EX-99.1 2 ex99_1.htm EXHIBIT 99.1
 

Exhibit 99.1

 

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Investor Presentation. OTCQB:MODD

 
 

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Forward Looking Statements, Other Disclaimers. THIS SUMMARY IS PROVIDED ON A CONFIDENTIAL AND LIMITED BASIS, SOLELY FOR YOUR USE AS A PART OF YOUR DETERMINATION OF WHETHER TO INVEST IN THE OPPORTUNITY. THIS SUMMARY IS BEING PROVIDED IN RELIANCE UPON SECTION 105(C) OF THE JUMPSTART OUR BUSINESS STARTUPS ACT OF 2012 AND SEC RULE 506 OF REGULATION D, AS AMENDED, AND IS INTENDED SOLELY FOR INVESTORS THAT ARE EITHER QUALIFIED INSTITUTIONAL BUYERS OR INSTITUTIONS THAT ARE ACCREDITED INVESTORS (AS SUCH TERMS ARE DEFINED UNDER SECURITIES AND EXCHANGE COMMISSION (SEC) RULES). THE DISTRIBUTION TO YOU IS MADE FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY SECURITIES, NOR SHALL THERE BE ANY SALE OF ANY OF SECURITIES IN ANY STATE OR JURISDICTION IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE OR JURISDICTION. ANY SUCH OFFER OR SOLICITATION WILL BE MADE ONLY TO QUALIFIED INVESTORS PURSUANT TO THE CONFIDENTIAL OFFERING AND SUBSCRIPTION DOCUMENTS AND WILL BE SUBJECT TO THE TERMS AND CONDITIONS CONTAINED IN SUCH DOCUMENTS. STATEMENTS CONTAINED HEREIN ARE MADE AS OF THE DATE OF THIS DOCUMENT UNLESS STATED OTHERWISE, AND NEITHER THE DELIVERY OF THIS SUMMARY AT ANY TIME, NOR ANY SALE OF SECURITIES, SHALL UNDER ANY CIRCUMSTANCES CREATE AN IMPLICATION THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME AFTER SUCH DATE OR THAT INFORMATION WILL BE UPDATED OR REVISED TO REFLECT INFORMATION THAT SUBSEQUENTLY BECOMES AVAILABLE OR CHANGES OCCURING AFTER THE DATE HEREOF. This summary may contain forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding future results of operations and financial position, business strategy, current and prospective products, planned development activities, product approvals, research and development costs, grants, current and prospective collaborations, timing and likelihood of success, plans and objectives of management for future operations, and future success of anticipated products, are forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. There can be no assurance that the opportunity will meet your investment objectives, that you will receive a return of all or part of such investment. Investment results may vary significantly over any given time period. The appropriateness of a particular investment or strategy will depend on an investor's individual circumstances and objectives. We recommend that investors independently evaluate specific investments and strategies.

 
 

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Type 1's in US 1.6 Million 3 | The Future of Diabetes Care is Easy. Insulin Pumps provide a higher standard of diabetes care. Better glycemic control reduces co-morbidity prevalence, trips to the ER, and leads to higher quality of life. Despite decades of advances in insulin delivery technology, only a minority of individuals with Type 1 diabetes use a pump. The cost and complexity of today's offerings mean that, for many, multiple daily injections remain the only practical Solution. People with Type 1 Diabetes are a cross section of society with widely varying motivation levels, technical sophistication, and resources. You cannot make the people more motivated. To grow the market, you need to make the best care more usable. 1. 2022 Est. based on 2015 actuals reported by ADA

 
 

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An Unmet Need in Type 1 Diabetes Care. There are 1.6 million individuals with Type 1 Diabetes in the US. 100% of patient population require daily insulin injection. Only 1 out of 3 currently use an insulin pump. Pumping 32% of population utilizes insulin pumps for diabetes management 32% Multiple Daily Injections (MDI's) 68% of the population rely on multiple daily injections for diabetes management 68% Almost Pumpers Almost Pumpers are 30% of the market. They would go on pump if it were less expensive, time consuming, and technically intimidating. $1.9bn Market Opportunity

