EX-99.2 4 v191489_ex99-2.htm Unassociated Document
 
PDL BioPharma, Inc.
2Q2010
July 28, 2010

 
The following document was compiled from public press releases for your convenience.  This document, together with the press release issued today, provides information regarding PDL related to its second quarter 2010 financial and business results.

Non-GAAP Earnings per Share
 
An important component of our current strategy is the improvement of our capital structure and reducing the dilution associated with our convertible notes.  To this end, in the second quarter of 2010, we repurchased $84.2 million face value of our 2.75% subordinated notes due in August 2023 at market prices at an average premium of 19% to face value for total consideration of $100.4 million in cash, plus accrued interest.  This transaction resulted in a charge to non-operating expense of $16.3 million or $14.7 million net of tax.  The effect of these transactions was to reduce net income per diluted share from $0.38 to $0.30.
 
 
During the second quarter of 2009, we repurchased at market prices $50.0 million face value of the 2023 Notes at approximately a 2% discount to face value for total consideration of $49.3 million in cash, plus accrued but unpaid interest, and $5.0 million face value of the 2012 Notes at a 10.75% discount to face value for total consideration of $4.5 million in cash, plus accrued but unpaid interest.  These transactions resulted in a gain of $1.2 million or $0.8 million net of tax.  The effect of these transactions was to increase net income per diluted share from $0.46 to $0.47.
 
 
The result of these repurchase transactions was to reduce shares used to compute net income per diluted share on an as converted basis by 14.9 million shares and 6.6 million shares in 2010 and 2009, respectively.  Excluding these transactions, non-GAAP earnings per share was:
 
   
Three Months Ended
   
Six Months Ended
 
   
June 30,
   
June 30,
 
   
2010
   
2009
   
2010
   
2009
 
                         
Net Income
  $ 50,138     $ 77,237     $ 76,145     $ 114,694  
Add back loss (gain) on repurchase of convertible notes
    16,327       (1,195 )     16,327       (1,195 )
Deduct income tax expense (benefit) on repurchase  of convertible notes
    (1,590 )     418       (1,590 )     418  
    Non-GAAP net income
    64,875       76,460       90,882       113,917  
Add back interest expense for convertible notes, net of estimated taxes
    1,360       1,819       2,995       3,761  
Non-GAAP income used to compute non-GAAP net income per diluted share
  $ 66,235     $ 78,279     $ 93,877     $ 117,678  
                                 
Non-GAAP net income per basic share
  $ 0.54     $ 0.64     $ 0.76     $ 0.95  
Non-GAAP net income per diluted share
  $ 0.38     $ 0.46     $ 0.52     $ 0.69  
 
We will continue to look for opportunities to further limit and reduce dilution associated with these securities in future quarters as well as to improve our capital structure.
 
 
PDL BioPharma, Inc.
2Q2010
July 28, 2010

 
Licensed Product Regulatory Updates
Trastuzumab-DM1 (T-DM1)
On July 6, 2010, Genentech and Roche submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for T-DM1 in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies. This submission is based on the results of a Phase 2 study, which showed T-DM1 shrank tumors in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer.1 According to analyst estimates, T-DM1 could reach peak sales of 2 to 5 billion Swiss francs and T-DM1 could win regulatory approval as early as 2011.2

Lucentis®(ranibizumab)
On June 22, 2010, Genentech and Roche announced the approval of Lucentis for an additional indication, the treatment of patients with macular edema (swelling in the retina) following retinal vein occlusion. The FDA approved the new indication after a six-month priority review.3

Avastin® (bevacizumab)
On July 20, 2010, ODAC voted that use of Avastin in combination with paclitaxel for previously untreated advanced HER2-negative breast cancer be removed from the US label. The FDA expects to make a final decision by September 17, 2010. If the FDA accepts the recommendation to remove approval for first line treatment in HER2-negative breast cancer, we would no longer receive royalties for this indication.  Based on our internal model, we estimate that in 2009, this indication represented less than 5% of total global Avastin sales.  The ODAC recommendation does not impact Avastin’s use in advanced colorectal, lung and kidney cancer, and glioblastoma.1
 
