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Investor Presentation November, 2013 NASDAQ: AMRI

Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

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Page 1: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Investor Presentation

November, 2013

NASDAQ: AMRI

Page 2: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Forward-Looking Statements

This presentation may contain projections, estimates and other forward-looking

statements that involve a number of risks and uncertainties, including those discussed

in the Company’s filings with the Securities and Exchange Commission. While this

presentation represents management’s current judgment on the future direction of the

Company’s business, such risks and uncertainties could cause actual results to differ

materially from any future performance suggested herein. The Company undertakes no

obligation to release publicly the results of any revisions to these forward-looking

statements to reflect events or circumstances arising after the date hereof.

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Page 3: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI: A Leading Contract Research and Manufacturing Organization

• A leading provider of fully integrated drug discovery, development and manufacturing services

• Reduce clients’ drug develop cycle times and improve their research productivity

• Provide clients access to leading scientific capabilities

• Deep scientific and therapeutic expertise

• 33% of scientific employees are Ph.D.s with 10 years average experience

• Delivered over 75 preclinical and clinical leads to over 50 customer IND's in last 10 years

• SMARTSOURCING™ and logistics with global scale

• Flexible service offering to accommodate customer preference, including integrated offerings

• Seamless project management collaboration for rapid advancement of drug candidates through lifecycle

• Locations throughout the U.S., Europe and Asia

• Strong customer partnerships and revenue visibility with multiyear contracts

• Participates in ~$21bn CRO/CMO market with double digit growth rates in relevant sectors

• Diversified mix of 300+ customers from large pharma, biotech, and specialty pharma

• Well positioned to capitalize on increased outsourcing in drug development and manufacturing

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Page 4: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Service Platform

• Target Validation

• Medicinal Chemistry

• High Throughput Screening

• In Vitro Biology

• Library Design & Synthesis

• Biocatalysis

• Custom Synthesis

• Natural Products Technologies

• Structure ID

• Early ADME

• Chemical Process Development

• Analytical Development

• Kilo Lab Scale-Up

• Phase I GMP

• Fermentation Development

• Salt & Polymorph Investigations

• Impurity Identification

• Formulation Development

• Phase II/III API

• Commercial API

• High Value Intermediates

• High Potency

• DEA Regulated API

• Sterile Fill & Finish Drug Product

• Niche Generics

• Formulation Manufacturing

Discovery Services: Identification of a

lead compound(s) that interacts with a

biological target

Early Development: Evaluates the

efficacy and safety of the compound(s)

in pre-clinical and clinical trials

Large Scale Contract Manufacturing:

Global facilities focus on API and

formulation manufacturing

Fully integrated platform spans drug development spectrum from discovery to manufacturing

to provide comprehensive service offering to customers.

Target

Discovery

Lead

Finding

Lead

Optimization

Candidate

Selection

Pre-

Clinical Phase I Phase II Phase III

Product

Approval

AMRI Service Offerings

4

Page 5: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI Global Footprint

5

Global footprint offers diverse service capabilities, ensures proximity to customers

D/SC = Development/Small Scale

Disc = Discovery Services

IS = Insourcing

LS = Large Scale

5

Page 6: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI Value Proposition

• Problem Solving - Strong intellectual input for creative customer solutions

• High ratio of Ph.D.’s compared to competitors

• 33% Ph.D. density, 10 years average experience

• Proven ability to identify discovery candidates

• Delivered over 75 preclinical and clinical leads leading to

over 50 customer IND’s in last 10 years

• >150 patents filed and >400 peer review publications

• Integrated global chemistry and biology services

• Flexible, customized solutions for our customers to

improve speed, cost and quality

• Seamless technology transfer from early

development to commercial production

• 54 Phase I & II customer compounds

• 22 Phase III customer compounds

• 38 Commercial products

• Partnering and out-licensing opportunities

for proprietary early-stage programs

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Page 7: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

