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8/6/2019 PDL BioPharma Corporate Overview June 20111
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June 2011
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verv ew o o arma
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Company Overview
PDL pioneered the humanization of monoclonal antibodies
targeted treatments for cancer and immunologic diseases
PDLs primary assets are its antibody humanization patents
and royalty assets which consist of its Queen et al. patents
Licensees consist of lar e biotechnolo andpharmaceutical companies including Roche/Genentech/Novartis, Elan/BiogenIdec, Pfizer/Wyeth/J&J and Chugai
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Antibody Humanization Technology
Antibodies are naturally produced by humans tofi ht forei n substances such as bacteria andviruses
In the 1980s, scientists began creating antibodies innon-human immune systems, such as those ofm ce, a cou arge spec c s es on ce s o gvarious human diseases
However, mouse derived antibodies are recognized
be rejected by the human immune system
PDLs technology allows for the humanization of mouse derived antibodies by movingthe important binding regions from the mouse antibody onto a human framework
PDLs humanization technology is important because the humanized antibodies retain thebinding and activity levels from the original mouse antibody
PDLs technology has been incorporated into antibodies to treat cancer, eye diseases,
6
ar r s, mu p e sc eros s an o er ea con ons w aggrega e annua sa es o over $17 billion
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Mission Statement
Queen et al. Patents
Manage patent portfolio Manage license agreements
Purchase new royalty generating assets sse s a mprove s are o er re urn
Commercial stage assets
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Corporate Governance
Management Board of Directors
John McLaughlinPresident & CEO
Fred FrankLead Director
VP & CFO
Christopher Stone
John McLaughlin
, enera ounseSecretary
Caroline Krumel
Harold Selick
VP of Finance
Danny HartAssociate General Counsel
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cense ro uc s an oya y evenue
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Licensed Products and Royalty Revenue
Product Licensor 2010 WW Sales Approved Indications
AvastinGenentech (US) and $6.4 billion
1 Metastatic colorectal cancer
- Advanced non-small cell lung cancer
Renal cancer
Metastatic HER2- breast cancer
Glioblastoma
HerceptinGenentech US and $5.4 billion
1 Metastatic HER2+ breast cancer
Roche (ex-US) Metastatic HER2+ stomach cancer
LucentisGenentech (US) and
Novartis (ex-US)
$3.0 billion1 Wet age-related macular degeneration (AMD)
Macular edema or swelling following retinal vein occlusion
Diabetic macular edema
Lucentis is the only approved treatment for wet AMD proven to improve or
maintain vision
XolairGenentech (US) and
Novartis (ex-US)
$1.0 billion1 Moderate to severe persistent allergic asthma
First approved therapy designed to target the antibody IgE, a key underlying
cause of the symptoms of allergy related asthma
Tysabri Biogen Idec and Elan $1.2 billion1 Multiple Sclerosis (MS) in adult patients with relapsing forms of the disease
Crohns disease in adult patients with moderate-to-severe forms of the disease who
have had an inadequate response to or are unable to tolerate conventional
therapies
Actemra 2oc e an uga m on euma o ar r s
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1. As reported to PDL by its licensee 2. As reported by Roche; assume 1.155 CHF/USD
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How Long will PDL Receive Royalties from
ueen et al. Patents? PDLs revenues consist of royalties generated on sales of licensed products
Sold before the expiration of the Queen et al. patents in mid-2013 through end of 2014
or
Made prior to the expiration of the Queen et al. patents and sold anytime thereafter
Exam le of Antibod Bulk Manufacturin Schedule
CellCulture
Quality ReleaseTesting
Bulk Frozen Storage3 mos 2-18 months1mo 1mo
Purification to Concentrated Bulk/Frozen
Example of Antibody Formulation, Fill and Finish Schedule
1 mo 3 mos 5 mos 10 mos 15 mos 20 mos 27 mos
month 1 month month 2-3 months
Thaw, Formulation& Vial Filling
QualityRelease
Packaging& Quality Inventory
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Queen et al Patents - Royalty Rates
Tysabri and Actemra
Flat, low single-digit royalty
Genentech Products (Avastin, Herceptin, Lucentis1 and Xolair)
Tiered royalties on product made or sold in US Flat, 3% royalty on product made and sold outside US
en e g o a roya y ra e on enen ec ro uc s n was .
