 2008, we also had commercial and manufacturing operations consisting which we partially divested in 2006 and fully divested in 2008. The financial results of our former biotechnology and manufacturing operations as well as our former commercial operations are presented as discontinued operations in the Condensed Consolidated Statement of Operations.
Recent Developments
As a result of the Spin-Off in December 2008, we significantly downsized our operations and currently have fewer than ten employees managing our intellectual property, our licensing operations, and efforts to monetize our antibody humanization patents and royalties assets, as well as providing for certain essential reporting and management functions of a public company. In December 2008, we moved our principal place of business to Incline Village, Nevada. We operate as an independent, publicly traded Delaware company located in Nevada.
In December 2008, we entered into a definitive license agreement and settlement agreement with Alexion Pharmaceuticals, Inc. (Alexion) that resolved the legal disputes between us relating to Alexion's humanized antibody Soliris® (eculizumab) and our Queen et al. patents. In consideration for this license, Alexion agreed to pay $25 million, of which it paid $12.5 million in January 2009 that we recognized in the fourth quarter of 2008 and $12.5 million in May 2009 that we recognized in the second quarter of 2009. In addition, Alexion took an option for up to four additional licenses under the Queen et al. patents at a four percent royalty rate.
In December 2008, MedImmune, LLC, a subsidiary of AstraZeneca plc, (MedImmune)
brought suit against us seeking a declaratory judgment that MedImmune is not
liable to pay a royalty to us on sales of Synagis and a second generation
product, when approved, because the Queen et al. patents are not valid or
infringed. In February 2009, we received a letter from MedImmune asserting that
it may be entitled to pay a lower royalty rate on sales of its product,
Synagis®, because of our settlement with Alexion. In April 2009, we sent a
letter notifying MedImmune of the exercise of certain of our rights under our
license agreement, the exercise of which we believe precludes MedImmune from
being entitled to a lower royalty rate based on the Alexion settlement. We have
received additional communications from MedImmune that suggest that MedImmune
believes it may be entitled to a lower royalty rate for past and/or future sales
of licensed products under the most favored licensee clause in our agreement. On
May 7, 2009, we filed our answer to MedImmune's lawsuit asserting certain
counterclaims and affirmative defenses and requested that the court find
(a) that Synagis and a second generation product, motavizumab, fall under the
scope of the Queen et al. patents and that the sale thereof requires that
MedImmune pay us royalties as specified in our license agreement with them;
(b) that the claims we are asserting against MedImmune are valid; (c) that
MedImmune is not entitled to different terms, including a lower royalty rate, as
a result of our December 2008 settlement with Alexion; and (d) that MedImmune is
liable for attorney's fees and costs related to the action. On August 18, 2009,
we attended a mandatory settlement conference with MedImmune held before the
Federal District Court for Northern California. No settlement resulted from the
meeting. A Markman claim construction hearing, which had previously been
scheduled for October 1, 2009, was postponed and took place on November 5, 2009.
We anticipate a decision in the next several months. Trial has been scheduled to
start June 14, 2010.
On October 14, 2009, the European Patent Office Technical Board of Appeal upheld the Opposition Division's revocation of our EP 682 040 patent on formal issues. The Technical Board of Appeal did not consider substantive issues of patentability.
We intend to distribute a substantial portion of our income to our stockholders. On February 26, 2009, our board of directors declared two cash dividends of $0.50 per share payable on April 1, 2009 and October 1, 2009. Using proceeds from our annual 2008 and first half 2009 earnings and based on the total shares outstanding as of the March 16, 2009 record date, we paid $59.7 million to our stockholders on April 1, 2009. The record date for the October 1, 2009 dividend was September 17, 2009 as determined by the board of directors at its June 4, 2009 meeting. As of September 30, 2009, we had accrued $59.9 million for the October 2009 dividend payment.
