form8k.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):  November 9, 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 Incorporation)
 
(I.R.S. Employer Identification No.)
 
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:
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
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 November 9, 2011, PDL BioPharma, Inc. (the Company) issued a press release announcing the financial results for the third quarter ended September 30, 2011. A copy of this earnings release is attached as Exhibit 99.1 hereto.  The Company will host an earnings call and webcast on November 9, 2011, during which the Company will discuss its financial results for the third quarter ended September 30, 2011.
 
Item 7.01  Regulation FD Disclosure.
 
On November 9, 2011, the Company distributed to analysts covering the Company’s securities a summary of certain information regarding the Company’s 2011 dividends 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 and its associated tables are attached hereto as Exhibits 99.2 and 99.3.
 
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 2010 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
99.2   Information Sheet
99.3   Tables to Information Sheet
     
 
 
 

 
 
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:  November 9, 2011      
 
 
 

 
 
EXHIBIT INDEX
 
Exhibit No.
 
Description
99.1   Press Release
99.2   Information Sheet
99.3   Tables to Information Sheet
 
 

ex99_1.htm

EXHIBIT 99.1
Graphic
                                                                                                                                                                                                                                      
Contacts:
Cris Larson 
PDL BioPharma, Inc. 
775-832-8505 
Cris.Larson@pdl.com 
 
 
Jennifer Williams
Cook Williams Communications, Inc.
360-668-3701
jennifer@cwcomm.org
                                                                                                
PDL BioPharma Announces Third Quarter 2011 Financial Results

INCLINE VILLAGE, NV   November 9, 2011PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today reported financial results for the third quarter ended September 30, 2011.

Revenues

Total revenues for the third quarter of 2011 were $83.8 million, compared to $86.4 million for the same period of 2010, a three percent year-over-year decrease. Total revenues for the nine months ended September 30, 2011, were $289.2 million, compared to $268.8 million for the same period of 2010, an eight percent increase.

The third quarter 2011 revenue decline is driven primarily by reduced royalties from second quarter 2011 sales of Avastin® partially offset by increased royalties from second quarter 2011 sales of Herceptin®, Lucentis® and Tysabri®. Also contributing to the decline is a lower average royalty rate on sales of Avastin, Herceptin, Lucentis and Xolair® (the Genentech Products) that are either made or sold in the United States (U.S.-based Sales) due to higher year-to-date sales in 2011. Sales of the Genentech Products are subject to a tiered royalty rate for U.S.-based Sales and a flat royalty rate of three percent for product that is manufactured and sold outside of the United States. Due to the tiering, in the second quarter of 2011, only 15% of U.S.-based Sales were above the lowest royalty rate of one percent as compared with 45% of U.S.-based Sales for the second quarter 2010. The net sales thresholds and the applicable royalty rates for product that is either 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 %

The third quarter 2011 royalty payment received from Genentech included royalties generated on all worldwide sales. Total revenue for the third quarter is net of the payment made pursuant to our February 2011 settlement agreement with Novartis, which is based on a portion of the royalties that the Company receives for Lucentis sales made by Novartis outside of the United States.

General and Administrative Expenses

Total general and administrative expenses for the third quarter of 2011 were $4.0 million, compared with $11.1 million for the same period of 2010. Total general and administrative expenses for the nine months ended September 30, 2011, were $13.5 million, compared to $29.3 million for the same period in 2010. The decrease in general and administrative expenses was driven primarily by a reduction in legal expenses for both the third quarter and first nine months of 2011 as a result of the conclusion of several legal matters in the first quarter of 2011.

 
 

 
 
Other Income (Expense)

Total other income (expense), for the three months ended September 30, 2011, was $(8.9) million, compared to $(12.1) million for the same period in 2010. Total other income (expense), for the nine months ended September 30, 2011, was $(28.2) million, compared to $(52.4) million for the same period of 2010. The decrease in other income (expense), for both the third quarter and first nine months of 2011 was driven primarily by reduced costs associated with the retirement or conversion of convertible notes and a reduction in interest expense. The reduction in interest expense for both the third quarter and first nine months of 2011 is primarily attributable to repayment and reduction in principal of PDL’s Non-recourse Notes Payable, for which the current principal balance at September 30, 2011, was $115.3 million as compared with $225.0 million at September 30, 2010.

