-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, QFGvjNQEAP5kdzTUUItvAW4ShEfx+fHBAkFlcQEa3A8CVS+jGCT7mj/dTcfwKg0o cxTI0AriStM/YL9KH1/X/g== 0001144204-11-011542.txt : 20110228 0001144204-11-011542.hdr.sgml : 20110228 20110228163817 ACCESSION NUMBER: 0001144204-11-011542 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20110228 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110228 DATE AS OF CHANGE: 20110228 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PDL BIOPHARMA, INC. CENTRAL INDEX KEY: 0000882104 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943023969 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19756 FILM NUMBER: 11646645 BUSINESS ADDRESS: STREET 1: 932 SOUTHWOOD BLVD CITY: INCLINE VILLAGE STATE: NV ZIP: 89451 BUSINESS PHONE: 775-832-8500 MAIL ADDRESS: STREET 1: 932 SOUTHWOOD BLVD CITY: INCLINE VILLAGE STATE: NV ZIP: 89451 FORMER COMPANY: FORMER CONFORMED NAME: PROTEIN DESIGN LABS INC/DE DATE OF NAME CHANGE: 19930328 8-K 1 v213024_8k.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):  February 28, 2011

PDL BioPharma, Inc.
 
(Exact name of Company as specified in its charter)
 
000-19756
(Commission File Number)
 
Delaware
 
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)
 
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 
 
 

 

Item 2.02 Results of Operations and Financial Condition.
 
On February 28, 2011, PDL BioPharma, Inc. (the “Company”) issued a press release announcing the financial results for the fourth quarter and year ended December 31, 2010. A copy of this earnings release is attached as Exhibit 99.1 hereto.  The Company will host an earnings call and webcast on February 28, 2011, during which the Company will discuss its financial results for the fourth quarter and year ended December 31, 2010.
 
Item 7.01 Regulation FD Disclosure.
 
On February 28, 2011, the Company distributed to analysts covering the Company’s securities a summary of certain information regarding the Company’s resolution of challenges against the Queen et al. patents, 2011 dividends, non-GAAP earnings per share, capital restructuring activities and licensed product development and regulatory updates (the “Information Sheet”) to assist those analysts in valuing the Company’s securities. 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 Items 2.02 and 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.
 
Cautionary Statements
 
This filing 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. 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 and other periodic reports filed with the Securities and Exchange Commission. 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 9.01 Financial Statements and Exhibits.
 
Exhibit No.
 
Description
99.1
 
Press Release, dated February 28, 2011
     
99.2
 
Information Sheet, dated February 28, 2011

 
 

 
 
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.
 
 
PDL BIOPHARMA, INC.
 
(Company)
   
 
By:
/s/ Christine R. Larson
   
Christine R. Larson
   
Vice President and Chief Financial Officer
 
Dated:  February 28, 2011

 
 

 

EXHIBIT INDEX
 
Exhibit No.
 
Description
99.1
 
Press Release, dated February 28, 2011
     
99.2
 
Information Sheet, dated February 28, 2011

 
 

 
EX-99.1 2 v213024_ex99-1.htm

Contacts:
   
Cris Larson
Jennifer Williams
 
PDL BioPharma, Inc.
Cook Williams Communications
 
775-832-8505
360-668-3701 
 
Cris.Larson@pdl.com  jennifer@cwcomm.org   
 
PDL BioPharma Announces Fourth Quarter and Full Year 2010 Financial Results
 
INCLINE VILLAGE, NV, February 28, 2011PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today reported financial results for the fourth quarter and full year ended December 31, 2010.

Total revenues in 2010 were $345.0 million, compared to $318.2 million in 2009. Excluding 2009 royalty revenues for sales of Synagis® received from MedImmune, royalty revenues for 2010 increased 30 percent over 2009. For the fourth quarter of 2010, total revenues were $76.1 million, compared to $58.3 million in the fourth quarter of 2009.

Royalty revenues for the fourth quarter of 2010 are based on third quarter product sales by PDL’s licensees.  Revenue growth for the fourth quarter of 2010 over the same period in 2009 was primarily driven by increased third quarter 2010 sales by the Company’s licensees of Avastin® and Herceptin®, which are marketed by Genentech and Roche; Lucentis®, which is marketed by Genentech and Novartis; and Tysabri®, which is marketed by Elan and Biogen Idec. PDL received royalties for these product sales in the fourth quarter of 2010.