Blended royalty rate on Genentech Products in 2010 made or sold in US
was 1.5%. .
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 Over $4.0 Billion 1.0%
Genentech Product Made and Sold Ex-U.S.
All Sales 3.0%
12
1. As part of a settlement with Novartis, which commercializes Lucentis outside US, PDL agreed to pay to Novartis certain
amounts based on net sales of Lucentis made by Novartis during calendar year 2011 and beyond. The amounts to be paid areless than we receive in royalties on such sales and we do not currently expect such amount to materially impact our total annualrevenues.
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Shift of Manufacturing Sites = Higher Royalties
Roche is moving some manufacturing ex-US which may result in higher royaltiesto PDL due to the flat 3% royalty for Genentech Products made and sold ex-US
Two new plants in Singapore (CHO = antibody and e. coli = antibody fragment)- E. coli (Lucentis) and CHO (Avastin) plants are approved for commercial supply to the US- E. coli and CHO plants are expected to be approved for commercial supply to the EU in 2011
- ,
Percent of Total Worldwide Sales1
70% 70%72%
70%
80%
49% 51%55%
27% 26%
47%
40%
30%40%
50%
60%
Ex-US Sales
20%
0%
10%
20% Ex-US Manufacturing& Sales
131. As reported to PDL by its licensee
- - - - - -
Avastin Herceptin
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Royalty Revenue & Licensed Products
Royalties by Product($ in millions)
$350$400
$250$300 Herceptin
Avastin
Lucentis
$150$200
Xolair
Synagis
$0$50 TysabriOther
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2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
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oya y ro uc s pprove
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Royalty Products - Avastin
Licensee Product Status Indications
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
ase var an ancerGastricProstate CancerAdjuvant settings
Retinopathy of Prematurity
On February 7, 2011, Genentech reported that Phase 3 trial in women with previouslytreated (recurrent), platinum-sensitive ovarian cancer showed an improvement in
HER2+ Stomach and Gastro-Esophageal cancers
Lucentis ApprovedApprovedPhase 3
AMDRVODME
progression free survival in those patients treated with Avastin in combination withchemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alonecompared to those treated with chemotherapy alone.
Two previous Phase 3 studies in women with newly diagnosed ovarian cancer-
Xolair ApprovedsBLA
Moderate-Severe AsthmaPediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche Chu ai Actemra A roved Rheumatoid Arthritis
(carboplatin and paclitaxel), followed by the continued use of Avastin alone, significantlyincreased progression free survival compared to treatment with chemotherapy alone.
Roche has submitted an application for approval for first line treatment in EU and expectsa decision later in 2011.
17
Genentech expects to file an application for approval in US in 2011.
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Royalty Products - Avastin
Licensee Product Status Indications
On February 16, Research to Prevent Blindness Foundation and the U.S. National EyeInstitute announced results from a trial showing that just 4% of the infants who developedretinopathy of prematurity and were treated with Avastin suffered a recurrence of thedisease compared to 22% of those babies with the disease who received laser treatment.
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
e nopa y o prema ur y s a sease a arms e re na an s e mos commoncause of blindness in infants.
Because the trial was not sponsored by Genentech/Roche, it is not clear whether they willseek approval for this indication.
The publication of this data in the February 17 issue of the New England Journal ofase
Phase 2 ISP
var an ancerGastricProstate CancerAdjuvant settings
Retinopathy of Prematurity
Medicineshould result in significant off-label use in this disease.
HER2+ Stomach and Gastro-Esophageal cancers
Lucentis ApprovedApprovedPhase 3
AMDRVODME
Xolair ApprovedsBLA
Moderate-Severe AsthmaPediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche Chu ai Actemra A roved Rheumatoid Arthritis
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Royalty Products - Lucentis
Licensee Product Status Indications On January 7, Novartis announced that Lucentis has been approved in the EU for the
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
treatment of visual impairment due to diabetic macular edema (DME).
