EX-99.2 3 ex99_2.htm EXHIBIT 99.2 ex99_2.htm

Exhibit 99.2
 
Presentation to Sales Force
November 16, 2011
 
 

 
Forward Looking Statements
This presentation contains forward-looking statements, including PDL’s expectations with respect to its future
royalty revenues, expenses, net income, and cash provided by operating activities.
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 PDL’s 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;
Changes in foreign currency rates;
Positive or negative results in PDL’s attempt to acquire royalty-related assets;
The outcome of pending litigation or disputes, including PDL’s current dispute with Genentech related to ex-U.S. sales of
 Genentech licensed products; 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 presentation 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
presentation are qualified in their entirety by this cautionary statement.
2
 
 

 
Company
PDL BioPharma, Inc.
Ticker
PDLI (NASDAQ)
Location
Incline Village, Nevada
Employees
Less than 10
2010 Revenues
$345 million
2011- Q3YTD Revenue
$289 million
2011 Regular Dividends
$0.15 /share paid on March 15, June 15,
September 15 & December 15
Q3-2011 Cash Position1
$225 million
Shares O/S2
~ 140 million
Average Daily Volume
~ 2.1 million shares
Key Information
1. As of September 30, 2011; 2. Not fully diluted
3
 
 

 
Overview of PDL BioPharma
4
 
 

 
Company Overview
 PDL pioneered the humanization of monoclonal antibodies
 which enabled the discovery of a new generation of targeted
 treatments for cancer and immunologic diseases
 PDL’s primary assets are its antibody humanization patents
 and royalty assets which consist of its Queen et al. patents
 and license agreements
 Licensees consist of large biotechnology and
 pharmaceutical companies including Roche/Genentech/
 Novartis, Elan/BiogenIdec, Pfizer/Wyeth/J&J and Chugai
5
 
 

 
Antibody Humanization Technology
 Antibodies are naturally produced by humans to fight
 foreign substances, such as bacteria and viruses
 In the 1980’s, scientists began creating antibodies in
 non-human immune systems, such as those of mice,
 that could target specific sites on cells to fight various
 human diseases
 However, mouse derived antibodies are recognized by
 the human body as foreign substances and may be
 rejected by the human immune system
 PDL’s technology allows for the “humanization” of mouse derived antibodies by moving the
 important binding regions from the mouse antibody onto a human framework
 PDL’s humanization technology is important because the humanized antibodies retain the
 binding and activity levels from the original mouse antibody
 PDL’s technology has been incorporated into antibodies to treat cancer, eye diseases, arthritis,
 multiple sclerosis and other health conditions with aggregate annual sales of over $17 billion
6
 
 

 
Mission Statement
 Queen et al. Patents
  Manage patent portfolio
  Manage license agreements
 
 Purchase new royalty generating assets
  Assets that improve shareholder return
  Commercial stage assets
  Prefer biologics with strong patent protection
 
 Optimize return for shareholders
7
 
 

 
Corporate Governance
Management
 John McLaughlin
  
President & CEO
 Christine Larson
   
VP & CFO
 Christopher Stone
   
VP, General Counsel &
    Secretary
 Caroline Krumel
   
VP of Finance
 Danny Hart
   
Associate General Counsel
Board of Directors
 Fred Frank
   
Lead Director
 Jody Lindell
 John McLaughlin
 Paul Sandman
 Harold Selick
8
 
 

 
Approved Licensed Products
9
 
 

 
Approved Licensed Products: Overview
1. As reported to PDL by its licensee 2. As reported by Roche; assume 1.155 CHF/USD
10
 
 

 
Avastin
 Licensee
  Genentech (US) and Roche (ex-US)
 Mechanism
  As tumor grows, it exceeds the ability of the local blood supply to
   nourish it
  Tumor causes up regulation of vascular endothelial growth factor
   (VEGF) stimulating angiogenesis (or the growth of leaky blood
    vessels) to nourish the tumor
  Avastin targets and inhibits VEGF reduction in blood vessels
   “starving” the tumor
 Approvals
  Metastatic colorectal cancer, advanced non-small cell lung
   cancer, renal cancer, metastatic HER2- breast cancer and
   glioblastoma
 Sales
  2010 worldwide net sales of $6.4 billion1
  Status
 - US is reviewing approval for metastatic HER2- breast cancer
    and EU has narrowed this label, resulting in drop in sales for
    this indication
 - Positive Phase 3 data in treatment of first line and recurrent
    ovarian cancer
Treatment with Avastin
reduces vascularization
or blood supply of tumor
1. As reported to PDL by its licensee
11
 
