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NAG4644-Product Bro.(pdf).qxp - ERO-TEX The Ground Control
Transcript of NAG4644-Product Bro.(pdf).qxp - ERO-TEX The Ground Control
Bank of America Merrill Lynch High Yield Conference
December 3, 2013
Biomet, Inc.
Daniel P. Florin
Senior Vice President & CFO
Forward-Looking Statements and Non-GAAP Financial Measures 2
Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements are often indicated by the use of words such as “will,” “intend,” “anticipate,” “estimate,” “expect,” “plan” and similar expressions. Forward-looking statements involve certain risks and uncertainties. Actual results may differ materially from those contemplated by the forward looking statements due to, among others, the following factors: the success of the Company’s principal product lines; the results of the ongoing investigation by the United States Department of Justice; the ability to successfully implement new technologies; the Company’s ability to sustain sales and earnings growth; the Company’s success in achieving timely approval or clearance of its products with domestic and foreign regulatory entities; the impact to the business as a result of compliance with federal, state and foreign governmental regulations and with the Deferred Prosecution Agreement; the impact to the business as a result of the economic downturn in both foreign and domestic markets; the impact of federal health care reform; the impact of anticipated changes in the musculoskeletal industry and the ability of the Company to react to and capitalize on those changes; the ability of the Company to successfully implement its desired organizational changes and cost-saving initiatives; the ability of the Company to successfully integrate the Trauma and Lanx acquisitions; the impact to the business as a result of the Company’s significant international operations, including, among others, with respect to foreign currency fluctuations and the success of the Company’s transition of certain manufacturing operations to China; the impact of the Company’s managerial changes; the ability of the Company’s customers to receive adequate levels of reimbursement from third-party payors; the Company’s ability to maintain its existing intellectual property rights and obtain future intellectual property rights; the impact to the business as a result of cost containment efforts of group purchasing organizations; the Company’s ability to retain existing independent sales agents for its products; the impact of product liability litigation losses; and other factors set forth in the Company’s filings with the SEC, including the Company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Although the Company believes that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or non-occurrence of future events. There can be no assurance as to the accuracy of forward-looking statements contained in this presentation. The inclusion of a forward-looking statement herein should not be regarded as a representation by the Company that the Company’s objectives will be achieved. The Company undertakes no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made.
Non-GAAP Financial Measures This presentation uses non-GAAP financial measures, such as net sales excluding the impact of foreign currency (constant currency), excluding the impact of the Trauma acquisition and Bracing divestiture, free cash flow, unlevered free cash flow, Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) as adjusted, adjusted net income, net debt, senior secured leverage ratio, total leverage ratio, inventory turnover as adjusted, and cash and cash equivalents (as defined by the Company’s credit agreement) as important financial measures to review and assess financial and operating performance of its principal lines of business. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are included on the Biomet website at www.biomet.com The term “adjusted” or “as adjusted,” a non-GAAP financial measure, refers to financial performance measures that exclude certain income statement line items, such as interest, taxes, depreciation or amortization, other income (expense), and/or exclude certain expenses as defined by our credit agreement, such as restructuring charges, non-cash impairment charges, integration and facilities opening costs or other business optimization expenses, new systems design and implementation costs, certain start-up costs and costs related to consolidation of facilities, certain non-cash charges, advisory fees paid to the private equity owners, certain severance charges, purchase accounting costs, stock-based compensation and payments, payments to distributors that are not in the ordinary course of business, litigation costs, loss on extinguishment of debt, and other related charges. These non-GAAP measures are not in accordance with, or an alternative for, generally accepted accounting principles in the United States. Biomet management believes that these non-GAAP measures provide useful information to investors; however, this additional non-GAAP financial information is not meant to be considered in isolation or as a substitute for financial information prepared in accordance with GAAP.
