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Gene-
Gene-alyzing GENENTECH

  Strategic Management
      for Executives

    GROUP 8 – HCEMBA’09
    Primary Contributor: Manas Kanungo




            Copyright: Manas Kanungo 2009
THE BIOTECH & PHARMA INDUSTRIES

                                    Agriculture
                                    Agri - Food




                                    Aqua/Marine

  PHARMA                                                            BIOTECH


                                   Animal Health
                                   Animal Health

- Chemistry Based, Orals                                     - Proteins & Peptides, Fluids
- “Small Molecules”                                          - “Large Molecules”
- Patents for Formulations                                   - Patents for Discovery, Process


                                   Human Therapy


                             Copyright: Manas Kanungo 2009
Biotech Industry Landscape – Room to Grow

  Few Large, $B Companies – 40%                                Amgen $16B

  Many Small Players < $50M ea

  1000 Companies ~ $85B
                                                                   Genentech $14B


Amongst Top 5 Biotechs:


                                                                   Baxter $12B
                                             Others 60%
  3 are Biotherapeutics Cos:                                      Monsanto $11B
  (Amgen, Genentech, Baxter)

  2 are in Agriculture:                                            Baxter $12B
  (Syngenta, Monsanto)
                               Copyright: Manas Kanungo 2009
Key Drivers for Biotech Industry Trends
  Increasing Biotech Markets from Globalization,
  New Indications, in several Segments

  Therapeutic demand driven by insurers’ willingness
  to reimburse new, off-label treatments (CURES!)
  vs. saturated pharma

  Formative FDA approval & regulatory processes:

  Whoever gets in first gets to pave the way…
                   Copyright: Manas Kanungo 2009
Key Drivers for Biotech Industry Trends ..contd

Large, fast growing, high ROI market potential

Small biotech companies can co exist with large
ones if they have research expertise, specialization

New original patents for Large Molecule Technology
Plus Process vs. small molecule chemistries only

Thinning Pipelines w/Generics Entry, Saturated
Disease Areas, Cost Pressures, Leading Pharmas to
Consolidate or buy Biotechs

                    Copyright: Manas Kanungo 2009
BIO-
     BIO-THERAPEUTIC INDUSTRY TRENDS
          Mass Patients        THERAPY                                Personalized Medicine
New
                                                  NUCLEIC ACIDS &
                                                  OLIGONUCLEOTIDES

 I                                                                                ROI
 N
 D
 I    PHARMAS
 C    Consolidation
 A
                                                                      - Few Major Players
 T
 I
                                          BIOTECHS                    - Niche Market
                                       LARGE MOLECULES, INJECTIONS - High Prices
 O                                     PROTEINS, PEPTIDES, ANTIBODIES - Low Volumes
                                       The Few & The Proud            - Large Capital Need
 N
                                                                      - Research & Tech
 S
                                                                      - Process & Marketing
               GENERICS
                Coming out of the woodworks


Known                                         DISEASES                               New
                                      Copyright: Manas Kanungo 2009
BIOTHERAPEUTIC INDUSTRY & APPROVALS 1982 - 2007
                       All Biotech Approvals                                           Genentech

• 1982 – 1995:                   42                                                    20: ~ 50% !!
• 1996 – 2007:                   243                                                   15
                                                                                       35
                                  30
                                                                1996:
                                                             Biotherape
   7.5% of all drugs                                          utic Era:                                        25
                                                                                                                         26

                                  25
   marketed                                                      28                                                           23
                                                             Approved!
                                                                                                                                             21

                                  20                                                                                               19
   20% CAGR: 32% of all                                                                         18
                                                                                                          17
                                                                                                                    18
                                                                                                                                        17
   pipeline research                                                                       15
                                                                                                     16

   programs                       15




                                  10                                                   9


                                                                       6       6

                                   5                 4                             4
                                                                 3 3       3
                                                         2
                                         1       1
                                             0 0             0
                                     0
                          Copyright: Manas Kanungo 2009
                                                                               Approvals
Top 25 Biotherapeutic Drugs = $70B
Drug        Company         $B ’07
                                            100% Biotech Companies: Top 5 & 12/25
Rituxan     Genentech       $ 5.5
Enbrel     Amgen            $ 5.3
                                            Amgen                   5/25   $ 15.7B (22.4%)
Hercepti   Genentech        $ 4.8
Avastin    Genentech        $ 4.1
Aranesp    Amgen            $ 3.6           Genentech               3/25   $ 14.4B (20.6%)
Remicade   J&J              $ 3.3
Lantus     Sanofi-Aventis   $ 3.2           Rest Pharmas: by acquiring smaller Biotechs
Humira     Abbott           $ 3.1
Gleevec    Novartis         $ 3.0           Roche, Sanofi 2/25 ea $ 3.7 / 6.1B

