1 unchanged sentence
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.
−Removed: and its subsidiaries (“MiniMed Group, Inc.,” “MiniMed,” the “Company,” or “we,” “us,” or “our”).
−Removed: 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.
−Removed: 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”).
−Removed: 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.
−Removed: 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.
+Added: (MiniMed, or the Company, or we, us, or our).
+Added: 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 Annual Report on Form 10-K for the fiscal year ended April 24, 2026, filed with the U.S.
+Added: Securities and Exchange Commission (the “SEC”).
+Added: In addition, you should read this discussion along with our condensed consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q.
+Added: Amounts reported in millions within this report may not total exactly, due to rounding.
Additionally, certain columns and rows within tables may not sum due to rounding.
−Removed: 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.
−Removed: 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.
+Added: Our actual results could differ materially from the results contemplated in any forward-looking statements due to a number of factors, including those described under “Risk Factors” in our Annual Report on Form 10-K as well as under “Cautionary Note Regarding Forward-Looking Statements” included herein.
+Added: We are a 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”).
−Removed: 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.
−Removed: The MiniMed 780G system is our flagship AID system.
−Removed: 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.
−Removed: 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.
−Removed: For additional information about our products and offerings, see the section of the IPO Prospectus entitled “Business – Our Products and Offerings.”
−Removed: Historically, MiniMed operated as Medtronic plc’s (“Medtronic”) global diabetes business (the “Diabetes Business”).
−Removed: 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.
−Removed: These financial statements include allocations of certain corporate and shared services expenses from Medtronic, which management believes are reasonable.
−Removed: Such allocations may not be indicative of the Company’s future cost structure as a standalone public company.
−Removed: On March 6, 2026, the Company launched its initial public offering (“IPO”) and became a publicly traded company.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: Our AID systems are composed of an insulin pump that administers insulin, consumable insulin infusion sets and reservoirs, a continuous glucose monitoring (“CGM”) sensor, such as Simplera Sync or Instinct (made by Abbott), that measures glucose levels, and a Smart Dosing algorithm.
+Added: Our newest AID platform, MiniMed Flex, expands patient choice, providing a smaller form factor and smartphone control, powered by our SmartGuard technology.
+Added: We also continue to offer the MiniMed 780G AID system.
+Added: For PWDs that prefer to self-administer insulin through manual injections or seek freedom from on-body devices, our Smart MDI systems offer an integrated solution for sensing, dosing, and administration.
+Added: Our MiniMed Go 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.
+Added: Historically, MiniMed operated as Medtronic plc’s (“Medtronic”) global diabetes business.
+Added: As a result, periods presented prior to our separation from Medtronic (the “Separation”) reflect the historical results of the diabetes business as managed within Medtronic and were prepared on a carve-out basis.
+Added: Those historical periods include allocations of certain corporate and shared services expenses from Medtronic, which management believes are reasonable.
+Added: However, such historical results may not be indicative of the results that would have been achieved had we operated as a standalone company during those periods.
+Added: On March 6, 2026, we completed our initial public offering (“IPO”), and on March 9, 2026, we began operating as a standalone public company.
+Added: We continue to maintain transitional and ongoing relationships with Medtronic pursuant to various separation‑related agreements, including transition services, manufacturing arrangements, and other commercial arrangements.
+Added: As a standalone public company, we incur costs related to corporate governance, internal controls, information systems, and public company compliance that were not historically reflected in the carve-out financial statements.
+Added: Accordingly, comparisons between current period results and historical periods presented may be affected by these changes.
Separation from Medtronic and Initial Public Offering
−Removed: On March 9, 2026, we completed our initial public offering (“IPO”) and became a publicly traded company.
−Removed: 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.
−Removed: to ultimately hold the Diabetes Business (the “Separation”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The costs associated with these arrangements are expected to change over time as we transition to standalone operations.
+Added: Our IPO was a result of Medtronic’s previously announced plan to separate its diabetes business.
+Added: In connection with the separation, MiniMed was incorporated to hold the diabetes business and became an independent publicly traded company upon completion of the IPO.
+Added: As of July 31, 2026, Medtronic continued to own approximately 90% of our outstanding common stock.
+Added: We have entered into a series of agreements with Medtronic governing the allocation of assets and liabilities and providing for certain transitional and ongoing services, including manufacturing, information technology, and other support services.
+Added: Under these arrangements, certain services continue to be provided between MiniMed and Medtronic for specified periods pursuant to agreed‑upon terms.
+Added: The costs associated with these arrangements are expected to change over time as we continue the 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.
−Removed: For additional information regarding these arrangements, see Note 17, “Related Party Transactions,” and Note 18, “Subsequent Events.”
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Management expects our cost structure, capital structure, and operating model to evolve as we complete our transition away from Medtronic.
−Removed: 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”).
−Removed: 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.
−Removed: For additional information about the Divestment, see the section of the IPO Prospectus entitled “The Separation and Divestment Transactions – The Divestment.”
+Added: For additional information regarding these arrangements, see Note 14.
+Added: “Related Party Transactions.”
+Added: Periods presented prior to the IPO reflect the historical results of the diabetes business and do not include all of the costs of operating as a standalone public company.
+Added: Accordingly, historical results may not be indicative of our future results of operations, financial position, or cash flows.
Recent Developments
−Removed: 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.
+Added: During the periods presented, we continued to advance our core diabetes technology platforms, including our insulin delivery systems, 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.
−Removed: On March 18, 2026, we announced that the U.S.
−Removed: FDA had cleared the MiniMed Flex, a next-generation discreet, smartphone-controlled insulin pump.
−Removed: In February 2026, we also submitted the MiniMed Flex for CE Mark approval.
−Removed: At commercial launch, we expect MiniMed Flex will support our newest sensor portfolio, including Simplera Sync sensor and the Instinct sensor, made by Abbott.
−Removed: 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.
−Removed: 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.
−Removed: See Note 14, “Research and Development Funding Arrangements” to the condensed combined financial statements for additional information.
−Removed: Additional detail regarding recent product approvals, partnerships, and pipeline initiatives is included in the IPO Prospectus.
