catalent, inc. 34 annual j.p. morgan healthcare...
TRANSCRIPT
Catalent, Inc.
34th Annual J.P. Morgan Healthcare Conference
John ChiminskiPresident & CEO
January 11, 2016
1
Disclaimer Statement
Forward-Looking Statements
This press release contains both historical and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate”, “intend”, “estimate”, “plan”, “project”, “foresee”, “likely”, “may”, “will”, “would” or other words or phrases with similar meanings. Similarly, statements that describe our objectives, plans or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: general industry conditions and competition; product or other liability risk inherent in the design, development, manufacture and marketing of our offerings; inability to enhance our existing or introduce new technology or services in a timely manner; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; our substantial debt and debt service requirements, which restrict our operating and financial flexibility and impose significant interest and financial costs; the consequences of operating in a highly regulated environment; and difficulty in integrating new acquisitions into our existing business, thereby reducing or eliminating the anticipated benefits of the transactions. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended June 30, 2015 filed with the Securities and Exchange Commission. All forward-looking statements in this release speak only as of the date of this release or as of the date they are made, and we do not undertake to update any forward-looking statement as a result of new information or future events or developments unless and only to the extent required by law.
2
Disclaimer Statement - Continued
Non-GAAP Financial Matters
Management measures operating performance based on consolidated earnings from continuing operations before interest expense, expense/(benefit) for income taxes and depreciation and amortization and adjusts for the income or loss attributable to non-controlling interests (“EBITDA from continuing operations”). EBITDA from continuing operations is not defined under U.S. GAAP, is not a measure of operating income, operating performance or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations. Management believes this non-GAAP financial measure and those identified below on this slide or the nextprovide useful supplemental information for our investors’ evaluation of our business performance and are useful for period-over-period comparisons of our business performance. Neither this measure nor any of the other identified measures is a U.S. GAAPmeasure, is meant to supersede a U.S. GAAP measure or is necessarily the same as any similarly titled measure that another company may use.
We believe that the presentation of EBITDA from continuing operations enhances an investor’s understanding of our financial performance. We believe this measure is a useful financial metric to assess our relative operating performance across periods byexcluding certain items that we believe are not representative of our core business and other one-time costs, and we use this measure for business planning purposes. In addition, given the significant investments that we have made in property, plant, equipment and new operations and technologies, depreciation and amortization expenses have a significant impact on our cost structure. We believe that EBITDA from continuing operations will provide investors with a useful tool for assessing the comparability between periods of our ability to generate cash from operations sufficient to pay taxes, to service debt, and to undertake capital expenditures because it does not include depreciation and amortization expense.
As our business takes place worldwide, currency exchange rates are an important factor in understanding period-to-period comparisons. We believe the presentation of results on a constant currency basis in addition to reported results helps improve investors’ ability to understand our operating results and evaluate our performance in comparison to prior periods. Constant currency information compares results between periods, as if exchange rates had remained constant period-over-period. We use results on aconstant currency basis as one measure to evaluate our performance. In this presentation, we calculate constant currency by calculating current-year results using prior-year foreign currency exchange rates. We generally refer to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange translation.
In addition, we evaluate the performance of our segments based on segment earnings before minority interest, other (income) expense, impairments, restructuring costs, interest expense, income tax (benefit)/expense, and depreciation and amortization (“Segment EBITDA”).
Under our debt instruments, our ability to engage in certain activities, such as incurring certain additional indebtedness, making certain investments and paying certain dividends, is tied to ratios based on Adjusted EBITDA (though the instruments may use different terminology). We have included calculations of Adjusted EBITDA where appropriate.
