Tandem Diabetes Care, Inc. · NASDAQ:TNDM
Tandem Diabetes Care — Investor Day (September 2018)
126 slides from Tandem Diabetes Care's investor day presentation, Sep 25, 2018
Slide 1: Institutional Investor & Analyst Day
Institutional Investor & Analyst Day September 25, 2018
Slide 2: Susan Morrison
Susan Morrison EVP & Chief Administrative Officer SLIDE 2
Slide 3: Agenda
AGENDA Welcome. Company Vision. Technology Roadmap and Product Innovation. Financial Outlook and International Expansion. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 3
Slide 4: Safe Harbor
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
Slide 5: Kim Blickenstaff
Kim Blickenstaff President & CEO SLIDE 5
Slide 6: Strong short-term momentum, solid long-term growth
Strong Solid short-term long-term momentum. growth trajectory. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 6
Slide 7: Delivery Device Glycemic Control
Delivery Device Glycemic Control INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 7
Slide 8: Expanding the market through innovation
Expanding the market through innovation. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 8
Slide 9: INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018
INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 9
Slide 10: Domestic Global
Domestic Global INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 10
Slide 11: Features and Clinical Outcomes
Features Clinical Outcomes Touchscreen Remote Update Capability Dexcom® CGM Improving Reducing time in range and hypoglycemic events, A1c’s hospital visits and cost Discrete Discrete Rechargeable Battery Connectivity INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 11
Slide 12: $100 Million to $1 Billion Annual Sales
$100 Million $1 Billion Annual Sales Annual Sales INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 12
Slide 13: Domestic Durable Pump Launches & Exits
Domestic Durable Pump Launches & Exits Manufacturer 2012 2013 2014 2015 2016 2017 2018 t:slim G4 t:slim X2 t:slim X2 t:slim t:slim X2 & t:flex with G5 Basal-IQ 530G 630G 670G Vibe G4 Exit Spirit Exit Combo Snap Exit INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 13
Slide 14: Tandem's Growth
Tandem’s Growth. Updated 2018 Sales Guidance: $160,000 $150M - $158M $140,000 $120,000 Sales in 000’s $100,000 $80,000 $60,000 $40,000 $20,000 $0 2012 2013 2014 2015 2016 2017 2018 INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 * Reflects $89 debt repayment in Q3 2018. SLIDE 14
Slide 15: Cadence of annual new product launches
Cadence of annual new product launches. Growing the worldwide insulin pump market and capturing share. Increasing leverage. Reducing losses. Debt free. SLIDE 15
Slide 16: John Sheridan
John Sheridan EVP & Chief Operating Officer SLIDE 16
Slide 17: Tandem mission statement
Tandem Diabetes Care® is dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 17
Slide 18: Tandem mission statement
Tandem Diabetes Care® is dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 18
Slide 19: First. Fast. Smart. Customer Focused.
First. Relentless Fast. Innovation Smart. Customer Focused. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 19
Slide 20: First
First Touch screen. Rechargeable battery. Remote updateable software. Designation as compatible with iCGM. Part of an automated insulin delivery system requiring no finger sticks. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 20
Slide 21: Fast
Fast INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 21
Slide 22: Smart
Smart Reliability & manufacturing efficiencies. Internal development processes. Automation. Partnerships. Lean R&D investment. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 22
Slide 23: Customer Focused
Customer Focused Easy to use. Look and feel like a consumer device. Software updatable. #1 rated customer service. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 23
Slide 24: Technology Roadmap
Regulatory strategy. Technology Automated insulin delivery. Roadmap Connected health. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 24
Slide 25: Interoperability is changing the regulatory landscape
Interoperability is changing the regulatory landscape. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 25
Slide 26: Historical PMA system approval
Historical PMA AID CGM Pump system approval. Algorithm CGM change required new PMA, new clinical data. New system CGM AID Pump approved. Algorithm INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 26
Slide 27: iCGM designation = no new PMA
iCGM AID Pump Algorithm System approved for any iCGM iCGM designation = no new PMA. Labeling Update iCGM AID Pump Algorithm INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 27
Slide 28: iPump designation = no new PMA
