Attached files
| file | filename |
|---|---|
| 8-K - PDL BIOPHARMA INC 8-K 4-27-2011 - PDL BIOPHARMA, INC. | form8k.htm |
| EX-99.1 - EXHIBIT 99.1 - PDL BIOPHARMA, INC. | ex99_1.htm |
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
The following document was compiled from public documents for your convenience. This document, together with the press release issued today, provides information regarding PDL related to its first quarter 2011 financial and business results.
2011 Dividends
In February 2011, PDL’s board of directors declared a regular quarterly dividend of $0.15 per share of common stock. The dividends are payable on March 15, June 15, September 15 and December 15 to all stockholders who own shares of PDL on March 8, June 8, September 8 and December 8, the Record Dates for each of the dividend payments, respectively. We paid $21 million to our stockholders on March 15, 2011, using earnings generated during the quarter and cash on hand. As of March 31, 2011, we had accrued $62.9 million in dividends payable for the June 15, September 15 and December 15 dividend payments and for dividends payable on restricted shares of our common stock.
Effective March 8, 2011, in connection with the payment of the dividend in March 2011, the conversion ratios for our outstanding 2.0% convertible notes due 2012 and for our 2.875% convertible notes due 2015 were adjusted to 144.474 shares per $1,000 principal amount or a conversion price of approximately $6.92 per share.
Licensed Product Development and Regulatory Updates
ACTEMRA® (tocilizumab): On April 15, 2011, Genentech and Roche announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older, given alone or with methotrexate. ACTEMRA is the first medicine approved by the FDA for the treatment of SJIA, a rare and severe form of arthritis affecting children.
AVASTIN® (bevacizumab): On April 15, 2011, Roche announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for an extension to the Avastin breast cancer label in Europe, proposing the use of Avastin in combination with Xeloda (capecitabine) for the first-line treatment of women with metastatic breast cancer in whom treatment with other chemotherapy options is not considered appropriate.
In March 2011, the European Commission confirmed that Avastin in combination with paclitaxel will remain a treatment option for women with metastatic breast cancer in Europe following recommendations made by CHMP to this effect.
LUCENTIS® (ranibizumab): There were several updates regarding Lucentis in the last two months:
|
|
·
|
In March 2011, Genentech announced that two Phase 3 studies using Lucentis for the treatment of diabetic macular edema (DME) met their primary endpoints. In the first study, a significantly larger number of patients treated with Lucentis demonstrated the ability to read at least 15 additional letters on an eye chart. Top line results from this study will be presented at the EURETINA Congress in London on May 29, 2011. The second study showed that patients with DME who received Lucentis over two years improved in a number of key areas including additional letters on an eye chart, average reading score on an eye chart at 24 months, improvement in reading an eye chart as early as 7 days following treatment and decreased retinal swelling.
|
|
|
·
|
On March 18, 2011, Novartis received a positive opinion from CHMP for Lucentis to treat patients with visual impairment due to macular edema secondary to branch-retinal vein occlusion and central-retinal vein occlusion, a sudden-onset disease where patients suffer from visual impairment and associated difficulties in daily activities such as reading and driving.
|
|
|
·
|
On April 4, 2011, Genentech and Johns Hopkins University reviewed files of 77,886 patients with age-related macular degeneration (AMD) who received either Avastin off-label or Lucentis. Patients receiving Avastin off-label had an 11% increased risk of overall mortality, 57% increased risk of hemorrhagic cerebrovascular accident, 80% more likely to have ocular inflammation and 11% more likely to have cataract surgery following treatment than Lucentis treated patients. The authors of the study note that it is limited due to incomplete information on confounding factors such as smoking, lipid and blood pressure levels.
|
Page 1
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
XOLAIR® (omalizumab): In March 2011, a small study conducted by Children’s Hospital Boston and Stanford University showed that Xolair may have the potential to help children with milk allergies overcome their sensitivities to milk. Further studies in larger patient populations will be conducted to confirm the results.
TYSABRI® (natalizumab): There were several updates regarding Tysabri in the last two months:
|
|
·
|
On April 18, 2011, Biogen Idec and Elan announced that the CHMP adopted a positive opinion for the inclusion of JC virus (JCV) status as a risk factor for the development of PML, to the product label for TYSABRI in the European Union. CHMP also issued a positive opinion for the five year renewal of the Marketing Authorisation for TYSABRI.
|
|
|
·
|
On April 22, 2011, the FDA announced that the estimated risk of Tysabri treated patients developing PML was 0.3 per 1,000 patients during the first two years of treatment, increasing to 1.5 per 1,000 patients during the third year and dropping to a rate of 0.9 per 1,000 thereafter. Limited data is available beyond four years.
|
T-DM1 (trastuzumab emtansine): On April 7, 2011, Roche announced positive Phase 2 results for its first randomized trial of T-DM1 in HER2-positive metastatic breast cancer. The trial showed that patients treated with T-DM1 lived significantly longer (progression free survival) and experienced fewer side effects that patients treated with a combination of Herceptin (trastuzumab) and docetaxel chemotherapy.
Forward-looking Statements
This document 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 manufactured 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 rates; and
|
|
|
·
|
The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.
|
Page 2
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
Other factors that may cause PDL's actual results to differ materially from those expressed or implied in the forward-looking statements in this document are discussed in PDL's filings with the SEC, including the "Risk Factors" sections of its annual and quarterly reports 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.
