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): March 1, 2013
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)) |
Item 2.02 Results of Operations and Financial Condition.
On March 1, 2013, PDL BioPharma, Inc. (the Company) issued a press release announcing the financial results for the fourth quarter and year ended December 31, 2012. A copy of this earnings release is attached hereto as Exhibit 99.1. The Company will host an earnings call and webcast on March 1, 2013, during which the Company will discuss its financial results for the fourth quarter and year ended December 31, 2012.
Item 7.01 Regulation FD Disclosure.
Presentation Materials
On March 1, 2013, the Company posted to its website a set of presentation materials that it will use during its earnings call and webcast to assist participants with understanding the Company’s financial results. A copy of this presentation is attached hereto at Exhibit 99.2
Information Sheet
On March 1, 2013, the Company distributed to analysts covering the Company’s securities a summary of certain information regarding the Company’s net income, dividends and licensed product development and sales (the Information Sheet) to assist those analysts in valuing the Company’s securities. The Information Sheet and its associated tables are attached hereto as Exhibit 99.3.
Limitation of Incorporation by Reference
In accordance with General Instruction B.2. of Form 8-K, the information in this report, including the exhibits, is furnished pursuant to Items 2.02 and 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
Cautionary Statements
This filing and its exhibits include “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 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. |
Description | |
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99.1 |
Press Release | |
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99.2 |
Presentation | |
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99.3 |
Information Sheet |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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PDL BIOPHARMA, INC. |
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| By: |
/s/ John P. McLaughlin |
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President, Chief Executive Officer and |
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Acting Chief Financial Officer |
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Dated: March 1, 2013
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Exhibit No. |
Description | |
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99.1 |
Press Release | |
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99.2 |
Presentation | |
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99.3 |
Information Sheet |
Exhibit 99.1
Contacts:
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John McLaughlin |
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Jennifer Williams | |||
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PDL BioPharma, Inc. |
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Cook Williams Communications | ||
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775-832-8500 |
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360-668-3701 | |||
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john.mclaughlin@pdl.com |
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jennifer@cwcomm.org | ||
PDL BioPharma Announces Fourth Quarter and Full Year 2012 Financial Results
INCLINE VILLAGE, NV, March 1, 2013 – PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today reported financial results for the fourth quarter and full year ended December 31, 2012.
Total revenues in 2012 were $374.5 million, compared to $362.0 million in 2011, with royalty revenues increasing seven percent over full year 2011. For the fourth quarter of 2012, total revenues were $86.0 million, compared to $72.8 million in the fourth quarter of 2011.
Royalty revenues for the fourth quarter of 2012 are based on third quarter product sales by PDL’s licensees. The fourth quarter 2012 revenue growth was primarily driven by increased royalties from third quarter 2012 sales of Herceptin® and Avastin®, which are marketed by Genentech and Roche. Royalty revenue for the fourth quarter and 2012 are net of payments made under our February 2011 settlement agreement with Novartis Pharma AG.
Operating expenses in 2012 were $25.5 million, compared with $18.3 million in 2011. For the fourth quarter of 2012, general and administrative expenses were $7.7 million compared with $4.8 million for the same period of 2011.
Net income in 2012 was $211.7 million, or $1.45 per diluted share as compared with net income of $199.4 million in 2011 or $1.15 per diluted share. Net income for the fourth quarter of 2012 was $49.4 million or $0.34 per diluted share as compared with net income of $38.9 million or $0.24 per diluted share for the same period of 2011.
Net cash provided by operating activities in 2012 was $210.2 million, compared with $169.8 million in 2011. At December 31, 2012, PDL had cash, cash equivalents and investments of $148.7 million, compared with $227.9 million at December 31, 2011. The reduction in cash relates primarily to the Company’s income generating asset transactions, repayment of the Company’s non-recourse notes and dividend payments.