Biomet: A Legacy of Innovation and Growth*
Legacy of product innovation
Fastest growing orthopedic joint company over the past 7 years
Consistent above market growth
Poised to continue with strong pipeline (XPA, G7™)
Fast growing S.E.T. segment
Lanx acquisition adds scale & MIS technology to spine
Continued growth in both developed & emerging international markets
Consistent EBITDA growth and excellent cash net income growth
Strong cash flow drives ability to continue de-leveraging
Note: International primarily includes Canada, South America, Mexico and Asia Pacific region
Q1 Fiscal ‘14 Revenues by Geography
Q1 Fiscal ‘14 Revenues ($731mm) by Product Category Biomet Highlights
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Cement, Biologics, & Other Products
$51
Hips $150
Spine, Bone Healing & Microfixation
$102
Sports, Extremities & Trauma (S.E.T.)
$149
Dental $54
7%
20%
14%
7%
21%
International $109
9% cc growth
United States $470
4% y/y growth
Europe $152
2% cc growth
15% 21%
64%
*See Non‐GAAP Financial Measures Disclosure on slide 2
4.3% y/y cc growth
31%
Knees $225
$2,107
$2,383 $2,504
$2,698 $2,732 $2,838
$3,053
$1,600
$2,000
$2,400
$2,800
$3,200
FY 2007
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
FY 2013
$719
$829
$926 $1,000 $1,010 $1,031
$1,077
$500
$700
$900
$1,100
$1,300
FY 2007
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
FY 2013
$58 $59 $135
$206 $198 $265
$0 $80
$160 $240 $320
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
FY 2013
Leverage Free Cash Flow(1)
Net Sales Adjusted EBITDA
(1) Free Cash Flow is calculated as Cash Flow from Operations less Capital Expenditures
4
Adjusted Net Income Inventory Turnover, Adjusted
1.14 1.30 1.34 1.50 1.45 1.50 1.55
0.00.61.21.8
FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2013
8.5x 7.4x 6.5x 5.7x 5.6x 5.2x 5.2x
LBO Close
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
FY 2013
5.0x 2.7x
3.1x 3.1x 3.6x 4.3x
2.7x
5%
8% cc
4%
3% cc
13%
9% cc
1%
1% cc
8%
7% cc
4%
2% cc
8%
9% cc
2% cc organic
$107 $158
$242 $205 $252
$368
$0
$200
$400
$600
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
FY 2013
Strong Record of Consistent Growth and De-Leveraging*
5.0% 3.8% 3.9%
2.6%
Percent of Sponsor Equity
34.1%
34.8%
37.0% 37.1% 37.0% 36.3%
35.3%
*See Non‐GAAP Financial Measures Disclosure on slide 2
Secured Leverage:
Note: organic excludes impact of trauma acquisition & bracing divestiture
We’ve always been a Leader in Innovation …enhancing patient care on both the implant side and the procedure side Rich clinical history
Pioneered use of titanium alloy as material of choice for hip stems Developed porous plasma spray technology for biological fixation Leader in polyethylene advances, including E1® vitamin E infused
highly cross-linked polyethylene
Market leading brands Oxford® Partial Knee Comprehensive® Shoulder System JuggerKnot™ Soft Anchor Technology DVR® Crosslock Plating System
Still many opportunities to solve unmet clinical needs …to further improve short and long term outcomes and patient satisfaction
Leader in Innovation 5
Our Mission: One Surgeon, One Patient®
®
6
Over 1 million times per year…
…we help one surgeon provide personalized care to one patient
Offering surgeons the best tools possible to deliver personalized patient care
Providing extraordinary service and advocating for physicians and their patients Defending surgeons’ freedom to choose the best implants for their patients
Promoting rational reimbursement that preserves patient access
Treating every implant as if it were meant for a family member
Biomet Strategic Goals
1. Drive above market growth through innovation & excellence at every intersection
2. Creative solutions that deliver value efficiently in a changing world