                                            Others: 1 each ... Including 1 Generic! (Teva)


            Indications: Chronic, End-stage , Life Saving, Rare Diseases

       Cancer:   Breast, Colon, Lung, Prostate, Gastric, Head/Neck,
                 Non-Hodgkins Lymphoma, Tumors

       Others:   Anemia, Crohn’s, Chemo Infection, Diabetes, Hepatitis B/C,
                 Hemophilia A, Various Types of Arthritis, Multiple Sclerosis
                                    Copyright: Manas Kanungo 2009
Top Pure Biotherapeutics Companies $40B
 Company      Tkr   Rev $B Cap $B x Rev 52Wk Lo Now 52Wk Hi EPS         P/E   Beta



Genentech DNA        11.7    89     7.6     66     85      99    3.02 28.10 0.64

Amgen        AMGN    14.8    60     4.1     39     52      74    3.91 14.70 0.80

Gilead Sc.   GILD    4.2     45    10.7     36     50      57    2.09 23.70 0.93

Celgene      CELG    1.4     25    17.9     45     54      77    -3.76 -14.30 1.00

Genzyme      GENZ    3.8     19     5.0     56     71      84    1.50 47.40 0.85

Biogen Idec BIIB     4.1     15     3.7     37     52      74    2.64 19.40 0.90

HIGH         Low

     Significant Lead in Revenue by Amgen & Genentech Over Others

     Genentech w/Highest Market Cap Even if NOT w/Highest Revenue or EPS

     Stock Prices Significantly Higher Than Pharma Stocks in Current Environment
                                   Copyright: Manas Kanungo 2009
Gene-
 Gene-sis of Gene-n-tech
             Gene-                                                                      $ 35 -- $ 88

                                                               Went Public: 1980           1980’s

                                                                                           Process
        External Contributors                                  Out-Licensed Sales:
                                                                                         Innovation:
                                                                      Lilly, Roche
                 Genomics, Proteomics,
                                                                                        Identification
                                                               FDA: Growth Hormone
                             Microarrays,                           Heart/Blood Clot
                                                                                          Cloning
                        Sensitive Assay Technologies,               1st Sales: 1985
                                                                                         Antibodies
                                       Molecular Biology           FDA Enforced
                                                                                         Humanizing
                                               Discoveries,          CUSTOMER
                                                                      TRACKING
                                                                                          Therapy
                                                      Economic Boom …
                                                                                      Focus: BioOncology

Internal Capabilities                             Genentech is Formed:
                                    1976
                                                  Boyer & Swanson

                                                  Technological Innovation: Genetic Engineering
                                 1977 - 1979
                                                  Identify absent, defective, excess protein;
          Discovery:                              Engineer protein or molecule for therapy;
          rDNA Technology                         Splice Genes in Fast Growing Bacteria
 70’s                                             to Produce Therapeutic Proteins
          Boyer: Biochem
          Chohen: Genetist
                                                  1st Cloning: Human Protein in E.Coli
                                                  Licensed to Eli Lilly: Human Insulin, Growth Hormone
                                    Copyright: Manas Kanungo 2009
1990’s: Building & Leveraging Core Competencies
Hamel – Prahalad / Internal, or Inside-Out Strategy Model: Specific, Inherent, Integrated, and Applied KSAs


                                        $$$$                                         $2.1B Roche Merger
                                                                                     Smith Kline – Hep. B
                                                                                      Biogen Idec – NHL
                                   Internal – USA                                    Alkermes - Nutropin
                                  External: Roche                                  Customer Service - SPOC
                                    Out-License


                          BIOTECH MANUFACTURING
                                                                                       Vacaville Plant
                             Internal      Cost Leader

                            Difficult for Others to Imitate   3

                           PRODUCT DEVELOPMENT
                                                                                   FDA Approvals – Int/Ext
               Internal   External Partnerships           Out-License
                 Strategic Portfolio: High Value Customer Benefits       2

