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Investor Presentation
November, 2013
NASDAQ: AMRI
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.
2
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
3
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
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
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
6
$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
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
8
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.
9
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
10
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 –
$135 million
(~1.0% of
market)
Estimated
Outsource
Market
AMRI
Contract Manufacturing
11
AMRI is Strategically Positioned to Capitalize on Macro Trends
Highly fragmented market – lack of CRO
differentiation
• Niche focus in key therapeutics enhances value add to demanding customer needs
• Meeting needs across drug discovery/manufacturing will enhance offering to broad
industry needs
• Insourcing model will enhance credibility
Emerging economies(e.g., India, China)
have large highly educated workforces and
a competitive price regime
• Global footprint offering competitive alternatives
• Low cost supply chain model
• Leverage core competency along with infrastructure in key regions to enhance value
proposition
Continued cost focus in pharmaceutical
industry even beyond patent cliff recovery
• Highly capable work force with broad range of skills to meet challenging needs in drug
discovery
• Low cost expansion capability including successful insourcing model
• Global footprint offering timely/cost effective solution
Aging population requires better drugs
and diagnostics
• Ongoing focus to improve science and leverage core acumen of drug discovery
• Broad capability in Chem Dev, Biology, Fill Finish and API
• Niche focus in key therapeutics enhances value add to demanding customer needs
Flexibility in outsourcing – reduces
investment in equipment and facilities
• Available low cost growth opportunities in Chem Dev/Biology
• Insourcing model successfully implemented at Eli Lilly, Indianapolis
• Ability to take insourcing to next level
AMRI Well-Positioned Macro Trends
12
Global Drug Discovery Outsourcing Forecast 2011 – 2017
Source: visiongain 2012
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
Re
ven
ue
($
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
13
$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
14
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
15
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
16
$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
*
*
17
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
18
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.
19
Thank You
APPENDIX
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
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.
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
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
25