Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in...

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(Nasdaq:EVAR) Corporate Update Simon Hubbert, CEO Bill Kullback, CFO June, 2015

Transcript of Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in...

Page 1: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

(Nasdaq:EVAR)

Corporate Update

Simon Hubbert, CEO

Bill Kullback, CFO

June, 2015

Page 2: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Safe Harbor

This presentation contains forward-looking statements as that term is defined in the Private Securities Litigation Reform

Act of 1995, as amended. These forward-looking statements are based on management’s current expectations, but are

subject to risks and uncertainties that could cause actual results to differ materially from either historical or anticipated

results depending on a variety of factors. All statements contained in this presentation that do not describe historical facts

may constitute forward-looking statements. Statements that address activities, events or developments that we expect or

anticipate may occur in the future, including such things as our outlook, future capital expenditures, changes to the

composition or level of our revenues, cash flow and liquidity, compound annual growth rates (CAGR), business strategies,

competitive strengths, goals, the benefits of new initiatives, growth of our business and operations, plans and references

to future successes, are forward-looking statements. Also, when we use the words such as “anticipate”, “believe”,

“estimate”, “expect”, “intend”, “plan”, “probably”, or similar expressions, we are making forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking

statements: risks and uncertainties relating to adverse changes in conditions in the global economy and volatility in the

capital markets, the development and commercialization of the Company’s products, the Company’s distribution network,

the cost and pricing of the Company’s products, physician education, manufacturing, competition, dependence on

collaborative partners and key suppliers, capital spending and funding policies, changes in governmental regulations,

intellectual property rights, litigation, and exposure to foreign currency fluctuations and other risk factors discussed from

time to time in the Company’s filings with the Securities and Exchange Commission (the “SEC”). These and other factors

are identified and described in more detail in the Company’s filings with the SEC, including, without limitation, the

Company’s recent Annual Report on Form 20-F and the Company’s other reports on Form 6-K.

All forward-looking statements in this presentation are made as of the date of this presentation. We do not undertake,

and expressly disclaim, any intent or duty to update these forward-looking statements whether as a result of new

information, future events or changes in expectations, other than as required by law.

This presentation is for information purposes only and does not constitute an offer of, or a solicitation to purchase or

subscribe for, any securities. You should make your own independent examination of us and consult your own

independent counsel, business advisors, tax advisors, investment advisors or other authorized advisors as to the legal,

business, tax, investment or any other matters pertaining to us or our securities.

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Page 3: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

An innovative vascular device company

Lombard Medical at a Glance

A global, commercial stage medical

technology company

Headquarters in Irvine, CA, manufacturing in

Oxfordshire, UK

Focused on the $1.6B abdominal aortic

aneurysm (“AAA”) repair market

Aorfix: The only globally approved AAA

stent-graft for aortic neck angles up to 90 degrees

Commercially focused in US, Europe, Japan

‒ FDA approved, formal launch Nov 2013

‒ Regulatory approval in Japan, launch in Sept 2014

NASDAQ IPO on Apr. 25, 2014 (ticker: EVAR) raised $55M

Objective – To offer Endovascular AAA repair to more patients than our

competitors 3

Page 4: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

1 Medtech Ventures: Aortic Intervention Market (2014)

Global addressable market of $1.6B growing at a CAGR of 6% annually

EVAR Market is Attractive with Strong Growth

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~500,000 patients diagnosed annually

Untreated AAA can rupture and cause death

Current AAA treatment

‒ Minimally invasive EVAR = 75% of procedures

‒ Open repair surgery = 25% of procedures

EVAR is growing vs. open surgical repair

‒ Lower mortality rate

‒ Lower morbidity/fewer complications

‒ Shorter hospital stay (approx. 3 days vs. 9 days)

‒ Shorter recovery period (2 weeks vs. 12 weeks)

Tortuous Anatomy is a significant issue

‒ 20% of AAA patients have neck angles

>60 degrees

‒ 10% of AAA patients have tortuous iliac vessels

EVAR market drivers

‒ Aging patient population

‒ Increase in AAA screening

‒ Better outcome vs. surgery

$1.9 Billion by 20181

‒ 2015 WW market = $1.6B1

‒ 6% CAGR growth annually1

$1.4$1.5

$1.6$1.7

$1.8 $1.9

2013 2014 2015 2016 2017 2018

EVAR MarketOverview of AAA

$B

illio

ns

Page 5: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Flexible halO™ Design Offers Unrivalled Flexibility

