Valeritas — Investor Presentation (May 2019)
33 slides from Valeritas's investor presentation, May 10, 2019
Slide 1: Valeritas Corporate Presentation May 2019
Valeritas Corporate Presentation NASDAQ: VLRX May 2019 Improving health and simplifying life for people with diabetes 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation shall not be deemed an offer to sell securities nor a solicitation of an offer to purchase securities. Any sale by the company shall be made pursuant to a definitive purchase agreement. Unless otherwise stated in this presentation, references to “Valerita
Slide 3: Large Market Opportunity & Poised for Significant Value Creation
Valeritas: Large Market Opportunity & Poised for Significant Value Creation Unrivaled Market Highly Attractive Opportunity Financial Profile Solid Top-Line Growth Global Type 2 diabetes Gross Margins ~48% New commercial model pandemic tracking to 80% validated 5.6 million U.S. Type 2 Pro
Slide 4: Key Problem Managing Type 2 Diabetes
Key Problem Managing Type 2 Diabetes “Drugs don’t work in people who don’t take them” – C. Everett Koop, M.D.1 Type 2 Insulin Users Intentionally Skip and/or Current Insulin Delivery Standard of Care Forget to Take Injections2 Most Type 2 patients will not inject away from home3 1. Eur J Heart Fail.
Slide 5: Valeritas' Massive U.S. Market Opportunity
Valeritas’ Massive U.S. Market Opportunity Our Core Focus 5.6M 4.5M ~23M Not Achieving Type 2 Insulin DiagnosedType 2 with Type 2 A1c Goal3,4 Users2 TypeNot 2on Diabetes Insulin 1 Insulin Users (~ (~5.6M) $10.7B Source: Company data, kff.org Annual U.S. Market Opportunity 1. CDC National Diabetes St
Slide 6: 4.5M U.S. Type 2 Patients on Insulin Not Achieving A1c Goal
4.5M U.S. Type 2 Patients on Insulin are Not Achieving A1c Goal Despite Serious Health Consequences % of Type 2 Patients on Insulin NOT at Goal1 Impact of Improving A1c Control2 Every 1% improvement in A1c decreases diabetes related events in: AT A1c Goal NOT AT A1c Goal 20% 80% Deaths Heart Attacks
Slide 7: Our Solution, V-Go: Discreet, Effective & Simple to Use
Our Solution, V-Go®: Discreet, Effective & Simple to Use Designed for the Patient with Type 2 Diabetes Discreet Simple to Use Convenient Benefits Better A1c Control* Of V-Go Cost Neutral Self-contained Sharps Container Pharmacy vs. DME ©2019 Valeritas, Inc. 7 * Company data, kff.org (14 published cl
Slide 8: V-Go Competition: Pens not Pumps
V-Go® Competition: Pens not Pumps Unique needs of Patients with Type 2 Diabetes Creates Valeritas’ Opportunity & Differentiates it from Others TYPE 1 TYPE 2 Typical Patient Engaged / Advocate Embarrassment / Stigma Attitude Complex Device More Likely Less Likely Acceptable? (~30% of Type 1 are on pu
Slide 9: New Higher-Service Sales and Marketing Model
New Higher-Service Sales and Marketing Model Model validated, driving targeted account penetration and robust top-line growth DIRECT SALES REPs ON-LINE ADs INDIRECT REPs EDUCATION PROMOTION Clinical Education DEMO KIT Team DESIRE PRESCRIBE Direct to Patient KOLs Marketing PATIENT PHYSICIAN V-Go Care
Slide 10: V-Go Cares Supporting Patients at a New Level
V-Go® Cares Supporting Patients at a New Level TM V-Go Cares Patient Support In-Person V-Go Training Demo Kits Customer Coaching Benefit Coaching with Clinical CRM & CRM Service (Initiation) Verification (Support) Education (VCC) Team Coaching • Supporting patients at an entirely new level • Matchin
Slide 11: Direct Sales Footprint – Significant Organic Growth Opportunity
Direct Sales Footprint – Significant Organic Growth Opportunity With sales model validated top-line growth can be accelerated by disciplined sales force expansion . Currently ~75 direct reps . ~50 in 2018, . added 25 reps in Q1‘19 . Large markets under- represented or uncovered . Potential to rapidl
Slide 12: Strong Clinical Evidence