iCGM AID iPump Algorithm iPump designation = no new PMA. Labeling Update iCGM AID iPump Algorithm INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 28
Slide 29: Algorithm change requires new PMA
iCGM iPump Algorithm change requires new PMA, AID new clinical data. Algorithm CGM iPump INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 29
Slide 30: Interoperable systems with multiple companies' devices
Interoperable systems can include devices from multiple companies. Business agreements define product development, product support & financial terms. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 30
Slide 31: Updated Regulatory Strategy
Previously planned to file a Updated modular PMA in September. Regulatory Now submitting an application for an interoperable pump as part of Strategy an AID System (iPump). Followed by a PMA submission for the AID algorithm. No change to launch goal of Summer 2019. t:slim X2 with Control-IQ Technolo
Slide 32: Escalating t:sport development
Escalating t:sport development. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 32
Slide 33: The Evolution of t:sport
The Evolution of t:sport First Final Market Advanced Concept Formative Hardware Research Prototyping Refinement Study Design 2009 2010-2012 2013-2015 2016-2017 2018 INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 33
Slide 34: Love Your Tubing
Love Your Tubing. Freedom to disconnect. Reduce insulin waste if and when adhesives fail. Preserves current reimbursement model. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018
Slide 35: t:sport features
Small Pump with Tubing Mobile Control Bolus Button Multiple Infusion Set Options 200 Unit Syringe Cartridge 200 u Quick & Easy Fill Process Syringe Delivery AID Algorithm iCGM Integration Bluetooth® Radio ® Wireless Charging Updateable Optional Adhesive Sleeve Ability to Disconnect from Site Water R
Slide 36: t:sport control and FDA submission
Controlled using a mobile app or a separate touchscreen controller. FDA submission as an iPump enabling use of Control IQ with no new clinical data. Launch goal: 2H 2020. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 36
Slide 37: Automated Insulin Delivery
Automated Insulin Delivery SLIDE 37
Slide 38: Predictive Low Glucose Suspension: What, Why, How, and Who?
Predictive Low Glucose Suspension : What, Why, How, and Who? LAUREL H. MESSER, RN, MPH, CDE SENIOR INSTRUCTOR, BARBARA DAVIS CENTER, UNIVERSITY OF COLORADO
Slide 39: Disclosures for Laurel Messer
Disclosures for Laurel Messer Contract Certified Product Trainer for Medtronic Received speaking honoraria from Tandem Diabetes Care Consultant: Tandem Diabetes, Capillary Biomedical, Clinical Sensors
Slide 40: Predicted Low Glucose Suspend: What, Why, How and Who?
Predicted Low Glucose Suspend: What, Why, How and Who? What is PLGS? Why do we need it? How does it work? PROLOG study results Patient experience
Slide 41: Why suspend insulin?
Why suspend insulin? HYPOGLYCEMIA– glucose levels dangerously low SEVERE HYPOGLYCEMIA: United States registry data: o 11.8% adults experienced severe hypo in past 12 months1 o 6% Loss of consciousness or seizure in past 3 months2 o Higher risk: ◦ Higher age2 ◦ Longer diabetes duration1,2 ◦ Insulin
Slide 42: Nocturnal Hypoglycemia
Nocturnal Hypoglycemia The overnight period is a particularly dangerous time for hypoglycemia. Sleep impairs hypoglycemia counter-regulation. Many individuals with T1D have impaired awareness of hypoglycemia.
Slide 43: Hypoglycemia: How to prevent?
Hypoglycemia: How to prevent? Automated insulin systems Insulin delivery that is responsive to glucose levels Insulin delivery Glucose sensor Algorithm changed
Slide 44: Automated Insulin pathway
Automated Insulin pathway Insulin delivery Glucose sensor Algorithm changed Kowalski, Diabetes Care 38: 1036-1042, 2015
Slide 45: Automated Insulin pathway
Automated Insulin pathway Insulin delivery Glucose sensor Algorithm changed Kowalski, Diabetes Care 38: 1036-1042, 2015
Slide 46: t:slim X2 with Basal-IQ Technology
t:slim X2™ with Basal-IQ™ Technology Insulin delivery Glucose sensor Algorithm changed Kowalski, Diabetes Care 38: 1036-1042, 2015
Slide 47: Predictive Low Glucose Suspend (PLGS)
Predictive Low Glucose Suspend (PLGS) 1) Sensor glucose levels falling… 2) Algorithm predicts hypoglycemia in future 3) Insulin pump stops delivering insulin Insulin delivery Glucose sensor Algorithm changed
Slide 48: CGM and Reference Glucose Values and Insulin Infusion Rates
CGM and Reference Glucose Values (top) and Insulin Infusion Rates (bottom) Figure 1. PLGS Example Patient (TAND1-001-0001): 2 CGM = YS! & Ins Challenge =x MBG + Suspend o* Resume © Carbs rp 00ZL r O0:bb y 00-01 y 00:60 y 00:80 r 00:40 r 00-6L ~ 00:8b 300 7 T fo} ire} a T T i=} i=} ie} wo a + OHO 6 1
Slide 49: Predicted Low Glucose Suspend: What, Why, How and Who?
