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NOVEMBER 6, 2019
Investor Presentation
SAFE HARBOR
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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 revenue guidance for the fourth quarter of 2019 and full fiscal year 2019 (and related assumptions and estimates); future revenue stabilization and growth strategies, cash burn reduction efforts; path and timing to attaining market growth and becoming cash flow breakeven and EPS positive; achievement of category-leading compliance; timing and success of new product launches; market opportunity, strategies and penetration; market share growth; timelines for Ovation/Ovation Alto, AFX, ChEVAS, Next Gen EVAS and Nellix enrollment and/or regulatory approvals; development of Ovation Alto, ChEVAS, Next Gen EVAS and other pipeline products and technologies; the benefits associated with our products and technologies; design, commencement, enrollment, progress and completion of clinical trials; management of employee attrition; restructuring/refinancing of debt and maintenance of related obligations; increased productivity; continuing expense control from efficiencies; and anticipated product attributes and labeling. Endologix® cautions that these forward-looking statements are based on management's current expectations, estimates, forecasts and projections, which are based upon assumptions and estimates that 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; our ability to comply with covenants and other restrictions under our borrowing; our ability to service our existing indebtedness and refinance or discharge it at or prior to maturity; changes to laws, regulations and industry guidance applicable to our company, products and industry; risks regarding the manufacture of our products; progress of our ongoing clinical trials; clinical trial results; decisions of regulatory authorities regarding our products and potential future products; key employee attrition; delays in new product launches; market acceptance of and reimbursement for our products; our ability to access equity and debt capital on acceptable terms, or at all; IP risks including risks related to product infringement and invalidity claims; 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.
DisclosuresEndologix 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. It is not currently commercially available in any market.
CAUTION: The Ovation Alto™ Abdominal Stent Graft System is an investigational device. Limited by federal (or United States) law to investigational use only.
CAUTION: Next Gen EVAS and Nellix® ChEVAS are pipeline technologies and are not currently approved for commercial purposes in any market.
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.
© 2019 Endologix, Inc. All Rights Reserved.
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Endologix’s anatomically adaptive products address a wide variety of anatomical challenges to enable effective, durable outcomes
ABDOMINAL AORTIC ANEURYSMS ARE 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.
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GLOBAL AORTIC MARKET EXPECTED TO REACH $3.9B BY 2023
$0.4
$0.9
Endo Treated Open Opportunity
Complex AAA*$1.3B
$1.4
$0.4
Endo Treated Open Opportunity
~30% endo penetrated
Traditional AAA$1.8B
~75% endo penetrated
CurrentMarket
$3.1B
ProjectedMarket
$3.9B(by 2023)
$1.7B
$2.2B
5%EndoCAGR
9%EndoCAGR
~33% endo penetrated
~80% endo penetrated
*Uses not yet approved for our products but part of our clinical development plan/in the pipeline
Endologix market model, third-party market research 5
EVAR IS THE STANDARD OF CAREBut Long-Term Outcomes Need to be Improved
Schermerhorn et al NEJM 2015; 373: 328-338 Patel et al Lancet 2016; 388: 2366
rAAA 8 years
EVARn=626
OPENn=626
N% N% Hazard Ratio (95% CI)
All patients 9%66/626
7%45/626
1.24 (0.84-1.83)
0-6 months 2%14/626
5%30/626
0.46 (0.24-0.87)
>6 months to 4 years
2%12/599
1%8/581
1.48 (0.60-3.62)
>4-8 years 3%14/474
1%4/464
3.46 (1.14-10.52)
>8 years 5%16/339
1%3/333
5.50 (1.60-18.89)
ANEURYSM-RELATED MORTALITYRUPTURE OR REINTERVENTION
5.4%EVAR 1.4%
OPEN
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§ Continued outcome limitations of conventional EVAR
§ Public health draft guidelines (NICE) limit use of conventional EVAR
§ Accepted paradigms challenged (failure modes, surveillance)
§ Aneurysm sac enlargement now established as a dominant failure mode influencing long-term patient outcomes (survival)
§ Poor outcomes partly attributed to large proximal aortic neck (LAN)(1)
CONVENTIONAL EVAR – READY FOR NEW INNOVATION
https://www.nice.org.uk/guidance/indevelopment/gid-cgwave0769
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(1) Kouvelos GN, Antoniou G, Spanos K, Giannoukas A, Matsagkas M. Endovascular aneurysm repair in patients with a wide proximal aortic neck: a systematic review and meta-analysis of comparative studies. J Cardiovasc Surg (Torino). 2019
Apr;60(2):167-174. doi: 10.23736/S0021-9509.19.10869-5. Epub 2019 Jan 18. PubMed PMID: 30665285.
