Transforming While We Grow Profitably

Transcription

1 Transforming While We Grow Profitably Gary Maharaj President and CEO Andy LaFrence Vice President of Finance and CFO June SurModics, Inc. 1

2 Safe Harbor Statement Some of the statements made during this presentation may be considered forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations regarding the Company s capital needs and its performance in the near- and long-term, including our revenue, earnings and cash flow expectations for fiscal 2015, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including (1) our reliance on third parties (including our customers and licensees) and their failure to successfully develop, obtain regulatory approval for, market and sell products incorporating our technologies; (2) the challenges and uncertainties inherent in product development, including the uncertainties of the GLP pre-clinical study and the timeline for receiving regulatory approval that would allow us to initiate a first-in-human trial for SurModics SurVeil Drug Coated Balloon; (3) our ability to achieve our corporate goals; (4) possible adverse market conditions and possible adverse impacts on our cash flows, and (5) the factors identified under Risk Factors in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2014, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at SurModics, Inc. 2

3 Investment Thesis Transforming SurModics SurVeil Drug Coated Balloon first-in-human by 9/30/2015 Whole product solutions provider develop and monetize proprietary medical devices Corporate development strategy enhance relevance Profitable Growth Established Provider to Medical Device OEMs Strong reputation in coronary and successful diversification into other anatomies Sticky business once device has regulatory approval IVD Segment Reduces risk of medical device-only applications Highly Profitable Business Model Operating margins of 31+% over past 3 years Strong Balance Sheet and Attractive Cash Flows $49.1 million of cash/investments at 3/31/2015, no debt EBITDA margin of 37+% over past three years Leading provider of innovative surface modification technologies and in vitro diagnostic chemical components Partner with medical device and diagnostic companies to support their development and commercialization of novel products 2015 SurModics, Inc. 3

4 Relevance Devices + Enabling Technology + Differentiated Manufacturing = Safe and Better Clinical Outcomes at an Economically Viable Cost 2015 SurModics, Inc. 4

5 Partnership Commitment Through Commercialization Ability to leverage SurModics DCB experience Drug processing Coating formulation Drug coating application In-house analytical characterization capabilities DCB Platform Extension Opportunities CURRENT FUTURE Coronary Committed to being a partner through commercialization and beyond No brain-drain ; our technology team is intact We stand-by our products with service and support SFA BTK AV Fistulas 2015 SurModics, Inc. 5

6 SurModics SurVeil Drug Coated Balloon* *SurModics SurVeil Drug Coated Balloon is not commercially available. Preclinical data shown for informational purposes only SurModics, Inc. 6

7 Efficient Coating Maximizes Drug Transfer Actual DCB Performance (current generation) Ideal DCB Performance (future generation) DISPOSITION OF DEVICE DRUG LOAD Lost During Procedure Retained on Balloon Transferred to Vessel 2015 SurModics, Inc. 7

8 SurModics SurVeil Delivers More Drug 100 PK Results -- Group Medians Treatment with 40mm Balloons Tissue Concentration (µg/g) 10 1 SurModics SurVeil DCB is: 3-5x greater tissue levels than currently available US DCB s SurModics 0 0 day 7 day 14 day 21 day 28 day 2015 SurModics, Inc. 8

9 Superior Drug Transfer and Retention = Uniform & Robust Biological Effect SurModics SurVeil DCB shows greater and more uniform drug effect than first-gen commercial US devices Blue/Green Color = Proteoglycan = Drug Effect SurModics 2 µg/mm² DCB #1 A 2µg/mm² DCB #2 3.5µg/mm² Uncoated Tissue stained with Movat Pentachrome, 28-days post-treatment in healthy swine femoral arteries 2015 SurModics, Inc. 9

10 SurModics SurVeil Designed for Manufacturing Efficiency SurModics DCB DCB #1 DCB # SurModics, Inc. 10

11 Corporate Development Strategy FOCUSED ON M&A OPPORTUNITIES THAT ENHANCE RELEVANCE Enhance Capabilities Expand Access to New Addressable Markets Add New Technology Content Strategy: Fit: Financials: Technologies and capabilities that enable device performance Complementary to existing customer base; sustainable competitive advantage; provides access to growing market segments Accretive to sales growth, EPS and ROIC over time 2015 SurModics, Inc. 11

12 Medical Device Hydrophilic Coating Royalty Model $37.9 Medical Device (in millions) Operating Income Revenue $41.1 $43.0 $18.4 $21.2 $ & 2015 SurModics, Inc. 12