 

 
Herceptin
 Licensee
  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 rapid growth of
 the breast cancer cell
  Herceptin works by attaching itself to the HER2 receptors on the
 surface of breast cancer cells, blocking them from receiving
 growth signals and slowing or stopping the growth of the breast
 cancer cell
  Herceptin may also fight breast cancer by alerting the immune
 system to destroy cancer cells onto which it is attached
 Approvals
  Metastatic HER2+ breast cancer, metastatic HER2+ stomach
 cancer
 Sales
  2010 worldwide net sales of $5.4 billion1
 Status
  Positive Phase 3 results that showed that subcutaneous (SQ)
 formulation of Herceptin has comparable safety and efficacy to
 intravenous (IV) formulation and can be administered in about 5
 minutes compared to 30 minutes for IV formulation.
Without Herceptin treatment,
cell surface receptors signal
into the HER2+ breast cancer
cell to proliferate
Herceptin binds to cell surface
receptors inhibiting
intracellular signals thus
preventing cancer cell
proliferation
and signaling the
immune system to “kill” the
cancer cell
1. As reported to PDL by its licensee
12
 
 

 
Lucentis
 Licensee
  Genentech (US) and Novartis (ex-US)
 Mechanism
  A form of VEGF known as VEGF-A causes the formation of leaky
 blood vessels resulting in the swelling in macula and vision loss
  Lucentis binds to and inhibits VEGF-A before it can cause the
 formation of the leaky blood vessels preserving and sometimes
 improving vision
 Approvals
  Wet age-related macular degeneration (AMD), macular edema or
  swelling following retinal vein occlusion, diabetic macular edema
 Sales
  2010 worldwide net sales of $3.0 billion1
 Status
 § Recent NIH study comparing safety and effectiveness of Lucentis
   finds less expensive Avastin equally efficacious - will adversely
   affect future Lucentis sales for AMD
 ü It’s estimated that in the U.S. 65% + of AMD patients are
 already being treated with off-label Avastin
 § FDA is scheduled to decide on November 18, 2011 whether to
   approve Regeneron’s Eylea, which has shown safety and efficacy
   comparable to Lucentis but can be dosed every other month in
    AMD patients instead of Lucentis’ monthly dosing
 § If approved, Eylea’s more convenient dosing regimen will likely
 adversely affect future Lucentis’ sales in AMD
 § Eylea less likely to affect newer Lucentis’ indications
 because Eylea is dosed same as Lucentis - monthly
Cross
section of
normal
macula at
back of eye
Cross
section of
macula with
AMD causing
loss of vision
Amsler Grid as
seen through
normal eyes
Amsler Grid as
seen through
eyes with AMD
1. As reported to PDL by its licensee
13
 
 

 
Xolair
 Licensee
  Genentech (US) and Novartis (ex-US)
 Mechanism
  IgE plays a role in allergic disease by
  causing the release of inflammatory
  mediators from mast cells that result in
  sneezing, wheezing and asthma
  Xolair binds to and neutralizes circulating
  IgE by preventing IgE from binding to its
  mast-cell receptor
 Approvals
  Moderate-to-severe persistent asthma
 Sales
  2010 worldwide net sales of $1.0 billion1
Xolair antibody (yellow) binds to IgE
(blue) preventing IgE from binding to
mast cell. Otherwise, IgE binding to
mast cell would result in wheezing,
sneezing and asthma.
1. As reported to PDL by its licensee
14
 
 

 
Tysabri
  As of October 4, 2011, Biogen Idec reported net patients
 adds of 2,100 and 170 cases of PML
In MS, the body’s
autoimmune system is
inappropriately activated,
resulting in it attacking the
body. Here, defense cells,
known as T cells, are
activated.
Activated T cells are able
to cross the blood brain
barrier affording them
access to nerve cells.
Activated T cells attack,
and recruit other defense
cells known as
macrophages, to attack
and consume the myelin
sheath or insulation
surrounding nerve fibers.
The resulting holes in the
myelin slow the
transmission of impulses
along the nerve and
cause the symptoms of
MS.
1. As reported to PDL by its licensee
15
 
 