Net Income

Net income for the third quarter of 2011 was $45.9 million, or $0.28 per diluted share, as compared with net income of $40.2 million, or $0.24 per diluted share, for the same period of 2010. Net income for the nine months ended September 30, 2011, was $160.4 million, or $0.88 per diluted share compared to $116.3 million, or $0.67 per diluted share, for the same period in 2010.

Non-GAAP Net Income

Adjusting for convertible note retirement or conversion transactions and amortization of the non-cash debt discount accounting treatment for the 3.75% Convertible Senior Notes due May 1, 2015 (the May 2015 Notes), non-GAAP net income for the third quarter of 2011 was $46.6 million, or $0.28 per diluted share, compared with $42.5 million, or $0.25 per diluted share, in the third quarter of 2010. Non-GAAP net income for the nine months ended September 30, 2011, was $162.0 million, or $0.89 per diluted share, compared with $133.4 million, or $0.77 per diluted share in the nine months ended September 30, 2010. A description of the non-GAAP adjustments is provided below in the accompanying table entitled “Reconciliation of GAAP Financial Information to Non-GAAP.”

Cash, Cash Equivalents and Investments

Net cash provided by operating activities in the nine months ended September 30, 2011, was $124.6 million, compared with $154.3 million for the nine months ended September 30, 2010. At September 30, 2011, PDL had cash, cash equivalents and investments of $225.3 million, compared with $248.2 million at December 31, 2010.

RECENT DEVELOPMENTS

Dividend Payment

PDL’s board of directors declared a regular quarterly dividend on February 25, 2011, of $0.15 per share of common stock, payable 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 of each of the dividend payment dates, respectively. The Company paid $21.0 million to PDL stockholders on each of March 15, June 15, and September 15, 2011, using current year earnings and cash on hand. As of September 30, 2011, the Company has accrued $21.0 million in dividends payable for the December 15, 2011, dividend.

Adjustments to Convertible Note Conversion Ratios

In connection with the September 15, 2011, dividend payment, the conversion ratios for PDL’s convertible notes increased. The conversion ratio for the 2.875% Convertible Senior Notes due February 15, 2015 (February 2015 Notes), was adjusted to 151.713 shares of common stock per $1,000 principal amount, or approximately $6.59 per share, effective September 9, 2011. The conversion ratio for the May 2015 Notes was adjusted to 132.6682 shares of common stock per $1,000 principal amount, or approximately $7.54 per share, effective September 6, 2011. The conversion ratio for the February 2015 Notes was previously 147.887 shares of common stock per $1,000 principal amount, or a conversion price of approximately $6.76 per share. The conversion ratio for the May 2015 Notes was previously 129.2740 shares of common stock per $1,000 principal amount, or a conversion price of approximately $7.74 per share.

 
 

 
 
Genentech and Roche Dispute

PDL received a letter from Genentech, Inc. (Genentech) in August 2010 sent on behalf of F. Hoffman-La Roche Ltd. (Roche) and Novartis AG (Novartis), asserting that Avastin, Herceptin, Lucentis and Xolair (the Genentech Products) do not infringe PDL’s supplementary protection certificates (SPCs) granted to the Company by various countries in Europe for each of the Genentech Products and seeking a response to these assertions. The SPCs covering the Genentech Products effectively extend the patent protection for PDL’s European Patent No. 0 451 216B (the ‘216B Patent) until December 2014, except that the SPCs for Herceptin will generally expire in July 2014. PDL responded to Genentech, stating that the Company believes its assertions of non-infringement are without merit and that it disagreed fundamentally with the assertions of non-infringement with respect to the Genentech Products. In August 2010, PDL filed a complaint in the Second Judicial District of Nevada, Washoe County, against Genentech and, Roche seeking to enforce the Company’s rights under the 2003 settlement agreement with Genentech and an order from the court declaring that Genentech is obligated to pay royalties to PDL on sales of the Genentech Products that are manufactured and sold outside of the United States.

