MiniMed Group Inc.

04/17/2026 | Press release | Distributed by Public on 04/17/2026 14:30

Quarterly Report for Quarter Ending January 23, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis provides information management believes to be relevant to understanding the financial condition and results of operations of MiniMed Group, Inc. and its subsidiaries ("MiniMed Group, Inc.," "MiniMed," the "Company," or "we," "us," or "our"). For a full understanding of financial condition and results of operations, you should read this discussion along with Management's Discussion and Analysis of Financial Condition and Results of Operations in our final prospectus filed with the U.S. Securities and Exchange Commission (the "SEC") on March 6, 2026 pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, relating to its Registration Statement on Form S-1 (the "IPO Prospectus"). In addition, you should read this discussion along with our combined financial statements and related notes thereto for the three and nine months ended January 23, 2026. Amounts reported in millions within this quarterly report are computed based on the amounts in thousands, and therefore, the sum of the components may not equal the total amount reported in millions due to rounding. Additionally, certain columns and rows within tables may not sum due to rounding. Our actual results could differ materially from the results contemplated by these forward-looking statements due to a number of factors, including those described in the section of our IPO Prospectus entitled "Risk Factors" and the section entitled "Cautionary Note Regarding Forward-Looking Statements" included herein.
Overview
We are a scaled global medical technology company that develops, manufactures, and markets a comprehensive suite of solutions for the management of diabetes, including automated insulin delivery ("AID") systems and smart multiple daily injection ("Smart MDI") systems. Our AID systems integrate insulin delivery, glucose sensing, and proprietary dosing algorithms to improve glycemic outcomes and reduce the burden of diabetes management for people with diabetes ("PWD"). Our AID systems are composed of an insulin pump that administers insulin, consumable insulin infusion sets and reservoirs, a continuous glucose monitoring ("CGM") sensor that measures blood glucose levels and a Smart Dosing algorithm. The MiniMed 780G system is our flagship AID system. For PWDs that prefer to self-administer insulin by manual injections or seek freedom from on-body devices, our Smart MDI systems offer an integrated solution for sensing, dosing, and administration. Our Smart MDI system includes a Smart Insulin Pen for insulin administration (which connects to our Smart Dosing software), a CGM sensor that measures blood glucose levels, and wraparound applications and services. For additional information about our products and offerings, see the section of the IPO Prospectus entitled "Business - Our Products and Offerings."
Historically, MiniMed operated as Medtronic plc's ("Medtronic") global diabetes business (the "Diabetes Business"). As a result, the unaudited condensed combined financial statements for periods presented have been prepared on a carve-out basis and reflect the historical results of the Diabetes Business as managed within Medtronic. These financial statements include allocations of certain corporate and shared services expenses from Medtronic, which management believes are reasonable. Such allocations may not be indicative of the Company's future cost structure as a standalone public company.
On March 6, 2026, the Company launched its initial public offering ("IPO") and became a publicly traded company. Following the IPO, MiniMed operates as a standalone entity, although it continues to maintain transitional and ongoing relationships with Medtronic pursuant to various separation-related agreements, including transition services and manufacturing arrangements. The Company is incurring incremental costs associated with operating as an independent public company, including costs related to corporate governance, internal controls, information systems, and public company compliance. In addition, results for the periods presented do not reflect the full impact of the Company's standalone capital structure, separation-related costs, or changes in commercial strategy that may occur following the IPO.
Separation from Medtronic and Initial Public Offering
On March 9, 2026, we completed our initial public offering ("IPO") and became a publicly traded company. This followed Medtronic's 2025 announcement of its intention to separate its diabetes business, primarily representing the diabetes business segment of Medtronic (the "Diabetes Operating Unit"), and the incorporation of MiniMed Group, Inc. to ultimately hold the Diabetes Business (the "Separation").
Since the IPO we have operated as a standalone public company, with Medtronic owning approximately 90.03% of the outstanding shares of our common stock. As part of the Separation, we entered into a series of agreements with Medtronic that govern the allocation of assets and liabilities and provide for certain transitional and ongoing services, including manufacturing, information technology, and other support services for a limited period following the Separation.
Under these arrangements, Medtronic will continue to provide certain services to us on a transitional basis, and we will provide certain services to Medtronic, for specified periods, subject to agreed-upon terms. The costs associated with these arrangements are expected to change over time as we transition to standalone operations.
The terms of these agreements may differ from those that could have been obtained in arm's-length transactions with unaffiliated third parties. For additional information regarding these arrangements, see Note 17, "Related Party Transactions," and Note 18, "Subsequent Events."
We are incurring incremental costs associated with operating as an independent public company, including costs related to corporate governance, internal controls, information systems, and public company compliance. In addition, results for the periods presented do not reflect the full impact of our standalone capital structure, separation-related costs, or changes in commercial strategy that may occur following the IPO.
The unaudited condensed combined financial statements for the periods presented reflect the historical results of the Diabetes Business and do not include all of the costs we expect to incur as a standalone public company. Management expects our cost structure, capital structure, and operating model to evolve as we complete our transition away from Medtronic.
Medtronic has informed us that it intends to make a generally tax-free distribution to its shareholders of all or a portion of its remaining equity interest in us, which may be structured as a spin-off, in which Medtronic would make a pro rata distribution of our common stock to all Medtronic shareholders, a split-off, in which Medtronic would effect an exchange of Medtronic shares for shares of our common stock, or any combination thereof (the "Divestment"). Medtronic has no obligation to pursue or consummate any further dispositions of its equity interest in us, including through the Divestment, by any specified date or at all. For additional information about the Divestment, see the section of the IPO Prospectus entitled "The Separation and Divestment Transactions - The Divestment."
Recent Developments
During the periods presented, we continued to advance our core diabetes technology platforms, including its MiniMed 780G automated insulin delivery system, Smart MDI offerings, and CGM portfolio. We also continued to invest in research and development activities and to expand regulatory approvals for certain products and indications across geographies.
On March 18, 2026, we announced that the U.S. FDA had cleared the MiniMed Flex, a next-generation discreet, smartphone-controlled insulin pump. In February 2026, we also submitted the MiniMed Flex for CE Mark approval. At commercial launch, we expect MiniMed Flex will support our newest sensor portfolio, including Simplera Sync sensor and the Instinct sensor, made by Abbott. For additional information about MiniMed Flex, see the section of the IPO Prospectus entitled "Business - Innovation / Pipeline and Future Initiatives." In connection with the U.S. FDA clearance of MiniMed Flex, we recognized a one-time charge of $157 million during the fourth quarter of fiscal year 2026 related to future minimum royalty payment obligations under our research and development funding arrangement with Blackstone. See Note 14, "Research and Development Funding Arrangements" to the condensed combined financial statements for additional information.
