MiniMed Group, Inc.

MiniMed’s total manufacturing and research space is approximately 838,000 square feet. Approximately 94 percent of the manufacturing and research facilities are owned by MiniMed and the remaining balance is leased. The Company’s largest manufacturing facilities are located in the U.S and Puerto Rico.

MiniMed also maintains leased sales and administrative offices outside the U.S. at approximately 42 locations in over 19 countries. The Company uses substantially all of its currently available productive space to develop, manufacture, and market its products. The Company’s facilities are well-maintained, suitable for their respective uses, and adequate for current needs.

• NPB Belgium B.V. Belgium⁵
• NPB Finland Oy Finland⁵
• NPB Germany GmbH Germany⁵
• Nutrino Health Ltd. Israel⁵

• We enter into development arrangements, investments, licensing arrangements, joint ventures, strategic alliances, and partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenues and that could potentially inhibit us from pursuing certain product development and acquisition opportunities outside of such arrangements.
• The continuing development of many of our products depends upon our ability to maintain strong relationships with HCPs.
• Our results of operations will be harmed if we are unable to accurately forecast market demand for our products and manage our inventory.
• If we fail to expand and maintain an effective sales force, predict and adapt to changes in markets, or successfully develop and maintain our relationships with intermediaries, our business, prospects, and brand may be materially and adversely affected.
• Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
• Future market or clinical studies may be unfavorable to our products and their efficacy, which could hinder our sales efforts and have a material adverse effect on our business, results of operations, financial condition, and cash flows.
• We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results.
• Failure to secure or retain adequate coverage or reimbursement for our current products and our potential future products by government entities or third-party payors could adversely affect our business, results of operations, financial condition, and cash flows.
• Failure to integrate any acquired businesses into our operations successfully, or challenges related to our strategic initiatives, including divestitures and third-party funding arrangements, as well as liabilities or claims relating to any such acquired businesses, divestitures, or arrangements, could adversely affect our business.
• We have recently approved and committed to a plan to terminate a third-party manufacturing agreement resulting in a pre-tax charge, and we may be required to recognize additional charges in the future, including contract write-offs and impairments to our property, plant, and equipment, goodwill, or other intangible assets, which could significantly reduce our earnings.
• If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operations could be adversely affected, resulting in a decrease in the market price of shares of our common stock.
• We may in the future have outstanding debt obligations that could adversely affect our business, results of operations, or financial condition.
• Legal and Regulatory Risks
• We are subject to extensive and complex laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.
• We are involved in, and may in the future become involved in, litigation, arbitration, and governmental proceedings or investigations, including those stemming from third-party conduct beyond our control.
• Quality problems have in the past and could in the future lead to recalls or safety alerts, product liability claims, reputational harm, adverse verdicts, or costly settlements, and could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
• We are substantially dependent on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to our rights or the rights of others may result in our payment of significant monetary damages or royalty payments, negatively impacting our ability to sell current or future products.
• We may be subject to fines, penalties, and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiated.
• Healthcare policy changes may have a material adverse effect on us.
• We rely on the proper function, security, and availability of our information technology systems and data, as well as those of third parties throughout our global supply chain and our customer and payor base, to operate our business, and a breach, cyber-attack, or other disruption to these systems or data, which we have experienced and may experience again in the future, could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation, or competitive position.
• We are subject to stringent and often unsettled privacy laws, regulations, policies, and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, and contractual obligations could adversely affect our business.
• The failure to comply with anti-corruption laws could materially adversely affect our business and result in civil or criminal sanctions.
• Laws and regulations governing international business operations could adversely impact our business.
• Climate change, or legal, regulatory, or market measures to address climate change, may materially adversely affect our financial condition and business operations.
• We are subject to EHS laws and regulations and the risk of environmental liabilities, violations, and litigation.
• We are subject to risks related to sustainability practices and initiatives.
• Changes in tax laws, adverse outcomes resulting from examination of our tax returns, or other exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition, and cash flows.
• Our ability to use our net operating losses (“NOLs”) to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability.
• Risks Related to the Separation and the Divestment
• We have a limited history of operating as a standalone public company, and our historical financial information included herein may not necessarily reflect the results that we would have achieved as a standalone company or may not be a reliable indicator of our future results.
• Following the Separation, our financial profile has changed, and we are a smaller, less diversified company than Medtronic prior to the Separation.
• We may not achieve some or all of the expected benefits of the Separation, and the Separation and/or the Divestment could adversely affect our business, results of operations, financial condition, and cash flows.
• Medtronic’s plan to divest the Diabetes Operating Unit into an independent, publicly traded company is subject to various risks and uncertainties and may not be completed in accordance with the expected plans or anticipated timeline, or at all, and will involve significant time and expense, which could disrupt or adversely affect our business.
• We could experience temporary interruptions in business operations and incur substantial additional costs as we build our information technology infrastructure and transition our data to our own systems.
• Our accounting, tax, and other management systems and resources may not be adequately prepared to meet the independent financial reporting, transparency, and other requirements to which we are subject as an independent, publicly traded company.