Competitors' “Z” type metallic ring designs are more rigid, may kink in tortuous anatomy increasing re-interventions and poor

clinical outcomes

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Page 6: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Source: Images courtesy of Musgrove Park Hospital, Taunton

Unique Design to Address Tortuous Anatomy

Aorfix can provide better outcomes for patients with tortuous vascular anatomy

Proprietary halO Stent Technology™ featuring helical and circular design

promotes flexibility

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Before procedure 12 months after

procedure

Page 7: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Company AAA Stent-GraftMax Approved US

Neck Angle Indication

Lombard Aorfix ≤ 90°

Medtronic Endurant ≤ 60°

Cook Zenith ≤ 60°

Gore Excluder ≤ 60°

Endologix Powerlink ≤ 60°

TriVascular Ovation ≤ 60°

Broadest Global Indication

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“Potential to expand physicians’

on-label practice by ~20%”

Page 8: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

13th leading cause of

death in US and the 10th

leading cause of death in

US men aged 65 years

and older

Each year, 200,000

patients are diagnosed

with AAA

High EVAR volumes and

higher selling price

2nd largest standalone EVAR

market in the world growing at

an average rate of 18%

Highly developed and lucrative

market with high barriers to

entry

~400 physicians at 200 clinics

performing EVAR and it is

estimated that approximately

55% of Japanese AAA

patients are treated using this

method

Market was estimated to be

$477M in 2014; growing at an

average growth rate of 6%

Germany and the United

Kingdom are two of the

three largest and the

most receptive EVAR

markets

Lombard is Focused on Three Key Markets

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United States

~ $714M1

Europe~ $477M2

Japan

~ $158M2

Global EVAR Market Landscape

1 iData Research Inc.: US Market for Peripheral Vascular Devices and Accessories (2013)2 Medtech Ventures: Aortic Intervention Market (2014)

Page 9: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

US Commercial Strategy

US is the largest AAA market valued

at an estimated $714M in 2014

Aorfix FDA approved - full commercial

launch November 2013

Build out experienced sales force to 35 in mid-2015

‒ Recruiting experienced EVAR reps or those with strong endovascular

experience

‒ Equipped with most advanced field training tools

Aorfix cases completed in almost 150 US centers since launch

using least invasive technique across all neck angles:

‒ ~50% below 60 degree neck angulation

‒ More than half performed percutaneously

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Page 10: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

1 Medtech Ventures: Aortic Intervention Market (2014)

Japanese Commercial Strategy

Japanese Market Dynamics

‒ World’s second largest AAA market

‒ ~8,000 AAA procedures in 2014

‒ Well reimbursed ~$14,0001

Launch of Aorfix in Japan

‒ Partnering with Medico’s Hirata

‒ Medico’s Hirata has significant experience in EVAR and a direct sales force trained in the Japanese AAA market due to a prior relationship with another AAA stent-graft company

‒ Unique regulatory approval for Aorfix to treat angulation ≤90 degrees granted in August 2014

‒ Formal launch in September 2014. Strong start, tracking toward 5% market share in Q2/3 2015

‒ Approval of latest Aorflex™ delivery system received in Q1 2015

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Page 11: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Spain and Italy

are supported by

a sales manager

in each country

Direct-markets with sales

team of 10

Expect to

increase sales

force in Germany

Direct

Distributor

Spain

U.K.