+Added: In February 2026, we launched the MiniMed Go, our Smart MDI system in Europe and beginning in May 2026, we continued the global rollout of the MiniMed Go with commercial launch in the U.S.
+Added: In June 2026, we announced an extension to our partnership with Abbott Laboratories to collaborate with them on an exclusive integration between the Abbott-manufactured dual glucose-ketone sensors and our smart dosing systems, which is expected in calendar year 2027.
+Added: In August 2026, we initiated the U.S.
+Added: launch of MiniMed Flex integrated with the Instinct continuous glucose monitoring sensor.
+Added: We believe this expanded compatibility enhances the flexibility of our automated insulin delivery ecosystem and supports broader patient adoption of our diabetes technology offerings.
+Added: The launch represents an important milestone in the continued expansion of the MiniMed Flex platform and our efforts to provide patients with additional sensor-integrated insulin delivery options.
+Added: In September 2026, we announced that MiniMed Flex received CE Mark approval, achieving a key regulatory milestone earlier than our previously anticipated timing.
+Added: We expect this approval to support the commercial launch of MiniMed Flex in applicable European markets starting in November 2026.
+Added: We believe the continued global expansion of the MiniMed Flex platform will further strengthen our product portfolio and support long-term growth opportunities within our diabetes business.
+Added: In September 2026, we announced the submission of our MiniMed Fit patch pump to the U.S.
+Added: Food and Drug Administration (“FDA”), with an expected full U.S.
+Added: product launch in Summer 2027.
Trends and Uncertainties Impacting Financial Results
−Removed: 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.
−Removed: We have experienced continued growth in demand for automated insulin delivery and CGM‑enabled solutions, particularly in international markets.
−Removed: At the same time, we face pricing pressure in certain markets, particularly within CGMs, as competition increases and reimbursement frameworks evolve.
−Removed: In addition, our results for the periods presented reflect our historical operating model within Medtronic and include allocated corporate expenses.
−Removed: 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.
−Removed: 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.
−Removed: These seasonal trends may be partially offset by recurring sales of consumable products, including CGMs and infusion sets.
+Added: We believe our future performance will be influenced by a number of factors, including those described in the section, “Risk Factors” of our most recent Annual Report on Form 10-K, and elsewhere in this Quarterly Report as well as the factors described below.
+Added: While each of these factors presents significant opportunities for us, these factors also pose challenges that we must successfully address in order to sustain the growth of our business and enhance our results of operations.
+Added: CGM Pricing Pressure
+Added: We have observed pricing pressure on CGMs globally, particularly in certain international markets.
+Added: Differences in reimbursement and pricing dynamics across geographies and sales channels can result in variability in average selling prices and gross margins, particularly as changes in sales mix occur.
+Added: Additionally, as competition in the CGM market intensifies, lower-cost CGM options in the market may contribute to further pricing pressure over time.
+Added: We are focused on continuing to invest in our pipeline to deliver differentiated solutions that reinforce our competitive positioning and our long-term growth.
+Added: Product Launches and Investment in Pipeline
+Added: We believe the success of our products correlates to the continued acceptance and growth of our product offerings, such as the MiniMed Flex, MiniMed 780G system, next-generation AID systems, and Smart MDI systems like MiniMed Go.
+Added: Our ability to meet growing demand for our existing products and to successfully develop, obtain regulatory approval or clearance of, and commercialize the products within our pipeline is essential to our results of operations.
+Added: Timing and successful launch of partnerships such as our agreement with Abbott may also contribute meaningfully to our future market performance.
+Added: For example, we believe the early FDA clearance of MiniMed Flex shifted demand of customers who preferred to wait for the new system, which resulted in a reduction of pump sales following the announcement of the FDA clearance in the fourth quarter of fiscal 2026.
+Added: Following the launch of MiniMed Flex insulin pump system with Simplera sensor in June, domestic pump sales returned to growth in the first quarter of fiscal 2027.
+Added: The ability to sustain ongoing investment in our pipeline will be required as we progress towards developing and launching our next generation of products.
+Added: We strive to develop ways in which we can make our research and development process as efficient as possible and reduce the amount of investment needed to progress a product to approval.
+Added: Users, New Patient Adoption, and Sales of CGMs and Other Consumables
+Added: Our financial performance is influenced by our ability to retain existing users, attract new patients to our technology platforms, and increase adoption of consumable products, including CGM sensors, infusion sets, and reservoirs.
+Added: Sales to new patients and continued utilization of our consumable products contribute to recurring revenue and are important drivers of growth.
+Added: Adoption of new products and enhancements, including improvements to our CGM portfolio, may influence new patient acquisition, user retention, and consumable attachment rates.
+Added: Manufacturing and Supply
+Added: Our business model requires the ability to produce high volumes of our products and reliably ship to various geographies in a time-efficient manner.
+Added: Disruptions to our supply lines or shipping channels may impact our customer experience and ability to meet market demand.
+Added: We also continue to invest in expanding our manufacturing capacity as a key strategic priority of our business as we strive to meet significant demand for our CGM sensors and drive profitable growth.
+Added: Impact of Increased CGM Share of Product Mix on Profit Margin
+Added: Relative to sales of our insulin pumps, pens, and other consumables, sales of our CGMs, particularly our Simplera and Simplera Sync products, have historically contributed to a lower profit margin.
+Added: As a result, we expect that an increased volume of sales with Simplera and Simplera Sync will likely have a negative impact on our profit margin, as we have observed in recent periods.
+Added: However, as we continue to ramp our manufacturing capacity to meet demand, we are focused on optimizing manufacturing efficiencies, driving innovation, and expanding premium offerings to help offset expected margin impacts while sustaining growth.
+Added: Reimbursement
+Added: Our business is dependent on obtaining and maintaining adequate coverage and reimbursement for our products from government and private payors.
+Added: Changes to reimbursement policies, coverage criteria, payment levels, or channel dynamics, including the classification of products within durable medical equipment (“DME”) or pharmacy benefit channels, may affect product adoption, net sales, and operating results.