The Second Judicial District Court of Nevada ruled in favor of PDL on July 7, 2011, on two motions to dismiss filed by Genentech and Roche in PDL’s lawsuit related to the 2003 settlement agreement with Genentech. The court denied Genentech and Roche’s motion to dismiss four of PDL’s five claims for relief and, further, denied Roche’s separate motion to dismiss for lack of personal jurisdiction. The court dismissed one of PDL’s claims that Genentech committed a bad-faith breach of the covenant of good faith and fair dealing stating that, based on the current state of the pleadings, no “special relationship” had been established between Genentech and PDL, as required under Nevada law.

The effect of the Court’s ruling is that PDL is permitted to continue to pursue its claims that (i) Genentech is obligated to pay royalties to PDL on international sales of the Genentech Products; (ii) Genentech, by challenging, at the behest of Roche and Novartis, whether PDL’s SPCs cover the Genentech Products breached its contractual obligations to PDL under the 2003 settlement agreement; (iii) Genentech breached the implied covenant of good faith and fair dealing with respect to the 2003 settlement agreement and (iv) Roche intentionally and knowingly interfered with PDL’s contractual relationship with Genentech in conscious disregard of PDL’s rights.
 
PDL seeks compensatory damages, including liquidated damages and other monetary remedies set forth in the 2003 settlement agreement, punitive damages and attorney’s fees as a result of Genentech and Roche’s conduct. The ultimate outcome of this litigation is uncertain and PDL may not be successful in its allegations.

Revenue Guidance for 2011

As previously announced, PDL will continue to provide revenue guidance for each quarter in the third month of that quarter. Fourth quarter and full year 2011 revenue guidance will be provided in early December.

 
 

 
 
Conference Call Details

Please dial (877) 677-9122 in the United States and Canada and (708) 290-1401 internationally to access the live conference today call via phone,. The conference ID is 19555218. 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 November 16, 2011, and may be accessed by dialing (855) 859-2056 in the United States and Canada or (404) 537-3406 internationally. The replay passcode is 19555218.

Go to the Company’s website at http://www.pdl.com and go to “Company Presentations & Events” to access the live and subsequently archived webcast of the conference call, 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. Today, PDL is focused on intellectual property asset management, investing in new royalty bearing assets and maximizing the value of its patent portfolio and related assets. 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:
 
 
o
The expected rate of growth in royalty-bearing product sales by PDL's existing licensees;
 
o
The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus manufactured or sold in the U.S.;
 
o
The ability of PDL’s licensees to receive regulatory approvals to market and launch new royalty-bearing products and whether such products, if launched, will be commercially successful;
 
o
Changes in any of the other assumptions on which PDL's projected royalty revenues are based;
 
o
The outcome of pending litigation or disputes;
 
o
The change in foreign currency exchange rates; and
 
o
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(Unaudited)
(In thousands, except per share amounts)

 
 
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
 
 
2011
   
2010
   
2011
   
2010
 
Revenues:
 
 
   
 
   
 
   
 
 
Royalties
  $ 83,370     $ 86,442     $ 278,833     $ 268,846  
License and other
    400       -       10,400       -  
Total revenues
    83,770       86,442       289,233       268,846  
                                 
General and administrative expenses
    3,960       11,110       13,516       29,340  
Operating income
    79,810       75,332       275,717       239,506  
                                 
Other income (expense)
                               
Loss on retirement or conversion of convertible notes
    -       (2,354 )     (766 )     (18,681 )
Interest and other income
    130       167       463       337  
Interest and other expense
    (9,007 )     (9,928 )     (27,941 )     (34,015 )
Total other income (expense)
    (8,877 )     (12,115 )     (28,244 )     (52,359 )
Income before income taxes
    70,933       63,217       247,473       187,147  
Income tax expense
    25,017       23,028       87,026       70,813  
                                 
Net income
  $ 45,916     $ 40,189     $ 160,447     $ 116,334  
                                 
Net income per share
                               
Basic
  $ 0.33     $ 0.32     $ 1.15     $ 0.95  
Diluted
  $ 0.28     $ 0.24     $ 0.88     $ 0.67  
                                 
Cash dividends declared and paid per common share
  $ 0.15     $ 0.50     $ 0.45     $ 0.50  
                                 
Weighted average shares outstanding
                               
Basic
    139,680       127,479       139,665       122,209  
Diluted
    167,019       172,217       186,756       178,448  

 
 

 
 
