Professional Documents
Culture Documents
OCTOBER 2, 2018
CONFIDENTIAL
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SAFE HARBOR
Forward-Looking Statements
This presentation includes statements that may be forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995. The words “believe,” “estimate,” “expect,” “anticipate,” “project,” “forecast” or the negative thereof and similar expressions,
among others, generally identify forward-looking statements. Forward-looking statements used in this presentation include statements
regarding preliminary financial results f or Q3; revenue, EPS and cash burn guidance for 2018, and 2019; future revenue stabilization and
growth, path to attaining cash independence and becoming cash flow breakeven and EPS positive; new product launches; market opportunity,
market penetration and market share growth; timelines for Ovation, AFX, ChEVAS and Nellix regulatory approvals; development of Next Gen
EVAS; commencement, enrollment, progress and completion of clinical trials; restructuring of debt and compliance with debt covenants;
gathering evidence of product superiority; increased productivity; continuing expense control from efficiencies; and anticipated product
labeling. Endologix® cautions that these forward-looking statements are based on management's current expectations, estimates, forecasts
and projections about Endologix, and assumptions management believes are reasonable, and are subject to risks and uncertainties that may
cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are
not limited to, competition from other products, technologies or therapeutic approaches; changes to laws and regulations applicable to our
company and industry; risks regarding the manufacture of our products; progress of our ongoing clinical trials; clinical trial results; decisions
and the timing of decisions of regulatory authorities regarding our products and potential future products; delays in new product launches;
market acceptance of and reimbursement for our products; our ability to access equity and debt capital on acceptable terms; our ability to
enter into or maintain existing financing arrangements on acceptable terms; and risks relating to foreign currency fluctuations. Additional
information about the factors that may affect Endologix’s operations and results is set forth in Endologix’s annual and periodic reports filed
with the Securities and Exchange Commission. Forward-looking statements contained in this presentation are made only as of the date
hereof, and Endologix undertakes no obligation to release publicly any revisions or updates to forward-looking statements as a result of
subsequent events or developments, except as required by law.
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Disclosures
Endologix products and associated components are not available in all countries or regions. Please contact your Endologix representative for
details regarding product availability. Prior to use, refer to the “Instructions for Use” for complete and specific indications, contraindications,
all warnings and precautions.
Rx only.
CAUTION: The Nellix® EndoVascular Aneurysm Sealing System is an investigational device. Limited by federal (or United States) law to
investigational use only.
The Nellix® EndoVascular Aneurysm Sealing System is approved in various geographies outside of the United States to treat infrarenal
abdominal aortic aneurysms and is not approved for any other intended use in any geography. CE Mark.
CAUTION: The Ovation Alto™ Abdominal Stent Graft System is an investigational device. Limited by federal (or United States) law to
investigational use only.
LEOPARDTM is a prospective, randomized, multicenter trial with a real-world patient population, some having anatomies outside approved
indications, to provide a head-to-head comparison of EVAR endograft systems.
ENCORE includes results from real-world post market studies. Four percent of patients had vascular characteristics beyond FDA-approved
anatomic IFU. Safety and effectiveness of Ovation when used outside the IFU have not been established.
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AGENDA
Strategy and Transformation: John Onopchenko
4:15-4:40 p.m.
Five Value Drivers Chief Executive Officer
Vaseem Mahboob
4:40-4:50 p.m. Financial Update Chief Financial Officer
Matt Thompson
4:50-5:00 p.m. Clinical Strategy, Product Portfolio Chief Medical Officer
Marc Schermerhorn, MD
Chief, Division of Vascular and Endovascular Surgery at
5:00-5:10 p.m. Clinical Experience, Ovation Beth Israel Deaconess;
Professor, Surgery, Harvard Medical Center
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KEY TOPICS WE WILL ADDRESS TODAY
1 Commercial Execution Plan
3
De-risked Balance Sheet and
Financing Covenants
5
Product Portfolio Updates and
Leading Clinician Perspectives
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AAA IS A LEADING CAUSE OF DEATH
Some images may illustrate anatomies outside the approved indications for Endologix products and do not imply safe or effective clinical outcomes
will result from use of such products.