                                                                                     Founders Research
           RESEARCH: Access to Wide Variety of Products & Markets
                                                                               1           Center
                                                                                        Various 1st:
    Internal               External Partnerships                  In License
                                                                                    Monoclonal Antibodies
                                                                                     Targeted Therapies
    Oncology                    Immunology          Specialty Biotherapeutics
                                         Copyright: Manas Kanungo 2009
2000’s: Genentech’s Sustained 1st Mover Leadership
                                                                Due To:
                                            • Process & Filing Expertise for Biologics
   FDA Approvals     To Date:               • Robust Clinicals w/HCP & Patients Inputs
                     35



                      Largest
   New Products       Pipeline              • Huge Staff w/most R&D Spending: 21%
                                            • Foster Basic & Outcomes Based Research, Partners



                    Global
                    Reach w/o
    Marketing &     Significant             • US Internal: Strategic, Targeted Plans w/Execution
      Sales         Investment              • Co-Marketing & Sales to Leverage Partners’ Strengths




      Profits,        Manufg:
   Capacity, Cost     Best In               • Optimized Volumes to Minimize Costs
                      Class                 • Strategic Partnerships, Purchases for Expansion

                                Copyright: Manas Kanungo 2009
GENENTECH – Setting & Achieving Goals – ’99 to ‘05
                                                           Target        Actual
  Avg EPS/yr Growth                                        1.25%         33%
  Approved Products / Indications                             5           7 w/Multi-Indic
                                                                            w/Multi-
  Late Stage Clinicals                                        5           6 w/21 Indications
  Rev from Alliances / Acquisitions                        $500M         $300M
  Net Income as % of Op. Revenue                             25%          21%
  (Rituxan w/Several Indications, need to share with other partners)


                                  2010 Vision & Goals
  Leader in revolutionizing treatment of patients w/cancer, immunological
  diseases, and angiogenic disorders, utilizing science and biotechnology
            Approved Products /Indications                               15
            New Molecules to Clinical Development                        20
            US Oncology Market Position                                   1
            Avg EPS/yr Growth                                            25%
            Cumulative Free Cash Flow                                    $12B
                                         Copyright: Manas Kanungo 2009
Genentech’s External Strategy
  Decisions            Red Ocean - Sharks                Blue Ocean - Dolphins
Market –         Compete in Existing Space           Create New Space
Therapeutic      (Mass Pts, Small Molecules)         (Personalized Meds, Large
Products                                             Molecules)
(Pharma)         Try to Beat, Eat, or Look Out       Ignore – Make Them Irrelevant
Competition
Patients /       Exploit / Steal Existing Patients   Create & Capture New Patients
Demand
                 Make Trade-offs: Brand or           Willing to Pay More: For Unmet,
Value Offering
                 Generic Aspirin?                    Life Saving Cancer Solutions
                 Systems & Activities to Chose       Systems & Activities for BOTH
Internal         Low Cost or Differentiation:        Low Cost & Differentiation: :
Alignment        Make/Buy, Other Compromises         Own Biotech Mfg:
                                                     Low Cost, High Profits

Although Kim & Mauborgne did not propose their Blue Ocean Strategy in HBR till
Oct 2004, Genentech’s inherently innovative culture extended beyond their R&D
Staff to develop a business strategy with a path of least resistance and execute
with precision for superb results. Copyright: Manas Kanungo 2009
Genentech’s Value Based Management Strategy
 McKinsey’s 7 – S Framework Model

                                                            Innovative, Co-operative,       “Best Companies
                                                            Partnership, Citizenship        to Work For”

  Clear, Challenging, Achievable                    Style
  Goals……..stay Focused!                                                 Very High Caliber People, Subject Area
                                                                         Experts……R&D: Nobel Laureates

                              Strategy                                    Skills
  Guiding Principles

• Scientific Excellence                           Shared
• Long-Term Planning                              values                    Built Streamlined Systems and
• Execution                                                                 Processes to Lead in Manufg,
                                                                            Technology, Approvals, Performance
• People & Culture
                                 Staff                                   Systems


11K People w/ > 1000 Scientists;
Unique Manufg & Mktg Staff;                      Structure
RaaRaa – Responsibility
w/Authority, Roles w/Accountability                           Centralized, Close Knit Family Atmosphere;
                                                              Basic Research feeds Value Based Screening
                                                              for Product Development; Execution Oriented

                                         Copyright: Manas Kanungo 2009
Financials ($B): Consistently Outperformed Industry

