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 23, 2012
PDL BioPharma, Inc.
(Exact name of Company as specified in its charter)
000-19756
(Commission File Number)
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Delaware
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94-3023969
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(State or Other Jurisdiction of
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(I.R.S. Employer Identification No.)
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Incorporation)
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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:
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 2.02 Results of Operations and Financial Condition.
On February 23, 2012, PDL BioPharma, Inc. (the Company) issued a press release announcing the financial results for the fourth quarter and year ended December 31, 2011. A copy of this earnings release is attached hereto as Exhibit 99.1. The Company will host an earnings call and webcast on February 23, 2012, during which the Company will discuss its financial results for the fourth quarter and year ended December 31, 2011.
Item 7.01 Regulation FD Disclosure.
On February 23, 2012, the Company distributed to analysts covering the Company’s securities a summary of certain information regarding the Company’s net income, non-GAAP net income, dividends, convertible notes, product development, and licensed product development and sales (the Information Sheet) to assist those analysts in valuing the Company’s securities. Copies of the Information Sheet and its associated tables are attached hereto as Exhibits 99.2 and 99.3, respectively.
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 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.
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Exhibit No.
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Description
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99.1
99.2
99.3
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Press Release
Information Sheet
Tables to Information Sheet
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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PDL BIOPHARMA, INC.
(Company)
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By:
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/s/ John P. McLaughlin | ||
| John P. McLaughlin
President, Chief Executive Officer and Acting
Chief Financial Officer
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Dated: February 23, 2012
EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
99.2
99.3
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Press Release
Information Sheet
Tables to Information Sheet
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Exhibit 99.1
| Contacts:
John McLaughlin
PDL BioPharma, Inc.
775-832-8500
john.mclaughlin@pdl.com
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Jennifer Williams
Cook Williams Communications
360-668-3701
jennifer@cwcomm.org
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PDL BioPharma Announces Fourth Quarter and Full Year 2011 Financial Results
INCLINE VILLAGE, NV, February 23, 2012 – PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today reported financial results for the fourth quarter and full year ended December 31, 2011.
Total revenues in 2011 were $362 million, compared to $345 million in 2010, with royalty revenues increasing two percent over full year 2010. For the fourth quarter of 2011, total revenues were $72.8 million, compared to $76.1 million in the fourth quarter of 2010.
Royalty revenues for the fourth quarter of 2011 are based on third quarter product sales by PDL’s licensees. The fourth quarter 2011 revenue decline is primarily driven by reduced royalties from third quarter 2011 sales of Avastin® and Herceptin®, which are marketed by Genentech and Roche, partially offset by increased royalties from third quarter 2011 sales of Lucentis® which is marketed by Genentech and Novartis, and Tysabri®, which is marketed by Elan and Biogen Idec. Royalty revenue for the fourth quarter and 2011 are net of payments made under our February 2011 settlement agreement with Novartis Pharma AG.
Operating expenses in 2011 were $18.3 million, compared with $133.9 million in 2010. Included in operating expenses in 2010 is a $92.5 million legal settlement with MedImmune and $41.4 million in general and administrative expenses. For the fourth quarter of 2011, general and administrative expenses were $4.8 million compared with $12.1 million for the same period of 2010.
Net income in 2011 was $199.4 million, or $1.15 per diluted share as compared with net income of $91.9 million in 2010 or $0.54 per diluted share. Net income for the fourth quarter of 2011 was $38.9 million or $0.24 per diluted share as compared with a net loss of $24.5 million or $(0.18) per diluted share for the same period of 2010. Adjusting for effects of certain convertible note transactions throughout the year, non-GAAP net income for 2011 was $201.6 million, or $1.17 per diluted share. Non-GAAP net income was $168.4 million, or $0.97 per diluted share in 2010, adjusting for the legal settlement with MedImmune and the effects of certain convertible note transactions in that year. Non-GAAP net income for the fourth quarter of 2011 was $39.6 million, or $0.24 per diluted share, compared to non-GAAP net income of $35.0 million, or $0.20 per diluted share for the fourth quarter of 2010.
Net cash provided by operating activities in 2011 was $169.8 million, compared with $184.3 million in 2010. At December 31, 2011, PDL had cash, cash equivalents and investments of $227.9 million, compared with $248.2 million at December 31, 2010.
