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As confidentially submitted to the Securities and Exchange Commission on July 15, 2021.

This draft registration statement has not been publicly filed with the Securities and Exchange Commission and all information herein remains strictly confidential.

File No. 001-            

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10

GENERAL FORM FOR REGISTRATION OF SECURITIES

Pursuant to Section 12(b) or (g) of

the Securities Exchange Act of 1934

Berra Newco, Inc.

(Exact name of Registrant as specified in its charter)

(201) 847-6800

(Registrant’s telephone number, including area code)

Securities to be registered pursuant to Section 12(b) of the Act:

Securities to be registered pursuant to Section 12(g) of the Act: None

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transaction period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

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BERRA NEWCO, INC.

INFORMATION REQUIRED IN REGISTRATION STATEMENT

CROSS-REFERENCE SHEET BETWEEN INFORMATION STATEMENT AND ITEMS OF FORM 10

Certain information required to be included herein is incorporated by reference to specifically identified portions of the body of the information statement filed herewith as Exhibit 99.1. None of the information contained in the information statement shall be incorporated by reference herein or deemed to be a part hereof unless such information is specifically incorporated by reference.

The information required by this item is contained under the sections of the information statement entitled “Information Statement Summary,” “Risk Factors,” “Cautionary Note Regarding Forward-Looking Statements,” “The Separation and Distribution,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business,” “Certain Relationships and Related Party Transactions” and “Where You Can Find More Information.” Those sections are incorporated herein by reference.

The information required by this item is contained under the section of the information statement entitled “Risk Factors.” That section is incorporated herein by reference.

The information required by this item is contained under the sections of the information statement entitled “Capitalization,” “Unaudited Pro Forma Condensed Combined Financial Information,” “Selected Historical Combined Financial Data of the Diabetes Care Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Index to Financial Statements” and the financial statements referenced therein. Those sections are incorporated herein by reference.

The information required by this item is contained under the section of the information statement entitled “Business.” That section is incorporated herein by reference.

The information required by this item is contained under the section of the information statement entitled “Security Ownership of Certain Beneficial Owners and Management.” That section is incorporated herein by reference.

The information required by this item is contained under the sections of the information statement entitled “Management” and “Directors.” Those sections are incorporated herein by reference.

The information required by this item is contained under the sections of the information statement entitled “Compensation Discussion and Analysis” and “Executive Compensation.” Those sections are incorporated herein by reference.

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The information required by this item is contained under the sections of the information statement entitled “Management,” “Directors” and “Certain Relationships and Related Party Transactions.” Those sections are incorporated herein by reference.

The information required by this item is contained under the section of the information statement entitled “Business—Legal Proceedings.” That section is incorporated herein by reference.

The information required by this item is contained under the sections of the information statement entitled “Dividend Policy,” “Capitalization,” “The Separation and Distribution,” and “Description of Newco Capital Stock.” Those sections are incorporated herein by reference.

The information required by this item is contained under the sections of the information statement entitled “Description of Material Indebtedness” and “Description of Newco Capital Stock—Sale of Unregistered Securities.” Those sections are incorporated herein by reference.

The information required by this item is contained under the sections of the information statement entitled “Dividend Policy,” “The Separation and Distribution” and “Description of Newco Capital Stock.” Those sections are incorporated herein by reference.

The information required by this item is contained under the section of the information statement entitled “Description of Newco Capital Stock—Charter and Bylaw Provisions.” That section is incorporated herein by reference.

The information required by this item is contained under the section of the information statement entitled “Index to Financial Statements” and the financial statements referenced therein. That section is incorporated herein by reference.

None.

(a) Financial Statements and Schedule

The information required by this item is contained under the sections of the information statement entitled “Unaudited Pro Forma Condensed Combined Financial Information” and “Index to Financial Statements” and the financial statements referenced therein. Those sections are incorporated herein by reference.

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(b) Exhibits

The following documents are filed as exhibits hereto:

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SIGNATURES

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized.

Date:                , 2021

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Exhibit 99.1

                , 2021

Dear Becton, Dickinson and Company (“BD”) Shareholder:

In May 2021, BD announced its plan to separate its diabetes care business into an independent public company. The separation will occur through a distribution by BD of all of the outstanding shares of a newly formed company, Berra Newco, Inc. (“Newco”), which will hold BD’s diabetes care business.

The separation will better position the diabetes care business and BD’s remaining businesses for long-term growth and success. The diabetes care business and BD’s remaining businesses have distinct business profiles, and the separation will allow Newco and BD to better allocate resources and deploy capital in line with the distinct growth and cash flow profiles of these businesses. BD’s decision to pursue the separation demonstrates its strong ongoing commitment to the BD 2025 strategy, which includes its three strategic pillars of Grow, Simplify and Empower. We expect the separation will allow BD to strengthen its growth profile, enables a greater investment focus on its other core businesses and high-growth opportunities, and make a greater impact for its customers and patients.

Upon completion of the separation, each BD shareholder as of                 , the record date for the distribution, will receive                 shares of Newco common stock for every share of BD common stock held as of the close of business on the record date. Newco common stock will be issued in book-entry form only, which means that no physical share certificates will be issued. For U.S. federal income tax purposes, the distribution is intended to be tax-free to BD shareholders (other than any cash that BD shareholders receive in lieu of fractional shares).

No vote of BD shareholders is required for the distribution. You do not need to take any action to receive shares of Newco common stock to which you are entitled as a BD shareholder, and you do not need to pay any consideration or surrender or exchange your BD common stock or take any other action to receive your shares of Newco common stock. 

Newco intends to apply to have its common stock authorized for listing on the                 under the symbol “                .” Following the distribution, BD common stock will continue to trade on the New York Stock Exchange under the symbol “BDX”

We encourage you to read the attached information statement, which is being made available to BD shareholders as of the record date for the distribution. The information statement describes the distribution in detail and contains important business and financial information about Newco.

We believe the separation provides tremendous opportunities for our businesses, as we work to continue to build long-term value. We appreciate your continuing support of BD and look forward to your future support of BD and Newco.

Confidential Treatment Requested by Berra Newco, Inc.

pursuant to 17 C.F.R. Section 200.83

[Berra Newco, Inc. Logo]

                , 2021

Dear Future Shareholder of Berra Newco, Inc.:

I am excited to welcome you as a future shareholder of Berra Newco, Inc. (“Newco”). Newco will hold BD’s diabetes care business, which includes the manufacturing and sale of syringes, pen needles and other products related to the injection or infusion of insulin and other drugs used in the treatment of diabetes.

As a pure-play company, we believe we will be attractively positioned to:

Although Newco will be a new, publicly traded company, its diabetes care business has an over 95-year history, starting when BD introduced the world’s first specialized insulin syringe in 1924. Since then, the diabetes care business has played a significant role in driving the adoption of insulin syringes and insulin pens combined with pen needles as the leading modality for insulin administration. Today, the diabetes care business is the leading producer of diabetes injection devices, producing approximately 7.5 billion units of injection devices annually and serving an estimated 30 million patients worldwide—more than any other company in the world.

Our vision for the future is clear. We intend to build innovative solutions and focus on improving care for people with diabetes. We plan to generate strong cash flow and maintain a capital structure that would allow for organic and inorganic growth opportunities, providing the best outcomes for our shareholders. We will strive to attract and retain superior talent to ensure operational excellence and accelerate growth. We look forward to our future as an independent, publicly traded company and to your support as a holder of Newco common stock.

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Information contained herein is subject to completion or amendment. A Registration Statement on Form 10 relating to these securities has been confidentially submitted to the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended.

Preliminary and Subject to Completion, Dated                

INFORMATION STATEMENT

Berra Newco, Inc.

This information statement is being furnished in connection with the distribution by Becton, Dickinson and Company (“BD”) to its shareholders of all of the outstanding shares of common stock of Berra Newco, Inc. (“Newco”), a wholly owned subsidiary of BD that will hold BD’s diabetes care business. To implement the separation, BD will contribute to Newco certain of the assets and liabilities associated with BD’s diabetes care business and then distribute all of the shares of Newco common stock on a pro rata basis to BD shareholders in a distribution that is intended to qualify as tax-free to the BD shareholders for U.S. federal income tax purposes (other than any cash that BD shareholders receive in lieu of fractional shares). Following the distribution, Newco will be an independent public company.

For every share of common stock of BD held of record by you as of the close of business on                , which is the record date for the distribution, you will receive                shares of Newco common stock. You will receive cash in lieu of any fractional shares of Newco common stock that you would have received after application of the above ratio. As discussed under “The Separation and Distribution—Trading Between the Record Date and Distribution Date,” if you sell your shares of BD common stock in the “regular-way” market after the record date and before the distribution date, you also will be selling your right to receive shares of Newco common stock in connection with the distribution. We expect the shares of Newco common stock to be distributed by BD to you at 12:01 a.m., Eastern Time, on                . We refer to the date of the distribution of the Newco common stock as the “distribution date.”

Until the separation and distribution occur, Newco will be a wholly owned subsidiary of BD, and consequently, BD will have the sole and absolute discretion to determine and change the terms of the separation (or to terminate the separation).

No vote of BD shareholders is required for the distribution. Therefore, you are not being asked for a proxy, and you are requested not to send BD a proxy, in connection with the distribution. You do not need to pay any consideration, exchange or surrender your existing shares of BD common stock or take any other action to receive your shares of Newco common stock.

There is no current trading market for Newco common stock, although we expect that a limited market, commonly known as a “when-issued” trading market, will develop on or shortly before the record date for the distribution, and we expect “regular-way” trading of Newco common stock to begin on the first trading day following the completion of the distribution. Newco intends to apply to have its common stock listed on                under the symbol “                .” Following the distribution, BD common stock will continue to trade on the New York Stock Exchange (“NYSE”) under the symbol “BDX.”

In reviewing this information statement, you should carefully consider the matters described under the section entitled “Risk Factors.”

Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved these securities or determined if this information statement is truthful or complete. Any representation to the contrary is a criminal offense.

This information statement does not constitute an offer to sell or the solicitation of an offer to buy any securities.

The date of this information statement is                .

This information statement will be made publicly available on or about                . Notice of this information statement’s availability will be first sent to BD shareholders on or about                 .

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Presentation of Information

Unless the context otherwise requires:

i

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Industry Information

Unless indicated otherwise, the information concerning the industries in which Newco participates contained in this information statement is based on Newco’s general knowledge of and expectations concerning the industry. Newco’s competitive position and industry size are based on estimates using Newco’s internal data and estimates, data from various industry analyses, our internal research and adjustments and assumptions that we believe to be reasonable. Newco has not independently verified data from industry analyses and cannot guarantee their accuracy or completeness. In addition, Newco believes that data regarding industry size and its competitive position within such industry provide general guidance but are inherently imprecise. Further, Newco’s estimates and assumptions involve risks and uncertainties and are subject to change based on various factors, including those discussed in the “Risk Factors” section. These and other factors could cause results to differ materially from those expressed in the estimates and assumptions.

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QUESTIONS AND ANSWERS ABOUT THE SEPARATION AND DISTRIBUTION

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RISK FACTORS

You should carefully consider the following risks and other information in this information statement in evaluating Newco and Newco common stock. Any of the following risks and uncertainties could materially adversely affect Newco’s business, financial condition or results of operations.

Risks Related to Newco’s Business

The medical technology industry is very competitive.

Newco faces significant competition from a wide range of companies in each market in which its products are sold. These include large companies with multiple product lines and non-traditional entrants such as technology companies, some of which may have greater financial and marketing resources than Newco in the United States or other markets, as well as smaller, more specialized companies.

Newco’s ability to compete will also be affected by changing preferences and requirements of people with diabetes, as well as changes in the ways healthcare services are delivered. Efforts to contain healthcare costs by governments and the private sector are also resulting in increased emphasis on products that reduce costs, improve clinical results and expand access. Newco’s ability to remain competitive will depend on how well it will meet these changing market demands in terms of its product offerings and marketing approaches.

The medical technology industry is subject to rapid technological change and frequent introduction of new products. The development of new or improved products, processes or technologies by other companies (such as new technologies to administer insulin) that provide better features, pricing, clinical outcomes or economic value may make Newco’s existing or new products less competitive. In some instances, competitors, including pharmaceutical companies, also offer, or are attempting to develop, alternative therapies for disease states (including diabetes) that may be delivered without a medical device, such as pen needles. Lower cost producers have also created pricing pressure, particularly in emerging markets. There can be no assurance that Newco’s products will be commercially successful, and it is possible that its business will be adversely affected from time to time as a result of products developed by its competitors.

