Annual General Meeting Roche Holding Ltd 5 March Art Levinson Chairman and CEO Genentech

Transcription

1 Annual General Meeting Roche Holding Ltd 5 March 2007 Art Levinson Chairman and CEO Genentech

2 Agenda Company Overview/Approach Accomplishments & Performance Research & Development Roche Partnership Patient Access 2

3 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. 3

4 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 longterm (5-10 years), not merely the short-term Be a great place to work 4

5 Bringing Innovative Products to Patients 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 Nutropin Depot commercialization was discontinued in June Slide # 5

6 Commitment to Science Founders Research Center Single largest biotechnology research facility in the world 50,000+ m 2 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, protein chemistry, bioinformatics and physiology ~150 scientific papers published per year ~6,500 current, non-expired patents worldwide ~5,400 patent applications pending worldwide -- Slide # 6

7 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. 7

8 Strong Top-line Growth Performance For 2006, total operating revenues were ~$9.3 billion, an increase of 40% from 2005 and a doubling from 2004 Total Operating Revenues (US$ in millions) $1,514 Contract Revenues 1) Royalty Revenues Total Product Sales $2,044 $2,584 $3,300 $4,621 $6,633 $9,284 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. 8

9 Strong Bottom-line Growth Performance For 2006, non-gaap EPS was $2.23, 74% growth compared to 2005 and 169% growth compared to 2004 Please refer to our website at under the investor tab and select financials for the most directly comparable GAAP financial measures, with a reconciliation to the non-gaap financial measures. 9

10 Science & Innovation: Development Pipeline Phase Anti-CD40 Chronic Lymphocytic Leukemia Multiple Myeloma Apo2L/TRAIL Solid Tumors and Hematologic Malignancies MEK Inhibitor* Oncology 1 I Phase 2nd Generation Anti-CD20 2 Relapsing Remitting Multiple Sclerosis 1 ALTU-238 Pediatric Growth Hormone Deficiency 1 Anti-CD40 Non-Hodgkin s Lymphoma Avastin Adjuvant HER2-Negative Breast Cancer Extensive Small Cell Lung Cancer 1 Glioblastoma Multiforme Non-squamous, Non-small Cell Lung Cancer with Previously Treated CNS Metastases PARP Inhibitor* HAE1 Malignant Melanoma Moderate-to-Severe Allergic Asthma Systemic Hedgehog Antagonist* Lucentis Solid Tumors Diabetic Macular Edema Trastuzumab-DM1 Omnitarg (pertuzumab) HER2+ Metastatic Breast Cancer Ovarian Cancer PARP Inhibitor* Acute Cardiovascular Conditions 4 Topical VEGF Diabetic Foot Ulcers As of February 20, 2007 * Indicates Small Molecule 1) Preparing for Phase 2)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 II Phase III 2nd Generation Anti-CD20 2 Lupus Nephritis 1 Rheumatoid Arthritis Systemic Lupus Erythematosus 1 ALTU-238 Adult Growth Hormone Deficiency 1 Avastin Adjuvant Breast Cancer 1 Adjuvant Colon Cancer Adjuvant Non-small Cell Lung Cancer 1 Adjuvant Rectal Cancer First-line Metastatic Breast Cancer 3 First-line Metastatic Non-squamous, Non-small Cell Lung Cancer First-line Metastatic Ovarian Cancer First-line Metastatic Renal Cell Carcinoma Gastrointestinal Stromal Tumors 1 Hormone Refractory Prostate Cancer Second-line Metastatic Breast Cancer 3 Second-line Metastatic Ovarian Cancer 1 Avastin +/- Tarceva First-line Metastatic Non-squamous, Non-small Cell Lung Cancer 3 Herceptin +/- Avastin First-line HER2+ Metastatic Breast Cancer 1 Lucentis Diabetic Macular Edema 1 Retinal Vein Occlusion 1 Rituxan (Hematology/Oncology) First-line Follicular Non-Hodgkin s Lymphoma 3 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 Cancer 3 First-line Metastatic Non-small Cell Lung Cancer Tarceva +/- Avastin First-line Metastatic Pancreatic Cancer 3 Second-line Metastatic Non-small Cell Lung Cancer Phase Avastin First-line Metastatic Breast Cancer 5 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 Phase Herceptin Adjuvant HER2-Positive Breast Cancer - Based on 1-year HERA Data Oncology Immunology Tissue Growth & Repair FDA Submission Prep Awaiting FDA Action -- Slide # 10

11 Science & Innovation: Changing the Practice of Medicine Time-to-First Distant Recurrence Joint Analysis Results (NSABP-B31 and NCCTG-9881) AC Paclitaxel + Herceptin 90% 90% Percentage AC Paclitaxel Regimen # of Patients Events AC Paclitaxel + Herceptin 1, AC Paclitaxel 1, HR=0.47, 2P=8x % Clearly the results reported in this issue of the Journal are not 74% 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, Years From Randomization 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

12 Science & Innovation: Combining Targeted Therapies Omnitarg + Herceptin combination therapy in a breast cancer xenograft model Control Herceptin Omnitarg Herceptin + Omnitarg 6/10 animals cured Data presented at ECCO/ESMO meeting in Vienna and EORTC in Prague. 12

13 Collaborating to Address Unmet Medical Needs Genentech and Roche have a unique relationship built to leverage each 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 trial recruitment strategies to enable patient access to our therapies 13

14 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. 14

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