barclays global healthcare conference 2014 · 2017. 7. 27. · this presentation may contain...
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Barclays Global Healthcare Conference 2014
March 12, 2014
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.
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Introduction to Bill Marth
14 Year tenure at Teva Pharmaceuticals, most recently as President and CEO of Teva
Americas
Led the growth of a $400 million business in 1999 to $12 billion in 2012
• Presided over 10 acquisitions in 10 years
• Transformed Teva’s US Generic business from the 4th ranking US Company to the
largest generics business in the world
• Led branded respiratory, neuroscience, oncology and women’s healthcare
divisions, including Canadian and Latin American affiliates
• Implemented supply chain strategies which ultimately changed the landscape of
Teva’s business and had profound impact on the US Generic industry as a whole.
2012 – Joined AMRI Board of Directors, most recently as Non-Executive Chairman
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Experienced Management Team with Extensive Backgrounds in
Global R&D Manufacturing Environment
• Mike Nolan, CFO
• Global finance, planning and analysis, commercial and M&A expertise
• Previously at Thermo Fisher Scientific, Rio Tinto / Alcan, DuPont
• Lori Henderson, General Counsel
• Global legal, corporate affairs, secretary and chief administrative officer roles
• Previously at Rand, Moldflow, CP Clare, Goodwin Procter
• Michael A. Luther, Ph.D., SVP Discovery and Development
• Head of Discovery and Development including the Buffalo Medical Innovation Hub
• Spearheading expanding biology and pharmacology capabilities
• Previously at Charles River Labs, Merck and GSK
• Steve Hagen, Ph.D., SVP Pharmaceutical Development and Manufacturing
• Responsible for analytical chemistry, QA, and regulatory affairs as well small and large scale
manufacturing operations
• Previously at Pfizer and Ribi ImmunoChem
• George Svokos, SVP Sales and General Manager - API
• 30 years experience in manufacturing, business development, R&D and sales and marketing
• Priorities: API commercial strategy and sales
• Previously at Teva, Biocraft Labs
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AMRI Service Platform
• Hit to Lead to Candidate Services
• Medicinal Chemistry
• High Throughput Screening
• In Vitro Biology and Pharmacology
• Library Design & Custom Synthesis
• Biocatalysis and Biotransformation
• Natural Product Libraries
• Profiling & Structure ID
• Bioprocess Development
• Early ADME
• Metabolite ID
• Process and Analytical
Development
• Kilo Lab Scale-Up
• Phase I GMP
• Salt & Polymorph
Investigations
• Formulation Development • Sterile Fill & Finish Drug Product
• Formulation Manufacturing
Discovery & Early Development Services
Formulation Manufacturing
Fully integrated platform spans drug development spectrum from discovery
to manufacturing, providing comprehensive service offering to customers
Target
Discovery
Lead
Finding
Lead
Optimization
Candidate
Selection
Pre-
Clinical Phase I Phase II Phase III
Product
Approval
API Manufacturing
• Phase II/III API
• Commercial API
• High Value Intermediates
• High Potency
• DEA Regulated API
• Niche Generics
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Bio-Pharma Looking to Simplify, Reduce Cost Structures
R&D Restructuring
• Reduction in internal R&D resources, generic competition, healthcare reform driving increased strategic outsourcing
• Increasingly willing to partner on/outsource discovery development and R&D
• Resulting outsourced R&D is projected to grow 13% from 2013 - 2016
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
Academic and VCs Increasing Roles
• Bio-pharma turning to VCs and academics as source of innovation. Academics need support to “Industrialize” concepts. VCs building virtual entities via outsourcing of R&D
AMRI is well positioned to capitalize on the increased use of outsourcing
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AMRI provides a seamless technology transfer from Discovery through
Contract Manufacturing, creating a “sticky” customer relationship
Market Opportunity and Trends in AMRI’s Key Market Segments
$13 billion(1)
Discovery & Development
$78 million
Estimated
Outsource
Market
AMRI
$127 million
Estimated
Outsource
Market
AMRI
API
$7 million
Estimated
Outsource
Market
AMRI
Drug Product
¹Source: Kalorama, McKinsey Analysis ; ²Source: Frost & Sullivan
• Pharma’s need for portfolio regeneration – forecasted NME output in the next ~4 - 5 years
• Greater variabilization of research cost & more strategic alliances
• Rise in Discovery Pharmacology outsourcing
• 2012 – 16 CAGR ~11% with 9% increased CRO Penetration(1); AMRI relevant markets growing 12 - 15%
