THE NEW SURMODICS LEADING PERIPHERAL ......† Includes revenue from Creagh Medical and NorMedix...

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THE NEW SURMODICS LEADING PERIPHERAL VASCULAR DEVICE INNOVATION Gary Maharaj President and CEO Andy LaFrence Vice President of Finance, Information Systems, and CFO MAY 2017

Transcript of THE NEW SURMODICS LEADING PERIPHERAL ......† Includes revenue from Creagh Medical and NorMedix...

Page 1: THE NEW SURMODICS LEADING PERIPHERAL ......† Includes revenue from Creagh Medical and NorMedix $43.1M $45.9 M $53.2M 0 10 20 30 40 50 60 2014 2015 2016† REVENUE (MILLIONS) $14.4

THE NEW SURMODICSLEADING PERIPHERAL VASCULAR DEVICE INNOVATION

Gary MaharajPresident and CEO

Andy LaFrenceVice President of Finance, Information Systems, and CFO

MAY 2017

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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, earnings and cash flow expectations for fiscal 2017, our fiscal 2017 priorities, our strategy to become

a provider of whole-product solutions, including our SurVeil drug-coated balloon and other proprietary products being developed,

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, obtain regulatory

approval for, and commercialize our SurVeil drug-coated balloon product; (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) our ability to successfully identify, acquire, and integrate target companies, and achieve expected benefits from

acquisitions that are consummated; (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, 2016, 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.

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THE NEW SURMODICS

Leverageable Platform

Strong cash flow generation from core businesses and

leverageable platform

New Product Innovations

Well-stocked R&D pipeline with multiple new product launches

planned over next 5 years

Strong Balance Sheet

Attractive cash flows to fund growth strategy with $46.3 million of cash and

investments as of March 31, 2017

Whole-Product Solutions

Designs, develops, manufactures differentiated products for uptake

and distribution by key medical device customers

Experienced Leadership Team

Passionate, entrepreneurial, disciplined and experienced

management team

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OUR BUSINESS FOCUS

Leveraging science and expertise to offer world-class coatings and drug delivery

IN VITRO DIAGNOSTICSSURFACE TECHNOLOGIES

Providing critical components for in vitro diagnostic tests and microarrays

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WHOLE-PRODUCT SOLUTIONS

Developing highly differentiated vascular device solutions

Xtreme™Catheter

Surmodics PTA Balloon Catheters

SurVeil™ DrugCoated Balloon

Serene® Hydrophilic

Coating

© 2017 Surmodics, Inc. CONFIDENTIAL All rights reserved.

CAUTION SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (United States) law to investigational use.

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SURMODICS VISION

VALUE PROPOSITION: We are an innovator – with the technology, design capability and agility of a startup and the operational excellence, manufacturing and process engineering to create sustainable margins for long-term growth and profitability.

MISSION: To improve the treatment and detection of disease.

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INVESTMENT THESIS

INCREASE R&DINVESTMENT

DRIVE COREREVENUE

INCREASESHAREHOLDER

VALUENEW PRODUCTINNOVATIONS

Continue to generate maximum revenue growth

from our core medical device and in vitro diagnostics

businesses

Execute medical device whole-product solutions provider

strategy via organic R&D and operational excellence

Well-stocked R&D pipeline leads to multiple differentiated product launches and uptake by

customers

Optimize strategic investments for long-term value creation,

with the short-term generation of earnings = BALANCE

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THE MARKET NEED

F O C U S E D O N P E R I P H E R A L V A S C U L A R

PATIENTS OUTCOMES CUSTOMERS

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WHOLE-PRODUCT SOLUTIONS

TOTAL MARKET OPPORTUNITIES

Pedal

Radial

FemoralSuperficial Femoral Artery (SFA).035 / .018

Arteriovenous(AV) Access30 ATM RBP*

Coronary

.014

INTERVENTIONAL ACCESSDRUG COATED BALLOONS

$2 Billion

BALLOON AND CATHETER TECHNOLOGIES

Below-the-Knee (BTK)

.014

*Demonstration of capabilities only. *Atmospheric Pressure (ATM), Rated-Burst-Pressure (RBP)8

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CUSTOMER OPTIONS

I N T E R N A L D E V E L O P M E N T F U L L Y D E V E L O P E D P R O D U C T S O L U T I O N

C U S T O M E R

- OR -

Surmodics designs, develops, manufactures and maintains its product innovations through the entire product lifecycle. Customers receive a fully developed and de-risked product solution with demonstrated clinical effectiveness and secured regulatory approvals.

