form8k.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):  September 7, 2011

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:
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o
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 September 8, 2011, PDL BioPharma, Inc. (the Company) issued a press release with revenue guidance for the quarter ending September 30, 2011. The Company notes that the royalty payment it received from Genentech was complete and without a reservation of rights. A copy of the press release is attached hereto as Exhibit 99.1.

Detailed Product Sales, Royalties and Manufacturing

On September 8, 2011, 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.

Item 8.01 Other Events.

On September 7, 2011, the Company issued a press release specifying the adjustment of the conversion rates of its outstanding convertible notes related to the Company’s upcoming September 15, 2011, dividend payment. The press release is attached hereto as Exhibit 99.3 and is incorporated herein by reference.

Cautionary Statements

This filing, the press release, the Information Sheet and the Company’s statements herein and in the attached press release regarding its intentions with respect to the quarterly dividend payment 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 are disclosed in the “Risk Factors” contained in the Company’s 2010 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2011, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission thereafter. 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, dated September 8, 2011
     
99.2
 
Information Sheet
     
99.3
 
Press Release, dated September 7, 2011

 
 

 

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/ Christine R. Larson
   
Christine R. Larson
   
Vice President and Chief Financial Officer

Dated:  September 8, 2011

 
 

 
 
EXHIBIT INDEX

Exhibit No.
 
Description
 
Press Release, dated September 8, 2011
     
 
Information Sheet
     
 
Press Release, dated September 7, 2011
 


ex99_1.htm

Exhibit 99.1
 

 
Contacts:
 
Cris Larson
Jennifer Williams
PDL BioPharma, Inc.
Cook Williams Communications, Inc.
775-832-8505
360-668-3701
Cris.Larson@pdl.com
jennifer@cwcomm.org

PDL BioPharma Provides ThirdQuarter 2011 Revenue Guidance of $83Million

INCLINE VILLAGE, NV, September 8, 2011PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced revenue guidance for the third quarter ending September 30, 2011, of approximately $83 million, as compared with actual results of $86 million for the third quarter of 2010, a three percent decrease. On a year-to-date basis, total anticipated revenue for the nine months ended September 30, 2011, is $288 million as compared with actual results of $269 million for the nine months ended September 30, 2010, a seven percent increase.

The forecasted third quarter 2011revenue decline is primarily driven by reduced royalties from second quarter 2011sales of Avastin® partially offset by increased royalties from second quarter 2011sales of Herceptin®, Lucentis® and Tysabri®. Also contributing to the decline is a lower average royalty rate on sales of Avastin, Herceptin, Lucentis and Xolair® (the Genentech Products) that are either made or sold in the United States due to higher year-to-date sales in 2011. Sales of 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. The net sales thresholds and the applicable royalty rates for product that is made or sold in the United States are outlined below:  

 
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%

The revenue guidance for the third quarter is net of the estimated payment due under our February 2011 settlement agreement with Novartis, which is based on a portion of the royalties that the Company receives for Lucentis sales made by Novartis outside of the United States. The third quarter 2011 royalty payment received from Genentech included royalties generated on all worldwide sales.

Reported worldwide sales for Herceptin increased 26 percent in the second quarter of 2011 when compared to the same period in 2010. Roche recently reported that sales growth is being driven by increased penetration in emerging markets, increased HER2 testing and continued uptake in HER2-postive gastric cancer. Ex-U.S. manufactured and sold Herceptin sales declined to 43 percent of total Herceptin sales in the second quarter of 2011 from 45 percent in the second quarter of 2010.

Reported worldwide sales for Lucentis increased 41percent in the second quarter of 2011 when compared to the same period in 2010. Lucentis is approved for the treatment of age-related macular degeneration in the United States and Europe. Lucentis received approval for the treatment of macular edema following retinal vein occlusion (RVO) in June 2010 in the United States and in June 2011 in Europe. Genentech and Novartis recently reported that sales growth is being driven by continued growth in the treatment of RVO in the United States and increased uptake in all indications in Europe. All sales of Lucentis were from inventory produced in the United States.

