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): June 13, 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 7.01 Regulation FD Disclosure.
Press Release
On June 13, 2012, PDL BioPharma, Inc. (the Company) issued a press release with revenue guidance for the second quarter ending June 30, 2012. A copy of the press release is attached hereto as Exhibit 99.1.
Detailed Product Sales, Royalties and Manufacturing
On June 13, 2012, the Company distributed to analysts covering the Company’s securities and posted to its website a summary of certain information underlying the Company’s receipt of royalty payments (the Information Sheet) to assist those analysts and its stockholders in valuing the Company’s securities. The Information Sheet is based on information provided to the Company by its licensees and includes reported net sales revenues by licensed product, royalty revenue by licensed product and where certain licensed products are manufactured and sold. 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 Current Report on Form 8-K, the information in Item 7.01 of this report, including Exhibits 99.1 and 99.2, is furnished 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. Such information will not be deemed an admission as to the materiality of any such information that is required to be disclosed solely by Regulation FD.
Cautionary Statements
This filing, the press release, the Information Sheet and the Company’s statements herein and in the attached press release include and constitute “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 and limit the Company’s ability to pay dividends, purchase royalty assets and take other corporate actions are disclosed in the “Risk Factors” contained in the Company’s 2011 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 23, 2012. 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.
(d) Exhibits.
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Exhibit No.
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Description
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99.1
99.2
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Press Release
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.
| PDL BIOPHARMA, INC. | |||
| (Company) | |||
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By:
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/s/ John P. McLaughlin | ||
| John P. McLaughlin | |||
| President and Chief Executive Officer | |||
Dated: June 13, 2012
EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
99.2
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Press Release
Information Sheet
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Exhibit 99.1
 |
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Contacts:
John McLaughlin
PDL BioPharma, Inc.
775-832-8500
john.mclaughlin@pdl.com
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Jennifer Williams
Cook Williams Communications, Inc.
360-668-3701
jennifer@cwcomm.org
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PDL BioPharma Provides Second Quarter 2012 Royalty Revenue Guidance of $125 Million
INCLINE VILLAGE, NV, June 13, 2012 – PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced royalty revenue guidance for the second quarter ending June 30, 2012, of approximately $125 million, as compared with actual royalty revenue of $122 million for the second quarter of 2011, a two percent increase.
The forecasted growth in royalty revenues is driven by increased first quarter 2012 sales of Herceptin®, Lucentis®, Xolair® and Tysabri® for which PDL receives royalties in the second quarter of 2012. Sales of Avastin®, Herceptin, Lucentis and Xolair (the Genentech Products) are subject to a tiered royalty rate for product that is made or sold in the United States and a flat royalty rate of three percent for product that is manufactured and sold outside of the United States (ex-US manufactured and sold). The net sales thresholds and the applicable royalty rates for the Genentech Products are outlined below:
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Genentech Products Made or Sold in US
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Royalty Rate
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||
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Net sales up to $1.5 billion
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3.0% | ||
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Net sales between $1.5 billion and $2.5 billion
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2.5% | ||
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Net sales between $2.5 billion and $4.0 billion
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2.0% | ||
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Net sales exceeding $4.0 billion
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1.0% | ||
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Genentech Products Made and Sold ex-US
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|||
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Net sales
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3.0% |
The second quarter royalty payment from Genentech will be based on all worldwide sales.
Revenue guidance for the second quarter of 2012 is net of an estimated payment due under our February 2011 settlement agreement with Novartis AG (Novartis). PDL pays to Novartis certain amounts based on net sales of Lucentis made by Novartis during calendar year 2011 and beyond. The amount paid is less than we receive in royalties on such sales.
Reported worldwide sales of Herceptin increased four percent in the first quarter of 2012 when compared to the same period in 2011. Roche reported that in 2012, Herceptin global sales growth was driven by expanded access in developing countries, increased and improved HER2 testing and continued uptake in HER2-positive stomach cancer. Additionally, Roche reported that sustained double-digit increases were recorded internationally, with strong demand in Latin America and the Asia-Pacific region. Ex-U.S. manufactured and sold Herceptin sales represented 41 percent of total Herceptin sales in the first quarter of 2012 as compared with 30 percent in the first quarter of 2011.