Effective September 18, 2009, in connection with the payment of the dividend in October 2009, the conversion rates for our outstanding 2.00% Convertible Senior Notes due February 15, 2012 (2012 Notes) and 2.75% Convertible Subordinated Notes due August 16, 2023 (2023 Notes) were adjusted to 94.447 and 131.0339 shares of common stock per $1,000 principal amount, respectively, or $10.59 and $7.63 per share for each of the notes, respectively. The adjustment was based on the amount of the dividend and the average trading price of our stock in for certain periods before the record date and adjusted for ex-dividend trading pursuant to the terms of the applicable indenture.
In November 2009, we completed a $300 million securitization transaction in which we monetized 60% of the net present value of the estimated five year royalties from sales of Genentech products (the Genentech Royalties) including Avastin, Herceptin, Lucentis, Xolair, and any future products, if any, under which Genentech may take a license under our related agreements with Genentech. The $300 million QHP PhaRMA Senior Secured Notes due 2015 (the QHP Notes) bear interest at 10.25% and were issued in a non-registered offering by QHP Royalty Sub LLC (QHP), a Delaware limited liability company, and a newly formed, wholly-owned subsidiary of PDL. Concurrent with the securitization transaction and pursuant to the terms of a purchase and sale agreement, we sold, transferred, conveyed, assigned, contributed and granted to QHP, certain rights under our non-exclusive license agreements with Genentech including the right to receive the Genentech Royalties in exchange for QHP's proceeds from the QHP Notes issuance. The Genentech Royalties and other payments, if any, that QHP will be entitled to receive under the agreements with Genentech, together with any funds made available from certain accounts of QHP, will be the sole source of payment of principal and interest on the QHP Notes. Once all obligations on the QHP Notes have been paid in full, including all other sums payable under the indenture, then the indenture shall cease to be of further effect and all of the security interests in the collateral shall terminate, including the pledge by PDL to the trustee of its equity interest in QHP. At such point there will be no further restrictions on the Genentech Royalties and PDL shall be free to either keep them in QHP, transfer them back to PDL, or to further dispose or monetize them.
Patents and Technology Outlicense Agreements
Patents
We have been issued patents in the U.S. and elsewhere, covering the humanization of antibodies, which we refer to as our Queen et al. patents. The Queen et al. patent estate is enforceable up to 2014 and covers among other things, humanized antibodies, methods for humanizing antibodies, polynucleotide encoding in humanized antibodies and methods of producing humanized antibodies. The following is a list of our U.S. and European patents within our Queen et al. patent portfolio.
Application Number Filing Date Patent Number Issue Date Jurisdiction
08/477,728 06/07/95 5,585,089 12/17/96 United States
08/474,040 06/07/95 5,693,761 12/02/97 United States
08/487,200 06/07/95 5,693,762 12/02/97 United States
08/484,537 06/07/95 6,180,370 01/30/01 United States
09/718,998 11/22/00 7,022,500 04/04/06 United States
90903576.8 12/28/89 0 451 216 01/24/96 Europe
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Our European Patent No. 0 451 216 (the '216 Patent) and European Patent No. 0 682 040 (the '040 Patent) expire in December 2009. We have applied for and been granted Supplemental Protection Certificates (SPCs) with respect to the Herceptin®, Synagis®, Xolair ®, Raptiva®, Avastin®, Tysabri ® and Lucentis® products in many of the jurisdictions in the European Union based on our '216 patent. We intend to file SPC applications with respect to Cimzia in countries of the European Union based on our '216 patent. These SPCs, upon grant thereof, effectively extend the patent protection with respect to these products generally until December 2014, except that the SPCs for Raptiva, Herceptin, and Synagis will generally expire in March 2013, July 2014, and August 2014, respectively. Because SPCs are granted on a jurisdiction-by-jurisdiction basis, the duration of the extension varies slightly in certain jurisdictions. We plan to file applications for SPCs on other humanized antibodies covered by our '216 Patent which are approved for marketing in Europe prior to the expiration of our '216 Patent in December 2009. We will not be able to file applications for any SPCs after December 2009. Therefore, if a product is first approved for marketing after December 2009 in a jurisdiction that issues SPCs, then we would not have any patent protection or SPC protection in this jurisdiction with respect to this product. We may still be eligible for royalties notwithstanding the unavailability of SPC protection if the relevant royalty-bearing humanized antibody product is also made, used, sold or offered for sale in or imported from a jurisdiction in which we have an unexpired Queen et al. patent such as the United States.