Recent Developments
2012 Dividends
On January 18, 2012, PDL’s Board of Directors declared regular quarterly dividends of $0.15 per share of common stock, payable on March 14, June 14, September 14 and December 14 of 2012 to stockholders of record on March 7, June 7, September 7 and December 7 of 2012, the record dates for each of the dividend payments, respectively.
Exchange and Retirement of Convertible Notes
In January and February 2012, we completed public and privately negotiated exchange transactions where we exchanged and subsequently retired $179.0 million aggregate principal amount, representing over 99% of our 2.875% Convertible Senior Notes due February 15, 2015 (February 2015 Notes), for $179.0 million aggregate principal amount of new 2.875% Series 2012 Convertible Senior Notes due February 15, 2015 (Series 2012 Notes). In the public exchanges, we made one-time cash payments of $5.00 for each $1,000 principal amount tendered for a total cash incentive payment of $0.8 million. Following settlement of the exchanges on February 2, 2012, $1.0 million of our February 2015 Notes and $179.0 million of our Series 2012 Notes were outstanding. Our Series 2012 Notes net share settle. The effect of issuing $179.0 million aggregate principal of our Series 2012 Notes with the net share settle feature in exchange for our February 2015 Notes was the reduction of 27.8 million shares of potential dilution to our stockholders.
Revenue Guidance for 2012
As previously announced, PDL will continue to provide revenue guidance for each quarter in the third month of that quarter. First quarter 2012 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 23, 2012.
To access the live conference call via phone, please dial (877) 677-9122 from the United States and Canada or (708) 290-1401 internationally. 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 1, 2012, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 50024423.
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. 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" 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. 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. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new royalty bearing assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission and updated by subsequent Quarterly Reports on Form 10-Q. 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.
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PDL BIOPHARMA, INC.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS DATA
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(Unaudited)
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(In thousands, except per share amounts)
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Three Months Ended
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Year Ended
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December 31,
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December 31,
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2011
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2010
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2011
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2010
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Revenues
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Royalties
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$ | 72,808 | $ | 74,629 | $ | 351,641 | $ | 343,475 | ||||||||
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License and other
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- | 1,500 | 10,400 | 1,500 | ||||||||||||
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Total revenues
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72,808 | 76,129 | 362,041 | 344,975 | ||||||||||||
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Operating Expenses
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General and administrative expenses
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4,822 | 12,056 | 18,338 | 41,396 | ||||||||||||
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Legal Settlement
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- | 92,500 | - | 92,500 | ||||||||||||
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Total operating expenses
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4,822 | 104,556 | 18,338 | 133,896 | ||||||||||||
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Operating income (loss)
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67,986 | (28,427 | ) | 343,703 | 211,079 | |||||||||||
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Non-operating expense, net
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Gain (loss) on retirement or conversion of convertible notes
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- | 1,033 | (766 | ) | (17,648 | ) | ||||||||||
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Interest and other income, net
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130 | 131 | 593 | 468 | ||||||||||||
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Interest expense
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(8,161 | ) | (9,514 | ) | (36,102 | ) | (43,529 | ) | ||||||||
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Total non-operating expense, net
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(8,031 | ) | (8,350 | ) | (36,275 | ) | (60,709 | ) | ||||||||
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Income before income taxes
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59,955 | (36,777 | ) | 307,428 | 150,370 | |||||||||||
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Income tax expense (benefit)
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21,013 | (12,317 | ) | 108,039 | 58,496 | |||||||||||
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Net income (loss)
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$ | 38,942 | $ | (24,460 | ) | $ | 199,389 | $ | 91,874 | |||||||
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Net income (loss) per share
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Basic
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$ | 0.28 | $ | (0.18 | ) | $ | 1.43 | $ | 0.73 | |||||||
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Diluted
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$ | 0.24 | $ | (0.18 | ) | $ | 1.15 | $ | 0.54 | |||||||
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Cash dividends declared per common share
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$ | - | $ | - | $ | 0.60 | $ | 1.00 | ||||||||
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Shares used to compute income (loss) per basic share
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139,680 | 139,542 | 139,663 | 126,578 | ||||||||||||
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Shares used to compute income (loss) per diluted share
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167,683 | 139,542 | 177,441 | 178,801 | ||||||||||||
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PDL BIOPHARMA, INC.