Operating expenses in 2010 were $133.9 million, compared with $21.1 million in 2009. Included in operating expenses in 2010 is a $92.5 million legal settlement with MedImmune and $41.4 million general and administrative expenses. For the fourth quarter of 2010, general and administrative expenses were $12.1 million compared with $5.5 million for the same period of 2009. Significant expense items included in general and administrative expenses in 2010 were legal fees of $29.3 million, compensation and benefits of $4.1 million and professional services fees of $2.9 million. Legal fees include costs associated with the Company’s litigation with MedImmune and Genentech, preparation for the hearing with the European Patent Office (EPO) and the interference proceedings with the U.S. Patent and Trademark Office.  Excluding the Genentech matter, the other matters have been concluded as of the date of this press release.  Professional services fees include fees for the Company’s ongoing global royalty audits of its licensees, tax consultation and the preparation of long-term sales and royalty forecasts by outside consultants.

Net income in 2010 was $91.9 million, or $0.54 per diluted share as compared with net income of $189.7 million in 2009 or $1.07 per diluted share. Net loss for the fourth quarter of 2010 was $24.5 million or $0.18 per diluted share as compared with net income of $28.6 million or $0.17 per diluted share for the same period of 2009. Adjusting for the legal settlement with MedImmune and the effects of certain convertible note transactions throughout the year, non-GAAP net income was $173.5 million or $0.97 per diluted share in 2010 as compared with $195.8 million or $1.06 per diluted share in 2009.  Non-GAAP net income for the fourth quarter of 2010 was $36.1 million or $0.20 per diluted share as compared with non-GAAP net income of $30.2 million or $0.17 per diluted share for the same period of 2009.

Net cash provided by operating activities in 2010 was $184.3 million, compared with $187.0 million in 2009. At December 31, 2010, PDL had cash, cash equivalents and investments of $248.2 million, compared with $303.2 million at December 31, 2009.
 
 
 

 

RECENT DEVELOPMENTS

2011 Dividends
On February 25, 2011, PDL’s board of directors adopted a regular, quarterly dividend policy and declared that the quarterly dividends to be paid to its stockholders in 2011 will be $0.15 per share of common stock and payable on March 15, June 15, September 15 and December 15 of 2011 to stockholders of record on March 8, June 8, September 8 and December 8 of 2011, the Record Dates for each of the dividend payments, respectively.  PDL’s board of directors will evaluate the Company’s dividend policy for subsequent years based on net income, debt service, income taxes and other corporate activities.

Settlement with MedImmune
As previously announced, PDL entered into a settlement agreement with MedImmune resolving all legal disputes between the companies, including those relating to MedImmune’s product Synagis, and PDL's patents known as the Queen et al. patents. Under the settlement agreement, PDL paid MedImmune $65.0 million on February 15, 2011 and will pay an additional $27.5 million by February 10, 2012, for a total of $92.5 million. No further payments will be owed by MedImmune to PDL under its license to the Queen et al. patents as a result of past or future Synagis sales and MedImmune agreed to cease any support, financial or otherwise, of any party involved in the appeal proceeding before the EPO relating to the opposition against PDL’s European Patent No. 0 451 216B (the ‘216B Patent) including the opposition owned by BioTransplant Incorporated (BioTransplant).

Settlement with UCB
Also in February 2011, PDL reached a settlement agreement with UCB Pharma S.A. (UCB) that resolves all legal disputes between the companies. Under the agreement, PDL provided UCB a covenant not to sue UCB for any royalties regarding UCB’s Cimzia® product under the Queen et al. patents in return for a lump sum payment of $10 million, to be recognized as revenue in the first quarter of 2011. In addition, UCB agreed to terminate pending patent interference proceedings before the U.S. Patent and Trademark office (PTO) involving PDL’s U.S. Patent No. 5,585,089 patent (the ‘089 Patent) and the ‘370 Patent in PDL’s favor. UCB also agreed to formally withdraw its opposition appeal challenging the validity of the ‘216B.

Settlement with Novartis
On February 25, 2011, PDL reached a settlement with Novartis. Under the settlement agreement, PDL agreed to dismiss its claims against Novartis in its action in Nevada state court which also includes Genentech, Inc. (Genentech) and F. Hoffman LaRoche Ltd (Roche). Novartis agreed to withdraw its opposition appeal in the EPO challenging the validity of the ‘216B Patent. The settlement does not affect PDL’s claims against Genentech and Roche in the Nevada state court action. Under the settlement agreement with Novartis, PDL will pay Novartis an amount based on net sales of Lucentis during calendar year 2011 and beyond.  The Company does not currently expect such amount to materially impact our total annual revenues.

