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Art 1236 rev b-valeritas investor deck 2.0 final_053118
1.
NASDAQ: VLRX May 2018 ©2018 Valeritas, Inc. Improving health and
simplifying life for people with diabetes Valeritas Corporate Presentation
2.
©2018 Valeritas, Inc. 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 “Valeritas,” “we,” “us,” “our” or “our company” refer to Valeritas Holdings, Inc. and its subsidiaries. This presentation contains estimates, projections and forward‐looking statements. Our estimates, projections 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, including but not limited to our revenue, gross margin and cash‐ flow break‐even projections. Although we believe that these estimates, projections and forward‐looking statements are based upon reasonable assumptions and expectations, they are subject to numerous known and unknown risks and uncertainties and are made in light of information currently available to us. Many important factors may adversely and materially affect our results as indicated in forward‐looking statements. All statements other than statements of historical fact are forward‐looking statements. The words “believe,” “may,” “might,” “could, “would,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and similar words are intended to identify estimates, projections and forward‐looking statements. Estimates, projections and forward‐ looking statements speak only as of the date they are made, and, except to the extent required by law, we undertake no obligation to update or review any estimate, projection or forward‐looking statement because of new information, future events or other factors. Our estimates, projections and forward‐looking statements may be influenced by one or more of the following factors: • our history of operating losses and uncertainty regarding our ability to achieve profitability; • our reliance on V‐Go® Wearable Insulin Delivery device, or V‐Go®, to generate all of our revenue; • our inability to retain a high percentage of our patient customer base or our significant wholesale customers; • the failure of V‐Go® to achieve and maintain market acceptance; • our inability to operate in a highly competitive industry and to compete successfully against competitors with greater resources; • competitive products and other technological breakthroughs that may render V‐Go® obsolete or less desirable; • our inability to maintain or expand our sales and marketing infrastructure; • any inaccuracies in our assumptions about the insulin‐dependent diabetes market; • manufacturing risks, including risks related to manufacturing in Southern China, damage to facilities or equipment and failure to efficiently increase production to meet demand; • our dependence on limited source suppliers and our inability to obtain components for our product; • our failure to secure or retain adequate coverage or reimbursement for V‐Go® by third‐party payers; • our inability to enhance and broaden our product offering, including through the successful commercialization of the V‐Go® SIMTM and V‐Go® pre‐fill; • our inability to protect our intellectual property and proprietary technology; • our failure to comply with the applicable governmental regulations to which our product and operations are subject; • our ability to operate as a going concern; and • our liquidity. Forward Looking Statements 2
3.
Valeritas: Rapidly Ramping Revenue & Poised for Significant Value Creation Significant Market Opportunity Global Type 2 diabetes pandemic 5.6 million U.S. Type 2 patients on insulin
High barriers to competitive entry Selling Model Validated, Revenue Growth Accelerating New high‐touch sales model validated Inflection and acceleration of revenue growth 2018 guidance +30% revenue growth to ~$26M ‐ $28M Attractive Financial Profile, Limited Additional Financing Significantly higher gross margin at lower revenue than other diabetes device players 45% at $5.8M qtly rev Profitability attained well‐ before 80% peak gross margin Turnaround Complete Company and its selling model revamped since Q1 ‘16 Performance validates turnaround success ©2018 Valeritas, Inc. 3
4.
Type 2 Diabetes Overview: V‐Go® $1.6B U.S. Opportunity ©2018 Valeritas, Inc. Source: Company data, kff.org ~23 million diagnosed people with diabetes (90%‐95% Type 2)2 U.S. Diabetes Market Overview1 ~7 million Insulin Users 1 . U.S. Roper Diabetes Market Study provided by GfK Customer Research LLC. 2. CDC National Diabetes Statistics Report, 2017 3. A1c is a measure of glucose control Key Type 2 Market Data Points 5.6 million U.S. Type 2 patients on insulin 80% of Type 2 patients on insulin
are not achieving A1c goals3 Our core focus is on these 4.5M Type 2 patients on insulin not at goal • 15% share in this segment = ~$1.6B revenue 4 Type 1 (~1M users) Type 2 Insulin Users (~5.6M) Type 2 Not on Insulin Today (~16.5M users)
5.