DME is a leading cause of blindness in the working-age population in mostdeveloped countries. On February 11, 2011, Genentech announced that one of two Phase 3 studies evaluating
ase var an ancerGastricProstate CancerAdjuvant settings
Herceptin Approved Breast HER2+ Cancer
monthly dosing of Lucentis achieved an improvement in vision of at least 15 letters on theeye chart at 24 months compared to those in a control group, who received a placeboinjection.
-
Lucentis ApprovedApproved
Phase 3 (US)
AMDRVODME
-
sBLA Pediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche (Chugai) Actemra Approved Rheumatoid Arthritis
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Royalty Products - Lucentis On November 22, 2010, Regeneron and its partner, Bayer, reported top line data from two
Licensee Product Status Indications
-patients which suggest that it may be injected into the eye every other month with safetyand efficacy comparable to that of monthly dosing of Lucentis.
On December 20, 2010, Regeneron has also reported positive Phase 3 data in thetreatment of retinal vein occlusion (RVO) for which Lucentis is approved.
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
Unlike the AMD trial, monthly administration was used in the RVO trial, which does
not afford a dosing advantage with respect to Lucentis. On February 22, 2011, Regeneron and its partner, Bayer, filed an application for approvalof its VEGF Trap for treatment of AMD with a PDUFA date of August 20, 2011 based on
ase var an ancerGastricProstate CancerAdjuvant settings
Retinopathy of Prematurity
. Regeneron filed suit in February 2011 seeking a summary judgment that it does not
infringe Genentechs patents. Genentech filed a countersuit in April 2011 asserting that Regeneron is willfully infringing
Genentechs patents, seeking treble damages and asking for injunctive relief.
HER2+ Stomach and Gastro-Esophageal cancers
Lucentis ApprovedApprovedPhase 3
AMDRVODME
Xolair ApprovedsBLA
Moderate-Severe AsthmaPediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche Chu ai Actemra A roved Rheumatoid Arthritis
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Royalty Products - Lucentis
Licensee Product Status Indications
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
On April 4, 2011, Genentech and Johns Hopkins University reported results of a review of
files of 77,886 patients with 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 ocularase var an ancer
GastricProstate CancerAdjuvant settings
Retinopathy of Prematurity
n amma on an more e y o ave ca arac surgery o ow ng rea men anLucentis treated patients.
Authors of the study note that it is limited due to incomplete information on confounding
factors such as smoking, lipid and blood pressure levels, etc.
HER2+ Stomach and Gastro-Esophageal cancers
Lucentis ApprovedApprovedPhase 3
AMDRVODME
Xolair ApprovedsBLA
Moderate-Severe AsthmaPediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche Chu ai Actemra A roved Rheumatoid Arthritis
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Royalty Products - Lucentis
Licensee Product Status Indications
On April 28, 2011, New England Journal of Medicinereported the results from the NEIsCATT study comparing Lucentis and Avastin on fixed and variable schedules in thetreatment of AMD.
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
,primary endpoint of mean change in visual acuity (number of lines of letters on an eye
chart) at 12 months, less expensive Avastin was not inferior to Lucentis. It is estimated that off label use of Avastin in the U.S. was 60% prior to the results of
the CATT trial.ase var an ancer
GastricProstate CancerAdjuvant settings
Retinopathy of Prematurity
At 12 months, serious adverse events (primarily hospitalizations) occurred at a 24 percentrate for patients receiving Avastin and a 19 percent rate for patients receiving Lucentis.However, preliminary 24 month safety data showed no difference between Lucentis and
Avastin treated patients in terms of death, stroke and all arteriothrombotic events.
HER2+ Stomach and Gastro-Esophageal cancers
Lucentis ApprovedApprovedPhase 3
AMDRVODME
Xolair ApprovedsBLA
Moderate-Severe AsthmaPediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche Chu ai Actemra A roved Rheumatoid Arthritis
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Royalty Products - Tysabri
Licensee Product Status Indications
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
Biogen Idec and Elan made regulatory filings with FDA and EMA to update the label ofTysabri to reflect that anti-JC virus antibody status could be used to stratify the risk ofprogressive multifocal leukoencephalopathy (PML).
ase var an ancer
GastricProstate CancerAdjuvant settings
Retinopathy of Prematurity
, ,factor the product label for Tysabri in the EU.
