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8-K - FORM 8K - WEST PHARMACEUTICAL SERVICES INCform8k.htm
WEST PHARMACEUTICAL SERVICES, INC.
Solutions for Injectable Drug Delivery NYSE:WST www.westpharma.com
© 2012 by West Pharmaceutical Services, Inc., Lionville, PA.
All rights reserved. This material is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any
form or by any means, electronic, mechanical, photocopying or otherwise, without written permission of West Pharmaceutical Services, Inc.. All
trademarks and registered trademarks are property of West Pharmaceutical Services, Inc., unless noted otherwise.
CL King 10th Annual Best Ideas Conference
New York, NY
September 12, 2012
 
 

 
Safe Harbor Statement
Cautionary Statement Under the Private Securities Litigation Reform Act of 1995
This presentation and any accompanying management commentary contain “forward-looking statements”
as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to statements about expected financial results for 2012 and future years.
Each of these estimates is based on preliminary information, and actual results could differ from these
preliminary estimates. We caution investors that the risk factors listed under “Cautionary Statement” in
our press releases, as well as those set forth under the caption "Risk Factors" in our most recent Annual
Report on Form 10-K as filed with the Securities and Exchange Commission and as revised or
supplemented by our quarterly reports on Form 10-Q, could cause our actual results to differ materially
from those estimated or predicted in the forward-looking statements. You should evaluate any statement
in light of these important factors. Except as required by law or regulation, we undertake no obligation to
publicly update any forward-looking statements, whether as a result of new information, future events, or
otherwise
.
Non-GAAP Financial Measures
Certain financial measures included in these presentation materials, and which may be referred to in
management’s discussion of the Company’s results and outlook, are Non-GAAP (Generally Accepted
Accounting Principles) financial measures. Please refer to the “Non-GAAP Financial Measures” and
“Notes to Non-GAAP Financial Measures” at the end of these materials for more information. Non-GAAP
financial measures should not be considered in isolation or as an alternative to such measures
determined in accordance with GAAP.
2
 
 

 
Pharmaceutical
Packaging Systems
Pharmaceutical
Delivery Systems
 A globally diverse manufacturer of
 products used primarily in containing
 and administering
 small-volume parenteral drugs
 Strong competitive position
 § Diversified customer base
 § Proprietary technology
 § Global footprint
 § Significant barriers to entry
 Stability with growth potential
 § Proprietary Products
 § Geographic Expansion
 Financial strength to invest
 § Reliable operating cash flow
 § Well capitalized
3
Who We Are
 
 

 
A Diverse, Stable Customer Base
(representative healthcare customers)
PHARMACEUTICAL / BIOTECHNOLOGY
GENERIC
MEDICAL DEVICE
4
 
 

 
The West Transition
 Founded in Philadelphia (1923) and listed on NYSE since 1980
 Initiated strategic transformation in 2001 to become a leading global supplier
 of value-added pharmaceutical packaging systems and components
5
‘03 ‘04 ‘05 ‘06 ‘07 ‘08 ‘09 ‘10 ‘11
2001
$392 M
2011
$1.2 B
Kinston
recovery
Sale of
CCI
Sale of
Drug
Delivery
Acquired
Tech Group,
Medimop
Began
Eur/Asia
expansion
Acquired
Pharma
Pen
Acquired
Normandy
Acquired
LaModel
China
plastics
completed
Global
Quality
Initiative
China
rubber
begun
 
 

 
Business Segments
$857
$337
2011 Revenues
($ millions)
Delivery Systems
 Contract manufacturing base
  Multi-material
  Project management
  Automated assembly
  Regulated products
 Capabilities + IP = proprietary
 delivery devices
 Proprietary devices are
 expected to drive growth
Packaging Systems
 Established leadership
 Designed-in revenue base
 Diverse global capabilities
 High market shares
 Steady growth in base
 Increasing unit value of products
 and geographic expansion are
 expected to enhance growth
6
 
 

 
2012 Q2 Overview
Second Quarter 2012 Sales Grew 5.5% (11.3% at constant
currency)
  High-value product growth and price were key components
  Backlog still growing: longer-lead times, customers building
 inventories
Pharmaceutical Packaging and Device markets:
  Customer’s new product pipelines showing signs of strength
  Patent cliff front and center
  Shift to large molecule products continues
  Global shift in product sourcing (e.g., India generic growth)
  More demanding regulatory environment
Convertible Debenture Tender Offer Completed
7
 