                            2004             2005                   2006    2007                2008
Rev Growth                 39.0%            44.0%                  41.0%   26.0%               15.0%
NI Growth                  39.0%            66.0%                  62.0%   33.0%               21.0%
NI % of Sales              17.0%            20.0%                  23.0%   24.0%               25.0%
OI Growth                  23.0%            73.0%                  68.0%   31.0%               26.0%
OI % of Sales              24.0%            29.0%                  34.0%   36.0%               40.0%
         16.0
         14.0
         12.0
         10.0
                                            Cash Flow: $4B from ‘08 Operations
          8.0
          6.0
          4.0
          2.0
          0.0
                 Revenue                            Net Income              Operating Income
          2001     2.0                                 0.15
          2002     2.6                                0.064                        0.03
          2003     3.3                                0.563                        0.898
          2004     4.6                                0.785                         1.1
          2005     6.6                                  1.3                         1.9
          2006     9.3                                  2.1                         3.2
          2007    11.7                                  2.8                         4.2
          2008    13.4                                  3.4                         5.3
                                   Copyright: Manas Kanungo 2009
Investor Performance – Stocks & EPS
  100 Shares @ $35 in May ‘80 IPO for $3500 = 5040 Shares @ $82 worth $43,280


           Return of 1,137%                     (Not Including Dividends!)



100
90                                                                             2008 Ind Avg
80                                                            EBIT             5.5B   1.4B
70                                                            P/E                26    30
60                                                            P/B               5.84  6.28
50                                                            LTD/Equity       14.86 30.46
40                                                            ROA                17     8
30
                                                              Gross Profit     87%     0%
20
10
 0
           Yrnd Share Price                    EPS x10                   EPS Growth x 10
2004             55                               7.3                        388.0%
2005             93                              11.8                        616.0%
2006             81                              19.7                        669.0%
2007             67                              25.9                        315.0%
2008             82                              32.1                        239.0%



                              Copyright: Manas Kanungo 2009
Biotherapeutic Industry Future
Biotech industry somewhat shielded from economic recession:
 • Globalization with Increasing Exports
 • Current Unmet Diseases, with Aging Human Market Segments
 • Growth in Agricultural, Animal, Aquatic, and Environmental Segments

Therapeutic Industry Revenue will Grow $86B               $147B from ‘08 –’13

   Growth of 11.4%, or 5 x Avg. US GDP over the same period

Market Driven by High ROIs, Dual Patent Protections, Personalized Meds

                           CHALLENGES

New Entrants, Pharma Companies Refocusing (Pfizer), Bio-Generics,
                                                       Bio-
Market Plateau in Existing Areas, Margin Threats from Cost Controls from
Medicare, Govt , Insurance

Nucleotides (DNA/RNAs) may Substitute Bio-Therapeutics
                                      Bio-
                          Copyright: Manas Kanungo 2009
Future for Genentech - Pros
Unmet Demands for New Indications and Therapies will continue
to ensure Market and Industry Attractiveness

Positive Paradigm Shift to Curative Solutions for Severe
Conditions that People are Willing to Pay (Blue Ocean) vs. only
alleviating conditions with threat of regression

Strong R&D with Over 100 New Products in Pipeline, mostly in
New or Expanded Areas, will ensure Increasing Market Shares
and Revenues

Expertise in Innovative Biotech Processes & Large Scale
Manufacturing will Generate Low Cost Products with High Profits
& Price Flexibility

High Barriers to Entry … Strong Technology & Process IPs
w/New & Expanded Extensions, Capital Intensive Mfg will limit
Competition to a Few Substitutes
                        Copyright: Manas Kanungo 2009
Future for Genentech – Pros ..                                    Contd




Foundation and Strength in Basic Biotech Research also gives
Genentech significant lead in next generation Nucleotides Era.

Excellent Financial Position (Cash, Earnings, Valuations, Stock) :
   Invest to Grow Core Competencies – Research & Development?
   Explore Further Economies of Scale in Manufacturing?
   Share Growth through Out-Licensing, In-Licensing, New Diseases?
                           Out-          In-
   Expand Biotech Moat – Agriculture, Marine, Environmental
   Invest in the Future – Nucleotides? Theranostics? Disease Management?

   Wait for anticipated blockbusters, and buy Roche???