Recent Developments
Kadcyla™ or T-DM1, a New Royalty-Bearing Product of PDL
On February 22, 2013, Genentech announced that the U.S. Food and Drug Administration (FDA) approved Trastuzumab emstansine (T-DM1), now named Kadcyla. Kadcyla was approved for second line treatment of HER2+ metastatic breast cancer and first line treatment for those patients who relapse within six months following adjuvant therapy. Roche has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for the same indication. Kadcyla is a licensed product of Genentech and has been priced at $9800 per month. PDL expects to receive royalties on sales of Kadcyla in the quarter following the first quarter of sales in accordance with Genentech's license agreements with PDL.
Avastin, a Royalty-Bearing Product of PDL
In October, Genentech and Roche announced that the European Commission approved Avastin in combination with standard chemotherapy (carboplatin and gemcitabine) as a treatment for women with first recurrence of platinum-sensitive ovarian cancer. In November, the European Medicines Agency adopted a positive opinion regarding the use of Avastin in second-line metastatic colorectal cancer. Also in November, additional details were announced regarding Phase 3 patients with newly diagnosed glioblastoma, who were treated with Avastin plus radiation and chemotherapy, which showed an increase in progression-free survival of 36 percent when compared to radiation and chemotherapy.
Obinutuzumab, a Potential Royalty-Bearing Product of PDL
In January, Genentech announced Phase 3 results from an obinutuzumab (GA101) trial showing a significant improvement in progression-free survival in people with chronic lymphocytic leukemia (CLL). Data from this trial will be submitted to European regulatory authorities and to the U.S. Food and Drug Administration (FDA) for potential approval.
2013 Dividends
On January 30, 2013, PDL’s Board of Directors declared regular quarterly dividends of $0.15 per share of common stock, payable on March 12, June 12, September 12 and December 12 of 2013 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2013, the record dates for each of the dividend payments, respectively.
Revenue Guidance for 2013
As previously announced, PDL will continue to provide revenue guidance for each quarter in the third month of that quarter. First quarter 2013 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, March 1, 2013.
To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 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 8, 2013, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 12523654.
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 income generating assets and maximizing value for its shareholders. 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 income generating 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. 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.
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME DATA
(Unaudited)
(In thousands, except per share amounts)
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Three Months Ended |
Year Ended |
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December 31, |
December 31, |
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2012 |
2011 |
2012 |
2011 |
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Revenues |
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Royalties |
$ | 86,046 | $ | 72,808 | $ | 374,525 | $ | 351,641 | ||||||||
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License and other |
- | - | - | 10,400 | ||||||||||||
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Total revenues |
86,046 | 72,808 | 374,525 | 362,041 | ||||||||||||
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Operating Expenses |
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General and administrative expenses |
7,732 | 4,822 | 25,469 | 18,338 | ||||||||||||
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Operating income |
78,314 | 67,986 | 349,056 | 343,703 | ||||||||||||
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Non-operating expense, net |
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Loss on retirement or conversion of convertible notes |
- | - | - | (766 | ) | |||||||||||
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Interest and other income, net |
4,728 | 130 | 7,113 | 593 | ||||||||||||
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Interest expense |
(5,950 | ) | (8,161 | ) | (29,036 | ) | (36,102 | ) | ||||||||
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Total non-operating expense, net |
(1,222 | ) | (8,031 | ) | (21,923 | ) | (36,275 | ) | ||||||||
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Income before income taxes |
77,092 | 59,955 | 327,133 | 307,428 | ||||||||||||
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Income tax expense |
27,684 | 21,013 | 115,464 | 108,039 | ||||||||||||
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Net income |
$ | 49,408 | $ | 38,942 | $ | 211,669 | $ | 199,389 | ||||||||
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Net income per share |
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Basic |
$ | 0.35 | $ | 0.28 | $ | 1.52 | $ | 1.43 | ||||||||
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Diluted |
$ | 0.34 | $ | 0.24 | $ | 1.45 | $ | 1.15 | ||||||||
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Shares used to compute income per basic share |
139,764 | 139,680 | 139,711 | 139,663 | ||||||||||||
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Shares used to compute income per diluted share |
145,419 | 167,683 | 146,403 | 177,441 | ||||||||||||
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Cash dividends declared per common share |
$ | - | $ | - | $ | 0.60 | $ | 0.60 | ||||||||
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In thousands)
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December 31, |
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2012 |
2011 |
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Cash, cash equivalents and investments |
$ | 148,689 | $ | 227,946 | ||||
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Total assets |
$ | 279,966 | $ | 269,471 | ||||
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Convertible notes payable |
$ | 309,952 | $ | 316,615 | ||||
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Non-recourse notes payable |
$ | - | $ | 93,370 | ||||
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Total stockholders' deficit |
$ | (68,122 | ) | $ | (204,273 | ) | ||
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW DATA
(Unaudited)
(In thousands)
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Year Ended |
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December 31, |
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2012 |
2011 |
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Net income |
$ | 211,669 | $ | 199,389 | ||||
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Adjustments to reconcile net income to net cash provided by operating activities |
26,644 | 43,574 | ||||||
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Changes in assets and liabilities |
(28,097 | ) | (73,181 | ) | ||||
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Net cash provided by operating activities |
$ | 210,216 | $ | 169,782 | ||||
PDL BIOPHARMA, INC.