Predicted Low Glucose Suspend: What, Why, How and Who? What is PLGS? Why do we need it? How does it work? PROLOG study results Patient experience
Slide 50: PROLOG: PLGS for Reduction of Low Glucose
PROLOG: PLGS for Reduction of Low Glucose Pivotal trial for PLGS Design: 6-week crossover RCT (3 weeks control, 3 weeks PLGS) o Control Arm: t:slim X2™ pump with commercially approved features and a Dexcom G5® CGM. o Experimental Arm: t:slim X2 pump with Basal-IQ™ PLGS feature. Multi Center study
Slide 51: Summary of PROLOG study
Summary of PROLOG study Significant reduction in hypoglycemia with PLGS (all metrics) 31% relative reduction in mean time <70 mg/dl Greater effect in participants with greater baseline hypoglycemia Safety o No safety issues o No increase in mean glucose or hyperglycemia System suspensions of in
Slide 52: Predicted Low Glucose Suspend: What, Why, How and Who?
Predicted Low Glucose Suspend: What, Why, How and Who? What is PLGS? Why do we need it? How does it work? PROLOG study results Patient experience
Slide 53: t:slim X2 with Basal-IQ
t:slim X2 with Basal-IQ TM TM No fingersticks: Dexcom G6® glucose sensor o No fingersticks for calibration o No fingersticks needed for insulin dosing Minimal alerts o Prevents hypoglycemia without disruption
Slide 54: Basal-IQ What should patients expect?
Basal-IQ What should patients expect? TM: Better quality of life Less worry about hypoglycemia, especially in overnight period Requires little to no BG tests (no calibration and approved to dose insulin based on SG value)
Slide 55: Summary
Summary Hypoglycemia is a common problem for people with T1D Basal-IQ (PLGS) can reduce occurrences of hypoglycemia (31% in PROLOG study) High user satisfaction– no fingersticks, minimal alarms, easy to use PLGS is important step in Automated Insulin Delivery pathway
Slide 56: Automated Insulin
Automated Insulin Automated Insulin is the future of insulin pumps and CGMs Insulin delivery Glucose sensor Algorithm changed
Slide 57: Thank you!
Thank you! Laurel.Messer@ucdenver.edu
Slide 58: Our Path to Automated Insulin Delivery
Our Path to Automated Insulin Delivery Patrick Keith-Hynes, PhD Chief Science Officer TypeZero Technologies Inc Tandem Diabetes Care September 25, 2018
Slide 59: Outline
OUTLINE • Brief History of TypeZero Algorithm • inControl System • Studies and Results © TypeZero 2018
Slide 60: Automated Insulin Delivery - The Beginning
AUTOMATED INSULIN DELIVERY - THE BEGINNING
Slide 61: Background
BACKGROUND Core technology is based on 10+ years of R&D All developed with Dexcom CGM NIH, JDRF, UVA, Helmsley have invested more than $40 million to date 30 clinical studies 450 patients > 300,000 hours of use in human trials
Slide 62: Algorithm Lineage - Academia to Industry
ALGORITHM LINEAGE - ACADEMIA TO INDUSTRY 2017 - Present 2016 2015 NIH-4: inControl - UVA Project 2014 JDRF-3: 6Nightlight 11-month month overnight andtest of 2013 24/7 CLC evening/overnight at home vs 24/7 CLC 2012 HCT-3: Summer camp study of 1- 2011 HCT-2: Summer weekcamp CLC,study of 5-UVA Stanfor
Slide 63: inControl Overview
AUTOMATED INSULIN DELIVERY inControl Overview Robust, exhaustively tested modular algorithmic stack Improved glycemic time in range with dramatically reduced hypoglycemia Highly differentiated User Experience with best of class CGM September 25, 2018
