Commercial Strategy. Tony Hooper Executive Vice President, Global Commercial Operations

Transcription

1 Commercial Strategy Tony Hooper Executive Vice President, Global Commercial Operations

2 Our Commercial Strategy 1. Transforming our commercial model 2. Grow and differentiate our in-market products Grow by demonstrating value Compete in the face of biosimilars Expand access 3. Augment with other growth opportunities Launch new pipeline products Enter and expand into new geographic markets Launch biosimilars portfolio 2

3 We Are Transforming Our Commercial Model Significantly expanding geographic footprint Leveraging our strong specialty market experience Building competitive biologic primary care competencies Delivering operating efficiencies with a focus on return on investment Creating holistic, integrated commercial model for payers, prescribers, and patients 3

4 Growth Strategies for In-Market Products

5 We Have a Diverse Portfolio of Innovative Products For additional information about Amgen products, including important safety information, please visit 5

6 Enbrel Is the Leading Biologic in the Fast-Growing Rheumatology and Dermatology Segments Rheumatology ($12.7B) 2012 Segment Growth = 20% US Share and Product Sales (2012) Dermatology ($3.1B) 2012 Segment Growth = 27% US Share and Product Sales (2012) 19% 31% 23% 5% 38% $0.8B 24% 25% 34% ENBREL REMICADE HUMIRA STELARA Other Potential for increased biologic penetration Source: IMS 6

7 Enbrel Continues to Be the Leading Choice for New-to-Biologic RA Patients Rheumatoid Arthritis Segment Bio-Naïve Share 40% 37% 30% 20% 10% 0% Q Q Q Q Q ENBREL HUMIRA REMICADE ORENCIA IV ORENCIA SubQ SIMPONI RITUXAN CIMZIA ACTEMRA Source: IMS RA = rheumatoid arthritis; ENBREL is indicated for moderate to severe RA 7

8 ENBREL Growth Driven By Increased Focus and Investment Direct-to-consumer campaigns prompted patients to discuss ENBREL ENBREL leads in patient requests Consolidated and expanded sales force gives ENBREL a competitive share of voice Expanded sales force and structure achieves optimal call reach and frequency Consistent and simplified messaging significantly lifted HCP customer perception of ENBREL Support as best in class Enrollment in and satisfaction with ENBREL Support continue to increase HCP = health care professional Amgen/BAI Market Research, Office Practice Manager ATU, Sept

9 Enbrel Is Poised for Continued Growth 1 Prolonged exclusivity 2 Unsurpassed access position 3 Renewed 2013 DTC campaign 4 Investment in ENBREL lifecycle management 5 New devices for patient-friendly experience Significant improvement in profitability with the expiry of the Pfizer profit share in November

10 Our Denosumab Franchise: Deriving Value From Innovation Emanated from Amgen s focus on innovation and science Value is recognized by physicians, payers, and patients Delivered $1.2B in sales in 2012 (over $1.8B since launch) Committed to building the franchise long term 10

11 Prolia : The Global PMO Segment Is Large and There Is Significant Unmet Need 2011 PMO Segment US/EU5/Japan G7 Osteoporosis Population 65M Not Treated 16M Large Majority at High-Risk Drug Treated 15M Not Diagnosed 34M Prolia is indicated for women with PMO at high risk for fracture PMO = postmenopausal osteoporosis G7 = US, EU5, and Japan *Estimates from Decision Resources, Dec 2012; Sources: Marketscan Claims Database, IMS Midas Days of Therapy 11

12 We Are Increasing Prolia Share in Several Key Regions US Europe Quarterly Avg DOT Thousands 250 Prolia Day of Therapy (DOT) and Share of PMO DOT % Share 8 Quarterly Avg DOT Thousands 350 Prolia Day of Therapy (DOT) and Share of PMO DOT % Share Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12 Prolia DOT Prolia Share Source: IMS Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12 Prolia DOT Prolia Share 0

13 Prolia Is Reimbursed in Most European Countries Germany Austria Greece Slovakia Sweden Belgium Czech Norway Denmark Netherlands Italy Poland Ireland Slovenia Spain Switzerland UK Reimbursed in > 90% of potential 13

14 Strategic Actions to Drive Prolia Growth Action Expand access Expand biologic primary care presence Invest in DTC in US Result Expedited prior authorization process Fewer insurance rejections Increased number of repeat visits Improved reach, coverage, and frequency Most requested PMO brand 95% of requests honored Source: Impact Rx 14

