UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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August 12, 2019
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Date of report (Date of earliest event reported)
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Surmodics, Inc.
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(Exact Name of Registrant as Specified in its Charter)
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Minnesota
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0-23837
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41-1356149
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(State of Incorporation)
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(Commission File Number)
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(I.R.S. Employer
Identification No.)
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9924 West 74th Street
Eden Prairie, Minnesota
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55344
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(Address of Principal Executive Offices)
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(Zip Code)
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(952) 500-7000
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(Registrant’s Telephone Number, Including Area Code)
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Check the appropriate box below if the Form 8‑K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2):
☐ Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12)
☐ Pre‑commencement communications pursuant to Rule 14d‑2(b) under the Exchange Act (17 CFR 240.14d‑2(b))
☐ Pre‑commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act (17 CFR 240.13e‑4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§240.12b-2 of this chapter).
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Emerging growth company
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☐
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
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☐
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Item 8.01 Other Events.
On August 12, 2019, Surmodics, Inc. (the “Company”) updated its investor presentation, which is available under the “Investors” section of the Company’s website at www.surmodics.com.
Representatives of the Company will use the updated presentation in various meetings with analysts and investors from time to time. A copy of the presentation is attached to this report as Exhibit 99.1.
The information in this Item 8.01 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
liabilities under Section 18, nor shall such information be deemed incorporated by reference into any filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit
Number
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Description
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99.1
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Investor Presentation Materials.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SURMODICS, INC. |
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| Date: August 12, 2019 |
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/s/ Bryan K. Phillips |
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Bryan K. Phillips |
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Sr. Vice President, Legal and Human Resources, |
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General Counsel and Secretary |
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EXHIBIT INDEX
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Exhibit
Number
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Description
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Exhibit 99.1
Gary MaharajPresident and CEOTim ArensVice President of Finance and CFOAugust 2019 1
Safe Harbor 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 our performance in the near- and long-term, including our revenue and earnings expectations for fiscal 2019, our
SurVeil™ drug-coated balloon (DCB) and other proprietary products, and the TRANSCEND clinical trial, 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 ability to successfully develop, timely complete clinical trials for, obtain regulatory approval for and, if approved, commercialize our SurVeil DCB product (including
realization of the full potential benefits of our agreement with Abbott) and other proprietary products; (2) 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; (3) possible adverse market conditions and possible adverse impacts on our cash flows, and (4) 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, 2018, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at www.surmodics.com. 2
Focused on product innovation VISION3 of the Top 10 InnovationsFocused on PAD and designed to be:
safe, clinically effective & improve healthcare economics IMPACT TO PATIENTSGrowing incidence of peripheral artery disease (PAD) IMPACT TO INVESTORSInvesting to build long-term sustainable growth and profitability ROIC INVESTMENT 3
4