MIX OF EX-U.S. SALES AND EX-U.S.-BASED MANUFACTURING AND SALESOF GENENTECH PRODUCTS
(Unaudited)
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Three Months Ended |
Year Ended |
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December 31, |
December 31, |
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2012 |
2011 |
2012 |
2011 |
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Avastin |
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% Ex-U.S. Sold |
57 | % | 53 | % | 56 | % | 55 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold |
40 | % | 28 | % | 29 | % | 21 | % | |||||||||
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Herceptin |
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% Ex-U.S. Sold |
69 | % | 68 | % | 69 | % | 71 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold |
35 | % | 26 | % | 37 | % | 35 | % | |||||||||
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Lucentis |
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% Ex-U.S. Sold |
66 | % | 60 | % | 63 | % | 59 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold |
0 | % | 0 | % | 0 | % | 0 | % | |||||||||
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Xolair |
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% Ex-U.S. Sold |
38 | % | 40 | % | 39 | % | 40 | % | |||||||||
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% Ex-U.S.-based Manufactured and Sold |
38 | % | 40 | % | 39 | % | 40 | % | |||||||||
Exhibit 99.2
Exhibit 99.3
PDL BioPharma, Inc.
Q4 / Year End 2012
March 1, 2013
Following are some of the key points regarding PDL’s fourth quarter 2012 financial and business results.
Net Income
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● |
Net income for the fourth quarter of 2012 was $49.4 million or $0.34 per diluted share as compared with net income of $38.9 million or $0.24 per diluted share for the same period of 2011. |
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● |
Net income for full-year 2012 was $211.7 million, or $1.45 per diluted share as compared with net income of $199.4 million in 2011 or $1.15 per diluted share. |
2012 and 2013 Dividends
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We paid $0.15 per share of common stock, or $21.0 million, on December 14, 2012, to our stockholders of record on December 7, 2012, as part of our regular, quarterly dividend policy for 2012. |
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● |
In January 2013, PDL announced that its board of directors declared that the regular, quarterly dividends to be paid to its stockholders in 2013 will be $0.15 per share of common stock. The $0.15 dividends will each be paid on March 12, June 12, September 12 and December 12 of 2013 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2013, the record dates for each of the dividend payments, respectively. |
Updates on Approved Royalty Bearing Products
Avastin® (bevacizumab):
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● |
On January 30, 2013, Roche reported that 2012 worldwide sales increased by 6% over 2011 sales on a constant exchange basis. |
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o |
In EU, higher sales were driven by the launch in ovarian cancer, and increased market share in lung cancer and breast cancer. |
|
o |
In Japan, higher sales were driven by increased uptake in colorectal cancer, non-small cell lung cancer and metastatic breast cancer. |
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● |
On November 16, 2012, Genentech/Roche announced that the EU’s CHMP adopted a positive opinion regarding the use of Avastin in second line metastatic colorectal cancer. |
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o |
A similar application has been granted priority review by the FDA in US. |
|
o |
Avastin is already approved for first line treatment of metastatic colorectal cancer in US and EU. |
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● |
On November 19, 2012, Genentech/Roche reported additional details from a Phase 3 trial in patients with newly diagnosed glioblastoma that showed that treatment with Avastin plus radiation and chemotherapy increased progression-free-survival by 36% compared to radiation and chemotherapy. |
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o |
Avastin is already approved for second line treatment of glioblastoma in US and EU. |
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● |
On February 7, 2013, the National Institutes of Health announced that a trial in patients with recurrent and metastatic cervical cancer comparing Avastin plus two chemotherapies against two chemotherapies met its primary endpoint of improving median overall survival by 3.7 months. |
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o |
Genentech/Roche said that they are analyzing the data to evaluate next steps. |
Herceptin® (trastuzumab):
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● |
On January 30, 2013, Roche reported that 2012 worldwide sales increased by 11% over 2011 sales on a constant exchange basis. |
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o |
Much of the growth was seen in US and emerging markets. |
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o |
Also contributing to the sales growth was increased HER2 testing and further uptake in HER2+ gastric cancer. |
PDL BioPharma, Inc.