The CHMP also recommended a five-year renewal of the Tysabris MarketingAuthorization in the EU.
On April 22, 2011, FDA disclosed the estimated risk of PML infection in Tysabri treated
HER2+ Stomach and Gastro-Esophageal cancers
Lucentis ApprovedApprovedPhase 3
AMDRVODME
pa en s s . per , pa en s ur ng e rs wo years o rea men , . per ,patients during months 25 to 36, and 0.9 per 1,000 after three years. Limited data isavailable beyond four years.
Xolair ApprovedsBLA
Moderate-Severe AsthmaPediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche Chu ai Actemra A roved Rheumatoid Arthritis
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Royalty Products - Actemra
Licensee Product Status Indications
sBLA
NSCLC
Metastatic Renal CellGlioblastomaMetastatic Breast HER2- 1st LineMetastatic Breast HER2- 2nd Line
On January 5, 2011, Roche announced that FDA expanded the Actemra label to include
ase var an ancerGastricProstate CancerAdjuvant settings
Retinopathy of Prematurity
, ,achievement of major clinical response in adult patients with moderately to severely activerheumatoid arthritis.
On April 18, 2011, FDA approved Actemra to treat patients age 2 and older with active
systemic juvenile idiopathic arthritis (SJIA).
HER2+ Stomach and Gastro-Esophageal cancers
Lucentis ApprovedApprovedPhase 3
AMDRVODME
s e rs an on y approve rea men or , a rare an severe orm o ar r saffecting children.
Xolair ApprovedsBLA Moderate-Severe AsthmaPediatric Asthma
Elan Tysabri Approved Multiple Sclerosis
Roche Chu ai Actemra A roved Rheumatoid Arthritis
24
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Potential Royalty Products eve opmen age
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Potential Royalty Products T-DM1
Licensee Product Status Indications
Roche (Genentech) T-DM1 Phase 2 & 3 Breast HER2+ Cancer
Ocrelizumab Phase 2b Relapsing Remitting Multiple SclerosisPertuzumab Phase 3 Metastatic HER2+ Breast Cancer
Roche Afutuzumab Phase 3 Chronic Lymphocytic Leukemia
Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimers Disease
Lilly Solanezumab Phase 3 Alzheimers Disease
Merck Datoluzumab Phase 2 Metastatic Colorectal Cancer
Abbott/Biogen Idec Daclizumab Phase 3 Relapsing Remitting Multiple Sclerosis
Eisai Farletuzumab Phase 3 Ovarian Cancer
On October 13, 2010, Roche/Genentech announced preliminary, six month results from aPhase 3 trial in second line HER2+ breast cancer patients which showed that 48% of
-
combination of Herceptin and Taxotere. Among the women taking the standard therapy, 75% had side effects of grade 3 or
higher on a 5-point scale, compared with 37% of those getting T-DM1.
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Licensed Unlicensed
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Potential Royalty Products - Pertuzumab
Licensee Product Status Indications
Roche (Genentech) T-DM1 Phase 2 & 3 Breast HER2+ Cancer
Ocrelizumab Phase 2b Relapsing Remitting Multiple SclerosisPertuzumab Phase 3 Metastatic HER2+ Breast Cancer
Roche Afutuzumab Phase 3 Chronic Lymphocytic Leukemia
Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimers Disease
Lilly Solanezumab Phase 3 Alzheimers Disease
Merck Datoluzumab Phase 2 Metastatic Colorectal Cancer
Abbott/Biogen Idec Daclizumab Phase 3 Relapsing Remitting Multiple Sclerosis
Eisai Farletuzumab Phase 3 Ovarian Cancer
On December 10, 2010, Roche/Genentech reported the results from a Phase 2 trialinvestigating the neoadjuvant (prior to surgery) use of pertuzumab and Herceptin pluschemotherapy for the treatment of early-stage, HER2+ breast cancer.
Treatment significantly improved the rate of complete tumor disappearance in the breastby more than half compared to Herceptin plus docetaxel, p=0.014.