• Highly regulated with significant unmet needs particularly in fill/finish
• Clear reputation for product quality, cost competitiveness and desire to reduce # of preferred suppliers
• Fragmented market with potential for significant consolidation
• 2012 – 16 CAGR 12%(2)
• Fixed cost pressure, complexity and need for flexibility pushes pharma to outsource
• Clear reputation for product quality, cost competitiveness and desire to reduce # of preferred suppliers
• Fragmented market with potential for significant consolidation
• 2012 – 16 CAGR 8%(2)
$14 billion(2) $15 billion(1)
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The API Environment – Next 5 Years
Market Characteristics
▪ Global pharmaceutical market to grow from ~$825B to
~$1,000B by 2016 – Generics are driving growth
– US is growing by 5% with 87% of prescriptions being filled as generics
– Japan is expected to be at only 31% generics in 2015
– Europe is less that 40% generic …but, there are branded generics
▪ Trend of outsourcing of API manufacturing by
pharmaceutical companies continues – Branded companies are moving towards their core competencies (S&M)
– Generic companies are finding that API manufacturing is a different
business and some are divesting assets or minimizing efforts in these
areas
▪ Estimated API market is $14B and growing
▪ Recent record of 39 products were approved by the
FDA in 2012 – 28 small molecules
– 14 cancer (i.e. cytotoxic)
– 5 peptides
– Only 3 biologics (CBER); remainder by CDER
– 2013 was weaker at 27 product approvals
Rule of Thumb:
API costs are < 5 % of the
price a typical branded
product and 20% of a generic
product.
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¹Source: IMS Market Research
¹
8
$40
$60
$72
$145
$122
$137
$153 $163
$195
$157 $163
$170
$190
$210
$236
$0
$50
$100
$150
$200
$250
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 *2014E
AMRI Revenue Growth and Mix
21%
20%
29%
30%
Spec Pharma
Large Pharma/Biotech
Other
Biotech
Discovery Development Large Scale
$ m
illio
ns
AMRI Revenue Growth of 14% Outperforms Pharma Services Market
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*Represents mid point of guidance
AMRI Discovery & Development Performance
% Growth $ millions
$ millions % Margin
• Streamlined operations to improve margins
• Increased multi-year strategic agreements in
Discovery & Development
• Lilly, NIH, Merck, Ono
• Maximizing strong customer clinical supply
pipeline
• Driving SMARTSOURCING™ - across
functional approach that maximizes the
strengths of both insourcing and outsourcing
• 58 Phase I & II compounds
• 23 Phase III compounds
• Five FDA decisions in the next 9 months
Challenging CRO market met with mitigating operational and commercial actions to position
Discovery / Development business to capture attractive growth opportunities
10 10
¹Excludes corporate overhead
Contract Manufacturing Performance
• Invested in operations to improve capability
and productivity
• Long term supply agreements for commercial
business
• 36 commercial products being manufactured
• Extensions on two large API supply
agreements
• Actavis API and royalty revenue
• Growing Aseptic Fill/Finish business
• 13 customer audits all leading to approved
supplier designation
• Cardium commercial launch of Excellagen™
• Successful FDA inspection of Burlington
facility; removal of 2010 warning letter
Previous investments in Contract Manufacturing along with solid execution has
driven impressive growth and margin improvement over the last four years
% Growth $ millions
$ millions % Margin
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¹Excludes corporate overhead
AMRI Key Financial Metrics
2010A 2011A 2012A 2013A
Cash & Equivalents1 $41.5 $20.2 $28.5 $180.5
Debt2 15.9 12.6 16.5 157.2
Net Debt ($25.6) ($7.6) ($12.0) ($23.3)
Revenue $198.0 $207.6 $226.7 $246.6
% growth — 4.8% 9.2% 8.8%
Adjusted EBITDA $8.1 $6.5 $33.1 $49.1
% margin 4.1% 3.1% 14.6% 19.9%
Debt / Adjusted EBITDA 2.0x 1.9x 0.5x 3.2x
Adjusted EBITDA / Interest Expense 27.7x 9.1x 71.4x 75.9x
$millions
Source: Company filings 1 Cash and equivalents includes restricted cash consistent with term loan included in debt 2 Debt includes outstanding letters of credit, term loan and industrial development authority bonds
Solid financial footing even before very attractive bond offering at 2.25%
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November Convertible Issuance: Attractive Capital with Minimal Dilution
Securities description Cash Convertible Senior Notes due 2018 Bookrunners JP Morgan & Morgan Stanley
Offering size Target $100 million Actual $130 million
Over-allotment amount Target $ 15 million Actual $ 20 million
Marketed coupon range Target 2.00 – 2.50% Actual 2.25%