Q4 / Year End 2012
March 1, 2013
Lucentis® (ranibizumab):
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● |
On January 30, 2013, Roche reported that 2012 US sales decreased by 8% over 2011 sales on a constant exchange basis. |
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o |
Roche said that it expects further pressure on sales for the treatment of age-related macular degeneration in 2013 partially offset by increased sales for the treatment of diabetic macular edema and stable share for the treatment of retinal vein occlusion. |
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● |
On January 23, 2013, Novartis reported that 2012 ex-US sales increased by 22% over 2011 sales on a constant exchange basis. |
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o |
Increased sales growth was driven by new launches for the treatment of diabetic macular edema and retinal vein occlusion. |
Actemra® (tocilizumab):
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● |
On January 30, 2013, Roche reported that 2012 worldwide sales increased by 33% over 2011 sales on a constant exchange basis. |
|
o |
On October 15, 2012, Genentech/Roche announced that the label had been expanded to include patients who had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). |
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o |
Subcutaneous formulation filed for approval in US and EU in December 2012. |
Perjeta™ (pertuzumab):
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● |
On January 30, 2013, Roche reported that 4Q12 demand increased by 53% over 3Q12 demand. |
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o |
Over 75% of relevant physicians are already prescribing Perjeta. |
Kadcyla™ (TDM-1 or ado-trastuzumab emtansine):
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● |
On February 22, 2013, Genentech/Roche announced that the FDA had approved the product for second line treatment of HER2+ metastatic breast cancer and first line treatment for those patients who relapse within six months following adjuvant therapy. |
|
o |
A similar application has been accepted for review in EU. |
|
o |
Kadcyla will be available in the US within two weeks. |
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o |
Pricing is $9,800 per month, significantly higher than many estimates in the financial community. |
Updates on Select Development Stage Potential Royalty Bearing Products
Obinutuzumab:
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● |
On January 30, 2013, Genentech/Roche announced positive results from Stage 1 of a Phase 3 trial in patients with previously untreated chronic lymphocytic leukemia that showed treatment with obinutuzumab plus chemotherapy significantly reduced the risk of disease worsening or death compared to treatment with chemotherapy. |
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o |
Stage1 also included a pre-planned progression-free-survival (PFS) futility analysis comparing obinutuzumab plus chemotherapy to Rituxan plus chemotherapy. The goal of the futility analysis was to evaluate the likelihood that the study would meet its pre-specified endpoint criteria during Stage 2 analysis - improved efficacy (PFS) in the direct comparison of obinutuzumab plus chemotherapy to Rituxan plus chemotherapy. |
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o |
The independent Data and Safety Monitoring Board (DSMB) assessment concluded that Stage 2 of the study should continue until its final analysis. |
PDL BioPharma, Inc.