ENDOLOGIX PORTFOLIO DIFFERENTIATED FROM “CONVENTIONAL EVAR”
Anatomically adaptive to help 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™)
We believe that ALTO and EVAS must be tested for superior outcomes relative to“conventional EVAR”, and we are generating evidence to support this claim
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Pioneered concept of “sac management”
Statistically significant mortality benefit vs. traditional EVAR despite higher rate of re-intervention
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STRATEGIES TO CAPTURE VALUE
ENCORE demonstrates excellent 5-year data
Polymer cuff at proximal aortic neck with sac management aspects of Nellix
Separate fixation from seal and sac management
Prevalence of Type IIIB leaks significantly higher with earlier version of the product
Industry’s first polymer based endograph achieves 5-year durability. New failure mode with manageable complication
Migration issues identified in 2-yr follow-up led to refined IFU and FSN’s
LEOPARD reports improved performance of AFXs since 2015
Data from industry's first randomized head-to-head study presented at VEITH
ALTO to address a broader array of patients given position of sealing rings
Data from pivotal study that is recruiting in the U.S.
Evaluating inclusion of ChEVAS protocol under the same IDE that would address complex anatomies not well served by existing devices
A category defining product if long-term complications of EVAR can be addressed and a “game changer” if survival benefit can be validated
FREEDOM FROM (FF)ENCORE Benchmark
ALL CAUSE MORTALITY 99%CONVERSION 99%RUPTURE 99%REINTERVENTION FOR TYPE IA ENDOLEAK 98%
DEVICE-RELATEDREINTERVENTION 93%
AFX2 OVATION / ALTO NELLIX NEXT-GEN EVAS
BEN
EFIT
S
CHAL
LEN
GES
STRA
TEG
IES
Unique anatomical fixation design is well suited for challenging proximal and distal anatomies
A "door opener” given ability to serve these niches
(1) Schermerhorn All-Cause-Mortality Analysis of Nellix IDE Patients vs. Vascular Quality Initiative® Registry
Nellix and Ovation Alto are investigational devices in the U.S. and are not currently commercially available in any market. Next Gen EVAS is a pipeline technology and is not currently approved for commercial purposes in any market. 9
LEOPARD DATA: AFX OUTCOMES EQUIVALENT TO COMPARATIVE GRAFTS
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• Directly compare endograft performance using methodology of a randomized controlled trial -
Level 1 evidence• 1:1 randomization sequentially powered to
evaluate non-inferiority and superiority
hypotheses with a primary end point of ARC• ~ 50% had source document validation at 1y
• 455 patients with planned 5 year follow up (235 AFX Duraply / AFX2 – 220 comparator grafts [Cook, Medtronic, Gore])
• Pre-op images core lab analysis, clinical events site reported
Free
dom
AR
C
INVESTING IN EVIDENCE-DRIVEN PRODUCTS
Q1 2019 Q2 2019 Q3 2019 Q4 2019 2020 2021
EVAS2 enrollment
Expected to fully enroll in early 2020, approval timeline unchanged
NELLIX 3.5 approval
ChEVAS IDE approval
Approved
NG EVAS development
11The timelines set forth are currently projected and subject to change based on market conditions, business considerations, and other unforeseeable events.
ChEVAS enrollment
• Designed to address physician feedback on Ovation iX
• Sealing collar moved to 4mm from renal
• Designed to increase patient applicability
• Integral balloon
• Designed to reduce time pressure for cannulation & ease
procedure technique
• Easier sizing
• U.S. approval is expected early 2020
• Aim to prove superiority in comparative RCT
OVATION ALTO: DESIGNED TO HAVE BROADEST PATIENT APPLICABILITY, TO TREAT 80% OF INFRARENAL CASES AND 26% OF COMPLEX CASES ON LABEL
12The timelines set forth are currently projected and subject to change based on market conditions, business considerations, and other unforeseeable events.
40% 55% 69% 80%
*Product-level market opportunities have overlap with one another and are not additive. Based on existing and estimated FDA Labeled Indications. Derived from M2S Database of 43,000 AAA CT scans, other sources and company estimates. Represents treatment applicability based upon company estimates, anticipated labeling and currently available information. Nellix and Ovation Alto are limited to investigational use only in the U.S. and are not currently commercially available in any market. Nellix ChEVAS is a pipeline technology and is not currently approved in any market. 13
PATIENT APPLICABILITY AND MARKET OPPORTUNITY
50% 26%
TRADITIONAL
COMPLEXTotal ELGX63%
PRODUCT LEVEL MARKET
OPPORTUNITY*
$0.7B $0.7B $1.3B$1.0BTOTAL MARKET
$3.1B$1.8B
TOTALELGX
$2.3B
Total ELGX80%
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2019 CATALYSTS
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Clinical Evidence
Product Approvals
Commercial Execution
ü Achieve approval for CHEVAS IDE & initiate enrollment in early 2020§ Complete enrollment in EVAS2 IDEü Disseminate updated LEOPARD data
§ Alto approval updated to early 2020ü Nellix CE mark re-instated (limited use under protocol)ü Ovation Prime approved in Japan
§ Stabilize USA AFX§ Achieve sequential sales growthü Targeted OUS presence
ü Announced Boston Scientific agreement in Chinaü Exited S. Korea
Continue investments in R&D and clinical development while focusing on commercial execution
These 2019 catalysts are anticipated and may not be realized for a variety of reasons, including clinical, regulatory and market conditions, business considerations, and other factors.