Consolidation among healthcare systems and other providers is resulting in greater purchasing power for these companies. Group purchasing organizations and integrated health delivery networks have also served to concentrate purchasing decisions for some customers, which has led to downward pricing pressure for medical device suppliers. Further consolidation in the industry could intensify competition among medical device suppliers and exert additional pressure on the demand for and prices of Newco’s products.

Newco generates a significant amount of its products and cash flows from a few key products, and any events that adversely affect the sale or profitability of these products could have an adverse impact on Newco’s sales, results of operations and cash flows.

Newco’s ability to generate profits and operating cash flow depends largely upon the continued profitability of its key products, such as its pen needles and syringes. For example, for the fiscal year ended September 30, 2020, sales of pen needles (including both conventional and safety pen needles) accounted for $872 million, or 80%, of its total sales. Any event that adversely affects the sale or profitability of this product could adversely affect Newco’s sales, results of operations and cash flows. These adverse events could include a decrease in the demand for such products, the pressure to decrease the price of such products, any increase in costs of manufacturing such products or other supply chain disruptions, increased availability of competitive products, increased competition from the introduction of new products related to the treatment of diabetes or removal from the market of these products for any reason.

Technological breakthroughs in diabetes treatment or prevention may reduce demand for Newco’s products.

The diabetes treatment industry is subject to technological change and product innovation. A number of companies and medical researchers are pursuing new ways to deliver insulin to patients, including insulin

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administration technologies that do not require the use of a needle, or to treat diabetes without the use of insulin or by delaying the use of insulin. If they are successful in developing these technologies or treatment therapies, the demand for Newco’s products could decline. Furthermore, the National Institutes of Health and other supporters of diabetes research are continually seeking ways to prevent diabetes. Any technological breakthroughs in diabetes prevention or treatment could decrease demand for Newco’s products and have a material adverse effect on its business or results of operations.

Newco will obtain components and raw materials for its products from third parties, including BD. These third parties may fail to perform under their agreements with Newco, or there may be a reduction or interruption in the manufacturing and supply of these components and raw materials. Any such failure to perform or a reduction or interruption in supply could have a material adverse effect on Newco’s business and operations.

Newco will rely on a number of third parties to supply and manufacture the components and raw materials for its products. For example, in connection with the separation and prior to the distribution, Newco and BD will enter into a cannula supply agreement, whereby BD will sell to Newco cannulas for incorporation into Newco’s products for sale within the diabetes care sector. Cannulas are a component part of a wide variety of medical devices that use needles to deliver fluid into, or through which blood is drawn from, the body. After the separation, BD will retain ownership of all cannula production activities and all intellectual property rights of BD and its subsidiaries relating to cannula, the manufacture thereof and other critical cannula-related technology. The cannula supply agreement will be terminable by BD without cause by providing at least 36 months’ written notice; however, such termination can be effective no earlier than seven years from the distribution date. The cannula supply agreement will also terminate automatically, subject to a 36-month wind-down period, if Newco’s yearly forecast is below the required minimum purchase amount, and the parties will have other customary termination rights for material breach or bankruptcy of the other party. Newco is also limited to a maximum number of cannulas that it can purchase under the cannula supply agreement. If BD fails to perform under this agreement or BD terminates this agreement in accordance with its terms and, in either case, Newco cannot find a way to purchase cannula from another party or manufacture cannula, or if Newco needs to purchase more cannula than it is permitted under cannula supply agreement, Newco may have insufficient cannulas for its products, which could materially adversely affect Newco’s business, financial condition or results of operations.

Newco also obtains other component parts and raw materials from other third parties. In many cases, Newco will not have long-term supply agreements with suppliers of these component parts and raw materials, and its arrangements with these suppliers are on a purchase-order basis. Certain raw materials that we obtain from suppliers are subject to fluctuations in price and availability attributable to a number of factors, including general economic conditions, commodity price fluctuations, the demand by other companies for the same raw materials and the availability of complementary and substitute materials. In some cases, Newco’s agreements with suppliers can be terminated by either party by convenience upon short notice.

Certain raw materials and components used in the manufacture of pen needles and syringes, including cannulas, certain oil-based resins and rubber stoppers, are not always available from multiple sources. In addition, for quality assurance, cost-effectiveness and other reasons, Newco purchases certain raw materials and components from a single supplier. The price and supply of these materials and components may be affected or disrupted for reasons beyond Newco’s control. While Newco works with suppliers to ensure continuity of supply, no assurance can be given that these efforts will be successful. In the event that any of its existing supply arrangements are terminated or there is a reduction or interruption of supply under these existing arrangements, Newco expects that it will be able to enter into new arrangements with alternative suppliers, but these new arrangements may be on terms that are less favorable, including with respect to price and volume, and it may be costly or cause delays in Newco’s manufacturing process to transition to a new supplier, particularly in cases in which Newco must comply with regulatory requirements relating to qualification of new suppliers. The termination, reduction or interruption in supply of these raw materials and components could adversely impact Newco’s ability to manufacture and sell certain of its products.

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Third-party suppliers may encounter problems during manufacturing for a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction, component part supply constraints and environmental factors, any of which could delay or impede their ability to supply the components and raw materials for Newco’s products. Any such failure to perform or a reduction or interruption in supply could have a material adverse effect on Newco’s business and operations.

Newco may experience difficulties and delays in the manufacturing of its products or sterilization operations, and any such difficulties and delays could adversely affect Newco’s business.

Newco may experience difficulties and delays inherent in manufacturing its products, such as failure of Newco or its suppliers to comply with applicable regulations and quality assurance guidelines, which failures may lead to: manufacturing shutdowns or manufacturing delays; delays related to the construction of new facilities or the expansion of existing facilities; and other manufacturing or distribution problems, including changes in manufacturing production sites and limits to manufacturing capacity resulting from regulatory requirements, changes in types of products produced and physical limitations that could affect supply. In addition, Newco could experience difficulties or delays in manufacturing its products caused by natural disasters. Manufacturing difficulties can also result in product shortages, leading to lost sales and reputational harm to us. In addition, many of Newco’s products require sterilization prior to sale. In some instances, only a few facilities are qualified under applicable regulations to conduct this sterilization. To the extent Newco or third parties are unable to sterilize Newco’s products, whether due to lack of capacity, regulatory requirements or otherwise, Newco may be unable to transition sterilization to other sites or modalities in a timely or cost effective manner, or at all, which could have an adverse impact on Newco’s business.

A substantial portion of Newco’s revenue is derived from sales to a few customers. If these customers reduce the amount of product that they purchase from Newco or reduce the amount that they are willing to pay for such products, Newco’s business, financial condition and results of operations could be adversely affected.

A substantial portion of Newco’s revenues is derived from sales to a few customers. For example, for the fiscal year ended September 30, 2020, sales to McKesson Corporation, Cardinal Health and AmerisourceBergen Drug Corporation, Newco’s three largest distributors, together represented approximately 39% of Newco’s worldwide sales. In addition, for the fiscal year ended September 30, 2020, direct sales to the five largest retail pharmacies for Newco’s products together represented approximately 14% of Newco’s worldwide sales. If any of Newco’s largest customers reduce the amount of product that they purchase from Newco or decrease the price that they pay for such products, it could have a material adverse effect on Newco’s business, financial condition and results of operations.

Newco’s products are subject to continuous reimbursement, coverage and access scrutiny by both private and government payers, including the scope of products covered, access and coverage among product brands and manufacturers, reimbursement limitations and price adjustment restrictions. A change in any of these factors could have an adverse impact on Newco’s financial condition and results of operations.

In the United States, both public and private payers continue to take aggressive steps to control their expenditures for medical devices by placing restrictions on how many and which brands of devices they will provide coverage for across the spectrum of available products. Important competitive factors include quality, price, price guarantees and demonstrated ability to supply markets. Any failure by Newco to differentiate its products with existing payers based on these and other factors or establish new payer relationships may adversely affect its financial condition and results of operations.

In addition, consolidation and integration among healthcare institutions and providers significantly affects the competitive landscape for medical devices. Health plans, pharmacy benefit managers, wholesalers, and other supply chain stakeholders have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importance. Specifically, private third-party insurers and governments typically maintain formularies that specify coverage (the conditions under which drugs and medical devices are included on a plan’s

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formulary) and reimbursement (including both the associated out-of-pocket cost to the consumer and payment to the distributor) to control costs by negotiating discounted prices, inflation guarantees and other terms in exchange for formulary inclusion.

Adverse formulary placement can lead to reduced usage of a medical device for the relevant patient population due to coverage restrictions, such as prior authorizations and formulary exclusions, or due to reimbursement limitations that result in higher consumer out-of-pocket cost, such as nonpreferred co-pay tiers, increased co-insurance levels, and higher deductibles. Consequently, medical device companies compete for formulary placement not only on the basis of product attributes but also by providing rebates. Price to the end customer is an increasingly important factor in formulary decisions, particularly in treatment areas in which the payer has taken the position that multiple branded products are therapeutically comparable (like that of diabetes). These downward pricing pressures could continue to negatively affect Newco’s business. In addition to formulary placement, changes in insurance designs continue to drive greater consumer cost-sharing through high deductible plans and higher co-insurance or co-pays, increasing consumer sensitivity to product choice.

Newco is consistently managing the burden of continued pressures associated with payers’ discount requirements to maintain positive formulary positions. If Newco fails to maintain these formulary positions or reduces prices on its products to maintain these formulary positions, it could adversely affect Newco’s results of operations. In addition to the evolving payer market that continues to put price pressure on Newco’s products, new competitors have emerged. Competitors that are new to the pen needle and insulin syringe categories, along with some that have emerged to begin engaging with payers, have accelerated the focus on these product categories, providing payers more choices for formulary partners within these medical device categories.    

In addition to the ongoing challenges faced across the United States, Newco faces similar access, pricing and reimbursement trends outside of the United States. Although payers’ preferences for particular devices varies regionally, key foundational considerations for choice include: product specifications, clinical evidence demonstrating efficacy and positive clinical outcomes and pricing. Newco is challenged to deliver new, innovative and differentiated products, along with price concessions, in markets outside of the United States, and price guarantees in these regions are critical to maintain access to key distributors and end users. For example, in EMEA (which includes Europe, the Middle East and Africa), the demand for medical devices that are paid out of pocket by the end user is limited. Access to these products is largely defined by the availability and size of government reimbursement, or, in a limited number of countries, the ability of manufacturers to negotiate reimbursement directly with insurance companies. In China, the most notable threat continues to be access through volume-based procurement and GPOs, with potential significant price erosions and cost containment within the healthcare landscape. These continued pricing pressures could adversely affect Newco’s financial condition and results of operations.

Newco may enter into strategic collaborations, in-licensing arrangements or alliances with third parties that may not result in the development of commercially viable products or the generation of revenue.

In the ordinary course of its business, Newco may enter into strategic collaborations, in-licensing arrangements or alliances to develop product candidates. Other companies, including those with substantially greater financial, marketing, sales, technology or other resources, may compete with us for these arrangements. These arrangements are subject to a variety of risks, including:

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Newco’s sales and marketing efforts rely upon independent distributors that are free to market products that compete with Newco’s products, and if Newco is unable to maintain or expand its network of independent distributors, its business could be materially adversely affected.

Newco believes that a significant portion of its sales will continue to be to independent distributors for the foreseeable future, and it is possible that the percentage of its sales to independent distributors could increase. None of Newco’s independent distributors in the United States has been required to sell Newco’s products exclusively, and each of them may freely sell the products of Newco’s competitors. If Newco is unable to maintain or expand its network of independent distributors, its sales may be negatively affected. For the fiscal year ended September 30, 2020, McKesson Corporation, Cardinal Health and AmerisourceBergen Drug Corporation, Newco’s three largest distributors, together represented approximately 39% of Newco’s worldwide sales. If any of its key independent distributors were to cease to distribute Newco’s products or reduce their promotion of such products as compared to the products of Newco’s competitors, Newco may need to seek alternative independent distributors or increase its reliance on other independent distributors or its direct sales representatives, which alternative arrangements may not be sufficient to prevent a material reduction in sales of its products.

Newco’s future growth is dependent in part upon the development of new products, and there can be no assurance that such products will be developed or be successful.

