clinical development year in review (2013)

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In 2013, R&D spending remained relatively flat and the number of studies started by industry also remained about the same, but outsourcing penetration is increasing. There are now more realistic options for sponsors seeking to outsource large studies. There will be more competition for large studies and the large CROs depend on large studies for their growth. 2013 Eisai slashes U.K. R&D jobs in 'global' restructuring AZ Restructures, To Build New HQ Forest Labs to Cut 9% of Workforce Post-restructuring, Pfizer R&D focused on its top blockbuster prospects Novartis plots sales cuts in U.K. amid R&D restructuring Merck Announces Global Initiative to Sharpen Commercial and R&D Focus R&D RESTRUCTURING CRO MERGERS & PARTNERSHIPS Revenue Backlog Q1,2013 $3.26B $24.03B Q2,2013 $3.22B $23.31 B $3.05B Q3,2013 $23.64 B CRO REVENUE & BACKLOG Pharma Biotech Generic $60.9B $57.8B $17.4B $17.2B $1.6B $1.9B 1st 3 Quarters of 2012 1st 3 Quarters of 2013 R&D SPENDING STAYS FLAT Q4,2011 Q1,2012 Q2,2012 Q3,2012 Q4,2012 Q1,2013 Q2,2013 Q3,2013 1 1 2 4 6 6 3 5 326 392 319 308 278 338 296 310 100 122 96 93 90 100 114 154 287 283 259 260 242 264 240 223 283 283 269 281 238 298 216 210 Phase 0 Phase I Phase II Phase III Phase IV CLINICAL TRIAL SUBMISSIONS IHE (Pharmaceutical Industry Index Fund) is up 35% for the first 11 months of 2013 vs. the Dow Jones Industrial Average which is up “only” 24% over the same period STOCK PRICES FARE OK Based on ISR’s market sizing model, we estimate that the top 5 CROs account for ~50% of the total market and the top 8 CROs account for ~66% of the market. But overall, sponsors are not overly satisfied with the outsourcing models currently employed. Fewer than 6% of respondents are “completely satisfied” with their outsourcing. KKR RPS PRA CoreLab Quintiles Novella PPD Acurian JLL BioClinica AQUISITIONS: PARTNERSHIPS: Quintiles Merck Serono ISR Research www.fiercebiotech.com www.mercknewsroom.com www.contractpharma.com online.wsj.com ir.kkr.com www.quintiles.com www.ppdi.com www.bioclinica.com ISRreports.com | [email protected] | @ISRreports • IHE is up 18% • DJIA is up 8% • Quintiles is up 1% PAREXEL is down 8% • ICON is up 13% • Covance is up 17% www.google.com/finance www.clinicaltrials.gov Bloomberg BusinessWeek June 1st to December 1st 2013 Quintiles, PAREXEL, Covance, ICON, and Charles River Quintiles, PAREXEL, Covance, ICON, and Charles River Quarterly Reports

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In 2013, R&D spending remained relatively flat and the number of studies started by industry also remained about the same, but outsourcing penetration is increasing. There are now more realistic options for sponsors seeking to outsource large studies. There will be more competition for large studies and the large CROs depend on large studies for their growth.

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Page 1: Clinical Development Year in Review (2013)

In 2013, R&D spending remained relatively flat and the number of studies started by industry also remained about the same, but outsourcing penetration is increasing. There are now more realistic options for sponsors seeking to

outsource large studies. There will be more competition for large studies and the large CROs depend on large studies for their growth.

2013

Eisai slashes U.K. R&D jobs in 'global' restructuring

AZ Restructures, To Build New HQ Forest Labs to Cut 9% of Workforce

Post-restructuring, Pfizer R&D focused on its top blockbuster prospects

Novartis plots sales cuts in U.K. amid R&D restructuring

Merck Announces Global Initiative to Sharpen Commercial and R&D Focus

R&D RESTRUCTURING

CRO MERGERS & PARTNERSHIPS

Revenue Backlog

Q1,2013

$3.26B

$24.03B

Q2,2013

$3.22B

$23.31 B

$3.05B

Q3,2013

$23.64 B

CRO REVENUE & BACKLOG

Pharma Biotech Generic

$60.9B $57.8B

$17.4B $17.2B

$1.6B $1.9B

1st 3 Quarters of 2012

1st 3 Quarters of 2013

R&D SPENDING STAYS FLATQ4,2011 Q1,2012 Q2,2012 Q3,2012 Q4,2012 Q1,2013 Q2,2013 Q3,2013

1 12 4 6 63 5

326

392

319308

278

338296 310

100122

96 93 90100 114154

287

283259 260

242264

240223

283283 269 281

238

298

216 210

Phase 0Phase IPhase IIPhase IIIPhase IV

CLINICAL TRIAL SUBMISSIONS

IHE (Pharmaceutical Industry Index Fund) is up 35% for the first 11 months of 2013 vs. the Dow Jones Industrial Average which is up “only” 24% over the same period

STOCK PRICES FARE OKBased on ISR’s market sizing model, we estimate that the top 5 CROs account for ~50% of the total market and the top 8 CROs account for ~66% of the market. But overall, sponsors are not overly satisfied with the outsourcing models currently employed. Fewer than 6% of respondents are “completely satisfied” with their outsourcing.

KKR

RPS

PRACoreLab

Quintiles

Novella

PPD

Acurian

JLL

BioClinica

AQUISITIONS:PARTNERSHIPS:

QuintilesMerck Serono

ISR Researchwww.fiercebiotech.com www.mercknewsroom.com

www.contractpharma.comonline.wsj.comir.kkr.com

www.quintiles.comwww.ppdi.comwww.bioclinica.com

ISRreports.com | [email protected] | @ISRreports

• IHE is up 18% • DJIA is up 8% • Quintiles is up 1% PAREXEL is down 8% • ICON is up 13% • Covance is up 17%

www.google.com/financewww.clinicaltrials.govBloomberg BusinessWeek

June 1st to December 1st 2013

Quintiles, PAREXEL, Covance, ICON, and Charles River

Quintiles, PAREXEL, Covance, ICON, and Charles River Quarterly Reports