2©2007 Genentech
Agenda
• Company Overview/Approach
• Accomplishments & Performance
• Research & Development
• Roche Partnership
• Patient Access
3©2007 Genentech
Founding of Genentech
• Genentech was founded in 1976 by venture capitalist Robert A. Swanson and biochemist Dr. Herbert Boyer. In the early 1970s, Boyer and geneticist Stanley Cohen pioneered a new scientific field called recombinant DNA technology.
• After hearing about the breakthrough, Swanson placed a call to Boyer and requested a short meeting. The meeting extended to three hours. By its conclusion, Genentech was born.
Our mission is to be the leading biotechnology company, using human genetic information to discover, develop, manufacture and commercialize biotherapeutics that address significant unmet medical needs.
4©2007 Genentech
Our Approach/Principles
• Develop novel and important drugs - must be first-in-class, or best-in-class
• Focus on basic scientific mechanisms of disease, not just translational research
• Place patient benefit first and foremost in every employee’s mind (and design clinical trials with endpoints that matter to patients)
• Rapidly incorporate technological advances into our Research methods, and pioneer methods ourselves
• Make every decision based on building value over the long-term (5-10 years), not merely the short-term
• Be a great place to work
5©2007 Genentech -- Slide #In 1998 we licensed U.S. marketing and development rights to interferon gamma, including Actimmune, to Connetics Corporation. Thereafter, Connetics sublicensed, then later assigned, all of its rights to InterMune Pharmaceuticals, Inc. Protropin manufacturing was discontinued at the end of 2002. Nutropin Depot commercialization was discontinued in June 2004.
Bringing Innovative Products to Patients
‘85 ‘87 ‘90 ‘93 ‘96 ‘97 ‘98 ‘99 ‘00 ‘01 ‘02 ‘03 ‘04 ‘06
6©2007 Genentech -- Slide #
Commitment to ScienceFounders Research Center•Single largest biotechnology research facility in the world •50,000+ m2 of research space
Top-Notch Research Organization• In 2006, Genentech was named “the top employer and most admired company in the biotechnology and pharmaceutical industries” by Science magazine for the fifth consecutive time. •Over 700 scientists with expertise in molecular biology, proteinchemistry, bioinformatics and physiology • ~150 scientific papers published per year• ~6,500 current, non-expired patents worldwide• ~5,400 patent applications pending worldwide
7©2007 Genentech
Preserving our Unique Culture
• In 2007, FORTUNE magazine named Genentech as the #2 company on the 2007 list of “The 100 Best Companies to Work For”. We have earned a place on the FORTUNE list for nine consecutive years.
•We remain focused on working to protect and nurture our culture.
• As of December 31, 2006 we have ~10,500 employees.
8©2007 Genentech
Strong Top-line Growth Performance
• For 2006, total operating revenues were ~$9.3 billion, an increase of 40% from 2005 and a doubling from 2004
Tota
l Ope
ratin
g R
even
ues
(US
$ in
mill
ions
)
$1,514 $2,044$2,584
$3,300$4,621
$6,633
$9,284Contract Revenues1)
Royalty RevenuesTotal Product Sales
1) Contract revenue generally includes upfront and continuing licensing fees, manufacturing fees, milestone payments and reimbursements of development and post-marketing costs and certain commercial costs.
9©2007 Genentech
Strong Bottom-line Growth Performance
Please refer to our website at www.gene.com under the investor tab and select financials for the most directly comparable GAAP financial measures, with a reconciliation to the non-GAAP financial measures.
• For 2006, non-GAAP EPS was $2.23, 74% growth compared to 2005 and 169% growth compared to 2004
10©2007 Genentech -- Slide #
2nd Generation Anti-CD202
Relapsing Remitting Multiple Sclerosis1
ALTU-238
Pediatric Growth Hormone Deficiency1
Anti-CD40
Non-Hodgkin’s Lymphoma
Avastin
•Adjuvant HER2-Negative Breast Cancer•Extensive Small Cell Lung Cancer1
•Glioblastoma Multiforme•Non-squamous, Non-small Cell Lung Cancer with Previously Treated CNS Metastases
HAE1
Moderate-to-Severe Allergic Asthma
Lucentis
Diabetic Macular Edema
Omnitarg (pertuzumab)
Ovarian Cancer
PARP Inhibitor*
Acute Cardiovascular Conditions4
Topical VEGF
Diabetic Foot Ulcers
Anti-CD40
•Chronic Lymphocytic Leukemia•Multiple Myeloma
Apo2L/TRAIL
Solid Tumors and Hematologic Malignancies
MEK Inhibitor*
Oncology1
PARP Inhibitor*
Malignant Melanoma
Systemic Hedgehog Antagonist*
Solid Tumors
Trastuzumab-DM1
HER2+ Metastatic Breast Cancer
PhasePhase
As of February 20, 2007* Indicates Small Molecule1)Preparing for Phase2)Our collaborator Biogen Idec disagrees with certain of our development decisions under our 2003
collaboration agreement. We continue to pursue a resolution of our differences with Biogen Idec, and the disputed issues have been submitted to arbitration in San Francisco, California.
3)Studies are ongoing or planned in this indication with different regimens.4)Genentech has the option to expand its licensed field to include certain acute cardiovascular indications,
including but not limited to the prevention of ischemia-reperfusion injury following angioplasty procedures or coronary arterial bypass graft surgery. Genentech has not yet exercised this option.
5)The FDA requested a substantial safety and efficacy update from the ECOG 2100 study, including an independent review of patient scans for progression-free survival. We expect to resubmit the application to the FDA by mid-2007.