+Added: We continue to monitor reimbursement developments across our key markets and work with payors and providers to support patient access to our products.
+Added: Our total revenues vary slightly from quarter to quarter.
+Added: Based on historical experience, we generally have higher revenues toward calendar year end and our fiscal year end.
+Added: The trend is primarily driven by annual insurance deductible resets and unfunded flexible spending account dynamics in the U.S.
+Added: market, which is partially counteracted by lower pump sales as our competitors push for a strong end to their fiscal years, which align to calendar years.
+Added: Sales of our single-use products such as infusion sets, reservoirs, and CGMs have generally mitigated quarterly seasonal fluctuations in pump sales.
Foreign Currency
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The Company continues to evaluate its exposure to foreign currency risk as it transitions to standalone operations.
−Removed: 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.
+Added: Components of Results of Operations
+Added: Our net sales are generated primarily from the sale of reusable and single-use products which collectively comprise our AID and Smart MDI systems.
+Added: 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.
+Added: Patients are generally eligible for reimbursement coverage of a new insulin pump every four to five years depending on both geography and payer type.
+Added: 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.
+Added: Patients using durable insulin pens typically obtain replacements on an annual cycle due to reimbursement and product life span.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Cost of Products Sold
+Added: 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.
+Added: Manufacturing overhead expenses include expenses relating to manufacturing engineering, material procurement, inventory and quality control, facilities, depreciation, information technology, and operations supervision and management.
+Added: Selling, General and Administrative
+Added: 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.
+Added: Selling, general, and administrative expense also includes amortization expense related to our customer list and tradename intangible assets.
+Added: Research and Development
+Added: 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.
+Added: Research and development costs also include pre-approval regulatory and clinical trial expenses.
+Added: Certain Litigation Charges
+Added: We classify specified certain litigation charges and gains related to significant legal matters as certain litigation charges, net in the consolidated statements of operations.
+Added: Other Operating Income and Expense, Net
+Added: Other operating expense (income), net primarily includes restructuring expense, currency remeasurement, and income from research and development funding arrangements.
+Added: Other Non-operating Income and Expense, Net
+Added: Other non-operating expense (income), net includes investment gains and losses.
+Added: Income Tax Provision
+Added: Income tax provision includes current and deferred income tax expense related to federal, state, and international jurisdictions.
Key Business Metrics
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The following table sets forth our key business metrics, including non-GAAP measures, for the periods indicated:
−Removed: Three Months Ended Nine Months Ended
−Removed: (Dollars in millions) January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
+Added: Three Months Ended
+Added: (Dollars in millions) July 31, 2026 July 25, 2025
Net Sales $ 843 $ 723
Gross Profit $ 465 $ 409
−Removed: $ (111) $ (7) $ (132) $ (30)
−Removed: New Pumps Sold 38,971 36,894 103,008 102,342
+Added: Net Income (Loss) $ — $ (16)
+Added: New Pumps Sold (in thousands) 34 32
Global CGM Attachment Rate 69 % 64 %
−Removed: Net Sales Growth 15.0 % N/A 13.7 % N/A
+Added: Net Sales Growth 16.6 % 16.1 %
Organic Revenue Growth (1)
−Removed: 8.6 % N/A 7.8 % N/A
Adjusted Gross Profit (1)
−Removed: $ 457 $ 401 $ 1,300 $ 1,162
Adjusted EBITDA (1)
−Removed: $ 89 $ 73 $ 218 $ 170
−Removed: (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.
−Removed: GAAP measure.
+Added: (1) See “Non-GAAP measures” below for a discussion of Organic Revenue Growth, Adjusted Gross Profit, Adjusted EBITDA, and reconciliations with the most directly comparable U.S.
+Added: GAAP measures.
Gross profit is our net sales, less cost of products sold.
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Global CGM Attachment Rate
−Removed: 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.
+Added: Because we commercialize 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.
1 unchanged sentence
Organic Revenue Growth
−Removed: 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.
+Added: 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 12.
+Added: “Commitments and Contingencies,” to the condensed consolidated 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.
9 unchanged sentences
Adjusted EBITDA
−Removed: 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.
+Added: 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 the impact of certain other non-operational items.
We use Adjusted EBITDA to supplement U.S.
3 unchanged sentences
RESULTS OF OPERATIONS
−Removed: 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.
+Added: The following table sets forth a summary of our condensed consolidated results of operations for the three months ended July 31, 2026 and July 25, 2025, and the changes between periods.
Three Months Ended Change
−Removed: (Dollars in millions) January 23, 2026 January 24, 2025 Amount Percent
−Removed: Net Sales $ 790 $ 687 $ 103 15 %
−Removed: Cost of products sold 428 292 136 47
−Removed: Gross profit 362 395 (33) (8)
−Removed: Operating expenses:
−Removed: Research and development expense 114 112 2 1
−Removed: Selling, general, and administrative expenses 309 268 41 15
−Removed: Certain litigation charges, net (6) — (6) NM (1)
−Removed: Other operating expense (income), net 45 (7) 52 NM (1)
−Removed: Operating (loss) profit (100) 21 (121) (565)
−Removed: Other non-operating (income) expense, net — — (1) (548)
−Removed: (Loss) profit before income taxes (99) 21 (121) (565)
−Removed: Income tax provision 12 28 (17) (59)
−Removed: Net loss $ (111) $ (7) $ (104) 1,502
−Removed: Net income attributable to noncontrolling interests $ (8) $ (3) $ (5) 184
−Removed: Net loss attributable to the Company $ (119) $ (10) $ (110) 1,117 %
−Removed: (1) Not meaningful
−Removed: 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.
