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Will the recent wave of megamergers and a slow revival of biotech nancing be enough to counter a looming storm surge of patent expirations? US health reform is the next big game-changer, as companies seek a balance between earning prots and placating a restive new breed of payers and the ever-expectant patient
By Jerry Cacciotti and Patrick Clinton
between two
The
Lull
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41
8%
Top 10 accounts for $352.5 billion in sales, which is 59.40% of total revenues of the Top 50 Top 20 accounts for $483.8 billion in sales, which is 81.53% of total revenues of the Top 50
* Figures are rounded
6%
4%
2%
0%
he Pharm Exec 50 ranks the worlds largest pharmaceutical companies by global sales of prescription drugsa key indicator of market change. After last years storm of activity, the 50 set a more placid pace, as major players worked on integrating blockbuster mergers and licked their wounds after the latest round of Phase III failures. Late-phase problems are nothing new, and drug candidates can come back from them, but there was something particularly heartbreaking about the recent crop of dead ends, given the huge unmet medical need associated with these therapies: P zers Dimebon and Lillys Semagacestat for Alzheimers, Mercks vicriviroc for HIV, and Roches ocrelizumab for rheumatoid arthritis, to name just a few. Change was most visible on the macro level. The list of the top 10 companies was shaken up a bit, with Novartis passing Sano -Aventis to move into second place, and Merck jumping from seventh to fourth. It was also the rst year the top company crossed the $50 billion mark in sales of prescrip-
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P z N n o ov a er - Av r t is en M e t is G la rc xo S m Ro c k Jo it h he hn A st r K s o a Z li n e n & en Jo ec a hn s Br is t E li o n ol L My A b ill y er s b S q ot t ui b b Te A m va Bo ge eh Ba n r in ge Ta yer r k N o I n gel e d a vo h e N o im r di Da ii c A s t e s k hi S a ll a s nk yo Me E B a G il e a r c k is a i x te d KG r In S ci a A ter e n c na es t io n M y al S e lan Mi rv t su b is C h i e r hi u g a Ta i M e nab e n G e ar in nz i A ll y m e er g F o an r es t CS L U O t CB s C e uka B io l g ge e n e nI de Sh c Wa r n e A ir e r C lcon h C e il c o t ph t a W lo n K D a yow a L u n a t s o n ini p p H ak d b e c o n ko k S u K ir mi in to m Sh io n o Ac ogi t H o av is N y sp ir co a m Ap ed ot S t ex ad a Sa
P Novartis Roche Sano -Aventis zer Merck GlaxoSmithKline Lilly Teva Bayer JohnsonBristol-MyersAmgen NovoIngelheim Baxter International Menarini Forest UCBCelgene Warner Chilcott Hakko Kirin Nycomed AstraZeneca & Johnson Squibb Eli Abbott Boehringer Daiichi Merck KGaAMylanChugai Genzyme CSL Otsuka Shire Cephalon Takeda AstellasEisai Sciences Nordisk Gilead Sankyo Servier Mitsubishi Tanabe Allergan Biogen Idec Alcon Watson Kyowa LundbeckShionogi Dainippon Sumitomo Apotex Actavis Hospira Stada
tion drugsas P zer, fueled by its acquisition of Wyeth, grew from $45.4 billion in Rx sales to $58.5 billion. Meanwhile, consolidation in the ranks continues to place a premium on size and scale: This was the rst year that it took $2 billion in Rx revenues to join the 50. As recently as 10 years ago, you could make the list with revenues of only $500 million. Overall, the 50 accounted for $593.4 billion in human prescription drug sales in 2010. That represents an increase of nearly 8 percent from 2009, when the total was $550.5 billion. But among the top 10, there was slightly better growth. This years group grew its Rx revenues from $319.4 billion in scal 2009 to $352.5 last yearan increase of over 10 percent. A good percentage of that growth was fueled by mergers and acquisitions. In addition to P zer and its 29 percent increase, big gainers included Merck (58 percent growth after its merger with Schering Plough) and Abbott (up nearly 28 percent in the wake of its acquisitions of Solvay and Pira-
mal). But the biggest single-year bump came at a much smaller company: The Irish rm Warner Chilcott last year acquired the pharmaceutical business of Procter & Gamble, including the billion-dollar drug Actonel, and raised its Rx revenues a whopping 111 percent to $2.9 billion. Looming over the yearand the decadeis the shadow of US healthcare reform. Many in pharma feel they have dodged the bullet of new regulation and stand to gain as a projected 30 million previously uninsured Americans nally obtain insurance coverage for healthcare. But the Patient Protection and Affordable Care Act is not the end of the discussionits more like the beginning of an avalanche. The economic forces it sets in motion today will be playing out for payers, patients, providers, and pharma for the foreseeable future, changing the way care is delivered and paid for, creating numerous business threats, but, with luck, ending up with the possibility of getting a better alignment between helping the patient and earning a pro t.