 

 
Q2 Summary Results
$ millions, except per-share data
(1) These are Non-GAAP measurements. For an explanation and reconciliation of these items, see “Cautionary Statement”
 (Slide 2) and “Non-GAAP Financial Measures” and “Notes to Non-GAAP Financial Measures” (Slides 30 - 32).
8
 
 

 
Selected Factors Expected to Impact
Second-Half 2012 and Comparisons
See “Cautionary Statement” on slide 2. This is not an exclusive list of risks.
 Stronger US dollar impact on reported sales, profits from
 international operations vs. first half and prior year
 Pricing changes vs. prior year smaller than first half 2012
 Normal seasonality: West and customer shutdowns for
 summer and holiday season impact sales and production
 efficiency vs. first half
 First-half sales that are not expected to recur:
  Production in response to drug shortages / regulatory constraints
  Customer new product launches
 Expectations for new products and development
9
 
 

 
What will drive growth?
  Growth in emerging markets
  Escalating regulatory and
 quality demands
  Adding plants: China, India
  Expanding Westar® and
 Envision® capacity,
 introducing NovaPure®
 components
 
 
 
 
  Growth in combination products:
  safety, dosing accuracy, ease of
 use
  deliver cost savings
  product differentiation
  Daikyo Crystal Zenith® products:
  Increasing awareness of glass
 quality issues
  Delivery technology platforms:
  SmartDose® electronic patch
 injector
  ConfiDose® auto-injector
  Reconstitution products
  Safety syringes
 
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Packaging Systems
Delivery Systems
10
 
 

 
 
Category
 
Key Customers
Projected
Growth
 
Diabetes
 
 
 
 
> 10 %
 
Oncology
 
 
> 10 %
 
Vaccines
 
 
> 10 %
 
Autoimmune
 
 
> 8%
 
Generics
 
 
>10%
IMS April 2010 Report; Business Insights 2009; GBI Research 2009
Therapeutic Category Growth Drivers
11
 
 

 
Packaging Segment Overview
2011 Revenue
($ millions)
Packaging Systems
 Market leader
 Strong recurring revenue base
 Global manufacturing
 Steady growth in base
 Future growth will be driven by:
 added value per unit sold;
 geographic expansion; and
 growth in key therapeutic
 segments
$857
12
 
 

 
Pharmaceutical Packaging Systems
Packaging Components for Small Volume Parenterals
Plungers, Tip caps,
Needle shields for Glass
Syringes
Plungers, lined seals
for Glass Cartridges
for Pens
Primary packaging components (those that touch the drug) are typically
proprietary to West and are “designed into” customers’ drug products
13
 
 

 
Providing Solutions to a Changing Market
14
 
 

 
Faster Growth of High-Value Products
Pharmaceutical Packaging Systems
15
 
 

 
Asia-Pacific Region Operations
Strategy
Singapore
1.High-value Product
Focus
2.A-P market & special
items
3.R&D hub & technical
center
China IV Plastic
Global supply
China Elastomer:
China Market,
Efficiency focus
India Elastomers for:
1.Domestic standard
products & local support
for multi-nationals
2.Standard product for
export
16
 
 

 
Delivery Systems Segment Overview
$337
 Contract manufacturing base
  Customer owned IP
  Project management
  Automated assembly
  Regulated products
 Proprietary Product
 Development
2011 Revenue
($ millions)
17
 
 

 
Acquisition of
Medimop:
Administration
Systems
2005
Licensing of
NovaGuard:
Safety
System
2006
Acquisition of
PharmaPen:
Auto-injector
2007
Daikyo CZ
Insert
Needle
License:
Prefillable
Syringe
Systems
2008
Acquisition
of Plastef:
Prefillable
Syringe
Safety
2009
Acquisition
of LaModel:
Electronic
Patch
Injector
2010
Marketing
agreement
Product
Development
Formation of
PDS division
Portfolio Expansion to Meet Market Needs
Acquisition
of B.safe:
Prefilled
syringe
safety
2011
18
 
