EX-99.3 4 ex99-3.htm EXHIBIT 99.3 ex99-3.htm
 
Exhibit 99.3
 
PDL BioPharma, Inc.
Q1-2013
May 9, 2013
 
Following are some of the key points regarding PDL’s first quarter 2013 financial and business results.
 
Net Income
 
·
Net income for the first quarter of 2013 was $53.5 million or $0.36 per diluted share as compared with $40.2 million, or $0.29 per diluted share in the comparable quarter of 2012. The increase in net income is due to the 19 percent increase in royalty revenues and the resulting 33 percent increase in net income.
 
2013 Dividends
 
·
On January 30, 2013, PDL’s Board of Directors declared regular quarterly dividends of $0.15 per share of common stock, payable on March 12, June 12, September 12 and December 12 of 2013 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2013, the record dates for each of the dividend payments, respectively.
 
·
On March 12, 2013, PDL paid the first quarterly dividend to stockholders of record totaling $21 million using earnings generated in the first quarter of 2013.
 
Income Generating Assets
 
·
Closed three significant transactions in 2012 and one so far in 2013
 
·
Credit Agreement / Royalty Transaction with Avinger, Inc. on April 18, 2013
 
 
o
PDL financing Avinger for $40 million, including $20 million cash funded on April 18 and up to $20 million more upon completion of certain revenue milestones.
 
 
o
PDL to receive interest on the principal and a low single-digit royalty on Avinger’s revenues from product sales through April 2018.
 
 
o
Avinger has developed a new technology and a new approach to treatment of vascular disease called lumivascular (lumi = light, vascular = artery). Already commercially available is Ocelot, the first line of devices using lumivascular technology, used in procedures to open totally occluded arteries in the legs.  The company is also developing a line of lumivascular atherectomy devices, called Pantheris, which will be used to remove plaque from the arteries affected by peripheral artery disease.
 
Updates on Approved Royalty Bearing Products

Avastin® (bevacizumab):
·
On April 11, 2013, Genentech/Roche reported that 1Q13 worldwide sales increased by 11% on a constant exchange basis.
 
o
In EU, higher sales were driven by increased use in ovarian cancer and metastatic colorectal cancer.
 
o
In US, increased sales also reflected greater use in the treatment of metastatic colorectal cancer through multiples lines.
 
o
In Japan, Avastin experienced steady growth in non-small cell lung cancer.
·
On December 12, 2012, Genentech/Roche announced that EMA approved the use of Avastin in second line metastatic colorectal cancer.
·
On January 24, 2013, FDA granted a similar approval.
·
At ASCO, Genentech/Roche will present additional data from the previously announced NIH trial in patients with recurrent and metastatic cervical cancer comparing Avastin plus two chemotherapies against two chemotherapies that met its primary endpoint of improving median overall survival by 3.7 months.

Herceptin® (trastuzumab):
·
On April 11, 2013, Genentech/Roche reported that 1Q13 worldwide sales increased by 11% on a constant exchange basis.
 
o
Much of the growth was seen in US and emerging markets.

 
 
 
PDL BioPharma, Inc.
Q1-2013
May 9, 2013
 
Lucentis® (ranibizumab):
·
On April 11, 2013, Genentech/Roche reported that 1Q13 US sales increased by 1% on a constant exchange basis.
 
o
In US, Roche said that the competitive environment in age-related macular degeneration remains challenging, that share is stable in retinal vein occlusion and that it is increasing in diabetic macular edema.
·
On April 24, 2013, Novartis reported that 1Q13 ex-US sales increased by 7% on a constant exchange basis.
 
o
Ex-US, Lucentis is facing competition in several markets, including Japan, Australia and Germany, from Eylea.

Actemra® (tocilizumab):
·
On April 11, 2013, Genentech/Roche reported that 1Q13 worldwide sales increased by 32% on a constant exchange basis.
 
o
Sales growth was driven by monotherapy use with US being the biggest contributor to growth.
 
·
On April 30, 2013, Genentech/Roche announced that FDA had approved its use for the treatment of a rare, debilitating condition in children known as polyarticular juvenile idiopathic arthritis.
 
Perjeta™ (pertuzumab):
·
On April 11, 2013 Genentech/Roche reported 1Q13 sales of CHF 50 million.
·
Genentech/Roche announced EMA approval in March 2013.
·
Genentech/Roche expects to file in 2Q13 for approval in US in neo-adjuvant setting for HER2+ breast cancer.

