Lombard Medical, Inc. (NASDAQ:EVAR) June 2016

Transcription

1 Lombard Medical, Inc. (NASDAQ:EVAR) June 2016

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 An Innovative Vascular Device Company A global, commercial stage medical technology company with 160 employees Headquarters in Irvine, CA, manufacturing in Oxfordshire, UK Focused on the $1.7B abdominal aortic aneurysm ( AAA ) repair market Objective To offer a patient focused, innovative portfolio approach to AAA treatment to treat the broadest range of patients Aorfix : The only globally approved AAA stent-graft for aortic neck angles up to 90 degrees Altura : New CE marked ultra low profile stent graft offering a simple, predictable and accurate solution for standard AAA anatomy 3

4 EVAR Market is Attractive with Strong Growth EVAR Market Broadest Anatomy Coverage EVAR market drivers Aging patient population Increase in AAA screening Better outcome vs. surgery $1.9 Billion by WW market = $1.7B 1 6% CAGR growth annually 1 30% 70% Mainstream On-label Challenging Anatomy $1.4 $1.5 $1.6 $1.7 $1.8 $1.9 Low Neck Angulation Moderate Neck Diameters Longer Necks High Neck Angulation Large Neck Diameters Short Necks $ Billions Lombard portfolio now allows patient-driven treatment choice with on-label coverage of 85% of cases 1 Medtech Ventures: Aortic Intervention Market (2014)

5 Altura: Revolutionizing AAA treatment Altura provides a simple, predictable solution for standard AAA anatomy with the ability to deliver out-patent and proctor free EVAR for many patients Design Concept Bilateral D-shaped (kissing stents) aortic grafts with overlapping iliac legs Features/Benefits 5 Simple Ultra-low profile (14F) percutaneous use No cannulation No polymer injection Market leading inventory requirement Predictable Altura 6 product codes cover all patients Market leaders 75+ Consistently shorter procedure time Traditional wire & material stent graft Accurate Proximal end can be recaptured and redeployed Reverse Iliac deployment for exact placement Offsetting bilateral stents allows use of total Aortic neck length

6 Altura: Device Overview Comparative Analysis Technology Comparisons System Altura - Lombard Endurant II - Medtronic Ovation - TriVascular French Size 14Fr (OD) 18-20Fr (OD) 14Fr (OD) Complexity - Cannulation No cannulation required for contralateral deployment Cannulation required for contralateral deployment Cannulation required for contralateral deployment Iliac Deployment Accurate reverse deployment Standard deployment Standard deployment Recapture Ability Yes Reposition during placement of proximal endograft Inventory 6 product codes 75 product codes 40+ product codes Polymer No No No No Yes Waiting time 20 mins before retraction. Renal off-set positioning Yes No No Stent Graft System

7 Altura Launch Update Controlled EU Launch in H Sales team training completed in Q1 Live case at LINC congress in late January Launched into selected reference centres in UK & Germany in late February Over 20 centers now active Training centers set up in Riga Latvia with UK and Germany centers to follow in Q2 Significant physician interest in Altura as out-patient EVAR stent graft Broader International launch through H US Approval Expectations and Milestones Submit IDE - H First patient enrollment H FDA approval anticipated in 2020 Japan approval 12 months after FDA 7

8 Aorfix 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 8

9 Aorfix: 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 9 Source: Images courtesy of Musgrove Park Hospital, Taunton

10 International Strategy Four main EU markets: UK, Germany, Spain and Italy Direct in UK & Germany with sales team of 14 Established direct-markets: UK and Germany U.K. Germany Country-specific distributors for other countries Build out of EU sales team complete: UK 5 sales territories Direct Distributor Germany 9 sales territories Spain and Italy distributor network Altura & IntelliFlex launches in 2016 expected to significantly boost EU sales through expanded sales teams Spain Spain Italy supported by direct sales head Italy 10

11 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 with over 700 cases completed and 7.5% market share achieved in 18 months. Approval of latest IntelliFlex LP delivery system anticipated H Medtech Ventures: Aortic Intervention Market (2014) 11

12 US Commercial Strategy US is the largest AAA market valued at an estimated $800M in 2016 Aorfix FDA approved - full commercial launch November commercial sales territories + 2 Clinical staff Recruited experienced EVAR reps or those with strong endovascular experience Equipped with most advanced field training tools Aorfix cases completed in more than 180 US centers since launch using least invasive technique across all neck angles: ~50% below 60 degree neck angulation More than half performed percutaneously IntelliFlex LP Delivery system launch planned for Q4 2016/Q Expect to drive increased share with existing users and open up new centers 12

13 New Product Development IntelliFlex LP delivery system Lower profile design treat patients with narrow access vessels Exchange sheath reduce vessel trauma Increased control accurate deployment Intuitive & compact ease of use Thoracic (TEVAR) and Fenestrated (FEVAR) stent-grafts Potential to develop both technology platforms to expand indications within Endovascular Aneurysm Repair 13

14 Lombard Revenue Contribution by Geography $MM US Market Japan Market W Europe Direct Markets ROW Distributor Markets 2016 Projection (+20%) 2015 Performance: +14% (US +42%, JP +42%) 14

15 Financial Highlights Income Statement Q revenue of $2.9 million was 15% below the prior year with the US down 24% and Japan down 43% US sales headcount decreased by 60%, while sales productivity increased 109% Japan experienced sales declines as well, however, procedure volume increased 73% y/y OPEX for the quarter was $8.3 million compared to $11.3 million in Q Results reflected a net loss of $7.6 million, or $0.38 loss per share, compared to a net loss of $9.5 million, or $0.59 loss per share, for the first quarter of 2015 Balance Sheet Quarter-end cash (3/31) was $22.4 million compared to $32.3 million at the end of 2015 Cash burn was $3.5 million per month for the 2015 fiscal year, but reduced to $3.3 million in Q Inventory was $8.0 million at 3/31, including ~ $1.0 million in Altura beginning to turn in Q Accounts receivable was $4.1 million at 3/31 w/ DSO at 55 days Debt at quarter-end was $23.3 million FY 2016 Guidance Remains unchanged with revenue growth of ~20.0% from

16 Summary A company with a clear strategy for global growth Patient focused portfolio approach launching in Europe in early 2016 will drive growth and market share capture from competitors: Altura - new AAA stent graft offering simple, accurate and predictable treatment option for patients with standard AAA anatomy and potential for out-patient EVAR treatment Aorfix with IntelliFlex LP delivery system only on-label treatment for AAA patients with Aortic neck angulation above 60 degrees; most conformable stent graft to treat patients with tortuous iliac arteries IntelliFlex launch in US through established sales team will accelerate growth from existing and new users Experienced distribution partner in Japan with strong growth trajectory that will accelerate with forthcoming IntelliFlex LP launch Two unique technology platforms for future innovation 16