Q4 / Year End 2012
March 1, 2013
Solanezumab:
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● |
On August 24, 2012, Lilly announced that both of its Phase 3 trials did not meet the primary endpoints of cognitive and functional benefit. |
|
o |
A pre-specified secondary subgroup analysis of the pooled data from both trials showed that solanezumab slowed the cognitive decline in patients with mild disease but not patients with moderate disease. |
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● |
On December 12, 2012, Lilly said that it will commence an additional Phase 3 trial in patients with mild Alzheimer’s disease by no later than 3Q2013. |
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● |
If solanezumab were to receive marketing authorization, PDL would receive a patent royalty of 3% in addition to a 12.5 year know-how royalty of 2% from date of first sale. |
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● |
On January 18, 2013, the NIH's National Institute of Aging (NIA) announced that it and other federal agencies will fund a three year trial investigating the use of solanezumab in 1,000 patients with abnormal amyloid protein buildup but who are at the pre-symptomatic stage of Alzheimer's disease. |
|
o |
The leading hypothesis explaining Alzheimer's disease is that abnormal amyloid accumulates into clumps on the brain, which clumps secrete toxins causing neuronal damage in brain tissue that eventually results in cognitive deficits. |
|
o |
NIA selected solanezumab after considering a number of anti-amyloid treatments. |
Forward-looking Statements
This document 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 income generating 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. 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.
PDL BioPharma, Inc.
Q4 / Year End 2012
March 1, 2013
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Royalty Revenue by Product ($ in 000's) * |
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Avastin |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
23,215 | 41,670 | 25,955 | 30,041 | 120,882 | |||||||||||||||
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2011 |
22,283 | 41,967 | 23,870 | 22,886 | 111,006 | |||||||||||||||
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2010 |
16,870 | 44,765 | 29,989 | 24,922 | 116,547 | |||||||||||||||
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2009 |
13,605 | 35,161 | 21,060 | 15,141 | 84,966 | |||||||||||||||
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2008 |
9,957 | 30,480 | 19,574 | 12,394 | 72,405 | |||||||||||||||
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2007 |
8,990 | 21,842 | 17,478 | 9,549 | 57,859 | |||||||||||||||
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2006 |
10,438 | 15,572 | 15,405 | 12,536 | 53,952 | |||||||||||||||
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Herceptin |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
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2012 |
25,702 | 44,628 | 30,433 | 28,307 | 129,070 | |||||||||||||||
|
2011 |
25,089 | 42,209 | 31,933 | 21,812 | 121,042 | |||||||||||||||
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2010 |
23,402 | 38,555 | 27,952 | 25,441 | 115,350 | |||||||||||||||
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2009 |
16,003 | 32,331 | 26,830 | 18,615 | 93,779 | |||||||||||||||
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2008 |
14,092 | 34,383 | 28,122 | 20,282 | 96,880 | |||||||||||||||
|
2007 |
19,035 | 28,188 | 22,582 | 14,802 | 84,608 | |||||||||||||||
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2006 |
15,142 | 19,716 | 21,557 | 20,354 | 76,769 | |||||||||||||||
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Lucentis |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
10,791 | 27,938 | 12,552 | 11,097 | 62,377 | |||||||||||||||
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2011 |
8,878 | 24,313 | 12,157 | 10,750 | 56,099 | |||||||||||||||
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2010 |
7,220 | 19,091 | 10,841 | 8,047 | 45,198 | |||||||||||||||
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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 | |||||||||||||||
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2006 |
- | - | 289 | 3,335 | 3,624 | |||||||||||||||
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Xolair |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
5,447 | 8,609 | 6,504 | 6,145 | 26,705 | |||||||||||||||
|
2011 |
4,590 | 7,621 | 5,916 | 5,823 | 23,949 | |||||||||||||||
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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 | |||||||||||||||
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2006 |
2,263 | 2,969 | 3,041 | 2,495 | 10,768 | |||||||||||||||
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Perjeta |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
- | - | 58 | 250 | 308 | |||||||||||||||
|
2011 |
- | - | - | - | - | |||||||||||||||
|
2010 |
- | - | - | - | - | |||||||||||||||
|
2009 |
- | - | - | - | - | |||||||||||||||
|
2008 |
- | - | - | - | - | |||||||||||||||
|
2007 |
- | - | - | - | - | |||||||||||||||
|
2006 |
- | - | - | - | - | |||||||||||||||
|
Tysabri |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
11,233 | 12,202 | 11,749 | 12,255 | 47,439 | |||||||||||||||
|
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 |
|||||||||||||||
|
2012 |
1,705 | 2,074 | 2,145 | 2,462 | 8,385 | |||||||||||||||
|
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 |
PDL BioPharma, Inc.