Kadcyla™ (TDM-1 or ado-trastuzumab emtansine):
·
On April 13, 2013, Genentech/Roche reported 1Q13 sales of CHF 18 million.
 
 
o
Already included in National Comprehensive Cancer Network (NCCN) guidelines.
 
 
o
Enrolled first patient in April 2013 in Phase 3 in adjuvant setting under SPA in US
 
Updates on Select Development Stage Potential Royalty Bearing Products
 
Obinutuzumab:
·
At ASCO, Genentech/Roche will present additional data from previously announced Stage 1 of Phase 3 trial in patients with previously untreated chronic lymphocytic leukemia that showed treatment with obinutuzumab plus chemotherapy significantly reduced the risk of disease worsening or death compared to treatment with chemotherapy. 
 
 
o
Stage1 also included a pre-planned progression-free-survival (PFS) futility analysis comparing obinutuzumab plus chemotherapy to Rituxan plus chemotherapy. The goal of the futility analysis was to evaluate the likelihood that the study would meet its pre-specified endpoint criteria during Stage 2 analysis - improved efficacy (PFS) in the direct comparison of obinutuzumab plus chemotherapy to Rituxan plus chemotherapy.
 
 
o
The independent Data and Safety Monitoring Board (DSMB) assessment concluded that Stage 2 of the study should continue until its final analysis.
 
Forward-looking Statements
 
This document contains "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. 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. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new income generating assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. 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.
 
 
Page 2
 
PDL BioPharma, Inc.
Q1-2013
May 9, 2013
 
Royalty Revenue by Product ($ in 000's) *
                               
Avastin
     Q1       Q2       Q3       Q4    
Total
  
2013
     33,234       -       -       -       33,234  
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
  
2013
     30,287       -       -       -       30,287  
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
  
2013
     12,032       -       -       -       12,032  
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
  
2013
     5,930       -       -       -       5,930  
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
  
2013
     340       -       -       -       340  
2012
     -       -       58       250       308  
2011
     -       -       -       -       -  
2010
     -       -       -       -       -  
2009
     -       -       -       -       -  
2008
     -       -       -       -       -  
2007
     -       -       -       -       -  
2006
     -       -       -       -       -  
                                         
Tysabri
     Q1       Q2       Q3       Q4    
Total
  
2013
     12,965       -       -       -       12,965  
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
  
2013
     2,631       -       -       -       2,631  
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
                          
 
 
Page 3
 
PDL BioPharma, Inc.
Q1-2013
May 9, 2013
 
Reported Net Sales Revenue by Product ($ in 000's) *
                               
Avastin
     Q1       Q2       Q3       Q4    
Total
  
2013
     1,653,108       -       -       -       1,653,108  
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
  
2013
     1,681,574       -       -       -       1,681,574  
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
  
2013
     1,203,179       -       -       -       1,203,179  
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
  
2013
     341,309       -       -       -       341,309  
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       969,179  
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  
                                         
Perjeta
     Q1       Q2       Q3       Q4    
Total
  
2013
     34,008       -       -       -       34,008  
2012
     -       -       5,080       25,000       30,079  
2011
     -       -       -       -       -  
2010
     -       -       -       -       -  
2009
     -       -       -       -       -  
2008
     -       -       -       -       -  
2007
     -       -       -       -       -  
2006
     -       -       -       -       -  
                                         
Tysabri
     Q1       Q2       Q3       Q4    
Total
  
2013
     434,677       -       -       -       434,677  
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
  
2013
     87,703       -       -       -       87,703  
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
                          
 
 
Page 4
 
PDL BioPharma, Inc.
Q1-2013
May 9, 2013

Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
              
                                     
Avastin Sales
     2011 - Q4       2012 - Q1       2012 - Q2       2012 - Q3       2012 - Q4       2013 - Q1  
US Made & Sold
     684,878       652,824       724,483       679,914       710,501       664,109  
US Made & ex-US Sold
     375,830       448,037       532,979       428,976       281,905       161,369  
ex-US Made & Sold
     409,286       401,896       316,265       442,437       670,572       827,629  
Total
     1,469,994       1,502,757       1,573,727       1,551,327       1,662,977       1,653,108  
US Made & Sold
     47 %     43 %     46 %     44 %     43 %     40 %
US Made & ex-US Sold
     26 %     30 %     34 %     28 %     17 %     10 %
ex-US Made & Sold
     28 %     27 %     20 %     29 %     40 %     50 %
                                                 