©2018 Valeritas, Inc. Current Insulin Delivery Standard of Care for Type 2 Highly Dissatisfying Current Insulin Delivery Standard of Care Type 2 Insulin Users Intentionally Skip and/or Type 2 Insulin Users Intentionally Skip and/or Forget to Take Injections1 Most Type 2 patients will not inject away from home2 1. Randlov J, et al. J Diabetes Schi Technol. 2008;Mar;2(2):229‐35 2. Data from U.S. Roper Diabetes Patient Market study provided by GfK Custom Research LLC and distributed only with express written permission of GfK Custom Research LLC. This study is an annual survey of over 2,000 diabetes patients (n=2,104 in 2011; 692 who use insulin) via telephone and internet. 3.
Eur J Heart Fail. 2017 Nov;19(11):1412‐1413 “Drugs don’t work in people who don’t take them.” ‐C. Everett Koop, M.D. (former U.S. Surgeon General)3 5
6.
©2018 Valeritas, Inc. The V‐Go® Solution Designed for Patients with Type 2 Diabetes V‐Go’s Benefits Discreet, Low Profile Simple to Use Convenient Cost Neutral Better A1c Control* Self‐contained Sharps Container Pharmacy vs. DME * Company data, kff.org (11 published clinical papers and 48 presentations at National Conferences) 6
7.
V‐Go® Competition: Pens not Pumps Unique Needs of Type 2 Patients Creates Valeritas’ Opportunity & Differentiates it from Others Typical Patient Attitude Complex Device Acceptable? Willing to Participate in Extensive Training Solutions Offered / Competitors TYPE 1 TYPE 2 Engaged / Advocate Embarrassment / Stigma More Likely (~30% of Type 1 are on pump therapy)1 More Likely Less Likely Less Likely V‐Go® Therapy 7 1. Sikes, et al. Diabetes and the Use of Insulin Pumps. 2016 ©2018 Valeritas, Inc.
8.
©2018 Valeritas, Inc.. 8 Demonstrated Statistically Significant Improvements in A1c1‐10 Improved Quality of Life1 Lowered Total Daily Dose of Insulin (Prescribed / Administered)1‐10 12 52 Published Clinical Papers V‐Go Patients Studied Presentations at National Conferences 1. Rosenfeld CR, et al. Endocr Pract. 2012; 18 (5):660‐667. 2. Grunberger, G, et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21‐25; Chicago, IL. 985‐P. 3. Omer, A. et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21‐25; Chicago, IL. 980‐P. 4.
Lajara, R, et al. Drugs‐Real World Outcomes 2016 Jun 2;3(2):191‐199. 5. Lajara R, et al. Diabetes Ther. 2015;6 (4):531‐545. 6. Lajara R et al. Endocr Pract. 2016 June; 22 (6): 726‐725. 7. Sutton D, et al. Advances in Therapy. 35(5), 631‐643 2018. 8. Abbott S, et al. Oral Presentation at the 77th Scientific Sessions of the ADA, June 2017. 9. Wu P, et al. Poster presented at AACE 27th Annual Scientific Meeting, May 2018. 10. Hundal R, et al. Poster presented at the Academy of Managed Care Pharmacy, April 2018. Demonstrated Cost Reductions4 Strong Clinical Evidence 1K>
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©2018 Valeritas, Inc. 1 Study conducted by HealthCore, Inc., an outcomes research subsidiary of Anthem, Inc. *Significant compared to baseline, Significant between groups Baseline A1C (%): V‐Go® 9.88 and STO 9.34 Baseline total daily insulin dose (u/day): V‐Go® 71 and STO 72 2 As measured by A1c levels 3 Cost includes the WAC cost for all diabetes treatments and medications and based on per patient/day (PPPD) at study end. The cost is calculated as the sum of published price of insulin, device and concomitant medications. Abbott, S, et al. Presented as an oral presentation at the 77th ADA Scientific Sessions, San Diego, CA 2017 V‐Go®: Improved A1c Control with Less Insulin ‐0.95* ‐0.46* Change in A1c (%) 29% Less Insulin with V‐Go vs STO at 4 months (54 vs 72 u/day) P<0.001 N= 415 patients across 52 Sites with duration of up to 4 months V‐Go $24.48 vs STO $39.95 per patient per day for each 1% drop in A1c3 P = 0.0018 STO n=246 V‐Go n=169 A Prospective Study of 415 Patients Showed V‐Go Superiority vs. Standard Treatment Optimization (STO)1 Greater Improvement in A1c2Greater Improvement in A1c2 Less Insulin Used & More Cost EffectiveLess Insulin Used & More Cost Effective 9