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RECONCILIATION OF GAAP FINANCIAL INFORMATION TO NON-GAAP
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(Unaudited)
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(In thousands, except non-GAAP net income per diluted share amounts)
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Three Months Ended
December 31,
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Year Ended
December 31,
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2011
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2010
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2011
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2010
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Net income (loss)
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$ | 38,942 | $ | (24,460 | ) | $ | 199,389 | $ | 91,874 | |||||||
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Add back:
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Legal settlement expense, net of estimated taxes
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- | 60,125 | - | 60,125 | ||||||||||||
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(Gain) loss on retirement or conversion of convertible notes, net of estimated taxes
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- | (660 | ) | 498 | 16,431 | |||||||||||
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Amortization of debt discount for May 2015 Notes, net of estimated taxes
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696 | - | 1,716 | - | ||||||||||||
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Non-GAAP net income
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39,638 | 35,005 | 201,603 | 168,430 | ||||||||||||
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Add back interest expense for implied conversion of convertible notes included in determination of fully diluted shares, net of estimated taxes
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1,122 | 1,105 | 5,544 | 5,087 | ||||||||||||
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Non-GAAP income used to compute non-GAAP net income per diluted share
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$ | 40,760 | $ | 36,110 | $ | 207,147 | $ | 173,517 | ||||||||
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Shares used to compute net income per diluted share
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167,683 | 139,542 | 177,441 | 178,801 | ||||||||||||
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Adjustment to shares issued to induce note conversion to common stock (1)
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- | (185 | ) | - | (73 | ) | ||||||||||
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Effect of dilutive stock options(2)
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- | 12 | - | - | ||||||||||||
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Restricted stock outstanding(2)
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- | 115 | - | - | ||||||||||||
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Assumed conversion of 2012 Notes(2)
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- | 23,399 | - | - | ||||||||||||
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Assumed conversion of February 2015 Notes(2)
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- | 16,777 | - | - | ||||||||||||
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Shares used to compute non-GAAP net income per diluted share
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167,683 | 179,660 | 177,441 | 178,728 | ||||||||||||
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Non-GAAP net income per diluted share
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$ | 0.24 | $ | 0.20 | $ | 1.17 | $ | 0.97 | ||||||||
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(1) Shares for the quarter and 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.
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(2) Shares for the quarter ended December 31, 2010, include the dilutive effect of stock options, restricted stock outstanding, assumed conversion of the 2012 Notes and assumed conversion of the February 2015 Notes. These shares were excluded from the GAAP net loss per diluted share calculation because they were anti-dilutive.
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PDL BIOPHARMA, INC.
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GENERAL AND ADMINISTRATIVE EXPENSE DATA
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(Unaudited)
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(In thousands)
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Three Months Ended
December 31,
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Year Ended
December 31,
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2011
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2010
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2011
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2010
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Operating expenses:
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General and administrative
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Compensation and benefits
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$ | 1,470 | $ | 1,103 | $ | 4,428 | $ | 4,065 | ||||||||
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Legal expense
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1,780 | 8,494 | 7,942 | 29,315 | ||||||||||||
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Professional services
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673 | 325 | 2,674 | 2,943 | ||||||||||||
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Insurance
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169 | 185 | 724 | 793 | ||||||||||||
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Stock-based compensation
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131 | 138 | 387 | 662 | ||||||||||||
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Depreciation
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14 | 14 | 58 | 91 | ||||||||||||
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Other
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585 | 1,797 | 2,125 | 3,527 | ||||||||||||
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Total general and administrative expenses
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4,822 | 12,056 | 18,338 | 41,396 | ||||||||||||
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Legal settlement
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- | 92,500 | - | 92,500 | ||||||||||||
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Total operating expenses
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$ | 4,822 | $ | 104,556 | $ | 18,338 | $ | 133,896 | ||||||||
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PDL BIOPHARMA, INC.
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CONDENSED CONSOLIDATED BALANCE SHEET DATA
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(Unaudited)
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(In thousands)
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December 31,
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2011
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2010
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Cash, cash equivalents and investments
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$ | 227,946 | $ | 248,229 | ||||
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Total assets
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$ | 269,471 | $ | 316,666 | ||||
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Convertible notes payable
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$ | 316,615 | $ | 310,428 | ||||
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Non-recourse notes payable
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$ | 93,370 | $ | 204,270 | ||||
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Total stockholders' deficit
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$ | (204,273 | ) | $ | (324,182 | ) | ||
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PDL BIOPHARMA, INC.