A significant element of Newco’s strategy is to increase revenue growth by focusing on innovation and new product development, including, for example, Newco’s ongoing development of an insulin patch pump focused on serving the needs of people with Type 2 diabetes. New product development requires significant investment in research and development. The results of Newco’s product development efforts may be affected by a number of factors, including Newco’s ability to anticipate the needs of people with diabetes, successfully complete clinical trials, obtain regulatory approvals for its products, manufacture such products in a cost-effective manner, obtain appropriate intellectual property protection for such products, gain and maintain market acceptance of such products and obtain reimbursement for such products. There can be no assurance that Newco will be able to successfully develop or commercialize any products now in development or that Newco may seek to develop or commercialize in the future.

If the third parties on which Newco relies to conduct its clinical trials and to assist it with pre-clinical development do not perform as contractually required or expected, or if market or clinical studies are unfavorable to its products in development, Newco may not be able to obtain regulatory clearance or approval or commercialize its products.

Newco relies on third parties, such as contract research organizations, medical institutions, clinical investigators, contract laboratories and other third parties, to conduct some of its clinical trials and pre-clinical investigations. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, or if the quality or accuracy of the data they obtain is compromised due to failure to adhere to Newco’s clinical protocols or regulatory requirements or for other reasons, Newco’s pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and Newco may not be able to obtain regulatory approval for, or successfully commercialize, its products on a timely basis, or at all, and Newco’s business and operating results may be adversely affected. Furthermore, Newco’s third-party clinical trial investigators may be delayed in conducting such clinical trials for reasons outside of their control.

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In addition, if future clinical trials fail to support the efficacy of Newco’s current or future products, Newco’s sales may be adversely affected and may have a material adverse effect on its business, financial condition and results of operations. Future clinical studies or other articles regarding Newco’s existing products or any competing products may be published that either support a claim, or are perceived to support a claim, that a competitor’s product is clinically more effective or easier to use than Newco’s insulin patch pump or that its insulin patch pump is not as effective as Newco claims. Any of these events may negatively affect Newco’s sales efforts and result in decreased revenue.

Newco’s failure to maintain strong relationships with physicians and other healthcare professionals could adversely affect its business.

Newco depends on its ability to maintain strong working relationships with physicians and other healthcare professionals in connection with research and development for some of its products. Newco relies on these professionals to provide it with considerable knowledge and advice regarding the development and use of these products. If Newco fails to maintain its working relationships with physicians and, as a result, no longer has the benefit of their knowledge and advice, Newco’s products may not be developed in a manner that is responsive to the needs and expectations of the professionals who use and support such products, which could have a material adverse effect on Newco’s business.

Newco may not be able to successfully execute its acquisition strategy, which could adversely affect its financial condition and results of operations.

Newco intends to explore strategic partnerships and acquisition opportunities that enable it to accelerate its growth. There is no assurance that future acquisitions will be available on attractive terms and Newco’s ability to consummate any acquisition will be subject to various risks and uncertainties, including the negotiation of agreements on satisfactory terms, obtaining applicable regulatory approvals and, after consummation, achieving anticipated synergies and other benefits. If Newco does not successfully execute on its acquisition strategy, it could adversely affect its financial condition and results of operations.

Newco’s international operations subject it to certain business risks.

A substantial amount of Newco’s sales come from its operations outside the United States, and Newco intends to continue to pursue growth opportunities outside of the United States, especially in emerging markets. Newco’s international operations subject it to certain risks relating to, among other things, fluctuations in foreign currency exchange, local economic and political conditions, competition from local companies, increases in trade protectionism, U.S. relations with the governments of the foreign countries in which Newco operates, foreign regulatory requirements or changes in such requirements, changes in local healthcare payment systems and healthcare delivery systems, local product preferences and requirements, longer payment terms for account receivables than we experience in the United States, difficulty in establishing, staffing and managing foreign operations, changes to international trade agreements and treaties, changes in tax laws, weakening or loss of the protection of intellectual property rights in some countries and import or export licensing requirements. The success of Newco’s international operations also depends, in part, on its ability to make necessary infrastructure enhancements to, among other things, its production facilities and sales and distribution networks. These and other factors may adversely impact its ability to pursue its growth strategy in these regions.

In addition to the risks discussed elsewhere, other risks associated with doing business internationally, include:

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In addition, Newco’s international operations are governed by the U.S. Foreign Corrupt Practices Act and similar anti-corruption laws outside the United States. Global enforcement of anti-corruption laws has increased substantially in recent years, with more enforcement proceedings by U.S. and foreign governmental agencies and the imposition of significant fines and penalties. Newco’s international operations, which often involve customer relationships with foreign governments, create the risk that there may be unauthorized payments or offers of payments made by employees, consultants, sales agents or distributors. Any alleged or actual violations of these laws may subject Newco to government investigations and significant criminal or civil sanctions and other liabilities, and negatively affect its reputation.

Changes in U.S. policy regarding international trade, including import and export regulation and international trade agreements, could also negatively impact Newco’s business. The United States has imposed tariffs on certain goods imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries. Additional tariffs imposed by the United States on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs that Newco may not be able to offset or that otherwise adversely impact its results of operations. In addition, political tensions between the United States and China have escalated in recent years. Rising political tensions could reduce trade, investment and other economic activities between the two major economies. Any of these factors could have a material adverse effect on Newco’s business, prospects, financial condition and results of operations.

The departure of the United Kingdom from the European Union (“EU”) (commonly known as “Brexit”) on January 31, 2020 has created uncertainties affecting business operations in the United Kingdom, the EU and a number of other countries, including with respect to compliance with the regulatory regimes regarding the labeling and registration of the products Newco sells in these markets. Newco could face increased costs, volatility in exchange rates, market instability and other risks as a result of Brexit.

Foreign currency exchange rate, inflation, commodity price and interest rate fluctuations may adversely affect Newco’s financial condition and results of operations.

Newco is exposed to a variety of market risks, including the effects of changes in foreign currency exchange rates, commodity prices and interest rates. Products manufactured in, and sold into, regions outside of the United States represent a significant portion of Newco’s operations. The combined financial statements of the diabetes care business reflect translation of financial statements denominated in non-U.S. currencies to U.S. dollars as well as the foreign currency exchange gains and losses resulting from the re-measurement of assets and liabilities. A strengthening or weakening of the U.S. dollar in relation to the foreign currencies of the countries in which Newco sells or manufacture its products, such as the euro, will affect its U.S. dollar-reported revenue and income. Changes in the relative values of currencies may, in some instances, have a significant effect on its results of operations.

Many of Newco’s products have significant resin content. Newco also uses quantities of other commodities, such as rubber, corrugate and steel. Increases in the prices of these commodities, including due to inflation in the

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United States or in other markets, could increase the production and other input costs of Newco’s products. Newco may not be able to pass on these costs to its customers, which could have a material adverse effect on its results of operations and cash flows.

Increases in interest rates may adversely affect the financial condition of Newco’s distributors and suppliers, thereby adversely affecting their ability to buy Newco’s products and supply the components or raw materials needed by Newco, in each case adversely affecting Newco’s financial condition or results of operations.

Fluctuations in Newco’s effective tax rate and changes to tax laws may adversely affect it.

As a global company, Newco is subject to taxation in numerous countries, states and other jurisdictions. Newco’s effective tax rate is derived from a combination of applicable tax rates in the various countries, states and other jurisdictions in which it operates. In preparing its financial statements, Newco estimates the amount of tax that will become payable in each of these jurisdictions. Newco’s effective tax rate may, however, differ from the estimated amount due to numerous factors, including a change in the mix of its profitability from country to country and changes in tax laws, including potential tax legislation sponsored by the Biden Administration. If these proposals are ultimately enacted into legislation, they could materially impact Newco’s tax provision, cash tax liability and effective tax rate. Any of these factors could cause Newco to experience an effective tax rate significantly different from previous periods or its current expectations, which could have an adverse effect on its business, financial condition, results of operations and cash flows.

If Newco fails to protect its intellectual property or proprietary technology, such failure could adversely affect its business and results of operations.

Newco relies primarily on patent, trademark and trade secret laws, as well as confidentiality and non-disclosure agreements covering its know-how and confidential information, to protect its proprietary technologies. Third parties, including its competitors, may contest or oppose its patents and trademarks and future patent and trademark applications, and if such patents or trademarks are successfully challenged, it may be easier for its competitors to offer the same or similar products or technologies or require Newco to rebrand its products. Newco can also lose the protection afforded by these intellectual property assets through patent expirations, legal challenges or governmental action. Patents attained by competitors may also adversely affect Newco’s competitive position. In addition, competitors may seek to invalidate patents on its products or claim that its products infringe upon their intellectual property, which could result in a loss of competitive advantage or the payment of significant legal fees, damage awards and past or future royalties, as well as injunctions against future sales of its products. Newco has entered into confidentiality agreements and intellectual property assignment agreements with its officers, certain employees, consultants and potential collaborators regarding its intellectual property and proprietary technology. In the event of unauthorized use or disclosure or other breaches of those agreements, Newco may not be provided with meaningful protection for its trade secrets, know-how or other proprietary information. Newco also operates in countries that do not protect intellectual property rights to the same extent as in the United States, which could make it easier for competitors to compete with Newco in those countries. The loss of a significant portion of its portfolio of intellectual property assets may have an adverse effect on its business and results of operations.

Newco’s products or processes may infringe the intellectual property rights of others, which may cause Newco to pay unexpected litigation costs or damages or prevent Newco from selling its products.

Newco cannot be certain that its products do not and will not infringe issued patents or other intellectual property rights of third parties. Newco may be subject to legal proceedings and claims in the ordinary course of its business, including claims of alleged infringement of the intellectual property rights of third parties. Any such claims, whether or not meritorious, could result in litigation and divert the time and attention of its management team. If Newco is found liable for infringement, it may be required to enter into licensing agreements (which may not be available on acceptable terms or at all) or to pay damages or cease making or selling certain products. Newco may also need to redesign some of Newco’s products or processes to avoid future infringement liability.

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Breaches of Newco’s information systems could have a material adverse effect on its operations.

Newco relies on information systems to process, transmit, and store electronic information in its day-to-day operations, including sensitive personal or proprietary information. In addition, some of its products include information systems that collect data regarding patients and patient therapy on behalf of Newco’s customers and some connect to Newco’s systems for maintenance and management purposes. These information systems are subject to attack via malicious code execution, and cyber- or phishing- attacks. Cyberattacks could result in unauthorized access to Newco’s systems and products that could also affect its compliance with privacy and other laws and regulations, and result in actions by regulatory bodies or litigation, which in turn could have a material adverse impact on Newco’s operations.

Newco needs to attract and retain key employees to be competitive.

Newco’s ability to compete effectively depends upon its ability to attract and retain executives and other key employees. Competition for experienced employees, particularly for persons with specialized skills, can be intense. Newco’s ability to recruit such talent will depend on a number of factors, including compensation and benefits, work location and work environment. If Newco cannot effectively recruit and retain qualified executives and employees, its business could be adversely affected.

Newco’s business may be adversely affected by work stoppages, union negotiations and labor disputes.

Only certain employees, all outside of the United States and representing approximately 27% of our headcount, are represented by various collective bargaining groups. Historically, the effects of collective bargaining and other similar labor agreements have not been significant. However, if a larger number of Newco’s employees were to unionize, including in the wake of any future legislation or administrative regulation that makes it easier for employees to unionize, the effect could be significant.

A significant portion of Newco’s unionized employees have collective bargaining agreements. Any inability to negotiate acceptable new contracts under these collective bargaining arrangements could cause strikes or other work stoppages, and new contracts could result in increased operating costs for Newco. If any such strikes or other work stoppages occur, or if additional employees become represented by a union, a disruption of Newco’s operations and higher labor costs could result. Labor relations matters affecting Newco’s suppliers of products and services could also adversely affect Newco’s business from time to time.

Newco is subject to extensive regulation.

Newco’s operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, product safety and efficacy, employment, privacy, financial transparency, conflict minerals and other areas. Violations of these laws can result in criminal or civil sanctions, including substantial fines and, in some cases, exclusion from participation in healthcare programs such as Medicare and Medicaid. Environmental laws, particularly with respect to the emission of greenhouse gases, are also becoming more stringent throughout the world, which may increase Newco’s costs of operations or necessitate closures of or changes to its manufacturing plants or processes or those of its suppliers, or result in liability to Newco. Newco is also subject to various laws and regulations relating to the safety and effectiveness of medical devices, including relating to design, development and manufacturing, advertising and promotion and clinical trials and post-market studies with respect to its products. Failure to comply with these laws may result in enforcement actions by the Food and Drug Administration (the “FDA”) and other liability to Newco. The enactment of additional laws or changes in existing laws may increase compliance costs or otherwise adversely impact Newco’s operations.