Marketed conversion premium range Target 27.5 – 32.5% Actual 32%
Bond Hedge Yield/Cost Actual 7.0%
Net Proceeds* Target $102 million Actual $135 million
Maturity 5-years Call features None Put features None
Stock price
(at maturity)
Convertible value
(owed to investors)
Bond hedge
payout
Warrants payout
(shares owed Net cost to AMRI
$11.00 $150 million $0 million 0.0mm shares $150 million
$12.00 $150 million $0 million 0.0mm shares $150 million
$13.00 $150 million $0 million 0.0mm shares $150 million
$14.00 $150 million $0 million 0.0mm shares $150 million
$15.00 $150 million $0 million 0.0mm shares $150 million
$16.00 $154 million $4 million 0.0mm shares $150 million
$17.00 $163 million $13 million 0.0mm shares $150 million
$18.00 $173 million $23 million 0.0mm shares $150 million
$19.00 $182 million $32 million 0.0mm shares $150 million + 0.0mm shares
$20.00 $192 million $42 million 0.5mm shares $150 million + 0.5mm shares
$21.00 $202 million $52 million 0.9mm shares $150 million + 0.9mm shares
$22.00 $211 million $61 million 1.3mm shares $150 million + 1.3mm shares
$23.00 $221 million $71 million 1.7mm shares $150 million + 1.7mm shares
$24.00 $230 million $80 million 2.0mm shares $150 million + 2.0mm shares
$25.00 $240 million $90 million 2.3mm shares $150 million + 2.3mm shares
Settlement at maturity (Total)
Attractive bond offering provides additional growth capital with limited dilution
Even at ~ 2.25x the
current share price
the dilution would
only be around 7%
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AMRI: On a Path to Industry Leading Returns
• A disciplined approach to evaluating and managing assets
• Demonstrated track-record of optimizing operations to drive profitability and value
• Consolidation of Biology and Pharmacology from Bothell to Singapore
• Consolidation of Chemical Library work from Hungary to India
• Vertical integration of intermediate production for Rensselaer through India
• Cessation of non-core activities (internal proprietary drug development)
• G&A rationalization
• Realized $18 million of savings
• Double digit revenue growth
• Actions taken, together with strong financial results, have placed AMRI on a path to
industry leading margins
14
A Disciplined Deployment of Capital Will Further Fuel Growth
and Shareholder Value
• Evaluating Organic and Inorganic Growth Opportunities
• Investment Priorities:
• Continue to invest in core areas to fuel growth in discovery, development and manufacturing
• Expand API capabilities in Rensselaer and India
• Improve large scale manufacturing capabilities in Burlington
• Add capabilities that complement our existing core areas
• API – Leverage expertise in controlled substances, more global footprint
• Drug Product – Increase scale to take advantage of growing market needs
• Investment Criteria:
• Use ROIC to weigh the cost of investing against its contribution to growth, margins, accretion
and ultimately value for shareholders
• ROIC needs to beat our hurdle rate
• Prioritize opportunities that will profitably drive revenue growth in excess of our current
business
• Several organic and inorganic opportunities meet these stringent criteria
15
Experienced management team in place to execute on these initiatives
AMRI is Strategically Positioned to Capitalize on Macro Trends
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• Operate in contract research market segments with attractive growth rates, driven by increased
R&D and increased penetration of outsourced drug discovery
• Operate in a contract manufacturing market segments with attractive revenue growth rates
projected across all relevant industry segments and formulation types
• Broad range of skills to meet the challenging needs in Pharma Services
• Discovery and Development
• API
• Drug Product
• Diversified mix of 300+ customers from large pharma, biotech, and specialty pharma
• Good visibility of contracts and pipeline
• Exposure to growing customer base
• Global footprint offering timely/cost effective solutions with high quality
• Demonstrated track record of operational performance
• Excellent liquidity and financial position to take advantage of attractive growth opportunities
AMRI is well positioned to capture increasing share of strategic outsourcing in coming years
Thank You
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 22
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 with 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. For more information about AMRI, please visit our website at www.amriglobal.com or follow us
on Twitter (@amriglobal).
Contacts:
Investor Relations: Michael Nolan, Chief Financial Officer, 518-512-2261
Media: Gina Rothe, AMRI Communications, 518-512-2512
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