Additional detail regarding recent product approvals, partnerships, and pipeline initiatives is included in the IPO Prospectus.
Trends and Uncertainties Impacting Financial Results
Our results of operations are influenced by a number of factors, including product adoption trends, geographic sales mix, reimbursement dynamics, manufacturing scale and efficiency, foreign currency fluctuations, and regulatory developments.
We have experienced continued growth in demand for automated insulin delivery and CGM-enabled solutions, particularly in international markets. At the same time, we face pricing pressure in certain markets, particularly within CGMs, as competition increases and reimbursement frameworks evolve.
In addition, our results for the periods presented reflect our historical operating model within Medtronic and include allocated corporate expenses. Future periods are expected to reflect increased standalone public company costs, changes in commercial and manufacturing strategies, and the expiration of transition service arrangements with Medtronic.
Seasonality
The Company's revenue may vary from quarter to quarter due to seasonal purchasing patterns, particularly in the U.S., where insurance deductible resets and reimbursement dynamics can impact the timing of customer purchases. These seasonal trends may be partially offset by recurring sales of consumable products, including CGMs and infusion sets.
Foreign Currency
A significant portion of the Company's revenues and expenses are denominated in currencies other than the U.S. dollar. As a result, changes in foreign currency exchange rates may impact reported revenue, gross margin, and operating results from period to period. The Company continues to evaluate its exposure to foreign currency risk as it transitions to standalone operations.
For a more comprehensive discussion of risks and uncertainties that may affect the Company's business and future results, see "Risk Factors" and "Key Factors Impacting Our Results" in the IPO Prospectus.
Key Business Metrics
We regularly review the following key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions. In assessing the performance of our business, in addition to considering a variety of measures in accordance with U.S. GAAP, we also consider a variety of other key business metrics, including non-GAAP measures.
We believe that these key business metrics provide useful information to users of our financial statements in understanding and evaluating our results of operations in the same manner as our management team. The presentation of these key business metrics, including Organic Revenue Growth, Adjusted Gross Profit, and Adjusted EBITDA, which are non-GAAP financial measures, is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with U.S. GAAP. See "Non-GAAP Measures" below.
The following table sets forth our key business metrics, including non-GAAP measures, for the periods indicated:
Three Months Ended Nine Months Ended
(Dollars in millions) January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
Net Sales $ 790 $ 687 $ 2,265 $ 1,991
Gross Profit $ 362 $ 395 $ 1,200 $ 1,123
Net Loss
$ (111) $ (7) $ (132) $ (30)
New Pumps Sold 38,971 36,894 103,008 102,342
Global CGM Attachment Rate 67 % 61 % 66 % 59 %
Net Sales Growth 15.0 % N/A 13.7 % N/A
Organic Revenue Growth (1)
8.6 % N/A 7.8 % N/A
Adjusted Gross Profit (1)
$ 457 $ 401 $ 1,300 $ 1,162
Adjusted EBITDA (1)
$ 89 $ 73 $ 218 $ 170
(1) See "Non-GAAP measures" below for a discussion of Organic Revenue Growth, Adjusted Gross Profit, Adjusted EBITDA, and a reconciliation with the most directly comparable U.S. GAAP measure.
Gross Profit
Gross profit is our net sales, less cost of products sold.
New Pumps Sold
A leading indicator of our pump user base growth is the number of new pumps sold. We define New Pumps Sold ("NPS") as the number of new pumps sold to patients in a given period, inclusive of pumps sold to new patients and renewals by existing patients. This metric illustrates the number of new pump starts and renewals during each period presented, highlighting our capability to identify, attract, and retain users.
Global CGM Attachment Rate
As the only company that commercializes all parts of the smart dosing insulin therapy ecosystem, we are uniquely positioned to capture greater revenue per user than our competitors that only offer certain components of such systems. A key growth driver is our ability to increase CGM revenue per pump user which is reflected by our CGM Attachment Rate. We define CGM Attachment Rate as the percentage of total pump user base that is also using an integrated MiniMed CGM.
Organic Revenue Growth
Organic Revenue Growth measures our revenue growth trends excluding the impacts of foreign currency rate fluctuations and adjustments to the Company's Italian payback accrual for certain prior years since 2015, which is further described in Note 15, "Commitments and Contingencies," to the unaudited condensed combined financial statements. We use Organic Revenue Growth to assess our performance on a consistent basis by removing the impacts of foreign currency rate fluctuations and adjustments to the Italian payback accrual that we believe do not directly reflect our underlying operations. See "Non-GAAP Measures" below for a reconciliation of Organic Revenue Growth to Net Sales Growth, its most directly comparable U.S. GAAP measure.
Adjusted Gross Profit
Adjusted Gross Profit is a non-GAAP measure that we use to assess our overall performance. We define Adjusted Gross Profit as U.S. GAAP gross profit, excluding amortization of intangible assets and certain other non-operational items. We believe Adjusted Gross Profit provides consistency and comparability with our past financial performance and facilitates period-to-period comparisons of operations, as these metrics eliminate the effects of the adjustments that are unrelated to overall operating performance. See "Non-GAAP Measures" below for a reconciliation of Adjusted Gross Profit to gross profit, its most directly comparable U.S. GAAP measure.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP measure, calculated as net loss adjusted to exclude interest expense, provision for income taxes, and depreciation and amortization, further adjusted to exclude other non-operational items. We use Adjusted EBITDA to supplement U.S. GAAP measures of performance in the evaluation of the effectiveness of our business strategies, to make budgeting decisions, and to compare our performance against that of other peer companies using similar measures. See "Non-GAAP Measures" below for a reconciliation of Adjusted EBITDA to net loss, its most directly comparable U.S. GAAP measure.
RESULTS OF OPERATIONS
The following table sets forth a summary of our combined results of operations for the three months ended January 23, 2026 and January 24, 2025, and the changes between periods.