15 XGEVA

16 Over the Past 5 Years, XGEVA Is the Only Oncology Brand With Global Sales > $1B Within 2 Years of Launch Oncology Brands Launched Since 2007 Total global sales within 2 years of launch ($M) IXEMPRA VOTRIENT TYKERB Oxaliplatin TASIGNA AFINITOR PROVENGE Halaven JEVTANA XGEVA Note: Includes only brands with at least $100M in US Sales within 2 years of launch. Brands launched after 1/1/2011 not shown. Source: EvaluatePharma, accessed 1/29/

17 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 XGEVA Growth 100% 2011: 8.1% Unit Growth 2012: 8.5% Unit Growth 80% 60% 40% 20% 0% XGEVA $ Share IVBP $ Share XGEVA Unit Share IVBP = ZOMETA and pamidronate Source: IMS/DDD data; Actuals as of 1/18/

18 XGEVA Is Now Reimbursed in All Major European Countries Norway Austria Netherlands Switzerland Belgium Portugal France Denmark Finland Germany Slovakia UK Czech Sweden Ireland Italy Slovenia Spain Reimbursed in > 90% of potential 18

19 XGEVA Is Poised for Continued Growth 1 Educate clinicians on disease burden and unmet needs 2 Execute on key EU launches 3 Highlight XGEVA s superior efficacy, safety profile, and convenient sub-q injection 4 Broaden direct-to-patient campaign 5 Marketing execution focused on key customer segmentation 6 Potential for new clinical indications 19

20 Neulasta /NEUPOGEN Franchise: Opportunity for Growth ~ 75% of the global Neulasta /NEUPOGEN franchise is in Neulasta The US filgrastim segment is large and there is room for growth Significant unmet medical need exists: In breast cancer, patients only receive Neulasta during 4 cycles, on average, vs 7.3 cycles of chemotherapy * As many as 60,000 patients are hospitalized each year for febrile neutropenia and many of these patients may benefit from Neulasta or NEUPOGEN Patients remain at risk for febrile neutropenia *Source: OSCER database (August 2012) 20

21 We Have a Strong Competitive Position Against New Entrants Near-term competitive entrants are not biosimilars Lack of differentiation and experience will create commercialization challenges for new entrants Biosimilars are not identical and will have to be established as new products Biosimilars require 8 10 years and $100M $200M to develop* *Source: Federal Trade Commission Report, June Emerging Health Care Issues: Follow-on Biologic Drug Competition 21

22 Our Neulasta /NEUPOGEN Franchise: We Are Ready to Compete 1 Grow Neulasta units through increased cycle penetration, particularly in breast cancer and NHL patients 2 We will invest in Direct-to-Patient programs 3 Differentiate Neulasta from short-acting competition 4 Differentiate the Amgen franchise 5 New investment in and expansion of patient and HCP support services High-quality, reliable supply of biologics requires commitment to world-class manufacturing NHL = non-hodgkin lymphoma 22

23 Amgen Launches Manufacturing Matters 23

24 ESAs Will Remain an Important Treatment Option Patent protection in the US through 2024 Practice patterns are largely stable Important treatment option for appropriate patients Exited 2012 with 96% share* Hb levels and dosing largely stabilized Strong customer relationships Long history of efficacy and safety Flexibility of treatment *Source: IMS ESA = erythropoiesis-stimulating agent; Hb = hemoglobin 24

25 Our Strong Customer Relationships Are Key in Competing Against New Entrants Patent Expiry EPOGEN Competition peginesatide peg-epo* DaVita Contract 2018 Customer FMC Contract MDO Contracts We believe EPOGEN will remain an important part of dialysis treatment even in the face of competition *Estimated; FMC = Fresenius Medical Care; MDO = midsize dialysis organization 25

26 Growth Phase Products Sensipar, Vectibix, and Nplate Have Strong Momentum $1.2B 16% $1.4B 18% $1.7B Sensipar Globally on track to exceed $1B in sales in 2013 Vectibix Approval in 1st- and 2nd-line CRC creates growth opportunity outside US Sensipar Vectibix Nplate Nplate Opportunities exist for earlier use in ITP and increased utilization Expect to launch in emerging markets AMG 416 is an opportunity to ensure drug delivery to patients CRC = colorectal cancer; ITP = immune thrombocytopenic purpura 26