 
 

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New kinds of offerings attract a new kind of user. Abbott Freestyle Libre made continuous glucose monitoring easier and more affordable. This expanded the product category and doubled its size. We believe the insulin pump market is ready for a similar transition. 5 | FreeStyle Libre vs. Dexcom Revenue 800 700 600 500 "In short, Flash Glucose Monitoring is fundamentally trying to take something that is more "professional" (i.e., traditional CGM) and make it more accessible to the masses. In consumer- packaged goods, examples of this strategy include home espresso makers (Keurig), cleaning products (e.g., dilatable floor cleaners, spray cleaners, wipes, toilet wands), and teeth whitening (e.g., whitening strips). In these cases, the new innovation completely changed the entire category; we look forward to seeing if Flash Glucose Monitoring does something similar in diabetes." Kelly Close, 2014 400 300 200 100 0 2Q16 4Q16 2Q17 4Q17 2Q18 4Q18 2Q19 4Q19 2Q20 4Q20 Dexcom FreeStyle Libre

 
 

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Expanding access to pumps requires a new kind of pump. Time Insulin pumps on the market today require a substantial amount of time to learn and manage ongoing therapy Money High out of pocket costs of today's pumps place these technologies out of reach for a large part of the population Technology Feature-heavy and complex systems have hampered adoption. These products are for "superusers" not for "the rest of us" It's Time to Change. Specialty products can be expensive, complex, and have difficult learning curves. Mass market products must be easy to afford, easy to learn, easy to take home, and easy to use. Our Mission At Modular Medical, our mission is to expand access to high quality, modern diabetes care by taking insulin pump delivery systems from a specialty market to a mass market. Our Vision We aspire to develop technology that liberates and empowers people to improve their health and well-being and take back more of their lives. Technology should simplify your life and make it better, not add new projects and new to do lists.

 
 

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Introducing MOD1 90 Day Reusable Designed to meet patient needs: ? Removable ? No External Controller Required ? Push Button to Bolus ? No Charging or Battery Replacement ? Easy to Use ? Learn to Use at Home ? 3 Day Consumable $0 Upfront Cost to Patient or Payor 20% Discount to Omnipod New microfluidics technology for a new kind of product. New design philosophy for a new kind of user. Optimized For provider driven sales Enables Telehealth and Distance care models

 
 

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Technology that Transforms Diabetes Care. (and diabetes company models) $4,086 Revenue Per Patient/Year1 8 | 78% Gross Margins Traditional Pumps Use Expensive Machining and Complex Modalities To PumpCoImnpsaunlyin 5 Years Development: Same Precision, Off the Shelf, High Volume Components from consumer electronics supply chain 70% Less Expensive to Manufacture Than Omnipod2 $158M Recurring Revenue from 2% Market Share of US Type 1 Diabetes 15% Of Revenue Spent on Discounting and Free Samples 20%+ Operating Margin 30 months after Launch. 1. Based on 20% discount to published CPT codes for Omnipod., revenues net of rebates and returns. 2. Calculation based on Omnipod US data from SGP 2019 diabetes bluebook and internal cost estimates $1.9B Expansion of Market

 
 

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Unit Economics. Profitable From the First Sale 180 Day Re-Usable Price: FREE Cost: $34 First month: 1 Re-Usable + 10 Disposables Price: $349.20 Cost: $34 + $76.80 = $111.80 Gross Profit: $238.40 68% Profit Margin 3 Day Disposable Subsequent Months: 10 Disposables Price: $34.92* Cost: $7.68 Price: $349.20 Cost: $76.80 = $76.80 Gross Profit: $272.40 78% Profit Margin *Omnipod CPT code with 20% discount

 
 