Three Months Ended Change
(Dollars in millions) January 23, 2026 January 24, 2025 Amount Percent
Net Sales $ 790 $ 687 $ 103 15 %
Cost of products sold 428 292 136 47
Gross profit 362 395 (33) (8)
Operating expenses:
Research and development expense 114 112 2 1
Selling, general, and administrative expenses 309 268 41 15
Certain litigation charges, net (6) - (6)
NM (1)
Other operating expense (income), net 45 (7) 52
NM (1)
Operating (loss) profit (100) 21 (121) (565)
Other non-operating (income) expense, net - - (1) (548)
(Loss) profit before income taxes (99) 21 (121) (565)
Income tax provision 12 28 (17) (59)
Net loss $ (111) $ (7) $ (104) 1,502
Net income attributable to noncontrolling interests $ (8) $ (3) $ (5) 184
Net loss attributable to the Company $ (119) $ (10) $ (110) 1,117 %

(1) Not meaningful
The following table sets forth a summary of our combined results of operations for the nine months ended January 23, 2026 and January 24, 2025, and the changes between periods.
Nine Months Ended Change
(Dollars in millions) January 23, 2026 January 24, 2025 Amount Percent
Net Sales $ 2,265 $ 1,991 $ 274 14 %
Cost of products sold 1,065 869 197 23
Gross profit 1,200 1,123 77 7
Operating expenses:
Research and development expense 349 329 21 6
Selling, general, and administrative expenses 884 804 80 10
Certain litigation charges, net 11 - 11
NM (1)
Other operating expense (income), net 53 (12) 65
NM (1)
Operating (loss) profit (97) 2 (99) (5,715)
Other non-operating expense (income), net - 1 (1) (84)
(Loss) profit before income taxes (97) 1 (99) (8,673)
Income tax provision 35 31 3 11
Net loss $ (132) $ (30) $ (102) 337
Net income attributable to noncontrolling interests $ (16) $ (10) $ (6) 54
Net loss attributable to the Company $ (148) $ (41) $ (108) 264 %

(1) Not meaningful
NET SALES
Our net sales are generated primarily from the sale of reusable and single-use products which collectively comprise our AID and Smart MDI systems.
Our insulin pumps and pens are considered reusable products as patients are able to continue their use of these products for a period of one year or more. Patients are generally eligible for reimbursement coverage of a new insulin pump every four to five years depending on both geography and payer type. Not all patients elect to replace their pump on this cycle and some use their pumps for longer than the replacement period because they can continue to operate as the patient continues to purchase consumables. Patients using durable insulin pens typically obtain replacements on an annual cycle due to reimbursement and product life span.
Our CGMs and the consumable components comprised of infusion sets and reservoirs associated with pumps are considered single-use products as these products are required to be replaced frequently for uninterrupted operation of our AID and Smart MDI systems. Patients using AID systems as well as Smart MDI systems typically replace their sensors either on a weekly basis as the Guardian 4 sensor and Simplera Sync sensors are indicated for up to 7 days of use, or on a bi-weekly basis as the Instinct sensor is indicated for up to 15 days of use. Patients using AID systems also replace their infusion sets and reservoirs either weekly or multiple times per week, depending on the type of infusion sets and reservoirs they use.
The below table includes net sales by product category for the three months ended January 23, 2026 and January 24, 2025:
Three Months Ended Change
(in millions) January 23, 2026 January 24, 2025 Amount Percent
Pumps $ 151 $ 136 $ 15 10.8 %
Consumables 244 213 31 14.6 %
CGM 390 330 61 18.4 %
Other (1)
5 8 (3) (37.7) %
Total net sales $ 790 $ 687 $ 103 15.0 %
(1) Primarily includes net sales generated from the sale of smart insulin pens and services.
The below table includes net sales by market geography for the three months ended January 23, 2026 and January 24, 2025:
Three Months Ended Change
(in millions) January 23, 2026 January 24, 2025 Amount %
U.S.(1)
$ 242 $ 231 $ 11 4.7 %
International(2)
548 456 92 20.3 %
Total $ 790 $ 687 $ 103 15.0 %

(1) U.S. includes the United States and U.S. territories
(2) International includes all other non-U.S. countries.
Net sales for the three months ended January 23, 2026 was $790 million as compared to $687 million for the three months ended January 24, 2025, growing 20% internationally and 5% in the U.S. Net sales growth is primarily the result of increased volumes. The international net sales growth is the result of 12% growth in pumps, 20% growth in consumables, 26% growth in CGM and favorable foreign currency exchange fluctuations. The sales performance in the U.S. is the result of 8% growth in pumps, a 1% decline in consumables, and 6% growth in CGM.
Pump sales grew 10.8% for the three months ended January 23, 2026. We experienced continued growth of 12% in international pump sales since the launch of the Simplera CGM in Europe in fiscal year 2025. Following the launch of Simplera and Instinct CGM in the U.S. in the third quarter of fiscal year 2026, domestic pump sales returned to growth and increased 8% for the three months ended January 23, 2026, as compared to the three months ended January 24, 2025.
Consumables sales increased 14.6% for the three months ended January 23, 2026, due to 20% growth internationally and partially offset by a 1% decrease in the U.S. Our international growth was the result of increased volume of patients using our AID systems which require frequent replacement of the infusion sets and reservoirs for uninterrupted operation. The increase in the volume of patients using our AID systems in international markets was due to the competitive strength of the MiniMed 780G system which has enabled us to attract new patients as well as retain our existing patient base.
CGM sales increased 18.4% for the three months ended January 23, 2026, as a result of continued increase in the Global CGM Attachment Rate, which rose from 61% in the three months ended January 24, 2025, to 67% in the three months ended January 23, 2026. Higher CGM Attachment Rate and pump user base in international markets resulted in 26% growth in international CGM sales which was primarily attributable to the introduction of the Simplera CGM in Europe in fiscal year 2025. The Simplera CGM is our first disposable, all-in-one CGM and approximately half the size of previous CGMs. The discreet design simplifies the insertion and wear experience. U.S. CGM sales grew 6% during the three months ended January 23, 2026, as a result of a sustained upward trend in CGM Attachment Rate. We have experienced a sustained upward trend in CGM Attachment Rate in the U.S. since the launch of the MiniMed 780G system in fiscal year 2024 as the automation algorithm is only compatible with our MiniMed CGMs.
The table below includes net sales by product category for the nine months ended January 23, 2026 and January 24, 2025:
Nine Months Ended Change
(in millions) January 23, 2026 January 24, 2025 Amount Percent
Pumps $ 401 $ 387 $ 14 3.6 %
Consumables 707 632 75 11.9 %
CGM 1,133 968 165 17.0 %
Other (1)
24 4 20
NM (2)
Total net sales $ 2,265 $ 1,991 $ 274 13.7 %
(1)Primarily includes net sales generated from the sale of smart insulin pens and services. Also reflects adjustments to the Company's Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy and the Legislative Decree published by the Italian government on June 30, 2025 for certain prior years since 2015. Refer to Note 15, "Commitments and Contingencies," to the condensed combined financial statements.