 

 
Pharma Industry Drug Life-Cycle
Management
Phase I
Phase II
Phase III
Post-Market Life Cycle Management
8 - 10 years
2 - 3 years
2 - 3 years
Regulatory
Approval
Discovery
19
 
 

 
Tungsten residue
Breakage
Silicone oil
variability
Cosmetic defects
Particles
Potential Glass Syringe Risk Areas
20
 
 

 
Action Associated with
Breakage Issue
Associated Costs
Estimated Cost*
Investigation and
 inspection of issues,
 complaints and syringe
 products
· Field complaints inquiry
· Investigation and resources
· Inspection
> $50 Million
Loss of market share
Loss of sales until re-launch, and loss of
5% of share at market price post re-
launch for
year 1
> $50 Million
Replacement of drug
 product, components
 and delivery system
 after re-launch
2 million units at $100 each
> $200 Million
Pipeline Assessment:
 Drugs in Phase II/III
 clinical trials
200,000 units x approx. $100 each cost
(assuming 1/10 total production)
>$20 Million
Significant impacts on product supply, market confidence, brand
value
Not estimable
* Source: Company estimates
Illustrative Estimates of Recall Costs
21
 
 

 
Daikyo CZ Solution
with Daikyo Flurotec® Barrier Film
 Reduces:
  drug exposure to extractables
  risk of protein aggregation caused by silicone oil in the drug product
  returns and in-process clean-ups caused by broken glass
  risk of delamination and glass-particulate contamination
 Consistent piston release and travel forces without using silicone oil
Flurotec® is a registered trademark of Daikyo Seiko, Ltd.
22
 
 

 
Orange color indicates Flurotec® film coverage
Complete coverage with
inert film on drug
contact surfaces
Flurotec Film
 Patent Protection from Daikyo Seiko
 Trade Secret Molding / Processing
 Silicone-Free System
 
Daikyo Crystal Zenith Syringe Barrel
 Custom Formulated Resin exclusive
 to Daikyo Seiko
 IP Filed on CZ 1ml-IN Process
 Other IP on packaging / designs

 
 
Daikyo Crystal Zenith Competitive Advantage
Fully laminated
piston
Inside-laminated
tip cap
 
 
 

 
Products Approved in Daikyo Crystal Zenith
hyaluronic acid
MRI contrast
media
bone cement
6 Contrast Media
5 MRI
2 Hyaluronic Acid
1 Calcitonin
1 Proton Pump
Inhibitor
fluconazole
oncology
anticoagulant
2 oncology
1 acyclovir
hyaluronic acid
3 oncology
API Container
Japan
MHLW
Europe
EMEA
US
FDA
Calcitonin
Bone
cement
Zometa
Hyaluronic
acid
24
 
 

 

SmartDose®
Electronic Patch Injector Technology Platform
Programmed by PDA or PC
Dose may be customized
Applied and activated by patient
  Controlled, subcutaneous, micro-infusion delivery
 of high volumes and high viscosity drugs
  Prefilled cartridge, no need for user filling
  Based on Daikyo CZ cartridge
  Compact
  Hidden needle for safety
  Single push-button operation
Prototype Operation
25
 
 

 
Revenue per-unit
Consumer product
manufacturing
Medical
device
manufacturing
Mix2Vial®
CZ vials
CZ Syringes

Effect of Increasing Proprietary Device Sales

Contract Manufacturing  Proprietary Devices
Products    
Auto-injector platform
technology
Electronic patch
injector technology
26
 
 

 
Our Long-Term Focus
 Pharmaceutical Packaging Systems
  Organic growth of 3-5% per year
  Margin expansion from efficiency, product mix
  Capital investments target enhanced quality and value
 Pharmaceutical Delivery Systems
  Deliver the potential of Daikyo CZ products
  Stronger mix of healthcare-consumable contract manufacturing
  Grow proprietary safety and delivery systems
 Financial discipline
  Operating cash flow supports R&D and capital spending
  Deliver returns (ROIC) that regularly exceed cost of capital (WACC)
  Maintain quarterly dividend
  Align incentives with financial performance and value creation
27
 
 

 
Pharmaceutical Packaging Systems
Pharmaceutical Delivery Systems
 Strong first half
 Established market leader
 Stability with growth potential
 New products well positioned to
 meet future market needs
 The financial strength to invest
Summary
28
 
 

 
Non-GAAP Financial Measures(3)
Three Months Ended March 31, 2012 and 2011
(in millions, except per share data)
(3) See “Notes to Non-GAAP Financial Measures” (Slides 31-32), “Cautionary Statement” (Slide 2) for an explanation and
reconciliation of these items.
 
