Delaware
|
94-3023969
|
|
(State or Other Jurisdiction of
|
(I.R.S. Employer Identification No.)
|
|
Incorporation)
|
¨
|
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))
|
Exhibit No.
|
Description
|
|
99.1
99.2
99.3
99.4
|
Press Release
Presentation
Information Sheet
Tables to Information Sheet
|
PDL BIOPHARMA, INC.
|
|||
(Company) | |||
|
By:
|
/s/ Bruce W. Tomlinson | |
Bruce W. Tomlinson | |||
Vice President and | |||
Chief Financial Officer |
Exhibit No.
|
Description
|
|
99.1
99.2
99.3
99.4
|
Press Release
Presentation
Information Sheet
Tables to Information Sheet
|
Contacts:
Bruce Tomlinson
PDL BioPharma, Inc.
775-832-8500
bruce.tomlinson@pdl.com
|
Jennifer Williams
Cook Williams Communications
360-668-3701
jennifer@cwcomm.org
|
|
PDL BioPharma Announces Second Quarter 2012 Financial Results
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||||
2012
|
2011
|
2012
|
2011
|
|||||||||||||
Revenues:
|
||||||||||||||||
Royalties
|
$ | 125,904 | $ | 122,127 | $ | 203,248 | $ | 195,463 | ||||||||
License and other
|
- | - | - | 10,000 | ||||||||||||
Total revenues
|
125,904 | 122,127 | 203,248 | 205,463 | ||||||||||||
General and administrative expenses
|
5,145 | 3,776 | 12,090 | 9,555 | ||||||||||||
Operating income
|
120,759 | 118,351 | 191,158 | 195,908 | ||||||||||||
Non-operating expense, net
|
||||||||||||||||
Loss on repurchase of convertible notes
|
- | (766 | ) | - | (766 | ) | ||||||||||
Interest and other income, net
|
428 | 157 | 518 | 332 | ||||||||||||
Interest expense
|
(7,872 | ) | (9,780 | ) | (16,573 | ) | (18,934 | ) | ||||||||
Total non-operating expense, net
|
(7,444 | ) | (10,389 | ) | (16,055 | ) | (19,368 | ) | ||||||||
Income before income taxes
|
113,315 | 107,962 | 175,103 | 176,540 | ||||||||||||
Income tax expense
|
39,813 | 37,976 | 61,417 | 62,009 | ||||||||||||
Net income
|
$ | 73,502 | $ | 69,986 | $ | 113,686 | $ | 114,531 | ||||||||
Net income per share
|
||||||||||||||||
Basic
|
$ | 0.53 | $ | 0.50 | $ | 0.81 | $ | 0.82 | ||||||||
Diluted
|
$ | 0.52 | $ | 0.38 | $ | 0.80 | $ | 0.63 | ||||||||
Cash dividends declared per common share
|
$ | - | $ | - | $ | 0.60 | $ | 0.60 | ||||||||
Weighted average shares outstanding
|
||||||||||||||||
Basic
|
139,683 | 139,650 | 139,681 | 139,645 | ||||||||||||
Diluted
|
142,213 | 186,060 | 142,890 | 186,055 |
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||||
2012
|
2011
|
2012
|
2011
|
|||||||||||||
Net income
|
$ | 73,502 | $ | 69,986 | $ | 113,686 | $ | 114,531 | ||||||||
Add back:
|
||||||||||||||||
Loss on repurchase of convertible debt, net of estimated taxes
|
- | 498 | - | 498 | ||||||||||||
Amortization of debt discount on Series 2012 Notes and May 2015 Notes, net of estimated taxes
|
1,642 | 337 | 3,238 | 337 | ||||||||||||
Non-GAAP net income
|
75,144 | 70,821 | 116,924 | 115,366 | ||||||||||||
Add back interest expense for convertible notes, net of estimated taxes
|
6 | 1,275 | 33 | 2,549 | ||||||||||||
Non-GAAP income used to compute non-GAAP net income per diluted share
|
$ | 75,150 | $ | 72,096 | $ | 116,957 | $ | 117,915 | ||||||||
Shares used to compute non-GAAP net income per diluted share
|
142,213 | 186,060 | 142,890 | 186,055 | ||||||||||||
Non-GAAP net income per diluted share
|
$ | 0.53 | $ | 0.39 | $ | 0.82 | $ | 0.63 |
June 30, 2012
|
December 31, 2011
|
|||||||
Cash, cash equivalents and investments
|
$ | 229,333 | $ | 227,946 | ||||
Total assets
|
$ | 259,829 | $ | 269,471 | ||||
Non-recourse notes payable
|
$ | 22,738 | $ | 93,370 | ||||
Convertible notes payable
|
$ | 304,767 | $ | 316,615 | ||||
Total stockholders' deficit
|
$ | (161,114 | ) | $ | (204,273 | ) |
Six Months Ended
June 30, |
||||||||
2012
|
2011
|
|||||||
Net income
|
$ | 113,686 | $ | 114,531 | ||||
Adjustments to reconcile net income to net cash provided by operating activities
|
12,779 | 24,941 | ||||||
Changes in assets and liabilities
|
(3,672 | ) | (51,549 | ) | ||||
Net cash provided by operating activities
|
$ | 122,793 | $ | 87,923 |
|
·
|
Net income for the second quarter of 2012 was $73.5 million, or $0.52 per diluted share, as compared with net income of $70.0 million, or $0.38 per diluted share, in the same quarter of 2011.
