Full Press Release Details
Investor Presentation.
Forward Looking Statements, Other Disclaimers.
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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 forwardlooking 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.
Diabetes Care for the Rest of Us.
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.
At Modular Medical, we are dedicated to helping people with diabetes gain access to high quality care by making it affordable and easy to use. Diabetics want their lives back. We aim to help.
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.
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
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.
32% of population utilizes insulin pumps for diabetes management
Multiple Daily Injections (MDI's)
68% of the population rely on multiple daily injections for diabetes management
Almost Pumpers are 30% of the market. They would go on pump if it were less expensive, time consuming, and technically intimidating.
Insulin pumps on the market today require a substantial amount of time to manage therapy
High out of pocket costs of today's pumps place these technologies out of reach for a large part of the population
Feature-heavy and complex systems have hampered adoption. These products are for "superusers" not for "the rest of us"
Today, insulin-requiring individuals with diabetes must invest significant time to manage therapy, cover high out-of- pocket expenses, and operate complicated "advanced" pump systems.
At Modular Medical, our mission is to simplify diabetes management and expand access to the higher quality of care that insulin pumps provide.
We aspire to develop technology that liberates and empowers people to improve their health and well-being and take back more of their lives.
Abbott Libre Freestyle 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.
"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."
Revenue (Millions of USD)
FreeStyle Ubre vs. Dexcom
All drugs and medical devices must meet three standards
The product must be desired by
the market: feature and cost
competitive, attractive to users.
The product must be approvable by the
FDA: meets all testing and regulatory
requirements and specifications. Able to
navigate the approval and
documentation process.
The product must be profitable to
manufacture and to sell. Engineered to
be low cost and easy to manufacture.
Designed to be sold to and through
providers, not users.
Remove the trade off between high cost and complexity and high-quality care: expand market by meeting unmet needs.
Features & Benefits:
No External Controller Required
Push Button to Bolus
No Charging or Battery Replacement
Learn to Use at Home
Upfront Cost to Patient Discount to Closest
Revenues Dedicated to Expansion of
Discounting &Co-Pay Buydown Market
Approval: 510(k) Predicate device approval pathway for FDA label. Same label as Omnipod. Testing is based on benchtop tests, no human trials required (no insulin pump has done pre-approval human trials)
Submission: First FDA meeting was held in Nov. 2019. Second meeting was Mar. 2020. FDA submission expected Q3 2021. Anticipated 6-month review period.
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Testing/Prepare Submit to the FDA
FDA Review Period ~6 Months
Anticipated FDA Approval
Andrew Mann: RA Lead
20 years of experience in regulatory affairs and submissions.
Led regulatory effort for Cellnovo Aladin Diabetes management system, 510k filing, CE mark.
Several filings Including FDA IDE for GSK, 4 companion diagnostic programs with GSK, Novartis, Immunocore, Regenron
10 years experience as design engineer.
Sue Finneran: RA Consultant
Current president, regulatory Compliance experts, Inc.
Formerly Sr. Director of Clin/Reg affairs at Insulet for Omnipod, handled Omnipod submission, VP regulatory for Neograft
New microfluidics technology allows for low-cost pumping of insulin.
New design philosophy makes product simple enough for provider driven sales.
Traditional Pumps Use
and Complex Modalities To
5 Years Development:
Off the Shelf, High Volume
Revenue Per Patient/Year1 Gross Margins
Less Expensive to Manufacture Than Omnipod2 Of Revenue Spent on Discounting and Free Samples
Recurring Revenue Per 1% Market Share Operating Margin at 1% Market Share
1. Based on 20% discount to published CPT codes for Omnipod.
2. Calculation based on Omnipod US data from SGP 2019 diabetes bluebook and internal cost estimates.
Price: FREE Cost: $34
*Omnipod CPT code with 20% discount
Profitable From the First Sale
First month: 1 Re-Usable + 10 Disposables
Cost: $34 + $76.80 = $111.80 Gross Profit: $238.40
Subsequent Months: 10 Disposables
Price: $349.20 Cost: $76.80 = $76.80 Gross Profit: $272.40
Designed with the Patient &Provider in Mind.
Direct sales Force Focused on Providers
Free Samples to Encourage Trial
Point of Prescription Couponing
Simple to Teach and Support Patients
Only product that you can take home today from doctor's office
App to Learn Product
Free 30-Day Trial Coupons
Reduced outlay of time and money
Telehealth Optimized
2020 saw personal telehealth go from beta test to mainstream. Customers and providers have become comfortable with it.
Endocrinologists are perfect candidates for telehealth. They are overworked, underpaid, and need to drive more volume through their practices. Most of what they do can be done online (tests, guidance). There are only 4,000 patient facing endos in the US.
Telemedicine is a force multiplier to better serve a large market.
The Pivot was designed to be affordable enough for free sampling and trial, and simple enough for self-guided user training. This is the product the industry has needed to take the step into telehealth.
Modular Medical products are designed to attain preferential reimbursement and avoid the coverage pitfalls many other pumps have experienced.