Acquisition of BioTransplant
On February 8, 2011, the United States Bankruptcy Court for the District of Massachusetts issued an order approving the acquisition of BioTransplant by PDL’s wholly owned subsidiary, BTI Acquisitions I, Inc. for $415,000. In February 2011, PDL instructed BioTransplant’s representative before the EPO to formally withdraw its opposition appeal challenging the validity of the ‘216B Patent. PDL believes that BioTransplant’s activities before the EPO, including payment of counsel fees, were financially supported by MedImmune. By virtue of PDL’s acquisition of BioTransplant and settlement of all of disputes with MedImmune, including their financial support of BioTransplant’s appeal in the opposition proceeding, PDL was able to ensure that BioTransplant’s opposition and appeal would be withdrawn in accordance with the governing rules of practice before the EPO.
 
 
 

 
 
Termination of European Opposition to ‘216B Patent
 
Pursuant to PDL’s settlements with UCB, MedImmune and Novartis, and as a result of PDL’s acquisition of BioTransplant and subsequent withdrawal of BioTransplant’s appeal, all of the active appellants in the EPO opposition have formally withdrawn their participation in the appeal proceeding. Accordingly, the EPO has cancelled the appeal proceeding and terminated the opposition proceeding in its entirety, with the result that the 2007 EPO decision upholds the claims of PDL’s ‘216B Patent as valid, which will become the final decision of the EPO.  In the year ended December 31, 2010, approximately 35 percent of PDL’s revenues were derived from sales of products that were made in Europe and sold outside of the United States.
 
Convertible Notes
In November 2010, PDL exchanged $92.0 million in aggregate principal of the 2012 Notes in separate, privately negotiated exchange transactions with the note holders. Pursuant to the exchange transactions, the note holders received $92.0 million in aggregate principal of new 2.875% Convertible Senior Notes due February 15, 2015 (the 2015 Notes). As part of the transaction, the Company also placed an additional $88.0 million in aggregate principal of the 2015 Notes.
 
In December 2010, PDL repurchased $2.5 million of 2012 Notes in the open market at a discount of 0.5% to face value in a privately negotiated transaction with an institutional holder, for an aggregate cost of $2.5 million in cash, plus accrued but unpaid interest. Following these transactions, $133.5 million of the 2012 Notes and $180 million of the 2015 Notes remain outstanding at December 31, 2010. The conversion rate for the 2015 Notes is 140.571 shares of common stock per $1,000 principal amount of the 2015 Notes or $7.11 per share of common stock.

The following table summarizes PDL’s debt outstanding at December 31, 2010 and December 31, 2009.
   
Debt Outstanding
(In millions)
 
   
12/31/2010
   
12/31/2009
 
2.75% Convertible Debt
           
Put Option - August 2010
  $ -     $ 200  
2.00% Convertible Debt
               
Maturity - February 2012
    133       228  
10.25% Non-recourse Note
               
Expected Maturity -  September 2012
    204       300  
2.875% Convertible Debt
               
Maturity - February 2015
    180       -  
Total Debt
  $ 517     $ 728  
 
Revenue Guidance for 2011
As previously announced, PDL will continue to provide revenue guidance for each quarter in the third month of that quarter. First quarter 2011 revenue guidance will be provided in early March.

Conference Call Details
PDL will hold a conference call to discuss financial results at 4:30 p.m. ET today, February 28, 2011.

To access the live conference call via phone, please dial (800) 260-8140 from the United States and Canada or (617) 614-3672 internationally. The conference ID is 90571277. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through March 7, 2011, and may be accessed by dialing (888) 286-8010 from the United States and Canada or (617) 801-6888 internationally. The replay passcode is 84230593.

 
 

 
 
To access the live and subsequently archived webcast of the conference call, go to the Company’s website at http://www.pdl.com and go to “Company Presentations & Events.” Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

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.
 
Non-GAAP Financial Information
The Company has presented certain financial information in conformance with generally accepted accounting principles in the U.S. (GAAP) and also on a non-GAAP basis for the three months and years ended December 31, 2010 and 2009.  Management believes that this non-GAAP information is useful for investors taken in conjunction with the Company’s GAAP financial statements.  Non-GAAP financial information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s net income as reported under GAAP.  A reconciliation between GAAP and non-GAAP financial information is provided in the table on page 6.

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 manufactured 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 rate; 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” section 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.
 