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW DATA
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(Unaudited)
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(In thousands)
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Year Ended
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December 31,
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2011
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2010
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Net income
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$ | 199,389 | $ | 91,874 | ||||
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Adjustments to reconcile net income to net cash provided by operating activities
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43,574 | 21,777 | ||||||
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Changes in assets and liabilities
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(73,181 | ) | 70,649 | |||||
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Net cash provided by operating activities
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$ | 169,782 | $ | 184,300 | ||||
| PDL BIOPHARMA, INC. | |||||||||||||||||
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MIX OF EX-U.S. SALES AND EX-U.S.-BASED MANUFACTURING AND SALES
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(Unaudited)
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|||||||||||||||||
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Three Months Ended
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Year Ended
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December 31,
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December 31,
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2011
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2010
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2011
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2010
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Avastin
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% Ex-U.S. Sold
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53 | % | 51 | % | 55 | % | 50 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold
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28 | % | 26 | % | 21 | % | 21 | % | |||||||||
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Herceptin
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% Ex-U.S. Sold
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68 | % | 70 | % | 71 | % | 70 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold
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26 | % | 40 | % | 35 | % | 44 | % | |||||||||
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Lucentis
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% Ex-U.S. Sold
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60 | % | 55 | % | 59 | % | 56 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold
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0 | % | 0 | % | 0 | % | 0 | % | |||||||||
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Xolair
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% Ex-U.S. Sold
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40 | % | 35 | % | 40 | % | 35 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold
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40 | % | 35 | % | 40 | % | 35 | % | |||||||||
Exhibit 99.2
PDL BioPharma, Inc.
Q4-2011
February 23, 2012
Following are some of the key points from PDL’s press release today regarding its fourth quarter and year end 2011 financial and business results.
Net Income
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·
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Net income for the fourth quarter of 2011 was $38.9 million or $0.24 per diluted share as compared with a net loss of $24.5 million or $(0.18) per diluted share for the same period of 2010.
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·
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Net income in 2011 was $199.4 million, or $1.15 per diluted share as compared with net income of $91.9 million in 2010 or $0.54 per diluted share.
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Non-GAAP Net Income
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·
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Non-GAAP net income for the fourth quarter of 2011 was $39.6 million, or $0.24 per diluted share, compared to non-GAAP net income of $35 million, or $0.20 per diluted share for the fourth quarter of 2010.
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·
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Non-GAAP net income for 2011 was $201.6 million, or $1.17 per diluted share, compared to non-GAAP net income of $168.4 million, or $0.97 per diluted share in 2010.
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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:
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·
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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.
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·
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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.
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2011 and 2012 Dividends
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·
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We paid $0.15 per share of common stock or $21.0 million to our stockholders on December 15, 2011, to stockholders of record on December 8, 2011, as part of our regular, quarterly dividend policy for 2011.
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·
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We declared a regular, quarterly dividend of $0.15 per share of common stock payable on March 14, June 14, September 14 and December 14 to stockholders of record on March 7, June 7, September 7 and December 7.
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Adjustments to Convertible Notes Conversion Ratios
In connection with the December 15, 2011 dividend payment, the adjusted conversion rates are:
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·
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For our 2.875% Convertible Senior Notes due February 15, 2015, 155.396 shares of common stock per $1,000 principal amount or approximately $6.44 per share,
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·
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For our 3.75% Convertible Senior Notes due May 2015, 135.9607 shares of common stock per $1,000 principal amount or approximately $7.36 per share.
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Page 1
PDL BioPharma, Inc.
Q4-2011
February 23, 2012
Updates On Approved Royalty Bearing Products
ACTEMRA®/RoACTEMRA (tocilizumab):
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·
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In February 2012, Roche announced that Health Canada approved Actemra for the treatment of systemic juvenile idiopathic arthritis (sJIA).
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·
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On February 21, 2012, Chugai and Roche announced that their supplemental Biologics License Application (sBLA) to broaden the approved patient population to include moderately to severely active rheumatoid arthritis (RA) who have either responded inadequately to, or who were intolerant to, previous therapy with other approved therapeutics, has been accepted, with a Prescription Drug User Fee Act (PDUFA) date in October 2012.