DESIRED OUTCOMESGoal of improving clinical outcomes while reducing healthcare costs PATIENTS202 million
patients worldwide living with Peripheral Artery Disease (PAD) 5
Impact to patients Product innovations aimed at making significant improvements in patient outcomes and
quality of life (QOL) PATIENTS DESIRED OUTCOMES Superficial Femoral Artery (SFA)> 500K procedures annuallyPain on ambulation – reduced QOL Reduction in reintervention ratesImproved QOL by reduction in pain and increase in
mobility Below-the-knee disease (BTK)More than 3.5 million patients with critical limb ischemia (CLI) by 202033% amputation; 20% die in 1 year Reduction in reintervention ratesImproved QOL as a result AV access for End Stage Renal Disease
(AV for ESRD) More than 5 million patients with ESRD WWAV access 1% of procedures but 7% of Medicare CostsImpacts QOL for ESRD patients Healthcare economic benefits across the board in all indications above IMPACT TO PATIENTS 6
7 Our whole product solutions strategy is focused on creating innovative, differentiated product
platforms that solve clinically meaningful problems in treating peripheral vascular disease Desired OutcomesImprove Clinical OutcomesReduce Healthcare Costs Initial PlatformsDrug Coated BalloonsSurVeil™ DCBAvess™ DCBSundance™
DCBThrombectomyPounce™ mechanical thrombectomy Sublime™ Radial Access PlatformGuide sheath.014” PTA balloon catheter
SurVeil™ DCB 12-Month Data Uniform drug topcoatPaclitaxel + proprietary excipient2.0 µg/mm² drug
load360°coating coverage 0.035” OTW PTA platform4–7 mm x 40–150 mm Shaft coatingSerene® hydrophilic coating Proprietary PhotoLink® basecoat “The ongoing positive results from this study demonstrate that the SurVeil DCB has the potential
to be a next-generation DCB with improved efficacy of drug transfer. These 12-month data continue to support the functionality and safety of the device.” — Kenneth Rosenfield, MD, Nov. 2018 PREVEIL 12-Month Study Results:First-in-human trial
conducted in the U.S. (13 patients / 3 sites)12 month data results:Acute success measures of safety achieved in 100% of subjects100% freedom from CD-TLR and CD-TVRContinued significant improvement in Rutherford classification, resting ankle
brachial index (ABI), and walking impairment questionnaire (WIQ) including walking distance, walking speed and stair-climbing scores Median paclitaxel plasma concentration peaked immediately post-procedure (Cmax 1.07 ng/mL) and was undetectable
at 30 days (reported in six-month results)Device met secondary performance criteriaKey secondary safety endpoints included freedom from major vascular complications, evidence of paclitaxel toxicity, or thrombolysis in myocardial infarction
(TIMI) VISION 8 CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
CURRENT DEBATE ON PACLITAXEL-coated DEVICES TO TREAT PAD 9 RECAP OF RECENTS EVENTS JANUARY 17FDA
CommunicationBenefits outweigh risks 2018 DECEMBER 8 Katsanos Meta-Analysispublished in JAHA SRDX DISCUSSIONS with FDA MARCH 2-3VIVA ForumIn-depth review JUNE 19-20FDA
PanelMeeting 2019 DEC JAN FEB MAR APR MAY JUN JUL AUG SEP MARCH 15FDA CommunicationPotentially concerning safety signal detected JANUARY 22LINC 2019 MARCH 5CRT 2019DCB Town Hall UPDATED INFORMED CONSENT FORM ENROLLMENT
RESUMES APRIL 16CX 2019Paclitaxel Debate MAY 21PCR 2019Paclitaxel Position Stmt. AUGUST 7FDA CommunicationPotentially associated with increased mortality
FDA PANEL Advisory Committee Meeting MEETING HIGHLIGHTS – JUNE 19-20, 2019Signal present from
meta-analysis, no plausible cause identifiedTotality of data should include large well-constructed observational studies where no signal has been foundBenefits of paclitaxel-coated devices are significant, must be considered when balancing
risk/benefit ratioPatient advocates stressed need to give patients ability to choose paclitaxel treatment; Quality of life is as important as quantity of lifePanel supports continued use and marketing of paclitaxel-coated devicesBroad support
for the continuation of existing paclitaxel device trials Increased emphasis on high quality data and adherence to follow-up through 5 years
December 8: Katsanos meta-analysis Meta-Analysis Limitations:No access to patient-level dataNo plausible
mechanism of action notedQuestions regarding statistical model usedSelection bias due to lack of complete follow upLost to follow up and withdrawals are not accurately or completely accountedPTA group is likely not paclitaxel-naïve for entirety
of analysis (prior disease in contralateral limb and potential post-treatment follow-up with paclitaxel-coated device) 11 Information represents a recap of key points and takeaways captured during the VIVA Leadership Forum meeting, March 1-2,
2019 in Washington DC. https://vascularnews.com/live-updates-vascular-leaders-forum-drug-eluting-devices Katsanos, Konstantinos & Spiliopoulos, Stavros & Kitrou, Panagiotis & Krokidis, Miltiadis & Karnabatidis, Dimitrios.
(2018). Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials. Journal of the American Heart Association. 7.
10.1161/JAHA.118.011245.