Roche ex ects a lobal re ulator filin of ertuzumab at the end of 2011.
27
Licensed Unlicensed
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Genentech / Roche Product Pipeline
AvastinBC Adjuvant HER2+US & EU Filings Calendar
AvastinmCRC TML
vas nBC Adj Triple Negative
AvastinGlioblastoma 1st Line
HER 2- BC adj
AvastinNSCLC adj
Avastin
Ovarian Cancer 1st
Line US
Herceptin
Subcutaneous Formulation
Avastin & HerceptinHER2+ mBC 1st Line
Actemra
Early Rheumatoid Arthritis
HerceptinBC HER 2+ Adj 2 Year
T-DM1HER 2+ mBC 1st Line
Pertuzumab1
HER 2+ EBC
Avastin + HerceptinmBC HER+ 2nd Line
AvastinRelapsed Ovarian Cancer
T-DM1HER 2+ Advanced mBC
ActemraAnkylosing Spondylitis
ActemraSC Formulation (US)
LucentisAMD High Dose (US)
Ocrelizumab1
PPMS & RRMS
Lebrikizumab1
Asthma
LucentisDiabetic Macular Edema (US)
Pertuzumab1
mBC HER2+ 1st LineActemraRA DMARD H2H (EU)
ActemraSC Formulation (EU)
Afutuzumab (GA101)Chronic Lymphocytic Leukemia
XolairChronic Idiopathic Urticaria
Afutuzumab (GA101)Non-Hod kins L m homa
Rontalizumab1Systemic Lupus Erythematosus
28
2011 2012 2013 Post 2013
1. Not a licensed product; source Roche investor update, April 14, 2011
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nanc a s
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Financial Overview
Income Statement Condensed Balance Sheet
($ in millions)
Fiscal Year Ending 12/31, As of
2009 20101
1Q'20112
3/31/2011 12/31/2010
Revenue 318 345 83
Cash, Cash Equivalents &Investments $193 $248
Expenses 21 134 6
EBIT $297 $211 $78 Total Assets $249 $317
Net Interest Expense 17 61 9 Total Debt $497 $518
Pre-Tax Profit $280 $150 $69
Total Stockholder's Deficit ($371) ($324)
Taxes 91 58 24
Net Income $190 $92 $45
1. Includes $92.5 million one time legal settlement to MedImmune. Net interest expenseincludes $17.6 million loss on convertible note retirement.
2. Includes $10.0 million one time legal settlement from UCB.
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urrent an ong- erm a t es
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Current and Long-Term Liabilities
$155 million 3.75 convertible senior notes due May 2015 Notes issued May 16, 2011; conversion rate is 129.2740 / $1,000 face amount ($7.74/share) . Proceeds will be used to redeem 2012 convertible senior notes on June 30, 2011
$250 million 2.00% convertible senior notes due February 2012; current
Conversion rate is 147.887 shares / $1,000 face amount ($6.76/share) Redemption date is June 30, 2011 subject to note holders conversion rights
180 million 2.875% convertible senior notes due Februar 2015 Conversion rate is 147.887 shares / $1,000 face amount ($6.76/share)
$300 million 10.25% secured non-recourse notes; current principal balance of184 million
Approximately 40% of Genentech royalties dedicated to quarterly principal and interestpayments; principal repayment fluctuates in relation to royalties received After retirement, securitized Genentech royalties will be retained by PDL
The purpose of restructuring PDLs debt is to free up cash for the acquisition ofroyalty assets
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ega a ers
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Recent Resolution of Legal Disputes
PDL has resolved all challenges to the Queen et al. Patents in theU.S. Patent and Trademark Office (USPTO) and the European
UCB Pharma- PDL received $10 million from UCB and PDL agreed not to sue UCB for any royaltiesrelated to Cimzia
- UCB terminated patent interference proceedings before the USPTO and withdrew itsopposition appeal in the EPO
MedImmune
- PDL paid MedImmune $65 million on February 15, 2011 and will pay them an additional. m on y e ruary
- MedImmune ceased support of any party in the EPO opposition appeal
Novartis- PDL dismissed its claims against Novartis in its Nevada lawsuit
- Novartis withdrew its opposition appeal to PDLs European patent in EPO- PDL will pay Novartis an amount based on Novartis net ex-U.S. sales of Lucentis duringcalendar year 2011 and beyond
BioTransplant- PDL acquired BioTransplant, a bankrupt company and instructed BioTransplant to
withdraw its opposition appeal in the EPO
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Pending Dispute with Genentech and Roche
In August 2010, Genentech sent a fax on behalf of Roche and Novartis