3. Maintain our energetic team culture and work environment, while always putting our customers and their patients first
Resulting in Excellent Financial Performance
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Above Market Growth through Innovation & Excellence at Every Intersection
SET as current growth driver
Reshape BSBH: high growth spine, stim
stability
Restore dental growth: back to basics
Increased investment in high-value
biologics programs
Strong base in above market recon growth
Invest in both emerging markets and attractive low-share developed markets
9
Biomet’s WW Hip/Knee Market Share Growth
Strong Base in Above Market Recon Growth
10
*Rates at constant currency; see Non-GAAP Financial Measures Disclosure on slide 2; Market rates reflect our internal estimates and are based on calendar quarters; Note: Biomet’s data reflects rates based on fiscal quarter press releases (ending one month prior to each calendar quarter end), which have not been restated for product line reclassifications
Biomet has Consistently Grown Faster than the Overall Joint Recon Market
We believe Share Gain is Sustainable: Strong Portfolio/Pipeline
Strength & Stability of Distribution
Creative Solutions That Deliver Value Efficiently in a Changing World
-4%
0%
4%
8%
12%
16%
CY'07 CY'08 CY'09 CY'10 CY'11 CY'12 YTD'13
WW Hip/Knee YOY Market Growth Rates* Biomet Market
Joint Recon Market is Improving
Biomet has been the Market Leader in Gaining Share
-2%
0%
2%
4%
6%
8%
CY'07 CY'08 CY'09 CY'10 CY'11 CY'12 YTD'13
Biomet WW Hip/Knee Growth vs. Market* (Delta to Market Growth)
210 160 70
-10
-370 -600
-300
0
300
600
Biomet SNN SYK JNJ ZMH
WW Hip/Knee Market Share Gain/Loss (basis points)
Q1 CY’07- Q3 CY’13
11 Strong Base in Above Market Recon Growth: Knees
Key Knee Growth Drivers Vanguard® Complete Knee System
Vanguard® 360 Revision System
Oxford® Partial Knee
Signature™ System for Oxford® Partial Knee*
New Knee Product (FY’15 planned commercial launch)
– Vanguard® XP
*The Signature™ System was developed through a partnership with Materialise NV.
Partial Primary Revision
Oxford® Partial Knee
Vanguard® Complete Knee System
Vanguard® 360 Revision System
XPA Platform: Combining the best of the Oxford® Partial and Vanguard® Total 12
Combining into XPA: Cruciate Preserving Arthroplasty
Oxford® Partial Knee Superior patient satisfaction with ADL in one study compared to
total knee replacement Vanguard® XP
bi-cruciate preserving arthroplasty (natural knee kinematics & feel) introduction at AAOS in March; launch planned for Fiscal 2015
Vanguard® : The Standard To Which
Others Are Aspiring
Oxford® knee patients were approximately 2.7x more likely to be satisfied with
their ability to perform activities of daily living compared to total knee replacement patients
Oxford® : The Only Free Floating Meniscal Bearing Partial Knee
Approved in the U.S.
Vanguard® Complete Knee System Ten femoral sizes
Nine tibial sizes
Seven levels of constraint
Complete interchangeability between femoral and tibial components
Goal: Partial knee patient satisfaction in a total knee
G7™
Acetabular System
Strong Base in Above Market Recon Growth: Hips Combination of Clinically Proven & New Products
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Current Hip Growth Drivers – Arcos® Modular Femoral Revision Hip System
– Taperloc® Complete Hip Stem
– Taperloc® Complete Microplasty® Stem
– Bone-conserving design
– Competes in fast-growing minimally invasive procedures segment (ASI, et. al.)
New Hip Products during FY’13/’14: – G7™ Acetabular System
– Color coding provides elegant simplicity in instruments and implants
– Multi-bearing system
– Began launch Q2 FY’14
– Signature™ Acetabular System*
– Designed for optimal cup placement
*The Signature™ System was developed through a partnership with Materialise NV.
