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Jefferies Global Health Care Conference June 1, 2015
Transcript

Jefferies Global Health Care Conference

June 1, 2015

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 press release issued today and 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

Fully Integrated Service Platform Spans

Drug Development Spectrum from Discovery

to Manufacturing

3

• Focusing on high value, technically challenging areas

• End-to-end sterile fill/finish capabilities

2015 Forecast*: $92M

• Focusing on high value, niche APIs; brands and high value generics

• Controlled substances, steroids, proteins, peptides and cytotoxics

2015 Forecast*: $162M

• Recognized experts

in medicinal and solid

state chemistry

• Flexible, competitive

cost structure

• Development services growing rapidly

2015 Forecast*: $98M

Discovery & Development

Services (DDS)

API Manufacturing

Drug Product Manufacturing

Target

Discovery

Lead

Finding

Lead

Optimization

Candidate

SelectionPre-Clinical Phase I Phase 2 Phase 3

Product

Approval

Generic

R&D

ANDA

Development &

Approval

*Represents mid point of guidance as of May 5, 2015

Key Milestones – Last Twelve Months

• Completed and integrated 4 acquisitions

• Cedarburg – API, controlled substances

• OsoBio – Commercial scale sterile injectable manufacturing

• SSCI/West Lafayette – Supplementing development capabilities with physical

chemistry, polymorph and DMPK expertise

• Glasgow, UK – Pre-formulation/small scale sterile injectable development

• Established differentiated, integrated discovery center in Buffalo

• Advanced growth in generics with multiple development programs across all

segments, capturing development, commercial and royalty revenue

potential

• Added key strategic positions in supply chain, IT and international sales

• Creating sustainable shareholder value by replacing declining royalties with

profitable contract business

44

Entering a New Growth Era as

Outsourcing Trends Increase

• Global pharma simplifying to core

competencies• Reducing internal resources

• Generic competition

• Divesting assets; Reducing fixed

cost structures

• Vendor consolidation programs

benefitting integrated providers

• Early to mid-stage companies

accessing outsourcing

• VCs / Academia / Virtual pharma

• Increased funding fueling increase in

early discovery and development

• Industry consolidation triggering

interest in larger outsourcing partners•

5

Phase I & II Phase III 505b/ANDAs Commercial

AP

ID

rug

Pro

du

ct

Pipeline of Development and Commercial

Contracts Expanding Rapidly

6

Development Supporting these Programs

Q1 2015 Financial Highlights

($ in millions, except per share amounts)

Q1

2015

Q1

2014

Growth

Y/Y

Contract Revenue $75.1 $51.0 47%

Royalties $6.7 $8.3 (19%)

Total Revenue $81.8 $59.3 38%

Adj. Cost of Contract Revenue* $57.9 $41.6 39%

Adj. SG&A as a % of Revenue* 18% 19% (1) PPT

Adjusted EBITDA* $14.5 $11.1 31%

Non-GAAP EPS* $0.20 $0.16 25%

Tax Rate 35.0% 29.1% 6 PPT

7 *Please refer to tables at the end of the presentation for a reconciliation of non-GAAP items

Adjusted Contract Margin

Q1 2015 Q1 2014

23% 18%

Contract Revenue Up 47% Q1 Y/Y

8

Contract Revenue +47% vs. Q1 2014

($ in millions)

Adjusted EPS Q1 2014 – Q1 2015

9

¹See tables at the end of the presentation for a reconciliation of GAAP EPS to non-GAAP EPS.

Contract Revenue Projected to Increase

Over 40% from 2014 - 2015

10 *Represents mid point of guidance as of May 5, 2015

DDS API Drug Product Q1 Actual Q2 – Q4 Estimate

$60 $72

$144

$122 $137

$153 $163

$195

$157 $163 $170

$190

$210

$251

$353

$0

$50

$100

$150

$200

$250

$300

$350

$400

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 *2015E

Sustainable Contract Operating Income

Offsetting Declining Royalties

11

Operating Income

(Ex. Royalties)Royalties

Contract Operating

Margin % Current

(Ex. Royalties)

*Represents mid-point of guidance as of May 5, 2015.