Anatomical challenges can make treatment difficult
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GLOBAL AORTIC MARKET EXPECTED TO REACH $3.3B BY 2021
Traditional AAA Complex AAA*
$1.6B $1.2B
Current
Market
$2.8B $0.3 $0.8
Projected $1.4B
Market
$1.9B
$3.3B
9%
(by 2021) 4%
Endo
Endo 86% endo 41% endo
CAGR
CAGR penetrated penetrated
>6 months to 2% 1%
rAAA 8 5.4% 4 years 12/599 8/581
1.48 (0.60-3.62)
Schermerhorn et al NEJM 2015; 373: 328-338 Patel et al Lancet 2016; 388: 2366
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THE ENDOLOGIX CALL TO ACTION
Realities We Faced in Q3 2018… …Precipitated Our Strategic Reset
Reality 1: Declining revenues Stabilize revenue, return to growth by Q4 2019
• Declining U.S. AFX2 sales following recall • AFX2 proving durable, strong brand and value prop
• EU sales declines from narrowed Nellix IFU • Ovation ENCORE™ data is compelling
• Alto launch preparations underway
Reality 2: Unprofitable, cash strapped
• Chased revenue with little regard to profitability Secured cash, lowered cash consumption
• U.S. sales expense >30% of global revenue • EU 40% reduction in force, 13 fewer countries
• Lack of effective performance management • U.S. sales expense reduction ($10M target)
• Unrealistic growth required to meet plan • Cash flow positive projected by 2020
• Covenants did not reflect risk of the business
Reality 3: Execution faltering, credibility eroded New leadership, focus on program discipline
• Broad leadership lapses, planning lacked rigor • Program Management Office, rigorous prioritization
• Uncompetitive costs to support platforms globally • New leadership in R&D, Manufacturing, Supply
• Ineffective incentives drove suboptimal behaviors Chain, Quality, Clinical and Regulatory Affairs
• Focus on retention of top performers, bottom 20%
removed
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THREE STAGES OF TRANSFORMATION
BEGINS WITH FOCUS ON FIVE VALUE DRIVERS
2022 & Beyond
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EARLY READ ON Q3 2018
Informed Improved 2018 Guidance U.S. Market Approach
Strengthen Our Foundation: 2018-2019
• Completed planned restructuring in U.S.
• Changes benchmarked by 3rd party experts. Stabilize and Grow AFX2 sales
• Continue to closely manage impact of FSNs and Targeted Move Upmarket to higher-
changes on customers and field through Q1 2019 volume centers with Ovation, Alto
Established new structure and performance management process with clearly defined objectives
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to rep-level Investment in independent customer data, refreshed 2x/yr, completed
U.S. CUSTOMER COVERAGE
16 7.5 6
YEARS YEARS YEARS
Top 20 reps consistently generate ~$2.7M per year
Clinical Specialist average tenure: 4.5 years
# HOSPITALS / ANNUAL EVAR 75 / 5,625 125 / 13,125 760 / 21,392 640 / 4,608
% HOSPITALS / % ANNUAL EVAR 5% / 13% 48% / 48% 40% / 10%
8% / 29%
Physicians
AVG # EVAR IMPLANTERS 4.5 5.0 2.5 1.5
AVG EVAR / YR / IMPLANTER 17 21 11 5
Endologix
Position AFX2 Mid-single digit Low-double digit
MARKET SHARE to mid-teens
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Endologix market model, Third-party market research; Annual EVAR for traditional AAA, excludes complex AAA.