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Healthcare reform may have a material adverse effect on Newco’s financial condition and results of operations.

Political, economic and regulatory developments have effected fundamental changes in the healthcare industry. The Patient Protection and Affordable Care Act (the “Affordable Care Act”) substantially changed the way healthcare is financed by both government and private insurers. It also encourages improvements in the quality of healthcare products and services and significantly impacts the U.S. pharmaceutical and medical device industries. Among other things, the Affordable Care Act:

We cannot predict at this time the full impact of the Affordable Care Act or other healthcare reform measures that may be adopted in the future on Newco’s financial condition, results of operations and cash flows. In this regard, several legislative initiatives to repeal and replace the Affordable Care Act have been proposed, and legal challenges to the constitutionality of the Affordable Care Act or its component parts have been made. The nature and effect of any modification or repeal of, or legislative substitution for, the Affordable Care Act, or any court decision regarding the Affordable Care Act’s validity, is uncertain, and we cannot predict the effect that any of these events would have on the longer-term viability of the act, or on Newco’s financial condition, results of operations or cash flows.

Certain modifications to Newco’s products may require new 510(k) clearances or other marketing authorizations and may require Newco to recall or cease marketing its products.

Once a medical device is permitted to be legally marketed in the United States pursuant to a 510(k) clearance, a manufacturer may be required to notify the FDA of certain modifications to the device. Manufacturers determine in the first instance whether a change to a product requires a new 510(k) clearance or premarket submission, but the FDA may review any manufacturer’s decision. The FDA may not agree with Newco’s decisions regarding whether new clearances are necessary. Newco has made modifications to its products in the past and has determined based on its review of the applicable FDA regulations and guidance that in certain instances new 510(k) clearances or other premarket submissions were not required. Newco may make similar modifications or add additional features in the future that it believes does not require a new 510(k) clearance. If the FDA disagrees with Newco’s determinations and requires it to submit new 510(k) notifications, Newco may be required to cease marketing or to recall the modified product until it obtains clearance, and it may be subject to significant regulatory fines or penalties.

Newco may be subject to enforcement actions if it engages in improper marketing or promotion of its products.

Newco’s promotional materials and training methods must comply with applicable laws and regulations, including of the FDA and the Federal Trade Commission (the “FTC”). If the FDA or the FTC determines that Newco’s promotional or training material constitutes off-label, false or misleading, unfair or deceptive promotion of its products, it could request that Newco modify its training or promotional materials or subject Newco to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider Newco’s promotional or training materials to constitute off-label, false or misleading, unfair or deceptive promotion of its products, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement, and reputational harm.

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Newco is subject to complex and evolving laws and regulations regarding privacy and data protection, many of which are subject to change and uncertain interpretation, which could result in claims, changes to its business practices, penalties, increased cost of operations or declines in user growth or engagement, or otherwise adversely affect its business.

Newco is subject to complex and frequently changing laws in the United States and elsewhere regarding privacy and the collection, use, storage and protection of personal information, and noncompliance with these laws could result in substantial fines or litigation. For instance, the EU has also adopted the General Data Protection Regulation (“GDPR”), which will apply to personal data involved in Newco’s operations in the EU or products and services that Newco offers to EU users involving personal data. The GDPR creates a range of new compliance obligations that could require Newco to change its existing business practices policies, and significantly increases financial penalties for noncompliance.

In the state of California, the California Consumer Privacy Act (“CCPA”), which provides certain privacy rights and consumer protection for residents of the state became effective in 2020, and the California Privacy Rights Act, which amends and expands the CCPA, will take effect in 2023. These consumer rights include the right to know what personal information is collected, the right to know whether the data is sold or disclosed and to whom, the right to request a company to delete the personal information it has collected, the right to opt-out of the sale of personal information and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right. California’s and other states’ laws apply more broadly and now or in the future may reach data we hold that relates to employees and healthcare providers, not just customers. In addition, data security protection laws passed by the federal government and many states require notification to data subjects, including customers and others, when there is a security breach of personal data. If we fail to comply with these regulations, we could be subject to civil sanctions, including fines and penalties for noncompliance.

In addition, foreign data protection, privacy, and other laws and regulations can be more restrictive than those in the United States. Data localization laws in some countries generally mandate that certain types of data collected in a particular country be stored and/or processed within that country. Newco could be subject to audits in Europe and around the world, particularly in the areas of consumer and data protection, as its continue to grow and expand its operations. Legislators and regulators may make legal and regulatory changes, or interpret and apply existing laws, in ways that make Newco’s products less useful to users, require us to incur substantial costs, expose us to unanticipated civil or criminal liability, or cause us to change Newco’s business practices. These changes or increased costs could affect Newco’s business and results of operations.

Newco is subject to risks associated with public health threats, including the ongoing COVID-19 pandemic.

Newco is subject to risks associated with public health threats, including the COVID-19 pandemic. The COVID-19 pandemic has the potential to significantly impact Newco’s supply chain if the manufacturing plants that produce its products, raw materials or product components, the distribution centers where Newco manages its inventory or the operations of its logistics and other service providers, including third parties that sterilize its products, are disrupted, temporarily closed or experience worker shortages for a sustained period of time.

Newco’s manufacturing sites in China, Ireland and the United States, where Newco manufactures a significant amount of its products, largely avoided any significant disruption due to the COVID-19 pandemic. However, notwithstanding that each of these communities has experienced a relative recovery in COVID-19 transmission and a lessening of restrictions related to COVID-19, a future outbreak of COVID-19 at any of Newco’s manufacturing sites in China, Ireland and/or the United States or in the surrounding communities, could lead to delays in the manufacturing of Newco’s products, which could have a material adverse effect on Newco’s business and results of operations.

Moreover, any resurgence in COVID-19 infections, including due to new variants of the virus for which current vaccines may not be effective, could result in the imposition of new governmental lockdowns, quarantine requirements or other restrictions to slow the spread of the virus, which could result in closures or other restrictions that significantly disrupt Newco’s operations or those of distributors or suppliers in Newco’s supply chain.

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Risks Related to the Separation and Distribution

Newco has no history of operating as an independent company, and its historical and pro forma financial information is not necessarily representative of the results that it would have achieved as a separate, publicly traded company and may not be a reliable indicator of its future results.

The historical information about Newco in this information statement refers to the diabetes care business as operated by and integrated with BD. The historical and pro forma financial information of Newco included in this information statement is derived from the Consolidated Financial Statements and accounting records of BD. Accordingly, the historical and pro forma financial information included in this information statement does not necessarily reflect the financial condition, results of operations or cash flows that we would have achieved as a separate, publicly traded company during the periods presented or those that Newco will achieve in the future primarily as a result of the factors described below:

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Other significant changes may occur in Newco’s cost structure, management, financing and business operations as a result of operating as a company separate from BD. For additional information about the past financial performance of its business and the basis of presentation of the historical combined financial statements and the Unaudited Pro Forma Condensed Combined Financial Statements of its business, see “Unaudited Pro Forma Condensed Combined Financial Statements,” “Selected Historical Combined Financial Data of the Diabetes Care Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the historical combined financial statements and accompanying notes included elsewhere in this information statement.

Following the separation, Newco’s financial profile will change, and it will be a smaller, less diversified company than BD prior to the separation.

The separation will result in Newco being a smaller, less diversified company than BD. As a result, Newco may be more vulnerable to changing market conditions, which could have a material adverse effect on its business, financial condition and results of operations. In addition, the diversification of Newco’s revenues, costs, and cash flows will diminish as a standalone company, such that its results of operations, cash flows, working capital and financing requirements may be subject to increased volatility and its ability to fund capital expenditures and investments, pay dividends and service debt may be diminished. Following the separation we may also lose capital allocation efficiency and flexibility, as Newco will no longer have access to cash flow from BD to fund Newco’s business.

Newco may not achieve some or all of the expected benefits of the separation.

Newco may not be able to achieve the full strategic and financial benefits expected to result from the separation, or such benefits may be delayed or not occur at all. The separation is expected to provide the following benefits, among others: (1) enabling management of BD and Newco to more effectively pursue the distinct operating priorities and strategies of their respective businesses; (2) permitting BD and Newco to allocate financial resources to meet the unique needs of their respective businesses, which will allow them to intensify their focus on distinct strategic priorities and to more effectively pursue their own distinct capital structures and capital allocation strategies; (3) allowing BD and Newco to more effectively articulate a clear investment thesis to attract a long-term investor base suited to their businesses and providing investors with a distinct and targeted investment opportunity; (4) creating an independent equity security tracking Newco’s underlying business, affording Newco with direct access to the capital markets and facilitating its ability to consummate future acquisitions or other transactions using its common stock; and (5) permitting Newco to more effectively recruit, retain and motivate employees through the use of stock-based compensation that more closely aligns management and employee incentives with specific business goals and objectives related to Newco’s business.

Newco may not achieve these and other anticipated benefits for a variety of reasons, including, among others: (1) the separation will demand significant management resources and require significant amounts of management’s time and effort, which may divert management’s attention from operating and growing Newco’s business; (2) following the separation, Newco may be more susceptible to market fluctuations, and other adverse events than if it were still a part of BD because Newco’s business will be less diversified than BD’s businesses prior to the completion of the separation; (3) after the separation, as a standalone company, Newco may be unable to obtain certain goods, services and technologies at prices or on terms as favorable as those BD obtained prior to completion of the separation; (4) the separation may require Newco to pay costs that could be substantial and material to its financial resources, including accounting, tax, legal and other professional services costs, recruiting and relocation costs associated with hiring key senior management and personnel new to Newco, tax costs and costs to separate information systems; (5) under the terms of the tax matters agreement that Newco will enter into with BD, it will be restricted from taking certain actions that could cause the distribution or certain related transactions to fail to qualify as tax-free to BD and BD shareholders and these restrictions may limit us

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for a period of time from pursuing certain strategic transactions and equity issuances or engaging in other transactions that might increase the value of its business; and (6) the contractual arrangements between Newco and BD may be on less favorable terms than the existing intercompany arrangements from which Newco benefits, and such arrangements may be inadequate to provide for the ongoing operation and growth of Newco’s business. If Newco fails to achieve some or all of the benefits expected to result from the separation, or if such benefits are delayed, it could have a material adverse effect on its competitive position, business, financial condition, results of operations and cash flows.

If Newco is unable to replace the services that BD currently provides to it on terms that are at least as favorable to Newco as the terms on which BD is providing such services, Newco’s business and results of operations could be adversely affected.

Newco will engage in the process of creating its own, or engaging third parties separate from BD to provide, systems and services to replace many of the systems and services that BD currently provides to Newco, including, for example, information technology infrastructure and systems and accounting and reporting systems. Newco may incur temporary interruptions in business operations if it cannot transition effectively from BD’s existing operating systems, databases and programming languages that support these functions to its own systems. The failure to implement the new systems and transition data successfully and cost-effectively could disrupt Newco’s business operations and have a material adverse effect on its profitability. In addition, Newco’s costs for the operation of these systems may be higher than the amounts reflected in its historical combined financial statements.

Newco’s accounting and other management systems and resources may not be adequately prepared to meet the financial reporting and other requirements to which it will be subject as a standalone publicly traded company following the distribution.

Newco’s financial results previously were included within the consolidated results of BD. Newco was not directly subject to the reporting and other requirements of the Exchange Act. As a result of the distribution, Newco will be directly subject to reporting and other obligations under the Exchange Act, including the requirements of Section 404 of Sarbanes-Oxley Act, which will require annual management assessments of the effectiveness of its internal control over financial reporting and a report by its independent registered public accounting firm addressing these assessments. These reporting and other obligations will place significant demands on Newco’s management and administrative and operational resources, including accounting resources.

Moreover, to comply with these requirements, Newco anticipates that it will need to migrate its systems, including information technology systems, implement additional financial and management controls, reporting systems and procedures and hire additional accounting and finance staff. Newco expects to incur additional annual expenses related to these steps, and those expenses may be significant. If Newco is unable to upgrade its financial and management controls, reporting systems, information technology and procedures in a timely and effective fashion, its ability to comply with its financial reporting requirements and other rules that apply to reporting companies under the Securities Exchange Act of 1934, as amended, could be impaired. Any failure to achieve and maintain effective internal controls could have a material adverse effect on its business, financial condition, results of operations and cash flows.