(2)Not meaningful.
The table below includes net sales by market geography for the nine months ended January 23, 2026 and January 24, 2025:
Nine Months Ended Change
(in millions) January 23, 2026 January 24, 2025 Amount %
U.S.(1)
$ 679 $ 668 $ 10 1.5 %
International(2)
1,586 1,323 263 19.9 %
Total $ 2,265 $ 1,991 $ 274 13.7 %

(1) U.S. includes the United States and U.S. territories
(2) International includes all other non-U.S. countries.
Net sales for the nine months ended January 23, 2026 was $2,265 million as compared to $1,991 million for the nine months ended January 24, 2025, growing 19.9% internationally and 1.5% in the U.S. Net sales growth was primarily the result of increased volumes. The international net sales growth was the result of 11% growth in pumps, 16% growth in consumables, 22% growth in CGM, changes in the Company's Italian payback accrual, and favorable impacts of foreign currency fluctuations. Sales performance in the U.S. is the result of a 7% decline in pumps, a 1% decline in consumables, and 7% growth in CGM. For the nine months ended January 23, 2026, the impact of the Italian payback adjustment resulted in an increase to net sales of $7 million as compared to a decrease in net sales of $20 million for the nine months ended January 24, 2025. This is due to changes in estimates relating to our Italian payback accrual resulting from the two July 2024 rulings by the Constitutional Court and the Legislative Decree published by the Italian government in June 2025 and formalized into law in August 2025 for certain prior years since 2015.
Pump sales grew 3.6% for the nine months ended January 23, 2026. While we experienced continued growth of 11% in international pump sales following the launch of the Simplera CGM in Europe in fiscal year 2025, we experienced a 7% decline in the U.S. due to the delayed launch of Simplera CGM and increased competition. The delayed launch of Simplera CGM in the U.S. resulted in a competitive disadvantage and limited our ability to grow NPS in the first half of fiscal year 2026. However, following the launch of Simplera and Instinct CGM in the U.S. in the third quarter of fiscal year 2026, domestic pump sales returned to growth, reducing year-to-date pump sales decline to 7% for the nine months ended January 23, 2026, as compared to a 15% decline for the six months ended October 24, 2025.
Consumables sales increased 11.9% for the nine months ended January 23, 2026, as a result of 16% growth internationally and 1% decline in the U.S. Our international growth is the result of increased volume of patients using our AID systems which require frequent replacement of the infusion sets and reservoirs for uninterrupted operation. The increase in the volume of patients using our AID systems in international markets is due to the competitive strength of the MiniMed 780G system which has enabled us to attract new patients as well as retain our existing patient base. Fewer NPS in the U.S. resulted in reduced consumables sales during the nine months ended January 23, 2026.
CGM sales increased 17.0% for the nine months ended January 23, 2026, as a result of the continued increase in the Global CGM Attachment Rate, which rose from 59% in the nine months ended January 24, 2025, to 66% in the nine months ended January 23, 2026. Higher CGM Attachment Rate and pump user base in international markets drove 22% growth in international CGM sales which is primarily attributable to the introduction of the Simplera CGM in Europe in fiscal year 2025. The Simplera CGM is our first disposable, all-in-one CGM and approximately half the size of previous CGMs. The discreet design simplifies the insertion and wear experience. CGM sales in the U.S. grew 7% during the nine months ended January 23, 2026, as a result of a sustained upward trend in CGM Attachment Rate and the launch of Simplera and Instinct CGM in the third quarter of fiscal year 2026. We have experienced a sustained upward trend in CGM Attachment Rate in the U.S. since the launch of the MiniMed 780G system in fiscal year 2024 as the automation algorithm is only compatible with our MiniMed CGMs.
COSTS AND EXPENSES
The following is a summary of cost of products sold, research and development, and selling, general, and administrative expenses as a percentage of net sales for the three months ended January 23, 2026 and January 24, 2025:
Three Months Ended % of Net Sales
(Dollars in millions)
January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
Cost of products sold
$ 428 $ 292 54.2 % 42.5 %
Research and development expense $ 114 $ 112 14.4 % 16.3 %
Selling, general, and administrative expenses $ 309 $ 268 39.2 % 39.0 %
The following is a summary of cost of products sold, research and development, and selling, general and administrative expenses as a percentage of sales for the nine months ended January 23, 2026 and January 24, 2025:
Nine Months Ended % of Net Sales
(Dollars in millions)
January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
Cost of products sold
$ 1,065 $ 869 47.0 % 43.6 %
Research and development expense $ 349 $ 329 15.4 % 16.5 %
Selling, general, and administrative expenses $ 884 $ 804 39.1 % 40.4 %
Cost of Products Sold
Cost of products sold includes raw materials, labor costs, manufacturing overhead expenses, shipping and handling costs incurred to store, move, and prepare products for shipment, amortization of purchased technology intangible assets, import tariffs and duties, reserves for expected warranty costs, scrap and excess, and obsolete inventory. Manufacturing overhead expenses include expenses relating to manufacturing engineering, material procurement, inventory and quality control, facilities, depreciation, information technology, and operations supervision and management.
Cost of products sold for the three and nine months ended January 23, 2026 was $428 million and $1.1 billion, respectively, as compared to $292 million and $869 million for the three and nine months ended January 24, 2025, respectively. The increase in cost of products sold for both periods was driven by the increased volume of products sold as well as changes in product mix as further described below. Additionally, the increase was driven by $84 million of asset write offs associated with a termination of a third-party manufacturing agreement, and $10 million and $21 million of warranty expense during the three and nine months ended January 23, 2026, respectively.
The increase in cost of products sold as a percentage of net sales for the three months ended January 23, 2026 as primarily driven by 1,130 basis points ("bps") increase from the asset write offs, 90 bps increase from product mix as a result of higher mix of CGMs, which have a lower gross profit margin relative to our insulin pumps and other consumables, and 100 bps from the warranty expense. The increase was partially offset by favorable currency impact on net sales for the three months ended January 23, 2026 and January 24, 2025.
The increase in cost of products sold as a percentage of net sales for the nine months ended January 23, 2026 was primarily driven by 390 bps increase from the asset write offs, 120 bps increase from product mix as a result of higher mix of CGMs, which have a lower gross profit margin relative to our insulin pumps and other consumables, and 60 bps from the warranty expense. The increase was partially offset by favorable currency impact on net sales in addition to changes in the Italian payback accruals impacting net sales for the nine months ended January 23, 2026 and January 24, 2025.
