John Ansell President, John Ansell Consultancy Thame, UK
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1 Rutgers University Monday 29 September 2014 Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva 1 Am ankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Take ovartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squi disk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Inge Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Am ankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Take ovartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squi disk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Inge Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Am ankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Taked ovartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squi disk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Inge Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Am ankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Taked ovartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Ingelheim Merck & Co Eli Lilly Bristol-Myers Squi disk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Amgen Daiichi Sankyo Bayer Boehringer Inge Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva Am John Ansell President, John Ansell Consultancy Thame, UK
2 John Ansell Consultancy 8 Southern Road, Thame, Oxon OX9 2EP, UK
3 TRANSFORMING BIG PHARMA Assessing The Strategic Alternatives I. How Pharma Differs from Other Industries II. Pharma s Strategic Options III. Prospects for New Products
4 I. HOW PHARMA DIFFERS FROM OTHER INDUSTRIES
5 LONGEVITY - Average time to peak sales for top 50 globally bestselling products Average Longevity (years) Source: John Ansell Consultancy
6 COST STRUCTURES: SMALL MOLECULES 1ry care/ Small molecule R & D 16.5% Cost of goods 13.2% Sales & marketing 35.0% General & administrative 8.0% Total 72.7% Margin 27.3% Source: James, B, Big Pharma: The Beginning of the End or the End of the Beginning? p 10, Decision Resources, Inc. Spectrum, Pharmaceutical Industry Dynamics, May 2003/John Ansell Consultancy John Ansell Consultancy
7 COST STRUCTURES: SMALL VS LARGE MOLECULES molecule 1ry care/ Specialist/ small molecule Large R & D 16.5% similar Cost of goods 13.2% often greater Sales & marketing 35.0% <10% General & administrative 8.0% similar Total 72.7% c.50% urce: Margin James, B, Big Pharma: The Beginning 27.3% of the End or the End c.50% of the Beginning?! p 10 Decision Resources, Inc. Spectrum, Pharmaceutical Industry Dynamics, May 2003/John Ansell Consultancy John Ansell Consultancy
8 HOW CONCENTRATED IS THE PHARMA INDUSTRY? Sales Taper for the Top 200 Globally Best-Selling Products 2011 ($ billion) Source: John Ansell Transforming Big Pharma Gower Publishing, 2013 John Ansell Consultancy
9 II. PHARMA S STRATEGIC OPTIONS
10 MAJOR STRATEGIC OPTIONS FOR PHARMA 10 Focussing down Diversification M&A Demergers More emphasis on emerging countries Develop new products
11 A CONUNDRUM 11 down or diversify?
12 DIVERSIFICATIO N 12 OTC Generics Pharmacy Benefit Biosimilars Management (PBMs)
13 MAJOR STRATEGIC OPTIONS FOR PHARMA 13 Focussing down Diversification M&A Demergers More emphasis on emerging countries Develop new products
14 III. PROSPECTS FOR NEW PRODUCTS
15 III. PROSPECTS FOR NEW PRODUCTS i. Trends in Numbers Launched 15 ii. Trends in Quality iii. Trends in Attrition Rates iv. Getting a True Fix on Sales Potential v. Getting a True Fix on Profitability
16 i. Trends in New Product Quantity
17 GLOBAL FIRST LAUNCHES FOR NEW PRODUCTS Source: John Ansell Consultancy. Based on data from CMR International ( ), Pharmaprojects ( ).
18 GLOBAL FIRST LAUNCHES FOR NEW PRODUCTS Source: John Ansell Consultancy. Based on data from CMR International ( ), Pharmaprojects ( ).
19 GLOBAL FIRST LAUNCHES FOR NEW PRODUCTS Source: John Ansell Consultancy. Based on data from CMR International ( ), Pharmaprojects ( ).
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22 ii. New Product Quality: Will tomorrow s products be as good as today s?
23 AIMING LOW WITH ME-TOO PRODUCTS
24 ME-TOO RESPIRATORY COMBINATIONS DIMINISHING RETURNS Sales in 2011 ($M.) No. 4 Foster No. 3 Combivent No. 2 Symbicort No. 1 Seretide/Advair 0 1,0002,0003,0004,0005,0006,0007,0008,0009,000 No. 5 Dulera and No. 6 Flutiform even less impact Source: John Ansell Consultancy
25 BLOCKBUSTERS FIRST LAUNCHED IN ORPHAN INDICATIONS
26 iii. What s happening on Attrition in New Product Development?