**See tables at the end of the presentation for a reconciliation of GAAP EPS to non-GAAP EPS.

Strategic Priorities for 2015

12

• Invest in core areas to fuel growth in discovery,

development and manufacturing

• Add capabilities that complement our existing

core areas

• DDS – Integrate chemistry and biology in

Buffalo

• API – Expand generic portfolio and global

footprint

• Drug Product – Increase scale to take

advantage of growing market needs

• Enhance operational efficiencies/Integrate AMRI

• Scope and begin ERP implementation

• Holywell site transition and closure

Disciplined Capital

Deployment

Organic Growth

Acquisitions

A Disciplined Deployment of Capital Will Fuel Growth and Shareholder Value

Thank You

Appendix

DDS Performance – 1Q 2015

• Q1 2015 Contract Revenue: $19.3M,

up 1%

• Operational efficiency programs

delivering enhanced margins

• SSCI on track with integration

• Initiating development work as part of

10-year NIH award

• Expanded API & Drug Product

capabilities and capacity increasing

demand for Development services

• Supporting development of 67 APIs

and 99 Drug Product formulations

15

($ in millions)

Q1

2015

Q1

2014

% Change

Y/Y

DDS Contract Revenue $19.3 $19.0 1%

Cost of Contract Revenue $14.8 $15.6 (6%)

Contract Gross Profit $4.5 $3.4 32%

Contract Gross Margin 23% 18% 5 PPT

API Performance - 1Q 2015

• Q1 2015 Contract Revenue:

$37.8M, up 27%

• Advancing growth in generics with

multiple development programs

• Expanding controlled substance

portfolio

• Long term supply agreements for

commercial business

• 53 commercial products being

manufactured

• Multiple late stage products and

scalable infrastructure for future

growth

• 48 Phase I & II Compounds

• 13 Phase III Compounds

• 6 - 505b2 or ANDAs

16

($ in millions)

Q1

2015

Q1

2014

% Change

Y/Y

API Contract Revenue $37.8 $29.8 27%

Cost of Contract Revenue $28.6 $23.2 23%

Contract Gross Profit $9.3 $6.5 43%

Contract Gross Margin 25% 22% 3 PPT

Drug Product Performance - 1Q 2015

• Q1 2015 Contract Revenue: $18M,

up 688%

• Reflects addition of OsoBio and

Glasgow, UK

• Gained 7 new customers 1Q

• Expansion of Drug Product leading

to increased development projects

• 14 Commercial Products

• 29 Products in Phase III

• 58 Products in Phase I & II

• 12 – 505b2 or ANDAs

17

($ in millions)

Q1

2015

Q1

2014

% Change

Y/Y

DP Contract Revenue $18.0 $2.3 688%

Cost of Contract Revenue $14.8 $2.7 448%

Contract Gross Profit $3.2 $(0.5) 740%

Contract Gross Margin 19% (20%) 39 PPT

Contract Revenue Projected to Increase

Over 40% in 2015

18

Contract Revenue +41% vs. 2014

*Represents mid-point of guidance as of May 5, 2015

($ in millions)

2015 Forecast*

($ in millions, except per share amounts) 2015 Y/Y

DDS $98 30%

API $162 11%

Drug Product $92 210%

Contract Revenue $335 – 370 40%

Royalties $13 – 14 -45%

Total Revenue $348 – 384 31%

Adjusted Contract Margins 25% 6 PPT

Adjusted EBITDA $59 - 65 35%

Non-GAAP EPS $0.80 - $0.90 33%

19

*Represents mid-point of guidance as of May 5, 2015. See tables at the end of the presentation for a

reconciliation of GAAP EPS to non-GAAP EPS.

About AMRI

Albany Molecular Research Inc. (AMRI) is a global contract research and manufacturing

organization that has been working with the Life Sciences industry to improve patient

outcomes and the quality of life for more than two decades. With locations in North

America, Europe and Asia, our key business segments include Discovery and

Development Services (DDS), Active Pharmaceutical Ingredients (API), and Drug Product

Manufacturing. Our DDS segment provides comprehensive services from hit identification

to IND, including expertise with diverse chemistry, library design and synthesis, in vitro

biology and pharmacology, drug metabolism and pharmacokinetics, as well as natural

products. API Manufacturing supports the chemical development and cGMP manufacture

of complex API, including potent, controlled substances, biologics, peptides, steroids, and

cytotoxic compounds. Drug Product Manufacturing supports pre-clinical through

commercial scale production of complex liquid-filled and lyophilized parenteral

formulations. For more information about AMRI, please visit our website at

www.amriglobal.com or follow us on Twitter (@amriglobal).