For additional information about the asset write-offs, refer to Note 4, "Restructuring", in the condensed combined financial statements.
Research and Development Expense
Research and development costs include costs of research, engineering, and technical activities to develop a new product or service or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses.
Research and development expense for the three months ended January 23, 2026 was $114 million as compared to $112 million for the three months ended January 24, 2025. The increase was not significant.
Research and development expense for the nine months ended January 23, 2026 was $349 million as compared to $329 million for the nine months ended January 24, 2025. The increase was primarily driven by an $11 million increase in personnel expenses to support product development efforts and $10 million of an acquisition of technology not yet approved by regulators.
Selling, General, and Administrative Expense
Selling, general, and administrative expense primarily consists of salaries and wages, benefits, other administrative costs, such as professional fees and marketing expenses, stock-based compensation, and restructuring associated expenses. Selling, general, and administrative expense also includes amortization expense related to our customer list and tradename intangible assets.
Selling, general, and administrative expense for the three months ended January 23, 2026 was $309 million as compared to $268 million for the three months ended January 24, 2025. The increase was primarily driven by $20 million in incremental commercialization activities to support Company sales growth, particularly Simplera Sync outside the United States, and increased marketing expenses in the U.S., and $9 million increase in provision for credit losses.
Selling, general, and administrative expense for the nine months ended January 23, 2026 was $884 million as compared to $804 million for the nine months ended January 24, 2025. The increase was primarily driven by $38 million for incremental commercialization activities to support Company sales growth, particularly Simplera Sync outside the United States, and increased marketing expenses in the U.S., $11 million increase for short-term and long-term incentives, and $8 million increase in provision for credit losses.
Restructuring Charges, Net
For the three and nine months ended January 23, 2026 and January 24, 2025, restructuring costs primarily related to employee termination benefits and facility consolidations to support cost reduction initiatives.
For additional information about our restructuring activities, refer to Note 4, "Restructuring", to the condensed combined financial statements.
Certain Litigation Charges, Net
We classify specified certain litigation charges and gains related to significant legal matters as certain litigation charges, net in the condensed combined statements of operations. During the nine months ended January 23, 2026, the Company recorded $17 million of certain litigation charges in connection with the Diabetes Pump Retainer Ring litigation. For additional information, refer to Note 15, "Commitments and Contingencies," in the condensed combined financial statements.
Other Operating Expense (Income), Net
Other operating expense (income), net primarily includes restructuring expense, currency remeasurement, and income from research and development funding arrangements.
Other operating expense (income), net was $45 million of expense for the three months ended January 23, 2026, as compared to $7 million of income for the three months ended January 24, 2025. The change was primarily driven by a $47 million increase in restructuring charges and $16 million of reduced proceeds from funded research and development due to the timing of certain product development spend. This is partially offset by a $6 million decrease in net foreign currency remeasurement.
Other operating expense (income), net was $53 million of expense for the nine months ended January 23, 2026 as compared to $12 million of income for the nine months ended January 24, 2025. The change was primarily driven by $45 million increase in restructuring charges, $35 million of reduced proceeds from funded research and development arrangements due to the timing of certain new product development spend, and partially offset by $7 million reduction in net foreign currency remeasurement.
For more information on our restructuring charges and research and development arrangements, refer to Note 4, "Restructuring Charges," and Note 14, "Research and Development Funding Arrangements," to the unaudited condensed combined financial statements.
Other Non-Operating (Income) Expense, Net
Other non-operating (income) expense, net primarily includes investment gains and losses. Other non-operating (income) expense, net was insignificant for both the three and nine months ended January 23, 2026 and January 24, 2025.
INCOME TAXES
Income tax provision includes current and deferred income tax expense related to federal, state, and international jurisdictions.
The income tax provision was $12 million and $35 million for the three and nine months ended January 23, 2026, respectively, as compared to $28 million and $31 million for the three and nine months ended January 24, 2025, respectively. The change in the effective tax rate and income tax provision primarily relates to year-over-year changes in operational results by jurisdiction and the impact of valuation allowances in certain jurisdictions.
On July 4, 2025, the U.S. government enacted The One Big Beautiful Bill Act of 2025 which includes, among other provisions, changes to the U.S. corporate income tax system including the allowance of immediate expensing of qualifying research and development expenses and permanent extensions of certain provisions within the Tax Cuts and Jobs Act. Certain provisions were effective for the Company beginning in fiscal year 2026. The impact of these provisions for the three and nine months ended January 23, 2026 were not significant, and the impacts of these provisions to fiscal year 2026 and beyond are not expected to be material.
NON-GAAP MEASURES
In addition to our financial results determined in accordance with U.S. GAAP, we present certain financial measures that facilitate management's review of the operational performance of the Company and as a basis for strategic planning; however, such financial measures are not presented in our financial statements prepared in accordance with U.S. GAAP. These financial measures are considered "non-GAAP financial measures" and are intended to supplement, and should not be considered as superior to, financial measures presented in accordance with U.S. GAAP. These include Organic Revenue Growth, Adjusted Gross Profit, and Adjusted EBITDA. We believe that non-GAAP financial measures provide information useful to investors in understanding our underlying operational performance and trends and may facilitate comparisons with the performance of other companies in the medical technologies industry.
In addition to our financial results determined in accordance with U.S. GAAP, we believe the following non-GAAP measures are useful in evaluating our operating performance. We use the following non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that these non-GAAP financial measures, when taken together with the corresponding U.S. GAAP financial measures, provide meaningful supplemental information regarding our performance by excluding certain items that may not be indicative of our business, results of operations, or outlook.
In particular, we believe that the use of Organic Revenue Growth, Adjusted Gross Profit, and Adjusted EBITDA are helpful to our investors as they are metrics used by management to assess the health of our business and our operating performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. In evaluating the non-GAAP financial information presented, investors should be aware that in the future that the Company may incur expenses that are the same as or similar to some of the adjustments in such presentation and the Company's presentation of non-GAAP information should not be construed as an inference that its future results will be unaffected by unusual or non-recurring items. In addition, other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison.
A reconciliation is provided below for each non-GAAP financial measure to the most directly comparable financial measure stated in accordance with U.S. GAAP. Investors are encouraged to review the related U.S. GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable U.S. GAAP financial measures, and not to rely on any single financial measure to evaluate our business.