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COMPETITIVE ADVANTAGE

STRATEGICS

INTERNAL R&D

OEMs START-UPS

DESIGN SERVICES TECHNOLOGY STARTUPS

Efforts focused on key strategic interests

Likely slow progress due to competing priorities

Ability to work like a start-up and move quickly

Focused on broader market needs and unsolved problems

LIM

ITAT

ION

SSO

LUTI

ON

Design to spec services

Limited technology capability

Independent problem solving

Fully staffed, in-house drug delivery and coatings technology

Limited capabilities

Limited resources

Focused on specific technology solution

Post-acquisition brain-drain

Comprehensive capabilities

Well-resourced

Ability to identify broad spectrum of market needs

Complete product lifecycle support

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M E D I C A L D E V I C E B U S I N E S S M O D E L E VO LU T I O N

RELEVANCE

IDEAS / NEEDS

TECHNOLOGY CAPABILITIES

CLINICAL / REGULATORY

VALUE

SHAREHOLDER VALUE

TECHNOLOGY ENABLER

TECHNOLOGY ENABLER + MANUFACTURING

DEVICE DEVELOPER

PAST PREVIOUS CURRENT FUTURE

DESIGN, DEVELOP & MANUFACTURING

Customer-Driven Customer-Driven Customer-Driven Clinically-Driven

Coatings Technology Coatings & Contract Services Whole-Product Solutions Design, Develop & Produce

Master File Reference Data Regulatory Support Assist in Regulatory Filings Regulatory Cleared Device

Royalty / License Model Royalty / License + Services Royalty / License + Device Manufactured Product

💲 💲💲 💲💲💲 💲💲💲💲💲

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SURMODICS SURVEIL™ DCB

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• Proprietary drug / excipient coating provides increased drug effect with lower drug dosage

• Paclitaxel drug dose (2.0 µg/mm2) provides wider therapeutic window which creates higher margin of safety

• Improved coating consistency and durability protect against distal embolization from particulates

• U.S. Early Feasibility Study (EFS) enrollment completed

• Planning to initiate the next phase of clinical study to obtain data for US and OUS regulatory approvals

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

© 2017 Surmodics, Inc. CONFIDENTIAL All rights reserved.

CAUTION SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (United States) law to investigational use.

“Some may see Surmodics’ decision to initiate human trials on their

drug-coated balloon in the U.S. as a bold move. Those of us who have

followed the development of this product are confident in its

potential given its performance in pre-clinical studies.”

— Renu Virmani, MD

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H I G H LY D I F F E R E N T I AT E D B A L LO O N C AT H E T E RS

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• Highest-pressure conventional catheters on the market

• Provide optimal deliverability, trackability and conformability

• Broad range of sizes for various clinical applications

• XtremeTM technology utilizes proprietary coiled/braided shaft construction

• Ultra-thin walled delivery technology with unsurpassed flexibility, kink-resistance, torque control and radial strength

• Control every step of the process to produce high-quality, reliable balloon catheters under rigorous testing

State-of-the-art facility with capacity for balloon catheter design, development and high-volume commercial manufacture

Surmodics PTA Balloon

Catheters

Xtreme™

Catheter

Hemostasis

Valve

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PRODUCT MILESTONES

CAUTION: SurVeilTM Drug-Coated Balloon is an investigational device. Limited by Federal (United States) law to investigational use.