Roche One of few w/+ve Outcomes from Mergers: BMC, Ventana


                          Copyright: Manas Kanungo 2009
Future for Genentech - Con
End of Pricing Honeymoon Around the Corner
- Increasing Cost Control Pressures from Govt and Private Payers

The Vultures are Waiting (Generics & Estrangeros)
                                     Estrangeros)
- Large Pharmas waiting to buy up
- Teva Already a Major Biotech Contender
- Strong Lobby to Allow Bio-Generics
                        Bio-
- Therapies with Oldest IPs at Risk
- UK, Germany, France, Singapore, South Korea
  Government Backed Programs

Forced into a Bad Marriage? (Roche)…..who benefits?
- $4B Cash Dowry too tempting for Roche not to cover debts
- No longer w/family, friends I grew up with….
- Oncology, Core Area, Relocating to Nutley..            Scare
- Career Path Issues                                     Away
- MBO vs. Innovative Incentives, Options                 Core
- New Decision Making Process                            Members
- Systems, Reporting, Accountabilities Changes           ???
                           Copyright: Manas Kanungo 2009
Sources



• Genentech Website, Archives, SEC Filings
• Roche Website, Archives, SEC Filings
• Analysts Reports
• Morningstar, Guru, Vanguard, Money
• CNBC, Bloomberg, Market Watch
• Pharmaprojects.com, IBIS, UCI Library
• WSJ, USA Today
• BioWorld, BioSpace, Scrips News
• valuebasedmanagement.net
• Business Week, HBJ
• Private consultants
• Personal experience in Roche




        Copyright: Manas Kanungo 2009

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Roche Genentech Acquisition Analysis

