20
NOVEMBER 6, 2019 Investor Presentation

2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

NOVEMBER 6, 2019

Investor Presentation

Page 2: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

SAFE HARBOR

2

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.

Page 3: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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.

3

Page 4: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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.

4

Page 5: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

Page 6: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

6

Page 7: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

§ 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

7

(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.

Page 8: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

8

Page 9: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

Pioneered concept of “sac management”

Statistically significant mortality benefit vs. traditional EVAR despite higher rate of re-intervention

1

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

Page 10: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

LEOPARD DATA: AFX OUTCOMES EQUIVALENT TO COMPARATIVE GRAFTS

10

• 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

Page 11: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

Page 12: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

• 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.

Page 13: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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%

13

Page 14: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

2019 CATALYSTS

14

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.

Page 15: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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)

1

2

3

4

Partnering with High-Volume Customers built by Four Common Beliefs:

Outcomes must improve

Not going backwards

Evidence more rigorous

Resulting claims more clinically impactful

15

Page 16: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

16

Q2’19 Act

$36.2

Q3’19 Act Q4’19 Est

$35.8

Page 17: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

17

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

Page 18: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

18

Page 19: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

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

Page 20: 2019.11.06 - ELGX FY19Q3 Investor Presentation - FINAL

20