 
Actemra
 Licensee
  Roche and Chugai
 Mechanism
  Rheumatoid arthritis (RA) is an autoimmune
 disease in which the body's immune system
 attacks itself
  One of the defense mechanisms inappropriately
 activated in RA is IL-6, which can result in
 destruction of the cartilage between joints causing
 the symptoms of RA
  Actemra binds to and neutralizes IL-6 preventing it
 from destroying cartilage, thereby blocking one of
 the causes of RA
 Approvals
  Treatment of signs and symptoms in moderate-to-
 severe adult RA patients, slowing of structural
 damage to joints caused by RA and preservation
 physical function of joints afflicted by RA
 Sales
  2010 worldwide net sales of $459 million1
It is the degradation and
eventual destruction of this
cartilage that causes the
symptoms of RA.
1. As reported by Roche; assume 1.155 CHF/USD
16
 
 

 
Royalty Revenue
17
 
 

 
How Long Will PDL Receive Royalties from
Queen et al. Patents?
 PDL’s revenues consist of royalties generated on sales of licensed products
  Sold in a patented jurisdiction 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 in a patented jurisdiction and sold anytime
 thereafter
Example of Antibody Formulation, Fill and Finish Schedule
½ month
1 month
½ month
2-3 months
Thaw, Formulation
& Vial Filling
Quality
Release
Packaging
& Quality
Inventory
Example of Antibody Bulk Manufacturing Schedule
Cell
Culture
Quality Release
Testing
Bulk Frozen Storage
1 mo
3 mos
5 mos
10 mos
15 mos
20 mos
27 mos
3 mos
2-18 months
1mo
1mo
Purification to Concentrated Bulk/Frozen
18
 
 

 
Genentech Product Made or Sold in U.S.
 
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%
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
  Blended global royalty rate on Genentech Products in 2010 was 1.9%
  Blended royalty rate on Genentech Products in 2010 made or sold in US was
 1.5%
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 are less than we receive in royalties on such sales and we do not currently expect such amount
to materially impact our total annual revenues in 2011.
19
 
 

 
Shift of Manufacturing Sites = Higher Royalties
 Roche is moving some manufacturing ex-US which may result in higher royalties to PDL due
 to the flat 3% royalty for Genentech Products made
and sold ex-US
  Current production at Penzburg (Herceptin) and Basel (Avastin) plants
  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
 - Currently, all Lucentis is made in the US
Percent of Total Worldwide Sales1
1. As reported to PDL by its licensee
20
 
 

 
Royalty Revenue from Licensed Products
Royalties by Product
($ in millions)
21
 
 

 
Potential Royalty Products - Development
Stage
22
 
 

 
Potential Royalty Products - T-DM1
T-DM1
Breast HER2+ Cancer
ü On October 13, 2010, Roche/Genentech announced preliminary,
 six month results from a Phase 3 trial in second line HER2+
 breast cancer patients which showed that 48% of women treated
 with T-DM1 had their tumors shrink compared with 41% of those
 taking the 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.
ü Roche highlighted this product in their November 7, 2011 update
 to the financial community on their late stage development
 products.
ü Roche/Genentech expect to file for second line approval in 2012
 and first line in 2014.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
23
 
 

 
Potential Royalty Products - Pertuzumab
T-DM1
Breast HER2+ Cancer
ü On December 10, 2010, Roche/Genentech reported the results
 from a Phase 2 trial investigating the neoadjuvant (prior to
 surgery) use of pertuzumab and Herceptin plus chemotherapy
 for the treatment of early-stage, HER2+ breast cancer.
ü Treatment significantly improved the rate of complete tumor
 disappearance in the breast by more than half compared to
 Herceptin plus docetaxel, p=0.014.
ü On July 15, 2011, Roche/Genentech reported the results from a
 Phase 3 trial in pertuzumab plus Herceptin and docetaxel met
 the primary endpoint of progression-free survival (PFS) vs.
 Herceptin plus docetaxel alone.
ü Roche highlighted this product in their November 7, 2011 update
 to the financial community on their late stage development
 products.
ü Roche/Genentech expect to file for approval at the end of 2011.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
24
 
 

