Attached files

file filename
8-K - FORM 8-K - PDL BIOPHARMA, INC.pdli20130228_8k.htm
EX-99 - EXHIBIT 99.1 - PDL BIOPHARMA, INC.pdli20130228_8kex99-1.htm
EX-99 - EXHIBIT 99.2 - PDL BIOPHARMA, INC.pdli20130228_8kex99-2.htm

Exhibit 99.3

PDL BioPharma, Inc.

Q4 / Year End 2012

March 1, 2013

 


Following are some of the key points regarding PDL’s fourth quarter 2012 financial and business results.


 

Net Income


Net income for the fourth quarter of 2012 was $49.4 million or $0.34 per diluted share as compared with net income of $38.9 million or $0.24 per diluted share for the same period of 2011.


Net income for full-year 2012 was $211.7 million, or $1.45 per diluted share as compared with net income of $199.4 million in 2011 or $1.15 per diluted share.


2012 and 2013 Dividends


We paid $0.15 per share of common stock, or $21.0 million, on December 14, 2012, to our stockholders of record on December 7, 2012, as part of our regular, quarterly dividend policy for 2012.


In January 2013, PDL announced that its board of directors declared that the regular, quarterly dividends to be paid to its stockholders in 2013 will be $0.15 per share of common stock. The $0.15 dividends will each be paid 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.


 

Updates on Approved Royalty Bearing Products

 

Avastin® (bevacizumab):

On January 30, 2013, Roche reported that 2012 worldwide sales increased by 6% over 2011 sales on a constant exchange basis.

 

o

In EU, higher sales were driven by the launch in ovarian cancer, and increased market share in lung cancer and breast cancer.

 

o

In Japan, higher sales were driven by increased uptake in colorectal cancer, non-small cell lung cancer and metastatic breast cancer.

On November 16, 2012, Genentech/Roche announced that the EU’s CHMP adopted a positive opinion regarding the use of Avastin in second line metastatic colorectal cancer.

 

o

A similar application has been granted priority review by the FDA in US.

 

o

Avastin is already approved for first line treatment of metastatic colorectal cancer in US and EU.

On November 19, 2012, Genentech/Roche reported additional details from a Phase 3 trial in patients with newly diagnosed glioblastoma that showed that treatment with Avastin plus radiation and chemotherapy increased progression-free-survival by 36% compared to radiation and chemotherapy.

 

o

Avastin is already approved for second line treatment of glioblastoma in US and EU.

On February 7, 2013, the National Institutes of Health announced that a trial in patients with recurrent and metastatic cervical cancer comparing Avastin plus two chemotherapies against two chemotherapies met its primary endpoint of improving median overall survival by 3.7 months.

 

o

Genentech/Roche said that they are analyzing the data to evaluate next steps.

 

Herceptin® (trastuzumab):

On January 30, 2013, Roche reported that 2012 worldwide sales increased by 11% over 2011 sales on a constant exchange basis.

 

o

Much of the growth was seen in US and emerging markets.

 

o

Also contributing to the sales growth was increased HER2 testing and further uptake in HER2+ gastric cancer.

 

 
 

 

 

PDL BioPharma, Inc.

Q4 / Year End 2012

March 1, 2013

 

Lucentis® (ranibizumab):

On January 30, 2013, Roche reported that 2012 US sales decreased by 8% over 2011 sales on a constant exchange basis.

 

o

Roche said that it expects further pressure on sales for the treatment of age-related macular degeneration in 2013 partially offset by increased sales for the treatment of diabetic macular edema and stable share for the treatment of retinal vein occlusion.

On January 23, 2013, Novartis reported that 2012 ex-US sales increased by 22% over 2011 sales on a constant exchange basis.

 

o

Increased sales growth was driven by new launches for the treatment of diabetic macular edema and retinal vein occlusion.