PDL BIOPHARMA, INC.
RECONCILIATION OF GAAP FINANCIAL INFORMATION TO NON-GAAP
(Unaudited)
(In thousands)
 
   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2011
   
2010
   
2011
   
2010
 
                         
Net income
  $ 45,916     $ 40,189     $ 160,447     $ 116,334  
Add Back:
                               
Loss on retirement or conversion of convertible notes, net of estimated taxes
    -       2,354       498       17,091  
Amortization of debt discount for May 2015 Notes, net of estimated taxes
    683       -       1,020       -  
Non-GAAP net income
    46,599       42,543       161,965       133,425  
                                 
Add back interest expense for implied conversion of convertible notes included in determination of fully diluted shares, net of estimated taxes
    841       987       3,391       3,982  
                                 
Non-GAAP income used to compute non-GAAP net income per diluted share
  $ 47,440     $ 43,530     $ 165,356     $ 137,407  
                                 
Shares used to compute net income per diluted share
    167,019       172,217       186,756       178,448  
Delete shares issued to induce note conversion to common stock (1)
    -       (104 )     -       (35 )
Shares used to compute non-GAAP net income per diluted share
    167,019       172,113       186,756       178,413  
                                 
Non-GAAP net income per diluted share
  $ 0.28     $ 0.25     $ 0.89     $ 0.77  
 
1)
The shares used to compute non-GAAP net income per diluted share amounts are the same as the shares used to calculate GAAP net income per diluted share amounts, except the shares used for the three and nine months ended September 30, 2010, exclude the weighted average effect of the shares issued as an incentive to induce conversion of the 2.75% convertible subordinated notes due 2023.

PDL management uses these non-GAAP financial measures to monitor and evaluate our net income and trends on an on-going basis and internally for operating, budgeting and financial planning purposes. PDL management believes the non-GAAP information is useful for investors by offering them the ability to better identify trends in our business and better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all expense items that affect PDL. These non-GAAP financial measures that management uses are not prepared in accordance with, and should not be considered in isolation of, or as an alternative to, measurements required by GAAP.

These non-GAAP financial measures exclude the following items from GAAP net income:

Loss on Retirement or Conversion of Convertible Notes, Net of Estimated Taxes

The effects of retirement or conversion of convertible notes, net of estimated taxes, are excluded because these capital restructuring charges are transaction specific and result from changes made to a capital structure established when PDL was a commercial, manufacturing, and research and development biotechnology company. For the three months ended September 30, 2010, the loss on retirement or conversion of convertible notes was $2.4 million which was not deductible for income tax purposes. During the nine months ended September 30, 2011 and 2010, the losses on retirement or conversion of convertible notes were $0.8 million, or $0.5 million net of estimated tax, and $18.7 million, or $17.1 million net of estimated tax, respectively.
 
Imputed Interest on May 2015 Notes, Net of Estimated Taxes

The effects of imputed interest on the May 2015 Notes, net of estimated taxes, are excluded because this expense is non-cash; such exclusion facilitates comparisons of PDL’s cash operating results. For the three months and nine months ended September 30, 2011, the additional interest expense attributable to using an imputed borrowing rate of 7.5% rather than the stated coupon rate of 3.75% was $1.1 million, or $0.7 million net of estimated tax, and $1.6 million, or $1.0 million net of tax, respectively.
 
 
 

 
 
PDL BIOPHARMA, INC.
GENERAL AND ADMINISTRATIVE EXPENSE DATA
(Unaudited)
(In thousands)
 
   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
(Dollars in thousands)
 
2011
   
2010
   
2011
   
2010
 
Compensation and benefits
  $ 1,045     $ 965     $ 2,958     $ 2,962  
Legal expense
    1,263       8,660       6,162       20,821  
Other professional services
    810       535       2,001       2,618  
Insurance
    176       185       556       608  
Depreciation
    14       14       43       76  
Stock-based compensation
    132       166       256       525  
Other
    520       585       1,540       1,730  
Total general and administrative expenses
  $ 3,960     $ 11,110     $ 13,516     $ 29,340  
 
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In thousands)

   
September 30,
2011
   
December 31,
2010
 
Cash, cash equivalents and investments
  $ 225,335     $ 248,229  
Total assets
  $ 270,525     $ 316,666  
Convertible notes payable
  $ 315,368     $ 310,428  
Non-recourse notes payable
  $ 115,268     $ 204,270  
Total stockholders' deficit
  $ (243,239 )   $ (324,182 )
 