Mylotarg® (gemtuzumab ozogamicin)
On June 21, 2010, at the request of the FDA after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in the trials, Pfizer, the parent company of Wyeth, voluntarily withdrew from the U.S. market the drug Mylotarg for patients with acute myeloid leukemia, a bone marrow cancer.  Pfizer will continue to make Mylotarg available for current patients.5

Motavizumab
On June 2, 2010, the FDA’s Antiviral Drugs Advisory Committee voted 14 to 3 against the license to market MedImmune’s motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.6
 

Foreign Currency Exchange Contracts
We hedge certain foreign currency exchange risk exposures related to our licensees’ product sales with foreign currency exchange contracts. In general, these contracts are intended to offset the underlying foreign currency market risk in our royalty revenues.   Approximately 50% of our revenue is based on  sales in currencies other than the US dollar.  As such, when the US dollar strengthens by 10%, our revenues will decline by 5%.
 
 
PDL BioPharma, Inc.
2Q2010
July 28, 2010
 
In January and May 2010, we entered into a series of foreign currency exchange contracts covering the 12 quarters in which our licensees’ sales occur through December 2012. We did not have foreign currency exchange contracts prior to January 2010. We have designated the foreign currency exchange contracts as cash flow hedges. At the inception of the hedging relationship and on a quarterly basis, we assess hedge effectiveness. The aggregate unrealized gain or loss on the effective component of our foreign currency exchange contracts net of estimated taxes is recorded in stockholders’ deficit as accumulated other comprehensive income. Gains or losses on cash flow hedges are recognized as royalty revenue in the same period that the hedged transaction (royalty revenue) impacts earnings.

 
 
PDL BioPharma, Inc.
2Q2010
July 28, 2010

 
Business Expansion through Acquisition of New Royalty Assets
PDL is exploring options to acquire additional royalty assets to diversify its business beyond the Queen et al patent estate. The Company has evaluated numerous opportunities, but will only proceed with transactions that fit the Company’s criteria. PDL’s primary targets are commercial-stage products with the opportunity for new indications consistent with our current portfolio. PDL is evaluating products that are first- in-class, or the gold standard of their treatment group.
 
Litigation Updates
European Opposition to ‘216 Patent
In November 2003, in an appeal proceeding of a prior action of the Opposition Division of the EPO, the Technical Board of Appeal of the EPO ordered that certain claims in our ‘216 Patent be remitted to the Opposition Division for further prosecution and consideration of issues of patentability, that is, entitlement to priority, novelty, enablement and inventive step. The Technical Board of Appeal has scheduled a hearing for the appeal with respect to the ‘216 Patent to begin on February 28, 2011. PDL intends to vigorously defend the ‘216 Patent in this proceeding.
 
Action for Declaratory Judgment by MedImmune
In December 2008, MedImmune filed a lawsuit against us in the United States District Court for the Northern District of California. MedImmune’s complaint seeks a declaratory judgment that the U.S. Queen et al. patents are invalid and/or not infringed by its Synagis and motavizumab products and, that therefore, MedImmune owes no royalties under its license agreement with us. A jury trial is scheduled to begin on January 25, 2011.

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 rate; and
 
    --  The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.
 
 
PDL BioPharma, Inc.
2Q2010
July 28, 2010
 
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.
 
Royalty Revenue by Product ($ in 000's) *
 
Avastin
Q1
Q2
Q3
Q4
Total
2010
    16,870
    44,765
   
    61,635
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
2010
    23,402
    38,555
   
    61,957
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
    28,188
    21,557
    20,354
    85,241
Lucentis
Q1
Q2
Q3
Q4
Total
2010
     7,220
    19,091
   
    26,310
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
            -
            -
     6,579
     3,335
     9,914
Xolair
Q1
Q2
Q3
Q4
Total
2010
     3,723
     6,386
   
    10,110
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
Raptiva
Q1
Q2
Q3
Q4
Total
2010
       (150)
        142
   