AUGUST 7 – UPDATE: FDA Communication to Health Care Providers Update to January 17 and March 15 FDA
notificationsFDA is taking additional steps to address the safety signal, including working with manufacturers on updates to device labeling and clinical trial informed consent documentsFDA is also continuing to actively work with the
manufacturers and investigators on additional clinical evidence development for assessment of the long-term safety of paclitaxel-coated devices FDA believes clinical studies of these devices may continue and should collect long-term safety
(including mortality) and effectiveness data Studies require appropriate informed consent and close safety monitoring to protect enrolled
patients 12 https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel
FDA Recommendations to US Health Care Providers (March 15 and August 7 Letters) 13 March 15, 2019
Letter August 7, 2019 Letter Continue diligent monitoring of patients Continue diligent monitoring of patients Evaluate and inform of potential risks Evaluate and inform of potential risks Consider there may be an increased rate of
long-term mortality with paclitaxel-coated devices when recommending treatment or consenting patients Consider there may be an increased rate of long-term mortality with paclitaxel-coated devices when recommending treatment or consenting
patients Discuss the risks and benefits of all available PAD treatment options with patientsFor most patients, alternative treatment options should generally be used until additional analysis of the safety signal has been performed Discuss
the risks and benefits of all available PAD treatment options with patientsFor many patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents provide a more favorable benefit-risk profile based on
currently available information In discussing treatment options, physicians should explore their patients' expectations, concerns and treatment preferences For some patients at particularly high risk for restenosis, clinicians may determine
the benefits may outweigh the risks For individual patients judged to be at particularly high risk for restenosis and repeat femoropopliteal interventions, clinicians may determine the benefits may outweigh the risk of late mortality Ensure
patients receive optimal medical therapy and guidance for healthy lifestyle Ensure patients receive optimal medical therapy and guidance for healthy lifestyle Report any adverse events or suspected adverse events experienced with the use of
paclitaxel-coated balloons and paclitaxel-eluting stents Report any adverse events or suspected adverse events experienced with the use of paclitaxel-coated balloons and paclitaxel-eluting stents
TRANSCEND: SURVEIL™ DCB PIVOTAL TRIAL PRINCIPAL INVESTIGATORSWilliam (Bill) Gray, MD, FACC,
FSCAIClinical Advisor — Main Line Health, Inc., Wynnewood, PAKenneth Rosenfield, MD Chair Advisory Board — Interventional Cardiology, Mass. General HospitalMarianne Brodmann MD, PhD Clinical Advisor — Interventional Cardiology, Division of
Angiology Medical University, Graz Received IDE approval from the U.S. FDA to begin pivotal trial for SurVeil DCB STUDY DESIGNSummaryRandomized control pivotal trial evaluates SurVeil drug-coated balloon for treatment of peripheral artery
disease in the upper leg compared to the Medtronic IN.PACT® Admiral® drug-coated balloon. Number of Subjects and SitesUp to 446 subjectsUp to 60 sites in U.S. and 18 outside U.S.Study Duration60 months post procedure PRIMARY
ENDPOINTSEffectivenessPrimary patency, defined as a composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] ≥2.4
or >50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.SafetyComposite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from
major target limb amputation (above the ankle) and clinically-driven target vessel revascularization (TVR) through 12 months post-index procedure. VISION TRANSCEND ENROLLMENT PROGRESSCurrently >90% enrollmentCE MARK PROGRESSCurrently
anticipate obtaining CE mark by December 2019 10/20/17 14
Strategic Agreement with Abbott Demonstrates value of whole-product solutions strategyLeverages
Surmodics’ leadership in drug-delivery technologies, design, development capabilities, and manufacturing capacityCombines with Abbott’s deep experience in vascular care products and worldwide strength in the market 15 CAUTION: SurVeil™
Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use. February 27, 2018 – Abbott and Surmodics Announce Agreement for Next-Generation Drug-Coated Balloon Development and
Commercialization
Terms of Agreement CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by
Federal (or United States) law to investigational use. 16 Exclusive worldwide commercialization rights for SurVeil™ drug-coated balloon (DCB) for superficial femoral artery (SFA)$25 million upfront payment$67 million for milestones associated
with product developmentAll milestones are pre-commercializationOptions to negotiate agreements for Sundance™ below-the-knee (BTK) and Avess™ arteriovenous (AV) fistula drug-coated balloon productsRevenue realized from product sales to
AbbottShare of profits resulting from Abbott sales
DCB platform extension Surmodics .014” PTA platform2 – 4 mm diameter20 – 220 mm lengths Uniform
sirolimus drug coatingSirolimus + Proprietary Excipient360° uniform coating coverage Avess™ AV Fistula DCB VISION Surmodics .035” PTA platform4 – 12 mm diameter40 – 80 mm lengths Uniform paclitaxel drug coatingPacliltaxel + Proprietary
Excipient360° uniform coating coverage Sundance™ Below-The-Knee DCB Treated initial patient in FIH study Q1 FY 2019Target completion of FIH in FY 2019 Hydrophilic shaft coatingSurmodics PRISTYNE™ hydrophilic coating Successfully completed
preclinical studiesCompleted selection of drug dose and coating formulationInitiate FIH filing process in FY 2019 17 CAUTION: Sundance™ and Avess™ Drug-Coated Balloons are investigational devices. Limited by Federal (or United States) law to
investigational use.