  • 1. Gene- Gene-alyzing GENENTECH Strategic Management for Executives GROUP 8 – HCEMBA’09 Primary Contributor: Manas Kanungo Copyright: Manas Kanungo 2009
  • 2. THE BIOTECH & PHARMA INDUSTRIES Agriculture Agri - Food Aqua/Marine PHARMA BIOTECH Animal Health Animal Health - Chemistry Based, Orals - Proteins & Peptides, Fluids - “Small Molecules” - “Large Molecules” - Patents for Formulations - Patents for Discovery, Process Human Therapy Copyright: Manas Kanungo 2009
  • 3. Biotech Industry Landscape – Room to Grow Few Large, $B Companies – 40% Amgen $16B Many Small Players < $50M ea 1000 Companies ~ $85B Genentech $14B Amongst Top 5 Biotechs: Baxter $12B Others 60% 3 are Biotherapeutics Cos: Monsanto $11B (Amgen, Genentech, Baxter) 2 are in Agriculture: Baxter $12B (Syngenta, Monsanto) Copyright: Manas Kanungo 2009
  • 4. Key Drivers for Biotech Industry Trends Increasing Biotech Markets from Globalization, New Indications, in several Segments Therapeutic demand driven by insurers’ willingness to reimburse new, off-label treatments (CURES!) vs. saturated pharma Formative FDA approval & regulatory processes: Whoever gets in first gets to pave the way… Copyright: Manas Kanungo 2009
  • 5. Key Drivers for Biotech Industry Trends ..contd Large, fast growing, high ROI market potential Small biotech companies can co exist with large ones if they have research expertise, specialization New original patents for Large Molecule Technology Plus Process vs. small molecule chemistries only Thinning Pipelines w/Generics Entry, Saturated Disease Areas, Cost Pressures, Leading Pharmas to Consolidate or buy Biotechs Copyright: Manas Kanungo 2009
  • 6. BIO- BIO-THERAPEUTIC INDUSTRY TRENDS Mass Patients THERAPY Personalized Medicine New NUCLEIC ACIDS & OLIGONUCLEOTIDES I ROI N D I PHARMAS C Consolidation A - Few Major Players T I BIOTECHS - Niche Market LARGE MOLECULES, INJECTIONS - High Prices O PROTEINS, PEPTIDES, ANTIBODIES - Low Volumes The Few & The Proud - Large Capital Need N - Research & Tech S - Process & Marketing GENERICS Coming out of the woodworks Known DISEASES New Copyright: Manas Kanungo 2009
  • 7. BIOTHERAPEUTIC INDUSTRY & APPROVALS 1982 - 2007 All Biotech Approvals Genentech • 1982 – 1995: 42 20: ~ 50% !! • 1996 – 2007: 243 15 35 30 1996: Biotherape 7.5% of all drugs utic Era: 25 26 25 marketed 28 23 Approved! 21 20 19 20% CAGR: 32% of all 18 17 18 17 pipeline research 15 16 programs 15 10 9 6 6 5 4 4 3 3 3 2 1 1 0 0 0 0 Copyright: Manas Kanungo 2009 Approvals
  • 8. Top 25 Biotherapeutic Drugs = $70B Drug Company $B ’07 100% Biotech Companies: Top 5 & 12/25 Rituxan Genentech $ 5.5 Enbrel Amgen $ 5.3 Amgen 5/25 $ 15.7B (22.4%) Hercepti Genentech $ 4.8 Avastin Genentech $ 4.1 Aranesp Amgen $ 3.6 Genentech 3/25 $ 14.4B (20.6%) Remicade J&J $ 3.3 Lantus Sanofi-Aventis $ 3.2 Rest Pharmas: by acquiring smaller Biotechs Humira Abbott $ 3.1 Gleevec Novartis $ 3.0 Roche, Sanofi 2/25 ea $ 3.7 / 6.1B Others: 1 each ... Including 1 Generic! (Teva) Indications: Chronic, End-stage , Life Saving, Rare Diseases Cancer: Breast, Colon, Lung, Prostate, Gastric, Head/Neck, Non-Hodgkins Lymphoma, Tumors Others: Anemia, Crohn’s, Chemo Infection, Diabetes, Hepatitis B/C, Hemophilia A, Various Types of Arthritis, Multiple Sclerosis Copyright: Manas Kanungo 2009
  • 9. Top Pure Biotherapeutics Companies $40B Company Tkr Rev $B Cap $B x Rev 52Wk Lo Now 52Wk Hi EPS P/E Beta Genentech DNA 11.7 89 7.6 66 85 99 3.02 28.10 0.64 Amgen AMGN 14.8 60 4.1 39 52 74 3.91 14.70 0.80 Gilead Sc. GILD 4.2 45 10.7 36 50 57 2.09 23.70 0.93 Celgene CELG 1.4 25 17.9 45 54 77 -3.76 -14.30 1.00 Genzyme GENZ 3.8 19 5.0 56 71 84 1.50 47.40 0.85 Biogen Idec BIIB 4.1 15 3.7 37 52 74 2.64 19.40 0.90 HIGH Low Significant Lead in Revenue by Amgen & Genentech Over Others Genentech w/Highest Market Cap Even if NOT w/Highest Revenue or EPS Stock Prices Significantly Higher Than Pharma Stocks in Current Environment Copyright: Manas Kanungo 2009
  • 10. Gene- Gene-sis of Gene-n-tech Gene- $ 35 -- $ 88 Went Public: 1980 1980’s Process External Contributors Out-Licensed Sales: Innovation: Lilly, Roche Genomics, Proteomics, Identification FDA: Growth Hormone Microarrays, Heart/Blood Clot Cloning Sensitive Assay Technologies, 1st Sales: 1985 Antibodies Molecular Biology FDA Enforced Humanizing Discoveries, CUSTOMER TRACKING Therapy Economic Boom … Focus: BioOncology Internal Capabilities Genentech is Formed: 1976 Boyer & Swanson Technological Innovation: Genetic Engineering 1977 - 1979 Identify absent, defective, excess protein; Discovery: Engineer protein or molecule for therapy; rDNA Technology Splice Genes in Fast Growing Bacteria 70’s to Produce Therapeutic Proteins Boyer: Biochem Chohen: Genetist 1st Cloning: Human Protein in E.Coli Licensed to Eli Lilly: Human Insulin, Growth Hormone Copyright: Manas Kanungo 2009