−Removed: Nine Months Ended Change
−Removed: (Dollars in millions) January 23, 2026 January 24, 2025 Amount Percent
+Added: (Dollars in millions) July 31, 2026 July 25, 2025 Amount Percent
Net sales $ 843 $ 723 $ 120 16.6 %
4 unchanged sentences
Selling, general, and administrative expenses 312 283 29 10.4 %
−Removed: Certain litigation charges, net 11 — 11 NM (1)
+Added: Certain litigation charges, net (2) 17 (19) (113.8) %
Other operating expense (income), net 36 (2) 37 NM
−Removed: Operating (loss) profit (97) 2 (99) (5,715)
−Removed: Other non-operating expense (income), net — 1 (1) (84)
−Removed: (Loss) profit before income taxes (97) 1 (99) (8,673)
+Added: Operating income (expense) 5 (13) 18 135.4 %
+Added: Other non-operating expense (income), net — — — NM
+Added: Income (loss) before income taxes 4 (13) 17 133.0 %
Income tax provision 4 3 1 20.8 %
−Removed: Net loss $ (132) $ (30) $ (102) 337
+Added: Net income (loss) $ — $ (16) $ 16 100.9 %
Net income attributable to noncontrolling interests $ — $ (3) $ 3 100.0 %
−Removed: Net loss attributable to the Company $ (148) $ (41) $ (108) 264 %
−Removed: (1) Not meaningful
−Removed: Our net sales are generated primarily from the sale of reusable and single-use products which collectively comprise our AID and Smart MDI systems.
−Removed: 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.
−Removed: Patients are generally eligible for reimbursement coverage of a new insulin pump every four to five years depending on both geography and payer type.
−Removed: 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.
−Removed: Patients using durable insulin pens typically obtain replacements on an annual cycle due to reimbursement and product life span.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The below table includes net sales by product category for the three months ended January 23, 2026 and January 24, 2025:
+Added: Net income (loss) attributable to the Company $ — $ (19) $ 20 100.7 %
+Added: The table below includes net sales by product category for the three months ended July 31, 2026 and July 25, 2025:
Three Months Ended Change
−Removed: (in millions) January 23, 2026 January 24, 2025 Amount Percent
+Added: (in millions) July 31, 2026 July 25, 2025 Amount Percent
Pumps $ 144 $ 119 $ 26 21.5 %
3 unchanged sentences
Total net sales $ 843 $ 723 $ 120 16.6 %
−Removed: (1) Primarily includes net sales generated from the sale of smart insulin pens and services.
−Removed: The below table includes net sales by market geography for the three months ended January 23, 2026 and January 24, 2025:
+Added: (1) Primarily includes revenue generated from the sale of smart insulin pens and services.
+Added: Amounts in this line also reflect adjustments to the Company's Italian payback accruals resulting from two rulings in 2024 by the Constitutional Court of Italy and the Legislative Decree published by the Italian government in 2025.
+Added: Refer to Note 12, Commitments and Contingencies, for more information.
+Added: The table below includes net sales by market geography for the three months ended July 31, 2026 and July 25, 2025:
Three Months Ended Change
−Removed: (in millions) January 23, 2026 January 24, 2025 Amount %
−Removed: $ 242 $ 231 $ 11 4.7 %
−Removed: International (2)
−Removed: 548 456 92 20.3 %
−Removed: Total $ 790 $ 687 $ 103 15.0 %
−Removed: includes the United States and U.S.
−Removed: (2) International includes all other non-U.S.
−Removed: 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.
−Removed: Net sales growth is primarily the result of increased volumes.
−Removed: 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.
−Removed: The sales performance in the U.S.
−Removed: is the result of 8% growth in pumps, a 1% decline in consumables, and 6% growth in CGM.
−Removed: Pump sales grew 10.8% for the three months ended January 23, 2026.
−Removed: We experienced continued growth of 12% in international pump sales since the launch of the Simplera CGM in Europe in fiscal year 2025.
−Removed: Following the launch of Simplera and Instinct CGM in the U.S.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Simplera CGM is our first disposable, all-in-one CGM and approximately half the size of previous CGMs.
−Removed: The discreet design simplifies the insertion and wear experience.
−Removed: CGM sales grew 6% during the three months ended January 23, 2026, as a result of a sustained upward trend in CGM Attachment Rate.
−Removed: We have experienced a sustained upward trend in CGM Attachment Rate in the U.S.
−Removed: since the launch of the MiniMed 780G system in fiscal year 2024 as the automation algorithm is only compatible with our MiniMed CGMs.
−Removed: The table below includes net sales by product category for the nine months ended January 23, 2026 and January 24, 2025:
−Removed: Nine Months Ended Change
−Removed: (in millions) January 23, 2026 January 24, 2025 Amount Percent
−Removed: Pumps $ 401 $ 387 $ 14 3.6 %
−Removed: Consumables 707 632 75 11.9 %
−Removed: CGM 1,133 968 165 17.0 %
−Removed: 24 4 20 NM (2)
−Removed: Total net sales $ 2,265 $ 1,991 $ 274 13.7 %
−Removed: (1) Primarily includes net sales generated from the sale of smart insulin pens and services.
−Removed: 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.
−Removed: Refer to Note 15, “Commitments and Contingencies,” to the condensed combined financial statements.
−Removed: (2) Not meaningful.
−Removed: The table below includes net sales by market geography for the nine months ended January 23, 2026 and January 24, 2025:
−Removed: Nine Months Ended Change
−Removed: (in millions) January 23, 2026 January 24, 2025 Amount %
+Added: (in millions) July 31, 2026 July 25, 2025 Amount %
$ 240 $ 212 $ 28 13.1 %
4 unchanged sentences
(2) International includes all other non-U.S.
−Removed: 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.
−Removed: Net sales growth was primarily the result of increased volumes.
−Removed: 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.
−Removed: Sales performance in the U.S.
−Removed: is the result of a 7% decline in pumps, a 1% decline in consumables, and 7% growth in CGM.
−Removed: 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.
−Removed: 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.
−Removed: Pump sales grew 3.6% for the nine months ended January 23, 2026.
−Removed: 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.
−Removed: due to the delayed launch of Simplera CGM and increased competition.
−Removed: The delayed launch of Simplera CGM in the U.S.
−Removed: resulted in a competitive disadvantage and limited our ability to grow NPS in the first half of fiscal year 2026.
−Removed: However, following the launch of Simplera and Instinct CGM in the U.S.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Fewer NPS in the U.S.
