Company Overview February 26, 2019

Similar documents
COMPANY OVERVIEW. July 30, 2018

COMPANY OVERVIEW. April 26, 2018

COMPANY OVERVIEW. October 12, 2017

Institutional Investor & Analyst Day. September 25, 2018

Patrick J. Sullivan Chief Executive Officer. January 9, 2018 Investor Presentation

Michael L. Levitz Chief Financial Officer. November 15, 2017 Investor Presentation

Cowen Investor Conference March confidently live life with ease

10:20 AM March 5, B 100% 235 u. 124 mg/dl 3 HRS INSULIN ON BOARD:

Predicts and helps prevent lows with. zero fingersticks NOW FEATURING BASAL-IQ TECHNOLOGY

January 2017 Investor Presentation. confidently live life with ease

Insulin Pumps and Continuous Glucose Sensors- Embracing Technology. Susan Cavalier, BS, RN, CDE Manager, Diabetes Educator Sanford Diabetes Education

Patrick J. Sullivan, President & CEO March 7, 2016 Raymond James 37 th Annual Institutional Conference

Genomic Health. Kim Popovits, Chairman, CEO and President

Annual Stockholder Meeting May 30, confidently live life with ease

Acquisition of Novartis Influenza Vaccines Business. 27 th October 2014

confidently live life with ease Management Presentation

Slide 1. Financial update and closing remarks. Jesper Brandgaard EVP and CFO. RAFAEL DE JESÚS FLORES, Mexico Rafael has haemophilia A

INVESTOR DAY JUN 5, 2018 NEW YORK CITY

Canaccord Growth Conference August confidently live life with ease

Diagnostics for the early detection and prevention of colon cancer. Fourth-Quarter 2014 Earnings Call February 24, 2015

HALOZYME REPORTS SECOND QUARTER 2018 RESULTS

INSPIRED BY GIVE HIM MORE. The MiniMed 670G system is the world s first insulin delivery system that automatically adapts to your child s needs.

The pump that gets updated, not outdated. *

Advances in Technology in the Treatment of Diabetes Mellitus 2017 How far have we come-how far are we going? Is there a final frontier?

INSPIRED BY GIVE HER MORE. The MiniMed 670G system is the world s first insulin delivery system that automatically adapts to your child s needs.

VolitionRx Announces First Quarter 2016 Financial Results and Business Update

Updates in Diabetes Technology

OBJECTIVES THE PAST INNOVATIVE TECHNOLOGY & DIABETES DIABETES MIS MANAGEMENT IMPROVEMENTS IN DIABETES MANAGEMENT

INVESTOR PRESENTATION

Committed to Transforming the Treatment Paradigm for Migraine Prevention

Universal Biosensors, Inc.

NEW TECHNOLOGIES FOR MANAGING DIABETES ANGELA THOMPSON DNP, FNP-C, BC-ADM, CDE, FAANP

Better Diagnostics for Life

OBALON THERAPEUTICS, INC. (OBLN) The first and only FDA-approved swallowable, gas-filled intragastric balloon for weight loss

ADA 2018 JUN 25, 2018 ORLANDO, FLORIDA

Investor Presentation

USPSTF Draft Recommendations Investor Call. October 6, 2015

BASICS OF INSULIN PUMPS. Jennifer Okemah MS RD BCADM CDE CSSD

Acasti Pharma Provides Business Update for the Third Quarter of Fiscal 2019

37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE

Slide 1. International Operations update. Mike Doustdar EVP International Operations. YASMIN FIEDLER, Germany Yasmin has type 1 diabetes

Visionary Private Equity Group is Pleased to Announce its Investment in MEDITE Cancer Diagnostics

MEDICAL POLICY Continuous Glucose Monitoring Systems and Insulin Pumps

N a s d a q : I N S Y

Approved by: Integrated Health Quality Management Subcommittee Effective Date: Department of Origin: Integrated Healthcare Services.