Strong Clinical Evidence Demonstrated Statistically Significant Improvements in A1c1-11 Published 15 Clinical Papers Improved Diabetes Management Performance Measures4,7,9,10,11 V-Go® >1,500 Patients Studied Lowered Total Daily Dose of Insulin Presentations 1-11 (Prescribed / Administered) at Nation
Slide 13: Robust Clinical Data
Robust Clinical Data Demonstrated Ability of V-Go® to Deliver Clinically Relevant Reductions in A1c with Less Insulin V-GoAL1 SIMPLE2 VALIDATE 13 EVIDENT4 IMPROVE5 JONES6 KAISER7 UMASS8 MOTIV9 ENABLE10 Baseline 9.9% 8.8% 9.6% 9.6% 9.8% 9.1% 9.8% 10.7% 8.7% 9.2% N=169 N=87 N=204 N=85 N= 103 N=69 N=60
Slide 14: V-Go: Improved A1c Control with Less Insulin
V-Go®: Improved A1c Control with Less Insulin A prospective study of 415 patients shows advantage of V-Go vs. Standard Treatment Optimization (STO)1, 2 Greater Improvement in A1c1 Less Insulin Used & More Cost Effective1,2 V-Go STO 29% V-Go $24.48 vs STO $39.95 n=169 n=246 Less Insulin per patient
Slide 15: Strong Gross Margin Mitigates Capital Needs to Break-Even
Strong Gross Margin Mitigates Capital Needs to Break-Even Quarterly Revenue Level at Which 45% Historical and Projected Gross Margin Gross Margin was Achieved* vs. ($ in million) Revenue $61.1 ~25% 80% Margin Improvement $26.4M $20M $20M 47% $27.0 40% $18M 36% $21.4 21% $5.8 Valeritas Dexcom Tandem
Slide 16: Diabetes A Global Pandemic
Diabetes A Global Pandemic - ~380M Type 2 Patients Partnering with experienced high quality regional diabetes distributors Global Diabetes Stats1 International Distribution Agreements . Currently 425 million suffer diabetes; expected to be . International distribution agreements signed with 629 mill
Slide 17: Robust Pipeline to Drive Long-Term Growth
Robust Pipeline to Drive Long-Term Growth V-Go® is a platform with the potential to disrupt the diabetes & insulin markets V-Go® Prefill1,3 h-PatchTM4 (Simple Insulin Management)1,2 Being developed to: (core technology behind V-Go) Being developed to: • Eliminate filling step as it would include a P
Slide 18: Growth and Milestones to Drive Significant Shareholder Value
Growth and Milestones to Drive Significant Shareholder Value Grow Our Share Expand Our Reach Leverage Pipeline Launch Expand V-Go Prefill Advance Sales Force Product Launch V-Go Next in U.S. Collaborate V-Go SIMTM Gen / Line Launch with (Int’l) Extensions Payors V-Go SIMTM Expand h-Patch Expansion o
Slide 19: Financial Summary 1Q 2019
Financial Summary 1Q 2019 y/o/y Comparison Financial Summary Quarterly Summary Full Year Summary ($ in millions) 1Q19 1Q18 Change 2018 2017 Change Revenue $6.4 $6.1 +5.3% $26.4 $20.2 +30.4% Gross Profit $3.0 $2.9 +5.1% $12.4 $8.2 +52.2% Gross Margin 47.6% 47.6% +0 bp 47.1% 40.3% +680 bp Net Loss $14
Slide 20: Large Market Opportunity & Poised for Significant Value Creation
Valeritas: Large Market Opportunity & Poised for Significant Value Creation Unrivaled Market Highly Attractive Opportunity Financial Profile Solid Top-Line Growth Global Type 2 diabetes Gross Margins ~48% New commercial model pandemic tracking to 80% validated 5.6 million U.S. Type 2 Pro
Slide 21: Valeritas Appendix May 2019
Valeritas Corporate Presentation Appendix NASDAQ: VLRX May 2019 Improving health and simplifying life for people with diabetes ©2019 Valeritas, Inc. 21
Slide 22: V-Go: Easy to Use & High Quality Commercial Scale Manufacturing
V-Go®: Easy to Use & High Quality Commercial Scale Manufacturing V-Go Device Overview V-Go® EZ FILL Basal rate is 24 hour Basal rate begins spring-driven with the push of a button Basal rate flow restrictor Needle • Simple filling does not require calculations, measuring On-demand bolus or needles f
Slide 23: V-Go Combines Simplicity and Physiologic Insulin
