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Investor Presentation
December, 2012
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
Global Services Provider
• A leading contract research and manufacturing organization. One of the only companies providing a fully integrated service offering from discovery, through early development to commercial manufacturing.
• Global capabilities with facilities in U.S., Europe and Asia
• Proprietary portfolio of early stage drug candidates provides free call option
• 1,300 employees including the highest ratio of Ph.D. to B.S. scientists compared to competitors
United States Europe Asia
3
Service Platform
Discovery Services Early Development Contract Manufacturing
• Target Validation• Medicinal Chemistry• HTS• In Vitro Biology• Library Synthesis• Biocatalysis• Custom Synthesis• Natural Products• 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
4
AMRI’s Global Footprint
5
*
*Closing in March 2013
Value Proposition
• Strong intellectual input for creative customer solutions
Higher ratio of Ph.D. to B.S. scientists compared to competitors- 45% Ph.D. density, 10 years average experience
Proven ability to bring discovery candidates to IND and clinical candidates to commercialization
- Delivered over 75 preclinical and clinical leads leading to over 50 IND’s in last ten years- 90 patents filed and 300 peer review publications
• Integrated global chemistry and biology services
Flexible, customized solutions for our customers toimprove speed, cost and quality
• Seamless technology transfer from early development to commercial production
- 53 Phase I & II customer compounds- 25 Phase III customer compounds- 35 Commercial customer products
• Partnering and out-licensing opportunitiesfor proprietary early-stage portfolio6
2012 Strategic Initiatives
• 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• Enhance international footprint- key appointments in Europe and ASIA
• Streamline operations to improve margins• ~$16M reductions vs. 2011• Hungary operations closed Q1’12; select services moved to Asia• Ongoing assessment of global operating structure
• Maximize licensing/partnering of proprietary compounds to enhance cash flow
Deliver Profitable Operating Performance in 2012.
7
Enhancing Revenue Profile
• Build multi-year collaboration agreements:• Lilly insourced chemistry• NIH award to develop pre-clinical drug candidates • Merck for discovery services at Singapore facility
• Drive Aseptic Fill/Finish business• Cardium agreement for aseptic fill for commercial launch of
Excellagen™• Two compounds with NDAs expected. Working on commercial
manufacturing contracts• Expand material commercial manufacturing agreements
• Signed extensions on two large API supply agreements• New generic compound approved by FDA in Quarter 2 with both
API and royalty revenue• 35 commercial products already in place
• Maximize strong customer clinical pipeline• 53 Phase I & II; 25 Phase III • Seven high potential compounds with two anticipated PDUFA
dates and five with potential NDA filings during the next 12 months. Some NDA filings may be fast tracked resulting in PDUFA dates during the same time period.
2012 Contract Revenue Guidance*
* - Mid-point of Guidance
Development
Large ScaleDiscovery
$112
$37
$34
8
22%
24%
21%
33%
18%
45%
26%
11%21%
16%
21%
42%
Diversifying The Customer Portfolio (2012)
25%
26%19%
30%
Large Pharma/Biotech Biotech Spec Pharma Other
Discovery Development/Small Scale Large Scale
TOTAL AMRI
9
Improving Cost Structure
• Ended development activities related to internal R&D programs– ~$7M reduction vs. 2011
• Right sized US operations
― ~$3M reduction vs. 2011
― Announced closure of Bothell, WA (March, 2013)
• Global cost-reduction initiatives to streamline business
― Closed Hungary facility $6M reduction vs. 2011
― Ongoing operating review― Sourcing initiatives― Lean initiatives
• Process improvement investments to increase future margins for generic/commercial products
Positioning business for improvement in margins while aligning capabilities to emerging customer needs.
10
Positive Long-term Industry Drivers
• Large pharma R&D restructuring• Reduction in internal R&D resources, generic competition,
healthcare reform driving increased strategic outsourcing• 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
We believe market pressures will exert increasing trend toward outsourcing.