−Removed: resulted in reduced consumables sales during the nine months ended January 23, 2026.
−Removed: 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.
−Removed: 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.
−Removed: The Simplera CGM is our first disposable, all-in-one CGM and approximately half the size of previous CGMs.
−Removed: The discreet design simplifies the insertion and wear experience.
−Removed: CGM sales in the U.S.
−Removed: 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.
−Removed: We have experienced a sustained upward trend in CGM Attachment Rate in the U.S.
−Removed: since the launch of the MiniMed 780G system in fiscal year 2024 as the automation algorithm is only compatible with our MiniMed CGMs.
+Added: Net sales for the three months ended July 31, 2026 was $843 million as compared to $723 million for the three months ended July 25, 2025.
+Added: This represents growth of 17% as reported and 16% organic growth.
+Added: The extra week in our 52-53 week fiscal calendar contributed approximately 4 to 6 percentage points of that growth.
+Added: International sales increased by 18% and U.S.
+Added: sales increased 13% primarily as a result of increased volumes, as well as the benefit of the additional week of sales in the current-year period as compared to the prior year period.
+Added: International net sales growth benefited from strong, broad-based growth across pumps, CGM, and consumables, on expanded Simplera sensor supply and the Instinct sensor launch.
+Added: For the three months ended July 31, 2026, there was no Italian payback adjustment to net sales as compared to an increase in net sales of $7 million for the three months ended July 25, 2025.
+Added: This was 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.
+Added: net sales benefited from the launch of MiniMed Flex with Simplera which started shipping in June 2026.
+Added: Pump sales grew 22% for the three months ended July 31, 2026.
+Added: International pump sales were driven by increased availability of new sensors with increased supply of Simplera, as well as the European commercial launch of the Instinct sensor at the start of July.
+Added: This increased availability of new sensors helped to drive both strong CGM growth as well as strong pump revenue growth.
+Added: In the U.S., pump sales were driven by the U.S.
+Added: launch of MiniMed Flex insulin pump system, which started shipping in June with our Simplera sensor.
+Added: As of July 31, 2026, the MiniMed Flex insulin pump had not yet launched in regions outside the U.S.
+Added: Consumables sales increased 14% for the three months ended July 31, 2026.
+Added: Our 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.
+Added: The increase in the volume of patients using our AID systems across global markets was due to the competitive strength of the MiniMed 780G system and launch of MiniMed Flex in the US which have enabled us to attract new patients as well as retain our existing user base.
+Added: CGM sales increased 20% for the three months ended July 31, 2026, as a result of the continued increase in the Global CGM Attachment Rate, which rose from 64% in the three months ended July 25, 2025, to 69% in the three months ended July 31, 2026.
+Added: CGM sales were boosted by increased Simplera sensor supply in Europe as well as the European commercial launch of the Instinct sensor at the start of July.
+Added: In the US, CGM sales benefited from continued momentum from the launch of Simplera and Instinct CGM in the third quarter of fiscal year 2026, and the launch of MiniMed Flex insulin pump system with Simplera which started shipping in June 2026.
COSTS AND EXPENSES
−Removed: 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:
+Added: 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 July 31, 2026 and July 25, 2025:
Three Months Ended % of Net Sales
(Dollars in millions)
−Removed: January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
−Removed: Cost of products sold
−Removed: $ 428 $ 292 54.2 % 42.5 %
−Removed: Research and development expense $ 114 $ 112 14.4 % 16.3 %
−Removed: Selling, general, and administrative expenses $ 309 $ 268 39.2 % 39.0 %
−Removed: 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:
−Removed: Nine Months Ended % of Net Sales
−Removed: (Dollars in millions)
−Removed: January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
+Added: July 31, 2026 July 25, 2025 July 31, 2026 July 25, 2025
Cost of products sold
2 unchanged sentences
Selling, general, and administrative expenses $ 312 $ 283 37.0 % 39.1 %
−Removed: Cost of Products Sold
−Removed: 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.
−Removed: Manufacturing overhead expenses include expenses relating to manufacturing engineering, material procurement, inventory and quality control, facilities, depreciation, information technology, and operations supervision and management.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The increase was partially offset by favorable currency impact on net sales for the three months ended January 23, 2026 and January 24, 2025.
−Removed: 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.
−Removed: 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.
−Removed: For additional information about the asset write-offs, refer to Note 4, “Restructuring”, in the condensed combined financial statements.
+Added: Cost of Products Sold and Gross Profit
+Added: Cost of products sold for the three months ended July 31, 2026, was $378 million, resulting in gross profit of $465 million, as compared to cost of products sold of $314 million and gross profit of $409 million for the three months ended July 25, 2025.
+Added: Gross margin for the three months ended July 31, 2026 was 55.1%, compared to 56.6% in the prior year, a decrease of 1.5 percentage points.
+Added: The decrease in gross margin was primarily driven by the higher mix of Simplera sensors, which currently have a lower gross margin than the Company's legacy and Instinct sensors.
Research and Development Expense
−Removed: 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.
−Removed: Research and development costs also include pre-approval regulatory and clinical trial expenses.
−Removed: 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.
−Removed: The increase was not significant.
−Removed: 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.
−Removed: 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.
+Added: Research and development expense for the three months ended July 31, 2026 was $115 million, as compared to $125 million for the three months ended July 25, 2025.
+Added: The decrease was primarily driven by a $10 million acquisition of technology not yet approved by regulators during the three months ended July 25, 2025.
Selling, General, and Administrative Expense
−Removed: 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.
−Removed: Selling, general, and administrative expense also includes amortization expense related to our customer list and tradename intangible assets.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Restructuring Charges, Net
−Removed: 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.
−Removed: For additional information about our restructuring activities, refer to Note 4, “Restructuring”, to the condensed combined financial statements.
+Added: Selling, general, and administrative expense for the three months ended July 31, 2026 was $312 million, as compared to $283 million for the three months ended July 25, 2025.
+Added: The increase was primarily driven by $19 million of incremental commercialization activities to support higher sales of the Company in the current year, as well as a $10 million increase in information technology and software development costs.