We are currently in an opposition proceeding with respect to the '216 Patent at the European Patent Office. MedImmune filed a declaratory judgment against us related to the Queen et al. patents in December 2008. In February 2009, the U.S. Patent and Trademark Office declared an interference proceeding between our U.S. Patent No. 5,585,089 and a patent application pending to Adair et al., which is assigned to UCB Pharma S.A. See "Part II. Other Information, Item 1, Legal Proceedings."
Licensing Agreements
We have entered into licensing agreements with numerous entities that are independently developing or have developed humanized antibodies pursuant to which we have licensed certain rights under our Queen et al. patents to make, use, sell, offer for sale and import humanized antibodies. In general, these agreements cover antibodies targeting antigens specified in the license agreements. Under most of our licensing agreements, we are entitled to receive a flat-rate royalty based upon our licensees' net sales of covered antibodies. We also expect to receive minimal annual maintenance fees from licensees of our Queen et al. patents.
Licensing Agreements for Marketed Products
We currently receive royalties on sales of the nine humanized antibody products listed below, eight of which are currently approved for use by the FDA and eight are approved by other regulatory agencies outside the United States. Approval for Raptiva was suspended in the European Union and Canada in February 2009 and the product was withdrawn from the United States market in April 2009. Thus, we do not expect to receive material amounts of royalties on future sales, if any, of Raptiva. In 2008, royalties attributable to Raptiva totaled $3.9 million or 1.3% of total revenue from continuing operations. For the nine months ended September 30, 2009, we received $1.1 million in royalties for sales of Raptiva as compared with $3.1 million for the same period in 2008. For the three and nine months ended September 30, 2009 and 2008, our most significant licensees were as follows:
Licensee Product Name
Genentech, Inc. (Genentech) Avastin®
Herceptin®
Xolair®
Raptiva®
Lucentis®
MedImmune, LLC (MedImmune) Synagis®
Elan Corporation, plc (Elan) Tysabri®
Wyeth Pharmaceuticals, Inc Mylotarg®
Chugai Pharmaceutical Co., LTD Actemra®
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Genentech
Our master patent license agreement with Genentech provides for a tiered royalty structure under which the royalty rate Genentech must pay on royalty-bearing products sold in the United States or manufactured in the United States and used or sold anywhere (U.S.-based Sales) in a given calendar year decreases on incremental U.S.-based Sales above certain net sales thresholds. The net sales thresholds and the applicable royalty rates are outlined below:
Aggregate Net Sales 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 %
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As a result of the tiered royalty structure, Genentech's average annual royalty rate for a given year will decline as Genentech's U.S.-based Sales increase during that year. Because we receive royalties one quarter in arrears, the average royalty rate for the payments we receive from Genentech in the second calendar quarter for Genentech's sales from the first calendar quarter has been and is expected to continue to be higher than the average royalty rate for following quarters. The average royalty rate for payments we receive from Genentech is generally lowest in the fourth and first calendar quarters for Genentech's sales from the third and fourth calendar quarter when Genentech's U.S.-based Sales bear royalties at the lowest royalty rate.
With respect to royalty-bearing products that are both manufactured and sold outside of the United States (ex-U.S.-based Manufacturing and Sales), the royalty rate that we receive from Genentech is a fixed rate of 3.0% based on a percentage of the underlying ex-U.S.-based Manufacturing and Sales. The mix of U.S.-based Sales and ex-U.S.-based Manufacturing and Sales has fluctuated in the past and may continue to fluctuate in future periods, particularly in light of the recent acquisition of Genentech by Roche. For example, in July 2009 Roche announced its decision to partially close its manufacturing site in Vacaville, California.