FY 2017 GOALS

FY 2018 – FY 2020

• Initiate clinical trials for SurVeil™ DCB

• Obtain regulatory clearance of .014” and .018” balloon catheters

• Obtain regulatory clearance of first microcatheter

• Complete manufacturing scale-up at Irish facility

• Complete BTK DCB preclinical development; demonstrate early clinical safety & effectiveness

• Assess clinical viability of AV access drug coated balloon

• Obtain regulatory clearances on at least eight new-to-the-world vascular devices in areas of unmet clinical needs

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OUR TEAM

S U R M O D I C S TA L E N T

1 in 3 employees is a scientist, engineer, or manufacturing specialist

15 percent of employees have advanced degrees

8 yearsis the average employee tenure

335 patentsU.S. and International patents held as of Sept. 2016

41 patentsAverage number of patents issued to SRDX annually

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MANAGEMENT TEAM

Gregg S. Sutton

Vice President of Research and

Development

(2016)

Gary R. Maharaj

President and Chief Executive Officer

(2010)

Andrew D. C. LaFrence

Vice President of Finance and Information

Systems and Chief Financial Officer

(2013)

Bryan K. Phillips

Senior Vice President of Legal and Human

Resources, General Counsel and Secretary

(2005)

Timothy J. Arens

Vice President of Corporate Development

and Strategy

(2007)

Charles W. Olson

Senior Vice President of Commercial and

Business Development, Medical Devices

(2001)

Joseph J. Stich

Vice President and General

Manager, In Vitro Diagnostics (2010)

Thomas Greaney

Executive Vice President of

Medical Devices

(2015)

INSERT PHOTO

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OUR ADVISORS

C L I N I C A L & S C I E N T I F I C A D V I S O R S

Ken Rosenfield, MD Chair Advisory Board — Interventional CardiologyMassachusetts General Hospital

Gary Ansel, MD, FACC Clinical Advisor — Interventional CardiologyOhio Health Research

Laura Mauri, MD, MSc Clinical Research Advisor— Interventional CardiologyBrigham and Women’s Hospital; HCRI

Marianne Brodmann MD, PhD Clinical Research 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

Chris White, MD, FACC, FAHA, FSCAI, FESCClinical Advisor — Interventional CardiologyOchsner Medical Center

Renu Virmani, MD, FACCClinical Research Advisor — Cardiovascular PathologistCVPath

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F INANCIALS

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FINANCIAL PERFORMANCE

INSERT PHOTO

$20.0

$18.2 $17.8 $17.5

Q3 2016 Q4 2016 Q1 2017 Q2 2017

QUARTERLY REVENUE (MILLIONS)

$57.4 $61.9

$71.4 $65.0 –$68.0

2014 2015 2016 2017E

ANNUAL REVENUE (MILLIONS)

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FINANCIALS BY SEGMENTMISSION: To improve the treatment and detection of disease.

Strong balance sheet and attractive cash flows to fund growth strategy

• $46.3 million of cash/investments as of March 31, 2017

• Operating cash flow of $25.2 million and adjusted EBITDA of $26.5 million in fiscal 2016

M E D I C A L D E V I C E S

75%

C O R E B U S I N E S S R E V E N U E

I V DB U S I N E S S

25%

MEDICAL DEVICE IN VITRO DIAGNOSTICS

† Includes revenue from Creagh Medical and NorMedix

$43.1M$45.9M

$53.2M

0

10

20

30

40

50

60

2014 2015 2016†

REVENUE (MILLIONS)

$14.4M$16.0M

$18.2M

0

2

4

6

8

10

12

14

16

18

20

2014 2015 2016

REVENUE (MILLIONS)

Growth 7%4% 16% Growth 11%(4%) 14%

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2017 GUIDANCE

Total Revenue: $65 million to $68 million

Diluted Earnings (Loss) per Share: $(0.02) to $0.08

Non-GAAP Earnings per Share: $0.15 to $0.25

Capital allocation in fiscal 2017 to invest in research and development is consistent with execution of our whole-product solutions strategy

2017 Financial Guidance

Long Term Objectives

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THE NEW SURMODICS

Leverageable Platform

Strong cash flow generation from core businesses and

leverageable platform

New Product Innovations

Well-stocked R&D pipeline with multiple new product launches

planned over next 5 years

Strong Balance Sheet

Attractive cash flows to fund growth strategy with $46.3 million of cash and

investments as of March 31, 2017

Whole-Product Solutions

Designs, develops, manufactures differentiated products for uptake

and distribution by key medical device customers

Experienced Leadership Team

Passionate, entrepreneurial, disciplined and experienced

management team

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I N V E S T O R R E L AT I O N SFor additional inquiries, please contact:

Andy LaFrence • 952-500-7062