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): April 27, 2011
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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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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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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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 April 27, 2011, PDL BioPharma, Inc. (the “Company”) issued a press release announcing the financial results for the first quarter ended March 31, 2011. A copy of this earnings release is attached as Exhibit 99.1 hereto. The Company will host an earnings call and webcast on April 27, 2011, during which the Company will discuss its financial results for the first quarter ended March 31, 2011.
Item 7.01 Regulation FD Disclosure.
On April 27, 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 is attached hereto as Exhibit 99.2.
Limitation of Incorporation by Reference
In accordance with General Instruction B.2. of Form 8-K, the information in this report, including the exhibits, is furnished pursuant to Items 2.02 and 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
Cautionary Statements
This filing includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Important factors that could impair the Company’s royalty assets or business are disclosed in the “Risk Factors” contained in the Company’s 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.
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Exhibit No.
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Description
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99.1
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Press Release, dated April 27, 2011
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| 99.2 | Information Sheet, dated April 27, 2011 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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PDL BIOPHARMA, INC.
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| (Company) | |||
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By:
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/s/Christine R. Larson | |
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Christine R. Larson
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Vice President and Chief Financial Officer
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| Dated: April 27, 2011 | |||
EXHIBIT INDEX
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Exhibit No.
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Description | |
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Press Release, dated April 27, 2011
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| 99.2 | Information Sheet, dated April 27, 2011 |
| Contacts: | |
| Cris Larson | Jennifer Williams |
| PDL BioPharma, Inc. | Cook Williams Communications |
| 775-832-8505 | 360-668-3701 |
| Cris.Larson@pdl.com | jennifer@cwcomm.org |
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PDL BioPharma Announces First Quarter 2011 Financial Results
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–Conference Call Today at 4:30 p.m. Eastern Time –
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INCLINE VILLAGE, NV, April 27, 2011 – PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today reported financial results for the first quarter ended March 31, 2011.
Total revenues for the first quarter of 2011 were $83.3 million, compared to $62.1 million for the same period of 2010, and include a one-time settlement payment of $10 million from UCB Pharma resolving all legal disputes between the two companies. Excluding the one-time settlement payment, total revenue increased 18 percent for the first quarter of 2011 when compared to total revenue for the same period of 2010.
Royalty revenues for the first quarter of 2011 are based on fourth quarter 2010 product sales by PDL’s licensees. Revenue growth for the first quarter of 2011 over the same period in 2010 was primarily driven by increased fourth quarter 2010 sales by the Company’s licensees of Herceptin®, which is marketed by Genentech and Roche; Lucentis®, which is marketed by Genentech and Novartis; and Tysabri®, which is marketed by Elan and Biogen Idec. Also contributing to the increased royalty revenue are increased royalties from sales of Avastin® that was both manufactured and sold outside of the United States. PDL received royalties for these product sales in the first quarter of 2011.
Total general and administrative expenses for the first quarter of 2011 were $5.8 million, compared with $9.4 million for the same period of 2010. The decrease in general and administrative expenses was primarily driven by decreases in legal and professional services expenses. The decrease in legal expense is a result of the conclusion of the outstanding legal issues with MedImmune, the opposition to PDL’s European patent in the European Patent Office (EPO) and the interference proceedings in the U.S. Patent and Trademark Office (PTO), all of which were resolved in the first quarter of 2011. The decrease in professional services expense resulted from reduced costs associated with one-time special project costs. Significant components of general and administrative expenses in the first quarter of 2011 were legal fees of $3.5 million, compensation and benefits expense of $0.9 million, and professional services expense of $0.6 million.
Net income for the first quarter of 2011 was $44.5 million, or $0.25 per diluted share, compared with net income of $26.0 million, or $0.15 per diluted share for the same period of 2010.
Net cash used in operating activities for the first quarter of 2011 was $13.2 million, compared with $26.9 million in net cash provided by operating activities for the first quarter of 2010. At March 31, 2011, PDL had cash, cash equivalents and investments of $193.5 million, compared with $248.2 million at December 31, 2010.
RECENT DEVELOPMENTS
Declaration of 2011 Regular Quarterly Dividends and March 15, 2011, Dividend Payment
On February 25, 2011, PDL’s board of directors adopted a regular, quarterly dividend policy and declared that the quarterly dividends to be paid to PDL stockholders in 2011 will be $0.15 per share of common stock. The dividends are payable on March 15, June 15, September 15 and December 15 of 2011 to stockholders of record on March 8, June 8, September 8 and December 8 of 2011, the Record Dates for each of the dividend payments, respectively. On March 15, 2011, PDL paid the first quarterly dividend to its stockholders totaling $21.0 million using earnings generated in the first quarter of 2011 and cash on hand.