Corporate Presentation Fourth Quarter 2017

Investor Presentation May 2016

DIABETES TECHNOLOGY: WHERE ARE WE NOW AND WHERE ARE WE GOING? Presented by: Tom Brobson

REATA PHARMACEUTICALS, INC. ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND AN UPDATE ON DEVELOPMENT PROGRAMS

Diagnostics for the early detection and prevention of colon cancer. Leerink Swann Global Health Care Conference February 2015

Slide 1. Investor presentation. London 5 February 2019

Diabetes Technology Update. Sarah Konigsberg, MD Diabetes & Endocrine Assoc. April 7, 2018

ST. JUDE MEDICAL / THORATEC TRANSACTION HIGHLIGHTS July 22, 2015

Investor Presentation March 2015

DIEBOLD NIXDORF AG AT GERMANY EQUITY FORUM

34 th Annual J.P. Morgan Healthcare Conference

MEDICAL POLICY Continuous Glucose Monitoring Systems and Insulin Pumps

Valeritas. Cowen Health Care Conference. Corporate Presentation. NASDAQ: VLRX March 12, 2018

Telekom Austria Group Results for the 1st Quarter May 27, 2003

MEDICAL POLICY Continuous Glucose Monitoring Systems and Insulin Pumps

For personal use only

Clovis Oncology Announces Q Operating Results and Corporate Update. November 3, :05 PM ET

36th Annual J.P. Morgan Healthcare Conference. Kevin Conroy, Chairman and CEO January 9, 2018

Infinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results

Designed with your patients lives in mind

ObsEva Reports Third Quarter 2018 Financial Results and Provides Business Update

Abbott FreeStyle Libre Pro System

Tandem Diabetes Care, Inc. (TNDM) - Medical Equipment - Deals and Alliances Profile

Emisphere Technologies, Inc. Announces 2008 Second Quarter Financial Results

ObsEva Reports First Quarter 2018 Financial Results and Provides Business Update

Oral semaglutide and production expansion. Henrik Wulff EVP Product Supply. Peter Kristensen SVP Global Development

The Growing Future of Diabetes: Insulin Pump Therapy in Type 1 and 2 Diabetes

For more comprehensive information, please refer to the t:connect Application User Guide available online at: Getting Started Guide.

Intercept Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Business Update

ObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update

Q3 18 Earnings Supplemental Slides

Forward-Looking Statements

Itamar Medical. December Investors Presentation.

ADAPTIMMUNE INVESTOR PRESENTATION. August 2016

Valeritas. Corporate Presentation. NASDAQ: VLRX October Improving health and simplifying life for people with diabetes Valeritas, Inc.

Corporate Overview. February 2018 NASDAQ: CYTR

Committed to Transforming the Treatment Paradigm for Migraine Prevention

AM-125 : Intranasal Betahistine

The Realities of Technology in Type 1 Diabetes

January 30, 2018 Dow Wilson President and Chief Executive Officer

Uroplasty, Inc. Investor Update Canaccord Genuity Conference December 6, 2011

Dexcom Current and Future Technology Innovations. Jorge Valdes Chief Technical Officer

Abbott FreeStyle Libre Pro System

A world leader in allergy immunotherapy

Building a Fully Integrated Biopharmaceutical Company. June 2014

PATENCY-1 Top-Line Results

Corporate Presentation. August 2016

Investor Presentation June 2012 NASDAQ: CEMI

1Q Fornebu, April 29, 2015 Luis Araujo and Svein Stoknes

4Q and Full Year 2017 Financial Results Call February 7, 2018

ARQ 087 Overview. FGFR Inhibitor. March 2017

Natus Medical Incorporated. Jeffries Global Healthcare CONFERENCE Tuesday June 6, 2017

Better Diagnostics for Life

Endesa 1Q 2017 Results 09/05/2017

External Insulin Pumps Corporate Medical Policy

Transcription:

Company Overview February 26, 2019

SAFE HARBOR Cautionary Note Regarding Forward-Looking Statements Certain statements in this presentation constitute forward-looking statements, including, without limitation, statements about: the perceived advantages of our products relative to competitive products and technologies; our anticipated growth and other measures of future operating results and financial performance; the development and commercialization of new products; our ability to secure and maintain necessary regulatory approvals for our existing products and new products under development. Our estimates and forward-looking statements are based on our management s current assumptions and expectations of future events and trends, which affect or may affect our business, strategy, operations or financial performance. These statements are not guarantees of future performance and involve a number of risks and uncertainties, many of which are beyond our control. Our actual results may differ materially from those expressed or implied by such forward-looking statements. Some of the factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements can be found under the captions Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report on Form 10-K, as well as in the other reports we file with the Securities and Exchange Commission. In addition, new risk factors and uncertainties emerge from time to time and it is not possible for our management to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Estimates and forward-looking statements speak only as of the date they were made, and, except to the extent required by law, we undertake no obligation to update or review any estimate and forward-looking statement because of new information, future events or other factors. Trademarks 2018 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, t:flex, t:slim, t:slim G4, t:slim X2, Basal-IQ, Control-IQ, t:lock, micro-delivery, t:connect, touch simplicity and our logos are trademarks, registered trademarks, and/or the subject of a pending trademark application in the US and other territories worldwide. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Tandem Diabetes Care is under license. All other trademarks and copyrights are the property of their respective owners. SLIDE 2