13 Medical Device Unmatched Commercial Track Record Applied to more than 150 commercial product families sold worldwide Neurological Infusion catheters Hydrocephalic shunts Stroke treatment Embolic protection Oncology Microcatheters Peripheral Vascular Cardiovascular Coronary stent systems Specialty guidewires Chronic total occlusion device Angioplasty catheters Percutaneous heart valves Access systems Defect repair delivery systems Endovascular graft systems Peripheral stent delivery catheters Atherectomy / Thrombectomy systems Intravascular imaging Vascular closure devices Ophthalmology Access instruments Cardiac Rhythm Management CRT leads Implantable Intravascular defibrillator Pacemaker leads Lead delivery catheters & guidewires Electrophysiology (mapping & ablation) catheters Urogenital Surgical Devices Endoscopy accessories Obesity management Incontinence devices Chest wound drainage Penile implants Stents / Catheters Contraceptive systems 2015 SurModics, Inc. 13

14 Medical Device Hydrophilic Partnering Revenue Model 3 to 12 months 6 to 48 months Feasibility Optimization Licensing Clinical Mfg Services Regulatory Approval Tech Transfer Commercialization Unparalleled Service Model Bridge Coating Services (some customers) Royalties & Reagent Sales $ 2015 SurModics, Inc. 14

15 Medical Device Hydrophilic Coatings Markets Undisputed leader in hydrophilic partnering market Serene launch in February 2013 best in class, high lubricious and low particulates Significant opportunity in-house coating Growth markets neurovascular, peripheral vascular and structural heart Patent portfolio multiple generations of coatings 2015 SurModics, Inc. 15

16 In Vitro Diagnostics In Vitro Diagnostics (in millions) Operating Income Revenue $14.0 $15.0 $14.4 $4.5 $4.2 $ Molecular diagnostics microarray slides Immunoassay chemistries 2015 SurModics, Inc. 16

17 SurModics IVD Providing critical components for diagnostics tests of today and tomorrow TRIDIA surfaces for Molecular Diagnostics Protein Stabilizers for Point of Care (POC) devices Gold standard detection chemistries for immunoassay diagnostics 2015 SurModics, Inc. 17

18 Corporate/Financial Perspective Strong operating margins Strong balance sheet 2015 SurModics, Inc. 18

19 GAAP Guidance Continuing Operations Long-term Goal: Double-digit revenue & EPS growth FY2015 Revenue Outlook Flat to 4% growth rate FY2015 EPS Outlook Incremental 5 to 7% R&D investment $65 $60 $55 $50 $51.9M $56.1M $57.4M $57.0M to $60.0M $1.20 $1.00 $0.80 $0.60 $0.58 $0.99 $0.88 $0.85 to $0.95 $45 $0.40 $40 $0.20 $35 FY12 FY13 FY14 FY15 Guidance* $0.00 FY12 FY13 FY14 FY15 Guidance* * refer to non-gaap pro forma results in the appendix; non-gaap EPS was $0.66, $0.85 and $0.96 in fiscal 2012, 2013 and 2014, respectively 2015 SurModics, Inc. 19

20 Investor Relations Contact For additional inquiries, please contact: Andy LaFrence SurModics, Inc. 20

21 Use of Non-GAAP Financial Information In addition to reporting financial results in accordance with generally accepted accounting principles, or GAAP, SurModics is reporting non-gaap financial results including non-gaap net income and non-gaap diluted net income per share. We believe that these non-gaap measures provide meaningful insight into our operating performance excluding certain event-specific matters, and provide an alternative perspective of our results of operations. We use non-gaap measures, including those set forth in this presentation, to assess our operating performance and to determine payout under our executive compensation programs. We believe that presentation of certain non-gaap measures allows investors to review our results of operations from the same perspective as management and our board of directors and facilitates comparisons of our current results of operations. The method we use to produce non-gaap results is not in accordance with GAAP and may differ from the methods used by other companies. Non-GAAP results should not be regarded as a substitute for corresponding GAAP measures but instead should be utilized as a supplemental measure of operating performance in evaluating our business. Non-GAAP measures do have limitations in that they do not reflect certain items that may have a material impact on our reported financial results. As such, these non-gaap measures should be viewed in conjunction with both our financial statements prepared in accordance with GAAP and the reconciliation of the supplemental non-gaap financial measures to the comparable GAAP results provided for the specific periods presented, which are attached to this presentation SurModics, Inc. 21