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Catalent Overview
Leader in serving Pharma/Biotech/Consumer
• 1,000+ customers in 80+ countries
• 82 of top 100 pharma, 19 of top 20 generics, 40 of top 50 biotech, 23 of top 25 consumer health
• ~7,000 products: brands, generics, consumer health
• Earned revenue from ~80% of the top 200 largest selling compounds globally in the last three years
Growth-driving strategy & assets
• Synergistic growth platforms: Advanced Delivery Technologies, Development Solutions
• Broad network: 31 facilities, five continents
• Significant scale: ~70 billion doses annually
Track record of profitable growth
• $1.83 billion FY’15 revenues, 4.6% CAGR since FY’09
• $443 million FY’15 Adjusted EBITDA, 8.4% CAGR since FY’09
• 24% Adjusted EBITDA margin, up 460 bps since FY’09
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• Our branded customers drive >90% of R&D spend, >65% of clinicals, and >80% of orphan designated products
• Our generics customers provide ~90% of the western hemisphere Gx volume
• Our unique model: we share in commercial product success, but not in the up-front R&D investments; lower product uptake and payor risk
4
Catalent’s Extensive Customer Relationships
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Strong diversification – no customers >10% of sales
Catalent Investment Highlights
5
� Premier technologies and services provider
���� Attractive industry
���� Leadership and scale
���� Global network; focus on regulatory excellence
���� Diversified operating platform
���� Enduring business, deep customer relationships
���� Multi-faceted growth opportunities
���� Platform provides potential for consolidation
Track record of strong financial performance
Oral Technologies
Medication Delivery Solutions
Global Scale
• $1.4B in FY’15 revenue (softgels ~60%)
• ~70B doses annually of ~7,000 customer products
• 20 sites across 5 continents
Leadership Positions
• #1 in softgels (overall, Rx)
• 90% of NCE softgel approvals over 25 years
• #1 in outsourced blow-fill-seal, fast dissolve
• Oral delivery leader
Technology Overview
• Broadest suite of technologies to address customer challenges, improve patient outcomes
— Improve efficacy; ability to tailor delivery profile
— Solve formulation and absorption challenges
— Improve patient and physician experience
Recent Growth Drivers
• Softgel consumer health initiative
• Winchester, KY controlled-release $52M expansion
6
The Leading Provider of Advanced Delivery Technologies
SoftgelsControlled
Release
Blow-Fill-Seal
Prefilled Syringes
GPEx®
SMARTag™
6
Zydis® fast dissolve
Global Scale
• $439M in FY’15 revenue
• Development and analytical services
— 350+ degreed scientists, 50+ PhDs
— Thousands of development projects annually
• Global clinical supply infrastructure
— 11 sites and 50 depots over 5 continents
Leadership Positions
• #1 integrated development solutions provider
• #1 in respiratory delivery, including metered
dose/dry powder inhalers, nebulized and nasal
Recent Growth Drivers
• Micron Technologies acquisition in Nov. 2014
• Specialty, orphan product commercial launches
at Kansas City facility
• Expanded clinical supplies business into China
Development Solutions Backlog
Development Solutions Global PresenceLeader in Development
Solutions
USD M
430
418
4Q’15 1Q’16
7
Attractive Industry Fundamentals
Global Prescription Drugs
Advanced Delivery TechnologiesDevelopment Solutions
8
$160B Global R&D Expenditure
Discovery 17%
Other 33%
Clinical 36%
CMC 14%
$22B addressable market
• Chemistry, manufacturing and controls
Organic growth driven by increased development activity, outsourcing
Only ~30% CMC outsourced today, vs. Clinical outsourcing ~50%+
Catalent’s addressable market
4,000+ compounds in development
• Growing need for advanced delivery
• Industry needs external providers to address this trend
~30% of spend is outsourced today
Estimated 6-10% end-market growth annually
<50% >50%
Simple, Immediate Release
10-40%
60-90%
Advanced Delivery Technologies
Simple, Immediate Release
Advanced Delivery Technologies
Today Development Pipeline
Branded
Drugs43%
Biologics11%
Generics
12%
OTC
14%
VMS &
Other20% Top 20
20%
All Other80%
US44%
Europe36%
ROW20%
9
Product Type Product
OfferingGeography
Oral Technologies
62%
Development and Clinical
Services 24%
Medication Delivery Solutions
14%
Top product <3%
Softgels: 45%
Modified Release: 17%
Limited payor or single-product risk
Diverse Revenue Base and Operating Platform
10
Advanced Delivery Technologies
• Softgels• Modified release
technologies
Development & Clinical Services
Oral TechnologiesMedication Delivery
Solutions