Certain Litigation Charges, Net
−Removed: 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.
−Removed: 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.
−Removed: For additional information, refer to Note 15, “Commitments and Contingencies,” in the condensed combined financial statements.
+Added: Certain litigation charges, net was a credit of $2 million for the three months ended July 31, 2026, as compared to a charge of $17 million for the three months ended July 25, 2025.
+Added: Amounts in both periods primarily related to litigation activity associated with the retainer ring matter.
+Added: The credit of $2 million during the three months ended July 31, 2026 was related to the reversal of a previous accrual.
+Added: For additional information, refer to Note 12.
+Added: “Commitments and Contingencies.”
Other Operating Expense (Income), Net
−Removed: Other operating expense (income), net primarily includes restructuring expense, currency remeasurement, and income from research and development funding arrangements.
−Removed: 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.
−Removed: 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.
−Removed: This is partially offset by a $6 million decrease in net foreign currency remeasurement.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Other Non-Operating (Income) Expense, Net
−Removed: Other non-operating (income) expense, net primarily includes investment gains and losses.
−Removed: Other non-operating (income) expense, net was insignificant for both the three and nine months ended January 23, 2026 and January 24, 2025.
−Removed: Income tax provision includes current and deferred income tax expense related to federal, state, and international jurisdictions.
−Removed: 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.
−Removed: 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.
−Removed: On July 4, 2025, the U.S.
−Removed: government enacted The One Big Beautiful Bill Act of 2025 which includes, among other provisions, changes to the U.S.
−Removed: 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.
−Removed: Certain provisions were effective for the Company beginning in fiscal year 2026.
−Removed: 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.
+Added: Other operating expense (income), net was $36 million of expense for the three months ended July 31, 2026 as compared to $2 million of income for the three months ended July 25, 2025.
+Added: The increase was primarily driven by service charges and transition costs arising from the Separation and ongoing agreements with Medtronic following our IPO.
+Added: Other Non-Operating Expense (Income), Net
+Added: Other non-operating expense (income), net was insignificant for the three months ended July 31, 2026 and July 25, 2025.
+Added: We recognized income tax expense of $4 million f or the three months ended July 31, 2026, as compared to $3 million for the three months ended July 25, 2025.
+Added: The change in the effective tax rate and income tax provision primarily related to year-over-year changes in operational results by jurisdiction and the impact of valuation allowances in certain jurisdictions.
NON-GAAP MEASURES
12 unchanged sentences
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.
−Removed: 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.
+Added: In evaluating the non-GAAP financial information presented, investors should be aware that in the future 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.
4 unchanged sentences
Organic Revenue Growth
−Removed: 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.
+Added: 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 12.
+Added: “Commitments and Contingencies,” to the condensed consolidated 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.
−Removed: GAAP net sales to Organic Revenue for the three months ended January 23, 2026, and January 24, 2025:
+Added: GAAP net sales to Organic Revenue Growth for the three months ended July 31, 2026 and July 25, 2025:
Three Months Ended
Reported net sales Adjustments Organic Revenue
−Removed: (in millions) January 23, 2026 January 24, 2025 Growth January 23, 2026 (3)
−Removed: January 24, 2025 January 23, 2026 (3)
−Removed: January 24, 2025 Growth
−Removed: $ 242 $ 231 4.7 % $ — $ — $ 242 $ 231 4.7 %
−Removed: International (2)
−Removed: 548 456 20.3 % 44 — 504 456 10.5 %
−Removed: Total $ 790 $ 687 15.0 % $ 44 $ — $ 746 $ 687 8.6 %
−Removed: includes the United States and U.S.
−Removed: (2) International includes all other non-U.S.
−Removed: (3) The three months ended January 23, 2026 excludes the $44 million of revenue adjustments related to favorable currency impact on net sales.
−Removed: The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.
−Removed: The following table presents a reconciliation of U.S.
−Removed: GAAP net sales to Organic Revenue Growth for the nine months ended January 23, 2026 and January 24, 2025:
−Removed: Nine Months Ended
−Removed: Reported net sales Adjustments Organic Revenue
−Removed: (in millions) January 23, 2026 January 24, 2025 Growth January 23, 2026 (3)
−Removed: January 24, 2025 (4)
−Removed: January 23, 2026 (3)
−Removed: January 24, 2025 (4)
+Added: (in millions) July 31, 2026 July 25, 2025 Growth July 31, 2026 (2)
+Added: July 25, 2025 (3)
+Added: July 31, 2026 (2)
+Added: July 25, 2025 (3)
$ 240 $ 212 13.1 % $ — $ — $ 240 $ 212 13.1 %
4 unchanged sentences
International includes all other non-U.S.
−Removed: (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.
+Added: (2) The three months ended July 31, 2026 excludes $14 million of revenue adjustments, 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.
−Removed: (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.
+Added: (3) The three months ended July 25, 2025 excludes $7 million of 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
4 unchanged sentences
The following table presents a reconciliation of U.S.
−Removed: GAAP gross profit to Adjusted Gross Profit for the three and nine months ended January 23, 2026 and January 24, 2025:
−Removed: Three Months Ended Nine Months Ended
−Removed: (in millions) January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
−Removed: $ 362 $ 395 $ 1,200 $ 1,123
−Removed: Restructuring and associated costs (1)
+Added: GAAP gross profit to Adjusted Gross Profit for the three months ended July 31, 2026 and July 25, 2025:
+Added: Three Months Ended
+Added: (in millions) July 31, 2026 July 25, 2025
Amortization of intangible assets 6 6
Other adjustments (1)
−Removed: Costs to comply with medical device regulations (3)
Adjusted Gross Profit (Non-GAAP) $ 471 $ 409
−Removed: (1) Primarily relates to asset write-offs associated with the December 2025 plan to terminate a third-party manufacturing agreement.
(1) 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.
−Removed: (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.
−Removed: 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
3 unchanged sentences
The following table presents a reconciliation of U.S.
−Removed: GAAP net loss to Adjusted EBITDA for the three and nine months ended January 23, 2026 and January 24, 2025.