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PHARMACEUTICAL EXECUTIVE
2011 Rank
Company HQ [website]
2010 Rx Sales
1 2 3 4 5 6 7 8 9 10
Pfizer
$58.5
[28.9%]
$9,413
Novartis
$42.0
[9.2%]
$7,100
Sanofi-Aventis
Paris, France
[sanofi-aventis.com]
$40.3
[4.1%]
$5,147
Merck
$39.8
[58.0%]
$11,000
Roche
$39.1
[4.1%]
$8,612
GlaxoSmithKline
$36.2
[4.2%]
$6,126
AstraZeneca
$33.3
[1.4%]
$4,200
$22.4
[0.4%]
$4,432
Eli Lilly
$21.1
[5.4%]
$4,880
Abbott
$19.9
[27.7%]
$3,724
Sources: corporate data (10Ks, annual reports, etc.) and Pharm Exec estimates
How the listings were compiled: Companies in the Pharm Exec 50 are ranked according to global human prescription drug sales. As far as company documentation allows, generics and vaccines are included; over-the-counter products, royalties, and contract manufacturing revenue are not. In most cases, numbers are taken from annual reports or SEC filings for the fiscal year that ended in 2010. For most American and European companies, that means the year ending Dec. 31, 2010; for many Japanese companies, it means the year ending March 31, 2010. In the case of private companies that do not report results, we have made estimates based on available data, including IMS reports. For companies that report in currencies other than US dollars, we have converted their numbers using the midpoint average interbank rate for the last day of the fiscal year. Some charts that accompany this article are based on numbers from IMS Health. These are based on a different methodology and will not be consistent with the figures we have compiled from financial filings. Percentage growth figures should be treated with caution, because they can be affected by fluctuating exchange rates.