Reported worldwide sales for Tysabri increased 32 percent in the second quarter of 2011 when compared to the same period in 2010. Biogen Idec recently announced that, at the end of June 2011, approximately 61,500 patients were on therapy worldwide, representing a 17 percent increase over the approximately 52,700 patients who were on therapy at the end of June 2010 and that cumulatively 88,100 patients have been treated with Tysabri in the post-marketing setting. Tysabri royalties are determined at a flat rate as a percent of sales regardless of location of manufacture or sale.

 
 

 
 
Reported worldwide sales of Avastin decreased one percent in the first quarter of 2011 when compared to the same period in 2010. Roche recently reported that sales in the United States declined 15 percent, negatively impacted by reimbursement uncertainty regarding the metastatic breast cancer indication. In Europe, sales were down 10 percent due to austerity measures and some decline in the metastatic breast cancer indication. Roche reported 12 percent growth in the rest of the world. Also contributing to the decrease in royalty revenue, ex-U.S. manufactured and sold Avastin sales declined to 19 percent of total Avastin sales in the second quarter of 2011 from 27 percent in the second quarter of 2010.

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. PDL is focused on maximizing the value of its antibody humanization patents and related assets. The Company receives royalties on sales of a number of humanized antibody products marketed by leading pharmaceutical and biotechnology companies today based on patents which expire in late 2014. 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 rates; 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 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.
 
 

ex99_2.htm

Exhibit 99.2
 
Royalty Revenue by Product ($ in 000's) *

Avastin
Q1
Q2
Q3
Q4
Total
2011
22,283
41,967
23,870
-
88,120
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
42,209
31,933
-
99,231
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
24,313
12,157
-
45,348
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
7,621
5,916
-
18,126
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
10,796
11,588
-
32,275
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
2011
913
1,136
1,401
-
3,450
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

 
 

 
 
Reported Net Sales Revenue by Product ($ in 000's) *

Avastin
Q1
Q2
Q3
Q4
Total
2011
1,597,461
1,582,705
1,581,095
-
4,761,261
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
2011
1,391,568
1,559,975
1,642,898
-
4,594,441
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
2011
887,757
943,418
1,052,809
-
2,883,984
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
2011
267,754
277,642
310,874
-
856,270
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
2011
329,696
356,876
388,758
-
1,075,330
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
2011
      30,433
      35,370
      46,709
               -
     112,512
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

 
 

 


Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *

Avastin Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
814,872
820,453
800,139
708,539
719,967
688,966
US Made & ex-US Sold
355,742
338,929
415,576
580,981
548,710
587,975
ex-US Made & Sold
426,277
435,325
430,503
307,941
314,028
304,155
Total
1,596,892
1,594,707
1,646,218
1,597,461
1,582,705
1,581,095
US Made & Sold
51%
51%
49%
44%
45%
44%
US Made & ex-US Sold
22%
21%
25%
36%
35%
37%
ex-US Made & Sold
27%
27%
26%
19%
20%
19%
 
Herceptin Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
406,222
410,563
416,611
409,854
442,903
445,395
US Made & ex-US Sold
312,792
306,085
425,303
423,053
642,670
495,086
ex-US Made & Sold
630,498
584,286
567,396
558,661
474,402
702,416
Total
1,349,512
1,300,934
1,409,310
1,391,568
1,559,975
1,642,898
US Made & Sold
30%
32%
30%
29%
28%
27%
US Made & ex-US Sold
23%
24%
30%
30%
41%
30%
ex-US Made & Sold
47%
45%
40%
40%
30%
43%
 
Lucentis Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
300,501
326,840
360,911
378,451
409,674
422,335
US Made & ex-US Sold
398,389
418,536
443,773
509,307
533,745
630,474
ex-US Made & Sold
-
-
-
-
-
-
Total
698,890
745,376
804,684
887,757
943,418
1,052,809
US Made & Sold
43%
44%
45%
43%
43%
40%
US Made & ex-US Sold
57%
56%
55%
57%
57%
60%
ex-US Made & Sold
0%
0%
0%
0%
0%
0%
 