Arcos® Modular Femoral Revision
Hip System
Taperloc® Complete & Taperloc® Complete Microplasty® Stems
Favorable market dynamics in each segment Opportunities within and across segments
Market leading brands Biomet well-positioned for growth
Segment Market
Size Market Growth
Biomet S.E.T. Growth
Sports $3.0B 5% Q1 FY’14:
19% cc
Extremities $1.2B 8%
Trauma $5.5B 5%
Key New Products
JuggerKnotless™
Soft Anchor
DVR® Crosslock ePAK™
Single Use Delivery System
14 S.E.T. (20% of Fiscal Q1 Sales) Strong Growth in Attractive Markets
Key New Products FY’13/’14: – Comprehensive® Segmental Revision System
– DVR® Crosslock ePAK™
– Signature™ Glenoid System*
– JuggerKnotless™ Soft Anchor
Signature™
Glenoid System
Comprehensive®
Segmental Revision System
Overall New leadership and new HQ reinvigorating organization Spine Unmet needs still drive growth opportunity Historically strong products, but lack of strength in distribution Lanx adds MIS & strength in distribution Bone Healing Stim market challenged by reimbursement pressures Recent Signs of Stabilization & Biomet share gains Microfix Highly successful business Unique solutions within core CMF space, plus seized the opportunity in sternal closure
Cellentra™ Lineum® SternaLock®
HTR PEKK
15 Reshape BSBH: High Growth Spine, Stim Stability
Continued Growth in Microfixation/Sternal Closure
Segment Market Growth
FY’13 Biomet Product
Category Growth*
Spine (2%) Q1 FY’14
3% cc
Bone Healing (2%)
Microfix (CMF) 4%
Products Launched/Key Growth Drivers – Lineum® OCT Spine System (translation screw)
– Cellentra™ VCBM (Viable Cell Bone Matrix)
– Lanx portfolio
*Organic: excludes Royalties & Bracing;
Lanx Investment Thesis
$147M all-cash deal closed on October 31st, 2013
Headquartered in Broomfield, CO
Market Leading Technologies in Minimally Invasive Surgery (MIS)
& Lateral Approach Fusions
Transformative for Biomet Spine:
Best in class products address Biomet’s portfolio gaps – New Timberline® lateral system is best in class in a $350M market – Interspinous fusion systems, Aspen® and Alpine™
Combined sales forces creates strong “top 20+” distributors
Significant sales synergies from combination of product lines & “best athlete”
sales force
Provides scale to compete more effectively
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0%
20%
40%
60%
80%
100%
$0 $1 $1 $2 $2 $3 $3 $4 $4 $5 $5
CY10 CY11 CY12 CY13 CY14 CY15 CY16 CY17
Global Industry Market Size by Segment*
Value / Discount
Premium
Premium Share (right-axes)
17
Market recovery slow and somewhat volatile NA stronger recovery than Europe and Japan
Southern Europe, emerging markets susceptible to value players
High proportion private pay → economic sensitivity
Back to basics to drive growth in the premium market: Introduce differentiated new products
T3 implants, Encode abutments, comprehensive regenerative line, streamlined instrumentarium
Support clinicians with practice building, training and education offerings
Add feet on the street in key markets
Evaluating “make v buy” entry into value market segment to enhance long-term growth potential
Restore Dental Growth: Back to Basics
T3® Implant
-10%
-5%
0%
5%
10%
15%
20%
FY07 FY08 FY09 FY10 FY11 FY12 FY13
3i Growth (WW) Premium Market (WW) Growth Trends
NStride™ APS
• Early Stage Osteoarthritis Autologous Therapy
• First in Human Safety Studies in Progress
Rejuvesol®
• Red Blood Cell Rejuvenation of Aged, Donated Blood
• Restores Oxygen Transport Capabilities
• Recent FDA approval for Blood Bank application • Ongoing work to expand market opportunity to point of
care application
MarrowStim® PAD
• Critical Limb Ischemia (CLI) – Revascularization Autologous Stem Cell Therapy for late stage patients