Following the separation, Newco will be required to rebrand its products, which could adversely affect its ability to attract and maintain end users.

Newco has historically marketed its products using the “BD” name and logo, which is a globally recognized brand with a strong reputation for high-quality products among people with diabetes and Newco’s distributors. Under the terms of the intellectual property agreements to be entered into with BD in connection with the separation and distribution, Newco will obtain a temporary license to use the “BD” name and logo on its products. Following the expiration of this license, Newco will be required to rebrand its products using the “Newco” name or other names and marks. These new names and brands may not benefit from the same

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recognition and association with product quality as the BD name, which could adversely affect Newco’s ability to attract and maintain its customers, who may prefer to use products with a stronger brand identity.

Newco will incur debt obligations that could adversely affect its business and profitability and its ability to meet other obligations.

Newco is expected to complete one or more financing transactions on or prior to the completion of the distribution. Approximately $                of the proceeds of such financings are expected to be used to distribute cash to BD. In addition, in partial consideration for the contribution of assets from BD to Newco, Newco will issue $                  of indebtedness to BD, which BD may use to retire outstanding BD indebtedness. As a result of such transactions, Newco anticipates having approximately $                 million of indebtedness upon completion of the distribution. Newco may also incur additional indebtedness in the future.

This significant amount of debt could potentially have important consequences to Newco and its debt and equity investors, including:

To the extent that Newco incurs additional indebtedness, the foregoing risks could increase. In addition, Newco’s actual cash requirements in the future may be greater than expected. Its cash flow from operations may not be sufficient to repay all of the outstanding debt as it becomes due, and Newco may not be able to borrow money, sell assets or otherwise raise funds on acceptable terms, or at all, to refinance its debt.

Newco may be affected by significant restrictions under the tax matters agreement, including on its ability to engage in certain corporate transactions for a two-year period after the distribution, in order to avoid triggering significant tax-related liabilities.

Under current U.S. federal income tax law, a spin-off that otherwise qualifies for tax-free treatment can be rendered taxable to the parent corporation and its shareholders as a result of certain post-spin-off transactions, including certain acquisitions of shares or assets of the spun-off corporation. Under the tax matters agreement that Newco will enter into with BD, Newco will be restricted from taking certain actions that could prevent the distribution and certain related transactions from being tax-free for U.S. federal income tax purposes. In particular, under the tax matters agreement, for the two-year period following the distribution, as described in the section entitled “Certain Relationships and Related Party Transactions—Agreements with BD—Tax Matters Agreement,” Newco will be subject to specific restrictions on its ability to pursue or enter into acquisition, merger, sale and redemption transactions with respect to Newco stock. These restrictions may limit Newco’s ability to pursue certain strategic transactions or other transactions that it may believe to be in the best interests of its stockholders or that might increase the value of its business. In addition, under the tax matters agreement, Newco may be required to indemnify BD and its affiliates against any tax-related liabilities incurred by them as a result of the acquisition of Newco’s stock or assets, even if Newco does not participate in or otherwise facilitate

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the acquisition. Furthermore, Newco will be subject to specific restrictions on discontinuing the active conduct of its trade or business, the issuance or sale of stock or other securities (including securities convertible into Newco stock but excluding certain compensatory arrangements), and sales of assets outside the ordinary course of business. Such restrictions may reduce Newco’s strategic and operating flexibility. For more information, see the section entitled “Certain Relationships and Related Party Transactions—Agreements with BD —Tax Matters Agreement.”

Newco may be held liable to BD if it fails to perform under its agreements with BD, and the performance of such services may negatively affect Newco’s business and operations.

In connection with the separation, Newco and BD will enter various agreements, including a separation and distribution agreement, a transition services agreement, a tax matters agreement, an employee matters agreement, a cannula supply agreement, contract manufacturing agreements, an intellectual property matters agreement and other transaction agreements. See “Certain Relationships and Related Party Transactions.” These agreements will provide for the performance of certain services by each company for the benefit of the other for a period of time after the separation. If Newco does not satisfactorily perform its obligations under these agreements, it may be held liable for any resulting losses suffered by BD, subject to certain limits. In addition, during the transition services periods under the transition services agreement, Newco’s management and employees may be required to divert their attention away from its business in order to provide services to BD, which could adversely affect Newco’s business.

Newco’s agreements with BD may be on terms that are less beneficial to Newco than the terms may have otherwise been from unaffiliated third parties.

The agreements that Newco will enter into with BD in connection with the separation include the separation and distribution agreement, a transition services agreement, a tax matters agreement, an employee matters agreement, a cannula supply agreement, contract manufacturing agreements, an intellectual property matters agreement and other transaction agreements. See “Certain Relationships and Related Party Transactions.” These agreements were prepared in the context of the separation while Newco was still a wholly owned subsidiary of BD. Accordingly, during the period in which the terms of those agreements were prepared, Newco did not have an independent Board of Directors or a management team that was independent of BD. As a result, the terms of those agreements may not reflect terms that would have resulted from arm’s-length negotiations between unaffiliated third parties.

If there is a determination that the distribution or certain related transactions are taxable for U.S. federal income tax purposes, BD and its shareholders could incur significant tax liabilities, and Newco could incur significant liabilities pursuant to its indemnification obligations under the tax matters agreement.

It is a condition to the distribution that BD receive an opinion of its outside tax counsel, satisfactory to the BD Board of Directors, regarding the qualification of the distribution, together with certain related transactions, as a “reorganization” within the meaning of Sections 368(a)(1)(D) and 355 of the Code. The opinion of its outside tax counsel will be based upon and rely on, among other things, various facts and assumptions, as well as certain representations, statements and undertakings of BD and Newco, including facts, assumptions, representations, statements and undertakings relating to the past and future conduct of the companies’ respective businesses and other matters. If any of these facts, assumptions, representations and statements are or become inaccurate or incomplete, or if any such undertaking is not complied with, BD may not be able to rely on the opinion of its outside tax counsel, and the conclusions reached therein could be jeopardized.

Notwithstanding BD’s receipt of the opinion of its outside tax counsel, the Internal Revenue Service (the “IRS”) could determine on audit that the distribution or certain related transactions are taxable for U.S. federal income tax purposes if it determines that any of the facts, assumptions, representations, statements and undertakings upon which the

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opinion was based are incorrect or have been violated, or if it disagrees with any of the conclusions in the opinion. Accordingly, notwithstanding BD’s receipt of the opinion of its outside tax counsel, there can be no assurance that the IRS will not assert that the distribution or certain related transactions do not qualify for tax-free treatment for U.S. federal income tax purposes, or that a court would not sustain such a challenge. In the event the IRS were to prevail in such a challenge, BD and BD’s shareholders could incur significant tax liabilities. For a discussion of the U.S. federal income tax consequences of the distribution, see “Material U.S. Federal Income Tax Consequences.”

Under the tax matters agreement that Newco will enter into with BD, Newco generally will be required to indemnify BD for any taxes incurred by BD that arise as a result of Newco taking or failing to take, as the case may be, certain actions that result in the distribution and certain related transactions failing to qualify as tax-free for U.S. federal income tax purposes. Any such indemnification could materially adversely affect Newco’s financial condition, results of operations and cash flows. For a more detailed discussion, see “Certain Relationships and Related Party Transactions—Agreements with BD—Tax Matters Agreement.”

The transfer to Newco of certain contracts, permits and other assets and rights may require the consents, approvals of, or provide other rights to, third parties and governmental authorities. If such consents or approvals are not obtained, Newco may not be entitled to the full benefit of such contracts, permits and other assets and rights, which could increase its expenses or otherwise harm its business and financial performance.

The separation and distribution agreement will provide that certain contracts, permits and other assets and rights are to be transferred from BD or its subsidiaries to Newco or its subsidiaries in connection with the separation. The transfer of certain of these contracts, permits and other assets and rights may require consents or approvals of third parties or governmental authorities or provide other rights to third parties. In addition, in some circumstances, Newco and BD are joint beneficiaries of contracts, and Newco and BD may need the consents of third parties in order to split or separate the existing contracts or the relevant portion of the existing contracts to Newco or BD.

Some parties may use consent requirements or other rights to seek to terminate contracts or obtain more favorable contractual terms from us, which, for example, could take the form of price increases. This could require us to expend additional resources in order to obtain the services or assets previously provided under the contract, or require us to seek arrangements with new third parties or obtain letters of credit or other forms of credit support. If Newco is unable to obtain required consents or approvals, it may be unable to obtain the benefits, permits, assets and contractual commitments that are intended to be allocated to Newco as part of its separation from BD, and Newco may be required to seek alternative arrangements to obtain services and assets that may be more costly and/or of lower quality. The termination or modification of these contracts or permits or the failure to timely complete the transfer or separation of these contracts or permits could negatively affect Newco’s business, financial condition, results of operations and cash flows.

Until the distribution occurs, the BD Board of Directors has sole and absolute discretion to change the terms of the separation in ways which may be unfavorable to Newco, including to determine not to effect the distribution at all.

In May 2021, BD announced its plan to separate the diabetes care business into an independent publicly traded company, Newco. The separation is subject to the satisfaction of certain conditions (or waiver by BD in its sole and absolute discretion), including final approval by BD’s Board of Directors of the separation and distribution. Furthermore, the separation is complex in nature, and unanticipated developments or changes, including changes in the law, the macroeconomic environment, competitive conditions of BD’s markets, regulatory approvals or clearances, the uncertainty of the financial markets and challenges in executing the separation, could delay or prevent the completion of the proposed separation, or cause the separation to occur on

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terms or conditions that are different or less favorable than expected. Additionally, the BD Board of Directors, in its sole and absolute discretion, may decide not to proceed with the distribution at any time prior to the distribution date.

No vote of BD shareholders is required in connection with the distribution. As a result, if the distribution occurs and you do not want to receive Newco common stock in the distribution, your sole recourse will be to divest yourself of your BD common stock prior to the distribution date.

No vote of BD shareholders is required in connection with the distribution. Accordingly, if the distribution occurs and you do not want to receive Newco common stock in the distribution, your only recourse will be to divest your BD common stock prior to the record date for the distribution or, following the record date, in the “regular way” market for BD common stock before the distribution date.

Risks Related to Newco Common Stock

There is no assurance that an active trading market for Newco common stock will develop or be sustained after the distribution and, following the distribution, the price of Newco common stock may fluctuate significantly.

A public market for Newco common stock does not currently exist. We anticipate that on or prior to the record date for the distribution, trading of shares of Newco common stock will begin on a “when-issued” basis and will continue through the distribution date. However, we cannot guarantee that an active trading market will develop or be sustained for Newco common stock after the distribution, nor can we predict the prices at which shares of Newco common stock may trade after the distribution. Similarly, we cannot predict the effect of the distribution on the trading prices of Newco common stock or whether the combined market value of                  shares of Newco common stock and one share of BD common stock will be less than, equal to or greater than the market value of one share of BD common stock prior to the distribution.

The prices at which shares of Newco common stock trade may fluctuate more significantly than might otherwise be typical, even with other market conditions, including general volatility, held constant. The market price of Newco common stock may fluctuate significantly due to a number of factors, some of which may be beyond our control, including:

A significant number of shares of Newco common stock may be sold following the distribution, which may cause the Newco stock price to decline.

Any sales of substantial amounts of Newco common stock in the public market or the perception that such sales might occur, in connection with the distribution or otherwise, may cause the market price of Newco common stock to decline. Upon completion of the distribution, we expect that Newco will have an aggregate of approximately                shares of common stock issued and outstanding. Shares distributed to BD shareholders in the separation will generally be freely tradeable without restriction or further registration under the U.S. Securities Act of 1933, as amended (the “Securities Act”), except for shares owned by Newco’s “affiliates,” as that term is defined in Rule 405 under the Securities Act.

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We cannot predict whether large amounts of Newco common stock will be sold in the open market following the distribution. We are also unable to predict whether a sufficient number of buyers of Newco common stock to meet the demand to sell shares of Newco common stock at attractive prices would exist at that time.

Your percentage of ownership in Newco may be diluted in the future.

In the future, your percentage ownership in Newco may be diluted because of equity issuances for acquisitions, capital market transactions or otherwise, including any equity awards that Newco will grant to its directors, officers and employees. Newco employees will have stock-based awards that correspond to shares of Newco common stock after the distribution as a result of conversion of their BD stock-based awards. Such awards will have a dilutive effect on Newco’s earnings per share, which could adversely affect the market price of Newco common stock. From time to time, Newco will issue additional stock-based awards to its employees under its employee benefits plans.