−Removed: Three Months Ended Nine Months Ended
−Removed: (in millions) January 23, 2026 January 24, 2025 January 23, 2026 January 24, 2025
−Removed: $ (111) $ (7) $ (132) $ (30)
+Added: GAAP net loss to Adjusted EBITDA for the three months ended July 31, 2026 and July 25, 2025.
+Added: Three Months Ended
+Added: (in millions) July 31, 2026 July 25, 2025
+Added: Net income (loss)
Income tax provision 4 3
2 unchanged sentences
Restructuring and associated costs (1)
−Removed: Certain litigation charges (2)
+Added: Certain litigation charges, net (2)
Transaction costs (3)
Other adjustments (4)
−Removed: Losses on minority investments (5)
−Removed: Costs to comply with medical device regulations (6)
Adjusted EBITDA $ 83 $ 50
−Removed: (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.
−Removed: Additionally, all periods presented include charges related to employee termination benefits and consulting expenses directly related to the restructuring efforts.
−Removed: (2) The nine months ended January 23, 2026 primarily relate to the Diabetes Pump Retainer Ring litigation.
+Added: (1) All periods presented include charges related to employee termination benefits and consulting expenses directly related to the restructuring efforts.
+Added: (2) Charges primarily relate to the Diabetes Pump Retainer Ring litigation and accruals associated with other legal proceedings, including matters resolved during the period.
(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.
−Removed: (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.
−Removed: (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.
−Removed: We consider these costs to be duplicative of previously incurred costs and/or one-time costs.
LIQUIDITY AND CAPITAL RESOURCES
−Removed: 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.
−Removed: As of January 23, 2026, we had $10 million in cash and cash equivalents.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: As of July 31, 2026, we had $207 million in cash and cash equivalents, and we had no long-term debt outstanding.
+Added: Our primary sources of liquidity are cash and cash equivalents on hand, cash generated from operations, and available borrowings under our revolving credit facility.
+Added: We believe that our cash and cash equivalents, future cash flows from operations, and availability under our revolving credit facility, will be sufficient to fund our ongoing core business activities for at least the next twelve months.
+Added: Following our Separation and the completion of our initial public offering in March 2026, we manage our own cash and financing activities and no longer participate in Medtronic's centralized cash management programs.
+Added: Our liquidity requirements are primarily driven by working capital needs, investments in product innovation and commercialization activities, capital expenditures, and other general corporate purposes.
+Added: We maintain a five‑year senior secured revolving credit facility (the “Revolving Credit Facility”) with an aggregate available principal amount of up to $500 million, available in U.S.
dollars and certain approved alternative currencies.
−Removed: Borrowings under the revolving credit facility became available upon completion of the IPO and were undrawn at closing.
−Removed: For further information, see Note 9, “Debt,” in the condensed combined financial statements.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Summary of Cash Flows for the nine months ended January 23, 2026 and January 24, 2025
+Added: For further information, see Note 7.
+Added: “Debt” to the condensed consolidated financial statements.
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:
−Removed: Nine Months Ended
−Removed: (in millions) January 23, 2026 January 24, 2025
−Removed: Cash (used in) provided by:
+Added: Three Months Ended
+Added: (in millions) July 31, 2026 July 25, 2025
+Added: Cash provided by (used in):
Operating activities $ (49) $ (141)
1 unchanged sentence
Financing activities — 202
+Added: Effect of exchange rate changes on cash and cash equivalents (1) —
Net change in cash and cash equivalents $ (91) $ (2)
Operating Activities
−Removed: 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.
+Added: Net cash used in operating activities was $49 million for the three months ended July 31, 2026, compared to $141 million for the three months ended July 25, 2025.
+Added: For the three months ended July 31, 2026, we reported break-even net income, net non-cash adjustments were $62 million, and the change in operating assets and liabilities was a decrease of $111 million.
+Added: For the three months ended July 31, 2025, we incurred a $16 million net loss, net non-cash adjustments were $64 million, and the change in operating assets and liabilities was a decrease of $188 million.
Investing Activities
−Removed: 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.
+Added: Net cash used in investing activities was $41 million for the three months ended July 31, 2026, which primarily consisted of purchases of property and equipment, primarily consisting of capital expenditures supporting product development and manufacturing efforts.
+Added: Net cash used in investing activities was $63 million for the three months ended July 25, 2025, which consisted of $53 million in purchases of property and equipment, and $10 million cash paid for certain technology purchase arrangements.
Financing Activities
−Removed: There was a $170 million increase in net cash provided by financing activities.
−Removed: 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.
−Removed: These transfers are utilized by the Company for general operating and investing activities.
−Removed: 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.
−Removed: Contractual Obligations and Cash Requirements
+Added: Net cash used in financing activities was not material for the three months ended July 31, 2026.
+Added: Net cash provided in financing activities of $202 million for the three months ended July 25, 2025 consisted of transfers from the Parent.
+Added: Contractual Obligations and Commitments
We have entered into various operating leases for certain office, manufacturing, and research facilities and warehouses, as well as transportation and other equipment.
−Removed: For a description of our contractual obligations related to leases, refer to Note 12, “Leases,” to the condensed combined financial statements.
+Added: For a description of our contractual obligations related to leases, refer to Note 10.
+Added: “Leases,” to the condensed consolidated financial statements.
+Added: Revolving Credit Facility
+Added: The Company is party to certain indebtedness arrangements, including the Revolving Credit Facility due 2031 providing up to $500 million of revolving borrowings for which none was outstanding as of July 31, 2026.
+Added: For a more detailed discussion of the material terms of the Revolving Credit Facility, see Note 7.
+Added: “Debt,” to the condensed consolidated financial statements, included in our Annual Report on Form 10-K for the fiscal year ended April 24, 2026.
Research and Development Arrangements
−Removed: 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.
−Removed: regulatory approval and commercial launch, we may be required to make future payments to Blackstone.
−Removed: On March 18, 2026, the FDA cleared MiniMed Flex.
−Removed: During the first two years following U.S.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Critical Accounting Estimates
−Removed: We have used various accounting policies to prepare the condensed combined financial statements in accordance with U.S.