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW DATA
(Unaudited)
(In thousands)

   
Nine Months Ended
September 30,
 
   
2011
   
2010
 
Net income
  $ 160,447     $ 116,334  
Adjustments to reconcile net income to net cash provided by operating activities
    34,393       20,199  
Changes in assets and liabilities
    (70,204 )     17,780  
Net cash provided by operating activities
  $ 124,636     $ 154,313  

 
 

 

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

 
 
 
 
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
 
 
 
2011
   
2010
   
2011
   
2010
 
Avastin
   
 
   
 
   
 
   
 
 
 
% Ex-U.S. Sold
    56 %     49 %     56 %     49 %
 
% Ex-U.S.-based Manufactured and Sold
    19 %     27 %     19 %     20 %
Herceptin
                                 
 
% Ex-U.S. Sold
    73 %     68 %     72 %     70 %
 
% Ex-U.S.-based Manufactured and Sold
    43 %     45 %     38 %     45 %
Lucentis
                                 
 
% Ex-U.S. Sold
    60 %     56 %     58 %     57 %
 
% Ex-U.S.-based Manufactured and Sold
    0 %     0 %     0 %     0 %
Xolair
                                 
 
% Ex-U.S. Sold
    41 %     34 %     40 %     35 %
 
% Ex-U.S.-based Manufactured and Sold
    41 %     34 %     40 %     35 %

 
 

ex99_2.htm

EXHIBIT 99.2
PDL BioPharma, Inc.
Q3-2011
November 9, 2011
 
Following are some of the key points from PDL’s press release today regarding its third quarter 2011 financial and business results.

Net Income

Net income for the third quarter of 2011 was $45.9 million, or $0.28 per diluted share, as compared with net income of $40.2 million, or $0.24 per diluted share, for the same period of 2010.
Net income for the nine months ended September 30, 2011, was $160.4 million, or $0.88 per diluted share compared to $116.3 million, or $0.67 per diluted share, for the same period in 2010.

Non-GAAP Net Income

Non-GAAP net income for the third quarter of 2011 was $46.6 million, or $0.28 per diluted share, compared with $42.5 million, or $0.25 per diluted share, in the third quarter of 2010.
Non-GAAP net income for the nine months ended September 30, 2011, was $162.0 million, or $0.89 per diluted share, compared with $133.4 million, or $0.77 per diluted share in the nine months ended September 30, 2010.

PDL management believes the non-GAAP information is useful for investors by offering them the ability to better identify trends in our business and better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all expense items that affect PDL. These non-GAAP financial measures exclude the following items from GAAP net income:

The effects of retirement or conversion of convertible notes, net of estimated taxes, are excluded because these capital restructuring charges are transaction specific and result from changes made to a capital structure established when PDL was a commercial, manufacturing, and research and development biotechnology company.
The effects of imputed interest on our 3.75% Convertible Senior Notes due May 1, 2015 (May 2015 Notes), net of estimated taxes, are excluded because this expense is non-cash; such exclusion facilitates comparisons of PDL’s cash operating results.

Dividend Payment

We paid $0.15 per share of common stock or $21.0 million to our stockholders on September 15, 2011, to stockholders of record on September 8, 2011, as part of our regular, quarterly dividend policy for 2011.

Adjustments to Convertible Notes Conversion Ratios
 
In connection with the September 15, 2011, dividend payment:
 
The conversion ratio for our 2.875% Convertible Senior Notes due February 15, 2015, was adjusted to 151.713 shares of common stock per $1,000 principal amount, or approximately $6.59 per share, effective September 9, 2011.
The conversion ratio for the May 2015 Notes was adjusted to 132.6682 shares of common stock per $1,000 principal amount, or approximately $7.54 per share, effective September 6, 2011. However, we entered into purchased call options and warrants to synthetically increase the conversion ratio on the May 2015 Notes. The strike price on the warrants is approximately $8.87 per share.