 

Actemra® (tocilizumab):

On January 30, 2013, Roche reported that 2012 worldwide sales increased by 33% over 2011 sales on a constant exchange basis.

 

o

On October 15, 2012, Genentech/Roche announced that the label had been expanded to include patients who had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).


 

o

Subcutaneous formulation filed for approval in US and EU in December 2012.

 

Perjeta™ (pertuzumab):

On January 30, 2013, Roche reported that 4Q12 demand increased by 53% over 3Q12 demand.

 

o

Over 75% of relevant physicians are already prescribing Perjeta.

 

Kadcyla™ (TDM-1 or ado-trastuzumab emtansine):

On February 22, 2013, Genentech/Roche announced that the FDA had approved the product for second line treatment of HER2+ metastatic breast cancer and first line treatment for those patients who relapse within six months following adjuvant therapy.


 

o

A similar application has been accepted for review in EU.


 

o

Kadcyla will be available in the US within two weeks.


 

o

Pricing is $9,800 per month, significantly higher than many estimates in the financial community.


 

Updates on Select Development Stage Potential Royalty Bearing Products

 

Obinutuzumab:

On January 30, 2013, Genentech/Roche announced positive results from Stage 1 of a 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.

 

 
 

 

 

PDL BioPharma, Inc.

Q4 / Year End 2012

March 1, 2013


Solanezumab:

On August 24, 2012, Lilly announced that both of its Phase 3 trials did not meet the primary endpoints of cognitive and functional benefit.


 

o

A pre-specified secondary subgroup analysis of the pooled data from both trials showed that solanezumab slowed the cognitive decline in patients with mild disease but not patients with moderate disease.


On December 12, 2012, Lilly said that it will commence an additional Phase 3 trial in patients with mild Alzheimer’s disease by no later than 3Q2013.


If solanezumab were to receive marketing authorization, PDL would receive a patent royalty of 3% in addition to a 12.5 year know-how royalty of 2% from date of first sale.


On January 18, 2013, the NIH's National Institute of Aging (NIA) announced that it and other federal agencies will fund a three year trial investigating the use of solanezumab in 1,000 patients with abnormal amyloid protein buildup but who are at the pre-symptomatic stage of Alzheimer's disease.  


 

o

The leading hypothesis explaining Alzheimer's disease is that abnormal amyloid accumulates into clumps on the brain, which clumps secrete toxins causing neuronal damage in brain tissue that eventually results in cognitive deficits.


 

o

NIA selected solanezumab after considering a number of anti-amyloid treatments.


 

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.

 

 
 

 

 

PDL BioPharma, Inc.

Q4 / Year End 2012

March 1, 2013

 

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

 

Avastin

Q1

Q2

Q3

Q4

Total

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

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

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

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

2012

    -     -     58     250     308

2011

    -     -     -     -     -

2010

    -     -     -     -     -

2009

    -     -     -     -     -

2008

    -     -     -     -     -

2007

    -     -     -     -     -

2006

    -     -     -     -     -

Tysabri

Q1

Q2

Q3

Q4

Total

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

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

 

 
 

 

 

PDL BioPharma, Inc.

Q4 / Year End 2012

March 1, 2013


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


Avastin

Q1

Q2

Q3

Q4

Total

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

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

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

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

2012

    -     -     5,080     25,000     30,079

2011

    -     -     -     -     -

2010

    -     -     -     -     -

2009

    -     -     -     -     -

2008

    -     -     -     -     -

2007

    -     -     -     -     -

2006

    -     -     -     -     -

Tysabri

Q1

Q2

Q3

Q4

Total

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

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


 

 
 

 

 

PDL BioPharma, Inc.