−Removed: 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.
−Removed: 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.
−Removed: The preparation of the condensed combined financial statements, in conformity with U.S.
−Removed: GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Valuation of Goodwill
−Removed: Goodwill attributed to the Company represents the historical goodwill balances in Medtronic’s Diabetes business arising from acquisitions specific to the Company.
−Removed: Goodwill is the excess of the purchase price over the estimated fair value of identified net assets of acquired businesses.
−Removed: Determining the fair value requires us to make significant estimates.
−Removed: 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.
−Removed: The estimates could be impacted by legal, technical, regulatory, economic, and competitive risks.
−Removed: We have one goodwill reporting unit.
−Removed: 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.
−Removed: After completing the annual goodwill impairment test in the third quarter, we concluded that goodwill was not impaired.
−Removed: 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.
−Removed: We estimated the fair value of the reporting unit using the income and the market approaches, weighted 50% each.
−Removed: Fair value under the income approach was determined by discounting to present value the estimated future cash flows of the reporting unit.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Subsequent to our IPO, our stock price experienced a decline.
−Removed: 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.
−Removed: If future goodwill impairment charges occur, they could have a material adverse effect on the Company’s financial condition and results of operations.
−Removed: Refer to Note 7, “Goodwill and Other Intangible Assets,” to the condensed combined financial statements for further information.
+Added: The development of certain products, including MiniMed Flex, has been funded in part through research and development funding arrangements with Blackstone.
+Added: Under these arrangements, following U.S.
+Added: regulatory approval and commercial launch, we are required to make future payments to Blackstone.
+Added: Following the commercial launch of MiniMed Flex in the U.S., we are required to make royalty and minimum payments to Blackstone.
+Added: These obligations are expected to represent a significant use of cash during the initial commercialization period of MiniMed Flex and will be funded through cash on hand, cash generated from operations, and available borrowing capacity under our revolving credit facility.
+Added: For additional information regarding these arrangements, see Note 11.
+Added: “Research and Development Funding Arrangements.”
+Added: Critical Accounting Policies and Estimates
+Added: We have used various accounting policies to prepare the condensed consolidated financial statements in accordance with U.S.
+Added: The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements and accompanying notes as of the date of the financial statements.
+Added: We evaluate our estimates and judgments on an ongoing basis.
+Added: We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about our financial condition and results of operations that are not readily apparent from other sources.
+Added: Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions.
+Added: There have been no material changes to our critical accounting policies and estimates from the information provided in our Annual Report on Form 10-K for the fiscal year ended April 24, 2026.
New Accounting Pronouncements
−Removed: Information regarding new accounting pronouncements is included in Note 2, “New Accounting Pronouncements,” to the condensed combined financial statements.
+Added: Information regarding new accounting pronouncements is included in Note 2.
+Added: “Summary of Significant Accounting Policies,” to the condensed consolidated financial statements.
Other Information
6 unchanged sentences
Accordingly, investors should monitor this channel, in addition to following our press releases, SEC filings and public conference calls and webcasts.
−Removed: The contents of our website are not, however, a part of this report.
+Added: The contents of our website are not a part of this report.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
−Removed: This report contains, and management may make, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.
+Added: This Quarterly 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.
31 unchanged sentences
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.
−Removed: Some of the factors that could cause actual results to differ include, but are not limited to, the following:
−Removed: Business and Operational Risks
−Removed: • We operate in a highly competitive industry and we may be unable to compete effectively.
−Removed: Our success depends on our ability to differentiate our products and keep pace with emerging technologies.
−Removed: • 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.
−Removed: • We have experienced, and may continue to experience, pricing pressure for our products.
−Removed: • We have in the past experienced, and may in the future experience, challenges or delays in the development and manufacturing of new products.
−Removed: • 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.
−Removed: • We are subject to additional risks associated with our reliance on sole suppliers.
−Removed: • Our products may not achieve or maintain market acceptance.
−Removed: • 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.
−Removed: • 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.
−Removed: • Future market or clinical studies may be unfavorable to our products and their efficacy.
−Removed: • We are subject to a variety of risks associated with global operations.
−Removed: • We are subject to risks relating to coverage or reimbursement for our products.
−Removed: • 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.
−Removed: • 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.
−Removed: Legal and Regulatory Risks
−Removed: • We are subject to extensive, complex, and changing laws and governmental regulations, including U.S.
−Removed: and international tax laws and the Foreign Corrupt Practices Act (the “U.S.
−Removed: FCPA”) and similar international anti-corruption laws.
−Removed: • 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.
−Removed: • We have been and are subject to risks relating to quality problems and improper promotion of our products.
−Removed: • 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.
−Removed: • 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.
−Removed: • 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.
−Removed: Risks Related to the Separation and Divestment
−Removed: • We have a limited history of operating as a standalone public company and will incur incremental costs as a result.
−Removed: • 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”).
−Removed: • Our rebranding strategy in connection with the Separation will involve substantial costs and may not produce the intended benefits.
−Removed: • We will incur significant charges in connection with the Separation.
−Removed: • 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.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations), and related transactions.
−Removed: • We may face difficulty and incur incremental costs related to the hiring and retention of an appropriately qualified employee workforce.
−Removed: Risks Related to Our Relationship with Medtronic
−Removed: • We will be a “controlled company” as defined under the corporate governance rules of Nasdaq Stock Market LLC.
−Removed: • 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.
−Removed: • 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.
−Removed: • Certain of our executive officers and directors may have actual or potential conflicts of interest.
−Removed: • We may have reached better terms from unaffiliated third parties than the terms we will receive in our agreements with Medtronic.
+Added: For a list of certain factors that could cause actual results to differ, refer to “Summary of Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 24, 2026 which was filed with the Securities and Exchange Commission (the “SEC”) on June 29, 2026 (our “2026 Form 10-K”).
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.
−Removed: 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.
+Added: For a more detailed discussion of these factors, see Part I, Item 1A “Risk Factors” in our 2026 Form 10-K and any additional risks described in our other filings with the SEC .
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.