Herceptin Sales
     2011 - Q4       2012 - Q1       2012 - Q2       2012 - Q3       2012 - Q4       2013 - Q1  
US Made & Sold
     453,168       456,920       497,109       503,612       515,790       514,113  
US Made & ex-US Sold
     612,908       523,353       466,477       545,625       552,127       486,400  
ex-US Made & Sold
     366,695       534,982       661,727       614,459       582,578       681,060  
Total
     1,432,771       1,515,255       1,625,313       1,663,695       1,650,495       1,681,574  
US Made & Sold
     32 %     30 %     31 %     30 %     31 %     31 %
US Made & ex-US Sold
     43 %     35 %     29 %     33 %     33 %     29 %
ex-US Made & Sold
     26 %     35 %     41 %     37 %     35 %     41 %
                                                 
Lucentis Sales
     2011 - Q4       2012 - Q1       2012 - Q2       2012 - Q3       2012 - Q4       2013 - Q1  
US Made & Sold
     428,884       433,428       412,131       385,746       381,592       392,207  
US Made & ex-US Sold
     646,131       645,665       674,411       711,795       728,103       810,972  
ex-US Made & Sold
     -       -       -       -       -       -  
Total
     1,075,015       1,079,092       1,086,543       1,097,541       1,109,695       1,203,179  
US Made & Sold
     40 %     40 %     38 %     35 %     34 %     33 %
US Made & ex-US Sold
     60 %     60 %     62 %     65 %     66 %     67 %
ex-US Made & Sold
     0 %     0 %     0 %     0 %     0 %     0 %
                                                 
Xolair Sales
     2011 - Q4       2012 - Q1       2012 - Q2       2012 - Q3       2012 - Q4       2013 - Q1  
US Made & Sold
     188,728       185,505       193,600       211,702       210,892       207,976  
US Made & ex-US Sold
     -       -       -       -       -       -  
ex-US Made & Sold
     126,184       124,729       121,039       136,094       129,540       133,333  
Total
     314,911       310,234       314,638       347,796       340,431       341,309  
US Made & Sold
     60 %     60 %     62 %     61 %     62 %     61 %
US Made & ex-US Sold
     0 %     0 %     0 %     0 %     0 %     0 %
ex-US Made & Sold
     40 %     40 %     38 %     39 %     38 %     39 %
                                                 
Perjeta Sales
     2011 - Q4       2012 - Q1       2012 - Q2       2012 - Q3       2012 - Q4       2013 - Q1  
US Made & Sold
     -       -       -       5,080       24,571       32,377  
US Made & ex-US Sold
     -       -       -       -       428       1,632  
ex-US Made & Sold
     -       -       -       -       -       -  
Total
     -       -       -       5,080       25,000       34,008  
US Made & Sold
     0 %     0 %     0 %     100 %     98 %     95 %
US Made & ex-US Sold
     0 %     0 %     0 %     0 %     2 %     5 %
ex-US Made & Sold
     0 %     0 %     0 %     0 %     0 %     0 %
                                                 
Total Sales
     2011 - Q4       2012 - Q1       2012 - Q2       2012 - Q3       2012 - Q4       2013 - Q1  
US Made & Sold
     1,755,657       1,728,678       1,827,323       1,786,053       1,843,345       1,810,783  
US Made & ex-US Sold
     1,634,869       1,617,054       1,673,867       1,686,395       1,562,564       1,460,373  
ex-US Made & Sold
     902,165       1,061,607       1,099,031       1,192,990       1,382,690       1,642,023  
Total
     4,292,691       4,407,339       4,600,221       4,665,438       4,788,598       4,913,178  
US Made & Sold
     41 %     39 %     40 %     38 %     38 %     37 %
US Made & ex-US Sold
     38 %     37 %     36 %     36 %     33 %     30 %
ex-US Made & Sold
     21 %     24 %     24 %     26 %     29 %     33 %
                                                 
* As reported to PDL by its licensees
                                          
   Totals may not sum due to rounding
                                          
 
 
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