• FY’15 Net Revenue $1,141M
• FY’15 Segment EBITDA $314M
% Margin 28%
• FY’15 Net Revenue $262M
• FY’15 Segment EBITDA $54M
% Margin 21%
Development Solutions
• Molecule analysis• Dose formulation• Clinical testing• Regulatory filings
• FY’15 Net Revenue $439M
• FY’15 Segment EBITDA $93M
% Margin 21%
Commercialization: On-Patent
Commercialization: Generic/OTC
ClinicalDevelopment
Pre-ClinicalDevelopment
• Injectables• Blow-fill-seal• Biologics
Catalent Business Model: We “Follow the Molecule” with Complementary Growth Platforms
Zydis® Dev’t Rx Supply OTC Switch - Supply
Softgels Dev’t OTC Supply
1995 2000 2005 2010 2015
Long-Duration RelationshipsProvide Sustainability
11
Combination of Capabilities Creates High Barriers to Switching/Exit
● Regulatory: Inclusion of Catalent in customers’ regulatory filings
● Technology: Liqui-Gels®, Zydis®, ADVASEPT®
● IP: 1,300+ patents/applications in 125+ families
● Know-How: Example - Softgel shell & fill formulation databases
● Contracting Excellence:
– 70% of Advanced Delivery Technology platform revenues
from long-term contracts
– 3-10 year terms with 1-3 year regular renewals
24-Year Relationship with a Leading Respiratory Brand
12
31 facilities on five continents
• ~8,700 employees; over 1,000 focused on
regulatory and quality compliance
• More than 5M square feet of manufacturing
and laboratory space
• >50% of facilities registered with FDA,
the rest with other global regulators,
many with multiple agencies
Track record of regulatory excellence
• 65 successful regulatory audits in FY’15
• 250 successful audits over last five years
• 500 customer audits annually
Quality and regulatory track records
are a competitive advantage in an
environment of increasingly stringent
regulation globally
Global Network of Facilities
Global Network Focused on Regulatory and Operational Excellence
13
59
97
175165
2012 2013 2014 2015
Recent Investments in Growth
Increased capacity
• Biomanufacturing in Wisconsin
• Kentucky controlled-release expansion
• Inhalation (MDI) build out in North Carolina
Expansion into new markets
• China: new softgel and clinical sites
• Brazil: acquisition of softgel provider
New and innovative technologies
• OptiPact™ launch (roller compaction)
• Acquired Redwood Bioscience Inc. and its SMARTagTM ADC technology
• Acquired Micron Technologies, the leader in particle size engineering
• Ongoing development of new technologies, including ADVASEPT®, OptiMeltTM
• Addition of OptiForm® Solutions Suite
(1) Fiscal years end June 30
Drivers of Current Growth
• Increased sales force by 20% since FY’09
• Global R&D team focused on new customer products, platform technology development
– Development pipeline at ~700 programs
– ADT development revenue of $142M in FY’15, +4% YoY
• Expanded product offerings and capacity
Number of New Product Launches (1)
Continued Investments Driving Growth
Catalent’s Recently LaunchedOptiForm® Solutions Suite
An important new advanced delivery tech offering –predicting the best form for new oral drugs
• Unmet need in early development
• Micron acquisition filled tech gap required to launch
• Enables Catalent to win more NCEs earlier – building our future manufacturing pipeline
• Nearly 500 active leads
• New signed business already generating revenue
14
Catalent Biologics -Gaining Growth Momentum
Proven GPEx® cell-line technology
• Extensive early-stage access – 500+ to date
• GPEx-based NBE entering Phase III
• 15 biosimilar lines to out-license, 5 launched
Strong demand for biomanufacturing
• $25M single-use bioreactor Madison facility
• Revenues doubled; new line addition planned
Expanding biologics analysis business
Next-generation SMARTag® antibody-drug conjugation tech ramping as expected
• Ongoing tech milestones reached; new patents
• 12+ agreements to date
15
Top 530%
16
Many Adjacent, Highly Fragmented Markets
• 11 deals in the last 3 years >$600M+
• Disciplined deal evaluation process; proven ability to integrate
Advanced Delivery TechnologiesMarket Share
Top 5 10%
Development SolutionsMarket Share
Ability to Build Catalent Through Strategic Transactions
Catalent’s Revenue Model Delivers Sustainable Growth
Supplement organic growth with acquisitions
17
Inorg
anic
gro
wth
Dev. &
Clin
ical
Serv
ices
Advanced D
eliv
ery
Technolo
gie
s
Sales order backlog reflects near-term growth potential
New product launches drive ADT growthnearly 700 products in development at 9/30/15
Stable base of diversified long-cycle revenues from 7,000+ currently approved products
USD MUSD M
$1,399
$1,480
$1,532
$1,695
$1,800$1,827 $1,831
1,000
1,400
1,800
2009 2010 2011 2012 2013 2014 2015
$274
$314
$354
$388
$413
$432$443
20%
24%
