MODDHIGH SIGNALREGULATORY10-K

MODD received FDA clearance for its MODD1 insulin pump in September 2024 and plans to commence initial shipments by Q1 2026, marking a critical transition from development to commercialization.

This FDA approval represents a pivotal milestone that transforms MODD from a pure development-stage company to one preparing for commercial launch. The company is simultaneously developing a second-generation tubeless "Pivot" version, indicating a clear product roadmap, though revenue generation remains at least a quarter away with shipments planned for September 2025.

Comparing 2025-06-20 vs 2024-06-21View on EDGAR →
FINANCIAL ANALYSIS

The balance sheet reflects successful capital raising with stockholders' equity growing to $17.1M and cash reserves strengthening to $13.1M, providing crucial runway for the commercial launch phase. Operating cash burn increased modestly to $15.7M while R&D spending rose 14% to $14.7M, consistent with pre-launch development activities. The improved financial position and reduced liabilities suggest MODD is well-positioned to fund its transition to commercial operations.

FINANCIAL STATEMENT CHANGES
Stockholders Equity
Balance Sheet
+48%
$11.5M→$17.1M

Equity base grew 48% — retained earnings accumulation or equity issuance strengthening the balance sheet.

Capital Expenditure
Cash Flow
+46.6%
$1.7M→$2.5M

Capital expenditure jumped 46.6% — major investment cycle underway; assess returns on deployment.

Cash & Equivalents
Balance Sheet
+41.8%
$9.2M→$13.1M

Cash position surged 41.8% — strong cash generation or capital raise providing significant financial cushion.

Current Assets
Balance Sheet
+39.4%
$9.7M→$13.5M

Current assets grew 39.4% — improving short-term liquidity or inventory/receivables build.

Total Assets
Balance Sheet
+35.7%
$13.8M→$18.7M

Asset base grew 35.7% — expansion through organic growth, acquisitions, or capital deployment.

Total Liabilities
Balance Sheet
-27%
$2.3M→$1.7M

Liabilities reduced 27% — deleveraging improves balance sheet strength and financial flexibility.

R&D Expense
P&L
+14.1%
$12.9M→$14.7M

R&D investment increased 14.1% — signals commitment to future product development, though near-term margin impact.

Current Liabilities
Balance Sheet
-13.1%
$1.5M→$1.3M

Current liabilities reduced — improved short-term financial position and working capital health.

Operating Cash Flow
Cash Flow
-12.7%
-$14.0M→-$15.7M

Operating cash flow softened — monitor whether temporary working capital timing or structural deterioration.

LANGUAGE CHANGES
NEW — 2025-06-20
PRIOR — 2024-06-21
ADDED
Management s Discussion and Analy sis of Financial Condition and Results of Operations 38 Item 7A.
Each reference to a fiscal year in this Report refers to the fiscal year ended March 31 of the calendar year indicated (for example, fiscal 2025 refers to the fiscal year ended March 31, 2025).
Through the creation of an innovative two-part patch pump, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care that presently require considerable motivation from the patient to use the available insulin pumps.
In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration, or the FDA, for our initial insulin pump product, the MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States.
We are actively working to manufacture and commercialize our MODD1 product and commence initial shipments during the quarter ending September 30, 2025.
We are currently preparing a second 510(k) premarket notification application to the FDA for an updated version of the MODD1, called the Pivot, which is a tubeless version of the product that integrates the set into a true tubeless patch.
The Pivot will provide us with cost and usability improvements and improved manufacturability, allowing our marketing to be focused on low cost and ease of use and learnability.
We believe we will submit the notification for the Pivot by October 31, 2025, and we believe we could obtain regulatory clearance to market and launch Pivot during the three months ending March 31, 2026.
We intend to replace the MODD1 with the Pivot, as soon as the required regulatory approval from the FDA is received.
We also intend to obtain Conformite Europeenne , or CE, mark clearance for both our MODD1 and Pivot products, which would allow us to market and sell in European markets.
REMOVED
Management s Discussion and Analysis of Financial Condition and Results of Operations 38 Item 7A.
Each reference to a fiscal year in this Annual Report on Form 10-K, refers to the fiscal year ended March 31 of the calendar year indicated (for example, fiscal 2024 refers to the fiscal year ended March 31, 2024).
Through the creation of an innovative two-part patch pump, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care requiring considerable motivation that presently available insulin pumps provide.
We believe that, by tailoring our insulin pump to address such factors, we can expand the scope and adoption rate of insulin pump usage.
This leads to limited or absent reimbursement/coverage and potentially high financial hurdles for patients to gain access.
While our initial target market is people with type 1 diabetes, we believe there is a substantial opportunity to penetrate the type 2 marketplace, whether through our initial MODD1 pump or further simplification of our pump to address the type 2 marketplace.
The MODD1 is a high-precision pump that we believe represents the best choice for new pump patients because it is easy to afford, easy to learn, easy to use, and has a revolutionary design and internal technology that enable precision with low-cost manufacture and high reproducibility.
Key features include: Two parts - one reusable, one disposable - snap together to form the working system; One button interface, easy to learn and use; 90-day reusable, 3-day disposable; Disposable portion removable at any time from an adhesive-backed retainer, which remains in place; No external controller required, no charging, no battery replacement; and Slim profile, lighter weight.
A proprietary survey of American healthcare payors representing 50 million covered lives (approximately 1/3 of U.S.
According to the Seagrove 2021 Diabetes Blue Book, approximately 18% of people with T2D in the United States, or approximately 4.7 million people, require insulin (basal alone represent 3.1 million and basal plus mealtime represent 1.6 million) to manage their diabetes.
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