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Investor Presentation December, 2012 NASDAQ: AMRI.

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Presentation on theme: "Investor Presentation December, 2012 NASDAQ: AMRI."— Presentation transcript:

1 Investor Presentation December, 2012 NASDAQ: AMRI

2 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 Companys filings with the Securities and Exchange Commission. While this presentation represents managements current judgment on the future direction of the Companys 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

3 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 StatesEuropeAsia 3

4 Service Platform Discovery ServicesEarly DevelopmentContract 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

5 AMRIs Global Footprint 5 * *Closing in March 2013

6 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 INDs in last ten years - 90 patents filed and 300 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 - 53 Phase I & II customer compounds - 25 Phase III customer compounds - 35 Commercial customer products Partnering and out-licensing opportunities for proprietary early-stage portfolio 6

7 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 Hungary operations closed Q112; 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

8 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 Contract Revenue Guidance* * - Mid-point of Guidance Development Large Scale Discovery 8

9 Diversifying The Customer Portfolio (2012) Large Pharma/Biotech Biotech Spec Pharma Other DiscoveryDevelopment/Small ScaleLarge Scale TOTAL AMRI 9

10 Improving Cost Structure Ended development activities related to internal R&D programs – ~$7M reduction vs Right sized US operations ~$3M reduction vs Announced closure of Bothell, WA (March, 2013) Global cost-reduction initiatives to streamline business Closed Hungary facility $6M reduction vs 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

11 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. 11

12 Market Opportunity Contract 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 Estimated Outsource Market AMRI Share $1 billion $33 – $35 million Estimated Outsource Market AMRI Share Early Development $12 – $14 billion $111 – $113 million Estimated Outsource Market AMRI Share Contract Manufacturing 12

13 Market Opportunity Sales & 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 Global Pharma/Biotech Industry* AMRI presently provides services to Companies. Large Opportunity to Expand Customer Base. * Data Source: Ernst & Young 13

14 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 $36 ($ Millions)

15 Partnering and Out-Licensing Opportunities 15

16 14% CAGR $40 $60 $72 $145 $122 $137 $153 $165 $201 $162 $163 $173 $183 Moving Forward Contract Revenue Growth 16

17 Book to Bill Ratio Improvement in the Book to Bill Ratio provides optimism for revenue growth. 17

18 2012 Contract Revenue & Margin Guidance 18 Margin25%1%8% - 11%19% - 23% *Amounts represent midpoint of guidance Revenue CAGR for 2011 – 2015 = 12%

19 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 19

20 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 20

21 Bothell Exit and Transition Decision made to exit Bothell by end Q 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 21

22 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 22

23 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. 23

24 APPENDIX

25 AMRI Contract Services Discovery 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 INDs over the past 10 years AMRIs 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. 25

26 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 customer compounds in Phase I-II pipeline feeding large scale business. 26

27 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 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 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 - 35 commercial products in place 25 customer compounds in Phase III pipeline. 27

28 Strategic Partnerships AMRI & 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 BMS viewed by BMS as one of its most promising development programs for treatment resistant depression. 28

29 Condensed Balance Sheet ($ millions) September 2012 June 2012 March 2012 December 2011 Assets Cash and Investments - Unrestricted$15.7$13.4$8.2 $20.2 Restricted Cash Accounts Receivable Royalty Receivable Inventory Net PP&E Total Assets$266.4$267.4$263.4$263.1 Liabilities and Equity Accounts Payable & Accrued Expenses$27.9 $25.0 $20.4 Deferred Revenue Debt Stockholders Equity Total Liabilities and Equity$266.4$267.4$263.4$

30 Major Competitors DiscoveryDevelopment/Small ScaleLarge Scale US Ash Stevens Cambridge Major Irix Norac Regis Ricerca Cambrex Johnson Matthey SAFC Ash Stevens Europe Aptuit Chem Div Evotec Galapagos Almac Aptuit Carbogen Hovione Onyx Scientific Solvias DSM Evonik Hovione Lonza Fabbrica Italiana Syntetici Saltigo Asia GVK Bio Shanghai Chem Partner WuXi Syngene Chembiotek GVK Bio Jubilant Syngene Aurigene Dishman Jubilant Dr. Reddys Labs Shasun Arch Pharmalabs AMRI only company which competes across all segments 30

31 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, Media: Gina Monari, AMRI Communications,


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