Reported worldwide sales for Lucentis increased 15 percent in the first quarter of 2012 when compared to the same period in 2011. Lucentis is approved for the treatment of age-related macular degeneration (AMD) in the U.S. and Europe. Lucentis received approval for the treatment of macular edema following retinal vein occlusion (RVO) in June 2010 in the U.S. and in June 2011 in Europe. In January 2011, Lucentis was approved in Europe for the treatment of visual impairment due to diabetic macular edema. All sales of Lucentis were from inventory produced in the U.S.
Reported worldwide sales for Avastin decreased one percent in the first quarter of 2012 when compared to the same period in 2011. Roche has reported that a significant portion of the decline in sales in the U.S. was due to reimbursement uncertainty regarding the metastatic breast cancer indication, which was revoked by the U.S. Food and Drug Administration in November 2011, and that U.S. market share for all other indications remained stable. In Europe, austerity measures along with lower use of Avastin for breast cancer led to lower sales, but market penetration in colorectal cancer remained stable.
Reported worldwide sales for Tysabri increased 13 percent in the first quarter of 2012 compared to the same period in 2011. Tysabri royalties are determined at a flat rate as a percentage of sales regardless of location of manufacture or sale.
The sales information presented above is based on information provided by PDL’s licensees in their quarterly reports to the Company as well as from public disclosures made by PDL’s licensees.
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 revenue generating assets and maximizing the value of its patent portfolio and related assets. For more information, please visit www.pdl.com.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.
Forward-looking Statements
This press release contains forward-looking statements. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Factors that may cause differences between current expectations and actual results include, but are not limited to, the following:
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·
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The expected rate of growth in royalty-bearing product sales by PDL’s existing licensees;
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·
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The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus made or sold in the U.S.;
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·
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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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·
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Changes in any of the other assumptions on which PDL’s projected royalty revenues are based;
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·
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The outcome of pending litigation or disputes;
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·
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The change in foreign currency exchange rate; and
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·
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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" sections of its annual report 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.
Exhibit 99.2
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Royalty Revenue by Product ($ in 000's) *
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|||||
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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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2012
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23,215
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41,670
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-
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-
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64,886
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2011
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22,283
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41,967
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23,870
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22,886
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111,006
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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
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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
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Q4
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Total
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2012
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25,702
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44,628
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-
|
-
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70,330
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2011
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25,089
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42,209
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31,933
|
21,812
|
121,042
|
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2010
|
23,402
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38,555
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27,952
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25,441
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115,350
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2009
|
16,003
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32,331
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26,830
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18,615
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93,779
|
|
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
|
|
2007
|
19,035
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28,188
|
22,582
|
14,802
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84,608
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2006
|
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
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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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2012
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10,791
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27,938
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-
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-
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38,728
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2011
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8,878