Q4 / Year End 2012
March 1, 2013
Reported Net Sales Revenue by Product ($ in 000's) *
|
Avastin |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
1,502,757 | 1,573,727 | 1,551,327 | 1,662,977 | 6,290,788 | |||||||||||||||
|
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 |
|||||||||||||||
|
2012 |
1,515,255 | 1,625,313 | 1,663,695 | 1,650,495 | 6,454,759 | |||||||||||||||
|
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 |
|||||||||||||||
|
2012 |
1,079,092 | 1,086,543 | 1,097,541 | 1,109,695 | 4,372,871 | |||||||||||||||
|
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 |
|||||||||||||||
|
2012 |
310,234 | 314,638 | 347,796 | 340,431 | 1,313,100 | |||||||||||||||
|
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 | |||||||||||||||
|
Perjeta |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
- | - | 5,080 | 25,000 | 30,079 | |||||||||||||||
|
2011 |
- | - | - | - | - | |||||||||||||||
|
2010 |
- | - | - | - | - | |||||||||||||||
|
2009 |
- | - | - | - | - | |||||||||||||||
|
2008 |
- | - | - | - | - | |||||||||||||||
|
2007 |
- | - | - | - | - | |||||||||||||||
|
2006 |
- | - | - | - | - | |||||||||||||||
|
Tysabri |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
|||||||||||||||
|
2012 |
374,430 | 401,743 | 391,623 | 408,711 | 1,576,508 | |||||||||||||||
|
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 |
|||||||||||||||
|
2012 |
56,662 | 66,624 | 71,505 | 82,053 | 276,843 | |||||||||||||||
|
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 |
PDL BioPharma, Inc.
Q4 / Year End 2012
March 1, 2013
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
|
Avastin Sales |
2011 - Q3 |
2011 - Q4 |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
||||||||||||||||||
|
US Made & Sold |
688,966 | 684,878 | 652,824 | 724,483 | 679,914 | 710,501 | ||||||||||||||||||
|
US Made & ex-US Sold |
587,975 | 375,830 | 448,037 | 532,979 | 428,976 | 281,905 | ||||||||||||||||||
|
ex-US Made & Sold |
304,155 | 409,286 | 401,896 | 316,265 | 442,437 | 670,572 | ||||||||||||||||||
|
Total |
1,581,095 | 1,469,994 | 1,502,757 | 1,573,727 | 1,551,327 | 1,662,977 | ||||||||||||||||||
|
US Made & Sold |
44 | % | 47 | % | 43 | % | 46 | % | 44 | % | 43 | % | ||||||||||||
|
US Made & ex-US Sold |
37 | % | 26 | % | 30 | % | 34 | % | 28 | % | 17 | % | ||||||||||||
|
ex-US Made & Sold |
19 | % | 28 | % | 27 | % | 20 | % | 29 | % | 40 | % | ||||||||||||
|
Herceptin Sales |
2011 - Q3 |
2011 - Q4 |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
||||||||||||||||||
|
US Made & Sold |
445,395 | 453,168 | 456,920 | 497,109 | 503,612 | 515,790 | ||||||||||||||||||
|
US Made & ex-US Sold |
495,086 | 612,908 | 523,353 | 466,477 | 545,625 | 552,127 | ||||||||||||||||||
|
ex-US Made & Sold |
702,416 | 366,695 | 534,982 | 661,727 | 614,459 | 582,578 | ||||||||||||||||||
|
Total |
1,642,898 | 1,432,771 | 1,515,255 | 1,625,313 | 1,663,695 | 1,650,495 | ||||||||||||||||||
|
US Made & Sold |
27 | % | 32 | % | 30 | % | 31 | % | 30 | % | 31 | % | ||||||||||||
|
US Made & ex-US Sold |
30 | % | 43 | % | 35 | % | 29 | % | 33 | % | 33 | % | ||||||||||||
|