Resolution of Legal Disputes
In early 2011, we resolved a number of challenges to our Queen et al. patent estate in the United States and in Europe:
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We reached a settlement agreement with MedImmune resolving all disputes between us related to both sales of their product, Synagis®, and the Queen et al. patent estate, including their challenge to our European patent before the EPO; we agreed to pay MedImmune $92.5 million as a result of this agreement of which we paid $65.0 million in February 2011 and the balance of $27.5 million is due in February 2012;
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We reached a settlement agreement with UCB Pharma resolving all disputes between us, including their challenges to our U.S. patents before the PTO and our European patent before the EPO; we received a $10 million payment in conjunction with this agreement;
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We reached a settlement agreement with Novartis resolving all disputes between us, including their challenge to our European patent before the EPO; the settlement agreement also included the dismissal of Novartis from all claims in the Nevada state court; and
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We acquired BioTransplant Incorporated, a bankrupt company, and instructed its representative to cease its activities before the EPO in the opposition against us.
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As a result of the settlements and the acquisition, the EPO cancelled its opposition hearing regarding the appeal of the validity of our European patent and the claims of our European patent are deemed to be valid in this final action of the EPO. In the three months ended March 31, 2011, approximately 40 percent of our revenues were derived from sales of products made in Europe and sold outside of the United States.
Convertible Notes
Effective March 7, 2011, in connection with the dividend payment on March 15, 2011, the conversion ratios for PDL’s 2.00% Convertible Senior Notes due February 15, 2012 (the 2012 Notes) and the 2.875% Convertible Senior Notes due February 15, 2015 (the 2015 Notes) were adjusted to144.474 shares of common stock per $1,000 principal amount or $6.92 per share. The conversion rate for each of the 2012 Notes and the 2015 Notes was previously 140.571 shares of common stock per $1,000 principal amount. In connection with a cash dividend, the conversion rate is increased by multiplying the previous conversion rate by a fraction, the numerator of which is the average closing price of PDL's common stock for the five consecutive trading days immediately preceding the ex-dividend date of March 4, 2011, for the cash dividend, and the denominator of which is the difference of such average closing price less the dividend amount.
Revenue Guidance for 2011
As previously announced, PDL will continue to provide revenue guidance for each quarter in the third month of that quarter. Second quarter 2011 revenue guidance will be provided in early June.
Conference Call Details
PDL will hold a conference call to discuss financial results at 4:30 p.m. ET today, April 27, 2011.
To access the live conference call via phone, please dial (888) 396-2384 from the United States and Canada or (617) 847-8711 internationally. The conference ID is 47670706. 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 May 4, 2011, and may be accessed by dialing (888) 286-8010 from the United States and Canada or (617) 801-6888 internationally. The replay passcode is 86999670.
To access the live and subsequently archived webcast of the conference call, go to the Company’s website at http://www.pdl.com and go to “Company Presentations & Events.” Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
About PDL BioPharma
PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases. PDL is focused on maximizing the value of its antibody humanization patents and related assets. The Company receives royalties on sales of a number of humanized antibody products marketed by leading pharmaceutical and biotechnology companies today based on patents which expire in late 2014. For more information, please visit www.pdl.com.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.
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:
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The expected rate of growth in royalty-bearing product sales by PDL’s existing licensees;
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The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus manufactured or sold in the U.S.;
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The ability of our licensees to receive regulatory approvals to market and launch new royalty-bearing products and whether such products, if launched, will be commercially successful;
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Changes in any of the other assumptions on which PDL’s projected royalty revenues are based;
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The outcome of pending litigation or disputes;
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The change in foreign currency exchange rates; and
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The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.
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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.
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PDL BIOPHARMA, INC.
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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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March 31,
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2011
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2010
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Revenues
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Royalties
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$ | 73,336 | $ | 62,061 | ||||
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License and other
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10,000 | - | ||||||
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Total revenues
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83,336 | 62,061 | ||||||
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General and administrative expense
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5,779 | 9,410 | ||||||
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Operating income
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77,557 | 52,651 | ||||||
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Interest and other income, net
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175 | 80 | ||||||
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Interest expense
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(9,154 | ) | (12,527 | ) | ||||
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Income before income taxes
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68,578 | 40,204 | ||||||
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Income tax expense
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24,033 | 14,197 | ||||||
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Net income
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$ | 44,545 | $ | 26,007 | ||||
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Net income per basic share
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$ | 0.32 | $ | 0.22 | ||||
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Net income per diluted share
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$ | 0.25 | $ | 0.15 | ||||
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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 per basic share
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139,640 | 119,525 | ||||||
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Shares used to compute income per diluted share
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184,954 | 184,308 | ||||||
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PDL BIOPHARMA, INC.