The mix of U.S.-based Sales and ex-U.S. based Manufacturing and Sales is outlined in the following table:
Three Months Ended Nine Months Ended
September 30, September 30,
2009 2008 2009 2008
U.S.-based Sales 81 % 79 % 87 % 85 %
Ex-U.S.-based Manufacturing and Sales 19 % 21 % 13 % 15 %
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The information in the table above is based on information provided to us by Genentech. We were not provided the reasons for the shift in the manufacturing split between U.S.-based Sales and ex-U.S.-based Manufacturing and Sales.
Currently, two of Genentech's licensed products, Herceptin and Xolair, generate ex-U.S.-based Manufacturing and Sales. Roche has announced a new Avastin production facility in Basel, Switzerland and that there are new plants in Singapore for the production of Avastin and Lucentis. The Genentech agreement continues until the expiration of the last patent to expire of our Queen et al. patents but may be terminated by Genentech prior to such expiration upon 60 days written notice or by us upon a material breach by Genentech. Either party may terminate upon the occurrence of certain bankruptcy-related events.
MedImmune
We entered into a patent license agreement, effective July 17, 1997, with MedImmune pursuant to which we granted to MedImmune a license under our Queen et al. patents to make, use, and sell antibodies that bind to respiratory syncytial virus. Pursuant to the agreement, we are entitled to receive a flat royalty rate in the low single digits based on MedImmune's net sales of its Synagis product. The agreement continues until the expiration of the last to expire of our Queen et al. patents but may be terminated by MedImmune prior to such expiration upon thirty days written notice. Either party may terminate the agreement upon a material breach by the other party or upon the occurrence of certain bankruptcy-related events.
MedImmune filed for approval of its motavizumab product, a second generation of Synagis, in the United States in January 2008 and received a Complete Response Letter from the FDA on December 1, 2008 asking for additional information on motavizumab. Astra Zeneca, which owns MedImmune, said it plans to continue discussions with the FDA and, subject to the outcome of those discussions, expected to resubmit the application for approval. There have been no further announcements from Astra Zeneca regarding the approval of motavizumab in the United States. We believe that sales of motavizumab will require payment to us of the royalty specified by the MedImmune agreement.
In December 2008, MedImmune filed a lawsuit against us seeking a declaratory
judgment that the U.S. Queen et al. patents are invalid and/or not infringed by
its Synagis and motavizumab products. MedImmune has further asserted that it may
be entitled to pay a lower royalty rate because of our settlement with Alexion.
In February 2009, we received a letter from MedImmune asserting that it may be
entitled to pay a lower royalty rate on sales of its product Synagis, because of
our settlement with Alexion. In April 2009, we sent a letter notifying MedImmune
of the exercise of certain of our rights under our license agreement, the
exercise of which we believe precludes MedImmune from being entitled to a lower
royalty rate based on the Alexion settlement. We have received additional
communications from MedImmune that suggest that MedImmune believes it may be
entitled to a lower royalty rate for past and/or future sales of licensed
products under the most favored licensee clause in our license agreement. On
May 7, 2009, we filed our answer to MedImmune's lawsuit asserting certain
counterclaims and affirmative defenses and requested that the court find
(a) that Synagis and a second generation product, motovizumab, fall under the
scope of the Queen et al. patents and that the sale thereof requires that
MedImmune pay us royalties as specified in our license agreement with them;
(b) that the claims we are asserting against MedImmune are valid; (c) that
MedImmune is not entitled to different terms, including a lower royalty rate, as
a result of our settlement with Alexion; and (d) that MedImmune is liable for
attorney's fees and costs related to the action. On August 18, 2009, we attended
a mandatory settlement conference with MedImmune held before the Federal
District Court for Northern California. No settlement resulted from the meeting.