27 CLASSICAL PORTRAYAL OF ATTRITION THROUGH R&D Source: PhRMA, Biopharmaceuticals in Perspective Facts and Figures 2012 (Washington, DC: PhRMA, March 2012)
28 PERCENTAGE OF PROJECTS PROGRESSING: PHASE I MARKET (FDA) % %
29 PERCENTAGE OF PROJECTS PROGRESSING: PHASE III MARKET (FDA) % 50%
30 Vioxx makers knew of drug's dangers three years before recall, says UW study
31 PAMMOLI ET AL.
32 PAMMOLI ET AL.
33 ENABLING TECHNOLOGIES: FROM COMBINATORIAL CHEMISTRY
34 ENABLING TECHNOLOGIES: FROM HIGH THROUGHPUT SCREENING (HTS)
35 PRODUCTS ORIGINATING FROM HTS Products Originating From HTS
36 PROJECTIONS FROM NO. PROJECTS NOW IN DEVELOPMENT AT EACH PHASE Ph. III Ph. II Ph. I PC Source: Ansell, J., Transforming Big Pharma, Gower Publishing, based on Citeline/Pharmaprojects data
37 HOW ARE WE DOING SO FAR? Global new products launches: 2012: :
38 iv. Getting a True Fix on New Product Sales Potential
39 UNDERFORECASTING SALES
40 Annual review edition headlines 1992 annus horribilis 1993 a year to retrench, restructure, rethink 1994 an end or a beginning? 1999 Will R&D provide jam tomorrow? 2000 Exciting times or just an ongoing slog? 2002 Looking back at an uncertain future 2003 The old order comes to an end 2004 Misery loves company
41 One of the Company s most exciting new products is CLARITIN, approved in 17 overseas markets with U.S. approval expected soon. When fully established, the product is projected to generate sales of $200 to $300 million annually. - Schering Corporation (1989) Peak sales: $3.159 billion!
42 Abilify has a solid shot at success, but our $1.4 billion projection by 2007 is insufficient to move Bristol Myers Squibb s underlying revenue growth in any given year beyond 2003 ICIS 2003 Reached sales of $4.991 billion by 2011
43 we would expect Nexium to achieve rapidly (and within two years) a 20 per cent+ share of the Losec franchise with corresponding sales of more than $1 billion. Peak sales reached: (SG Securities) $5.216 billio
44 Could have sales of $1 billion in four or five years time Scrip 1996 Peak sales of $5.026 billion in 2010!
45 Analysts see huge potential for Advair/Seretide in the US, particularly in light of its successful start elsewhere By 2003, global sales predictions for the combination product are in the region of billion. Scrip
46 46 Global Sales of Advair/Seretide and its Component Prod 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Serevent Flovent/Flixotide Source: John Ansell Consultancy based on ex-company sales
47 Aricept could easily make sales in excess of $500 million a year A.G. Edwards, Pharma Letter, 1996) Sales peaked at $4.4 billion in 2009!
48 Annual sales could reach: ʻover $500 million within a few yearsʼ ($000s) The Pharma Letter (1998) $6,000 $5,000 $4,000 $3,000 $2,000 Sales peaked at > $5 billion! $1,000 $0
49 Analysts feel that clopidogrel has the potential to become a blockbuster product, breaking the $500 million mark The Pharma Letter (1998) Sales peaked at $9.6 billion!
50 first peak sale estimates of $500 million were off by a factor of 25 Freda Lewis-Hall, Pfizer Economist Pharma Summit, London (2011)
51 v. Getting a True Fix on New Product Profitability
52 2002 assessment: only 30% of new products covered their costs 2010 reassessment: down to 20% 52
53 HOW NEW PRODUCTS FIRST LAUNCHED HAD PERFORMED BY Smaller products Third-blockbusters Half-blockbusters Blockbusters Source: John Ansell Consultancy; based on ex-company sales. John Ansell Consultancy 53
54 HOW NEW PRODUCTS FIRST LAUNCHED HAD PERFORMED BY % 59% 14% Blockbusters Half-blockbusters Third-blockbusters Smaller products 6% Source: John Ansell Consultancy John Ansell Consultancy 54
55 2002 assessment: only 30% of new products covered their costs 2010 reassessment: down to 20% 2014 survey: Of all new products first launched so far 21% have become BLOCKBUSTERS! 55
56 HOW NEW PRODUCTS FIRST LAUNCHED HAD PERFORMED BY % 59% 14% Blockbusters Half-blockbusters Third-blockbusters Smaller products 6% Source: John Ansell Consultancy John Ansell Consultancy 56
57 John Ansell Consultancy 57
58 John Ansell Consultancy 58
59 HOW NEW PRODUCTS FIRST LAUNCHED HAD PERFORMED BY % 59% 14% Blockbusters Half-blockbusters Third-blockbusters Smaller products 6% At very least, 35% of new products are profitable > 40% are likely eventually to prove profitable. John Ansell Consultancy 59
60 LONGEVITY Longevity - average time to peak sales for Top 50 globally best-selling products Average Longevity (years) Source: John Ansell Consultancy
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