 
Page 1

 
 
PDL BioPharma, Inc.
Q3-2011
November 9, 2011
 
Updates On Approved Royalty Bearing Products
 
ACTEMRA®/RoACTEMRA (tocilizumab):
  
On August 3, 2011, Roche announced that the European Commission has approved the use of RoACTEMRA for the treatment of active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients two years of age or older who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoACTEMRA can be used alone or in combination with methotrexate in patients with sJIA.

AVASTIN® (bevacizumab):
On September 23, 2011, Roche announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Avastin in combination with standard chemotherapy (carboplatin and paclitaxel) as a front-line therapy for women with advanced ovarian cancer.
On September 26, 2011, Chugai announced that Avastin in combination with paclitaxel has been approved by the Japanese Ministry of Health, Labour and Welfare to treat inoperable or recurrent breast cancer.

HERCEPTIN® (trastuzumab):
On October 18, 2011, Roche announced positive results from a Phase 3 study demonstrating that a subcutaneous formulation showed comparable efficacy to the standard intravenous infusion of Herceptin in women with HER2+ early breast cancer.

LUCENTIS® (ranibizumab):
On August 30, 2011, FDA issued a health warning alert after at least 16 AMD patients suffered eye infections after being treated with repackaged Avastin.

TYSABRI® (natalizumab):
On October 28, 2011, Biogen Idec announced that at the end of September 2011, they estimated that approximately 63,500 patients were on commercial and clinical TYSABRI therapy worldwide as compared with 61,500 at the end of June 2011.
Updates on Selected Development Stage Potential Royalty Bearing Products

OCRELIZUMAB:
On October 20, 2011, Roche announced results from a Phase 2 study of ocrelizumab in patients with relapsing-remitting multiple sclerosis  that showed the significant reduction in the total number of active brain lesions and relapses previously reported for 24 weeks was maintained through 96 weeks.

PERTUZUMAB (Unlicensed Product):
In July 2011, Roche announced positive results from a Phase 3 clinical trial using pertuzumab combined with Herceptin (trastuzumab) and docetaxel chemotherapy to treat patients with HER2-positive metastatic breast cancer. Based on this data, Roche plans to seek approval with US and EU regulatory authorities in 2011.

T-DM1 (trastuzumabemtansine):
On September 23, 2011, Roche/Genentech announced results from a Phase 2 trial in first line HER2+ breast cancer patients which showed a progression free survival of 14.2 months in the T-DM1 treated patients compared to 9.2 months in the women treated with combination of Herceptin and docetaxel.
Overall response rate was 64.2% in the T-DM1 treated patients and 58% in the Herceptin and docetaxel treated patients.
Roche/Genentech expect to file for second line approval in 2012 and first line approval in 2014.
 
 
Page 2

 
 
PDL BioPharma, Inc.
Q3-2011
November 9, 2011
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 PDL’s 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" 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.

###
 
 Page 3

ex99_3.htm

EXHIBIT 99.3
 
Royalty Revenue by Product ($ in 000's) *
           
Avastin
Q1
Q2
Q3
Q4
Total
2011
    22,283
    41,967
    23,870
            -
    88,120
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
2011
    25,089
    42,209
    31,933
            -
    99,231
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
2011
     8,878
    24,313
    12,157
            -
    45,348
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
2011
     4,590
     7,621
     5,916
            -
    18,126
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
2011
     9,891
    10,796
    11,588
            -
    32,275
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
 
Actemra
Q1
Q2
Q3
Q4
Total
2011
        913
     1,136
     1,401
            -
     3,450
2010
     1,587
        237
        315
        688
     2,827
2009
        585
        537
        909
     1,197
     3,228
2008
          44
            -
        146
        369
        559
2007
          32
            -
            -
          17
          49
2006
            -
            -
            -
            -
            -
* As reported to PDL by its licensees
   

 
 

 
 
Reported Net Sales Revenue by Product ($ in 000's) *
           
Avastin
Q1
Q2
Q3
Q4
Total
2011
  1,597,461
  1,582,705
  1,581,095
               -
  4,761,261
2010
  1,506,788
  1,596,892
  1,594,707
  1,646,218
  6,344,605
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
2011
  1,391,568
  1,559,975
  1,642,898
               -
  4,594,441
2010
  1,270,846
  1,349,512
  1,300,934
  1,409,310
  5,330,602
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
2011
     887,757
     943,418
  1,052,809
               -
  2,883,984
2010
     721,967
     698,890
     745,376
     804,684
  2,970,917
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
2011
     267,754
     277,642
     310,874
               -
     856,270
2010
     228,859
     225,878
     251,055
     263,389
     969,179
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
2011
     329,696
     356,876
     388,758
               -
  1,075,330
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
 