• In connection with the Separation and the Divestment, we may be required to indemnify Medtronic for certain liabilities, Medtronic’s indemnities to us may be insufficient, and we have very limited access to Medtronic’s insurance and are essentially uninsured for many types of claims related to events that occurred before the Separation.
• Medtronic may fail to perform under various transaction agreements entered into in connection with the Separation, or we may fail to have necessary infrastructure, systems, and services in place when certain of the transaction agreements expire.
• We may be held liable to Medtronic if we fail to perform certain services or supply obligations under the Transition Services Agreement, and the performance of such services or supply obligations may negatively impact our business and operations.
• We may have received better terms from unaffiliated third parties than the terms we received in our agreements with Medtronic.
• Under the terms of the Separation, our ability to manage our manufacturing operations is restricted under the terms of the Juncos Lease and Master Services Agreements and the Tax Matters Agreement, and we therefore may not be able to fully conduct these operations in a manner that is optimal for our business.
• Under the Transition Manufacturing and Supply Agreement, Medtronic will continue to provide certain product development and manufacturing services for only a limited period of time after the Separation, and we therefore need to put in place alternatives to maintain our ability to develop and produce certain of our products.
• Following the Divestment, certain of our directors and executive officers may have actual or potential conflicts of interest because of their positions with or financial interests in Medtronic.
• The divestment of Medtronic’s remaining equity interest in us may not occur.
• If Medtronic completes the Divestment in a transaction that is intended to be generally tax-free for U.S. federal income tax purposes and there is later a determination that certain steps of the Separation or the Divestment are taxable because the facts, assumptions, representations, or undertakings underlying the Tax Opinion are incorrect or for any other reason, then Medtronic and its shareholders could incur significant U.S. federal, state, and foreign income tax liabilities and we could incur significant liabilities through our indemnification obligations under the Tax Matters Agreement.
• Although, under the Tax Matters Agreement, Medtronic is generally responsible for taxes due with respect to consolidated or joint tax returns for all periods prior to the Separation for consolidated groups including Medtronic or its subsidiaries and us and our subsidiaries, we nevertheless have joint and several liability with Medtronic for certain consolidated U.S. federal income taxes of such groups for taxable periods during which we or our affiliates were members of such groups.
• We may be affected by significant restrictions, including on our ability to engage in certain corporate transactions, for a two-year period following the completion of the Divestment, if pursued, in order to avoid triggering significant tax-related liabilities.
• Our rebranding strategy in connection with the Separation involves substantial costs and may not produce the intended benefits if it is not favorably received by PWD or third-party partners. In addition, our continued use of legacy Medtronic branding, including the “Medtronic” brand, could adversely affect our reputation.
• The transfer of certain assets and liabilities from Medtronic to us contemplated by the Separation may not be complete prior to the completion of the Divestment and may be significantly delayed or not occur at all.
• The transfer to us of certain contracts, permits, and other assets and rights may require the consents or approvals of, or provide other rights to, third parties and governmental authorities. If such consents or approvals are not obtained, we may not be entitled to the benefit of such contracts, permits, and other assets and rights, which could increase our expenses or otherwise harm our business and financial performance.
• The assets that we acquired from Medtronic in the Separation may not be sufficient for us to operate as an independent, publicly traded company, and we may experience difficulty in acquiring or separating new assets from Medtronic.
• Risks Related to Our Relationship with Medtronic
• Medtronic controls the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.
• We are a “controlled company” as defined under the corporate governance rules of Nasdaq and, as a result, qualify for, and rely on, exemptions from certain corporate governance requirements of Nasdaq.
• If Medtronic sells a sufficiently large equity interest in us to a third party in a private transaction, such transaction could result in a change of control of us, and you may not realize any change-of-control premium on your shares of our common stock.
• Risks Related to Our Common Stock
• An active trading market for our common stock may not be sustained.
• The price of our common stock may fluctuate substantially, and you could lose all or part of your investment in our common stock as a result.
• Future distributions or sales by Medtronic or other holders of shares of our common stock, or the perception that such distributions or sales may occur, including following the expiration of applicable lock-up periods, could cause our common stock’s price to decline.
• If we are unable to implement and maintain effective internal control over financial reporting in the future, investors could lose confidence in the accuracy and completeness of our financial reports and the market price of shares of our common stock could be adversely affected.
• The obligations associated with being an independent publicly traded company require significant resources and management attention.
• Your percentage ownership in us may be further diluted in the future.
• We are a holding company and our only material assets are our equity interests in our subsidiaries. As a consequence, we depend on the ability of our subsidiaries to pay dividends and make other payments and distributions to us in order to meet our obligations.
• We do not expect to pay dividends on our common stock for the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock.
• Certain provisions in our second amended and restated certificate of incorporation and our amended and restated bylaws, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our common stock.
• Our classified board of directors and other features of our amended and restated certificate of incorporation make it more difficult for our stockholders to remove directors and may prevent our stockholders from effecting a change in the control of our board of directors.
• Our second amended and restated certificate of incorporation provides that certain courts within the State of Delaware or the federal district courts of the United States are the sole and exclusive forum for the resolution of certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against us or our directors, officers, employees, or stockholders.