• Expanded Clinical Studies in Development
18 Increased Investment in High-Value Biologics Programs
Potential platform for expansion in adjacent segments
Invest in Both Emerging Markets & Attractive Low-Share Developed Markets 19
Biomet International has delivered rapid growth by focusing on
both developed and emerging markets
Developed Markets
Led by strong share gains in Japan
Opportunities in Australia
Emerging Markets
Strong base in China
Seasoned Management Team delivering above Market Growth
~1,000 Team Members between 2 manufacturing plants & a direct selling organization
Continue to Expand Distribution
Potential for growth in other emerging markets
Biomet International
Fiscal 2007
Fiscal 2013
CAGR ’07 - ’13
Int’l Net Sales $ 205.1 M $ 480.5 M 15.2%
% of Consolidated Net Sales 9.7% 15.7%
20
Innovation in Product Delivery & Working Capital Management Today Limited data on surgeon preference and patient Hospitals hold excess Biomet inventory & multiple instrument sets Future Digital templating for vast majority of surgeries Patient-specific procedure kits delivered Just In Time Benefits Biomet
Working capital efficiency, easier launches Surgeon
More efficient OR, personalized service Hospital
More efficient OR, less storage/handling Patient
Personalized patient education, improved implant positioning
Improved Patient Experience &
Center-of-Excellence Designation
Improved quality & satisfaction
Maximized operating room efficiency
Targeted length of stay
Service optimization for Joint Replacement Centers of Excellence & Spine, Fracture /
Trauma, & Sports Medicine Practices
Sterilisation Biomet – Bridgend
Facility
Named Patient TKR Procedure
Pack
Just in Time Delivery
Theatre Care Rapide
*The Signature™ System was developed through a partnership with Materialise NV.
Creative Solutions that Deliver Value Efficiently in a Changing World Partnerships to Address Changing Customers
Value Creation Initiatives
Value Creation Program initiated post LBO in mid-2007 has delivered significant cash savings (+$100M) & EBITDA contribution (+$65M), while maintaining the highest levels of quality and customer service
Plant Network Optimization: Reduced Plant Facilities from 17 to 11 (including 2 new China plants) to Lower Cost of Production and Optimize Capacity Utilization
Lean Manufacturing
Strategic Sourcing
SIOP and Inventory Management
Program Now Embedded in Day to Day Operations
Pursuing additional COGS reduction opportunities to offset price pressures and device tax Relentless focus on lean manufacturing
Continue to Evaluate Plant Network in Light of Evolving Health Care Environment
Lower Global Distribution/Warehousing Costs and E&O Inventory
One Patient Solutions Initiative
Improving both efficiency and effectiveness in SG&A and R&D Global Orthopaedics Product Engine Structure
G&A Shared Service and Out-Sourcing Models
Lean and effective Corp HQ Infrastructure
Ensure Sales Force Structure and Service Levels Provide Acceptable ROI
21
($ in millions)
Q1 FY 2014
Q1 FY 2013 Growth
Net Sales $ 730.7 $ 707.4
3.3%
4.3% cc
Adjusted EBITDA(1) $ 246.3 $ 237.8 3.6%
Adjusted Net Income(1) $ 80.8 $ 60.4 33.8%
Total (Net Debt) Leverage Ratio(1) 5.2x 5.4x -
Q1 FY 2014 Financial Summary* 22
(1) As defined by our credit agreement *See Non-GAAP Financial Measures Disclosure on Slide 2
Summary
• From a $17,000 start-up company to a more than $3 billion worldwide enterprise in 35 years
• An unmatched culture of responsiveness to our customers
• A leading innovator in orthopedics
• A strong record of above market growth and excellent financial results
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