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PHARMACEUTICAL EXECUTIVE
North America Europe Asia/Africa/Australia 98.1 Japan 85.7 Latin America 42.0
4.2%
Sales represent audited market for pharma products only (Dec. 2009Dec 2010) IMS figures do not account for off-invoice discounts/rebates and can vary from reported mfr sales
2010
7.2 6.3 6.1 4.7 4.7 4.6 4.0 4.4 4.2 4.1 3.7 3.8 3.0 3.5 3.4 3.3 3.2 3.3 3.2 3.3 3.3 3.2 2.8 3.1 3.0 3.1 2.9 3.0 3.0 3.0 2.7 2.9 2.5 2.8 2.8 2.8 2.6 2.5 2.3 2.3 2.8 2.2 1.9 2.2 1.7 2.0 1.7 2010: $307.4
2009
7.6 6.3 5.6 -5.26
% Change
FLAT 8.92 FLAT 15.00 4.76 10.81 26.66 2.94 3.13 3.13 FLAT 14.29 3.33 6.90 FLAT 11.11 16.00 FLAT 7.69 8.7 -17.86 15.79 29.41 17.65 2.36%
Figures (rounded) in US billions
2009: $300.3
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PHARMACEUTICAL EXECUTIVE
2011 Rank
Company HQ [website]
2010 Rx Sales
11 12 13 14 15 16 17 18 19 20
Bristol-Myers Squibb
New York [bms.com]
$19.5
[3.6%]
$3,566
Plavix [6.7]
Teva
$16.1
[16.0%]
$933
Copaxone [2.9]
Amgen
$14.7
[1.8%]
$2,894
Neulasta/Neupogen [4.8]
Bayer
$14.5
[3.6%]
$2,320
Betaferon/Betaseron [1.6]
Takeda
$14.2
[0.1%]
$3,198
Actos/Glustin [4.2]
Boehringer Ingelheim
Ingelheim, Germany [boehringer-ingelheim.com]
$12.9
[10.8%]
$3,056
Spiriva [3.8]
Novo Nordisk
$10.8
[9.9%]
$1,709
NovoRapid [2.1]
Astellas
$10.5
[6.0%]
$2,109
Prograf [1.9]
Daiichi Sankyo
$9.8
[20.0%]
$2,124
Olmesartan [2.6]
Eisai
$8.4
[8.0%]
$1,932
Aricept [3.5]
Sources: corporate data (10Ks, annual reports, etc.) and Pharm Exec estimates
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PHARMACEUTICAL EXECUTIVE
22.3 21.5 1 Oncologics 19.3 18.1 2 Respiratory Agents 18.8 18.6 3 Lipid Regulators 16.9 15 4 Antidiabetes 16.1 14.7 5 Antipsychotics 11.9 14.1 6 Antiulcerants 11.6 11.5 7 Antidepressants 10.6 9.7 8 Autoimmune Diseases 9.2 8.2 9 HIV Antivirals 8.7 8.6 10 Angiotensin II 8.4 8.0 11 Narcotic Analgesics 7.2 6.3 12 ADHD 7.1 6.5 13 Platelet Aggregation Inhibitors 6.1 6.3 14 Erythropoietins 15 Multiple Sclerosis 5.7 4.9 6.9 16 Antiepileptics 5.6 17 Vaccines (Pure, Combo, Other) 5.0 4.6 18 Hormonal Contraceptives 4.8 4.7 19 Anti-Alzheimers 4.5 4.0 20 Immunostimulating Agents 4.2 4.1 TOTAL US SCRIP MARKET: 2010: $307.4 2009: $300.3
-18.84
Figures (rounded) in USD billions Therapy Class defined using ATC-defined product groups and synthesized based on proprietary IMS Health definitons Immunostimulating Agents excludes interferons
2010
2009
249.7 246.1 241.0
% Change
2.28 3.05 1.37 14.12 1.81 3.77 0.59 0.96 -0.53 5.55 4.42 1.8 3.16 2.70 -1.70 -0.83 -0.65 6.64 3.01 0.76 1.16%
255.4 253.6 244.3 191.5 167.8 168.7 165.7 165.0 159.0 153.3 152.4 147.1 145.7 131.0 131.7 121.7 115.3 108.6 104.0 107.2 105.3 97.9 94.9 95.0 92.5 92.3 93.9 83.7 84.4 76.1 76.6 73.9 69.3 71.9 69.8 66.0 65.5 2009: 3,949.2
2010: 3,995.2