Tandem Diabetes Care. Technology For A Simply Better Life Approximately 85,000 insulin pumps shipped worldwide in the past 4 years 6 differentiated insulin pumps launched t:slim X2 with Basal-IQ technology launched in the U.S. in Q3 2018 First pump compatible with icgm Scaling international launch began Q3 2018 Robust product pipeline 1 t:slim X2 with Control-IQ technology 2 nd automated insulin delivery product t:sport - our next-generation hardware platform Connected (mobile) health offerings Sales momentum 2019 sales guidance as of 2/26/19: $255M - $270M 2018 sales: $183.9M 2017 sales: $107.6M 1. Under development, not approved for sale. SLIDE 3

6 Insulin pumps launched in the past 6 years. SLIDE 4

SALES IN 000 S Tandem s growth. $300,000 $250,000 $200,000 $150,000 $100,000 2019 Sales Guidance:* $255M - $270M, including international sales of approximately $45M to $50M $50,000 $0 * Guidance as of Feb 26, 2019 SLIDE 5

Diabetes overview. Cause Onset Type 1 Type 2 Autoimmune Body does not create insulin hormone Sudden Typically before age 40 Lifestyle Related Insulin resistance where cells do not use insulin properly Progressive Typically appears late in life Prevention None Diet and exercise Therapy Insulin Oral medication, insulin SLIDE 6

Insulin replacement therapy. Multiple Daily Injection MDI Continuous Subcutaneous Insulin Infusion CSII SLIDE 7

Blood Glucose Levels Pump therapy is optimal. Basal and Bolus Insulin Release Like The Pancreas SLIDE 8

Approximately 1.7 million people live with type 1 diabetes in the United States. Approximately 1.6 million people who live with type 2 diabetes are candidates for pump therapy. Source: Centers for Disease Control. Internal estimates. SLIDE 9

Goal: Grow the U.S. pump market from less than 30% penetration to more than 50%. 550K Pumpers (28% T1D Penetration) 350K New Pumpers 900K Pumpers (50% T1D Penetration) SLIDE 10

Apx. 42.5 million people OUS with type 1 diabetes, ~3 million of which are in our long-term target markets. Source: International Diabetes Federation, 2017 SLIDE 11

Our international pump capture opportunity. 550,000 pumpers OUS 300,000 pumpers in long-term target markets 150,000 pumpers in near-term target markets Source: American Diabetes Association and internal estimates. SLIDE 12

The pump that gets updated, not outdated. Touchscreen Remote Update Capability Up to 38% smaller than other pumps 1 Rechargeable Battery Dexcom CGM Ease of use 1) 38% smaller than MiniMed 630G and 670G and at least 28% smaller than MiniMed 530G, Animas Vibe and Omnipod System. SLIDE 13

Our customers. 90% have type 1. Wide age distribution. Equal mix of women and men. 50% previously used multiple daily injection; 50% converted from a different pump. 40% integrate with CGM. All figures are approximations SLIDE 14

Smallest pump, big unique features. t:slim X2 Medtronic 670G Touchscreen? YES NO 38% Smaller Pump 22% Larger Screen 13% Lighter Pump Smallest CGM enabled pump? Updateable? YES NO Bluetooth wireless technology? Rechargeable battery? YES NO YES YES NO NO Source: Company websites and product user guides. SLIDE 15

Dexcom Technology benefits our patients ecosystem. Dexcom G6 CGM Adult MARD* 9.0% Finger Sticks/Day Calibration 0 Glucose Data Sharing * Mean Absolute Relative Difference Medtronic Guardian CGM 10.6% (Based on 2 calibrations/day) 0 5 9 SHARE feature allows up to five followers to monitor a user s glucose 4 calibrations/day recommended 2 calibrations/day required None Source: Company websites and product user guides. SLIDE 16

Bridging today s hardware with tomorrow s software. *A prescription and additional training may be required to access certain future software updates. Offer only available to in-warranty customers in the United States. Additional feature updates are subject to future FDA approvals. SLIDE 17