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©2018 Valeritas, Inc. New High‐Touch Sales and Marketing Model PATIENT PHYSICIAN • Target high insulin volume prescribers •
High frequency of office contact • High support with service to prescriber and patient • Activate patients to seek and ask for V‐Go® • Direct‐to‐Patient multi‐channel marketing • Patient education and support DESIRE EDUCATION PROMOTION ON‐LINE ADs DEMO KIT TARGETED PRINT ADs PRESCRIBE 10 DIRECT SALES REPs DIRECT SALES REPs INDIRECT REPsINDIRECT REPs KOLsKOLs CONFERENCESCONFERENCES
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11 U.S. Direct Sales Footprint ~50 Direct Reps Disciplined addition of reps over time to achieve national coverage Significant Opportunity for Sustained Robust Growth via Disciplined Sales Force Expansion ©2018 Valeritas, Inc.
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©2018 Valeritas, Inc. Accelerating 20%+ Revenue Growth $4,000 $4,500 $5,000 $5,500 $6,000 $6,500 Q1'16 Q2'16 Q3'16
Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Sequential Quarterly Revenue (Q1 2016‐Q1 2018) Inflection point for growth, fueled by high‐touch / higher‐service model Q1 ‘16 revamped sales & marketing model • Direct reps reduced from 64 to 28 in Jan ‘16 • Focused high‐touch and higher‐service sales & marketing model adopted Q2 ‘17 increased direct reps to 48 Market reception has been positive Model validated in 2017 • 4 consecutive quarters of accelerating growth • Scope of unmet need creates a long runway for robust growth Key ObservationsKey Observations (in 000’s) 12
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©2018 Valeritas, Inc. 13 Target ShareTarget Share Addressable U.S. Type 2 Patient Population Addressable U.S. Type 2 Patient Population Annual U.S. RevenueAnnual U.S. Revenue With 15% Market Share 2M Multiple Daily Injections 4.5M Insulin Users not at Goal $700M1 $1.6B2 1. 2M patients x $6.50 per V‐Go® x 360 days x 15% share = ~ $700M 2. 4.5M patients x $6.50 per V‐Go® x 360 days x 15% share = ~$1.6B Our Goal: 15% Share in Addressable U.S. Markets 15% Share of Type 2 Patients in U.S. (Already on Insulin but not at Goal) can Generate ~$1.6B Revenue 13
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©2018 Valeritas, Inc. International Markets – Significant Market Opportunity Global Diabetes Stats1 International Distribution Agreements
Recent international distribution agreements signed with premier regional distributors May 2018: MED TRUST (Austria & Germany) Apr 2018: AMSL Diabetes (Australia) & NZMS Diabetes (New Zealand) Feb 2018: Movi SpA (Italy) Additional distributor discussions currently on‐going No contribution from international partnerships included in our financial guidance 1. IDF Annual Report, 2017; IDF Atlas 2017, 8th Edition, Page 48 Currently 425 million suffer diabetes; expected to be 629 million by 2045 (~90% Type 2) Regions of highest diabetes prevalence Regions with significant prevalence of diabetes 14
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V‐Go Line Extension Products Provide Path to the Broader Diabetes & Insulin Market ©2018 Valeritas, Inc.. V‐Go® SIMTM (Simple Insulin Management)2 Expected to: • Provide connectivity to smart phones and data aggregation glucose meters and other devices • Permit tracking and reporting of basal rate and bolus insulin usage •