Q4 / Year End 2012

March 1, 2013

 

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

 

Avastin Sales

2011 - Q3

2011 - Q4

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

US Made & Sold

    688,966     684,878     652,824     724,483     679,914     710,501

US Made & ex-US Sold

    587,975     375,830     448,037     532,979     428,976     281,905

ex-US Made & Sold

    304,155     409,286     401,896     316,265     442,437     670,572

Total

    1,581,095     1,469,994     1,502,757     1,573,727     1,551,327     1,662,977

US Made & Sold

    44 %     47 %     43 %     46 %     44 %     43 %

US Made & ex-US Sold

    37 %     26 %     30 %     34 %     28 %     17 %

ex-US Made & Sold

    19 %     28 %     27 %     20 %     29 %     40 %

Herceptin Sales

2011 - Q3

2011 - Q4

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

US Made & Sold

    445,395     453,168     456,920     497,109     503,612     515,790

US Made & ex-US Sold

    495,086     612,908     523,353     466,477     545,625     552,127

ex-US Made & Sold

    702,416     366,695     534,982     661,727     614,459     582,578

Total

    1,642,898     1,432,771     1,515,255     1,625,313     1,663,695     1,650,495

US Made & Sold

    27 %     32 %     30 %     31 %     30 %     31 %

US Made & ex-US Sold

    30 %     43 %     35 %     29 %     33 %     33 %

ex-US Made & Sold

    43 %     26 %     35 %     41 %     37 %     35 %

Lucentis Sales

2011 - Q3

2011 - Q4

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

US Made & Sold

    422,335     428,884     433,428     412,131     385,746     381,592

US Made & ex-US Sold

    630,474     646,131     645,665     674,411     711,795     728,103

ex-US Made & Sold

    -     -     -     -     -     -

Total

    1,052,809     1,075,015     1,079,092     1,086,543     1,097,541     1,109,695

US Made & Sold

    40 %     40 %     40 %     38 %     35 %     34 %

US Made & ex-US Sold

    60 %     60 %     60 %     62 %     65 %     66 %

ex-US Made & Sold

    0 %     0 %     0 %     0 %     0 %     0 %

Xolair Sales

2011 - Q3

2011 - Q4

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

US Made & Sold

    184,837     188,728     185,505     193,600     211,702     210,892

US Made & ex-US Sold

    -     -     -     -     -     -

ex-US Made & Sold

    126,037     126,184     124,729     121,039     136,094     129,540

Total

    310,874     314,911     310,234     314,638     347,796     340,431

US Made & Sold

    59 %     60 %     60 %     62 %     61 %     62 %

US Made & ex-US Sold

    0 %     0 %     0 %     0 %     0 %     0 %

ex-US Made & Sold

    41 %     40 %     40 %     38 %     39 %     38 %

Perjeta Sales

2011 - Q3

2011 - Q4

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

US Made & Sold

    -     -     -     -     5,080     24,571

US Made & ex-US Sold

    -     -     -     -     -     428

ex-US Made & Sold

    -     -     -     -     -     -

Total

    -     -     -     -     5,080     25,000

US Made & Sold

    0 %     0 %     0 %     0 %     100 %     98 %

US Made & ex-US Sold

    0 %     0 %     0 %     0 %     0 %     2 %

ex-US Made & Sold

    0 %     0 %     0 %     0 %     0 %     0 %

Total Sales

2011 - Q3

2011 - Q4

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

US Made & Sold

    1,741,534     1,755,657     1,728,678     1,827,323     1,786,053     1,843,345

US Made & ex-US Sold

    1,713,535     1,634,869     1,617,054     1,673,867     1,686,395     1,562,564

ex-US Made & Sold

    1,132,608     902,165     1,061,607     1,099,031     1,192,990     1,382,690

Total

    4,587,677     4,292,691     4,407,339     4,600,221     4,665,438     4,788,598

US Made & Sold

    38 %     41 %     39 %     40 %     38 %     38 %

US Made & ex-US Sold

    37 %     38 %     37 %     36 %     36 %     33 %

ex-US Made & Sold

    25 %     21 %     24 %     24 %     26 %     29 %

 

* As reported to PDL by its licensees

Totals may not sum due to rounding