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Designed to make adoption easy. Telehealth Optimized 10 | 10 2020 saw personal telehealth go from beta test to mainstream. Customers and providers have become comfortable with it. Provider ? Direct sales Force Focused on Providers ? Free Samples to Encourage Trial ? Point of Prescription Couponing Patient ? Only product that you can take home today from ? App to Learn Product ? Free 30-Day Trial Coupons ? Co-Pay buydowns There are only 4,000 patient-facing endos in the US. The treatment of diabetes will be significantly enhanced with telehealth to drive more volume and clinical enhancements through Telemedicine is a force multiplier to better MOD1 was designed to be affordable enough for self-guided user training. This is the product the industry has needed to take the step into ? Simple to Teach and Support Patients ? Reduced outlay of time and money

 
 

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Payor Preferred. National Payor Survey Retained ISA to perform National Payors Survey on 1/3 of all commercial lives in US (50 million lives) 11 | 10 Modular Medical products are designed to attain preferential reimbursement and avoid the coverage pitfalls many other pumps have experienced. Payor Benefits: ? 20% Discount vs Insulet (PODD) Will Drive Preferred Status ? Designed to use PBM codes as a disposable ? No New Code: Reimbursed at Launch ? Saves Provider $1,062/Patient/Year vs Omnipod Survey data1 shows that a product with Gen-1 features set at 10-20% discount to Omnipod will gain equivalent or preferential reimbursement at launch. "I would say that if they could come in with an average monthly cost of, say, 20% less than Omnipod we would make this our preferred." - IDN Data shows that discounting and rebates have been uncommon and small in insulin pumps. 5% is currently the largest in the space. "We expect that the manufacturer will come to the table, probably with an access rebate [of approx. 5%]. This is based on the fact that Medtronic has already come to us with this kind of rebate." - National Health Plan Payors showed an interest in a simple product that was less expensive. "I like the simplicity and so as a consequence, it's attractive to me mostly because I'm very price sensitive. I don't think there's any meaningful evidence basis for all those fancy and high-tech products." - Regional Health Plan - 1. Primary research, Precision Xtract, Modular Medical Insulin Pump Rapid-Pulse Payer Assessment, June 2019.

 
 

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Milestones to Launch. Approval: 510(k) Predicate device pathway for FDA clearance. Same label as Omnipod. Testing is based on benchtop tests, no human trials required (no insulin pump has done pre-approval human trials) Led by Paul Diperna and Andy Mann each with over 20 years of FDA submission expertise. Submission: First FDA meeting was held in Nov. 2019. Second meeting was Mar. 2020. FDA submission expected Q1 2022. Anticipated 6-month review/comment period. 12 | 10 2021 2022 2023 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Full Design Lock Test and Submit to the FDA FDA Review Period ~6 Months Anticipated FDA Clearance "Soft" Launch Commercial Launch

 
 

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1 MOD1 (Basal with user Bolus) 2 MOD1+ (Cell phone controlled adjusted by algorithm) 3 Product Roadmap. The Path to the Artificial Pancreas MOD2 Dual Chamber (Autonomous, multiple chamber, drug revenue)

 
 

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In Development MOD1+. Cell Phone Controlled 14 | 10 Enhanced Modular Patch Pump: Cell Phone Controlled 2-Factor Authentication Allows use of user's own cell phone as controller. No dedicated controller required. CGM Integration Allows algorithms to adjust basal rate for meals and exercise. Ease of Use Same modular design and ease of use as Pivot G-1, with enhanced control functionality. Development 75% complete

 
 