Slide 64: inControl Features
AUTOMATED INSULIN DELIVERY inControl Features Modular Closed Loop Control increases glycemic time in range while dramatically reducing hypoglycemia System automatically and smoothly decreases insulin infusion rate based on predicted hypoglycemic risk Automatically modulates basal infusion and genera
Slide 65: Core Concepts
CORE CONCEPTS • Metabolic State Estimation • Quantitative Risk Assessment
Slide 66: Algorithm - Control Loop
ALGORITHM - CONTROL LOOP Blood State Glucose Estimation Prediction CGM Core 5-minute Retrieve Data Quantitative Cycle CGM, insulin Pre- Risk history Processing Assessment Insulin Pump Dosing Algorithms Measure > Model > Predict > Act > Repeat
Slide 67: Algorithm Modules
ALGORITHM MODULES Basal Attenuation Module smoothly reduces basal insulin delivery in response to predicted hypoglycemia } Hypo Safety Basal Increase Module manages increased basal rate in response to hyperglycemia prediction Hyperglycemia Correction Module delivers periodic automated correction bol
Slide 68: Results from Overnight Intensive Insulin Therapy
RESULTS FROM OVERNIGHT INTENSIVE INSULIN THERAPY Sensor-Augmented Pump (SAP), mean; quartiles Control-to-Range (CTR), mean; quartiles 250 Blood Glucose Level (mg/dl) 200 150 100 Time of Day (h) 23:00 01:00 03:00 05:00 07:00 Brown, Kovatchev et al, Diabetes Technology and Therapeutics, 2015
Slide 69: Algorithm Performance - Stanford Summer Camp
ALGORITHM PERFORMANCE - STANFORD SUMMER CAMP Publication Ly, Buckingham et al, Diabetes Care, 2016 Structure 24/7 - 17 subjects, 85 days and nights 24/7 Time 70-180 mg/dl 78.6% 24/7 Time below 70 mg/dl 1.8%
Slide 70: Algorithm Performance - Month Home Use
ALGORITHM PERFORMANCE - 6 MONTH HOME USE Kovatchev, Cheng et al, Diabetes Technology and Therapeutics, Publication Vol 19 Number 1 2017 Structure 24/7 - 14 subjects, 6 months at home 24/7 Time 70-180 mg/dl 77% 24/7 Time below 70 mg/dl 1.3%
Slide 71: iDCL Trial
IDCL TRIAL - NIH UC4 DK 108483 (2016-19) Primary Outcome: • Time < 70 mg/dl with non-inferiority for time above 180 mg/dl the International Secondary Outcomes: Diabetes Closed • hba1c, technology acceptance Loop (iDCL) Trial Objectives: University of Virginia • Establish Closed Loop Control as a via
Slide 72: Key Takeaways
KEY TAKEAWAYS TypeZero algorithm is robust and exhaustively tested Improved glycemic time in range with dramatically reduced hypoglycemia Highly differentiated User Experience with best of class Dexcom CGM
Slide 73: Thank You
t) typezero THANK YOU
Slide 74: Control-IQ Technology: Automated Insulin for Better Glycemic Control
Control-IQ Technology: Automated Insulin for Better Glycemic control LAUREL H. MESSER, RN, MPH, CDE SENIOR INSTRUCTOR, BARBARA DAVIS CENTER, UNIVERSITY OF COLORADO
Slide 75: Control IQ: Automated insulin for better glycemic control
Control IQ: Automated insulin for better glycemic control Why do we need Control-IQ? How does it work? Ongoing studies Patient experience
Slide 76: Glycemic control
Glycemic control Hypoglycemia Hyperglycemia 2015 data on overall glycemic control in United States ADA/JDRF A1c Cutoffs
Slide 77: How to improve overall glucose control?