 
 

 

PDL BIOPHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(Unaudited)
(In thousands, except per share amounts)

   
Quarter Ended
   
Year Ended
 
   
December 31,
   
December 31,
 
   
2010
   
2009
   
2010
   
2009
 
                         
Revenues
                       
Royalties
  $ 74,629     $ 57,902     $ 343,475     $ 305,049  
License and other
    1,500       350       1,500       13,135  
Total revenues
    76,129       58,252       344,975       318,184  
Operating expenses:
                               
General and administrative
    12,056       5,526       41,396       21,064  
Legal settlement
    92,500       -       92,500       -  
Total operating expenses
    104,556       5,526       133,896       21,064  
Operating income (loss)
    (28,427 )     52,726       211,079       297,120  
Gain (loss) on retirement or conversion of convertible notes
    1,033       -       (17,648 )     1,518  
Interest and other income, net
    131       144       468       1,004  
Interest expense
    (9,514 )     (9,321 )     (43,529 )     (19,357 )
                                 
Income before income taxes
    (36,777 )     43,549       150,370       280,285  
Income tax expense (benefit)
    (12,317 )     14,989       58,496       90,625  
Net income (loss)
  $ (24,460 )   $ 28,560     $ 91,874     $ 189,660  
                                 
Net income (loss) per basic share
  $ (0.18 )   $ 0.24     $ 0.73     $ 1.59  
Net income (loss) per diluted share
  $ (0.18 )   $ 0.17     $ 0.54     $ 1.07  
                                 
Cash dividends declared per common share
  $ -     $ 1.67     $ 1.00     $ 2.67  
                                 
Shares used to compute income (loss) per basic share
    139,542       119,509       126,578       119,402  
Shares used to compute income (loss) per diluted share
    139,542       179,739       178,801       184,400  

 
 

 
 
PDL BIOPHARMA, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(Unaudited)
(In thousands, except per share amounts)

   
Quarter Ended
   
Year Ended
 
   
December 31,
   
December 31,
 
   
2010
   
2009
   
2010
   
2009
 
                         
Net income (loss)
  $ (24,460 )   $ 28,560     $ 91,874     $ 189,660  
Add back legal settlement expense
    92,500       -       92,500       -  
Deduct income tax benefit on legal settlement expense
    (32,375 )     -       (32,375 )     -  
Add back loss (gain) on retirement or conversion of convertible notes
    (1,033 )     -       17,648       (1,518 )
Deduct income tax expense (benefit) on retirement or conversion of convertible notes
    373       -       (1,217 )     531  
Non-GAAP net income
    35,005       28,560       168,430       188,673  
Add back interest expense for convertible notes, net of estimated taxes
    1,105       1,635       5,087       7,079  
Non-GAAP net income used to compute non-GAAP net income per diluted share
  $ 36,110     $ 30,195     $ 173,517     $ 195,752  
                                 
Non-GAAP net income per diluted share
  $ 0.20     $ 0.17     $ 0.97     $ 1.06  
                                 
Shares used to compute net income (loss) per diluted share
    139,542       179,739       178,801       184,400  
Delete shares issued to induce note conversion to common stock (1)
    -       -       (73 )     -  
Effect of dilutive stock options(2)
    12       -       -       -  
Restricted stock outstanding(2)
    115       -       -       -  
Assumed conversion of 2012 Notes(2)
    23,399       -       -       -  
Assumed conversion of 2015 Notes(2)
    16,777       -       -       -  
Shares used to compute non-GAAP net income per diluted share
    179,845       179,739       178,728       184,400  

(1) Shares for the year ended December 31, 2010 exclude the weighted average effect of the shares issued as an incentive to induce conversion of the 2023 Notes in August 2010.

(2) Shares for the quarter ended December 31, 2010 include the dilutive effect of stock options, restricted stock outstanding, assumed conversion of 2012 Notes and assumed conversion of 2015 Notes that were excluded from GAAP net loss per diluted share due to their anti-dilutive effect.

PDL BIOPHARMA, INC.
OPERATING EXPENSE DATA
(Unaudited)
(In thousands)

   
Quarter Ended
   
Year Ended
 
   
December 31,
   
December 31,
 
   
2010
   
2009
   
2010
   
2009
 
Operating expenses:
                       
General and administrative
                       
Compensation and benefits
  $ 1,103     $ 967     $ 4,065     $ 3,355  
Legal fees
    8,494       3,454       29,315       10,869  
Professional services
    325       241       2,943       2,374  
Insurance
    185       238       793       992  
Stock-based compensation
    138       203       662       821  
Depreciation
    14       34       91       991  
Other
    1,797       389       3,527       1,662  
Total general and administrative
    12,056       5,526       41,396       21,064  
Legal settlement
    92,500       -       92,500       -  
Total operating expenses
  $ 104,556     $ 5,526     $ 133,896     $ 21,064  

 
 

 
 
PDL BIOPHARMA, INC.
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In thousands)