Organic Revenue Growth
Organic Revenue Growth measures our revenue growth trends excluding the impacts of foreign currency rate fluctuations and adjustments to the Company's Italian payback accrual for certain prior years since 2015, which is further described in Note 15, "Commitments and Contingencies," to the condensed combined financial statements. We use Organic Revenue Growth to assess our performance on a consistent basis by removing the impacts of foreign currency rate fluctuations and adjustments to the Italian payback accrual that we believe do not directly reflect our underlying operations.
The following table presents a reconciliation of U.S. GAAP net sales to Organic Revenue for the three months ended January 23, 2026, and January 24, 2025:
Three Months Ended
Reported net sales Adjustments Organic Revenue
(in millions) January 23, 2026 January 24, 2025 Growth
January 23, 2026 (3)
January 24, 2025
January 23, 2026 (3)
January 24, 2025 Growth
U.S.(1)
$ 242 $ 231 4.7 % $ - $ - $ 242 $ 231 4.7 %
International(2)
548 456 20.3 % 44 - 504 456 10.5 %
Total $ 790 $ 687 15.0 % $ 44 $ - $ 746 $ 687 8.6 %
(1) U.S. includes the United States and U.S. territories.
(2) International includes all other non-U.S. countries.
(3) The three months ended January 23, 2026 excludes the $44 million of revenue adjustments related to favorable currency impact on net sales. The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.
The following table presents a reconciliation of U.S. GAAP net sales to Organic Revenue Growth for the nine months ended January 23, 2026 and January 24, 2025:
Nine Months Ended
Reported net sales Adjustments Organic Revenue
(in millions) January 23, 2026 January 24, 2025 Growth
January 23, 2026 (3)
January 24, 2025 (4)
January 23, 2026 (3)
January 24, 2025 (4)
Growth
U.S.(1)
$ 679 $ 668 1.5 % $ - $ - $ 679 $ 668 1.5 %
International(2)
1,586 1,323 19.9 % 97 (20) 1,489 1,343 10.9 %
Total $ 2,265 $ 1,991 13.7 % $ 97 $ (20) $ 2,168 $ 2,012 7.8 %
(1) U.S. includes the United States and U.S. territories.
(2) International includes all other non-U.S. countries.
(3) The nine months ended January 23, 2026 excludes $97 million of revenue adjustments, including $7 million reduction in the Italian payback accruals due to changes in estimates as a result of the Legislative Decree published by the Italian government on June 30, 2025 for years 2015 to 2018 and $90 million of favorable currency impact on the remaining net sales. The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.
(4) The nine months ended January 24, 2025 excludes $20 million of revenue adjustments related to incremental Italian payback accruals as a result of the two July 22, 2024 rulings by the Constitutional Court of Italy for certain prior years since 2015.
Adjusted Gross Profit
Adjusted Gross Profit measures our gross profit excluding the impact of factors unrelated to overall operating performance. Management uses Adjusted Gross Profit to assess our overall performance on a consistent basis by removing the impact of certain items that we believe do not directly reflect our underlying operations. We calculate Adjusted Gross Profit as U.S. GAAP gross profit, adjusted for the amortization of intangible assets and certain other non-operational items.
The following table presents a reconciliation of U.S. GAAP gross profit to Adjusted Gross Profit for the three and nine months ended January 23, 2026 and January 24, 2025:
Three Months Ended Nine Months Ended
(in millions) January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
Gross profit
$ 362 $ 395 $ 1,200 $ 1,123
Adjustments:
Restructuring and associated costs (1)
89 - 89 -
Amortization of intangible assets 6 6 18 18
Other adjustments (2)
- - (7) 20
Costs to comply with medical device regulations (3)
- - - 1
Adjusted Gross Profit (Non-GAAP) $ 457 $ 401 $ 1,300 $ 1,162
(1) Primarily relates to asset write-offs associated with the December 2025 plan to terminate a third-party manufacturing agreement.
(2) Reflects adjustments to the Company's Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court and the Legislative Decree published by the Italian government on June 30, 2025 for certain prior years since 2015.
(3) The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that we use to assess our overall performance. Management uses Adjusted EBITDA for business planning purposes as this measure facilitates internal comparisons of our historical operating performance on a more consistent basis. We calculate Adjusted EBITDA as Net Loss before interest, taxes, depreciation, and amortization, further adjusted to remove the impact of certain other non-operational items.
The following table presents a reconciliation of U.S. GAAP net loss to Adjusted EBITDA for the three and nine months ended January 23, 2026 and January 24, 2025.
Three Months Ended Nine Months Ended
(in millions) January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
Net loss
$ (111) $ (7) $ (132) $ (30)
Income tax provision 12 28 35 31
Depreciation and amortization 39 37 117 105
Adjustments:
Stock-based compensation 11 11 38 32
Restructuring and associated costs (1)
138 2 142 8
Certain litigation charges (2)
(6) - 11 -
Transaction costs (3)
6 1 13 2
Other adjustments (4)
- - (7) 20
Losses on minority investments (5)
- - 1 1
Costs to comply with medical device regulations (6)
- - - 1
Adjusted EBITDA $ 89 $ 73 $ 218 $ 170
(1) The three and nine months ended January 23, 2026 primarily includes asset write-offs and contract termination costs associated with the December 2025 plan to terminate a third-party manufacturing agreement. Additionally, all periods presented include charges related to employee termination benefits and consulting expenses directly related to the restructuring efforts.
(2) The nine months ended January 23, 2026 primarily relate to the Diabetes Pump Retainer Ring litigation.
(3) These charges represent costs incurred associated with the Separation.
(4) Reflects adjustments to the Company's Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court and the Legislative Decree published by the Italian government on June 30, 2025 for certain prior years since 2015.
(5) We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
(6) The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity
We measure liquidity in terms of our ability to fund the cash requirements of our business operations, including working capital needs, investments in research and development, property, plant, and equipment, and other operating costs. As of January 23, 2026, we had $10 million in cash and cash equivalents.
Prior to the Separation, our working capital requirements, capital expenditures, and investment opportunities were funded primarily through Medtronic's centralized cash management and funding programs. Following the Separation, we no longer participate in Medtronic's cash management strategy, and instead operate with our standalone capital structure and sources of liquidity.
As part of the Separation, we used a portion of the net proceeds from the IPO to repay (or cause one or more of our subsidiaries to repay) intercompany indebtedness owed to Medtronic. After giving effect to the settlement of this intercompany debt and other transactions contemplated by the separation agreements, we retained approximately $309 million from the net proceeds of the IPO, plus cash on hand at the completion of the offering.