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AVASTIN® (bevacizumab):
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·
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On November 18, 2011, FDA revoked its approval for treatment of HER2-negative breast cancer effective immediately. This decision does not affect any of the Avastin’s other approvals.
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·
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Genentech announced that it will start a Phase 3 trial in 2012 of Avastin plus paclitaxel in previously untreated metastatic breast cancer.
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·
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EMEA narrowed, but did not withdraw, Avastin’s approval for first line treatment of HER2-negative breast cancer in combination with paclitaxel or with Xeloda.
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·
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In December 2011, Avastin received approval in the EU for the treatment of women with newly diagnosed advanced ovarian cancer, which allows the use of Avastin in combination with standard chemotherapy (carboplatin and paclitaxel) for the front-line treatment (first-line treatment following surgery) of advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma.
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LUCENTIS® (ranibizumab):
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·
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On November 18, 2011, FDA approved Regeneron and Bayer’s Eylea (aflibercept) for the treatment of age-related macular degeneration (AMD). In February 2012, Regeneron reported that Eylea has been administered to more than 30,000 patients since launch, and while there have been reports of intraocular inflammation, it is within the reported incidence in the literature relevant to Eylea.
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·
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FDA approved a dosing schedule of monthly injections for the first three months and bi-monthly injections thereafter.
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·
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Eylea is priced at $100 less per injection than Lucentis. Lucentis is $1,950 per injection.
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·
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On January 3, 2012, Regeneron and Genentech announced a settlement of their patent litigation regarding Eylea under which Regeneron will pay royalties to Genentech on Eylea sales.
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TYSABRI® (natalizumab):
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·
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As of December 2011, Biogen Idec estimates that approximately 64,400 patients were on commercial and clinical TYSABRI therapy worldwide.
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Updates on Selected Development Stage Potential Royalty Bearing Products
PERTUZUMAB:
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·
|
In December, Roche and Genentech filed EU and US marketing applications for pertuzumab for HER2-positive metastatic breast cancer, based on study results which showed that pertuzumab combined with Herceptin and chemotherapy significantly extended progression free survival, compared with Herceptin and docetaxel alone.
|
|
|
·
|
In February 2012, Roche announced that FDA accepted the company’s BLA for pertuzumab and grated Priority Review with an action date of June 8, 2012. Pertuzumab is under review for use in combination with Herceptin and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable breast cancer, who have not received previous treatment or whose disease has relapsed after adjuvant therapy.
|
|
|
·
|
In February 2012, Roche forecast sales of more than $1 billion for Pertuzumab when it is approved.
|
Page 2
PDL BioPharma, Inc.
Q4-2011
February 23, 2012
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new royalty bearing assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, and updated by subsequent Quarterly Reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward-looking statement except as required by law.
###
Page 3
Exhibit 99.3
|
Reported Net Sales Revenue by Product ($ in 000's) *
|
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||
|
2011
|
1,597,461
|
1,582,705
|
1,581,095
|
1,469,994
|