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The Future of Care MOD2. The Pivot G-3 is a native multi-chamber pump developed with enhanced ease of use in mind. Designed to be prefilled, the Pivot G-3 will enable Modular Medical to capture drug revenue. Modular Medical will become the one-stop shop for all of a user's diabetes needs. Artificial Pancreas 15 | 10 MOD2 Features ? Closed Loop System ? Continuous Glucose Monitor Measures Blood Sugar, Feeds Data to Pump ? Algorithms Inform Pump Activity ? No Human Intervention Required 1. Reuters "US insulin costs" 2012-16, Good RX. 2. $1,088 Avg price for monthly supply from Good RX. Assume ~50% price drop for generic. 3. ($4,800 + $6,000 + $4,300) X 1.5 million T1 Diabetics = $22.65bn $4,800 Insulin Spend Patient / Year1 $6,000 Symlin Spend Patient / Year2 $4,300 Pump System Patient / Year $22.6 B US Addressable Market3

 
 

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The Team. Chairman, President and CTO Paul DiPerna 35 years of experience in medical device industry CEO Lynn Vos ? Forward thinking healthcare business leader ? Market development expert with track record of success in healthcare, pharma and med tech ? Leader in healthcare marketing and communications having built major healthcare advertising enterprise-Grey Health ? Launched breakthrough products in every major disease category with integrated, multi-channel offerings ? Led innovative campaigns, tackling important healthcare challenges with a vision to improve healthcare delivery, physician/patient engagement and health outcomes. ? Led over 10 projects to FDA approval ? Founder CEO and CTO Tandem Diabetes (TNDM:NAS) ? Designer and lead developer of t:slim pump, a leading insulin pump in type 1 diabetes ? Founder and CEO, Modular Medical: an innovative next generation insulin pump ? Over 70 granted patents in device & microfluidics Proven ability to develop products and win FDA approval Tandem Diabetes Care - 510k approval on their T-Slim -2012 National Cardiac - 510k approval on a disposable EKG sensor -2018 VP Operations, Project Leader Jason Ng ? 28 years of product development experience from concept through launch and manufacturing in medical devices, most in insulin pumps. ? Led engineering teams at Insulet and Medtronic/Minimed. ? VP Asian Ops for Insulet. ? Managed migration of US manufacturing of Omnipod to Asia, validated high volume manufacturing process and transfer of class 2 medical device to China.

 
 

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Investor Relations ir@modular-medical.com OTCQB:MODD

 
 

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Appendix.

 
 

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T1D Insulin Pump Comparisons (US Market) . 19 | Product Features t:slim X2 Medtronic 780G Omnipod DASH MOD1 Manufacturer Tandem Diabetes Care Medtronic (MiniMed) Insulet Modular Medical Reservoir Size 300 units/3mL 300 units/3mL 200 units/2mL 300 units/3mL Pump Cost Pump: $4,200 Disposables: $134/month Pump: $4,600 Disposables: $148/month Pump: $0 Disposables: $437/month(PBM Pricing) Pump: $03-Day Disposables:$349/month(PBM Pricing) Monitorable Via User'sCell Phone No Yes No Yes User Interface Color Touchscreen on Pump Color Screen on Pump, Scroll wheel Locked PDM Handset Simple Analog Button / Optional Smartphone App External Controller Required No No Yes No Charger/Battery Requirement Charger Required Battery Required Handset Charging Required No Charger/Single-use disposable battery provided User-Learnable No No No Yes Remove & Reattach Yes Yes No Yes

 
 

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Artificial Pancreas Will Be Multi-Chamber. ? FDA has established 70% Time In Range "no human intervention" standard for AP. ? "Control IQ" study published in NE Journal of medicine barely reached 70% despite announcing meals, sleep, and exercise. ? Prominent KOL's and Algo designers feel 70% TIR without intervention is out of reach with insulin alone: the Artificial Pancreas will have to be multiple liquid. ? Multiple liquid will require small, simple, affordable pumps. Complexity and cost are multiplied. Legacy technology is not well suited. ? MODD well positioned to be first to market with viable multi-chamber product. Artificial Pancreas Pivot G-3 Pump CGM Pivot G-3 Features ? Closed Loop System ? Continuous Glucose Monitor Measures Blood Sugar, Feeds Data to Pump ? Algorithms Inform Pump Activity ? No Human Intervention Required 20 |