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 JANUARY 510 (K) Clearance for Telemark™ Coronary /
Peripheral Support Catheter We Are Making Progress On Our Whole-Product Solutions Strategy 18 Drug-Coated Balloons (DCB) 510 (K) / CE Mark FY2017 SEPTEMBER Global Clearance of .014” Low-Profile PTA Balloon Catheter APRIL FDA Clearance
for .018” Low-Profile PTA Balloon Dilation Catheter IDE Approval to Initiate Pivotal Trial for SurVeil™ DCB JULY FEBRUARY Abbott & Surmodics Announce Agreement for SurVeil™ DCB First Patient Enrolled in TRANSCEND Clinical Trial for
SurVeil™ DCB OCTOBER May Surmodics Announces Acquisition of Embolitech Thrombectomy Technology & IP Initial patient treated in First-in-Human Study for Avess™ AV Access DCB DECEMBER FY2019 FY2018 APRIL 510 (K) Clearance for
Sublime™ Guide Sheath Commercialization agreement signed for Telemark™ Coronary Support Catheter JULY
POUNCE™ Thrombectomy Platform Technology Game-changing technology designed for removal of organized
thrombi and emboli, in an approximately $400M growing global marketSimple stand-alone intervention, eliminates need for capital equipment and may reduce the need for thrombolytics and complex proceduresDevelopment is on schedule with successful
early pre-clinical results and positive hands-on physician feedbackExpect to submit for our first regulatory clearance in Q1 FY 2020 19 Mesh trumpet designed to entrain clot and compress fluid during removal Two self-expanding cages
designed to break up clot and capture within mesh trumpet
Radial Access Platform Technology 20 Radial artery access offers many benefits relative to femoral
artery access including reduced bleeding complications, early ambulation, reduced length of stay and costsWidely adopted in coronary procedures where devices existInitial radial-based products in development include:Sublime™ Guide Sheath (FDA
Cleared):Surmodics Xtreme™ braided technology offers the ability to treat peripheral procedures, including below-the-knee applicationsFull-length hydrophilic coating for Guide Sheaths5 Fr and 6 Fr:120 cm and 150 cm working lengths.018” and
.035” Guidewire compatibleTherapeutic Devices to Treat Lesions:.014” Radial BTK PTA Balloon Catheter Q4 FY 2019 submission for 510 (K) clearance2 mm - 4 mm, up to 220 mm long150 cm working length .014 Radial BTK PTA Balloon Catheter Braided
Peripheral Radial Guide Sheath
Product Milestones CAUTION: SurVeil™, Avess™ and Sundance™ Drug-Coated Balloons are investigational
devices. Limited by Federal (or United States) law to investigational use. IMPACT TO INVESTORS CY 2019 GOALS FY 2019 – FY 2021 GOALS Enroll the TRANSCEND trial as fast as reasonable: complete enrollment by Q4 FY 2019Attain CE marking for
SurVeil™ by December 2019Initiate and complete first-in-human trial for AV DCB and initiate first-in-human trial for BTK DCB Submit for 510(k) regulatory clearance on three to four devices Complete design freeze for initial thrombectomy device
by end of fiscal 2019Secure commercialization agreements for approved devices Secure PMA of SurVeil™ DCBComplete pivotal trial of Avess™ AV DCBInitiate pivotal trial for Sundance™ BTK DCBObtain regulatory clearance on the initial device for
vascular thrombosis and on at least seven other new-to-the-world vascular devices in areas of unmet clinical needs 21
PIPELINE PRODUCTSSurVeil™ DCBSundance™ Below-the-knee DCBAvess™ AV DCBMultiple 510(k)’s Financial
Performance Targets>10% revenue growth (achieved fiscal 2018 – on track for fiscal 2019)>30% EBITDA margin by 2021 22 The agreement with Abbott has a meaningful positive impact on our commitment to deliver the returns described above
within the targeted time frame given the potential for pre-commercialization revenue within the next 5 yearsIn addition, successful US and OUS commercialization of the SurVeil DCB contributes in a meaningful way to the long-term consistency of
