pdl_8k-120612.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):  December 6, 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 December 6, 2012, PDL BioPharma, Inc. (the Company) issued a press release with revenue guidance for the fourth quarter ending December 31, 2012. A copy of the press release is attached hereto as Exhibit 99.1.
 
Detailed Product Sales, Royalties and Manufacturing
 
On December 6, 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 revenue generating assets and take other corporate actions are disclosed in the “Risk Factors” contained in the Company’s 2011 Annual Report on Form 10-K, as updated by subsequent quarterly reports, 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
 
Press Release
     
99.2
 
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:  December 6, 2012
 
 
 

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

 

 
ex99-1.htm
Exhibit 99.1
 

 
 
Contacts:
 
John McLaughlin Jennifer Williams
PDL BioPharma, Inc.  Cook Williams Communications, Inc.
775-832-8500  360-668-3701
John.McLaughlin@pdl.com   Jennifer@cwcomm.org
 
 
PDL BioPharma Provides Fourth Quarter 2012 Royalty Revenue Guidance of $86 Million
 
INCLINE VILLAGE, NV, December 6, 2012PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced royalty revenue guidance for the fourth quarter ending December 31, 2012, of approximately $86 million, as compared with actual royalty revenue of $73 million for the fourth quarter of 2011, an 18 percent increase.  Total anticipated revenue for the year ended December 31, 2012, is $374 million as compared with actual results of $362 million for the year ended December 31, 2011, a three percent increase.  Revenues in 2011 include a one-time legal settlement payment of $10 million.

The forecasted growth in royalty revenues is driven by increased third quarter 2012 sales for all licensed products for which PDL receives royalties in the fourth quarter of 2012. Fourth quarter revenues are expected to include $250,000 in royalties on third quarter sales of PerjetaTM, which was approved in the U.S. on June 8, 2012.  Sales of Avastin®, Herceptin®, Lucentis®, Xolair® and Perjeta (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 fourth quarter royalty payment received from Genentech included royalties based on worldwide sales.

Revenue guidance for the fourth 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 for Herceptin increased 15.2 percent in the third quarter of 2012 when compared to the same period in 2011. Ex-U.S. manufactured and sold Herceptin sales represented 35 percent of total Herceptin sales in the third quarter of 2012 as compared with 26 percent in the third quarter of 2011.

Reported worldwide sales for Lucentis increased 3 percent in the third quarter of 2012 when compared to the same period in 2011. All sales of Lucentis were from inventory produced in the United States.

Reported worldwide sales for Avastin sales increased 13 percent in the third quarter of 2012 when compared to the same period in 2011.

Reported worldwide sales for Tysabri increased 7 percent for the third 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 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. 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.
ex99-2.htm
Exhibit 99.2
 
Royalty Revenue by Product ($ in 000's) *
 
Avastin
Q1
 
Q2
 
Q3
 
Q4
 
Total
 
2012
23,215
 
41,670
 
25,955
 
30,041
 
120,882
 
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
 
30,433
 
28,307
 
129,070
 
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
 
12,552
 
11,097
 
62,377
 
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
 
6,504
 
6,145
 
26,705
 
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
 
 
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
 
 
 

 
 
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
 
969,180
 
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
 
 
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
 
 
 

 
 
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