Rx figures (rounded) in millions; Therapy classes defined using ATC defined product groups and synthesized based on proprietary IMS Health definitions
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PHARMACEUTICAL EXECUTIVE
2011 Rank
Company HQ [website]
2010 Rx Sales
21 22 23 24 25 26 27 28 29 30
Merck KGaA
$7.8
[0.4%]
$1,547
Rebif [2.2]
Gilead Sciences
$7.4
[14.2%]
$1,073
Atripla [3.0]
Baxter International
$5.6
[1.3%]
$915
Advate [1.7]
Mylan
$5.2
[7.5%]
$282
EpiPen [0.3]
Servier
Neuilly-sur-Seine [servier.com]
$4.9
[6.6%]
$1,226
Coversil [1.5*]
Chugai
$4.6
[1.3%]
$671
Avastin [0.6]
Mitsubishi Tanabe
$4.4
[2.4%]
$897
Remicade [0.5]
Menarini
$4.0*
[0.2%]
N/A
Migard/Allegro [0.1*]
Genzyme
$4.0
[2.3%]
$847
Cerezyme [0.7]
Allergan
$4.0
[7.9%]
$805
Botox [1.4]
Sources: corporate data (10Ks, annual reports, etc.) and Pharm Exec estimates
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% Change
-5.75 -5.05 FLAT 8.33 13.22 0.78 1.60 1.89 7.77 6.82 15.00 18.94
26.2 1 Pzer 18.8 2 Merck 18.3 3 AstraZeneca 15.7 13.2 4 Novartis 14.3 13.2 5 Lilly 13.8 14.2 6 Roche 13.7 12.1 7 Teva 13.6 15.0 8 GlaxoSmithKline 12.9 12.8 9 Johnson & Johnson 12.7 12.5 10 Amgen 10.8 10.6 11 Abbott 10.4 11.2 12 Sano-Aventis 9.7 9.0 13 Bristol-Myers Squibb 6.4 7.6 14 Boehringer Ingelheim 6.0 7.9 15 Takeda 4.7 4.4 16 Forest 4.7 3.9 17 Mylan 4.7 3.9 18 Gilead 4.6 4.0 19 Otsuka America 4.6 4.4 20 Eisai 4.5 3.7 21 Novo Nordisk 22 Watson 3.3 3.2 23 Nestle S.A. 3.2 2.8 24 Purdue 3.2 3.0 25 Galen Holdings 3.0 2.8
-2.82 -9.33
14.28
2010: $307.4
2009: $300.3
2.36%
Figures (rounded) in billions
2010
265.3 242.0 233.6 141.0 114.5 134.0 96.2 104.2 123.3 97.9 67.5 86.8 93.8 80.2 91.2 72.6 71.1 68.1 63.5 58.1 53.9 49.5 45.2 44.3 42.5 42.2 40.2 40.0 39.7 379.9 240.9 265.7 235.1
2009
639.3 347.2 629.8
% Change
-8.92 -0.64 -15.49 -7.46 -12.06 -7.16 -1.79 -4.22 -13.60 -4.75 -0.60 -4.11 -4.31 -16.60 -4.99 31.78 37.09 1.51 9.41 10.13 23.14
39.29 45.04
78.2 72.4 71.1 73.5 61.0 34.9 49.8 34.3 46.2 31.0 44.1 48.2 42.1 38.9
54.44
2.06
2010: 3,995.2
2009: 3,949.2
1.16%
Figures (rounded) in millions
2010
94.1 87.4 70.5 66.0 57.2 51.3 53.4 45.4 52.6 53.8 52.3 52.4 48.3 44.3 47.8 47.9 46.3 43.9 45.3 51.7 43.4 43.5 38.9 41.1 38.0 35.1 36.3 39.3 35.7 34.2 33.0 26.9 32.1 27.1 32.0 31.6 31.9 30.2 31.1 30.3 29.5 29.9 29.3 25.4 28.7 28.6 131.2
2009
83.8 82.8 128.2
% Change
2.34 5.56 6.82 -2.23 -0.19 -0.21 -12.38 -0.23 -5.35 -7.63 4.38 1.27 5.63 2.64 0.35 18.45 5.47 12.29 11.5
17.62
9.03
8.26 22.68
-1.34
15.35
2010: 3,995.2
2009: 3,949.2
1.16%
Figures (rounded) in millions
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PHARMACEUTICAL EXECUTIVE
2011 Rank
Company HQ [website]
2010 Rx Sales
31 32 33 34 35 36 37 38 39 40
Forest
$3.9
[7.4%]
$1,054
Lexapro [2.3]
CSL
$3.8
[3.6%]
$272
N/A [N/A]
UCB
$3.7
[4.0%]
$1,044
Keppra [1.2]
Otsuka
$3.6*
[46.1%]
N/A
Abilify [4.5*]
Celgene
$3.5