 
Potential Royalty Products - Bapineuzumab &
Solanezumab
T-DM1
Breast HER2+ Cancer
ü Both antibodies to beta amyloid are in Phase 3.
ü On July 19, 2011, researchers from Pfizer and Johnson &
 Johnson reported long-term safety of 194 patients in a mid-stage
 trial of bapineuzumab that stayed on treatment after the initial
 phase ended.
ü Data on both drugs expected in second half of 2012.
ü PDL has 12.5 year know-how royalty on Solanezumab and
 patent royalty on both drugs.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
25
 
 

 
Genentech / Roche - Product Pipeline
2011
2012
2013
2014
Avastin
Ovarian Cancer 1st Line (US)
Lucentis
Diabetic Macular Edema (US)
Pertuzumab
mBC HER2+ 1st Line
Avastin
Relapsed Ovarian Cancer (EU)
T-DM1
HER 2+ Advanced mBC
Actemra
RA DMARD H2H (EU)
Actemra
DMARD IR (US)
Herceptin
Subcutaneous Formulation
Avastin & Herceptin
HER2+ mBC 1st Line
Avastin
mCRC TML
Actemra
SC Formulation (EU)
Afutuzumab (GA101)
Chronic Lymphocytic Leukemia
Actemra
Avastin
BC Adjuvant HER2+
Avastin
BC Adj Triple Negative
Herceptin
BC HER 2+ Adj 2 Year
Xolair
Chronic Idiopathic
Urticaria
Avastin
Glioblastoma 1st Line
Actemra
SC Formulation (US)
T-DM1
HER 2+ mBC 1st Line
Ocrelizumab1
PPMS & RRMS
1.Not a licensed product
Source: Roche investor update, September 30, 2011
US & EU Filings Calendar
Avastin
MBC 2nd line (EU)
Avastin
Relapsed Ovarian Cancer (US)
Lucentis
AMD 0.5 mg PRN (US)
26
 
 

 
Financials
27
 
 

 
Financial Overview
1. Includes $92.5 million one time legal settlement to MedImmune. Net interest expense
 includes $17.6 million loss on convertible note retirement.
2. Includes $10.0 million one time legal settlement from UCB.
28
 
 

 
Debt
29
 
 

 
Current and Long-Term Liabilities
 $155 million 3.75% senior convertible notes due May 2015
  Notes issued May 16, 2011; conversion rate is 132.6682 / $1,000 face amount ($7.54/share)
  Bond hedge effectively increases conversion price to $8.87 / share
  Notes “net share settle” and are excluded from diluted EPS
 $180 million 2.875% convertible senior notes due February 2015
  Conversion rate is 151.713 shares / $1,000 face amount ($6.59/share) 
  PDL has commenced a tender offer for all or a substantial portion of these Notes in exchange for new
    notes that net share settle - similar to terms of “net share settle” provision in 3.75% Notes which excludes
    such shares from diluted EPS
 $300 million 10.25% secured non-
 recourse notes; principal balance of
 $115 million as of September 30, 2011
  Approximately 40% of Genentech royalties
 dedicated to quarterly principal and interest
  After retirement, securitized Genentech royalties
 will be retained by PDL
 The purpose of restructuring PDL’s debt
  is to free up cash for the acquisition of
  new royalty assets
 
 

 
Legal Matters
31
 
 

 
Pending Dispute with Genentech and Roche
•  In August 2010, Genentech sent a fax on behalf of Roche and Novartis
 asserting its products do not infringe PDL’s supplementary protection
 certificates (SPCs)
  Products include Avastin, Herceptin, Lucentis and Xolair
  SPCs are patent extensions in Europe that are issued on a country-by-country and product-
 by-product basis
 
 PDL Response
  Genentech’s assertions are without merit
  PDL disagrees with Genentech’s assertions of non-infringement
  Genentech had waived its rights to challenge our patents, including SPCs in its 2003
 Settlement Agreement with PDL
 
 2003 Settlement Agreement
  Resolved intellectual property disputes between the two companies at that time
  Limits Genentech’s ability to challenge infringement of PDL’s patent rights, including SPCs,
 and waives Genentech’s right to challenge or assist other in challenging the validity of our
 patent rights
32
 
 

 
Nevada Lawsuit Against Genentech/Roche
 PDL filed a lawsuit against Genentech and Roche in Nevada state court
  Lawsuit states that fax constitutes a breach of 2003 Settlement Agreement because Genentech assisted
   Roche in challenging PDL’s patents and SPCs
  Complaint seeks compensatory damages, including liquidated damages and other monetary remedies set
   forth in the 2003 Settlement Agreement, punitive damages and attorney’s fees
 