A Markman claim construction hearing, which had previously been scheduled for
October 1, 2009, was postponed and took place on November 5, 2009. We anticipate
a decision in the next several months. Trial has been scheduled to start
June 14, 2010. MedImmune has paid us a total of $282.4 million in royalties
under the MedImmune agreement with respect to sales of Synagis on a quarterly
basis since the fourth quarter of 1998 through the third quarter of 2009, but we
cannot assure you that MedImmune will continue to pay us royalties. See "Part
II. Other Information. Item 1. Legal Proceedings."
Elan
We entered into a patent license agreement, effective April 24, 1998, with Elan pursuant to which we granted to Elan a license under our Queen et al. patents to make, use, and sell antibodies that bind to the cellular adhesion molecule a4. Pursuant to the agreement, we are entitled to receive a flat royalty rate in the low single digits of Elan's net sales of the Tysabri product. The agreement continues until the expiration of the last to expire of our Queen et al. patents but may be terminated by Elan prior to such expiration upon sixty days written notice, by either party upon a material breach by the other party or upon the occurrence of certain bankruptcy-related events.
Wyeth
We entered into a patent license agreement, effective September 1, 1999, with American Home Products Corporation acting through its Wyeth-Aherst Laboratories Division (Wyeth) pursuant to which we granted to them a license under our Queen et al. patents to make, use, and sell antibodies that bind to CD33, an antigen that is found in about 80% of patients with acute myeloid leukemia, and conjugated to a cytotoxic agent. Pursuant to the agreement, we are entitled to receive a flat royalty rate in the low single digits of Wyeth's net sales of the Mylotarg product. The agreement continues until the expiration of the last to expire of our Queen et al. patents but may be terminated by Wyeth prior to such expiration upon sixty days written notice, by either party upon a material breach by the other party or upon the occurrence of certain bankruptcy-related events.
Chugai
We entered into a patent license agreement, effective May 18, 2000, with Chugai Pharmaceutical Co., LTD (Chugai) pursuant to which we granted to Chugai a license under our Queen et al. patents to make, use, and sell antibodies that bind to interleukin-6 receptor to prevent inflammatory cascades involving multiple cell types. Pursuant to the agreement, we are entitled to receive a flat royalty rate in the low single digits of Chugai's net sales of the Actemra product (RoActemra in Europe). The agreement continues until the expiration of the last to expire of our Queen et al. patents but may be terminated by Chugai prior to such expiration upon sixty days written notice, by either party upon a material breach by the other party or upon the occurrence of certain bankruptcy-related events.
Licensing Agreements for Non-Marketed Products
We have also entered into licensing agreements pursuant to which we have licensed certain rights under our Queen et al. patents to make, use, and sell certain products in development that have not yet reached commercialization. Certain of these development stage products are currently in Phase 3 clinical trials. With respect to these agreements, we may receive milestone payments based on certain development milestones. We may also receive royalty payments if the licensed products receive marketing approval and generate sales before the expiration of our Queen et al. patents. For example, both Wyeth Pharmaceuticals, Inc. (Wyeth), a wholly owned subsidiary of Pfizer Inc., and Eli Lilly and Company (Lilly) have licensed antibodies for the treatment of Alzheimer's disease that are currently in Phase 3 clinical trials.
Economic and Industry-wide Factors
Various economic and industry-wide factors are relevant to us and could affect our business, including the factors set forth below.
• The manufacture of drugs and antibodies for use as therapeutics in compliance with regulatory requirements is complex, time-consuming and expensive. If our licensees are unable to manufacture product or product candidates in accordance with FDA and European good manufacturing practices, they may not be able to obtain or retain regulatory approval for products licensed under our patents.
• Our licensees are subject to stringent regulation with respect to product safety and efficacy by various international, federal, state and local . . .
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