Designed for use with or without advanced features. SLIDE 18

Basal-IQ Technology. SLIDE 19

How It Works. Helping to reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dl or if a CGM reading falls below 70 mg/dl. Insulin delivery resumes once glucose begins to rise. Predicts glucose 30 minutes ahead Suspends insulin to help avoid the low Resumes insulin once glucose rises SLIDE 20

Control-IQ Technology. 1 t:slim X2 with TypeZero s hybrid closed loop algorithm; utilizes Dexcom s G6 CGM data Increases or decreases basal insulin to minimize hyper/hypoglycemia and improve time-in-range, and delivers automated correction boluses Launch goal: 2H 2019, subject to completion of the study, FDA review and approval t:slim X2 was first pump to receive FDA s ACE (alternate controller enabled) designation in Feb 2019; a key step in the regulatory process for Control-IQ technology Pivotal study fully enrolled 1. Investigational Device, not approved for sale. Note: The graphics presented on this page are for illustrative purposes only, and do not reflect individual results SLIDE 21

t:sport Pump our next-gen hardware platform. 1 Apx. 50% of t:slim X2 s size. 200 unit cartridge. Automated insulin delivery algorithm. Uses a short infusion set. Controlled via a separate device or mobile app. Preserves current reimbursement model. 1 Not approved for use or sale. Note: The graphics presented on this page are for illustrative purposes only, and do not reflect individual results SLIDE 22

Diabetes Management Application 1) dq&a USA Patient Connections Surveys, 2013-2017 Note: The graphics presented on this page are for illustrative purposes only, and do not reflect individual results SLIDE 23

Mobile A Foundation for Remote Control (In development). Wireless pump uploads. Health app integration. Personalization. Biometric authentication. Secondary pump display. Diet, sleep & exercise integration. Decision support. SLIDE 24

Insulin pump business model in the U.S. Highly seasonal business Sales are typically back-end loaded (Q1 lowest percent of sales, Q4 highest percent of sales) Highly influenced by timing of when people typically meet their insurance deductibles Customer Order Payor Contract? DTC sales model (commercial payors and patient coinsurance) Billed using existing HCPC codes with longstanding defined allowable rates Utilize direct contracts with commercial payors or distributor arrangements Network of distributors used for 75% - 80% of sales Distributors pricing adjusted for a logistics margin Process w/ Payor Process w/ Distributor Single Case Agreemen t Allowed? Negotiate Single Case Agreement w/ Payor SLIDE 25

Solid long-term growth trajectory Product pipeline. Renewals. Animas conversions. International. SLIDE 26

Reimbursement differs by product but total amount realized per patient is approximately the same in a four-year reimbursement cycle. Domestic OUS % Distributor 80% 85% - 90% Pump 1 reimbursed every 4 years Supplies 120 cartridges and infusion sets used per patient per year Total realized per patient at projected near-term distributor mix $4K $2K - $3K $4K $5K $8K $7K - $8K SLIDE 27

Leverage Manufacturing Overhead Manufacturing Facility Capacity Equipment Lines 2 4 Annual Unit Capacity 110K 12M Installed Base Equivalent N/A 100K Additional On-Site Equipment Capacity N/A 2 lines* * 5 th cartridge line currently on order SLIDE 28

Gross Margin Expand Gross Margin Historical progress driven by volume, efficiency & reliability. >60% 60% 40% 20% 0% 55% Longer-term gross margin driven by reimbursement & new products, offset by international. * Guidance as of Feb 26, 2019 SLIDE 29

Key Financial Milestones & Goals. >$100M Cash and No Debt First Positive Adjusted EBITDA, Cash Generated Adjusted EBITDA Annual Breakeven 25%+ Operating Margin Q3 2018 Q4 2018 2019 Guidance* Long Term Goal EBITDA is a non-gaap financial measure defined as net income (loss) excluding income taxes, interest and other non-operating items and depreciation and amortization. Adjusted EBITDA further adjusts for non-cash stock-based compensation expense. This definition of Adjusted EBITDA may differ from similar measures used by other companies, even when similar terms are used to identify such measures. Adjusted EBITDA is a key measure used by the Company to evaluate operating performance, generate future operating plans and make strategic decisions for the allocation of capital. The Company presents Adjusted EBITDA to provide information that may assist investors in understanding its financial results. However, Adjusted EBITDA is not intended to be a substitute for net loss. * Guidance as of Feb 26, 2019 SLIDE 30

Investor Relations 858-366-6900 x7005 IR@tandemdiabetes.com SLIDE 31