Contacts:

Investor Relations: Patty Eisenhaur, AMRI Investor Relations, 518-512-2261

Media: Gina Rothe, AMRI Communications, 518-512-2512

20

Fully Integrated Service Platform Spans Drug

Development Spectrum from Discovery to Manufacturing

21

Discovery and Development Services

(DDS)

• 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

API Manufacturing

• Phase II/III API

• Commercial API

• High Value Intermediates

• High Potency

• DEA Regulated API

• Complex API R&D

• Global Regulatory

• Niche Generics

Drug Product

Manufacturing

• Top 10 US Fill/Finish Manufacturer

• Formulation Manufacturing

• Pre-formulation

Target

Discovery

Lead

Finding

Lead

Optimization

Candidate

SelectionPre-Clinical Phase I Phase 2 Phase 3

Product

Approval

Generic

R&D

ANDA

Development &

Approval

Focused on Higher Growth Segments of

Discovery/Development Market

22Source: Kalorama; McKinsey analysis.

¹ High throughput screening.

$2.9 $2.7 $2.8 $3.0 $3.1 $3.4 $3.6 $3.7

$1.5 $1.8 $2.0 $2.4 $2.8

$3.1 $3.5

$4.0 $2.5 $2.7$3.2

$3.8$4.2

$4.7

$5.2

$5.9

$0.5$0.5

$0.5

$0.6

$0.6

$0.7

$0.7

$0.8

$1.9$2.2

$2.6

$3.0

$3.5

$3.9

$4.7

$5.3

$9.2$9.9

$11.1

$12.8

$14.2

$15.8

$17.6

$19.7

$0.0

$5.0

$10.0

$15.0

$20.0

$25.0

2009 2010 2011 2012 2013 2014 2015 2016

Safety & Tox Lead Pharmacology Early Chemistry HTS Biology

16%

6%

13%

15%

4%

CAGR

2009 - 2016

1

$ in billions

1

Worldwide CRO Discovery / Preclinical Outlook

The API Environment – Next 5 Years

$0

$200

$400

$600

$800

$1,000

$1,200

2011 2012 2013 2014 2015 2016

Developed Emerging ROW

Global Spending (US$, Billions)

ROW – 6.8% CAGR to $62B

Emerging – 16.2% CAGR to $234B

Developed – 16.7% CAGR to $121B

Branded – $594BBranded – 1.2% CAGR to $631B

Branded and Generic Drug Market 2011–20161

• Global pharmaceutical market to grow

from ~$825B to ~$1,000B by 20161

• Generics driving growth

• US is growing 5%; 87% of prescriptions generic

• Japan expected to be at only 31% generics in

2015

• Europe is less than 40% generic; branded

generics

• Trend of outsourcing of API manufacturing

by pharmaceutical companies continues

• Branded companies moving towards core

competencies

• API manufacturing is a different business; some

are divesting assets or minimizing efforts

• Recent record of 41 branded products

approved in 2014.2

Market Characteristics

¹ Source: IMS Market Research.2 Source: FDA

23

Earnings Per Share Reconciliation(Dollars in thousands, except for per share data) Non-GAAP Measures

24

First Quarter First Quarter (Dollars in thousands, except for per share data)

Non-GAAP Measures 2015 2014

Earnings per diluted share, as reported $ (0.07) $ 0.11

Adjustments, net of tax:

Impairment charges 0.08 -

Restructuring charges 0.05 0.01

Executive transition costs 0.03 0.01

Business acquisition costs 0.02 0.01

Purchase accounting depreciation and amortization 0.02 -

Postretirement benefit plan settlement gain - (0.03)

Non-recurring professional fees 0.01 -

Debt interest and amortization charges 0.06 0.05

Earnings per diluted share, as adjusted $ 0.20 $ 0.16

EBITDA Reconciliation(Dollars in thousands, except for per share data) Non-GAAP Measures

25

First Quarter

2015

First Quarter

2014

Income from operations, as reported

$ 1,229

$ 7,465

Impairment charges

2,615

-

Restructuring charges

1,487

230

Executive transition costs

1,325

640

Business acquisition costs

1,090

322

Purchase accounting depreciation and

amortization 1,003

-

Postretirement benefit plan settlement gain

-

(1,285)

ERP Implementation costs

204

-

Non-recurring professional fees

617

-

Income from operations, as adjusted

$ 9,570

$ 7,372

Add: Non-operating (expense) income net, as reported 469

(40)

Add: Depreciation and amortization

4,483

3,761

Adjusted EBITDA

$ 14,522

11,093


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