Corporate Update Simon Hubbert, CEO Bill Kullback, CFO June, 2015

Transcription

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

2 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. 2

3 Lombard Medical at a Glance An innovative vascular device company 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

4 $Billions EVAR Market is Attractive with Strong Growth Global addressable market of $1.6B growing at a CAGR of 6% annually Overview of AAA ~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 Market EVAR market drivers Aging patient population Increase in AAA screening Better outcome vs. surgery $1.9 Billion by WW market = $1.6B 1 6% CAGR growth annually 1 EVAR is growing vs. open surgical repair Lower mortality rate Lower morbidity/fewer complications Shorter hospital stay (approx. 3 days vs. 9 days) $1.4 $1.5 $1.6 $1.7 $1.8 $1.9 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 Medtech Ventures: Aortic Intervention Market (2014)

5 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 5

6 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 Before procedure 12 months after procedure 6 Source: Images courtesy of Musgrove Park Hospital, Taunton

7 Broadest Global Indication Company AAA Stent-Graft Max Approved US Neck Angle Indication Lombard Aorfix 90 Medtronic Endurant 60 Cook Zenith 60 Gore Excluder 60 Endologix Powerlink 60 TriVascular Ovation 60 Potential to expand physicians on-label practice by ~20% 7

8 Lombard is Focused on Three Key Markets Global EVAR Market Landscape United States Europe Japan ~ $714M 1 ~ $477M 2 ~ $158M 2 13 th leading cause of death in US and the 10 th 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 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 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 8 1 idata Research Inc.: US Market for Peripheral Vascular Devices and Accessories (2013) 2 Medtech Ventures: Aortic Intervention Market (2014)

9 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 9

10 Japanese Commercial Strategy Japanese Market Dynamics World s second largest AAA market ~8,000 AAA procedures in 2014 Well reimbursed ~$14,000 1 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 Strong start, tracking toward 5% market share in Q2/ Approval of latest Aorflex delivery system received in Q Medtech Ventures: Aortic Intervention Market (2014)

11 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 % UK market share in 3 years U.K. Direct Distributor Direct-markets with sales team of 10 Expect to increase sales force in Germany Germany Western Europe direct market sales increased 14% in 2014 to $3.4M Spain Spain and Italy are supported by a sales manager in each country Italy 11

12 Lombard Revenue Contribution by Geography $M $M Q Q Q US Market W Europe Direct Markets 2015 Projection ($18-20M) JP Market ROW Distributor Markets JP Market ROW Distributor Markets US Market W Europe Direct Markets Accelerating Revenue from US and Japan Launch 12

13 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 Q 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 13 New Product Development Potential to develop technology to expand indications within endovascular surgery To treat thoracic aneurysms (TEVAR) To treat complex short neck anatomy (FEVAR)

14 Thoracic EVAR (TEVAR) Market Aorfix technology can be applied to TEVAR segment US market forecasted to grow by 79% from TEVAR Stent Business Opportunity Aorfix flexibility should offer significant advantages over competitors in thoracic arch Market Size Units $450 38,395 $M $287 23, E 2018E 2013E 2018E EU US 14 idata Research Inc.: US Market for Peripheral Vascular Devices and Accessories (2013)

15 Fenestrated EVAR (FEVAR) Market FEVAR Business Opportunity 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 grow 1 Several studies have shown that the average incidence of short necks (<10mm) is at least 20% of the $1.4B aortic endograft market 2 $280M market opportunity which is currently underserved 15 1.Aortic Endografts Market 2015 Report 2.Company Estimates based on currently available published studies

16 Financial Highlights Q and Guidance Total 2015 first quarter Aorfix revenue grew 66% to $3.4M compared to revenue of $2.1M in the first quarter of US Aorfix revenue grew to $1.1M in the first quarter of 2015, up 125% from $0.5M in the first quarter of 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) 16

17 Conclusion: A Differentiated Growth Opportunity in AAA Large Addressable Market Opportunity Focused on attractive $1.6B global EVAR market forecast to grow at 6% CAGR Approved and Highly Differentiated Product Aorfix is the only globally-approved endovascular stent-graft for neck angulations up to 90 Platform technology can expand into new indications and areas Strong Supporting Clinical Data Strong clinical data from US IDE study (PYTHAGORAS) Strong Financial Profile Strong Aorfix revenue growth Public market track record and $45.1M in cash (3/31/15) Clear Strategy for Growth 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 Experienced Management Team Highly experienced management team with significant medtech experience 17