Newco has not yet determined its dividend policy, and even if Newco determines that its dividend policy will be to pay a regular dividend, Newco cannot guarantee the timing, declaration, amount or payment of dividends on its common stock.

Newco has not yet determined whether it expects to pay a regular dividend after the separation and distribution. The timing, declaration, amount and payment of any dividends following the separation and distribution will be within the discretion of Newco’s Board of Directors, and will depend upon many factors, including Newco’s financial condition, earnings, capital requirements of its operating subsidiaries, covenants associated with certain of Newco’s debt service obligations, legal requirements, regulatory constraints, industry practice, ability to access capital markets, and other factors deemed relevant by Newco’s Board of Directors. Moreover, if Newco determines to pay any dividend in the future, there can be no assurance that it will continue to pay such dividends or the amount of such dividends. For more information, see the section entitled “Dividend Policy.”

Anti-takeover provisions could enable Newco’s Board of Directors to resist a takeover attempt by a third-party and limit the power of its shareholders.

Newco’s amended and restated certificate of incorporation and amended and restated bylaws will contain, and Delaware law contains, provisions that are intended to deter coercive takeover practices and inadequate takeover bids by making such practices or bids unacceptably expensive to the bidder and to encourage prospective acquirers to negotiate with Newco’s Board of Directors rather than to attempt a hostile takeover. These provisions are expected to include, among others:

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In addition, Newco will be subject to Section 203 of the Delaware General Corporate Law, which could have the effect of delaying or preventing a change of control that you may favor. Section 203 provides that, subject to limited exceptions, persons that acquire, or are affiliated with persons that acquire, more than 15% of the outstanding voting stock of a Delaware corporation may not engage in a business combination with that corporation, including by merger, consolidation or acquisitions of additional shares, for a three-year period following the date on which that person or any of its affiliates becomes the holder of more than 15% of the corporation’s outstanding voting stock.

We believe these provisions will protect Newco shareholders from coercive or otherwise unfair takeover tactics by requiring potential acquirers to negotiate with Newco’s Board of Directors and by providing the Board with more time to assess any acquisition proposal. These provisions are not intended to make Newco immune from takeovers; however, these provisions will apply even if the offer may be considered beneficial by some shareholders and could delay or prevent an acquisition that Newco’s Board of Directors determines is not in the best interests of Newco and its shareholders. These provisions may also prevent or discourage attempts to remove and replace incumbent directors. See “Description of Newco Common Stock—Anti-Takeover Effects of Governance Provisions.”

In addition, an acquisition or further issuance of Newco common stock could trigger the application of Section 355(e) of the Code, causing the distribution to be taxable to BD. For a discussion of Section 355(e) of the Code, see “Material U.S. Federal Income Tax Consequences.” Under the tax matters agreement, Newco would be required to indemnify BD for the resulting tax, and this indemnity obligation might discourage, delay or prevent a change of control that Newco shareholders may consider favorable.

Newco’s amended and restated certificate of incorporation will designate the state courts within the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by Newco shareholders, which could discourage lawsuits against Newco and its directors and officers.

Newco’s amended and restated certificate of incorporation will provide that, unless Newco (through approval of the Board of Directors) consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (1) any derivative action brought on behalf of Newco, (2) any action asserting a claim of breach of a fiduciary duty owed by any director or officer or other employee of Newco to Newco or Newco’s stockholders, (3) any action asserting a claim against Newco or any director or officer or other employee of Newco arising pursuant to, or seeking to enforce any right, obligation or remedy under, any provision of the Delaware General Corporation Law (“DGCL”) or Newco’s amended and restated certificate of incorporation or amended and restated bylaws (as either may be amended from time to time), (4) any action asserting a claim against Newco or any director or officer or other employee of Newco governed by the internal affairs doctrine, which is a conflict of laws principle which recognizes that only one state should have the authority to regulate a corporation’s internal affairs or (5) any action as to which the DGCL (as it may be amended from time to time) confers jurisdiction on the Court of Chancery of the State of Delaware. If and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state court sitting in the State of Delaware (or, if no state court located within the State of Delaware has jurisdiction, the federal district court for the District of Delaware). These exclusive forum provisions will apply to all covered actions, including any covered action in which the plaintiff chooses to assert a claim or claims under federal law in addition to a claim or claims under Delaware law. These exclusive forum provisions will not apply to actions asserting only federal law claims under the Securities Act or the Exchange Act, regardless of whether the state courts in the State of Delaware have jurisdiction over those claims. Although Newco believes the exclusive forum provision benefits it by providing increased consistency in the application of law in the types of lawsuits to which it applies, the provision may limit the ability of Newco stockholders to bring a claim in a judicial forum that such stockholders find favorable for disputes with Newco or its directors or officers, which may discourage such lawsuits against Newco and its directors and officers.

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Although Newco’s amended and restated certificate of incorporation will include this exclusive forum provision, it is possible that a court could rule that this provision is inapplicable or unenforceable. Alternatively, if a court were to find this exclusive forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings described above, Newco may incur additional costs associated with resolving such matters in other jurisdictions, which could negatively affect its business, results of operations and financial condition.

The combined post-separation value of one share of BD common stock and                shares of Newco common stock may not equal or exceed the pre-distribution value of one share of BD common stock.

As a result of the separation, the trading price of shares of BD common stock immediately following the separation may be different from the “regular-way” trading price of such shares immediately prior to the separation because the trading price of BD common stock will no longer reflect the value of the diabetes care business. There can be no assurance that the aggregate market value of a share of BD common stock and                shares of Newco common stock following the separation will be higher than, lower than or the same as the market value of a share of BD common stock if the separation did not occur.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This information statement and other materials BD and Newco have filed or will file with the SEC (and oral communications that BD or Newco may make) contain or incorporate by reference statements that relate to future events and expectations and, as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include those containing such words as “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “guidance,” “intends,” “may,” “outlook,” “plans,” “projects,” “seeks,” “sees,” “should,” “targets,” “will,” “would,” or other words of similar meaning. All statements that reflect BD’s or Newco’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, forecasts relating to discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth and cash flows) and statements regarding BD’s or Newco’s strategy for growth, future product development, regulatory approvals, competitive position and expenditures. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and changes in circumstances that are difficult to predict. Although each of BD and Newco believes that the expectations reflected in any forward-looking statements it makes are based on reasonable assumptions, it can give no assurance that these expectations will be attained and it is possible that actual results may differ materially from those indicated by these forward-looking statements due to a variety of risks and uncertainties. Such risks and uncertainties include, but are not limited to:

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There can be no assurance that the separation, distribution or any other transaction described above will in fact be consummated in the manner described or at all. The above list of factors is not exhaustive or necessarily in order of importance. For additional information on identifying factors that may cause actual results to vary materially from those stated in forward-looking statements, see the discussions under “Risk Factors” in this information statement. Any forward-looking statement speaks only as of the date on which it is made, and each of BD and Newco assumes no obligation to update or revise such statement, whether as a result of new information, future events or otherwise, except as required by applicable law.

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THE SEPARATION AND DISTRIBUTION

Background

On May 6, 2021, BD announced that it intended to separate its diabetes care business into an independent public company. BD announced that it intended to effect the separation through a pro rata distribution to the BD shareholders of all of the common stock of a new entity formed to hold the assets and liabilities associated with the diabetes care business.

In connection with the distribution, it is expected that:

On                 , the BD Board of Directors approved the distribution of all of Newco’s issued and outstanding shares of common stock on the basis of                shares of Newco common stock for every share of BD common stock held as of the close of business on                , the record date for the distribution.

At 12:01 a.m., Eastern Time, on                , the distribution date, each BD shareholder will receive                shares of Newco common stock for every share of BD common stock held at the close of business on the record date for the distribution, as described below. BD shareholders will receive cash in lieu of any fractional shares of Newco common stock that they would have received after application of this ratio. Upon completion of the separation, each BD shareholder as of the record date will continue to own shares of BD and will receive a proportionate share of the outstanding common stock of Newco to be distributed. You will not be required to make any payment, surrender or exchange your BD common stock or take any other action to receive your shares of Newco common stock in the distribution. The distribution of Newco common stock as described in this information statement is subject to the satisfaction or waiver of certain conditions. For a more detailed description of these conditions, see “—Conditions to the Distribution.”

Reasons for the Separation

The BD Board of Directors believes that the separation of the diabetes care business from BD into an independent, publicly traded company is in the best interests of BD and its shareholders for a number of reasons, including:

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The BD Board of Directors also considered a number of potentially negative factors in evaluating the separation, including:

In determining to pursue the separation, the BD Board of Directors concluded the potential benefits of the separation outweighed the foregoing factors. See the section entitled “Risk Factors” included elsewhere in this information statement.

Formation of Newco

Newco was formed in Delaware on July 8, 2021 for the purpose of holding BD’s diabetes care business. As part of the plan to separate the diabetes care business from the remainder of BD’s businesses, in connection with the internal reorganization, BD plans to transfer the equity interests of certain entities and the assets and liabilities of the diabetes care business to Newco prior to the distribution.

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When and How You Will Receive the Distribution

With the assistance of Computershare, BD expects to distribute Newco common stock at 12:01 a.m., Eastern Time, on                , the distribution date, to all holders of outstanding BD common stock as of the close of business on                , 20 , the record date for the distribution. Computershare, which currently serves as the transfer agent and registrar for BD common stock, will serve as the settlement and distribution agent in connection with the distribution and the transfer agent and registrar for Newco common stock.

If you own BD common stock as of the close of business on the record date for the distribution, Newco common stock that you are entitled to receive in the distribution will be issued electronically, as of the distribution date, to you in direct registration form or to your bank or brokerage firm on your behalf. If you are a registered holder, Computershare will then mail you a direct registration account statement that reflects your shares of Newco common stock. If you hold your BD shares through a bank or brokerage firm, your bank or brokerage firm will credit your account for the Newco shares. Direct registration form refers to a method of recording share ownership when no physical share certificates are issued to shareholders, as is the case in this distribution. If you sell BD common stock in the “regular-way” market up to and including the distribution date, you will be selling your right to receive shares of Newco common stock in the distribution.

Commencing on or shortly after the distribution date, if you hold physical share certificates that represent your BD common stock and you are the registered holder of the shares represented by those certificates, the distribution agent will mail to you an account statement that indicates the number of shares of Newco common stock that have been registered in book-entry form in your name.

Most BD shareholders hold their common stock through a bank or brokerage firm. In such cases, the bank or brokerage firm is said to hold the shares in “street name” and ownership would be recorded on the bank or brokerage firm’s books. If you hold your BD common stock through a bank or brokerage firm, your bank or brokerage firm will credit your account for the Newco common stock that you are entitled to receive in the distribution. If you have any questions concerning the mechanics of having shares held in “street name,” please contact your bank or brokerage firm.

Transferability of Shares You Receive

Shares of Newco common stock distributed to holders in connection with the distribution will be transferable without registration under the Securities Act, except in certain cases for shares received by persons who may be deemed to be Newco’s affiliates. Persons who may be deemed to be Newco’s affiliates after the distribution generally include individuals or entities that control, are controlled by or are under common control with Newco, which may include certain of its executive officers or directors. Securities held by Newco’s affiliates will be subject to resale restrictions under the Securities Act. Newco’s affiliates will be permitted to sell shares of Newco common stock only pursuant to an effective registration statement or an exemption from the registration requirements of the Securities Act, such as the exemption afforded by Rule 144 under the Securities Act.

Number of Shares of Newco Common Stock You Will Receive

For every share of BD common stock that you own at the close of business on                , the record date for the distribution, you will receive                shares of Newco common stock on the distribution date. No fractional shares of Newco common stock will be distributed. Instead, if you are a registered holder, Computershare will aggregate fractional shares into whole shares, sell the whole shares in the open market at prevailing market prices and distribute the aggregate cash proceeds (net of discounts and commissions) of the sales pro rata (based on the fractional share such holder would otherwise be entitled to receive) to each holder who otherwise would have been entitled to receive a fractional share in the distribution. The distribution agent, in its sole discretion, without any influence by BD or Newco, will determine when, how, and through which broker-dealer and at what price to

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sell the whole shares. Any broker-dealer used by the distribution agent will not be an affiliate of either BD or Newco and the distribution agent is not an affiliate of either BD or Newco. Neither Newco nor BD will be able to guarantee any minimum sale price in connection with the sale of these shares. Recipients of cash in lieu of fractional shares will not be entitled to any interest on the amounts paid in lieu of fractional shares.