 In November 2010, Genentech and Roche filed two motions to dismiss
  They contend that 2003 Settlement Agreement applies only to PDL’s U.S. patents
  They asserted that the Nevada court lacks personal jurisdiction over Roche
 
 On July 11, 2011, court denied Genentech and Roche's motion to dismiss four of PDL's
 five claims for relief and denied Roche's separate motion to dismiss for lack of personal
 jurisdiction.
  The court dismissed one of PDL's claims that Genentech committed a bad-faith breach of the covenant of
   good faith and fair dealing
  Subsequent to the ruling, Roche has waived its defense that the Nevada court lacks personal jurisdiction for
   the purposes of this lawsuit
 
 The court ruling allows PDL to continue to pursue its claims that:
  Genentech is obligated to pay royalties to PDL on international sales of the Genentech Products
  Genentech, by challenging, at the behest of Roche and Novartis, whether PDL's SPCs cover the Genentech
  Products breached its contractual obligations to PDL under the 2003 settlement agreement
  Genentech breached the implied covenant of good faith and fair dealing with respect to the 2003 settlement
   agreement
  Roche intentionally and knowingly interfered with PDL's contractual relationship with Genentech in
   conscious disregard of PDL's rights
 Parties are currently in discovery
33
 
 

 
Optimizing Stockholder Return
34
 
 

 
Business Strategy
 Purchase new royalty assets and
 ladder like a bond portfolio
  Continue to reinvest in new royalty
 assets and pay dividends
 - Commercial stage products
 - Sweet spot $75MM to $150MM
  Debt repaid by end of 2015
  Company continues as long as it can
 generate satisfactory return
 If unable to acquire royalty assets on
 attractive terms, build cash reserves
 to:
  Repay debt
  Use all excess cash to pay dividends to
 enhance shareholder return
  Wind-up company in 2016 timeframe
 
 Queen et al. patents expire in mid-2013
 to December 2014; we anticipate
 royalties will likely continue to ~2016
 PDL has two possible future pathways
35
 
 

 
Investment Highlights
 Strong historic revenue growth from approved products
 Potential for additional indications from existing
   products, new product approvals and purchase of new
   royalty 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 2.1 million shares/day
 Return to stockholders
  In 2011, $0.60/share to be paid in quarterly regular dividends of
 $0.15/share on March 15, June 15, September 15 and
 December 15
36
 
 

 
Appendix
37
 
 

 
Royalty Products - Approved
38
 
 

 
Royalty Products - Avastin
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü Since June 29, 2011, an FDA advisory committee, an FDA
 special committee and FDA staff have recommended that
 approval of Avastin for the treatment of HER2- breast cancer
 should be revoked.
ü Genentech has submitted a new proposal to maintain the
 approval with more restrictive labeling, REMS and a
 commitment to conduct a new 480 patient confirmatory trial.
ü Final decision rests with the FDA Commissioner.
ü EMEA narrowed, but did not withdraw Avastin’s approval for
 first line treatment of HER2- breast cancer in combination
 with paclitaxel or with Xeloda.
ü Roche lowered its estimate of peak annual sales of Avastin
 from CHF8 - CHF9 billion to CHF7 billion.
ü PDL believes that this indication is generating little US
 revenue.
39
 
 

 
Royalty Products - Avastin
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü On June 4, 2011, Genentech announced results from Phase 3
 study evaluating Avastin in combination with chemotherapy
 (gemcitabine and carboplatin) followed by the continued use of
 Avastin alone in women with previously treated (recurrent)
 platinum-sensitive ovarian cancer which showed that women
 who received Avastin experienced a 52% reduction in the risk of
 their disease progressing (HR=0.48, p<0.0001) compared to
 women who received chemotherapy alone.
ü Two previous Phase 3 studies in women with newly diagnosed
 ovarian cancer demonstrated that front-line Avastin in
 combination with standard chemotherapy (carboplatin and
 paclitaxel), followed by the continued use of Avastin alone,
 significantly increased progression free survival compared to
 treatment with chemotherapy alone.
ü In August 2011, Roche submitted an application for approval for
 first line treatment in EU.
ü Genentech expects to file an application for approval in US in
 late 2011 so that it can meet FDA’s request for overall survival
 data.
40
 
 