Xolair Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
145,245
165,109
170,001
164,621
167,608
184,837
US Made & ex-US Sold
-
-
-
-
-
-
ex-US Made & Sold
80,632
85,945
93,388
103,133
110,034
126,037
Total
225,878
251,055
263,389
267,754
277,642
310,874
US Made & Sold
64%
66%
65%
61%
60%
59%
US Made & ex-US Sold
0%
0%
0%
0%
0%
0%
ex-US Made & Sold
36%
34%
35%
39%
40%
41%
 
Total Sales
2010 - Q2
2010 - Q3
2010 - Q4
2011 - Q1
2011 - Q2
2011 - Q3
US Made & Sold
1,666,840
1,722,965
1,747,662
1,661,465
1,740,152
1,741,534
US Made & ex-US Sold
1,081,147
1,063,551
1,284,652
1,513,340
1,725,125
1,713,535
ex-US Made & Sold
1,137,407
1,105,556
1,091,287
969,735
898,464
1,132,608
Total
3,885,394
3,892,072
4,123,601
4,144,540
4,363,741
4,587,677
US Made & Sold
43%
44%
42%
40%
40%
38%
US Made & ex-US Sold
28%
27%
31%
37%
40%
37%
ex-US Made & Sold
29%
28%
26%
23%
21%
25%
 
* As reported to PDL by its licensees

 

ex99_3.htm

 Exhibit 99.3
 

 
Contacts:
 
Cris Larson
Jennifer Williams
PDL BioPharma, Inc.
Cook Williams Communications, Inc.
775-832-8505
360-668-3701
cris.larson@pdl.com
jennifer@cwcomm.org

PDL BioPharma Announces Conversion Rate Adjustments for Its Convertible Notes

INCLINE VILLAGE, NV, September 7, 2011 -- PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced adjustments to the conversion rates for:

 
·
The 2.875% Convertible Senior Notes due February 15, 2015 (the February 2015 Notes), effective September 9, 2011; and

 
·
The 3.75% Convertible Senior Notes due May 1, 2015 (the May 2015 Notes), effective September 6, 2011,

in connection with the regular dividend of $0.15 to be paid on September 15, 2011, to all stockholders who own shares of PDL on September 8, 2011, the record date.
The conversion rate for the February 2015 Notes, as adjusted, is 151.713 shares of common stock per $1,000 principal amount or approximately $6.59 per share. The conversion rate for the February 2015 Notes was previously 147.887 shares of common stock per $1,000 principal amount of the February 2015 Notes. In connection with a cash dividend, the conversion rate is increased by multiplying the previous conversion rate by a fraction, the numerator of which is the average closing price of PDL's common stock for the five consecutive trading days immediately preceding the ex-dividend date of September 6, 2011, for the cash dividend, and the denominator of which is the difference of such average closing price less the dividend amount.

The conversion rate for the May 2015 Notes, as adjusted, is 132.6682 shares of common stock per $1,000 principal amount or approximately $7.54 per share. The conversion rate for the May 2015 Notes was previously 129.2740 shares of common stock per $1,000 principal amount of the May 2015 Notes. In connection with a cash dividend, the conversion rate is increased by multiplying the previous conversion rate by a fraction, the numerator of which is the average closing price of PDL's common stock for the ten consecutive trading days immediately preceding the ex-dividend date of September 6, 2011, for the cash dividend, and the denominator of which is the difference of such average closing price less the dividend amount.

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. PDL is focused on maximizing the value of its antibody humanization patents and related assets. The Company receives royalties on sales of a number of humanized antibody products marketed today and also may receive royalty payments on additional humanized antibody products launched before patent expiry in late 2014. 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
The foregoing statements regarding PDL's intentions with respect to the cash dividend payment described above are forward-looking statements under the Private Securities Litigation Reform Act of 1995 and actual results could vary materially from the statements made. PDL's ability to pay the dividend described above is subject to various risks, many of which are outside its control, including prevailing conditions in the capital markets, the continued strength of its royalty assets and other risks and uncertainties as detailed from time to time in the reports filed by PDL with the Securities and Exchange Commission.

 
###