The net cash proceeds of these sales of fractional shares will be taxable for U.S. federal income tax purposes. See “Material U.S. Federal Income Tax Consequences” for an explanation of certain material U.S. federal income tax consequences of the distribution. If you hold physical certificates for shares of BD common stock and are the registered holder, you will receive a check from the distribution agent in an amount equal to your pro rata share of the net cash proceeds of the sales. Newco estimates that it will take approximately two weeks from the distribution date for the distribution agent to complete the distribution of the net cash proceeds. If you hold your shares of BD common stock through a bank or brokerage firm, your bank or brokerage firm will receive, on your behalf, your pro rata share of the net cash proceeds of the sales and will electronically credit your account for your share of such proceeds.

Treatment of Equity-Based Compensation

In connection with the separation, equity-based awards granted by BD that are outstanding immediately prior to the separation will be treated as follows:

Restricted Stock Units

Restricted Stock Units Held by Newco Employees and Non-Employee Directors. Each award of BD restricted stock units (including any performance-based restricted stock units) held by an individual who will be an employee or non-employee director of Newco following the separation will be converted into an award of restricted stock units with respect to Newco common stock. The number of shares subject to each such award will be adjusted in a manner intended to substantially preserve the aggregate value of the original BD award as measured immediately before and immediately after the separation. Such adjusted award will otherwise generally be subject to the same terms and conditions that applied to the original BD award immediately prior to the separation. The treatment of the performance goals applicable to performance-based awards held by Newco employees is under consideration and will be disclosed in an amendment to this information statement.

Restricted Stock Units Held by BD Employees and Non-Employee Directors. Each award of BD restricted stock units (including any performance-based restricted stock units) held by an individual who will be an employee or non-employee director of BD following the separation will continue to relate to BD common stock, provided that the number of shares subject to each such award will be adjusted in a manner intended to substantially preserve the aggregate value of the original BD award as measured immediately before and immediately after the separation. Such adjusted award will otherwise generally be subject to the same terms and conditions that applied to the original BD award immediately prior to the separation. The treatment of the performance goals applicable to performance-based awards held by BD employees is under consideration and will be disclosed in an amendment to this information statement.

Stock Options

Stock Options Held by Newco Employees. Each award of BD stock options held by an individual who will be an employee of Newco following the separation will be converted into an award of stock options with respect to Newco common stock. The exercise price of, and number of shares subject to, each such award will be adjusted in a manner intended substantially to preserve the aggregate intrinsic value of the original BD award as measured immediately before and immediately after the separation. Such adjusted award will otherwise generally be subject to the same terms and conditions that applied to the original BD award immediately prior to the separation.

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Stock Options Held by BD Employees and Former Employees. Each award of BD stock options held by an individual who will be an employee of BD following the separation, or who is a former employee of BD as of the separation, will continue to relate to BD common stock, provided that the exercise price of, and number of shares subject to, each such award will be adjusted in a manner intended to substantially preserve the aggregate intrinsic value of the original BD award as measured immediately before and immediately after the separation. Such adjusted award will otherwise generally be subject to the same terms and conditions that applied to the original BD award immediately prior to the separation.

Stock Appreciation Rights

Stock Appreciation Rights Held by Newco Employees. Each award of BD stock appreciation rights held by an individual who will be an employee of Newco following the separation will be converted into an award of stock appreciation rights with respect to Newco common stock. The exercise price of, and number of shares subject to, each such award will be adjusted in a manner intended substantially to preserve the aggregate intrinsic value of the original BD award as measured immediately before and immediately after the separation, subject to rounding. Such adjusted award will otherwise generally be subject to the same terms and conditions that applied to the original BD award immediately prior to the separation.

Stock Appreciation Rights Held by BD Employees and Former Employees. Each award of BD stock appreciation rights held by an individual who will be an employee of BD following the separation, or who is a former employee of BD as of the separation, will continue to relate to BD common stock, provided that the exercise price of, and number of shares subject to, each such award will be adjusted in a manner intended substantially to preserve the aggregate intrinsic value of the original BD award as measured immediately before and immediately after the separation, subject to rounding. Such adjusted award will otherwise generally be subject to the same terms and conditions that applied to the original BD award immediately prior to the separation.

Internal Reorganization

As part of the separation, and prior to the distribution, BD and its subsidiaries expect to complete an internal reorganization in order to transfer to Newco the diabetes care business. The internal reorganization is expected to include various restructuring transactions pursuant to which (1) the operations, assets and liabilities of BD and its subsidiaries used to conduct the diabetes care business will be separated from the operations, assets and liabilities of BD and its subsidiaries used to conduct the BD Business and (2) such diabetes care business operations, assets and liabilities will be contributed, transferred or otherwise allocated to Newco or one of its direct or indirect subsidiaries. These restructuring transactions may take the form of asset transfers, mergers, demergers, dividends, contributions and similar transactions, and may involve the formation of new subsidiaries in U.S. and non-U.S. jurisdictions to own and operate the diabetes care business or BD Business in such jurisdictions.

As part of this internal reorganization, BD will contribute to Newco certain liabilities and certain assets, including equity interests in entities that are expected to conduct the diabetes care business.

Following the completion of the internal reorganization and immediately prior to the distribution, Newco will be the parent company of the entities that are expected to conduct the diabetes care business, and BD will remain the parent company of the entities that are expected to conduct the BD Business.

Results of the Distribution

After the distribution, Newco will be an independent, publicly traded company. The actual number of shares to be distributed will be determined at the close of business on                , the record date for the distribution, and will reflect BD shares issued under BD equity compensation awards and BD share repurchases between the date

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on which the BD Board of Directors declares the distribution and the record date for the distribution. The distribution will not affect the number of outstanding shares of BD common stock or any rights of BD shareholders. No fractional shares of Newco common stock will be distributed.

Newco will enter into a separation and distribution agreement and other related agreements with BD to effect the separation and to provide a framework for its relationship with BD after the separation, and will enter into certain other agreements, including a transition services agreement, a tax matters agreement, an employee matters agreement, a cannula supply agreement, contract manufacturing agreements, an intellectual property matters agreement and other transaction agreements. See “Certain Relationships and Related Party Transactions.” These agreements will provide for the allocation between Newco and BD of the assets, employees, liabilities and obligations (including, among others, investments, property and employee benefits and tax-related assets and liabilities) of BD and its subsidiaries attributable to periods prior to, at and after Newco’s separation from BD and will govern the relationship between Newco and BD subsequent to the completion of the separation. For additional information regarding the separation and distribution agreement and other transaction agreements, see the sections entitled “Risk Factors—Risks Related to the Separation and Distribution” and “Certain Relationships and Related Party Transactions.”

Market for Newco Common Stock

There is currently no public trading market for Newco common stock. Newco intends to apply to list its common stock on                under the symbol “                .” Newco has not and will not set the initial price of its common stock. The initial price will be established by the public markets.

Newco cannot predict the price at which its common stock will trade after the distribution. In fact, the combined trading prices, after the distribution, of the shares of Newco common stock that each BD shareholder will receive in the distribution, together with the BD common stock held at the record date for the distribution, may not equal the “regular-way” trading price of the BD common stock immediately prior to the distribution. The price at which Newco common stock trades may fluctuate significantly, particularly until an orderly public market develops. Trading prices for Newco common stock will be determined in the public markets and may be influenced by many factors. See “Risk Factors—Risks Related to Newco Common Stock.”

Incurrence of Debt

Newco expects to complete one or more financing transactions on or prior to the completion of the distribution. Approximately $                 of the proceeds of such financings are expected to be used to distribute cash to BD. In addition, in partial consideration for the contribution of assets from BD to Newco, Newco will issue $                 of indebtedness to BD, which BD may use to retire outstanding BD indebtedness. As a result of such transactions, Newco anticipates having approximately $                 million of indebtedness upon completion of the distribution. On the distribution date, Newco anticipates that the debt will consist of                . For more information, see “Description of Material Indebtedness.”

Trading Between the Record Date and Distribution Date

Beginning on or shortly before the record date for the distribution and continuing up to and including through the distribution date, BD expects that there will be two markets in BD common stock: a “regular-way” market and an “ex-distribution” market. BD common stock that trades on the “regular-way” market will trade with an entitlement to Newco common stock distributed in the distribution. BD common stock that trades on the “ex-distribution” market will trade without an entitlement to Newco common stock distributed in the distribution. Therefore, if you sell shares of BD common stock in the “regular-way” market up to and including through the distribution date, you will be selling your right to receive shares of Newco common stock in the distribution. If you own BD common stock at the close of business on the record date and sell those shares on the “ex-distribution” market up to and including through the distribution date, you will receive the shares of Newco common stock that you are entitled to receive pursuant to your ownership of shares of BD common stock as of the record date.

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Furthermore, beginning on or shortly before the record date for the distribution and continuing up to and including the distribution date, Newco expects that there will be a “when-issued” market in its common stock. “When-issued” trading refers to a sale or purchase made conditionally because the security has been authorized but not yet issued. The “when-issued” trading market will be a market for Newco common stock that will be distributed to holders of BD common stock on the distribution date. If you owned BD common stock at the close of business on the record date for the distribution, you would be entitled to Newco common stock distributed pursuant to the distribution. You may trade this entitlement to shares of Newco common stock, without trading the BD common stock you own, on the “when-issued” market. On the first trading day following the distribution date, “when-issued” trading with respect to Newco common stock will end, and “regular-way” trading with respect to Newco common stock will begin.

Conditions to the Distribution

The distribution will be effective at 12:01 a.m., Eastern Time, on                , which is the distribution date, provided that the conditions set forth in the separation and distribution agreement have been satisfied (or waived by BD in its sole and absolute discretion), including, among others:

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BD will have the sole and absolute discretion to determine (and change) the terms of, and whether to proceed with, the distribution and, to the extent it determines to so proceed, to determine the record date for the distribution, the distribution date and the distribution ratio. BD will also have sole and absolute discretion to waive any of the conditions to the distribution. BD does not intend to notify its shareholders of any modifications to the terms of the separation or distribution that, in the judgment of its Board of Directors, are not material. For example, the BD Board of Directors might consider material such matters as significant changes to the distribution ratio and the assets to be contributed or the liabilities to be assumed in the separation. To the extent that the BD Board of Directors determines that any modifications by BD materially change the material terms of the distribution, BD will notify BD shareholders in a manner reasonably calculated to inform them about the modification as may be required by law, by, for example, publishing a press release, filing a current report on Form 8-K or circulating a supplement to this information statement.

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DIVIDEND POLICY

Newco has not yet determined whether it expects to pay a regular dividend after the separation and distribution. The timing, declaration, amount of and payment of any dividends following the separation and the distribution will be within the discretion of Newco’s Board of Directors and will depend upon many factors, including its financial condition, earnings, capital requirements of its operating subsidiaries, covenants associated with certain of its debt service obligations, legal requirements, regulatory constraints, industry practice, ability to access capital markets and other factors deemed relevant by Newco’s Board of Directors. Moreover, if Newco determines to pay any dividend in the future, there can be no assurance that Newco will continue to pay such dividends or the amount of such dividends.

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CAPITALIZATION

The following sets forth the capitalization of Newco as of September 30, 2021, on a historical and a pro forma basis, which reflects the adjustments described in more detail in the notes to the unaudited pro forma financial information included elsewhere in this information statement. You should read this information in conjunction with those notes, as well as “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the audited annual combined financial statements and the related notes included elsewhere in this information statement.

Newco has not yet finalized its post-distribution capitalization. Pro forma financial information reflecting the Diabetes Care Business (as defined in the historical combined financial statements included in this information statement) post-distribution capitalization will be included in an amendment to this information statement.

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SELECTED HISTORICAL COMBINED FINANCIAL DATA OF THE DIABETES CARE BUSINESS

References in this section to the “Diabetes Care Business” refer to the Diabetes Care Business as defined in the historical combined financial statements included in this information statement.

The following table presents the selected historical combined financial data for the Diabetes Care Business as of and for each of the fiscal years in the three-year period ended September 31, 2021. The selected combined statement of income data for the fiscal years ended September 30, 2021, 2020 and 2019, and the selected combined balance sheet data as of September 30, 2021 and 2020, was derived from the Diabetes Care Business’ audited combined financial statements, which are included in the “Index to Financial Statements” section of this information statement.