$134

$42

$36

AMRI Revenue Profile

• Multi-year collaboration agreements in Discovery & Development

• Lilly insourced chemistry - Indianapolis

• NIH contract for translational research

• Merck - discovery services at Singapore facility

• Ono for discovery & development services

• Long term supply agreements for commercial business

• Signed extensions on two large API supply agreements in 2012

• Actavis generic product approved by FDA in 2012 with both API

and royalty revenue

• Customer with existing commercial API agreement received FDA

approval in early 2013

• 38 commercial products currently being manufactured

• Maximize strong customer clinical supply pipeline

• 54 Phase I & II; 22 Phase III

• Seven Phase III compounds with one pending PDUFA date and four

with potential NDA filings during the next 12 months

• Growing Aseptic Fill/Finish business

• Cardium agreement for aseptic fill for commercial launch of

Excellagen™

• 13 customer audits all leading to approved supplier designation

• Successful FDA inspection; removal of 2010 warning letter

2013 Contract Revenue Guidance*

* - Mid-point of Guidance

Development

Large

Scale Discovery

($ millions)

7

Page 8: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

21%

20%

29%

30%

13%

51%

20%

16%20%

10%

35%

35%

AMRI Customer Portfolio

(2013)*

31%

25%

18%

26%

Discovery Development/Small Scale Large Scale

TOTAL

*Based on 2013 mid-point guidance

Spec Pharma

Large Pharma/Biotech

Other

Biotech

AMRI’s 300+ customers are diversified across pharmaceutical sub-sectors

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Page 9: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Positive Long-term Industry Drivers

• Large pharma R&D restructuring • Reduction in internal R&D resources, generic competition,

healthcare reform driving increased strategic outsourcing

• Customers increasingly willing to partner on / outsource discovery development and R&D

• More stringent regulatory environment • Requires the use of service providers with strong intellectual

capacity and high quality standards

• Globalization of R&D activities • Customers are seeking lower cost alternatives with the same quality

standards they receive in the US

• Biotech funding environment • Availability of capital has stabilized

• Academic institutional role • Large pharma turning to academics as source of innovation.

Academics need support to “Industrialize” concepts

AMRI is well positioned to capitalize on the increased use of outsourcing.

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Page 10: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Market Opportunity Sales & Marketing Strategic Direction

• AMRI “SMARTSOURCING™” SMARTSOURCING™ is an industry leading movement to strategic decision making and the true measurement of results and success in drug discovery, development and manufacturing.

• Increasing customer focused relationships leveraging quality and breadth of services

• Strategic Account Plan launched to increase penetration and market share in the large pharma segment

• Geographically expanded team

throughout US, Europe and Asia to

capture larger customer base

318 167 156

1,552 1,716

614

US Europe Asia

# o

f C

om

pan

ies

Public Private

Global Pharma/Biotech Industry*

AMRI presently provides services to 300+ companies,

large opportunity to expand customer base.

* Data Source: Ernst & Young

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Page 11: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Market Opportunity Contract Services

$1 billion

Sources: Sterne Agee, Frost & Sullivan

Discovery Services

• Predict long-term growth due to increased outsourcing by Big Pharma and entrance of more

virtual Biotech, non-profit, academic organizations

• Historically fragmented market subject to significant consolidation

• Increased penetration of outsourced Pharma Services market over the next five years

$41 –

$42 million

(~2.0% of

market)

Estimated

Outsource

Market

AMRI

$7 billion

$36 million

(~3.5% of

market)

Estimated

Outsource

Market

AMRI

Early Development

$13 billion

$133 –

$135 million

(~1.0% of

market)

Estimated

Outsource

Market

AMRI

Contract Manufacturing

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Page 12: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI is Strategically Positioned to Capitalize on Macro Trends