GAINING SHARE IN THE U.S. BY YE2019
1 3
Shift the basis of
Change sales model, Anticipate AFX2 is stable by YE
competition from niche
aligning top talent with key anatomic needs to achieving 2019, Growth then realized by
accounts/ opportunities superior outcomes Ovation, then Alto with both
base and new customer
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INTERNATIONAL MARKETS: PROGRESS IN ALL MARKETS, FOCUSING
INVESTMENT, ALIGNING TO EXECUTE
EU: Lower Revenue & Lower Investment Latin America: Continue to invest in existing
distributors to drive growth
New European device regulations impacting Med- Tech
Strong growth in Argentina despite currency issues,
industry negatively
strong market share positions
Nellix IFU realities drove sequential sales declines. AFX and
Brazil starting to grow again through investments in
Ovation growth remains modest
channel and market development,
Stabilize direct country coverage
Expecting product approvals to drive growth
Effective management of expenses as revenue lowered;
retiring distributors in exited countries South East Asia: Focus on durable and
Invest in Alto introduction predictable growth: Japan and Korea
Reinforce Nellix procedural training Solid growth experience in Japan
Continue to grow relationship with JLL
Product launches planned
Korea: push for reimbursement and product
approval launches in next 12-24 months
Exit non-profitable, high cost-to-serve markets,
focus on indirect channel
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STRATEGIES TO CAPTURE VALUE
AFX2 OVATION / ALTO NELLIX NEXT-GEN EVAS
Unique Pioneered concept of “sac
anatomical ENCORE demonstrates Polymer cuff at
BENEFITS
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Vaseem Mahboob,
Chief Financial Officer
OCTOBER 2, 2018
CONFIDENTIAL
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KEY TOPICS WE WILL ADDRESS TODAY
1 Commercial Execution Plan
3
De-risked Balance Sheet and
Financing Covenants
5
Product Portfolio Updates and
Leading Clinician Perspectives
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Raising Low End of Guidance Range to $150M
Revenue Guidance Bridge
FY 2018 REVENUE
(in millions)
$175 (8)
$150-155M
$167 (7)
$160 (2) (1) - (3)
(2) - (5)
Second-Half Drivers Update
$150 - $155
AFX (3)
MKT (2)
LA (3)
FSN (2)
Field Safety Notices: impact
Reg (2)
CTS (2) less than anticipated
U.S. and EU cost to serve:
better than expected in Q3,
monitoring attrition risk
Executed on OUS
restructuring: assessing
distributor contracts and
timing
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FY 2018 REVENUE GUIDANCE
(in millions)
FY 2018 REVENUE
Ovation
AFX2
Q317 Q417 Q118 Q218 Q318 Q418 Q119 Q219 Q319 Q419
Strong Ovation
Slow AFX2 Strategic reset Modest growth Stable AFX2 and
growth not
recapture post and associated in Ovation and growing Ovation
enough to
supply issues disruption small declines in
offset AFX2
AFX2
decline
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GLOBAL REVENUE DYNAMICS
OUS
U.S.
Q317 Q417 Q118 Q218 Q318 Q418 Q119 Q219 Q319 Q419
(6.5)
$130 - $140
R&D: Focus on Next-gen
EVAS, Thoracic program
discontinued
Clinical: Alto, ChEVAS &
EVAS2 IDE studies
Sales & Marketing: U.S.
Reps & Clinical ~95. OUS
footprint reduction.
G&A: Impact of one-time
items in FY18 & reduced
Midpoint of FY18 R&D Clinical investments Cost to Serve G&A FY19 Target
headcount.