How to improve overall glucose control? Automated insulin systems Insulin delivery that is responsive to glucose levels Insulin delivery Glucose sensor Algorithm changed
Slide 78: Automated Insulin pathway
Automated Insulin pathway Insulin delivery Glucose sensor Algorithm changed Kowalski, Diabetes Care 38: 1036-1042, 2015
Slide 79: Control-IQ: Automated Insulin delivery
Control-IQ: Automated Insulin delivery Insulin delivery Glucose sensor Algorithm changed OK glucose Programmed insulin Low glucose Less insulin High glucose More insulin
Slide 80: Control IQ: Automated insulin for better glycemic control
Control IQ: Automated insulin for better glycemic control Why do we need Control-IQ? How does it work? Ongoing studies Patient experience
Slide 81: Control-IQ put to the test
Control-IQ put to the test 2017: Preliminary studies in adults with T1D 2018: Preliminary studies in children with T1D Current: Control-IQ Pivotal trial in adults and adolescents with T1D
Slide 82: 2018: Control-IQ ski camp
2018: Control-IQ ski camp 3 days/2 nights in Breckenridge, Colorado 12 children ages 6-12 with T1D Randomized: ½ control group, ½ Control-IQ group Went home for three days wearing system
Slide 83: Results of Ski Camp
Results of Ski Camp Everyone had fun! No one broke any bones! System performed very well… … But that’s all I can say
Slide 84: Current Control-IQ pivotal trial
Current Control-IQ pivotal trial Clinical Trials NCT03563313 6 month RCT comparing Control-IQ with standard insulin pump and sensor Ages 14-75 years old 168 participants Outcome: Time in glucose range 70-180 mg/dl
Slide 85: Control-IQ Technology: Automated insulin for better glycemic control
Control-IQ Technology: Automated insulin for better glycemic control Why do we need Control-IQ? How does it work? Ongoing studies Patient experience
Slide 86: t:slim X2 with Control-IQ
t:slim X2 with Control-IQ TM TM Technology acceptance comes down to: o Usefulness o Ease of Use Technology acceptance Ease of Use Usefulness
Slide 87: t:slim X2 with Basal-IQ
t:slim X2 with Basal-IQ TM TM HIGH EASE OF USE No fingersticks: Dexcom G6® glucose sensor o No fingersticks for calibration o No fingersticks needed for insulin dosing Minimal alerts o Prevents hypoglycemia without disruption Remote software updating (new versions, new functionality, etc.)
Slide 88: t:slim X2 with Control-IQ
t:slim X2 with Control-IQ TM TM HIGH USEFULNESS Assistance mitigating HIGH and LOW glucose levels Expect more glucose levels in target range
Slide 89: What are our study patients saying?
What are our study patients saying? Sleeping through the night for the first time since diagnosis Not having to interrupt life to test glucose levels and treat low/high glucose levels Feeling safer driving, working, etc. Better glucose control with exercise
Slide 90: Thank you!
Thank you! Laurel.Messer@ucdenver.edu
Slide 91: Reducing Patient Interaction
Reducing Patient Interaction Predictive Hybrid Fully Low Advanced Closed Closed Glucose HCL Loop (HCL) Loop Suspend 2018: Basal-IQ 2019: Control-IQ No carb counting Bolus automation. technology. technology featuring for meals. automated correction Personalized boluses.* settings. INVESTOR & ANALYST
Slide 92: Xavier de Anda
Xavier de Anda Director, Connected Health SLIDE 39
Slide 93: Connected Health at Tandem
Connected Health at Tandem. To produce value-driven innovation throughout the entire diabetes healthcare ecosystem. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 40
Slide 94: Diabetes Management Application
Diabetes Management Application INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 41
Slide 95: Mobile
Mobile A Foundation for Remote Control Wireless pump uploads. • . Secondary pump display. Health app integration. Diet, sleep & exercise integration. Personalization. Decision support. Biometric authentication. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 42
Slide 96: Ecosystem Expansion
Ecosystem Expansion Support pump roadmap. Remotely control pump. Smartwatch technology. Data analytics. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 43
Slide 97: Amassing Useful Data
Billions of data points. Insulin, CGM, carbs, site change, pump utilization, Amassing BG, bolusing. Useful Data 3.7M cumulative days of combined CGM and insulin therapy data. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 44
Slide 98: Providing customers flexible opportunities to engage with data
Providing customers flexible opportunities to engage with data and HCPs and better self-manage their care. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 45
Slide 99: Proven design philosophy
Proven design philosophy. Simple, easy-to-use products that reduce customer burden and improve the experience. Rapid innovation. 6 product launches in 6 years. Committed to our goal of launching a new product each year. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 46 46
Slide 100: Leigh Vosseller
Leigh Vosseller EVP & Chief Financial Officer SLIDE 47
Slide 101: Strong short-term momentum
Increased 2018 Sales Guidance Strong As of 2018 Sales 9/25/18 $150M - $158M 7/30/18 $140M - $148M short-term International Q318 Sales $7M - $8M $42M - $44M - - momentum International $2M - INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 48
Slide 102: Solid long-term growth trajectory
Solid Product pipeline. long-term Renewals. growth Animas conversions. trajectory International. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 49
Slide 103: Brian Hansen
Brian Hansen EVP & Chief Commercial Officer SLIDE 50
Slide 104: People with type 1 and type 2 diabetes in the US