Highly fragmented market – lack of CRO

differentiation

• Niche focus in key therapeutics enhances value add to demanding customer needs

• Meeting needs across drug discovery/manufacturing will enhance offering to broad

industry needs

• Insourcing model will enhance credibility

Emerging economies(e.g., India, China)

have large highly educated workforces and

a competitive price regime

• Global footprint offering competitive alternatives

• Low cost supply chain model

• Leverage core competency along with infrastructure in key regions to enhance value

proposition

Continued cost focus in pharmaceutical

industry even beyond patent cliff recovery

• Highly capable work force with broad range of skills to meet challenging needs in drug

discovery

• Low cost expansion capability including successful insourcing model

• Global footprint offering timely/cost effective solution

Aging population requires better drugs

and diagnostics

• Ongoing focus to improve science and leverage core acumen of drug discovery

• Broad capability in Chem Dev, Biology, Fill Finish and API

• Niche focus in key therapeutics enhances value add to demanding customer needs

Flexibility in outsourcing – reduces

investment in equipment and facilities

• Available low cost growth opportunities in Chem Dev/Biology

• Insourcing model successfully implemented at Eli Lilly, Indianapolis

• Ability to take insourcing to next level

AMRI Well-Positioned Macro Trends

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Page 13: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Global Drug Discovery Outsourcing Forecast 2011 – 2017

Source: visiongain 2012

-

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

Re

ven

ue

($

m)

Year

Current Relevant Market Chemistry Services Biology Services

Lead Optimization Screening Services

CAGR 15.5%

CAGR 13.0%

CAGR 14.7%

CAGR 10.7%

Adjacent Market

AMRI operates in market segments with attractive growth rates, driven by increased R&D

and increased penetration of outsourced drug discovery.

Global Drug Discovery Outsourcing Forecast by Segment

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Page 14: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

$40

$60 $72

$145

$122 $137

$153 $163

$195

$157 $163 $170

$190

$212

$0

$50

$100

$150

$200

$250

2000 2002 2004 2006 2008 2010 2012

Discovery Development LS

AMRI Contract Revenue Growth

2001 2003 2005 2007 2009 2011 2013E

* Amounts represent mid point of guidance

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Page 15: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI Contract Revenue & Margin Guidance

Contract

Margin

25% 12% 17% - 18% 19% - 23%

*Amounts represent midpoint of guidance

Revenue CAGR for 2011 – 2015 = 12%

$114

$74 $77 $100

$82

$116 $134

$165

0%

5%

10%

15%

20%

25%

30%

$0

$50

$100

$150

$200

$250

$300

2008 2012 2013* 2015*

Co

ntr

act

Mar

gin

%

Co

ntr

act

Rev

enu

e ($

mm

)

DDS LSM Margin

Clear path to continued growth and margin enhancement

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Page 16: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Continuous Improvement

AMRI Productivity Culture Continues to Expand Margins

Low Cost Region Manufacturing

Facility Rationalization

Global Sourcing

• Completed exit of Bothell and co-located

Biology with Med Chem in Singapore

• Optimize Med Chem footprint in Albany

• Reduce rental expense to improve profitability

and optimize space needs

• Drive India Large Scale volume via FDA

upgrade

• Improve product mix for India Large Scale to

enhance margins

• Fit out and grow India, Singapore Med Chem

• Focus on operation excellence, not perfection:

Cost, Productivity, Quality

• Enhance cash flow with better working

capital/supply chain management

• Ensure staffing key roles with impactful

leadership

• Provide CI training/opportunities to grow talent

in the organization

• Increase spend under contract and amount of

indirect from LCR

• Optimize intermediate supply chain to

increase margin, including make vs. buy

decisions

• Utilize optimal supply chain model to increase

tax efficiency

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Page 17: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

$35 $35 $35

$31

$27

$17

$5

AMRI Royalties

Allegra®

• AMRI licensed technology to Sanofi in 1995

• Earn royalties through 2015

• Sanofi launched OTC in March 2011 in US

Other

• Actavis royalty for a generic product from previous agreement

• Five-year royalty stream commenced June 2012; Restarted November 2012 with new drug launch