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OPERATING EXPENSE DATA
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(Unaudited)
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(In thousands)
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Three Months Ended
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March 31,
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2011
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2010
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General and administrative expenses:
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Compensation and benefits
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$ | 942 | $ | 1,001 | ||||
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Legal fees
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3,495 | 6,350 | ||||||
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Professional services
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568 | 1,078 | ||||||
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Insurance
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204 | 228 | ||||||
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Stock-based compensation
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50 | 188 | ||||||
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Depreciation
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14 | 34 | ||||||
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Other
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506 | 531 | ||||||
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Total general and administrative
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5,779 | 9,410 | ||||||
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PDL BIOPHARMA, INC.
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CONSOLIDATED BALANCE SHEET DATA
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(Unaudited)
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(In thousands)
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March 31,
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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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$ | 193,463 | $ | 248,229 | ||||
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Total assets
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$ | 248,704 | $ | 316,666 | ||||
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Convertible notes payable
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$ | 310,601 | $ | 310,428 | ||||
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Non-recourse notes payable
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$ | 183,959 | $ | 204,270 | ||||
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Total stockholders' deficit
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$ | (371,204 | ) | $ | (324,182 | ) | ||
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PDL BIOPHARMA, INC.
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CONSOLIDATED STATEMENT OF CASH FLOW DATA
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(Unaudited)
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(In thousands)
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Three Months Ended
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March 31,
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2011
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2010
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Net income
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$ | 44,545 | $ | 26,007 | ||||
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Adjustments to reconcile net income to net cash provided by operating activities
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2,409 | 2,653 | ||||||
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Changes in assets and liabilities
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(60,106 | ) | (1,724 | ) | ||||
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Net cash provided by (used in) operating activities
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$ | (13,152 | ) | $ | 26,936 | |||
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PDL BIOPHARMA, INC.
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MIX OF EX-U.S.-BASED SALES AND EX-U.S.-BASED MANUFACTURING AND SALES
OF GENENTECH PRODUCTS
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(Unaudited)
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Three Months Ended
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March 31,
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2011
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2010
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Avastin
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% Ex-U.S.-based Sales
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56 | % | 50 | % | ||||
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% Ex-U.S.-based-Manufacturing and Sales
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19 | % | 5 | % | ||||
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Herceptin
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% Ex-U.S.-based-Sales
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71 | % | 70 | % | ||||
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% Ex-U.S.-based Manufacturing and Sales
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40 | % | 43 | % | ||||
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Lucentis
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% Ex-U.S.-based Sales
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57 | % | 57 | % | ||||
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% Ex-U.S.-based Manufacturing and Sales
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- | - | ||||||
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Xolair
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% Ex-U.S.-based Sales
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39 | % | 35 | % | ||||
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% Ex-U.S.-based Manufacturing and Sales
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39 | % | 35 | % | ||||
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
The following document was compiled from public documents for your convenience. This document, together with the press release issued today, provides information regarding PDL related to its first quarter 2011 financial and business results.
2011 Dividends
In February 2011, PDL’s board of directors declared a regular quarterly dividend of $0.15 per share of common stock. The dividends are payable on March 15, June 15, September 15 and December 15 to all stockholders who own shares of PDL on March 8, June 8, September 8 and December 8, the Record Dates for each of the dividend payments, respectively. We paid $21 million to our stockholders on March 15, 2011, using earnings generated during the quarter and cash on hand. As of March 31, 2011, we had accrued $62.9 million in dividends payable for the June 15, September 15 and December 15 dividend payments and for dividends payable on restricted shares of our common stock.
Effective March 8, 2011, in connection with the payment of the dividend in March 2011, the conversion ratios for our outstanding 2.0% convertible notes due 2012 and for our 2.875% convertible notes due 2015 were adjusted to 144.474 shares per $1,000 principal amount or a conversion price of approximately $6.92 per share.
Licensed Product Development and Regulatory Updates
ACTEMRA® (tocilizumab): On April 15, 2011, Genentech and Roche announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older, given alone or with methotrexate. ACTEMRA is the first medicine approved by the FDA for the treatment of SJIA, a rare and severe form of arthritis affecting children.
