0001437749-12-006098.txt : 20120613 0001437749-12-006098.hdr.sgml : 20120613 20120613162136 ACCESSION NUMBER: 0001437749-12-006098 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20120613 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120613 DATE AS OF CHANGE: 20120613 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PDL BIOPHARMA, INC. CENTRAL INDEX KEY: 0000882104 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943023969 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19756 FILM NUMBER: 12905339 BUSINESS ADDRESS: STREET 1: 932 SOUTHWOOD BLVD CITY: INCLINE VILLAGE STATE: NV ZIP: 89451 BUSINESS PHONE: 775-832-8500 MAIL ADDRESS: STREET 1: 932 SOUTHWOOD BLVD CITY: INCLINE VILLAGE STATE: NV ZIP: 89451 FORMER COMPANY: FORMER CONFORMED NAME: PROTEIN DESIGN LABS INC/DE DATE OF NAME CHANGE: 19930328 8-K 1 pdl_8k-061312.htm FORM 8-K pdl_8k-061312.htm

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 

FORM 8-K
 

CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of Earliest Event Reported):  June 13, 2012

PDL BioPharma, Inc.
 
(Exact name of Company as specified in its charter)
 
000-19756
(Commission File Number)
 
     
Delaware
 
94-3023969
(State or Other Jurisdiction of
 
(I.R.S. Employer Identification No.)
Incorporation)
   
 
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:
 
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
 
 
 
 
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.
 
Exhibit No.
 
Description
99.1
 
99.2
 
Press Release
 
Information Sheet

 
 

 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 

  PDL BIOPHARMA, INC.  
  (Company)  
     
       
 
By:
/s/ John P. McLaughlin  
    John P. McLaughlin  
    President and Chief Executive Officer  
       
 
Dated:  June 13, 2012
 
 
 

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

 
EX-99.1 2 ex99-1.htm EXHIBIT 99.1 ex99-1.htm
 
Exhibit 99.1
 
 
   
Contacts:
John McLaughlin
PDL BioPharma, Inc.
775-832-8500
john.mclaughlin@pdl.com
 
Jennifer Williams
Cook Williams Communications, Inc.
360-668-3701
jennifer@cwcomm.org
 
 
PDL BioPharma Provides Second Quarter 2012 Royalty Revenue Guidance of $125 Million
 
INCLINE VILLAGE, NV, June 13, 2012PDL 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:  
 
Genentech Products Made or Sold in US
 
Royalty Rate
 
Net sales up to $1.5 billion
  3.0%  
Net sales between $1.5 billion and $2.5 billion
  2.5%  
Net sales between $2.5 billion and $4.0 billion
  2.0%  
Net sales exceeding $4.0 billion
  1.0%  
       
Genentech Products Made and Sold ex-US
     
Net sales
  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:

 
·
The expected rate of growth in royalty-bearing product sales by PDL’s existing licensees;
 
·
The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus made or sold in the U.S.;
 
·
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;
 
·
Changes in any of the other assumptions on which PDL’s projected royalty revenues are based;
 
·
The outcome of pending litigation or disputes;
 
·
The change in foreign currency exchange rate; and
 
·
The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.

Other factors that may cause PDL's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are discussed in PDL's filings with the SEC, including the "Risk Factors" 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.
EX-99.2 3 ex99-2.htm EXHIBIT 99.2 ex99-2.htm
 
Exhibit 99.2
 
Royalty Revenue by Product ($ in 000's) *
           
Avastin
Q1
Q2
Q3
Q4
Total
2012
23,215
41,670
-
-
64,886
2011
22,283
41,967
23,870
22,886
111,006
2010
16,870
44,765
29,989
24,922
116,547
2009
13,605
35,161
21,060
15,141
84,966
2008
9,957
30,480
19,574
12,394
72,405
2007
8,990
21,842
17,478
9,549
57,859
2006
10,438
15,572
15,405
12,536
53,952
           
Herceptin
Q1
Q2
Q3
Q4
Total
2012
25,702
44,628
-
-
70,330
2011
25,089
42,209
31,933
21,812
121,042
2010
23,402
38,555
27,952
25,441
115,350
2009
16,003
32,331
26,830
18,615
93,779
2008
14,092
34,383
28,122
20,282
96,880
2007
19,035
28,188
22,582
14,802
84,608
2006
15,142
19,716
21,557
20,354
76,769
           
Lucentis
Q1
Q2
Q3
Q4
Total
2012
10,791
27,938
-
-
38,728
2011
8,878
24,313
12,157
10,750
56,099
2010
7,220
19,091
10,841
8,047
45,198
2009
4,621
12,863
8,123
6,152
31,759
2008
3,636
11,060
7,631
4,549
26,876
2007
2,931
6,543
6,579
3,517
19,570
2006
-
-
289
3,335
3,624
           
Xolair
Q1
Q2
Q3
Q4
Total
2012
5,447
8,609
-
-
14,056
2011
4,590
7,621
5,916
5,823
23,949
2010
3,723
6,386
4,980
4,652
19,741
2009
2,665
5,082
4,085
3,722
15,553
2008
1,488
4,866
3,569
2,927
12,850
2007
1,684
3,942
3,332
2,184
11,142
2006
2,263
2,969
3,041
2,495
10,768
           
Tysabri
Q1
Q2
Q3
Q4
Total
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
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
-
-
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
 
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