Page 3
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
|
Royalty Revenue by Product ($ in 000's) *
|
|||||
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2011
|
22,283
|
-
|
-
|
-
|
22,283
|
|
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
|
|
2011
|
25,089
|
-
|
-
|
-
|
25,089
|
|
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
|
|
2011
|
8,878
|
-
|
-
|
-
|
8,878
|
|
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
|
|
2011
|
4,590
|
-
|
-
|
-
|
4,590
|
|
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
|
|
2011
|
9,891
|
-
|
-
|
-
|
9,891
|
|
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
|
|
* As reported to PDL by its licensees
|
|||||
Page 4
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
|
Reported Net Sales Revenue by Product ($ in 000's) *
|
|||||
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
|
2011
|
1,597,461
|
-
|
-
|
-
|
1,597,461
|
|
2010
|
1,586,093
|
1,596,892
|
1,594,707
|
1,646,218
|
6,423,910
|
|
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
|
|
2011
|
1,391,568
|
-
|
-
|
-
|
1,391,568
|
|
2010
|
1,337,732
|
1,349,512
|
1,300,934
|
1,409,310
|
5,397,488
|
|
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
|
|
2011
|
887,757
|
-
|
-
|
-
|
887,757
|
|
2010
|
759,965
|
698,890
|
745,376
|
804,684
|
3,008,915
|
|
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
|
|
2011
|
267,754
|
-
|
-
|
-
|
267,754
|
|
2010
|
240,904
|
225,878
|
251,055
|
263,389
|
981,225
|
|
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
|
|
2011
|
329,696
|
-
|
-
|
-
|
329,696
|
|
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
|
|
* As reported to PDL by its licensees
|
|||||
Page 5
PDL BioPharma, Inc.
Q1-2011
April 27, 2011
|
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
|
||||||
|
Avastin Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
795,199
|
795,453
|
814,872
|
820,453
|
800,139
|
708,539
|
|
US Made & ex-US Sold
|
718,855
|
703,661
|
355,742
|
338,929
|
415,576
|
580,981
|
|
ex-US Made & Sold
|
-
|
86,979
|
426,277
|
435,325
|
430,503
|
307,941
|
|
Total
|
1,514,053
|
1,586,093
|
1,596,892
|
1,594,707
|
1,646,218
|
1,597,461
|
|
US Made & Sold
|
53%
|
50%
|
51%
|
51%
|
49%
|
44%
|
|
US Made & ex-US Sold
|
47%
|
44%
|
22%
|
21%
|
25%
|
36%
|
|
ex-US Made & Sold
|
0%
|
5%
|
27%
|
27%
|
26%
|
19%
|
|
Herceptin Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
386,654
|
394,883
|
406,222
|
410,563
|
416,611
|
409,854
|
|
US Made & ex-US Sold
|
608,046
|
372,146
|
312,792
|
306,085
|
425,303
|
423,053
|
|
ex-US Made & Sold
|
283,926
|
570,703
|
630,498
|
584,286
|
567,396
|
558,661
|
|
Total
|
1,278,626
|
1,337,732
|
1,349,512
|
1,300,934
|
1,409,310
|
1,391,568
|
|
US Made & Sold
|
30%
|
30%
|
30%
|
32%
|
30%
|
29%
|
|
US Made & ex-US Sold
|
48%
|
28%
|
23%
|
24%
|
30%
|
30%
|
|
ex-US Made & Sold
|
22%
|
43%
|
47%
|
45%
|
40%
|
40%
|
|
Lucentis Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
266,405
|
323,153
|
300,501
|
326,840
|
360,911
|
378,451
|
|
US Made & ex-US Sold
|
348,808
|
436,812
|
398,389
|
418,536
|
443,773
|
509,307
|
|
ex-US Made & Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Total
|
615,212
|
759,965
|
698,890
|
745,376
|
804,684
|
887,757
|
|
US Made & Sold
|
43%
|
43%
|
43%
|
44%
|
45%
|
43%
|
|
US Made & ex-US Sold
|
57%
|
57%
|
57%
|
56%
|
55%
|
57%
|
|
ex-US Made & Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
|
Xolair Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
150,950
|
157,503
|
145,245
|
165,109
|
170,001
|
164,621
|
|
US Made & ex-US Sold
|
10
|
-
|
-
|
-
|
-
|
-
|
|
ex-US Made & Sold
|
68,733
|
83,401
|
80,632
|
85,945
|
93,388
|
103,133
|
|
Total
|
219,693
|
240,904
|
225,878
|
251,055
|
263,389
|
267,754
|
|
US Made & Sold
|
69%
|
65%
|
64%
|
66%
|
65%
|
61%
|
|
US Made & ex-US Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
|
ex-US Made & Sold
|
31%
|
35%
|
36%
|
34%
|
35%
|
39%
|
|
Total Sales
|
2009 - Q4
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
|
US Made & Sold
|
1,599,208
|
1,670,992
|
1,666,840
|
1,722,965
|
1,747,662
|
1,661,465
|
|
US Made & ex-US Sold
|
1,675,718
|
1,512,620
|
1,081,147
|
1,063,551
|
1,284,652
|
1,513,340
|
|
ex-US Made & Sold
|
352,659
|
741,083
|
1,137,407
|
1,105,556
|
1,091,287
|
969,735
|
|
Total
|
3,627,585
|
3,924,694
|
3,885,394
|
3,892,072
|
4,123,601
|
4,144,540
|
|
US Made & Sold
|
44%
|
43%
|
43%
|
44%
|
42%
|
40%
|
|
US Made & ex-US Sold
|
46%
|
39%
|
28%
|
27%
|
31%
|
37%
|
|
ex-US Made & Sold
|
10%
|
19%
|
29%
|
28%
|
26%
|
23%
|
|
* As reported to PDL by its licensees
|
||||||
Page 6