Be used as diagnostic tool to make treatment adjustments • Increase patient adherence V‐Go® • Current product • Filled by patient by transferring insulin from vial using V‐Go® EZ Fill • Commercially available in U.S. • Approved in E.U. with initial country distribution agreement executed V‐Go® Prefill1 Expected to: • Eliminate filling step as it would include a prefilled insulin cartridge • Eliminate need for & cost of V‐Go® EZ Fill • Lower number of co‐pays2 • Provide revenue from insulin • Expand target population (1st line Insulin) • Extend patent life to 2032 1. Product currently under development. 2. Assumes V‐Go® devices and insulin cartridges packaged in a single box under a single NDC thereby potentially reducing the number of prescriptions and the number of co‐pays required per patient. Robust Pipeline of New V‐Go Products 15
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©2018 Valeritas, Inc. Strategy for Sustained Growth & Expansion Grow Our Share Expand Our Reach Leverage Pipeline + •
~50 direct sales reps • Targeting ~1,200 prescribers (accounts) • Drive V‐Go® share in these accounts • Leverage patient to increase demand Expand international presence V‐Go® Prefill V‐Go® SIMTM • Expand # of targets per rep • Expand U.S. field presence • V‐Go accessory with blue tooth connectivity • Tracking and reporting of insulin use • Prefilled insulin cartridge • Capture insulin economics • Expand reachable patient population 16
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©2018 Valeritas, Inc. $5.8 $21.4 $27.0 $61.1 $0 $10 $20 $30 $40 $50 $60 $70 Valeritas Dexcom Tandem
Insulet Quarterly Revenue Level at Which 45% Gross Margin was Achieved* *Respective past company public filings. Gross margins from each company and product may not be directly comparable Valeritas Projected Gross Margins 50% GM in Q4 2018 at $7M to $8M Revenue High margin at low revenue Profitability attained well‐ before 80% peak gross margin Significant gross margin expansion potential ($ in million) Stronger Device Margin Mitigates Future Capital Needed to Break‐Even 17
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Financial Summary ($ in millions) Quarterly Summary Full
Year Summary 1Q18 1Q17 Change 2017 2016 Change Revenue $6.1 $4.6 +32% $20.2 $19.6 +3.6% Gross Profit $2.9 $1.7 +67.2% $8.2 $6.9 +17.6% Gross Margin 47.6% 37.6% +1000 bp 40.3% 35.5% +480 bp Net Loss $12.1 $11.9 +2.3% $49.3 $46.3 +6.3% Total Debt $37.0 $33.1 +11.8% $36.0 $59.0 ‐38.9% Cash and Cash Equivalents $14.5* $51.2 ‐71.7% $26.0 $9.9 +163.1% ©2018 Valeritas, Inc.. Financial Summary 18 *Cash and Cash Equivalents does not include $26M in equity capital raised on May 1, 2018.
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Valeritas: Rapidly Ramping Revenue & Poised for Significant Value Creation Significant Market Opportunity Global Type 2 diabetes pandemic 5.6 million U.S. Type 2 patients on insulin
High barriers to competitive entry Selling Model Validated, Revenue Growth Accelerating New high‐touch sales model validated Inflection and acceleration of revenue growth 2018 guidance +30% revenue growth to ~$26M ‐ $28M Attractive Financial Profile, Limited Additional Financing Significantly higher gross margin at lower revenue than other diabetes device players 45% at $5.8M qtly rev Profitability attained well‐ before 80% peak gross margin Turnaround Complete Company and its selling model revamped since Q1 ‘16 Performance validates turnaround success ©2018 Valeritas, Inc. 19