Guidance
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IMPLICATIONS TO FINANCIAL COVENANTS: Status at 3Q 2018
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* Tested excluding one time items
FINANCING & LIQUIDITY PLANS
ABOVE-MARKET GROWTH &
CASH FLOW BREAKEVEN
2020
STEP 3: Exchange/Refinance $84.5M 2020 maturities in 2019
Completed exchange of $40.5 of $125M into non-dilutive debt
Goal: Clear path to cash independence
2019
2018
STEP 1: Refinance ABL
Bridge to cash flow positive
GOAL: Improve short-term liquidity, ABL secured
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1. 2H 2018 tracking better than expected
- Updated range reflects disruption risk in U.S. and impact of
market exits
FINANCIAL - Confident in $150M-$155M revenue range for 2018
SUMMARY 2. Q4 guidance $29M-$33M driven by two major factors
- Field Safety Notices for AFX and Ovation
- Commercial changes in U.S. and Europe
3. Management team confident in ability to clear financial covenant risk
- Forecasting $140M floor to 2019 sales
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Matt Thompson, M.D.,
Chief Medical Officer
OCTOBER 2, 2018
CONFIDENTIAL
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KEY TOPICS WE WILL ADDRESS TODAY
1 Commercial Execution Plan
3
De-risked Balance Sheet and
Financing Covenants
5
Product Portfolio Updates and
Leading Clinician Perspectives
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CONVENTIONAL EVAR – READY FOR NEW INNOVATION
https://www.nice.org.uk/guidance/indevelopment/gid-cgwave0769
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THE LIMITATIONS OF CONVENTIONAL EVAR
Current Device
Competitors
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ENDOLOGIX PORTFOLIO DIFFERENTIATED FROM
“CONVENTIONAL EVAR”
Anatomically adaptive to mitigate the late
failures compromising “conventional EVAR”
and assessed with unrelenting commitment to
high-quality evidence
Current products achieve excellent outcomes
as assessed by large cohort studies (ENCORE)
and the only randomized controlled trial of
EVAR (LEOPARD™)
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STABILIZING AFX2
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AFX TYPE III ENDOLEAKS - CUMULATIVE PREVALENCE
AFX STRATA IIIb
IIIb ENDOLEAKS 0.8
0.7
2.50%
0.6
2.00% 0.5
0.4
Type IIIb Endoleaks Rate
1.50% 0.3
0.2
1.00% 0.1
AFX w/Strata 0
0.50% AFX w/Duraply Y1 Y2 Y3 Y4 Y5 Y6
AFX2 w/Duraply USA STRATA SALES – 18,217
0.00% 7,000
Years Post-Implant
Y1 Y2 Y3 Y4 Y5 6
Y1 Y2 Y3 Y4 Y5 Y6 6,000 64% HAVE
AFX 0.1% 0.4% 0.9% 1.6% 2.0% 2.0% 5,000 REACHED
w/Strata 32/23,965 101/23,965 225/23,960 318/19,606 210/10,598 73/3,614 5Y
AFX 0.2% 0.3% 0.5% 4,000
w/Duraply 30/19,152 40/14,579 22/4,883
3,000
AFX2 w/ 0.1% 0.0%
Duraply 5/5,868 0/285 2,000
1,000
0
2011 2012 2013 2014 2015
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AFX Strata FIELD SAFETY NOTICE – CLASSIFICATION
Continuing to address management of patients with Strata in collaboration with
FDA and other regulatory agencies (FSN and re-lining instruction)
Dec. 2016 – ELGX issued FSN that constituted a voluntary recall of AFX Strata
July 2018 – ELGX issues FSN reintervention instructions and IIIb rates of all AFX
branded products
Oct. 2, 2018 – FDA classified our July, 2018 voluntary recall as Class I
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GROWING OVATION, THEN ALTO
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INVESTING IN EVIDENCE-DRIVEN PRODUCTS
Q1 2019 Q2 2019 Q3 2019 Q4 2019 2020 2021
Design goals:
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ESTABLISHING THE ENDOLOGIX ADVANTAGE
EVAS
Ovation/ALTO/EVAS
Ovation/ALTO/EVAS
AFX2
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Physician Panel
OCTOBER 2, 2018
CONFIDENTIAL
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John Onopchenko,
Chief Executive Officer
OCTOBER 2, 2018
CONFIDENTIAL
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1. We are a company undertaking a transformation
• With new, highly experienced leaders
• Aligned by a new strategy and a common belief that our products and supporting
clinical evidence are undervalued.
STRENGTHENING
OUR 2. We’ve completed a U.S. and EU restructuring
FOUNDATION • Providing clear line-of-sight to reducing cash burn from $12M to $5M a quarter by
YE ’19
• On a path to cash flow positive by 2020.
• Our return to sequential growth is expected to begin in the 2H 2019.
• Cash management and executing upcoming refinancing remain critically important
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