27 Augmenting Business With Additional Growth Opportunities

28 Our Pipeline Offers Many Opportunities Disease Area Molecule Phase Primary Indication Area Cardiovascular Bone Inflammation AMG 145 Phase 3 Hyperlipidemia Primary care Omecamtiv mecarbil* Phase 2 Heart failure Specialty Romosozumab (AMG 785) *Developed in collaboration with Cytokinetics; Developed in collaboration with UCB Developed in collaboration with AstraZeneca/MedImmune 28 Phase 3 Postmenopausal osteoporosis Primary care AMG 181 Phase 2 Inflammatory bowel disease Specialty Brodalumab (AMG 827) Phase 3 Psoriasis Specialty Nephrology AMG 416 Phase 2 Secondary hyperparathyroidism Specialty Oncology Neuroscience Trebananib (AMG 386) Talimogene laherparepvec Rilotumumab (AMG 102) Blinatumomab (AMG 103) Phase 3 Ovarian cancer Specialty Phase 3 Melanoma Specialty Phase 3 Gastric cancer Specialty Phase 2 Acute lymphoblastic leukemia (ALL) Specialty AMG 747 Phase 2 Schizophrenia Specialty AMG 334 Phase 1 Migraine Specialty

29 Market Opportunity for PCSK9 Therapy 2011 Dyslipidemia Segment US/EU5/Japan Dyslipidemia Population 265M Not Treated 38M High-Risk Primary Prevention 13M Potential Target 17M > 30% above goal* Not Diagnosed 133M Drug Treated 95M Low/Med Risk Primary Prevention 37M 5M CHD/CHD Equivalent 40M 17M 28M High-Risk Statin Intolerant Within 30% of goal* Outcomes data will be an important inflection point Source: NHANES, Decision Resources, Kantar Health, and Wolters Kluwers *Goal = LDL-C < 70 mg/dl; CHD = coronary heart disease; LDL-C = low-density lipoprotein cholesterol 29

30 Unique Opportunity for Romosozumab: Evolving Standard of Care ± Anti-Resorptive Therapy Bone-Forming Intervention Anti-Resorptive Therapy Convenient QM dosing Patient-friendly, self-administered device Leverage Prolia footprint and experience Anticipated coverage on pharmacy benefit/ Part D plans 30

31 Global Biosimilars Strategy

32 Biosimilars: Amgen s Competitive Advantages Technical Decades of proven biologics R&D experience Manufacturing Strong biologics manufacturing heritage High-quality and reliable supply Commercial Infrastructure and access Synergistic and flexible Actavis partnership Supports our global expansion strategy 32

33 Opportunity for Amgen to Capture Meaningful Value Originator Worldwide Peak Sales* HUMIRA ~ $11B REMICADE ~ $8B Avastin ~ $7B Herceptin ~ $6B RITUXAN ~ $7B ERBITUX ~ $2B Total ~ $41B We expect to launch the portfolio starting in 2017 *Per EvaluatePharma (8/13/12) 33

34 Global Expansion

35 Delivering Well Over $1B in New and Emerging Market Sales By 2015 Sales By Region $ Millions 1, $350M Bergamo MN Pharma PharmEco (Russia) $580M* CAGR +30% $1B+* Launching Products Sensipar Nplate Vectibix Aranesp *Includes MN Pharma and Bergamo 35

36 We Are Expanding Globally With a Focus on Japan and China Amgen Presence in 2012 Making progress everywhere; future focus on Japan and China 36

37 Maximizing the Value of the Japanese Market $2B legacy Amgen products in Japan Late-stage pipeline with significant potential Exploring near-term partnership opportunities Targeting a fully-scaled Amgen subsidiary by 2020 Launch first products by

38 Our Strategy for Succeeding in China Is Multi-Pronged Drive growth through advancing pipeline Establish R&D foothold Develop biosimilars registration plan Establish local manufacturing when needed Explore partnership and acquisitions to accelerate commercial presence Launch first products by

39 We Are Ready to Compete and Deliver Growth Deliver significantly higher Enbrel profits Maximize the Prolia and XGEVA opportunities Drive growth of Neulasta and lifecycle management Stabilize ESAs and position for long term Bring innovative new pipeline products to market Commercialize biosimilars portfolio Expand globally with a near-term focus on Japan and China ESA = erythropoiesis-stimulating Focus agent on return on investment 39