   
December 31,
   
December 31,
 
   
2010
   
2009
 
Cash, cash equivalents and investments
  $ 248,229     $ 303,227  
Total assets
  $ 316,666     $ 338,411  
Convertible notes payable
  $ 310,428     $ 427,998  
Non-recourse notes payable
  $ 204,270     $ 300,000  
Total stockholders' deficit
  $ (324,182 )   $ (415,953 )

PDL BIOPHARMA, INC.
CONSOLIDATED STATEMENT OF CASH FLOW DATA
(Unaudited)
(In thousands)

   
Year Ended
 
   
December 31,
 
   
2010
   
2009
 
Net income
  $ 91,874     $ 189,660  
Adjustments to reconcile net income to net cash provided by operating activities
    21,777       7,481  
Changes in assets and liabilities
    70,649       (10,187 )
Net cash provided by operating activities
  $ 184,300     $ 186,954  

PDL BIOPHARMA, INC.
MIX OF EX-U.S.-BASED SALES AND EX-U.S.-BASED MANUFACTURING AND SALES
OF GENENTECH PRODUCTS
(Unaudited)

   
Quarter Ended
   
Year Ended
 
   
December 31,
   
December 31,
 
   
2010
   
2009
   
2010
   
2009
 
Avastin
                       
% Ex-U.S.-based Sales
    51 %     47 %     50 %     46 %
% Ex-U.S.-based-Manufacturing and Sales
    26 %     -       21 %     -  
Herceptin
                               
% Ex-U.S.-based-Sales
    70 %     70 %     70 %     70 %
% Ex-U.S.-based Manufacturing and Sales
    40 %     22 %     44 %     29 %
Lucentis
                               
% Ex-U.S.-based Sales
    55 %     57 %     56 %     53 %
% Ex-U.S.-based Manufacturing and Sales
    -       -       -       -  
Xolair
                               
% Ex-U.S.-based Sales
    35 %     31 %     35 %     29 %
% Ex-U.S.-based Manufacturing and Sales
    35 %     31 %     35 %     29 %

 
 

 
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PDL BioPharma, Inc.
Q4-2010
February 28, 2011

 
The following document was compiled from public documents for your convenience.  This document, together with the press release issued today, provides information regarding PDL related to its fourth quarter 2010 financial and business results.
 
Resolution of Challenges against the Queen et al. Patents in the United States and Europe
 
Settlement with MedImmune
 
In February we announced that we had entered into a definitive settlement agreement with MedImmune resolving all legal disputes between the companies, including those relating to MedImmune’s product Synagis®, and PDL's Queen et al. patents. Under the settlement agreement, PDL paid MedImmune $65.0 million on February 15, 2011 and will pay an additional $27.5 million by February 10, 2012 for a total of $92.5 million.
 
Settlement with UCB
 
In February 2011, we announced that we had reached a settlement agreement with UCB that resolves all legal disputes between the companies for a lump sum payment of $10 million to us. Under the agreement, PDL agreed not to sue UCB for any royalties regarding UCB’s Cimzia® product and UCB agreed to terminate pending patent interference proceedings before the U.S. Patent and Trademark office as well as their appeal in the European Patent Office (EPO).
 
Settlement with Novartis
 
Earlier today, we announced that we had reached a settlement with Novartis. Under the settlement agreement, we agreed to dismiss our claims against Novartis in our action in Nevada state court and Novartis agreed to withdraw its opposition appeal in the EPO. The settlement does not affect PDL’s claims against Genentech and Roche in the Nevada state court action. Under the settlement agreement with Novartis, PDL will pay Novartis an amount based on net sales of Lucentis during calendar year 2011 and beyond.
 
Acquisition of BioTransplant
 
In February 2011, we acquired BioTransplant, a bankrupt company, from the United States Bankruptcy Court for the District of Massachusetts. We then instructed BioTransplant’s representative before the EPO to formally withdraw its opposition appeal in the EPO. We believe that BioTransplant’s activities before the EPO, including payment of counsel fees, were financially supported by MedImmune.
 
Termination of European Opposition to ‘216B Patent
 
Pursuant to PDL’s settlements with UCB, MedImmune and Novartis, and as a result of PDL’s acquisition of BioTransplant and subsequent withdrawal of BioTransplant’s appeal, all of the active appellants in the EPO opposition have formally withdrawn their participation in the appeal proceeding. Accordingly, the EPO has cancelled the appeal proceeding and terminated the opposition proceeding in its entirety. The effect of the termination of the opposition appeal proceeding is that the 2007 EPO decision upholding the claims of PDL’s ‘216B Patent as valid will become the final decision of the EPO.  In the year ending December 31, 2010, approximately 35 percent of PDL’s revenues were derived from sales of products that were made in Europe and sold outside of the United States.
 