PhasePhase II
PhasePhase
Oncology
Immunology
Tissue Growth & Repair
Science & Innovation: Development Pipeline
Herceptin +/- Avastin
First-line HER2+ Metastatic Breast Cancer1
Lucentis
•Diabetic Macular Edema1
•Retinal Vein Occlusion1
Rituxan (Hematology/Oncology)
•First-line Follicular Non-Hodgkin’s Lymphoma3
•Relapsed Chronic Lymphocytic Leukemia
Rituxan (Immunology)
•ANCA-Associated Vasculitis•Lupus Nephritis•Primary Progressive Multiple Sclerosis•Rheumatoid Arthritis (DMARD Inadequate Responders)•Systemic Lupus Erythematosus
Tarceva
•Adjuvant Non-small Cell Lung Cancer3
•First-line Metastatic Non-small Cell Lung Cancer
Tarceva +/- Avastin
•First-line Metastatic Pancreatic Cancer3
•Second-line Metastatic Non-small Cell Lung Cancer
2nd Generation Anti-CD202
•Lupus Nephritis1
•Rheumatoid Arthritis •Systemic Lupus Erythematosus1
ALTU-238
Adult Growth Hormone Deficiency1
Avastin
•Adjuvant Breast Cancer1
•Adjuvant Colon Cancer•Adjuvant Non-small Cell Lung Cancer1
•Adjuvant Rectal Cancer•First-line Metastatic Breast Cancer3
•First-line Metastatic Non-squamous, Non-small Cell Lung Cancer •First-line Metastatic Ovarian Cancer •First-line Metastatic Renal Cell Carcinoma•Gastrointestinal Stromal Tumors1
•Hormone Refractory Prostate Cancer •Second-line Metastatic Breast Cancer3
•Second-line Metastatic Ovarian Cancer1
Avastin +/- Tarceva
First-line Metastatic Non-squamous, Non-small Cell Lung Cancer3
Avastin
•First-line Metastatic Breast Cancer5
•First-line Metastatic Renal Cell Carcinoma
Herceptin
Adjuvant HER2-Positive Breast Cancer -Based on BCIRG-006 Data
Rituxan
Rheumatoid Arthritis - Based on REFLEX Radiographic Data
Herceptin
Adjuvant HER2-Positive Breast Cancer -Based on 1-year HERA Data
PhasePhase
PhasePhase
I
III
FDA Submission
Prep
Awaiting FDA Action
11©2007 Genentech
81%81%
74%74%
ACAC Paclitaxel + Herceptin+ Herceptin
ACAC Paclitaxel
0 1 2 3 4 5
50
60
70
80
90
100
Regimen # of Patients EventsAC Paclitaxel + Herceptin 1,672 96AC Paclitaxel 1,679 194
HR=0.47, 2P=8x10-10
Years From Randomization
90%90% 90%90%
Per
cent
age
AC = DOXIL® (doxorubicin HCI) liposome injection and cyclophosphamide (Brand names: Cytoxan®, Neosar®). Taxol® (generic name = paclitaxel) Injections is a registered trademark of Bristol-Myers Squibb Company. Data presented by Romond EH et al. at ASCO May 2005.
Science & Innovation: Changing the Practice of Medicine
• Time-to-First Distant Recurrence Joint Analysis Results (NSABP-B31 and NCCTG-9881)
“Clearly the results reported in this issue of the Journal are not evolutionary but revolutionary. The rational development of molecularly targeted therapies points the direction toward continued improvement in breast cancer therapy. Other targets and other agents will follow. However, trastuzumab and the two reports in this issue will completely alter our approach to the treatment of breast cancer.”
- Gabriel N. Hortobagyi, M.D., NEJM, October 20, 2005
12©2007 GenentechData presented at ECCO/ESMO meeting in Vienna and EORTC in Prague.
6/10 animals cured
Herceptin +Omnitarg
Herceptin
Omnitarg
Control
Science & Innovation: Combining Targeted Therapies• Omnitarg + Herceptin combination therapy in a breast cancer
xenograft model
13©2007 Genentech
Collaborating to Address Unmet Medical Needs
• Genentech and Roche have a unique relationship built to leverageeach company’s strengths
• We collaborate across many different areas including Research, Development and Manufacturing
• Joint global development plans have enabled important innovations for patients:- Rituxan use in rheumatoid arthritis and non-Hodgkin’s lymphoma
- Herceptin use in the adjuvant breast cancer setting
- Avastin across multiple tumor types
• Manufacturing supply agreements as well as global clinical trialrecruitment strategies to enable patient access to our therapies
14©2007 Genentech
Genentech is Committed to Eligible Patients Having Access to Our Therapies
•For those eligible patients treated for approved indications in the U.S. who do not have insurance or who cannot afford their out-of-pocket co-pay costs, Genentech has several support programs.
- 1) Since 1985, Genentech has provided free product to uninsured patients and those deemed uninsured due to payor denial
• In 2006 alone, the company supported over 14,000 patients by providing approximately $205 million of free product
• In February 2007, we expanded our current patient assistance program to help address the needs of financially eligible Medicare beneficiaries enrolled in Part D who are prescribed Tarceva
•2) Since 2005, Genentech has donated approximately $70 million to various independent public charities that provide financial assistance to eligible patients who cannot access needed medical treatment due to co-pay costs.
•3) In February 2007, we launched the Avastin Patient Assistance Program to cap the annual cost of therapy of Avastin at $55,000 or 10,000 mg per year for eligible patients . We plan to make the program retroactive to include eligible patients currently on Avastin for all approved indications.