Germany

Italy

Well Established European Union Strategy

Four main EU markets are: UK,

Germany, Spain and Italy

‒ Direct-markets: UK and Germany

‒ Key distribution markets: Spain and Italy

‒ Primarily utilize country-specific

distributors for smaller EU countries

Aorfix high angle approval in 2009 –

7% UK market share in 3 years

Western Europe direct market sales

increased 14% in 2014 to $3.4M

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Page 12: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

0

0.5

1

1.5

2

2.5

3

3.5

4

Q1 2013 Q1 2014 Q1 2015

$M

0

2

4

6

8

10

12

14

16

18

20

2012 2013 2014 2015

$M

Lombard Revenue Contribution by Geography

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Accelerating Revenue from US and Japan Launch

JP Market

ROW Distributor

Markets

US Market

W Europe

Direct Markets

US Market

W Europe Direct Markets

2015 Projection ($18-20M)

JP Market

ROW Distributor

Markets

Page 13: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Platform Technology with Strong Development Pipeline

Aorfix™Plus size range extension FDA approved to 36mm

‒ Ability to treat patients with larger anatomies

‒ Allows treatment of up to 10% more patients with Aorfix

‒ US launch of 34mm stent graft in Q1 2015

Next-generation delivery systems

‒ Lower profile design – treat patients with narrow access vessels

‒ Exchange sheath – reduce vessel trauma

‒ Intuitive & compact – ease of use

‒ Regulatory submission of next generation IntelliFlex™LP system anticipated 2H 2015 with expected approval within 90 days of submission

Thoracic stent-graft

‒ Potential to develop technology to expand indications within endovascular surgery

• To treat thoracic aneurysms (TEVAR)

• To treat complex short neck anatomy (FEVAR) 13

New Product Development

Page 14: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

iData Research Inc.: US Market for Peripheral Vascular Devices and Accessories (2013)

Market Size

EU US

Units

Thoracic EVAR (TEVAR) Market

Aorfix technology can be applied to TEVAR segment

US market forecasted to grow by 79% from 2013 – 2018

Aorfix flexibility should offer significant advantages over competitors in

thoracic arch

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TEVAR Stent Business Opportunity

$287

2013E 2018E

$450

23,504

2013E

38,395

2018E

$M

Page 15: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

1.Aortic Endografts Market 2015 Report

2.Company Estimates based on currently available published studies

Fenestrated EVAR (FEVAR) Market

Aorfix technology has the potential to address the FEVAR segment

Aorfix technology may offer significant advantages over competitors

‒ Compliant construction allows fenestrations to have mobility and reduces ‘No-Go’ areas for fenestration

‒ Off-the-shelf devices could treat many more anatomies

‒ Flexible construction eases angulation restrictions placed on existing commercial FEVAR IFUs

Fenestrated and branched aortic endografts in 2014 totaled $50M in global sales and is expected to grow1

Several studies have shown that the average incidence of short necks (<10mm) is at least 20% of the $1.4B aortic endograft market2

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$280M market opportunity which is currently underserved

FEVAR Business Opportunity

Page 16: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Financial Highlights – Q1 2015 and Guidance

Total 2015 first quarter Aorfix revenue grew 66% to $3.4M compared to revenue of $2.1M in the first quarter of 2014. US Aorfix revenue grew to $1.1M in the first quarter of 2015, up 125% from $0.5M in the first quarter of 2014.

Gross margin for the 2015 first quarter was 46% compared to 34% for the prior year period.

In April, the Company entered into a $26M secured term loan facility with Oxford Finance LLC. Lombard Medical received $11M in proceeds at the loan closing on April 24 with additional funds becoming available upon achievement of near-term revenue milestones. Cash at March 31, 2015 was $45.1M.

FY 2015 Guidance

‒ Revenues of $18M - $20M

‒ Procedure numbers to more than double in four key markets (US, Japan, Germany, UK)

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Page 17: Corporate Update - Jefferies...A global, commercial stage medical technology company Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.6B abdominal aortic

Conclusion: A Differentiated Growth Opportunity in AAA

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Focused on attractive $1.6B global EVAR market forecast to grow at

6% CAGRLarge Addressable

Market Opportunity

Aorfix is the only globally-approved endovascular stent-graft for neck

angulations up to 90°

Platform technology can expand into new indications and areas

Approved and Highly

Differentiated Product

Strong clinical data from US IDE study (PYTHAGORAS)Strong Supporting

Clinical Data

Strong Aorfix revenue growth

Public market track record and $45.1M in cash (3/31/15)

Strong Financial

Profile

Highly experienced management team with significant medtech experienceExperienced

Management Team

Geography – expand US sales force and accelerate roll out, launch in

Japan, expand presence in Europe and Asia

Product – Enhanced Aorfix delivery systems; thoracic stent graft

Clear Strategy

for Growth