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. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 Source: Centers for Disease Control. Internal estimates. SLIDE 51
Slide 105: Approximately 70 sales territories
Apx. 70 sales territories calling on healthcare prescribers and people with diabetes. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 52
Slide 106: Domestic Insulin Pump Market Share by Manufacturer
Domestic Insulin Pump Market Share by Manufacturer* Animas & Tandem and Others Tandem 8% Medtronic are the 12% remaining domestic Insulet Medtronic durable insulin pump 15% 65% manufacturers. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 *Internal estimates SLIDE 53
Slide 107: Our customers
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. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 All figures are approximations SLIDE 54
Slide 108: Designed for use with or without advanced features
Designed for use with or without advanced features INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 55
Slide 109: t:slim X2 vs 670G customer survey
(Top 2 Box 9 -10) t:slim X2 670G n=168 n=112 “My pump is 70% 38% easy to use” “Helps me have 60% 44% good BG control” “Helps me feel more in control 57% 39% of my diabetes” All comparisons between Top 2 box scores shown are statistically significant, p <.001 INVESTOR & ANALYST DAY | SEPTEMBER 25, 20
Slide 110: Pump therapy + CGM offers the greatest benefit
Pump therapy + CGM offers the greatest benefit. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 T1D Exchange Patient Registry (n=17,731) SLIDE 57
Slide 111: INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018
INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 58
Slide 112: Reimbursement Opportunities
Advocacy for choice. Fewer competitive pump offerings. Reimbursement Opportunities Financial position. Robust data – share in payor cost-savings. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 59
Slide 113: Time in Range, Payor X Patient Examples
Payor X Patient Examples from t:connect 100% 94% 90% 90% 82% 78% Time in Range (70-180mg/dl) 80% 74% 75% 69% 69% 70% 56% 59% 60% 55% 50% 46% 40% 30% 20% 10% 0% Patient A Patient B Patient C Patient D Patient E Patient F Before Basal-IQ After Basal-IQ INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 Note:
Slide 114: Goal: Grow U.S. pump market penetration to more than 50%
Goal: Grow the U.S. pump market from less than 30% penetration to more than 50%. 550K 900K Pumpers 350K New Pumpers (28% T1D Pumpers (50% T1D Penetration) Penetration) INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 61
Slide 115: People with type 1 diabetes outside the US
Apx. 42.5 million people OUS with type 1 diabetes. Source: International Diabetes Federation, 2017 INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 62
Slide 116: Type 1 diabetes in long-term target markets outside the US
Approximately 3 million people live with type 1 diabetes in our long-term target markets outside the United States. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 Source: internal estimates. SLIDE 63
Slide 117: Our international pump capture opportunity
550,000 pumpers OUS Our international 300,000 pumpers in long-term target pump capture markets opportunity. 150,000 pumpers in near-term target markets INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 Source: American Diabetes Association and internal estimates. SLIDE 64
Slide 118: Distributor support differs by geography
Tandem’s involvement to support distributors differs in the U.S., Canada, and in other geographies OUS. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 65
Slide 119: 5-Year Installed Base Goals
5-Year Installed Base Goals: Domestic: Nearly triple from 66,000 today to more than 175,000 customers. International: Grow to more than 50,000 customers. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 66
Slide 120: Reimbursement differs by product, per-patient amount similar
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 $4K $2K - $3K 1 reimbursed every 4 years Supplies 120 cartridges and infusion sets $4K $5K used per patient per year Tota
Slide 121: Focus on Profitability
Reimbursement. Sales volume. Focus on Product cost reduction. Profitability Managed expense growth. INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 68
Slide 122: Manufacturing Facility Capacity
Manufacturing Facility Capacity Leverage Manufacturing Overhead Equipment Lines 2 4 Annual Units 110K 12M Installed Base Equivalent N/A 100K Additional On-Site N/A 2 lines Equipment Capacity INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 69
Slide 123: Expand Gross Margin
Expand Gross Historical progress Margin driven by volume, efficiency & reliability. >60% 60% 55% Longer-term gross 50% margin driven by Q4 Gross Margin 40% reimbursement & 30% 20% new products, offset 10% by international. 0% 2017 2019 Goal INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 70
Slide 124: Manage Operating Expenses
Manage Operating Expenses Long-term Average Annual Growth Rate R&D 10% SG&A 15% INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 71
Slide 125: Key Financial Milestones & Goals
Key Financial Milestones & Goals >$100M First Annual 25%+ Cash Flow Cash and Positive EBITDA Operating Breakeven No Debt EBITDA Profit Margin Q3 2018 Q4 2018 2H 2019 2020 Long Term Goal Goal Goal Goal INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 72
Slide 126: INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018
INVESTOR & ANALYST DAY | SEPTEMBER 25, 2018 SLIDE 73