In connection with the Separation, we also entered into a five-year senior secured revolving credit facility providing for aggregate commitments of $500 million, available in U.S. dollars and certain approved alternative currencies. Borrowings under the revolving credit facility became available upon completion of the IPO and were undrawn at closing. For further information, see Note 9, "Debt," in the condensed combined financial statements.
Following the Separation, our primary sources of liquidity consist of cash on hand, net proceeds from the IPO, cash generated from operations, and borrowings available under the revolving credit facility, as well as our ability to obtain additional debt financing or issue additional equity or equity-linked securities, if necessary. We believe that these sources of liquidity, taken as a whole, will be sufficient to meet our anticipated cash requirements and obligations for at least the next 12 months. For additional information regarding the net proceeds of the IPO, see Part II, Item 2, "Unregistered Sales of Equity Securities and Use of Proceeds," herein and the "Description of Certain Indebtedness" in our IPO Prospectus.
Summary of Cash Flows for the nine months ended January 23, 2026 and January 24, 2025
The following is a summary of cash (used in) provided by operating, investing, and financing activities, the effect of exchange rate changes on cash and cash equivalents, and the net change in cash and cash equivalents:
Nine Months Ended
(in millions) January 23, 2026 January 24, 2025
Cash (used in) provided by:
Operating activities $ (27) $ 57
Investing activities (177) (136)
Financing activities 204 35
Net change in cash and cash equivalents $ - $ (44)
Operating Activities
The $84 million increase in net cash used in operating activities was primarily driven by an increase in certain litigation payments and cash paid to vendors partially offset by an increase in cash collected from customers due to an increase in sales.
Investing Activities
The $41 million increase in net cash used in investing activities was primarily due to an increase in net additions to property, plant, and equipment of $31 million.
Financing Activities
There was a $170 million increase in net cash provided by financing activities. The financing activities cash flows primarily reflect transfers from the Parent of $204 million for the nine months ended January 23, 2026 and $37 million for the nine months ended January 24, 2025. These transfers are utilized by the Company for general operating and investing activities. For further details on the transfers from the Parent, refer to Note 1, "Description of the Business and Basis of Presentation," to the condensed combined financial statements.
Contractual Obligations and Cash Requirements
Leases
We have entered into various operating leases for certain office, manufacturing, and research facilities and warehouses, as well as transportation and other equipment. For a description of our contractual obligations related to leases, refer to Note 12, "Leases," to the condensed combined financial statements.
Research and Development Arrangements
The development of certain diabetes products, including MiniMed Flex, has been funded in part through research and development funding arrangements with affiliates of Blackstone Life Sciences Advisors LLC ("Blackstone") Under these arrangements, following U.S. regulatory approval and commercial launch, we may be required to make future payments to Blackstone. On March 18, 2026, the FDA cleared MiniMed Flex. During the first two years following U.S. regulatory approval and commercial launch, Blackstone is entitled to receive the greater of (i) a mid-to-high single-digit royalty percentage of applicable net sales or (ii) a minimum payment of $157 million. As a result, we expect to recognize a one-time charge of $157 million in the fourth quarter of fiscal year 2026 related to these future payment obligations. The related cash payments are expected to represent a material liquidity requirement during the initial commercialization period and will be funded from available liquidity resources.
Critical Accounting Estimates
We have used various accounting policies to prepare the condensed combined financial statements in accordance with U.S. GAAP. Our significant accounting policies are disclosed in Note 1, "Summary of Significant Accounting Policies," to the audited combined financial statements ended April 25, 2025, in the IPO Prospectus. There were no material changes during the three and nine months ended January 23, 2026 to the items disclosed as critical accounting estimates in the section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our IPO Prospectus.
The preparation of the condensed combined financial statements, in conformity with U.S. GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses. These estimates reflect our best judgment about economic and market conditions and the potential effects on the valuation and/or carrying value of assets and liabilities based upon relevant information available. We base our estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
Our critical accounting estimates are more fully described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the IPO Prospectus, and there have been no material changes to our critical accounting estimates compared to those filed in the IPO Prospectus.
Valuation of Goodwill
Goodwill attributed to the Company represents the historical goodwill balances in Medtronic's Diabetes business arising from acquisitions specific to the Company. Goodwill is the excess of the purchase price over the estimated fair value of identified net assets of acquired businesses. Determining the fair value requires us to make significant estimates. These estimates include the amount and timing of projected future cash flows of each project or technology, the discount rate used to discount those cash flows to present value, and the assessment of the asset's life cycle. The estimates could be impacted by legal, technical, regulatory, economic, and competitive risks.
We have one goodwill reporting unit. We assess the impairment of goodwill at the reporting unit level annually as of the first day of the third quarter and whenever an event occurs or circumstances change that would indicate that the carrying amount may be impaired. After completing the annual goodwill impairment test in the third quarter, we concluded that goodwill was not impaired. The goodwill impairment test requires us to make several estimates related to projected future cash flows to determine the fair value of the goodwill reporting unit. We estimated the fair value of the reporting unit using the income and the market approaches, weighted 50% each. Fair value under the income approach was determined by discounting to present value the estimated future cash flows of the reporting unit. Fair value under the market approach utilized revenue multiples using comparable public company information, which uses valuation indicators determined from other businesses that are similar to our reporting unit. We use estimates that are consistent with the highest and best use of the assets based on a market participant's view of the assets being evaluated.
The most critical assumptions used in the calculation of the fair value of each reporting unit are the projected revenue, projected future cash flows, and discount rate. Our forecast of future cash flows is based on estimates of projected revenue, based primarily on pricing, raw material costs, market share, industry outlook, general economic conditions and strategic actions to improve our earnings. The fair value of the reporting unit's goodwill is sensitive to differences between estimated and actual cash flows, including changes in the projected revenue and discount rate used to evaluate the fair value of the reporting unit.
Subsequent to our IPO, our stock price experienced a decline. There is a risk of future impairment charges if there is a decline in the fair value of the Company, actual financial results are lower than forecasts, an adverse change in valuation assumptions, or other macroeconomic factors continue to exist. If future goodwill impairment charges occur, they could have a material adverse effect on the Company's financial condition and results of operations.
Refer to Note 7, "Goodwill and Other Intangible Assets," to the condensed combined financial statements for further information.
New Accounting Pronouncements
Information regarding new accounting pronouncements is included in Note 2, "New Accounting Pronouncements," to the condensed combined financial statements.
Other Information
Our website is www.minimed.com. Information contained on our website is not part of this report. Information that we furnish to or file with the SEC, including our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to, or exhibits included in, these reports are made available for download, free of charge, through our website as soon as reasonably practicable. Our SEC filings, including exhibits filed therewith, are also available directly on the SEC's website at www.sec.gov.