  • 11. 1990’s: Building & Leveraging Core Competencies Hamel – Prahalad / Internal, or Inside-Out Strategy Model: Specific, Inherent, Integrated, and Applied KSAs $$$$ $2.1B Roche Merger Smith Kline – Hep. B Biogen Idec – NHL Internal – USA Alkermes - Nutropin External: Roche Customer Service - SPOC Out-License BIOTECH MANUFACTURING Vacaville Plant Internal Cost Leader Difficult for Others to Imitate 3 PRODUCT DEVELOPMENT FDA Approvals – Int/Ext Internal External Partnerships Out-License Strategic Portfolio: High Value Customer Benefits 2 Founders Research RESEARCH: Access to Wide Variety of Products & Markets 1 Center Various 1st: Internal External Partnerships In License Monoclonal Antibodies Targeted Therapies Oncology Immunology Specialty Biotherapeutics Copyright: Manas Kanungo 2009
  • 12. 2000’s: Genentech’s Sustained 1st Mover Leadership Due To: • Process & Filing Expertise for Biologics FDA Approvals To Date: • Robust Clinicals w/HCP & Patients Inputs 35 Largest New Products Pipeline • Huge Staff w/most R&D Spending: 21% • Foster Basic & Outcomes Based Research, Partners Global Reach w/o Marketing & Significant • US Internal: Strategic, Targeted Plans w/Execution Sales Investment • Co-Marketing & Sales to Leverage Partners’ Strengths Profits, Manufg: Capacity, Cost Best In • Optimized Volumes to Minimize Costs Class • Strategic Partnerships, Purchases for Expansion Copyright: Manas Kanungo 2009
  • 13. GENENTECH – Setting & Achieving Goals – ’99 to ‘05 Target Actual Avg EPS/yr Growth 1.25% 33% Approved Products / Indications 5 7 w/Multi-Indic w/Multi- Late Stage Clinicals 5 6 w/21 Indications Rev from Alliances / Acquisitions $500M $300M Net Income as % of Op. Revenue 25% 21% (Rituxan w/Several Indications, need to share with other partners) 2010 Vision & Goals Leader in revolutionizing treatment of patients w/cancer, immunological diseases, and angiogenic disorders, utilizing science and biotechnology Approved Products /Indications 15 New Molecules to Clinical Development 20 US Oncology Market Position 1 Avg EPS/yr Growth 25% Cumulative Free Cash Flow $12B Copyright: Manas Kanungo 2009
  • 14. Genentech’s External Strategy Decisions Red Ocean - Sharks Blue Ocean - Dolphins Market – Compete in Existing Space Create New Space Therapeutic (Mass Pts, Small Molecules) (Personalized Meds, Large Products Molecules) (Pharma) Try to Beat, Eat, or Look Out Ignore – Make Them Irrelevant Competition Patients / Exploit / Steal Existing Patients Create & Capture New Patients Demand Make Trade-offs: Brand or Willing to Pay More: For Unmet, Value Offering Generic Aspirin? Life Saving Cancer Solutions Systems & Activities to Chose Systems & Activities for BOTH Internal Low Cost or Differentiation: Low Cost & Differentiation: : Alignment Make/Buy, Other Compromises Own Biotech Mfg: Low Cost, High Profits Although Kim & Mauborgne did not propose their Blue Ocean Strategy in HBR till Oct 2004, Genentech’s inherently innovative culture extended beyond their R&D Staff to develop a business strategy with a path of least resistance and execute with precision for superb results. Copyright: Manas Kanungo 2009
  • 15. Genentech’s Value Based Management Strategy McKinsey’s 7 – S Framework Model Innovative, Co-operative, “Best Companies Partnership, Citizenship to Work For” Clear, Challenging, Achievable Style Goals……..stay Focused! Very High Caliber People, Subject Area Experts……R&D: Nobel Laureates Strategy Skills Guiding Principles • Scientific Excellence Shared • Long-Term Planning values Built Streamlined Systems and • Execution Processes to Lead in Manufg, Technology, Approvals, Performance • People & Culture Staff Systems 11K People w/ > 1000 Scientists; Unique Manufg & Mktg Staff; Structure RaaRaa – Responsibility w/Authority, Roles w/Accountability Centralized, Close Knit Family Atmosphere; Basic Research feeds Value Based Screening for Product Development; Execution Oriented Copyright: Manas Kanungo 2009