22 SurModics, Inc. and Subsidiaries Supplemental Non-GAAP Information For the Three Months Ended March 31, 2015 (In thousands, except per share data) (Unaudited) SurModics, Inc. and Subsidiaries Supplemental Non-GAAP Information For the Three Months Ended March 31, 2014 (In thousands, except per share data) (Unaudited) As Reported GAAP(1) Adjustments Adjusted Non-GAAP(2) As Reported GAAP(1) Adjustments Adjusted Non-GAAP(2) Revenue Royalties and license fees $ 7,383 $ 7,383 Product sales 5,651 5,651 Research and development 1,381 1,381 Total revenue $ 14,415 $ 14,415 Revenue Royalties and license fees $ 7,329 $ 7,329 Product sales 5,165 5,165 Research and development 1,110 1,110 Total revenue $ 13,604 $ 13,604 Operating income $ 3,932 $ 3,932 Operating income $ 3,480 $ 914 (3) $ 4,394 Net income $ 3,051 $ (523) (3) $ 2,528 Diluted net income per share(4) $ 0.23 $ 0.19 Net income $ 2,459 $ 580 (4) $ 3,039 Diluted net income per share(5) $ 0.18 $ 0.22 (1) Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). (2) Adjusted Non-GAAP considers an adjustment to reflect a $523 reduction in net investment income associated with the sale of Intersect ENT shares. The adjustment to reduce net investment income did not generate a tax benefit as there was an offsetting establishment of a capital loss valuation reserve. (3) Reflects the impact of the net investment income adjustment noted in (2) above. (4) Diluted net income per share is calculated using the diluted weighted average shares outstanding for the period presented. (1) Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). (2) Adjusted Non-GAAP amounts consider adjustments to reflect a $914 reduction to operating expenses associated with acceleration of Board of Director stock-based compensation awards and adjustment to the income tax provision utilizing a 36.5% incremental effective tax rate. (3) Reflects the pre-tax impact of the operating expense adjustment noted in (2) above. (4) Adjusted to reflect the adjustment noted in (2) above. (5) Diluted net income per share is calculated using the diluted weighted average shares outstanding for the period presented SurModics, Inc. 22

23 SurModics, Inc. and Subsidiaries Supplemental Non-GAAP Information For the Year Ended September 30, 2014 (in thousands, except per share data) (Unaudited) As Reported GAAP(1) Adjustments Adjusted Non-GAAP(2) Revenue Royalties and license fees $ 30,277 $ 30,277 Product sales 22,798 22,798 Research and development 4,364 4,364 Total revenue $ 57,439 $ 57,439 Operating income $ 18,576 $ 914 (3) $ 19,490 Income from continuing operations $ 12,207 $ 1,055 (4) $ 13,262 Diluted earnings per share from continuing operations(5) $ 0.88 $ 0.96 (1) Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). (2) Adjusted Non-GAAP amounts consider adjustments to reduce operating expenses by $914 associated with acceleration of Board of Director stock-based compensation awards, a $709 reduction in net investment income associated with contingent milestone payments related to the sale of Vessix Vascular shares which were sold in fiscal 2013 and a $1,184 increase in net investment income associated with the impairment loss on our investment in ThermopeutiX. The income tax provision includes an adjustment associated with the stock-based compensation awards utilizing a 36.5% incremental effective tax rate. The adjustments to increase net investment income by $475 did not generate an income tax expense as there was an offsetting release of a capital loss valuation allowance. (3) Reflects the pre-tax impact of the operating expense adjustment discussed in note (2) above. (4) Adjusted to reflect the adjustments discussed in note in (2) above. (5) Diluted earnings per share from continuing operations is calculated using the diluted weighted average shares outstanding for the 2015 SurModics, Inc. period presented. 23