AVASTIN® (bevacizumab): On April 15, 2011, Roche announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for an extension to the Avastin breast cancer label in Europe, proposing the use of Avastin in combination with Xeloda (capecitabine) for the first-line treatment of women with metastatic breast cancer in whom treatment with other chemotherapy options is not considered appropriate.
In March 2011, the European Commission confirmed that Avastin in combination with paclitaxel will remain a treatment option for women with metastatic breast cancer in Europe following recommendations made by CHMP to this effect.
LUCENTIS® (ranibizumab): There were several updates regarding Lucentis in the last two months:
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In March 2011, Genentech announced that two Phase 3 studies using Lucentis for the treatment of diabetic macular edema (DME) met their primary endpoints. In the first study, a significantly larger number of patients treated with Lucentis demonstrated the ability to read at least 15 additional letters on an eye chart. Top line results from this study will be presented at the EURETINA Congress in London on May 29, 2011. The second study showed that patients with DME who received Lucentis over two years improved in a number of key areas including additional letters on an eye chart, average reading score on an eye chart at 24 months, improvement in reading an eye chart as early as 7 days following treatment and decreased retinal swelling.
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On March 18, 2011, Novartis received a positive opinion from CHMP for Lucentis to treat patients with visual impairment due to macular edema secondary to branch-retinal vein occlusion and central-retinal vein occlusion, a sudden-onset disease where patients suffer from visual impairment and associated difficulties in daily activities such as reading and driving.
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On April 4, 2011, Genentech and Johns Hopkins University reviewed files of 77,886 patients with age-related macular degeneration (AMD) who received either Avastin off-label or Lucentis. Patients receiving Avastin off-label had an 11% increased risk of overall mortality, 57% increased risk of hemorrhagic cerebrovascular accident, 80% more likely to have ocular inflammation and 11% more likely to have cataract surgery following treatment than Lucentis treated patients. The authors of the study note that it is limited due to incomplete information on confounding factors such as smoking, lipid and blood pressure levels.
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Page 1
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
XOLAIR® (omalizumab): In March 2011, a small study conducted by Children’s Hospital Boston and Stanford University showed that Xolair may have the potential to help children with milk allergies overcome their sensitivities to milk. Further studies in larger patient populations will be conducted to confirm the results.
TYSABRI® (natalizumab): There were several updates regarding Tysabri in the last two months:
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On April 18, 2011, Biogen Idec and Elan announced that the CHMP adopted a positive opinion for the inclusion of JC virus (JCV) status as a risk factor for the development of PML, to the product label for TYSABRI in the European Union. CHMP also issued a positive opinion for the five year renewal of the Marketing Authorisation for TYSABRI.
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On April 22, 2011, the FDA announced that the estimated risk of Tysabri treated patients developing PML was 0.3 per 1,000 patients during the first two years of treatment, increasing to 1.5 per 1,000 patients during the third year and dropping to a rate of 0.9 per 1,000 thereafter. Limited data is available beyond four years.
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T-DM1 (trastuzumab emtansine): On April 7, 2011, Roche announced positive Phase 2 results for its first randomized trial of T-DM1 in HER2-positive metastatic breast cancer. The trial showed that patients treated with T-DM1 lived significantly longer (progression free survival) and experienced fewer side effects that patients treated with a combination of Herceptin (trastuzumab) and docetaxel chemotherapy.
Forward-looking Statements
This document contains forward-looking statements. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Factors that may cause differences between current expectations and actual results include, but are not limited to, the following:
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The expected rate of growth in royalty-bearing product sales by PDL's existing licensees;
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The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus manufactured or sold in the U.S.;
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The ability of our licensees to receive regulatory approvals to market and launch new royalty-bearing products and whether such products, if launched, will be commercially successful;
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Changes in any of the other assumptions on which PDL's projected royalty revenues are based;
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The outcome of pending litigation or disputes;
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The change in foreign currency exchange rates; and
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The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.