V-Go® Combines Simplicity and Physiologic Insulin in Patient- Friendly and Easy-to-Use Wearable Device Start Basal Press button to insert needle and start basal rate of insulin delivered at a constant rate Deliver on-demand insulin for mealtime coverage in 2 units/click Activate Bolus Ready Button D
Slide 24: V-Go Filling Process
V-Go® Filling Process Requires no syringes, measuring or calculating….. Remove plug and insert V-Go Insert vial and draw insulin into EZ Fill Fill with insulin and check V-Go Remove V-Go, check and clean D V-Go is filled with a single type of insulin, a U-100 fast-acting insulin (also referred to as
Slide 25: V-Go Demonstrated Reduction in Glucose
V-Go® Demonstrated Reduction in Glucose at 14 Months Switched to V-Go 0.0 All Patients (N=103) All Patients Previously on Insulin (n=80) -0.4 Patients Previously on Basal-Bolus MDI (n=58) -0.8 -1.2 -1.3* -1.3* Change in A1c A1c in Change -1.5* -1.4* -1.5* -1.6 -1.5* -1.6* -1.7* -1.7* -2.0 Baseline 2
Slide 26: V-Go Offers Efficient Delivery for Improved Glycemic Control
V-Go® Offers Efficient Delivery for Improved Glycemic Control V-Go Demonstrated Significant Reductions in A1C and Insulin For Patients with Type 2 Diabetes Compared to Pen Therapy Mean Change in A1c On V-Go Mean Change in Insulin (units/day) On V-Go 3 Months 7 Months 3 Months 7 Months -10* -11* -13*
Slide 27: Less Insulin Needed and Lower A1c vs. Multiple Injections
Less Insulin Needed and Lower A1c vs. Multiple Injections Switching from Prior Multiple Daily Injections to V-Go® Results in Significant Reductions in Insulin and A1c VALIDATE evaluated patients switched to V-Go when Glycemic Control was Suboptimal on Prior Regimens Prescribed On V-Go 117 Patient 10
Slide 28: Simple Titration Approach Significantly Lowered A1c
Simple Titration Approach Significantly Lowered A1c Use of a weekly physician-driven mealtime dosing titration approach with patients with Type 2 Diabetes uncontrolled on prior regimens A1c (%) Insulin Dose (Units) A1c Goal Achievement 8.7 144 Before V-Go® On V-Go < 7% 13% 47% < 8% 40% 7.1* 87% 60*
Slide 29: Clinical Benefit Realized with V-Go
Clinical Benefit Realized with V-Go® Switching Patients from Prior Insulin Injections to V-Go Resulted in Improved A1c and Less Insulin Regardless of Baseline Insulin Regimen or Dose All Patients Switched to V-Go1 Patients with High Dose MDI Switched to V-Go2 (MDI Patients Prescribed between 90- 300
Slide 30: Significant Market Opportunity for Valeritas in the U.S.
Significant Market Opportunity for Valeritas in the U.S. U.S. Type 2 Diabetes Initial V-Go® Target Market V-Go Potential Revenue 5.6M Patients with Type 2 2M Type 2 on Multiple Daily Injections Diabetes On Insulin1 With Current Sales Force 15% “IF” Market Share V-Go Revenue 2 2M on 15% $75 Million M
Slide 31: Patients Who Utilize V-Go Like How it Fits into Their Lifestyle
Patients Who Utilize V-Go® Like How it Fits into Their Lifestyle >90% of Patients are satisfied with the ability of V-Go to fit with their Lifestyle Extremely Satisfied = 39% Very Satisfied= 32% Satisfied= 16% Somewhat Satisfied= 7% Not Satisfied=6% N=720 patients prescribed V-Go dLife Survey 1Q 201
Slide 32: V-Go with V-Go SIM Technology
V-Go® with V-Go SIMTM Technology Simple Insulin Management™ MANAGEMENT APPLICATIONS PATIENT PHYSICIAN INDUSTRY PAYERS V-Go SIM sends data one-way to a V-Go SIM will enable simple and Adherence, utilization and other Evidence of treatment smart device. SIM App provides data timely access to data that
Slide 33: Experienced and Proven Executive Management Team
Experienced and Proven Executive Management Team Geoffrey Jenkins EVP Manufacturing Joseph Saldanha Operations, R&D Chief Business Officer John Timberlake President & CEO, Board Member Matt Nguyen ErickLucera Chief Commercial Officer Chief Financial Officer ART-1507 Rev D 5/19 ©2019 Valeritas, Inc.
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