As Reported
March 31,
2012
Restructuring
and related
charges
Acquisition-
related
contingencies
Discrete
tax items
Non-GAAP
March 31,
2012
Operating profit
$41.7
$0.4
$0.2
$-
$42.3
 Interest expense, net
3.9
-
-
-
3.9
Income before income taxes
37.8
0.4
0.2
-
38.4
 Income tax expense
9.8
0.1
0.1
(0.3)
9.7
 Equity in net income of affiliated companies
1.2
-
-
-
1.2
Net income
$29.2
$0.3
$0.1
$0.3
$29.9
 
 
 
 
 
 
Net income per diluted share
$0.81
$0.01
$-
$0.01
$0.83
 
As Reported
March 31,
2011
Restructuring
and related
charges
Discrete
tax items
Non-GAAP
March 31,
2011
Operating profit
$28.8
$1.9
$-
$30.7
 Interest expense, net
4.5
-
-
4.5
Income before income taxes
24.3
1.9
-
26.2
 Income tax expense
6.1
0.6
(0.2)
6.5
 Equity in net income of affiliated companies
1.4
-
-
1.4
Net income
$19.6
$1.3
$0.2
$21.1
 
 
 
 
 
Net income per diluted share
$0.56
$0.04
$-
$0.60
29
 
 

 
30
Non-GAAP Financial Measures(1)
Three Months Ended June 30, 2012 and 2011
(in millions, except per share data)
(1) See “Notes to Non-GAAP Financial Measures” (Slides 31-32) and “Cautionary Statement” (Slide 2) for an explanation and reconciliation of these
 items.
 
As Reported
June 30,
2012
Restructuring,
impairment &
related charges
Acquisition-
related
contingencies
Extinguishment
of debt
Non-GAAP
June 30,
2012
Operating profit
$35.6
$3.7
$0.2
$-
$39.5
 Loss on debt extinguishment
11.6
-
-
11.6
-
 Interest expense, net
4.0
-
-
-
4.0
Income before income taxes
20.0
3.7
0.2
11.6
35.5
 Income tax expense
6.5
1.4
-
1.8
9.7
 Equity in net income of affiliated companies
2.1
-
-
-
2.1
Net income
$15.6
$2.3
$0.2
$9.8
$27.9
 
 
 
 
 
 
Net income per diluted share
$0.45
$0.06
$0.01
$0.27
$0.79
 
As Reported
June 30,
2011
Restructuring,
impairment &
related charges
Acquisition-
related
contingencies
Special separation
benefits
Non-GAAP
June 30,
2011
Operating profit
$27.8
$1.3
($0.7)
$2.1
$30.5
 Interest expense, net
4.3
-
-
-
4.3
Income before income taxes
23.5
1.3
(0.7)
2.1
26.2
 Income tax expense
5.3
0.4
(0.1)
0.8
6.4
 Equity in net income of affiliated companies
1.9
-
-
-
1.9
Net income
$20.1
$0.9
($0.6)
$1.3
$21.7
 
 
 
 
 
 
Net income per diluted share
$0.57
$0.02
($0.01)
$0.04
$0.62
 
 