[36.7%]
$1,128
Revlimid [2.5]
Biogen Idec
$3.5
[10.1%]
$1,249
Avonex [3.5]
Shire
$3.1
[16.1%]
$662
Vyvanse [0.6]
Alcon
$3.1
[14.5%]
$747
Warner Chilcott
$2.9
[111.0%]
$147
Actonel [1.0]
Cephalon
$2.8
[28.3%]
$440
Provigil [1.1]
Sources: corporate data (10Ks, annual reports, etc.) and Pharm Exec estimates
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PHARMACEUTICAL EXECUTIVE
LOE date
Q4 2011 Q3 2011 Q4 2011 Q2 2011 Q1 2011 Q2 2011 Q4 2011 Q3 2011 Q2 2011 Q2 2011 Q1 2011
2010 Sales
7,244.1 4,711.4 2,957.6 1,522.4 710.8 681.6 331.1 254.6 241.1 215.0 215.0
Total Rx 2010
45.8 19.7 5.3 10.9 6.9 1.3 0.4 1.1 2.3 2.1 3.2
2010
36.4 35.8 34.4 56.0
% Change
6.7 2.0 7.0 -6.7 4.5 3.4 -3.3 -1.8 1.5 6.4 5.8 3.5 3.6 5.3 13.9
15.4 14.6 12.6 12.0 11.6 10.6 10.5 9.8 9.8 9.5 9.2
20.7 20.2
12.2
9.0
14.7
Source: IMS Health, MIDAS Source: IMS Health, MIDAS
13.2
-8.8
2009: $384.9
6.10%
Figures (rounded) in USD billions (Dec 2009Dec 2010) Sales represent audited market for pharma products only IMS figures do not account for off-invoice discounts/rebates and can vary from reported mfr sales
2010
8,816.5 8,468.6 8,361.5 6,815.6 6,796.3 6,167.2 6,038.6 5,959.5 5,736.3 5,532.2 5,465.4 5,430.3 5,033.2 4,685.3 4,432.1 4,317.3 4,282.0 4,165.1 4,156.4 12,656.1
% Change
-6.2 -3.4 4.4 1.3 5.2
24 19.7
6.6
16.3 16.7
-5.3
2010: $123,315.5
2009: 116,221.7
6.10% Increase
Figures (rounded) in USD millions (Dec. 2009Dec. 2010) Figures do not account for off-invoice discounts/rebates and can vary from reported mfr sales
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PHARMACEUTICAL EXECUTIVE
2011 Rank
Company HQ [website]
2010 Rx Sales
41 42 43 44 45 46 47 48 49 50
Watson
$2.6
[27.0%]
$296
Lundbeck
$2.6
[0.6%]
$542
Cipralex/Lexapro [1.5]
$2.6
[14.7%]
$429
Nesp/Espo [0.6*]
Dainippon Sumitomo
$2.6
[20.1%]
$554
Amlodin [0.6]
Shionogi
$2.4*
[35.2%]
$135
Crestor [0.3]
Actavis
$2.4*
[32.5%]
N/A
Oxycodone [0.4]
Hospira
$2.3
[13.3%]
$301
N/A [N/A]
Nycomed
$2.2
[20.2%]
$281
Pantoprazole [1.2]
Apotex
$2.1*
[19.2%]
N/A
N/A [N/A]
Stada
$2.1
[5.0%]
$73
Sources: corporate data (10Ks, annual reports, etc.) and Pharm Exec estimates
TOTALS:
7.79%
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PHARMACEUTICAL EXECUTIVE
Completed purchase of Alcon from Nestl for $38.7 billion. Jonathan Symonds promoted to CFO. David Epstein replaced CEO Joe Jimenez as Division Head, Pharmaceuticals. Thirteen major pharmaceutical approvals in the US, Europe, and Japan, with 147 products in development. Tasigna was approved in the US, the EU, Japan, and Switzerland for patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), a form of blood cancer. Menveo (vaccine against meningococcal disease) launched in the US, EU, and parts of Latin America and Asia. Sandoz launched generic enoxaparin, its most successful launch to date, and acquired Oriel Therapeutics.