Annual Legal Expenses
 
As a result of our recent settlements with MedImmune, UCB and Novartis as well as our acquisition of BioTransplant and termination of the opposition hearing in the EPO, we anticipate that legal expenses will be substantially reduced in future periods.  For the year ended December 31, 2010, our total legal fees of $29.3 million represented 71% of total general and administrative expenses.  These matters represented approximately 90% of our legal fees in 2010.
 
 
Page 1

 
PDL BioPharma, Inc.
Q4-2010
February 28, 2011
  
2011 Dividends
 
Earlier today, we also announced that our board of directors has adopted a regular dividend policy for 2011 and beyond and declared that the four quarterly dividends to be paid to our stockholders in 2011 will be $0.15 per share of common stock.  The $0.15 dividends will be paid on March 15, June 15, September 15 and December 15 to all stockholders who own shares of PDL on March 8, June 8, September 8, and December 8, the Record Dates for each of the dividend payments, respectively. We made the change to quarterly dividends in response to requests from our stockholders.
 
Non-GAAP Earnings per Share
 
We believe that the information given below, on a non-GAAP basis, provides information that is useful for investors when taken in conjunction with the Company’s GAAP financial statements. The effect of the non-GAAP adjustments to earnings per share increases net income per diluted share from $0.54 to $0.97 for the year ended December 31, 2010 and decreases net income per diluted share from $1.07 to $1.06 for the year ended December 31, 2009. The adjustments comprise our $92.5 million settlement with MedImmune described above as well as certain gains and losses associated the following capital restructuring activities in 2010 and 2009:
 
 
·
During the year ended December 31, 2010 we exchanged an aggregate of $61.6 million face value of the 2023 Notes in privately negotiated transactions with institutional holders and we repurchased at market prices an aggregate $84.2 million face value of the 2023 Notes. Also in 2010, the company exchanged $92.0 million in aggregate principal of the 2012 Notes for 2015 Notes. In the aggregate, these transactions resulted in a charge to non-operating expense of $17.6 million or $16.4 million net of tax.
 
 
·
During the year ended December 31, 2009, we repurchased at market prices $22.0 million face value of the 2012 Notes and we repurchased at market prices $50.0 million face value of the 2023 Notes. In the aggregate, these transactions resulted in a gain of $1.5 million or $0.9 million net of tax.
 
Excluding the MedImmune settlement and the convertible note transactions described above, non-GAAP net income per diluted share was:
 
 
Page 2

 
 
PDL BioPharma, Inc.
Q4-2010
February 28, 2011
 
PDL BIOPHARMA, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(Unaudited)
(In thousands, except per share amounts)
 
   
Quarter Ended
   
Year Ended
 
   
December 31,
   
December 31,
 
   
2010
   
2009
   
2010
   
2009
 
                         
Net income (loss)
  $ (24,460 )   $ 28,560     $ 91,874     $ 189,660  
Add back legal settlement expense
    92,500       -       92,500       -  
Deduct income tax benefit on legal settlement expense
    (32,375 )     -       (32,375 )     -  
Add back loss (gain) on retirement or conversion of convertible notes
    (1,033 )     -       17,648       (1,518 )
Deduct income tax expense (benefit) on retirement or conversion of convertible notes
    373       -       (1,217 )     531  
Non-GAAP net income
    35,005       28,560       168,430       188,673  
                                 
Add back interest expense for convertible notes, net of estimated taxes
    1,105       1,635       5,087       7,079  
Non-GAAP net income used to compute non-GAAP net income per diluted share
  $ 36,110     $ 30,195     $ 173,517     $ 195,752  
                                 
Non-GAAP net income per diluted share
  $ 0.20     $ 0.17     $ 0.97     $ 1.06  
                                 
Shares used to compute net income (loss) per diluted share
    139,542       179,739       178,801       184,400  
Delete shares issued to induce note conversion to common stock (1)
    -       -       (73 )     -  
Effect of dilutive stock options(2)
    12       -       -       -  
Restricted stock outstanding(2)
    115       -       -       -  
Assumed conversion of 2012 Notes(2)
    23,399       -       -       -  
Assumed conversion of 2015 Notes(2)
    16,777       -       -       -  
Shares used to compute non-GAAP net income per diluted share
    179,845       179,739       178,728       184,400  

 
(1) Shares for the year ended December 31, 2010 exclude the weighted average effect of the shares issued as an incentive to induce conversion of the 2023 Notes in August 2010.
 
(2) Shares for the quarter ended December 31, 2010 include the dilutive effect of stock options, restricted stock outstanding, assumed conversion of 2012 Notes and assumed conversion of 2015 Notes that were excluded from GAAP net loss per diluted share due to their anti-dilutive effect.
 