assertin its roducts do not infrin e PDLs su lementar rotection
certificates (SPCs) Products include Avastin, Herceptin, Lucentis and Xolair SPCs are extensions of patent term in Europe that are issued on a country-by-country
an pro uc - y-pro uc as s
PDL Response Genentechs assertions are without merit
PDL disa rees with Genentechs assertions of non-infrin ement
Genentech had waived its rights to challenge our patents, including SPCs in its 2003
Settlement Agreement with PDL
2003 Settlement Agreement eso ve n e ec ua proper y spu es e ween e wo compan es a a me
Limits Genentechs ability to challenge infringement of PDLs patent rights, including
SPCs, and waives Genentechs right to challenge or assist other in challenging the
validity of our patent rights
35
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Nevada Lawsuit Against Genentech/Roche
PDL filed a lawsuit against Genentech and Roche in Nevadastate court Lawsuit states that fax constitutes a breach of 2003 Settlement
Agreement because Genentech assisted Roche in challenging PDLspatents and SPCs
,and other monetary remedies set forth in the 2003 SettlementAgreement, punitive damages and attorneys fees
n ovem er , enen ec an oc e e wo mo onsto dismiss They contend that 2003 Settlement Agreement applies only to PDLs
. .
They asserted that the Nevada court lacks personal jurisdiction overRoche
On April 21, 2011, Nevada court heard arguments on two Genentech
If case proceeds, trial is not yet scheduled and not expected until 2012
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p m z ng oc o er e urn
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Business Strategy
Queen et al. patents expire end of 2014;we anticipate royalties will likely
continue to ~ 2016
Purchase new royalty assets andladder like a bond portfolio Continue to reinvest in new royalty
assets and pay dividends
If unable to acquire royalty assetson attractive terms, build cashreserves to: Repay debt
-
- Sweet spot $75MM to $150MM Debt repaid by end of 2015 Company continues as long as it
can enerate satisfactor return
se a excess cas o pay
dividends to enhance shareholderreturn
Wind-up company in 2016timeframe
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Optimizing Stockholder Return
Continuously evaluating alternatives
Dividends Ca ital restructure
Share repurchase
Purchase of commercial stage, royalty
39
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Investment Highlights
Strong historic revenue growth from approved products
Potential for additional indications from existing
products, new product approvals and purchase of newro alt assets
Potential to grow and diversify revenues with the
addition of new royalty assets Significantly reduced expenses with no R&D burn
Liquidity volume averages 3 million shares/day
Return to stockholders In 2011, $0.60/share to be paid in quarterly regular dividends of
. , ,December 15
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ppen x
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Avastin
Licensor Genentech (US) and Roche (ex-US)
Mechanism As a tumor grows, it exceeds the ability of the local
blood supply to nourish it
growth factor (VEGF) stimulating angiogenesis or thegrowth of leaky blood vessels to nourish the tumor
Avastin targets and inhibits VEGF reduction in blood
Approvals Metastatic colorectal cancer, advanced non-small cell
lung cancer, renal cancer, metastatic HER2- breastcancer and glioblastoma
Sales 2010 worldwide net sales of $6.4 billion1
- -has narrowed this label, resulting in drop in sales for this indication
42
Treatment with Avastinreduces vascularizationor blood supply of tumor
1. As reported to PDL by its licensee
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Herceptin
Licensor Genentech (US) and Roche (ex-US)
Mechanism Some breast cancer cells make too many (over-express)
copies of a particular gene known as HER2 that causes
Herceptin works by attaching itself to the HER2receptors on the surface of breast cancer cells, blocking
them from receiving growth signals and slowing or
Herceptin also fights breast cancer by alerting theimmune system to destroy cancer cells onto which it isattachedWithout Herceptin treatment,
cell surface receptors signal
Approvals Metastatic HER2+ breast cancer, metastatic HER2+
stomach cancer
into the HER2+ breast cancer