2. Novartis
Bought Inspire for $430 million. Rotateq vaccine awarded top honor at Prix Galien USA 2010. Merck BioVentures entered into an alliance with Parexel for biosimilar development. Signed commercialization agreement with Lundbeck for Sycrest and a letter of mutual intent with Chinas Sinopharm. Pipeline has more than 20 late-stage candidates. Licensed oral mTOR inhibitor for multiple cancers from Ariad. Oral hepatitis C protease inhibitor Boceprevir granted Priority Review status by FDA.
EU. Kombiglyze XR, the only once-daily dose of DPP4/metformin, developed with Bristol-Myers Squibb, also approved in US. Nine molecules in Phase III trials or submitted for regulatory approval, with another 92 projects in development. Completed deal with Rigel for development of fostamatinib (rheumatoid arthritis).
Rituxan approved in US as first-line treatment for chronic lymphocytic leukemia (CLL) and relapsed/refractory CLL. Tarceva approved in US and EU for first-line treatment of non-small-cell lung cancer after chemotherapy. FDA rejected use of Avastin as a treatment for metastatic breast cancer; Roche has requested a hearing to appeal this decision. Daniel ODay appointed COO of the Pharmaceuticals division. Alan Hippe named CFO. Jean-Jacques Garaud appointed Head of Roche Pharma Research and Early Development.
5. Roche
6. GlaxoSmithKline Benlysta
3. Sanofi-Aventis Initiated
acquisition of Genzyme for $16.6 billion (completed in April) and finished acquisition of OTC company Chattem. Began collaboration programs with Harvard and Columbia Universities and a research alliance with Scripps Genomic Medicine. Jevtana approved in US for second-line treatment of metastatic hormone-refractory prostate cancer.
(belimumab, the first new lupus treatment in 60 years) approved by FDA in March. Six products in total approved by US and EU; seven more filed with regulators. Malaria vaccine in Phase III trials in Africa, with 30 other late-stage assets. Julian Heslop retired as CFO, succeeded by Simon Dingemans. Patents for active ingredients in Seretide/Advair expired.
Completed acquisition of Alnara and Avid Radiopharmaceuticals. Launched statin Livalo in the US with partner Kowa. Has 68 molecules in development. Several monoclonal antibodies for cancer in late-stage development. Phase III candidates include Necitumumab for non-small-cell lung cancer and Ramucirumab for metastatic breast and gastric cancers. Signed commercialization deal with Acrux for newly approved experimental testosterone solution Axiron.
9. Eli Lilly
Crestor substance patent upheld in US court. Approvals include Vimovo (naproxen/esomeprazole magnesium) in US and EU and Brilique (atherothrombotic event prevention) in
7. AstraZeneca
The year was marked by acquisitions, including the pharmaceutical business of Solvay for $6.1 billion plus milestones, and Piramal Healthcares Healthcare Solutions business, a leader in the Indian branded generics market, for $2.2 billion in cash, plus $1.6 billion in annual payments through 2014. Additional acquisitions included Advanced Medical Optics, STARLIMS Technologies (informatics), and the remaining shares of Facet Biotech.
10. Abbott
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