Capital Restructuring Activities
 
As noted above, we have actively been working to restructure the Company’s capital and reduce dilution associated with our convertible notes. The following summarizes the Company’s debt outstanding at December 31, 2010 and at December 31, 2009.
 
   
Debt Outstanding
(In millions)
 
   
12/31/2010
   
12/31/2009
 
2.75% Convertible Debt
           
Put Option - August 2010
  $ -     $ 200  
2.00% Convertible Debt
               
Maturity - February 2012
    133       228  
10.25% Non-recourse Note
               
Expected Maturity - September 2012
    204       300  
2.875% Convertible Debt
               
Maturity - February 2015
    180       -  
Total Debt
  $ 517     $ 728  
 
 
Page 3

 
 
PDL BioPharma, Inc.
Q4-2010
February 28, 2011
 
Licensed Product Development and Regulatory Updates
 
ACTEMRA®: On January 5, 2011, Genentech announced that the Food and Drug Administration (FDA) extended the Actemra label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given methotrexate.
 
AVASTIN®: There were a number of recent events regarding Avastin:
 
·
In December 2010, the FDA notified Roche/Genentech of its intent to withdraw Avastin’s approval as a first line treatment for HER2-breast cancer in combination with paclitaxel. In response, Roche /Genentech submitted a request to FDA for a hearing on the matter and were subsequently granted a hearing date for June 28 and 29, 2011. In addition, FDA provided a complete response letter rejecting Roche/Genentech’s application for approval for Avastin for second line treatment of HER2-positive breast cancer.
 
·
Also in December 2010, European Medicines Agency narrowed, but did not withdraw, Avastin’s approval for first-line treatment of HER2-breast cancer to use in combination with paclitaxel only.
 
·
In February 2011, Genentech reported positive results from a Phase 3 clinical trial evaluating Avastin in combination with chemotherapy, followed by Avastin alone to treat recurrent ovarian cancer. The study showed that women who followed this treatment regimen lived longer without their disease worsening (progression-free survival) compared to women who received chemotherapy alone. Full data from the trial will be submitted for presentation at an upcoming medical meeting.
 
·
Also in February 2011, the New England Journal of Medicine published positive results from a Phase 2 clinical study using intravitreal Avastin to treat retinopathy of prematurity in infants. The study demonstrated that Avastin significantly reduced the recurrence of retinopathy of prematurity versus conventional laser therapy (6% vs. 26%, p=0.002).
 
LUCENTIS®: In January, 2011, Novartis announced that Lucentis has been approved in the EU for the treatment of visual impairment due to diabetic macular edema (DME). DME is a leading cause of blindness in the working-age population in most developed countries. Also in February 2011, Genentech reported positive results from one of two Phase 3 clinical trials using monthly Lucentis. The trial met its primary endpoint, demonstrating that a significantly higher percentage of patients with DME receiving monthly Lucentis achieved an improvement in vision of at least 15 letters on the eye chart at 24 months, compared to the control group.
 
TYSABRI®: In December 2010, Biogen Idec and Elan submitted a supplemental BLA to the FDA and a Type II Variation to the EMA to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics. The companies are proposing updated product labeling to include anti-JC virus antibody status as one potential factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection, in the TYSABRI-treated population.
 
PERTUZUMAB (not a licensed product): In December 2010, Genentech reported positive results from a Phase 2 neoadjuvant study evaluating the effect of a novel combination regimen of pertuzumab and Herceptin® plus chemotherapy in women with early-stage, HER2-positive breast cancer. The data showed that the two antibodies plus docetaxel, given in the neoadjuvant setting prior to surgery, significantly improved the rate of complete tumor disappearance in the breast by more than half compared to Herceptin plus docetaxel.
 
 
Page 4

 
PDL BioPharma, Inc.
Q4-2010
February 28, 2011
Forward-looking Statements
 
This document 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 manufactured 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 rate; 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 document 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.

 
Page 5

 

PDL BioPharma, Inc.
Q4-2010
February 28, 2011
 
Royalty Revenue by Product ($ in 000's) *
 
Avastin
  Q1     Q2     Q3     Q4    
Total
 
2010
  16,870     44,765     29,989     24,922       116,547  
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     25,441       115,350  
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     8,047       45,198  
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     4,652       19,741  
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  
                                 
Tysabri
  Q1     Q2     Q3     Q4    
Total
 
2010
  8,791     8,788     8,735     9,440       35,754  
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  

* As reported to PDL by its licensees

 
Page 6

 
 