           (8)
2009
        477
        589
          22
        150
     1,238
2008
        405
     1,618
     1,111
        802
     3,937
2007
        588
     1,246
     1,160
        738
     3,733
2006
        776
     1,060
     1,069
        874
     3,780
Synagis
Q1
Q2
Q3
Q4
Total
2010
            -
            -
   
            -
2009
    17,145
    18,869
     1,568
     3,159
    40,741
2008
    16,268
    17,376
     2,278
     4,251
    40,173
2007
    14,352
    16,747
     1,608
     4,042
    36,748
2006
    14,171
    14,689
     1,608
     3,664
    34,131
Tysabri
Q1
Q2
Q3
Q4
Total
2010
     8,791
     8,788
   
    17,579
2009
     6,656
     7,200
     7,642
     8,564
    30,062
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
2010
     1,587
     1,950
   
     3,538
2009
        585
        537
        909
     1,197
     3,228
2008
          44
        116
        179
        369
        708
2007
          32
        326
          32
          34
        425
2006
            -
            -
            -
            -
            -
Mylotarg
Q1
Q2
Q3
Q4
Total
2010
        366
        153
   
        519
2009
        293
        370
        805
        453
     1,921
2008
        314
        132
        288
        209
        943
2007
        276
        137
        292
        426
     1,131
2006
        309
        168
        311
        568
     1,355
 
* As reported to PDL by its licensees
Reported Net Sales Revenue by Product ($ in 000's) *
 
Avastin
Q1
Q2
Q3
Q4
Total
2010
  1,586,093
  1,596,892
   
  3,182,984
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
2010
  1,337,732
  1,349,512
   
  2,687,244
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
2010
     759,965
     698,890
   
  1,458,855
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
2010
     240,904
     225,878
   
     466,781
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
Raptiva
Q1
Q2
Q3
Q4
Total
2010
               -
      14,224
   
      14,224
2009
      62,653
      21,526
        1,502
               -
      85,681
2008
      55,541
      57,601
      66,992
      65,216
     245,349
2007
      45,134
      47,401
      52,914
      53,885
     199,333
2006
      32,672
      35,458
      39,610
      41,353
     149,093
Synagis
Q1
Q2
Q3
Q4
Total
2010
               -
               -
   
               -
2009
     571,486
     623,951
      57,271
     105,314
  1,358,021
2008
     542,283
     574,207
      80,930
     141,696
  1,339,116
2007
     478,388
     548,227
      53,586
     139,736
  1,219,936
2006
     472,362
     489,634
      30,185
     124,629
  1,116,811
Tysabri
Q1
Q2
Q3
Q4
Total
2010
     293,047
     287,925
   
     580,972
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
2010
      52,908
      62,511
   
     115,420
2009
      19,504
      17,920
      30,313
      39,888
     107,627
2008
        1,452
        1,377
        5,981
      12,305
      21,116
2007
        2,388
           873
        1,071
        1,137
        5,470
2006
               -
               -
               -
               -
               -
Mylotarg
Q1
Q2
Q3
Q4
Total
2010
        8,500
        8,658
   
      17,159
2009
        8,367
        8,406
        8,813
        8,654
      34,240
2008
        8,978
        8,050
        8,225
        8,140
      33,393
2007
        7,879
        8,202
        8,345
        7,878
      32,304
2006
        8,832
        9,084
        8,874
      16,081
      42,871
 
* As reported to PDL by its licensees
 
1 Genentech (July 6, 2010). “Genentech Submits Application to FDA for Trastuzumab-DM1 in Previously Treated Advanced HER2-Positive Breast Cancer.” Press release.
 
2 Dow Jones News Service. “Roche Flags Cancer Pipeline, Sees 5 Drugs Ready by 2013.” June 4, 2010.
 
3 Genentech (June 22, 2010). “FDA Approves Lucentis® (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion.” Press release.
 
4 Roche (July 22, 2010). “Roche Posts Good Half Year Results.” Investor Update.
 
5 Pfizer (June 21, 2010). “Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®.” Press release.
 
6 MedImmune (June 2, 2010). “FDA Advisory Committee Reviews MedImmune’s Motavizumab.” Press release.