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Page 2
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
Other factors that may cause PDL's actual results to differ materially from those expressed or implied in the forward-looking statements in this document are discussed in PDL's filings with the SEC, including the "Risk Factors" sections of its annual and quarterly reports filed with the SEC. Copies of PDL's filings with the SEC may be obtained at the "Investors" section of PDL's website at www.pdl.com. PDL expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in PDL's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
Page 3
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
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Royalty Revenue by Product ($ in 000's) *
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Avastin
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Q1
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Q2
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Q3
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Q4
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Total
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2011
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22,283
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-
|
-
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-
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22,283
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2010
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16,870
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44,765
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29,989
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24,922
|
116,547
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2009
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13,605
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35,161
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21,060
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15,141
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84,966
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2008
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9,957
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30,480
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19,574
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12,394
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72,405
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2007
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8,990
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21,842
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17,478
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9,549
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57,859
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2006
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10,438
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15,572
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15,405
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12,536
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53,952
|
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Herceptin
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Q1
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Q2
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Q3
|
Q4
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Total
|
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2011
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25,089
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-
|
-
|
-
|
25,089
|
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2010
|
23,402
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38,555
|
27,952
|
25,441
|
115,350
|
|
2009
|
16,003
|
32,331
|
26,830
|
18,615
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93,779
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|
2008
|
14,092
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34,383
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28,122
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20,282
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96,880
|
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2007
|
19,035
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28,188
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22,582
|
14,802
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84,608
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2006
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15,142
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19,716
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21,557
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20,354
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76,769
|
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Lucentis
|
Q1
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Q2
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Q3
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Q4
|
Total
|
|
2011
|
8,878
|
-
|
-
|
-
|
8,878
|
|
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
|
-
|
-
|
-
|
4,590
|
|
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
|
-
|
-
|
-
|
9,891
|
|
2010
|
8,791
|
8,788
|