  • 16. Financials ($B): Consistently Outperformed Industry 2004 2005 2006 2007 2008 Rev Growth 39.0% 44.0% 41.0% 26.0% 15.0% NI Growth 39.0% 66.0% 62.0% 33.0% 21.0% NI % of Sales 17.0% 20.0% 23.0% 24.0% 25.0% OI Growth 23.0% 73.0% 68.0% 31.0% 26.0% OI % of Sales 24.0% 29.0% 34.0% 36.0% 40.0% 16.0 14.0 12.0 10.0 Cash Flow: $4B from ‘08 Operations 8.0 6.0 4.0 2.0 0.0 Revenue Net Income Operating Income 2001 2.0 0.15 2002 2.6 0.064 0.03 2003 3.3 0.563 0.898 2004 4.6 0.785 1.1 2005 6.6 1.3 1.9 2006 9.3 2.1 3.2 2007 11.7 2.8 4.2 2008 13.4 3.4 5.3 Copyright: Manas Kanungo 2009
  • 17. Investor Performance – Stocks & EPS 100 Shares @ $35 in May ‘80 IPO for $3500 = 5040 Shares @ $82 worth $43,280 Return of 1,137% (Not Including Dividends!) 100 90 2008 Ind Avg 80 EBIT 5.5B 1.4B 70 P/E 26 30 60 P/B 5.84 6.28 50 LTD/Equity 14.86 30.46 40 ROA 17 8 30 Gross Profit 87% 0% 20 10 0 Yrnd Share Price EPS x10 EPS Growth x 10 2004 55 7.3 388.0% 2005 93 11.8 616.0% 2006 81 19.7 669.0% 2007 67 25.9 315.0% 2008 82 32.1 239.0% Copyright: Manas Kanungo 2009
  • 18. Biotherapeutic Industry Future Biotech industry somewhat shielded from economic recession: • Globalization with Increasing Exports • Current Unmet Diseases, with Aging Human Market Segments • Growth in Agricultural, Animal, Aquatic, and Environmental Segments Therapeutic Industry Revenue will Grow $86B $147B from ‘08 –’13 Growth of 11.4%, or 5 x Avg. US GDP over the same period Market Driven by High ROIs, Dual Patent Protections, Personalized Meds CHALLENGES New Entrants, Pharma Companies Refocusing (Pfizer), Bio-Generics, Bio- Market Plateau in Existing Areas, Margin Threats from Cost Controls from Medicare, Govt , Insurance Nucleotides (DNA/RNAs) may Substitute Bio-Therapeutics Bio- Copyright: Manas Kanungo 2009
  • 19. Future for Genentech - Pros Unmet Demands for New Indications and Therapies will continue to ensure Market and Industry Attractiveness Positive Paradigm Shift to Curative Solutions for Severe Conditions that People are Willing to Pay (Blue Ocean) vs. only alleviating conditions with threat of regression Strong R&D with Over 100 New Products in Pipeline, mostly in New or Expanded Areas, will ensure Increasing Market Shares and Revenues Expertise in Innovative Biotech Processes & Large Scale Manufacturing will Generate Low Cost Products with High Profits & Price Flexibility High Barriers to Entry … Strong Technology & Process IPs w/New & Expanded Extensions, Capital Intensive Mfg will limit Competition to a Few Substitutes Copyright: Manas Kanungo 2009
  • 20. Future for Genentech – Pros .. Contd Foundation and Strength in Basic Biotech Research also gives Genentech significant lead in next generation Nucleotides Era. Excellent Financial Position (Cash, Earnings, Valuations, Stock) : Invest to Grow Core Competencies – Research & Development? Explore Further Economies of Scale in Manufacturing? Share Growth through Out-Licensing, In-Licensing, New Diseases? Out- In- Expand Biotech Moat – Agriculture, Marine, Environmental Invest in the Future – Nucleotides? Theranostics? Disease Management? Wait for anticipated blockbusters, and buy Roche??? Roche One of few w/+ve Outcomes from Mergers: BMC, Ventana Copyright: Manas Kanungo 2009
  • 21. Future for Genentech - Con End of Pricing Honeymoon Around the Corner - Increasing Cost Control Pressures from Govt and Private Payers The Vultures are Waiting (Generics & Estrangeros) Estrangeros) - Large Pharmas waiting to buy up - Teva Already a Major Biotech Contender - Strong Lobby to Allow Bio-Generics Bio- - Therapies with Oldest IPs at Risk - UK, Germany, France, Singapore, South Korea Government Backed Programs Forced into a Bad Marriage? (Roche)…..who benefits? - $4B Cash Dowry too tempting for Roche not to cover debts - No longer w/family, friends I grew up with…. - Oncology, Core Area, Relocating to Nutley.. Scare - Career Path Issues Away - MBO vs. Innovative Incentives, Options Core - New Decision Making Process Members - Systems, Reporting, Accountabilities Changes ??? Copyright: Manas Kanungo 2009
  • 22. Sources • Genentech Website, Archives, SEC Filings • Roche Website, Archives, SEC Filings • Analysts Reports • Morningstar, Guru, Vanguard, Money • CNBC, Bloomberg, Market Watch • Pharmaprojects.com, IBIS, UCI Library • WSJ, USA Today • BioWorld, BioSpace, Scrips News • valuebasedmanagement.net • Business Week, HBJ • Private consultants • Personal experience in Roche Copyright: Manas Kanungo 2009