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Market OpportunityContract Services
$2 billion
Data Sources: William Blair & Co, Jefferies & Co., Merrill Lynch, Kalorama Research, Sterne Agee
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
$36 –$38 million
EstimatedOutsource
Market
AMRIShare
$1 billion $33 –$35 million
EstimatedOutsource
Market
AMRIShare
Early Development
$12 –$14 billion $111 –
$113 million
EstimatedOutsource
Market
AMRIShare
Contract Manufacturing
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Market OpportunitySales & Marketing Strategic Direction
• AMRI “SMARTSOURCING™”
• Transitioning from a scientific to a customer relationship focus
• 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
US Europe Asia
318167 156
1,5521,716
614
Public Private
# o
f C
om
pa
nie
s
Global Pharma/Biotech Industry*
AMRI presently provides services to 300+ Companies.Large Opportunity to Expand Customer Base.
* Data Source: Ernst & Young 13
AMRI Royalties
Allegra®
• AMRI licensed technology to Sanofi in 1995• Earn royalties through 2015• At risk launch of generic version by Teva/Barr
in September 2005• Amended license agreement in 2008 to allow
sublicense to Teva/Barr• Received $10M upfront payment for sublicense• Received increased royalties from Sanofi; royalties on
Teva/Barr sales
• Sanofi launched OTC in March 2011 in US
Other• New royalty for a generic from previous agreement• Five-year royalty stream commencing June 2012• Rolling five-year window with any new drug launch
$28
$35
08 09 10 11 12
14
$35 $35$36
($ Millions)
Partnering and Out-Licensing Opportunities
15
$0
$50
$100
$150
$200
2000 2002 2004 2006 2008 2010 2012E
Contract Revenue Milestone Revenue
14% CAGR
$40$60
$72
$145
$122$137
$153$165
$201
$162 $163$173
$183
Moving ForwardContract Revenue Growth
16
Book to Bill Ratio
Improvement in the Book to Bill Ratio provides optimism for revenue growth.
17
FY 2010 FY 2011 YTD 20120
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
0.37
0.07
Series2
1.261.33
1.37
2012 Contract Revenue & Margin Guidance
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2008 2011 2012* 2015*$0
$50
$100
$150
$200
$250
$300
0%
5%
10%
15%
20%
25%
30%
$114$74 $71
$112
$82
$96 $112
$153
DDS LSM Margin
Reve
nue
in M
illio
ns o
f USD
Cont
ract
Mar
gin
%
$196
$170$183
$265
Margin 25% 1% 8% - 11% 19% - 23%
*Amounts represent midpoint of guidance Revenue CAGR for 2011 – 2015 = 12%
Discovery Biology
• Biology Marketplace• Forecast as the fastest growing sector within the Discovery outsourcing market, (estimated to be
as high as 20% compound annual growth over the next 5 years) • Increasing trend towards sourcing end-to-end integrated drug discovery services• Customers increasingly seeking co-location with chemistry• HTS market relatively mature; demand is mainly for niche specialty technologies
• AMRI Biology Services:• As standalone and as key component of Integrated Drug Discovery programs• Bothell site provides “High end” custom biology, HTS and Natural Products• Singapore much smaller scale, mainly program-support biology, some HTS• Well-received by clients (NPS = 45); highly related on all customer feedback metrics (except
pricing)• About 20% AMRI Discovery business is dependent upon our biology capabilities• Biology increasingly an entry-point for wider range of services
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Discovery Biology Challenges
• Bothell site is running ~10% capacity => substantial losses• US biology carries high costs inherent in HTS and natural products capabilities• Singapore biology lacks certain important capabilities
(molecular biology, microbiology)• Small scale of Singapore biology raises credibility questions• Very little market-appetite for US pricing in biology• US biology is not co-located with chemistry services
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Bothell Exit and Transition
Decision made to exit Bothell by end Q1-2013 and consolidate biology operations at Singapore Integrated Discovery location
• Bothell staff notified Thursday November 29, 2012• Of 24 staff, approximately 25% will leave Dec 31st, remainder end-Q1, 2013• Several projects will continue through March 2013• Ongoing (and new) biology projects will be executed in Singapore• Work commenced on Singapore biology lab expansion to accommodate broader-scope of work
(including HTS, molecular biology and microbiology)• Structural analysis operation will be relocated to Albany, as part of PQS
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Discovery Biology Summary
• Biology consolidation in single location provides:• A biology operation of credible scale• Presents a clear integrated discovery offering to our clients• Supports vision of “Asia Discovery” (Singapore hybridized with India)• Eliminates duplication of existing and future cost-structure
• Relocation of Structural Analysis business:• Plays to overlap of impurity ID service with chemical development and gmp services• Presents logically to clients as associated with existing analytical and separation services• Leverages overlaps in equipment resource with PQS operations
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Strategic Priorities for 2012
• Return to profitability• Right size operating structure• Increase global market share• Continue to enhance quality profile• Expand long-term strategic partnerships (insourcing, not-for-profit/government collaborations,
venture capital relationships, etc.)• Out-license/partner remaining proprietary compounds
Adjusting business strategy to address changing market.