cell to proliferate
Herceptin binds to cell surfacereceptors inhibiting
a es 2010 worldwide net sales of $5.4 billion1
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preventing cancer cellproliferation and signaling the
immune system to kill thecancer cell 1. As reported to PDL by its licensee
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Lucentis
Licensor Genentech (US) and Novartis (ex-US)
Mechanism
A form of VEGF known as VEGF-A causes theformation of leaky blood vessels result in theswelling in the macula and vision loss
Lucentis binds to and inhibits VEGF-A before itcan cause the formation of the leaky blood vesselspreserving and sometimes improving vision
Approvals
Crosssection ofnormalmacula at
back of eye
Crosssection ofmacula withAMD causing
loss of vision
Wet age-related macular degeneration(AMD), macular edema or swelling followingretinal vein occlusion, diabetic macular edema
Sales
2010 worldwide net sales of $3.0 billion1
- Recent NIH study comparing safety and effectivenessof Lucentis finds less expensive Avastin equallyefficacious will adversely affect future Lucentis sales
Amsler Grid as Amsler Grid as
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- Its estimated that in the U.S. 60% of AMD patients are
already treated with off-label Avastin
seen throughnormal eyes
seen througheyes with AMD
1. As reported to PDL by its licensee
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Xolair
Licensor
-
Mechanism IgE plays a role in allergic disease by
mediators from mast cells that result insneezing, wheezing and asthma
Xolair binds to and neutralizes circulatingIgE by preventing IgE from binding to itsmast-cell receptor
Approvals
Moderate-to-severe persistent asthma Sales
1
Xolair antibody (yellow) binds to IgE(blue) preventing IgE from binding tomast cell. Otherwise, IgE binding tomast cell would result in wheezing,
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.sneezing and asthma.
1. As reported to PDL by its licensee
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Tysabri
Licensor Biogen Idec and Elan
Mechanism
In MS, the bodysautoimmune system isinappropriately activated,
Tysabri binds to an integrin that reduces the ability ofthe immune response cells to cross the blood brain
barrier and attack nerve cells Approvals
Treatment for patients with relapsing forms of multiple
resulting in it attackingthe body. Here, defense
cells, known as T cells,are activated.
sclerosis (MS) who have had an inadequateresponse to, or are unable to tolerate, alternative MStherapies
Treatment for adult patients with moderate-to-severeCrohn's disease who have had an inadequate
response to, or are unable to tolerate, conventional
Activated T cells are ableto cross the blood brainbarrier affording themaccess to nerve cells.
Sales 2010 worldwide net sales of $1.2 billion1
Use of Tysabri is associated with a rare but often fatalbrain infection
,and recruit other defensecells known asmacrophages, to attackand consume the myelinsheath or insulation
e a e or ysa r s e ng up a e o re ec e
use of a test that can be used to stratify whetherpatients are at risk for developing this rare condition EU authorities have recommended renewal of
Tysabris approval for the typical five yearperiod
surroun ng nerve ers.
The resulting holes in themyelin slow thetransmission of impulsesalong the nerve andcause the symptoms of
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MS.
1. As reported to PDL by its licensee
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Actemra
Licensor Roche and Chugai
ec an sm Rheumatoid arthritis (RA) is an autoimmune disease in
which the body's immune system attacks itself One of the defense mechanisms inappropriately
- ,the cartilage between joints causing the symptoms ofRA
Actemra binds to and neutralizes IL-6 preventing it from
destroying cartilage thereby blocking one of the causes
Approvals Treatment of signs and symptoms in moderate-to-
severe adult RA patients, slowing of structural damageto joints caused by RA and preservation physicalunc on o o n s a c e y
Sales 2010 worldwide net sales of $459 million1
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It is the degradation andeventual destruction of thiscartilage that causes the
symptoms of RA. 1. As reported by Roche; assume 1.155 CHF/USD