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24,313
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12,157
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10,750
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56,099
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2010
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7,220
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19,091
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10,841
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8,047
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45,198
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2009
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4,621
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12,863
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8,123
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6,152
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31,759
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2008
|
3,636
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11,060
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7,631
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4,549
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26,876
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2007
|
2,931
|
6,543
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6,579
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3,517
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19,570
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2006
|
-
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-
|
289
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3,335
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3,624
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Xolair
|
Q1
|
Q2
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Q3
|
Q4
|
Total
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|
2012
|
5,447
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8,609
|
-
|
-
|
14,056
|
|
2011
|
4,590
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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
|
|
2012
|
11,233
|
12,202
|
-
|
-
|
23,435
|
|
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
|
-
|
-
|
3,778
|
|
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
|
|||||
|
Reported Net Sales Revenue by Product ($ in 000's) *
|
|||||
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2012
|
1,502,757
|
1,573,727
|
-
|
-
|
3,076,484
|
|
2011
|
1,597,461
|
1,582,705
|
1,581,095
|
1,469,994
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6,231,255
|
|
2010
|
1,506,788
|
1,596,892
|
1,594,707
|
1,646,218
|
6,344,605
|
|
2009
|
1,345,487
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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
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746,587
|
797,013
|
875,084
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3,096,752
|
|
2006
|
439,318
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516,052
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570,551
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592,897
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2,118,817
|
|
Herceptin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2012
|
1,515,255
|
1,625,313
|
-
|
-
|
3,140,569
|
|
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
|
-
|
-
|
2,165,635
|
|
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
|
-
|
-
|
624,873
|
|
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
|
|
2012
|
374,430
|
401,743
|
-
|
-
|
776,173
|
|
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
|
-
|
-
|
123,286
|
|
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
|
|||||
|
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
|
||||||
|
Avastin Sales
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
2012 - Q1
|
2012 - Q2
|
|
US Made & Sold
|
708,539
|
719,967
|
688,966
|
684,878
|
652,824
|
724,483
|
|
US Made & ex-US Sold
|
580,981
|
548,710
|
587,975
|
375,830
|
448,037
|
532,979
|
|
ex-US Made & Sold
|
307,941
|
314,028
|
304,155
|
409,286
|
401,896
|
316,265
|
|
Total
|
1,597,461
|
1,582,705
|
1,581,095
|
1,469,994
|
1,502,757
|
1,573,727
|
|
US Made & Sold
|
44%
|
45%
|
44%
|
47%
|
43%
|
46%
|
|
US Made & ex-US Sold
|
36%
|
35%
|
37%
|
26%
|
30%
|
34%
|
|
ex-US Made & Sold
|
19%
|
20%
|
19%
|
28%
|
27%
|
20%
|
|
Herceptin Sales
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
2012 - Q1
|
2012 - Q2
|
|
US Made & Sold
|
409,854
|
442,903
|
445,395
|
453,168
|
456,920
|
497,109
|
|
US Made & ex-US Sold
|
423,053
|
642,670
|
495,086
|
612,908
|
523,353
|
466,477
|
|
ex-US Made & Sold
|
558,661
|
474,402
|
702,416
|
366,695
|
534,982
|
661,727
|
|
Total
|
1,391,568
|
1,559,975
|
1,642,898
|
1,432,771
|
1,515,255
|
1,625,313
|
|
US Made & Sold
|
29%
|
28%
|
27%
|
32%
|
30%
|
31%
|
|
US Made & ex-US Sold
|
30%
|
41%
|
30%
|
43%
|
35%
|
29%
|
|
ex-US Made & Sold
|
40%
|
30%
|
43%
|
26%
|
35%
|
41%
|
|
Lucentis Sales
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
2012 - Q1
|
2012 - Q2
|
|
US Made & Sold
|
378,451
|
409,674
|
422,335
|
428,884
|
433,428
|
412,131
|
|
US Made & ex-US Sold
|
509,307
|
533,745
|
630,474
|
646,131
|
645,665
|
674,411
|
|
ex-US Made & Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Total
|
887,757
|
943,418
|
1,052,809
|
1,075,015
|
1,079,092
|
1,086,543
|
|
US Made & Sold
|
43%
|
43%
|
40%
|
40%
|
40%
|
38%
|
|
US Made & ex-US Sold
|
57%
|
57%
|
60%
|
60%
|
60%
|
62%
|
|
ex-US Made & Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
|
Xolair Sales
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
2012 - Q1
|
2012 - Q2
|
|
US Made & Sold
|
164,621
|
167,608
|
184,837
|
188,728
|
185,505
|
193,600
|
|
US Made & ex-US Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
|
ex-US Made & Sold
|
103,133
|
110,034
|
126,037
|
126,184
|
124,729
|
121,039
|
|
Total
|
267,754
|
277,642
|
310,874
|
314,911
|
310,234
|
314,638
|
|
US Made & Sold
|
61%
|
60%
|
59%
|
60%
|
60%
|
62%
|
|
US Made & ex-US Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
|
ex-US Made & Sold
|
39%
|
40%
|
41%
|
40%
|
40%
|
38%
|
|
Total Sales
|
2011 - Q1
|
2011 - Q2
|
2011 - Q3
|
2011 - Q4
|
2012 - Q1
|
2012 - Q2
|
|
US Made & Sold
|
1,661,465
|
1,740,152
|
1,741,534
|
1,755,657
|
1,728,678
|
1,827,323
|
|
US Made & ex-US Sold
|
1,513,340
|
1,725,125
|
1,713,535
|
1,634,869
|
1,617,054
|
1,673,867
|
|
ex-US Made & Sold
|
969,735
|
898,464
|
1,132,608
|
902,165
|
1,061,607
|
1,099,031
|
|
Total
|
4,144,540
|
4,363,741
|
4,587,677
|
4,292,691
|
4,407,339
|
4,600,221
|
|
US Made & Sold
|
40%
|
40%
|
38%
|
41%
|
39%
|
40%
|
|
US Made & ex-US Sold
|
37%
|
40%
|
37%
|
38%
|
37%
|
36%
|
|
ex-US Made & Sold
|
23%
|
21%
|
25%
|
21%
|
24%
|
24%
|
|
* As reported to PDL by its licensees
|
||||||
|
Totals may not sum due to rounding
|
||||||