 
Royalty Products - Herceptin
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü On October 18, 2011, Roche announced Phase 3 results that
 showed that subcutaneous (SQ) formulation of Herceptin has
 comparable safety and efficacy to intravenous (IV) formulation.
ü SQ formulation is ready-to-use and requires about 5 minutes to
 administer compared to 30 minutes administration time for IV
 formulation.
41
 
 

 
Royalty Products - Lucentis
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü On January 7, 2011, Novartis announced that Lucentis has been
 approved in the EU for the treatment of visual impairment due to
 diabetic macular edema (DME).
ü On June 6, 2011, Novartis announced that Lucentis has been
 approved in the EU for the treatment of visual impairment due to
 macular edema secondary to retinal vein occlusion.
 § DME is a leading cause of blindness in the working-age
 population in most developed countries.
ü On June 28, 2011, Genentech reported positive results from two
 pivotal Phase 3 clinical studies in patients with diabetic macular
 edema.
 § Both studies showed that patients treated with Lucentis
 experienced significant, rapid and sustained improvement in
 vision compared to those who received sham injections.
 § Additional analyses showed that patients who received
  Lucentis were significantly more likely to achieve 20/40 vision
  and experience less progression of underlying diabetic
  retinopathy disease.
42
 
 

 
Royalty Products - Lucentis
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü On November 22, 2010, Regeneron and Bayer reported top line data
 from two Phase 3 trials investigating VEGF Trap in age-related
 macular degeneration (AMD) patients which suggest that it may be
 injected into the eye every other month with safety and efficacy
 comparable to that of monthly dosing of Lucentis.
ü On December 20, 2010, Regeneron reported positive Phase 3 data in
 the treatment of retinal vein occlusion (RVO) for which Lucentis is
 approved.
 § Unlike the AMD trial, monthly administration was used in the RVO
   trial, which does not afford a dosing advantage with respect to
   Lucentis.
ü On February 22, 2011, Regeneron and Bayer filed an application for
 approval of VEGF Trap for AMD with an initial PDUFA date of August
 20, 2011 which was subsequently extended to November 18, 2011.
 An FDA Advisory Committee recommended approval of VEGF Trap
 on June 17, 2011.
ü On June 7, 2011, Regeneron and Bayer filed an application for AMD
 in EU.
ü Regeneron filed suit in February 2011 seeking a summary judgment
 that it does not infringe Genentech’s patents.
ü Genentech filed a countersuit in April 2011 asserting that Regeneron
 is willfully infringing Genentech’s patents, seeking treble damages and
 asking for injunctive relief.
43
 
 

 
Royalty Products - Lucentis
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü 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.
ü 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 ocular
 inflammation and 11% more likely to have cataract surgery
 following treatment than Lucentis treated patients.
ü 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.
44
 
 

 
Royalty Products - Lucentis
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü On April 28, 2011, New England Journal of Medicine reported
 the results from the NEI’s CATT study comparing Lucentis and
 Avastin on fixed and variable schedules in the treatment of AMD.
ü Efficacy results from the first year of the two year study showed
 that, with respect to the 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.
ü At 12 months, serious adverse events (primarily hospitalizations)
 occurred at a 24% rate for patients receiving Avastin and a 19%
 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.
ü On August 30, 2011, FDA issued a health warning alert after at
 least 16 AMD patients suffered eye infections after being treated
 with repackaged Avastin.
45
 
 

 
Royalty Products - Tysabri
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü In the label for Tysabri, EMEA has included, and FDA is
 considering including, JC virus (JCV) status as a risk factor for the
 rare but sometimes fatal brain infection known as PML.
ü Because patients have increased risk of developing PML after 24
 months of Tysabri treatment and because physicians can use this
 assay to detect presence of JC virus and take patients off Tysabri if
 JC virus is detected, physicians have become more comfortable
 prescribing Tysabri.
ü As of October 4, 2011, Biogen Idec reported net patients adds of
 2,100 and 170 cases of PML.
 § Net patient adds is the difference between new patients
   treated less those who discontinued Tysabri therapy due to
   JC virus status or other reasons.
46
 
 

