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Catalent, Inc. 34 th Annual J.P. Morgan Healthcare Conference John Chiminski President & CEO January 11, 2016

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Page 1: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

Catalent, Inc.

34th Annual J.P. Morgan Healthcare Conference

John ChiminskiPresident & CEO

January 11, 2016

Page 2: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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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.

Page 3: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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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.

Page 4: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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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

3

Page 5: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

• 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

4

Strong diversification – no customers >10% of sales

Page 6: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

Catalent Investment Highlights

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� 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

Page 7: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

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The Leading Provider of Advanced Delivery Technologies

SoftgelsControlled

Release

Blow-Fill-Seal

Prefilled Syringes

GPEx®

SMARTag™

6

Zydis® fast dissolve

Page 8: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 9: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 10: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 11: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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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

Page 12: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 13: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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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

Page 14: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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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

Page 15: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 16: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 17: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 18: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 19: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 20: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

Recent Financial and Operating Highlights

19

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

Page 21: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 22: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 23: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

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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.

Page 24: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

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

Page 25: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

Appendix

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Page 26: Catalent, Inc. 34 Annual J.P. Morgan Healthcare Conferenceinvestor.catalent.com/sites/catalent.investorhq.businesswire.com/... · As our business takes place worldwide, ... • Earned

Reconciliation of Adjusted EBITDA to Earnings / (Loss) from Continuing Operations

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