PDL BioPharma, Inc.
Q4-2010
February 28, 2011
 
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     1,646,218       6,423,910  
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  
2006
  439,318     516,052     570,551     592,897       2,118,817  
                                 
Herceptin
  Q1     Q2     Q3     Q4    
Total
 
2010
  1,337,732     1,349,512     1,300,934     1,409,310       5,397,488  
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     804,684       3,008,915  
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     263,389       981,225  
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  
                                 
Tysabri
  Q1     Q2     Q3     Q4    
Total
 
2010
  293,047     287,925     293,664     316,657       1,191,292  
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  

* As reported to PDL by its licensees

 
Page 7

 

PDL BioPharma, Inc.
Q4-2010
February 28, 2011
 
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
 
Avastin Sales
  2009 - Q3     2009 - Q4     2010 - Q1     2010 - Q2     2010 - Q3     2010 - Q4  
US Made & Sold
  777,635     795,199     795,453     814,872     820,453     800,139  
US Made & ex-US Sold
  662,095     718,855     703,661     355,742     338,929     415,576  
ex-US Made & Sold
  -     -     86,979     426,277     435,325     430,503  
Total
  1,439,730     1,514,053     1,586,093     1,596,892     1,594,707     1,646,218  
US Made & Sold
  54 %   53 %   50 %   51 %   51 %   49 %
US Made & ex-US Sold
  46 %   47 %   44 %   22 %   21 %   25 %
ex-US Made & Sold
  0 %   0 %   5 %   27 %   27 %   26 %
                                     
Herceptin Sales
  2009 - Q3     2009 - Q4     2010 - Q1     2010 - Q2     2010 - Q3     2010 - Q4  
US Made & Sold
  391,401     386,654     394,883     406,222     410,563     416,611  
US Made & ex-US Sold
  256,693     608,046     372,146     312,792     306,085     425,303  
ex-US Made & Sold
  578,341     283,926     570,703     630,498     584,286     567,396  
Total
  1,226,435     1,278,626     1,337,732     1,349,512     1,300,934     1,409,310  
US Made & Sold
  32 %   30 %   30 %   30 %   32 %   30 %
US Made & ex-US Sold
  21 %   48 %   28 %   23 %   24 %   30 %
ex-US Made & Sold
  47 %   22 %   43 %   47 %   45 %   40 %
                                     
Lucentis Sales
  2009 - Q3     2009 - Q4     2010 - Q1     2010 - Q2     2010 - Q3     2010 - Q4  
US Made & Sold
  251,182     266,405     323,153     300,501     326,840     360,911  
US Made & ex-US Sold
  304,114     348,808     436,812     398,389     418,536     443,773  
ex-US Made & Sold
  -     -     -     -     -     -  
Total
  555,296     615,212     759,965     698,890     745,376     804,684  
US Made & Sold
  45 %   43 %   43 %   43 %   44 %   45 %
US Made & ex-US Sold
  55 %   57 %   57 %   57 %   56 %   55 %
ex-US Made & Sold
  0 %   0 %   0 %   0 %   0 %   0 %
                                     
Xolair Sales
  2009 - Q3     2009 - Q4     2010 - Q1     2010 - Q2     2010 - Q3     2010 - Q4  
US Made & Sold
  146,022     150,950     157,503     145,245     165,109     170,001  
US Made & ex-US Sold
  47     10     -     -     -     -  
ex-US Made & Sold
  64,937     68,733     83,401     80,632     85,945     93,388  
Total
  211,006     219,693     240,904     225,878     251,055     263,389  
US Made & Sold
  69 %   69 %   65 %   64 %   66 %   65 %
US Made & ex-US Sold
  0 %   0 %   0 %   0 %   0 %   0 %
ex-US Made & Sold
  31 %   31 %   35 %   36 %   34 %   35 %
                                     
Total Sales
  2009 - Q3     2009 - Q4     2010 - Q1     2010 - Q2     2010 - Q3     2010 - Q4  
US Made & Sold
  1,567,742     1,599,208     1,670,992     1,666,840     1,722,965     1,747,662  
US Made & ex-US Sold
  1,222,949     1,675,718     1,512,620     1,081,147     1,063,551     1,284,652  
ex-US Made & Sold
  643,279     352,659     741,083     1,137,407     1,105,556     1,091,287  
Total
  3,433,970     3,627,585     3,924,694     3,885,394     3,892,072     4,123,601  
US Made & Sold
  46 %   44 %   43 %   43 %   44 %   42 %
US Made & ex-US Sold
  36 %   46 %   39 %   28 %   27 %   31 %
ex-US Made & Sold
  19 %   10 %   19 %   29 %   28 %   26 %
 
* As reported to PDL by Genentech

 
Page 8

 
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