 
Royalty Products - Actemra
Avastin
Herceptin
Lucentis
Xolair
Tysabri
Actemra
ü On January 5, 2011, Roche announced that FDA expanded the
 Actemra label to include inhibition and slowing of structural joint
 damage, improvement of physical function, and achievement of
 major clinical response in adult patients with moderately to
 severely active rheumatoid arthritis.
ü On April 18, 2011, FDA approved Actemra to treat patients age 2
 and older with active systemic juvenile idiopathic arthritis (SJIA).
 § It is the first approved treatment for SJIA, a rare and severe
   form of arthritis affecting children.
ü On July 19, 2011, Chugai/Roche announced that a
 subcutaneous formulation of Actemra has shown efficacy in
 rheumatoid arthritis comparable to the approved intravenous
 formulation. Based on these non-inferiority data, the company
 plans to file for approval in Japan in 2012.
47
 
 

 
Potential Royalty Products
- Development Stage
48
 
 

 
Potential Royalty Products - T-DM1
T-DM1
Breast HER2+ Cancer
ü On October 13, 2010, Roche/Genentech announced preliminary,
 six month results from a Phase 3 trial in second line HER2+
 breast cancer patients which showed that 48% of women treated
 with T-DM1 had their tumors shrink compared with 41% of those
 taking the 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.
ü Roche highlighted this product in their November 7, 2011 update
 to the financial community on their late stage development
 products.
ü Roche/Genentech expect to file for second line approval in 2012
 and first line in 2014.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
49
 
 

 
Potential Royalty Products - Ocrelizumab
T-DM1
Breast HER2+ Cancer
ü Phase 2b.
ü Genentech announced 96-week results from Phase 2 study in
 patients with relapsing-remitting multiple sclerosis which showed
 that the significant reduction in disease activity as measured by
 the total number of active brain lesions and relapses, previously
 reported for 24 weeks, was maintained through 96 weeks.
ü Unlicensed product.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
50
 
 

 
Potential Royalty Products - Pertuzumab
T-DM1
Breast HER2+ Cancer
ü On December 10, 2010, Roche/Genentech reported the results
 from a Phase 2 trial investigating the neoadjuvant (prior to
 surgery) use of pertuzumab and Herceptin plus chemotherapy
 for the treatment of early-stage, HER2+ breast cancer.
ü Treatment significantly improved the rate of complete tumor
 disappearance in the breast by more than half compared to
 Herceptin plus docetaxel, p=0.014.
ü On July 15, 2011, Roche/Genentech reported the results from a
 Phase 3 trial in pertuzumab plus Herceptin and docetaxel met
 the primary endpoint of progression-free survival (PFS) vs.
 Herceptin plus docetaxel alone.
ü Roche highlighted this product in their November 7, 2011 update
 to the financial community on their late stage development
 products.
ü Roche/Genentech expect to file for approval at the end of 2011.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
51
 
 

 
Potential Royalty Products - Afutuzumab
T-DM1
Breast HER2+ Cancer
ü Phase 3.
ü Roche/Genentech expect to file for approval in 2013.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
52
 
 

 
Potential Royalty Products - Bapineuzumab
T-DM1
Breast HER2+ Cancer
ü   Phase 3.
ü   On July 19, 2011, researchers from Pfizer and Johnson &
   Johnson reported long-term safety of 194 patients in a mid-stage
   trial of the drug that stayed on treatment after the initial phase
   ended.
 § The brain swelling condition called vasogenic edema, which
   caused safety concerns early on in the trial, may decrease
   over time.
ü   Data expected in second half of 2012.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
53
 
 

 
Potential Royalty Products - Solanezumab
T-DM1
Breast HER2+ Cancer
ü Phase 3.
ü Data expected in second half of 2012.
ü 12.5 year know how royalty in addition to patent royalty.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
54
 
 

 
Potential Royalty Products - Datoluzumab
T-DM1
Breast HER2+ Cancer
ü Phase 2.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
55
 
 

 
Potential Royalty Products - Daclizumab
T-DM1
Breast HER2+ Cancer
ü Positive efficacy data reported from first of two Phase 3 trials.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
56
 
 

 
Potential Royalty Products - Farletuzumab
T-DM1
Breast HER2+ Cancer
ü Phase 3.
Ocrelizumab
Multiple Sclerosis
Pertuzumab
Breast HER2+ Cancer
Afutuzumab
Chronic Lymphocytic
Leukemia
Solanezumab
Alzheimer’s Disease
Daclizumab
Multiple Sclerosis
Datoluzumab
Colorectal Cancer
Bapineuzumab
Alzheimer’s Disease
Farletuzumab
Ovarian Cancer
57