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APPENDIX
AMRI Contract ServicesDiscovery
• A broad spectrum of lead discovery services backed by decades of experience• AMRI U.S. discovery chemists average 10 years plus of industrial experience, 50% 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.
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AMRI Contract ServicesEarly 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
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53 customer compounds in Phase I-II pipelinefeeding large scale business.26
AMRI Contract ServicesContract Manufacturing
• Assets in US, Europe and India allow AMRI to assist customers in product life cycle management
• Excellent FDA compliance history Thirteen consecutive FDA inspections across global API facilities with no 483s. Approved by MHRA in UK
• Formulation manufacturing added in solid dosage and sterile fill/finish drug product to decrease clinical trial timelines and costs
• Specialized capabilities in high potency andcontrolled substances
• Portfolio of niche generic APIs provides abase level of cost absorption
• Multiple successes in supportingcustomers progressing to NDA andCommercialization
- 35 commercial products in place
25 customer compounds in Phase III pipeline.27
Strategic PartnershipsAMRI & BMS Licensing Agreement
• Received over $33 million in upfront fees, research funding and milestones
• Milestones up to $66 million per compound for first two compounds and up to $22 million per compound on subsequent compounds
• Opportunity for multiple drug candidates
• Royalties on worldwide sales of commercialized compounds
• One compound in Phase II, milestones received for one compound that entered Phase II and two compounds that entered preclinical development
Development of biogenic amine reuptake inhibitors for depression and other CNS disorders. Preclinical lead compounds licensed in October 2005.
BMS-820836 viewed by BMS as one of its most promising development programs for treatment resistant depression.
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Condensed Balance Sheet
($ millions) September2012
June2012
March2012
December 2011
Assets
Cash and Investments - Unrestricted $15.7 $13.4 $8.2 $20.2
Restricted Cash 5.0 5.0 4.5 --
Accounts Receivable 35.2 35.3 33.4 30.4
Royalty Receivable 9.3 7.0 10.7 6.8
Inventory 33.2 35.9 29.3 26.0
Net PP&E 141.5 142.2 145.0 149.8
Total Assets $266.4 $267.4 $263.4 $263.1
Liabilities and Equity
Accounts Payable & Accrued Expenses $27.9 $27.9 $25.0 $20.4
Deferred Revenue 7.2 7.2 7.3 6.5
Debt 8.0 8.0 5.4 5.8
Stockholders’ Equity 204.6 205.0 205.3 206.4
Total Liabilities and Equity $266.4 $267.4 $263.4 $263.1
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Major Competitors
Discovery Development/Small Scale Large Scale
US Ash StevensCambridge MajorIrixNoracRegisRicerca
CambrexJohnson MattheySAFCAsh Stevens
Europe AptuitChem DivEvotecGalapagos
AlmacAptuitCarbogenHovioneOnyx ScientificSolvias
DSMEvonikHovioneLonzaFabbrica Italiana SynteticiSaltigo
Asia GVK BioShanghai Chem PartnerWuXiSyngeneChembiotek
GVK BioJubilantSyngeneAurigene
DishmanJubilantDr. Reddy’s LabsShasunArch Pharmalabs
AMRI only company which competes across all segments
30
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, 518-512-2261Media: Gina Monari, AMRI Communications, 518-512-2512
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