6,231,255
|
|||||
|
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
|
1,432,771
|
6,027,211
|
|||||
|
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
|
1,075,015
|
3,958,999
|
|||||
|
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
|
314,911
|
1,171,182
|
|||||
|
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
|
381,618
|
1,456,948
|
|||||
|
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
|
48,671
|
161,183
|
|||||
|
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
|
||||||||||
|
Totals may not sum due to rounding
|
||||||||||
|
Royalty Revenue by Product ($ in 000's) *
|
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|||||
|
2011
|
22,283
|
41,967
|
23,870
|
22,886
|
111,006
|
|||||
|
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
|
21,812
|
121,042
|
|||||
|
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
|
10,750
|
56,099
|
|||||
|
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
|
5,823
|
23,949
|
|||||
|
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
|
11,450
|
43,725
|
|||||
|
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
|
1,460
|
4,910
|
|||||
|
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
|
|
Totals may not sum due to rounding
|
|
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
|
|
Avastin Sales
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
||||||
|
US Made & Sold
|
820,453
|
800,139
|
708,539
|
719,967
|
688,966
|
684,878
|
||||||
|
US Made & ex-US Sold
|
338,929
|
415,576
|
580,981
|
548,710
|
587,975
|
375,830
|
||||||
|
ex-US Made & Sold
|
435,325
|
430,503
|
307,941
|
314,028
|
304,155
|
409,286
|
||||||
|
Total
|
1,594,707
|
1,646,218
|
1,597,461
|
1,582,705
|
1,581,095
|
1,469,994
|
||||||
|
US Made & Sold
|
51%
|
49%
|
44%
|
45%
|
44%
|
47%
|
||||||
|
US Made & ex-US Sold
|
21%
|
25%
|
36%
|
35%
|
37%
|
26%
|
||||||
|
ex-US Made & Sold
|
27%
|
26%
|
19%
|
20%
|
19%
|
28%
|
||||||
|
Herceptin Sales
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
||||||
|
US Made & Sold
|
410,563
|
416,611
|
409,854
|
442,903
|
445,395
|
453,168
|
||||||
|
US Made & ex-US Sold
|
306,085
|
425,303
|
423,053
|
642,670
|
495,086
|
612,908
|
||||||
|
ex-US Made & Sold
|
584,286
|
567,396
|
558,661
|
474,402
|
702,416
|
366,695
|
||||||
|
Total
|
1,300,934
|
1,409,310
|
1,391,568
|
1,559,975
|
1,642,898
|
1,432,771
|
||||||
|
US Made & Sold
|
32%
|
30%
|
29%
|
28%
|
27%
|
32%
|
||||||
|
US Made & ex-US Sold
|
24%
|
30%
|
30%
|
41%
|
30%
|
43%
|
||||||
|
ex-US Made & Sold
|
45%
|
40%
|
40%
|
30%
|
43%
|
26%
|
||||||
|
Lucentis Sales
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
||||||
|
US Made & Sold
|
326,840
|
360,911
|
378,451
|
409,674
|
422,335
|
428,884
|
||||||
|
US Made & ex-US Sold
|
418,536
|
443,773
|
509,307
|
533,745
|
630,474
|
646,131
|
||||||
|
ex-US Made & Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||
|
Total
|
745,376
|
804,684
|
887,757
|
943,418
|
1,052,809
|
1,075,015
|
||||||
|
US Made & Sold
|
44%
|
45%
|
43%
|
43%
|
40%
|
40%
|
||||||
|
US Made & ex-US Sold
|
56%
|
55%
|
57%
|
57%
|
60%
|
60%
|
||||||
|
ex-US Made & Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
||||||
|
Xolair Sales
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
||||||
|
US Made & Sold
|
165,109
|
170,001
|
164,621
|
167,608
|
184,837
|
188,728
|
||||||
|
US Made & ex-US Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||
|
ex-US Made & Sold
|
85,945
|
93,388
|
103,133
|
110,034
|
126,037
|
126,184
|
||||||
|
Total
|
251,055
|
263,389
|
267,754
|
277,642
|
310,874
|
314,911
|
||||||
|
US Made & Sold
|
66%
|
65%
|
61%
|
60%
|
59%
|
60%
|
||||||
|
US Made & ex-US Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
||||||
|
ex-US Made & Sold
|
34%
|
35%
|
39%
|
40%
|
41%
|
40%
|
||||||
|
Total Sales
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
||||||
|
US Made & Sold
|
1,722,965
|
1,747,662
|
1,661,465
|
1,740,152
|
1,741,534
|
1,755,657
|
||||||
|
US Made & ex-US Sold
|
1,063,551
|
1,284,652
|
1,513,340
|
1,725,125
|
1,713,535
|
1,634,869
|
||||||
|
ex-US Made & Sold
|
1,105,556
|
1,091,287
|
969,735
|
898,464
|
1,132,608
|
902,165
|
||||||
|
Total
|
3,892,072
|
4,123,601
|
4,144,540
|
4,363,741
|
4,587,677
|
4,292,691
|
||||||
|
US Made & Sold
|
44%
|
42%
|
40%
|
40%
|
38%
|
41%
|
||||||
|
US Made & ex-US Sold
|
27%
|
31%
|
37%
|
40%
|
37%
|
38%
|
||||||
|
ex-US Made & Sold
|
28%
|
26%
|
23%
|
21%
|
25%
|
21%
|
||||||
|
* As reported to PDL by its licensees
|
|
Totals may not sum due to rounding
|