GAINING SHARE IN THE U.S. BY YEAR-END 2019
Anticipate stability in AFX2 sales by YE 2019. Ovation and, subsequently, Alto expected to then drive growth by both existing and new customers
Target 2% segment shift, yielding $10M in additionalrevenue
Goal is attainable with less than 10 additional cases/year/rep
Change sales model, aligning top talent with key accounts/opportunities
Shift the basis of competition from niche anatomic needs to achieving superior outcomes
Leverage clinical evidence more effectively
Deploy clinical specialists to support base business (AFX2)
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2
3
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Partnering with High-Volume Customers built by Four Common Beliefs:
Outcomes must improve
Not going backwards
Evidence more rigorous
Resulting claims more clinically impactful
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FY 2019 REVENUE GUIDANCE(in millions)
2019 CRITICAL CONSIDERATIONSTO CREATE A MORE COMPETITIVE ENDOLOGIX
§ Drive sequential growth in 2019
§ Stabilize U.S. AFX business in second half 2019
§ Continue to manage attrition
FY 2019 REVENUE GUIDANCE
At least $140M
$34.8 $34.7
Q3’18 Act Q4’18 Act
$32.5 – 35.5$35.6
Q1’19 Act
2019: $140M
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Q2’19 Act
$36.2
Q3’19 Act Q4’19 Est
$35.8
Q4'18 Q1'19 Q2'19 Q3'19FinancialRevenue + + + +MarginsOPEX +Guidance + + +
ClinicalEVAS2CHEVASALTO 2H 2019 2H 2019 Early 2020 Early 2020
CommercialUS AFX Stability +USA OvationAttritionOUS vs. Expectations +
Q3 FY19 OPERATIONAL SCORECARD TO MEASURE THE SUCCESS OF OUR TRANSFORMATION
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Continue to make progress on foundational goals, reflected in better-than-expected performance since Q3 ‘18
Stabilize, then grow AFX2 sales
Grow Ovation, then Alto sales
Increase Commercial Productivity, aligning resources, and overall lower cost of sales
Targeted Move Upmarket to higher-volume centers with Ovation, Alto
U.S. Market ApproachStrengthen Our Foundation: 2018-2019
Scorecard as of 9/30/19
Accelerate Innovation & Profitable Growth
Grow Above Market
Next Gen EVAS Global IDE
Demonstrate Superiority of Alto
Consistently Achieve Category Leading Compliance
Launch Next Gen EVAS in US & EU
EPS Positive
2022 & Beyond
Re-establish Durable, Predictable Growth
Grow Above Market
World-Class US Alto Launch
Generate Evidence to Demonstrate Superiority of Alto
Nellix 3.5 approval in U.S.
Initiate Next Gen EVAS
Complete Enrollment in ChEVAS IDE
Achieve Cash Flow Breakeven
2020-2021
2018-2019
Strengthen Our FoundationOptimize Global Presence & Restore Credibility
Prioritize, Resource, and Perform Predictably
World-Class EU Alto Launch
THREE STAGES OF TRANSFORMATION BEGINS WITH FOCUS ON FIVE VALUE DRIVERS
MARKETS
PRODUCTSCLINICAL DEV
OPEXCULTURE
ONE ENDOLOGIXAligned actions towards achieving results
PATIENTS FIRST!Prioritize patients above all else
ACCOUNTABILITYConsistently expect high performance
OPERATIONAL EXCELLENCEEnsure compliant, high-quality execution
Five
Val
ue D
river
s
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FINANCING & LIQUIDITY PLANS
STEP 1: Refinance ABLü Improve short-term liquidity, ABL secured
STEP 2: Right-size business for long-term growthü Restructure business in line with Med Tech comparatorsü Lower cost to serve & reduce headcountü Complete exchange of $40.5M of $125M Convertible Note into non-dilutive
debt
STEP 3: Address the Balance Sheetü Address 2020 maturities, reduce debt & enhance liquidity § Reduce 2019 cash burn to approximately $20M
ABOVE-MARKET GROWTH & OPERATING CASH FLOW BREAKEVEN2020 / 2021
2019
2018
19
20