We may use our website as a distribution channel of material MiniMed information. Financial and other important information regarding MiniMed is routinely posted on and accessible through our website at https://investors.minimed.com. Accordingly, investors should monitor this channel, in addition to following our press releases, SEC filings and public conference calls and webcasts. The contents of our website are not, however, a part of this report.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains, and management may make, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, may be forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "looking ahead," "may," "plan," "possible," "potential," "project," "should," "will," and similar words or expressions are used to identify these forward-looking statements. These statements include, among other things, MiniMed Group, Inc.'s ("MiniMed's" or the "Company's") statements about:
•our ability to drive long-term stockholder value;
•development and future launches of products and continued or future acceptance of products, therapies, and services in our segments;
•expected timing for completion of research studies relating to our products;
•integration of new technologies, including AI and data analytics, into our products, therapies, and services;
•market positioning and performance of our products, including stabilization of certain product markets;
•divestitures and the potential benefits thereof;
•the costs and benefits of integrating previous acquisitions;
•anticipated timing for U.S. FDA and non-U.S. regulatory approval or clearance of new products;
•increased presence in new markets, including markets outside the United States;
•changes in the market and our market share;
•our ability to meet growing demand for our existing products; acquisitions and investment initiatives, including the timing of regulatory approvals as well as integration of acquired companies into our operations;
•the resolution of tax matters;
•our approach towards cost containment;
•our expectations regarding healthcare costs, including potential changes to reimbursement policies and pricing pressures;
•our expectations regarding changes to patient standards of care;
•our ability to identify and maintain successful business partnerships;
•the elimination of certain positions or costs related to restructuring initiatives;
•outcomes in our litigation matters and governmental proceedings and investigations;
•general economic conditions;
•the adequacy of available working capital and our working capital needs;
•our payment of dividends and redemption of shares;
•the continued strength of our balance sheet and liquidity;
•our accounts receivable exposure;
•our human capital management with respect to our global workforce;
•the management of environmental, health, and safety ("EHS") and sustainability matters; and
•the potential impact of our compliance with governmental laws and regulations and accounting guidance.
The Company cautions investors that such statements are subject to risks and uncertainties, many of which are difficult to predict and generally beyond the Company's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
Some of the factors that could cause actual results to differ include, but are not limited to, the following:
Business and Operational Risks
•We operate in a highly competitive industry and we may be unable to compete effectively. Our success depends on our ability to differentiate our products and keep pace with emerging technologies.
•Competing products, therapeutic techniques, or other technological developments and breakthroughs for the monitoring, treatment, or prevention of diabetes may render our products obsolete or less desirable.
•We have experienced, and may continue to experience, pricing pressure for our products.
•We have in the past experienced, and may in the future experience, challenges or delays in the development and manufacturing of new products.
•We have experienced, and may continue to experience, a reduction or an interruption in supply or other manufacturing difficulties, including in connection with our Simplera CGMs and certain other products.
•We are subject to additional risks associated with our reliance on sole suppliers.
•Our products may not achieve or maintain market acceptance.
•We may fail to expand or maintain an effective sales force, predict and adapt to changes in markets, or develop and maintain relationships with healthcare providers ("HCPs") or intermediaries to market and sell our products.
•Interim, "top-line," and preliminary data from clinical trials that we announce or publish may change as more patient data become available or as a result of audit and verification procedures.
•Future market or clinical studies may be unfavorable to our products and their efficacy.
•We are subject to a variety of risks associated with global operations.
•We are subject to risks relating to coverage or reimbursement for our products.
•We undertake research and development efforts, make investments, and enter into arrangements with third parties that may not successfully develop viable products or generate future revenues.
•We may fail to integrate any acquired businesses into our operations successfully or may experience challenges related to our strategic initiatives, including divestitures and third-party funding arrangements.
Legal and Regulatory Risks
•We are subject to extensive, complex, and changing laws and governmental regulations, including U.S. and international tax laws and the Foreign Corrupt Practices Act (the "U.S. FCPA") and similar international anti-corruption laws.
•We have been, and may in the future become, subject to, or involved in, adverse regulatory action, litigation, and arbitration, including those stemming from third-party conduct beyond our control.
•We have been and are subject to risks relating to quality problems and improper promotion of our products.
•We are substantially dependent on patent and other proprietary rights, and failing to protect such rights may negatively impact our ability to sell current or future products.
•We rely on the proper function, security, and availability of our information technology systems and data to operate our business and comply with privacy and data protection regulations.
•We are subject to EHS laws and regulations that may increase costs, impact or limit business plans, or expose us to environmental liabilities, violations, and litigation.
Risks Related to the Separation and Divestment
•We have a limited history of operating as a standalone public company and will incur incremental costs as a result.
•We may not achieve some or all of the expected benefits of the Separation (as defined in Note 1, "Description of the Business and Basis of Presentation," to the condensed combined financial statements), the Separation could adversely affect our business, and we may have difficulty separating our assets or operations from Medtronic plc ("Medtronic").
•Our rebranding strategy in connection with the Separation will involve substantial costs and may not produce the intended benefits.
•We will incur significant charges in connection with the Separation.
•We may face restrictions on our business, potential tax and indemnification liabilities, and substantial charges in connection with the Separation, the Divestment (as defined in Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations), and related transactions.
•We may face difficulty and incur incremental costs related to the hiring and retention of an appropriately qualified employee workforce.
Risks Related to Our Relationship with Medtronic
•We will be a "controlled company" as defined under the corporate governance rules of Nasdaq Stock Market LLC.
•Medtronic will continue to control the direction of our business, and the distribution of Medtronic's remaining equity interest in us may not occur, or Medtronic may privately sell a sufficiently large equity interest in us to a third party that could result in a change of control of us.
•Medtronic may fail to perform under various transaction agreements that will be executed as part of the Separation, or we may fail to have replacement systems and services in place when certain of the transaction agreements expire.
•Certain of our executive officers and directors may have actual or potential conflicts of interest.
•We may have reached better terms from unaffiliated third parties than the terms we will receive in our agreements with Medtronic.
The Company's forward-looking statements speak only as of the date of this report or as of the date they are made, and the Company undertakes no obligation to update forward-looking statements. For a more detailed discussion of these factors, see the "Risk Factors" and "Business-Government Regulation and Product Approval Process" sections and elsewhere in our IPO Prospectus.
MiniMed Group Inc. published this content on April 17, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on April 17, 2026 at 20:30 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]