revenue and EBITDA growth at the targeted levelsWe continue to assess the impact of regulatory actions and any effect on our fiscal 2019 financial and long-term guidance Achieving SurVeil DCB milestone successes (positive clinical results and
regulatory approvals) enables the business to reach the financial performance targets
MANAGEMENT TEAM Gary R. MaharajPresident and Chief Executive Officer (2010) Timothy J. ArensVice
President of Finance and Chief Financial Officer (2007) Joseph J. Stich Vice President and General Manager of In Vitro Diagnostics (2010) Thomas GreaneyChief Operating Officer of Medical Devices (2015) Gregg S. SuttonVice President of
Research and Development (2016) Bryan K. PhillipsSenior Vice President of Legal and Human Resources, General Counsel and Secretary (2005) 23 Teryl L.W. Sides Senior Vice President and Chief Marketing Officer (2018)
Clinical & scientific ADVISORS Ken Rosenfield, MD Chair Advisory Board — Interventional
CardiologyMassachusetts General Hospital Gary Ansel, MD, FACC Clinical Advisor — Interventional CardiologyOhio Health Research Marianne Brodmann MD, PhD Clinical Advisor— Interventional CardiologyDivision of Angiology Medical University
Graz Michael Jaff, DO Clinical Advisor — Vascular MedicineNewton Wellesley Hospital Mike Dake, MDClinical Advisor — Interventional RadiologyStanford Health Care Renu Virmani, MD, FACCClinical Research Advisor — Cardiovascular
PathologistCVPath Peter Schneider, MDClinical Advisor — Vascular SurgeryUniversity California San Francisco 24 Prof. Ramon VarcoeClinical Research Advisor — Vascular SurgeonPrince of Wales Hospital
Surmodicsbusiness segments For the nine months ended June 30,
2019 BUSINESSSEGMENTREVENUE IVDBUSINESS23% MEDICAL DEVICES77% 25
Surmodics CORE Offerings vascular access sheath coronary guidewire peripheral clad guidewire coronary
stent delivery catheter coronary balloon dilatation catheter peripheral balloon dilatation catheter diagnostic guide catheter vascular access and support catheter MEDICAL DEVICE COATINGS IN VITRO DIAGNOSTICS Leveraging science and
expertise to offer world-class coatings and drug delivery Providing critical components for in vitro diagnostic tests and microarrays Creating sustainable margins for long-term growth and profitabilityTechnologyDesign capabilityAgility of a
start-upOperational excellenceManufacturingProcess Engineering 26
FINANCIAL PERFORMANCE 27
FINANCIALS BY SEGMENT MISSION: To improve the treatment and detection of diseaseStrong balance sheet and
attractive cash flows to fund growth strategy$45.0 million of cash/investments as of June 30, 2019Operating cash flow of $34.1 million and adjusted EBITDA of $7.3 million in fiscal 2018 MEDICAL DEVICES77%
BUSINESSSEGMENTREVENUE‡ IVDBUSINESS23% MEDICAL DEVICE Growth 2% 16% 12% IN VITRO DIAGNOSTICS Growth 5% 14% 9% 28 ‡For the nine months ended June 30, 2019
2019 Guidance 2019 Financial Guidance Long Term Objectives Total Revenue: $92.0 million to $94.0
million (includes $7.5 million to $8.0 million of SurVeil™ DCB revenue)(1) GAAP Earnings per Share(2): $0.24 to $0.32Non-GAAP Earnings per Share(2): $0.41 to $0.49 Continue consistent double-digit top line revenue growth and generate EBITDA
margins at or above 30% by 2021 29 Our fiscal 2019 SurVeil DCB revenue is driven by the recognition of a portion of the $25 million up front license fee received following the execution of the distribution agreement in late February 2018.GAAP
earnings per share is the estimated fiscal 2019 diluted earnings per share as determined by U.S. generally accepted accounting principles. Non-GAAP earnings per share adjusts GAAP earnings per share for estimated fiscal 2019 contingent
consideration adjustment, acquired intangible amortization, foreign exchange gain on contingent consideration, claim settlement and acquired in-process research and development of $0.01, $0.16, $(0.01), $(0.04) and $0.05 per share,
respectively.
INVESTOR RELATIONSFor additional inquiries, please contact:Tim Arens • 952-500-7056 30