 
31
NOTES TO NON-GAAP FINANCIAL MEASURES
For additional details, please see today’s press release and Safe Harbor Statement.
(continued on following slide)
These presentation materials and associated presentation use the following financial measures that have not been calculated in accordance with
generally accepted accounting principles (GAAP) accepted in the U.S., and therefore are referred to as non-GAAP financial measures:
·Adjusted operating profit
·Adjusted net income
·Adjusted diluted EPS
·Net debt
·Net debt to total invested capital
West believes that these non-GAAP measures of financial results provide useful information to management and investors regarding business
trends, results of operations, and the Company’s overall performance and financial position. Our executive management team uses these
financial measures to evaluate the performance of the Company in terms of profitability and efficiency, to compare operating results to prior
periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources to our segments. The
Company believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing
operating results and trends in comparing its financial measures with other companies.
Our executive management does not consider such non-GAAP measures in isolation or as an alternative to such measures determined in
accordance with GAAP. The principal limitation of these financial measures is that they exclude significant expenses and income that are
required by GAAP to be recorded. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management
about which items are excluded. In order to compensate for these limitations, non-GAAP financial measures are presented in connection with
GAAP results. We urge investors and potential investors to review the reconciliations of our non-GAAP financial measures to the comparable
GAAP financial measures, and not to rely on any single financial measure to evaluate the Company’s business.
In calculating adjusted operating profit, adjusted net income and adjusted diluted EPS, we exclude the impact of items that are not considered
representative of ongoing operations. Such items include restructuring and related costs, certain asset impairments, other specifically identified
gains or losses, and discrete income tax items. A reconciliation of these adjusted non-GAAP measures to the comparable GAAP financial
measures is included in the accompanying tables.
The following is a description of the items excluded from adjusted operating profit, adjusted net income and adjusted diluted EPS for the three
- and six-month periods presented in the accompanying tables:
Restructuring, impairment & related charges - During the three months ended June 30, 2012, we incurred restructuring, impairment and
related charges of $3.7 million, the majority of which related to impairment charges of $3.4 million, as we concluded that the estimated fair
 
 

 
32
NOTES TO NON-GAAP FINANCIAL MEASURES
For additional details, please see today’s press release and Safe Harbor Statement.
value of one of our product lines no longer exceeded the carrying value of the related assembly equipment and intangible asset. The
remaining charges were restructuring and related charges associated with the restructuring plan announced in December 2010, primarily for
employee severance and benefits, as well as asset transfer and facility closure costs.
 
Acquisition-related contingencies - During the three months ended June 30, 2012, we increased the liability for contingent consideration
related to our 2010 acquisition of technology used in our SmartDose™ electronic patch injector system by $0.2 million, due to accretion
expense. During the three months ended June 30, 2011, we eliminated $0.8 million of contingent consideration related to our July 2009 éris
safety syringe system acquisition. This reflected our assessment that none of the contractual operating targets will be achieved over the earn-
out period, which ends in 2014. Partially offsetting this reduction was accretion expense related to the SmartDose electronic patch injector
technology acquisition.
 
Extinguishment of debt - During the three months ended June 30, 2012, we recognized a loss on debt extinguishment of $11.6 million
related to our repurchase of $158.4 million in aggregate principal amount of 4.00% Convertible Junior Subordinated Debentures Due 2047,
which included the purchase premium, transaction costs and a non-cash charge for unamortized debt issuance costs of the purchased
Convertible Debentures. The purchase of the Convertible Debentures results in a 2.9 million share, or 7.8%, prospective reduction in West
common shares included in the measurement of diluted earnings per share. Excluding the loss on debt extinguishment recognized in the
current quarter, the effect is expected to be accretive to earnings per diluted share going forward, after accounting for interest expense to be
incurred in connection with notes issued on July 5, 2012, the proceeds of which provided the permanent financing for the purchase of the
Convertible Debentures.
 
Special separation benefits - During the three months ended June 30, 2011, we incurred $2.1 million in special separation benefits related to
the retirement of our former President and Chief Operating Officer. These costs were primarily for the revaluation and acceleration of stock-
based compensation expense as a result of amendments to equity awards that allow certain of his awards to continue to vest over the original
vesting period instead of being forfeited upon separation.
 
 
 

 
WEST PHARMACEUTICAL SERVICES, INC.
Solutions for Injectable Drug Delivery NYSE:WST www.westpharma.com
© 2012 by West Pharmaceutical Services, Inc., Lionville, PA.
All rights reserved. This material is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any
form or by any means, electronic, mechanical, photocopying or otherwise, without written permission of West Pharmaceutical Services, Inc.. All
trademarks and registered trademarks are property of West Pharmaceutical Services, Inc., unless noted otherwise.