Actemra
Q1
Q2
Q3
Q4
Total
2011
      30,433
      35,370
      46,709
               -
     112,512
2010
      52,908
        5,405
      10,493
      22,919
      91,725
2009
      19,504
      17,920
      30,313
      39,888
     107,625
2008
        1,452
        1,377
        5,981
      12,305
      21,115
2007
               -
               -
               -
        1,137
        1,137
2006
               -
               -
               -
               -
               -
 
* As reported to PDL by its licensees
   

 
 

 

Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
             
Avastin Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
      814,872
      820,453
      800,139
      708,539
      719,967
      688,966
US Made & ex-US Sold
      355,742
      338,929
      415,576
      580,981
      548,710
      587,975
ex-US Made & Sold
      426,277
      435,325
      430,503
      307,941
      314,028
      304,155
Total
   1,596,892
   1,594,707
   1,646,218
   1,597,461
   1,582,705
   1,581,095
US Made & Sold
            51%
            51%
             49%
           44%
           45%
            44%
US Made & ex-US Sold
            22%
            21%
             25%
           36%
           35%
            37%
ex-US Made & Sold
            27%
            27%
              26%
           19%
           20%
            19%
 
Herceptin Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
      406,222
      410,563
      416,611
      409,854
      442,903
      445,395
US Made & ex-US Sold
      312,792
      306,085
      425,303
      423,053
      642,670
      495,086
ex-US Made & Sold
      630,498
      584,286
      567,396
      558,661
      474,402
      702,416
Total
   1,349,512
   1,300,934
   1,409,310
   1,391,568
   1,559,975
   1,642,898
US Made & Sold
             30%
            32%
              30%
           29%
           28%
            27%
US Made & ex-US Sold
             23%
            24%
             30%
           30%
           41%
            30%
ex-US Made & Sold
             47%
            45%
              40%
           40%
           30%
            43%
 
Lucentis Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
      300,501
      326,840
      360,911
      378,451
      409,674
      422,335
US Made & ex-US Sold
      398,389
      418,536
      443,773
      509,307
      533,745
      630,474
ex-US Made & Sold
                -
                -
                -
                -
                -
                -
Total
      698,890
      745,376
      804,684
      887,757
      943,418
   1,052,809
US Made & Sold
             43%
            44%
             45%
           43%
           43%
            40%
US Made & ex-US Sold
             57%
            56%
             55%
           57%
           57%
            60%
ex-US Made & Sold
              0%
              0%
               0%
             0%
             0%
              0%
 
Xolair Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
      145,245
      165,109
      170,001
      164,621
      167,608
      184,837
US Made & ex-US Sold
                -
                -
                -
                -
                -
                -
ex-US Made & Sold
       80,632
       85,945
       93,388
      103,133
      110,034
      126,037
Total
      225,878
      251,055
      263,389
      267,754
      277,642
      310,874
US Made & Sold
             64%
            66%
             65%
            61%
           60%
            59%
US Made & ex-US Sold
               0%
              0%
               0%
             0%
             0%
              0%
ex-US Made & Sold
             36%
            34%
              35%
            39%
           40%
            41%
 
Total Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
   1,666,840
   1,722,965
   1,747,662
   1,661,465
   1,740,152
   1,741,534
US Made & ex-US Sold
   1,081,147
   1,063,551
   1,284,652
   1,513,340
   1,725,125
   1,713,535
ex-US Made & Sold
   1,137,407
   1,105,556
   1,091,287
      969,735
      898,464
   1,132,608
Total
   3,885,394
   3,892,072
   4,123,601
   4,144,540
   4,363,741
   4,587,677
US Made & Sold
             43%
            44%
             42%
           40%
           40%
            38%
US Made & ex-US Sold
             28%
            27%
             31%
           37%
           40%
            37%
ex-US Made & Sold
            29%
            28%
             26%
           23%
           21%
            25%
 
* As reported to PDL by its licensees