24 SurModics, Inc. and Subsidiaries Supplemental Non-GAAP Information For the Year Ended September 30, 2013 (In thousands, except per share data) (Unaudited) SurModics, Inc. and Subsidiaries Supplemental Non-GAAP Information For the Year Ended September 30, 2012 (in thousands, except per share data) (Unaudited) As Reported GAAP(1) Adjustments Adjusted Non-GAAP(2) As Reported GAAP(1) Adjustments Adjusted Non-GAAP(2) Revenue Royalties and license fees $ 29,774 $ (570) (3) $ 29,204 Product sales 22,506 22,506 Research and development 3,852 3,852 Total revenue $ 56,132 $ (570) (3) $ 55,562 Revenue Royalties and license fees $ 27,445 $ 27,445 Product sales 20,742 20,742 Research and development 3,741 3,741 Total revenue $ 51,928 $ 51,928 Operating income from continuing operations $ 18,820 $ (691) (4) $ 18,129 Operating income from continuing operations $ 16,342 $ 507 (3) $ 16,849 Income from continuing operations $ 14,579 $ (1,987) (5) $ 12,592 Income from continuing operations $ 10,129 $ 1,311 (4) $ 11,440 Diluted earnings per share from continuing operations(6) $ 0.99 $ 0.85 Diluted earnings per share from continuing operations(5) $ 0.58 $ 0.66 (1) Reflects operating results from our continuing operations in accordance with U.S. generally accepted accounting principles ( GAAP ). Our Pharmaceuticals segment results are presented as discontinued operations. (2) Adjusted Non-GAAP amounts consider adjustments to reduce royalty revenue associated with a one-time $570 catch-up payment received in fiscal 2013, a $597 increase to operating expenses as a result of the recovery of legal fees associated with the SRI litigation (this amount represents the recovery of costs incurred in periods prior to fiscal 2013), a $476 decrease to operating expenses associated with a fiscal fourth quarter 2013 restructuring charges, a reduction in net investment income of $1,136 associated with the sale of Vessix Vascular and OctoPlus shares offset by impairment losses on the Company s investment in ViaCyte and Nexeon, adjustment to the income tax provision for these items, excluding the net investment gains which did not generate a tax benefit, utilizing a 36.5% incremental effective tax rate as well as adjustment to increase the income tax provision for $412 of discrete income tax benefits recognized for the period as noted in detail in (4) below. (3) Reflects the pre-tax impact of the $570 royalty revenue catch-up payment noted in (2) above. (4) Reflects the $570 royalty revenue catch-up payment, the $597 recovery of legal fees and $476 restructuring charges noted in (2) above. (5) Adjusted to reflect the items noted in (2) above as well as non-recurring discrete income tax benefits of $261 associated with realization of capital loss carrybacks and $151 from the January 2013 signing of the American Taxpayer Relief Act of 2012 which retroactively reinstated federal R&D tax credits for calendar (6) Diluted earnings per share from continuing operations is calculated using the diluted weighted average shares outstanding for the period presented. (1) Reflects continuing operating results in accordance with U.S. generally accepted accounting principles ( GAAP ). (2) Adjusted Non-GAAP amounts consider adjustments related to Dutch auction tender offer expenses and an impairment loss on investment recognized in the period in accordance with GAAP. (3) Reflects a $507 adjustment to reduce operating expenses associated with the fiscal fourth quarter 2012 Dutch auction tender offer. (4) Reflects the after tax impact of the adjustments associated with the $507 Dutch auction tender offer expenses and the $804 impairment loss on investment. These transactions are non-deductible for tax purposes and did not generate a tax benefit. (5) Diluted net income per share from continuing operations is calculated using the diluted weighted average shares outstanding for the period presented SurModics, Inc. 24

25 Management Team Growth and Value Creation Track Record Gary R. Maharaj, President and Chief Executive Officer Joined SurModics in 2010 President & CEO of Arizant Inc. (sold to 3M for $810 million in 2010) 25 years in med-device Served in research for orthopedic implant and rehabilitation divisions of Smith & Nephew Timothy J. Arens, Vice President of Corporate Development and Strategy Joined SurModics in 2007 Served as Vice President of Finance & interim CFO and General Manager of IVD business unit Was Director of Research and Analysis at St. Jude Worked in product development and product management at four other companies Andrew D. C. LaFrence, Vice President of Finance and Chief Financial Officer Joined SurModics in 2013 Previously CFO for CNS Therapeutics (sold to Covidien for $102 million in 2012) CPA with more than 30 years of financial and management experience including audit partner at KPMG supporting venturebacked, high-growth companies Charles W. Olson, Senior Vice President and General Manager, Medical Device Joined SurModics in year career also includes General Manager at Minnesota Extrusion and project management and technical sales at Lake Region Bryan K. Phillips, Senior Vice President of Legal and Human Resources, General Counsel and Secretary Joined SurModics in year career also includes patent counsel at Guidant s Cardiac Rhythm Management Group (now part of Boston Scientific) Practiced law at Merchant & Gould Joseph J. Stich, Vice President and General Manager, In Vitro Diagnostics Joined SurModics in years of management experience including corporate development for Abraxis Bioscience; business development and sales at MGI PHARMA President/COO of Pharmaceutical Corp. of America (subsidiary of Publicis Healthcare Specialty Group) Sales and marketing at Sanofi-Aventis 2015 SurModics, Inc. 25