• Rolling five-year window with any new drug launch

09 10 11 12 13

($ Millions)

14 15

*

* Current Guidance + Estimates

Allegra Royalties Only

*

*

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Page 18: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI 2013 Strategic Milestones Achieved

• Enhance revenue growth and mix

• Increase multi-year strategic relationships

• Strengthen aseptic fill/finish business

• Drive SMARTSOURCING™ - a cross functional approach that maximizes the strengths of both

insourcing and outsourcing

• Streamline operations to improve margins

• ~$18M reductions vs. 2011

• Executed on Biology strategy including successful transition from Bothell at the end of Q1 2013

• Enhance international footprint - key appointments in Europe and Asia

• Maximize licensing/partnering of proprietary compounds to enhance cash flow

Profitable Contract Margin Business in 2013 YTD

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Page 19: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI Near-term Strategic Priorities

• Solidify Run Rate Profitability for Contract Business

• Optimize Operating Structure and Cost Position

• Continue to Enhance Quality Profile

• Strengthen Positioning of Service Offerings

• Drive Performance Across All Segments

• Reinforce Core Values and Focus on Development

• Out-License/Partner Remaining Proprietary Compounds

• Raise Capital for a Variety of Investment Opportunities; Both Organic & Inorganic

• Execute on Pipeline of Investment Opportunities, Both Organic & Inorganic

AMRI is well positioned to capture increasing share of

strategic outsourcing in coming years.

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Page 20: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

Thank You

Page 21: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

APPENDIX

Page 22: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI Contract Services Discovery

• A broad spectrum of lead discovery services backed by decades of

experience • AMRI discovery chemists average 10 years plus of industrial experience, 42% PhD density

• AMRI has delivered over 75 pre-clinical and clinical leads to customers resulting in over 50 customer

IND’s over the past 10 years

• AMRI’s expertise demonstrated by over 90 patents filed and 300 peer review publications

• Tightly integrated services can be accessed individually or as a full discovery

program

Extensive depth across multiple therapeutic areas and target classes.

Helping customers discover/advance clinical leads. 22

Page 23: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI Contract Services Early Development

• A suite of drug development services to bring a

clinical candidate from laboratory scale to

commercialization

• Exceptional track record and strong compliance

history

• Clients benefit from individual components of a

development/ manufacturing program, while

harnessing synergies in discovery

• Highly integrated with Large Scale business to

effect technology transfer and accelerate

customer timelines for both API and drug

product

23 54 customer compounds in Phase I-II pipeline feeding large scale business.

Page 24: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

AMRI Contract Services Contract Manufacturing

• Assets in US, Europe and India allow AMRI to assist customers in product life cycle management

• Excellent FDA compliance history

• Formulation manufacturing added in solid dosage and sterile fill/finish drug product to decrease clinical trial timelines and costs

• Specialized capabilities in high potency and controlled substances

• Portfolio of niche generic APIs provides a base level of cost absorption

• Multiple successes in supporting customers progressing to NDA and Commercialization

- 38 commercial products in place

22 customer compounds in Phase III pipeline. 24

Page 25: Corporate Presentation Template - AMRI Global · Forward-Looking Statements This presentation may contain projections, estimates and other forward-looking statements that involve

About AMRI

Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization

offering customers fully integrated drug discovery, development, and manufacturing services. For over 21

years AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology industries have

undergone tremendous change in response to multiple challenges. This experience, a track record of

success and locations in the United States, Europe and Asia now provides our customers with

SMARTSOURCING™, a full range of value-added opportunities providing customers informed decision-

making, enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI has also

successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further

development.

Contacts:

Investor Relations: Michael Nolan, Chief Financial Officer, 518-512-2261

Media: Gina Monari, AMRI Communications, 518-512-2512

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