|
|
·
|
Second quarter net income per diluted share is higher in 2012 when compared to 2011 due to increased revenue and the elimination of 44 million shares from the diluted earnings per share calculation after we restructured two of our convertible notes to "net share settle."
|
|
·
|
We declared a regular, quarterly dividend of $0.15 per share of common stock payable on March 14, June 14, September 14 and December 14 to stockholders of record on March 7, June 7, September 7 and December 7.
|
|
·
|
We paid $0.15 per share of common stock, or $21.0 million, on June 14, 2012 to our stockholders of record on June 7, 2012 as part of our regular, quarterly dividend policy for 2012.
|
|
·
|
The conversion rate for our 2.875% Convertible Senior Notes due February 15, 2015 (February 2015 Notes) was adjusted to 162.885 shares of common stock per $1,000 principal amount, or a conversion price of approximately $6.14 per share, effective June 8, 2012.
|
|
·
|
The conversion rate for our 3.75% Senior Convertible Notes due May 1, 2015 (May 2015 Notes) was adjusted to 142.5217 shares of common stock per $1,000 principal amount, or a conversion price of approximately $7.02 per share, effective June 5, 2012.
|
|
·
|
The conversion rate for our 2.875% Series 2012 Convertible Notes due February 15, 2015 (Series 2012 Notes) was adjusted to 162.885 shares of common stock per $1,000 principal amount, or a conversion price of approximately $6.14 per share, effective June 5, 2012.
|
|
·
|
On Thursday, July 26th, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted that safety and efficacy data support approval of the 0.3 mg and 0.5 mg doses of Lucentis for diabetic macular edema.
|
|
·
|
Genentech and Roche are only seeking approval of the 0.3 mg dose.
|
|
·
|
PDUFA date for this application for approval is August 10, 2012.
|
|
·
|
Lucentis is already approved for this indication in EU.
|
|
·
|
On June 8, 2012, Genentech and Roche announced the U.S. Food and Drug Administration (FDA) approval of Perjeta in combination with Herceptin and docetaxel for the first line treatment of patients with HER2+ metastatic breast cancer.
|
|
•
|
Perjeta launched the day after approval.
|
|
•
|
Price is $5,900 per month.
|
|
•
|
Genentech and Roche have notified PDL of its status as a licensed product.
|
|
•
|
PDL will begin receiving royalties in 3Q12 based on sales occuring in 2Q12.
|
|
•
|
Royalties will be subject to the tiered system applicable to Avastin, Herceptin, Lucentis and Xolair sales.
|
|
•
|
Genentech and Roche projected peak sales in excess of $1 billion annually for Perjeta.
|
|
·
|
On June 22, 2012, Genentech and Roche announced that Perjeta met the secondary endpoint of OS in its Phase 3 trial.
|
|
·
|
In the adjuvant setting, Phase 2 data showed patients on Perjeta, Herceptin and docetaxel had a pathologic complete response or pCR of 45.8% compared to 29% for those HER2+ breast cancer patients receiving only Herceptin and docetaxel.
|
|
•
|
Perjeta is currently being studied in Phase 3 in the adjuvant setting.
|
|
·
|
On July 23, 2012, Pfizer reported that, in a Phase 3 clinical study using bapineuzumab to treat patients with mild-to-moderate Alzheimer’s disease and carry the apolipoprotein E epsilon 4 (ApoE4) allele, bapineuzumab did not meet the trial’s endpoints.
|
|
·
|
In its Tuesday, July 31st earnings call, Pfizer disclosed that data from Phase 3 trial which enrolled non-apoe4 carriers is being analyzed and that the data will be presented in September.
|
|
·
|
Lilly has advised that data from its two Phase 3 trials will be disclosed in 2H12 with many speculating that it will be presented at one or both of the Alzheimer’s Disease conferences in the beginning and end of October.
|
|
·
|
Lilly has said that it will stratify the patients by apoe4 carrier status when analyzing the results but it is not known how many patients with and without the apoe4 allele have been enrolled in the two trials.
|
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
|
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
|
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%
|