18
21
24
27
30
100
250
400
2009 2010 2011 2012 2013 2014 2015
Net Revenue CAGR 4.6%, and Adjusted EBITDA CAGR 8.4%; Margin improved more than 460 bps
18
Net Revenue (1) Adjusted EBITDA (1)
(1) Fiscal years end June 30th
(2) CAGRs represent FY’09 – FY’15 financials, including acquisitions from the point of inception
Strong Historical Financial Performance
Recent Financial and Operating Highlights
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Strong finish to FY’15, our first year as a public company
● Constant currency revenue growth of 7% and Adj. EBITDA growth of 9%
● Two successful secondary offerings completed since the IPO
● Strategic acquisitions completed: Micron Technologies, SMARTag™, Pharmapak
FY’16 off to a solid start; 1Q’16 11% constant currency revenue growth
● ADT – development revenue up 22%, 46 new products introduced
● Dev-Clin backlog up 3% to $430M; new business wins of $130M, up 8% YoY
Entered into a research collaboration with Roche to develop next-generation molecules using Catalent's proprietary SMARTag™ technology
Announced long term exclusive agreement with Pfizer to produce Nexium® 24HR, the company’s leading OTC heart burn medication
ANSM Suspension of Catalent Beinheim
1 of 11 Softgel facilities; 300+ employees; 2 billion capsules annually
Hundreds of customer & regulatory authority audits; Strong track record
13NOV2015 l’Agence National de Sécurité du Médicament et des produitsde santé (ANSM) Notice of Suspension
ANSM suspension arises from:
● Catalent’s internal detection of a series of “out-of-place” capsule incidents
● 1 customer pre-market packaging detection; 0 known market detections
● Strong likelihood of deliberate action
● Concerns with potential for adulteration in manufacturing process
● Classifications of incidents and customer/agency notification
20
ANSM Suspension of Catalent Beinheim
Since Suspension:
● Full cooperation with ANSM, law enforcement officials and customers
─ Comprehensive risk assessments conducted
─ Enhanced security measures implemented
─ Alternative Catalent site manufacturing
─ Customer exemption process provided; several applications pending
─ Number of products recalled
● Proposed overall restart plan submitted
● 18DEC2015 meeting with ANSM: Commitment to engage in further discussions for development of a restart process following prioritized protocols among Catalent, our customers and ANSM
● 30DEC2015 ANSM approved production of simulation (placebo) batch
Next steps:
● Manufacturing under ANSM approved exemption
● ANSM audit and individual restart processes with customers, hopefully over a matter of weeks
● Continued regulatory and criminal investigations
Financial Impact to 2Q’16: $2M - $5M EBITDA, net of one-time offset21
Catalent’s Financial Objectives
Organic Revenue Growth (2) • 4 – 6% CAGR
Organic Adjusted EBITDA
Growth (3)• 6 – 8% CAGR
Leverage• Long-term target of 3.5x
• Ability to increase for acquisitions
22
Strategic plans targeting substantial growth over 5-yr period(1)
(1) Organic growth is presented on a constant currency basis(2) These goals are forward-looking, are subject to significant business, economic, regulatory and competitive uncertainties and contingencies,
many of which are beyond the control of the Company and its management, and are based upon assumptions with respect to futuredecisions, which are subject to change. Actual results will vary and those variations may be material. For discussion of some of the important factors that could cause these variations, please consult the “Risk Factors” section of our Annual Report on Form 10-K for the year ended June 30, 2015. Nothing in this presentation should be regarded as a representation by any person that these goals will be achieved, and the Company undertakes no duty to update its goals
(3) The most directly comparable GAAP measure to both adjusted EBITDA and adjusted net income is earnings/(loss) from continuing operations. An example of the factors involved in the reconciliation was provided with fiscal 2015 Annual Report on Form 10-K.
Catalent Investment Highlights
23
� Premier technologies and services provider
���� Attractive industry
���� Leadership and scale
���� Global network; focus on regulatory excellence
���� Diversified operating platform
���� Enduring business, deep customer relationships
���� Multi-faceted growth opportunities
���� Platform provides potential for consolidation
Track record of strong financial performance
Appendix
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Reconciliation of Adjusted EBITDA to Earnings / (Loss) from Continuing Operations
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