8,735
|
9,440
|
35,754
|
|
2009
|
6,656
|
7,050
|
7,642
|
8,564
|
29,912
|
|
2008
|
3,883
|
5,042
|
5,949
|
6,992
|
21,866
|
|
2007
|
839
|
1,611
|
2,084
|
2,836
|
7,370
|
|
2006
|
-
|
-
|
-
|
237
|
237
|
|
* As reported to PDL by its licensees
|
|||||
Page 4
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
|
Reported Net Sales Revenue by Product ($ in 000's) *
|
|||||
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2011
|
1,597,461
|
-
|
-
|
-
|
1,597,461
|
|
2010
|
1,586,093
|
1,596,892
|
1,594,707
|
1,646,218
|
6,423,910
|
|
2009
|
1,345,487
|
1,295,536
|
1,439,730
|
1,514,053
|
5,594,806
|
|
2008
|
980,715
|
1,084,930
|
1,180,427
|
1,239,382
|
4,485,454
|
|
2007
|
678,068
|
746,587
|
797,013
|
875,084
|
3,096,752
|
|
2006
|
439,318
|
516,052
|
570,551
|
592,897
|
2,118,817
|
|
Herceptin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2011
|
1,391,568
|
-
|
-
|
-
|
1,391,568
|
|
2010
|
1,337,732
|
1,349,512
|
1,300,934
|
1,409,310
|
5,397,488
|
|
2009
|
1,210,268
|
1,133,993
|
1,226,435
|
1,278,626
|
4,849,323
|
|
2008
|
1,105,426
|
1,195,215
|
1,211,982
|
1,186,806
|
4,699,428
|
|
2007
|
891,761
|
949,556
|
979,602
|
1,015,033
|
3,835,952
|
|
2006
|
529,585
|
659,719
|
761,099
|
803,576
|
2,753,979
|
|
Lucentis
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2011
|
887,757
|
-
|
-
|
-
|
887,757
|
|
2010
|
759,965
|
698,890
|
745,376
|
804,684
|
3,008,915
|
|
2009
|
462,103
|
469,736
|
555,296
|
615,212
|
2,102,347
|
|
2008
|
363,615
|
393,682
|
460,167
|
454,922
|
1,672,386
|
|
2007
|
224,820
|
219,579
|
299,995
|
322,300
|
1,066,695
|
|
2006
|
-
|
-
|
10,689
|
157,742
|
168,431
|
|
Xolair
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2011
|
267,754
|
-
|
-
|
-
|
267,754
|
|
2010
|
240,904
|
225,878
|
251,055
|
263,389
|
981,225
|
|
2009
|
184,669
|
181,086
|
211,006
|
219,693
|
796,454
|
|
2008
|
137,875
|
169,521
|
177,179
|
183,753
|
668,329
|
|
2007
|
129,172
|
130,700
|
144,250
|
147,754
|
551,876
|
|
2006
|
95,241
|
99,354
|
112,608
|
118,002
|
425,204
|
|
Tysabri
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2011
|
329,696
|
-
|
-
|
-
|
329,696
|
|
2010
|
293,047
|
287,925
|
293,664
|
316,657
|
1,191,292
|
|
2009
|
221,854
|
229,993
|
257,240
|
285,481
|
994,569
|
|
2008
|
129,430
|
163,076
|
200,783
|
233,070
|
726,359
|
|
2007
|
30,468
|
48,715
|
71,972
|
94,521
|
245,675
|
|
2006
|
-
|
-
|
-
|
7,890
|
7,890
|
|
* As reported to PDL by its licensees
|
|||||
Page 5
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
|
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
|
||||||
|
Avastin Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
795,199
|
795,453
|
814,872
|
820,453
|
800,139
|
708,539
|
|
US Made & ex-US Sold
|
718,855
|
703,661
|
355,742
|
338,929
|
415,576
|
580,981
|
|
ex-US Made & Sold
|
-
|
86,979
|
426,277
|
435,325
|
430,503
|
307,941
|
|
Total
|
1,514,053
|
1,586,093
|
1,596,892
|
1,594,707
|
1,646,218
|
1,597,461
|
|
US Made & Sold
|
53%
|
50%
|
51%
|
51%
|
49%
|
44%
|
|
US Made & ex-US Sold
|
47%
|
44%
|
22%
|
21%
|
25%
|
36%
|
|
ex-US Made & Sold
|
0%
|
5%
|
27%
|
27%
|
26%
|
19%
|
|
Herceptin Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
386,654
|
394,883
|
406,222
|
410,563
|
416,611
|
409,854
|
|
US Made & ex-US Sold
|
608,046
|
372,146
|
312,792
|
306,085
|
425,303
|
423,053
|
|
ex-US Made & Sold
|
283,926
|
570,703
|
630,498
|
584,286
|
567,396
|
558,661
|
|
Total
|
1,278,626
|
1,337,732
|
1,349,512
|
1,300,934
|
1,409,310
|
1,391,568
|
|
US Made & Sold
|
30%
|
30%
|
30%
|
32%
|
30%
|
29%
|
|
US Made & ex-US Sold
|
48%
|
28%
|
23%
|
24%
|
30%
|
30%
|
|
ex-US Made & Sold
|
22%
|
43%
|
47%
|
45%
|
40%
|
40%
|
|
Lucentis Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
266,405
|
323,153
|
300,501
|
326,840
|
360,911
|
378,451
|
|
US Made & ex-US Sold
|
348,808
|
436,812
|
398,389
|
418,536
|
443,773
|
509,307
|
|
ex-US Made & Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Total
|
615,212
|
759,965
|
698,890
|
745,376
|
804,684
|
887,757
|
|
US Made & Sold
|
43%
|
43%
|
43%
|
44%
|
45%
|
43%
|
|
US Made & ex-US Sold
|
57%
|
57%
|
57%
|
56%
|
55%
|
57%
|
|
ex-US Made & Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
|
Xolair Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
150,950
|
157,503
|
145,245
|
165,109
|
170,001
|
164,621
|
|
US Made & ex-US Sold
|
10
|
-
|
-
|
-
|
-
|
-
|
|
ex-US Made & Sold
|
68,733
|
83,401
|
80,632
|
85,945
|
93,388
|
103,133
|
|
Total
|
219,693
|
240,904
|
225,878
|
251,055
|
263,389
|
267,754
|
|
US Made & Sold
|
69%
|
65%
|
64%
|
66%
|
65%
|
61%
|
|
US Made & ex-US Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
|
ex-US Made & Sold
|
31%
|
35%
|
36%
|
34%
|
35%
|
39%
|
|
Total Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
1,599,208
|
1,670,992
|
1,666,840
|
1,722,965
|
1,747,662
|
1,661,465
|
|
US Made & ex-US Sold
|
1,675,718
|
1,512,620
|
1,081,147
|
1,063,551
|
1,284,652
|
1,513,340
|
|
ex-US Made & Sold
|
352,659
|
741,083
|
1,137,407
|
1,105,556
|
1,091,287
|
969,735
|
|
Total
|
3,627,585
|
3,924,694
|
3,885,394
|
3,892,072
|
4,123,601
|
4,144,540
|
|
US Made & Sold
|
44%
|
43%
|
43%
|
44%
|
42%
|
40%
|
|
US Made & ex-US Sold
|
46%
|
39%
|
28%
|
27%
|
31%
|
37%
|
|
ex-US Made & Sold
|
10%
|
19%
|
29%
|
28%
|
26%
|
23%
|
|
* As reported to PDL by its licensees
|
||||||
Page 6