ex-US Made & Sold |
43 | % | 26 | % | 35 | % | 41 | % | 37 | % | 35 | % | ||||||||||||
|
Lucentis Sales |
2011 - Q3 |
2011 - Q4 |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
||||||||||||||||||
|
US Made & Sold |
422,335 | 428,884 | 433,428 | 412,131 | 385,746 | 381,592 | ||||||||||||||||||
|
US Made & ex-US Sold |
630,474 | 646,131 | 645,665 | 674,411 | 711,795 | 728,103 | ||||||||||||||||||
|
ex-US Made & Sold |
- | - | - | - | - | - | ||||||||||||||||||
|
Total |
1,052,809 | 1,075,015 | 1,079,092 | 1,086,543 | 1,097,541 | 1,109,695 | ||||||||||||||||||
|
US Made & Sold |
40 | % | 40 | % | 40 | % | 38 | % | 35 | % | 34 | % | ||||||||||||
|
US Made & ex-US Sold |
60 | % | 60 | % | 60 | % | 62 | % | 65 | % | 66 | % | ||||||||||||
|
ex-US Made & Sold |
0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||
|
Xolair Sales |
2011 - Q3 |
2011 - Q4 |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
||||||||||||||||||
|
US Made & Sold |
184,837 | 188,728 | 185,505 | 193,600 | 211,702 | 210,892 | ||||||||||||||||||
|
US Made & ex-US Sold |
- | - | - | - | - | - | ||||||||||||||||||
|
ex-US Made & Sold |
126,037 | 126,184 | 124,729 | 121,039 | 136,094 | 129,540 | ||||||||||||||||||
|
Total |
310,874 | 314,911 | 310,234 | 314,638 | 347,796 | 340,431 | ||||||||||||||||||
|
US Made & Sold |
59 | % | 60 | % | 60 | % | 62 | % | 61 | % | 62 | % | ||||||||||||
|
US Made & ex-US Sold |
0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||
|
ex-US Made & Sold |
41 | % | 40 | % | 40 | % | 38 | % | 39 | % | 38 | % | ||||||||||||
|
Perjeta Sales |
2011 - Q3 |
2011 - Q4 |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
||||||||||||||||||
|
US Made & Sold |
- | - | - | - | 5,080 | 24,571 | ||||||||||||||||||
|
US Made & ex-US Sold |
- | - | - | - | - | 428 | ||||||||||||||||||
|
ex-US Made & Sold |
- | - | - | - | - | - | ||||||||||||||||||
|
Total |
- | - | - | - | 5,080 | 25,000 | ||||||||||||||||||
|
US Made & Sold |
0 | % | 0 | % | 0 | % | 0 | % | 100 | % | 98 | % | ||||||||||||
|
US Made & ex-US Sold |
0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 2 | % | ||||||||||||
|
ex-US Made & Sold |
0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||
|
Total Sales |
2011 - Q3 |
2011 - Q4 |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
||||||||||||||||||
|
US Made & Sold |
1,741,534 | 1,755,657 | 1,728,678 | 1,827,323 | 1,786,053 | 1,843,345 | ||||||||||||||||||
|
US Made & ex-US Sold |
1,713,535 | 1,634,869 | 1,617,054 | 1,673,867 | 1,686,395 | 1,562,564 | ||||||||||||||||||
|
ex-US Made & Sold |
1,132,608 | 902,165 | 1,061,607 | 1,099,031 | 1,192,990 | 1,382,690 | ||||||||||||||||||
|
Total |
4,587,677 | 4,292,691 | 4,407,339 | 4,600,221 | 4,665,438 | 4,788,598 | ||||||||||||||||||
|
US Made & Sold |
38 | % | 41 | % | 39 | % | 40 | % | 38 | % | 38 | % | ||||||||||||
|
US Made & ex-US Sold |
37 | % | 38 | % | 37 | % | 36 | % | 36 | % | 33 | % | ||||||||||||
|
ex-US Made & Sold |
25 | % | 21 | % | 24 | % | 24 | % | 26 | % | 29 | % | ||||||||||||
|
* As reported to PDL by its licensees | ||||||||||||||||||||||||
|
Totals may not sum due to rounding |