The historical results do not necessarily indicate the results expected for any future period. The selected historical combined financial data presented below should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the Diabetes Care Business’ audited combined financial statements and accompanying notes, which are included elsewhere in this information statement. Per share data has not been presented since Newco was wholly owned by BD during the periods presented.

Selected Combined Financial Data

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UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

References in this section to the “Diabetes Care Business” refer to the Diabetes Care Business as defined in the historical combined financial statements included in this information statement.

On                 , the BD Board of Directors approved the distribution of all of Newco’s issued and outstanding shares of common stock on the basis of                shares of Newco common stock for every share of BD common stock held as of the close of business on                , the record date for the distribution. The following unaudited pro forma condensed combined financial information of Newco gives effect to the separation and related adjustments in accordance with Article 11 of Regulation S-X under the Exchange Act.

The unaudited condensed combined pro forma balance sheet gives effect to the separation and related transactions described below as if they had occurred on September 30, 2021. The unaudited pro forma adjustments to the condensed combined statement of income for the year ended September 30, 2021 assume that the separation and related transactions occurred as of October 1, 2020.

The unaudited pro forma condensed combined statement of income for the year ended September 30, 2021 has been derived from the audited historical combined statement of income for the year ended September 30, 2021. The unaudited pro forma condensed combined balance sheet as of September 30, 2021 has been derived from the audited historical combined balance sheet as of September 30, 2021.

The unaudited pro forma condensed combined statement of income for the year ended September 30, 2021 and the unaudited pro forma condensed combined balance sheet as of September 30, 2021 have been prepared to reflect adjustments to the Diabetes Care Business’ historical combined financial information for transaction and autonomous entity adjustments.

Transaction accounting adjustments that reflect the effects of Newco’s legal separation from BD include the following adjustments:

Autonomous entity adjustments, which consist of incremental expense or other changes necessary to reflect the operations and financial position of Newco as an autonomous entity, include the following adjustments:

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The unaudited pro forma financial information is for informational purposes only and does not purport to represent what the Diabetes Care Business’ financial position and results of operations actually would have been had the separation and distribution occurred on the dates indicated, or to project the Diabetes Care Business’ financial performance for any future period. The audited annual combined financial statements of the Diabetes Care Business have been derived from BD’s historical accounting records and reflect certain allocation of expenses. All of the allocations and estimates in such financial statements are based on assumptions that BD’s management believes are reasonable. The historical combined financial statements of the Diabetes Care Business do not necessarily represent the financial position or results of operations of the Diabetes Care Business had it been a standalone company during the periods or at the dates presented. As a result, autonomous entity adjustments have been reflected in the pro forma condensed combined financial information.

The unaudited pro forma condensed combined financial information should be read in conjunction with the Diabetes Care Business’ historical combined financial information, “Capitalization” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this information statement. The unaudited pro forma condensed combined financial information constitutes forward-looking information and is subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. See “Cautionary Note Regarding Forward-Looking Statements” included elsewhere in this information statement.

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DIABETES CARE BUSINESS

UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF INCOME

See accompanying notes to unaudited condensed combined pro forma financial information.

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DIABETES CARE BUSINESS

UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET

See accompanying notes to unaudited condensed combined pro forma financial information.

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Notes to the Unaudited Pro Forma Condensed Combined Financial Information

Note 1: Transaction Accounting Adjustments

This note should be read in conjunction with other notes in the pro forma condensed combined financial information. Adjustments included in the column under the header “Transaction Accounting Adjustments” represent the following:

Note 2: Autonomous Entity Adjustments

This note should be read in conjunction with other notes in the pro forma combined financial statements. Adjustments included in the column under the header “Autonomous Entity Adjustments” represent the following:

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Newco expects to incur approximately $                million of expenses (including one-time expenses of approximately $                million expected to be incurred within 12 months following the completion of the

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separation), in addition to BD’s corporate and shared costs allocated in the historical combined financial statements. Accordingly, the pro forma condensed combined financial statements have been adjusted to depict Newco as an autonomous entity. The additional expenses have been estimated based on assumptions that Newco management believes are reasonable. However, actual additional costs that will be incurred could be different from the estimates and would depend on several factors, including the economic environment and strategic decisions made in areas such as separation, manufacturing, selling and marketing, research and development, information technology and infrastructure. Additionally, the separation and distribution agreement will provide for the allocation between BD and Newco of rights and obligations under existing insurance policies with respect to occurrences prior to the distribution and set forth procedures for the administration of insured claims and related matters.

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OUR BUSINESS

This section discusses Newco’s business assuming the completion of all of the transactions described in this information statement, including the separation. References to “we,” “us,” and “our” refer to the diabetes care business to be held by Newco and its subsidiaries.

Overview

We are a leading global medical device company focused on providing solutions to improve the health and wellbeing of people living with diabetes. Over the 95-year history of our business, we believe that our products have become one of the most widely recognized and respected brands in diabetes management in the world. We estimate that our products are used by nearly 30 million people in over 100 countries for insulin administration and to aid with the daily management of diabetes. Our business traces its origins to 1924, when BD developed the first dedicated insulin syringe. Since then, we have built a world-class organization with a unique manufacturing supply chain and commercial footprint, delivering over 7.5 billion units of diabetes injection devices globally in 2020. We generated revenues of $1,086 million and $1,109 million in 2020 and 2019, respectively.    

Diabetes is a serious chronic disease for which there is no known cure. According to the International Diabetes Federation (the “IDF”), approximately 463 million adults (aged 20-79) worldwide were living with diabetes in 2019, with the number projected to increase to 578 million adults by 2030. Diabetes can require complex, daily management or otherwise it can result in serious health conditions, including nerve damage, cardiovascular disease, acidosis, amputation, vision loss, kidney disease, seizure and death. The IDF estimates the annual global health expenditure for diabetes care was approximately $760 billion in 2019 and is expected to increase to $825 billion by 2030. Insulin therapy is the most common approach to diabetes management, and we estimate that approximately 90-120 million people require insulin therapy, and that 95% of those who are undergoing insulin therapy administer insulin through injection. Our products are primarily used to administer insulin, but they can also be used to administer other classes of injectable diabetes medications, such as GLP-1 agonists. Based on internal estimates, we believe the total addressable market for insulin administration devices is approximately $6 billion to $8 billion per year, based on the number of insulin-dependent individuals worldwide.

We have a broad portfolio of marketed products, including a variety of pen needles, syringes and safety devices, which are complemented by our proprietary digital applications designed to assist people with managing their diabetes. Our pen needles are sterile, single-use, medical devices, designed to be used in conjunction with insulin pens and are used to inject insulin or other diabetes medications. We also sell safety pen needles, which includes resin injection-molded shields on both ends of the cannula that automatically deploy to help prevent needlestick exposure and injury during injection and disposal. Our traditional and safety pen needles are compatible and frequently used with widely available pen injectors in the market today. In addition to pen needles, we sell sterile, single-use insulin syringes, which are used to inject insulin drawn from insulin vials. We also sell safety insulin syringes, which incorporates a manually activated sliding sleeve to help prevent needlestick exposure and injury during injection and disposal.

In addition to selling pen needles, syringes and safety devices, we seek to promote advances in diabetes care through thought leadership and engagement with the diabetes community, healthcare providers and other stakeholders. To foster connection with and offer support to people with diabetes, we launched our diabetes care app in 2018, which has been downloaded over 300,000 times. The app serves as a channel for our support, education of and engagement with the diabetes community. We are also proud sponsors of key scientific seminars seeking to improve the management of diabetes. For example, we founded and sponsor the Forum for Injection Technique & Therapy Expert Recommendations (FITTER), which is the latest in a series of scientific seminars focused on improving the management of diabetes. FITTER seeks to promote evidence-based clinical

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best practice, safety and self-care of diabetes injectable and infusion therapies for improved health outcomes, well-being, lower healthcare costs and reduced burden on care providers and the wider society.

We believe that the technology and know-how incorporated into our products distinguishes them in a meaningful way from other products in the market in the minds of our end-user customers and healthcare providers. We have a track record of delivering innovation in diabetes care informed by our deep understanding of the needs of people with diabetes. For example, we were instrumental in the development and global commercialization of the pen needle, which revolutionized insulin delivery and today is the primary mode of insulin delivery globally. As an independent diabetes-focused entity, our research and development programs will be geared toward both incremental improvements in our existing products as well as the development of new products, such as a potential insulin patch pump focused on serving the needs of people living with Type 2 diabetes.

Our global manufacturing, commercial team and distribution networks enable us to produce and distribute our products to end users and healthcare providers in over 100 countries. We have three manufacturing sites located in Ireland, the United States and China. We believe that these manufacturing sites enable us to efficiently and consistently produce high-quality, safe and reliable products. Upon the separation, we also expect to have over 600 employees focused on commercialization activities, including general management, sales, marketing, digital, market access & development and insights & analytics, over 50% of whom will be in emerging markets within Eastern Europe, the Middle East, Africa, Latin America, Central and Southeast Asia and Mainland China. We will distribute our products through a variety of channels, including retail, hospitals, pharmacies and other institutional channels. Our commercial team and distribution networks enable us to reach a broad base of customers across the globe.

Our Competitive Strengths

We believe the following strengths position us with long-term competitive advantages:

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Our Business Strategy

We intend to continue to grow our business by pursuing the following core strategies:

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Our Industry

Diabetes is a serious chronic condition for which there is no known cure. Diabetes is caused either when the pancreas produces insufficient insulin or when the body cannot efficiently use insulin. Insulin is a peptide hormone produced by the pancreas. Insulin enables glucose formed by the breakdown of carbohydrates in food to enter cells to provide energy and regulates the storage of excess glucose in the liver in the form of glycogen. In healthy individuals, insulin levels will vary throughout the day depending, on among other things, activity levels, sleep and meals. This normal modulation of insulin levels helps to manage glucose levels in the bloodstream. The interplay between cellular absorption of glucose for energy and storage and release of stored excess glucose keeps blood glucose levels within a well-regulated range in healthy individuals. A lack of insulin or a body’s insulin resistance causes a harmful dysregulation in blood glucose levels, known as hypo- (low) and hyper- (high) glycemia. Type 1 diabetes causes the body’s immune system to attack cells responsible for producing insulin, reducing or eliminating an individual’s ability to produce insulin. Type 2 diabetes is the most common form of diabetes (representing approximately 90% of cases) and is characterized by insulin resistance, or insufficient insulin production in the later stages of the disease. Left untreated or improperly managed, diabetes can lead to serious health problems, such as nerve damage, cardiovascular disease, acidosis, amputation, vision loss, kidney disease, seizure, and death.

According to the IDF, approximately 463 million adults (aged 20-79) worldwide were living with diabetes in 2019, including those who are not yet diagnosed, and the number is projected to increase to 578 million adults by 2030 and 700 million adults by 2045. The U.S. Centers for Disease Control and Prevention (the “CDC”) estimates that approximately 34 million adults in the United States have diabetes, either diagnosed or undiagnosed. The IDF estimates annual global health expenditures on diabetes management was approximately $760 billion in 2019, an increase of 4.5% in the aggregate from its 2017 estimate. The IDF anticipates the direct costs of diabetes will increase to $825 billion by 2030 and $845 billion by 2045. A 2020 study published in the Journal of the American Medical Association found that diabetes was the third highest healthcare expenditure in the United States, estimated at approximately $111 billion in 2016.

Individuals with Type 1 diabetes make little or no insulin and therefore all require daily insulin administration to control blood sugar levels. Individuals with Type 2 diabetes still make insulin and, depending on the status of their condition, may be able to control blood glucose levels with lifestyle changes (diet and exercise), oral medications, noninsulin injectable medications (such as glucagon-like peptide GLP-1 receptor agonists), insulin or a combination of these approaches, among others. While the initial care for Type 2 diabetes often does not include insulin therapy, Type 2 diabetes is progressive and people with Type 2 diabetes often eventually require insulin. According to the CDC, approximately 2.9 million adults aged 20 years or older—or 10.9% of all U.S. adults with diagnosed diabetes—start using insulin within a year of their initial diagnosis. Once an individual with Type 2 diabetes progresses to insulin therapy, they will typically use insulin for the remainder of their lifetime.

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Our products are used to administer diabetes medication. The primary medication administered with our products is insulin; however, our pen needles can also be used for the administration of other classes of injectable diabetes medications such as GLP-1 agonists. The two primary means to administer insulin are injection through pen needles or syringes, and continuous subcutaneous insulin infusion, administered through insulin pumps. We estimate that approximately 95% of people with diabetes undergoing insulin therapy use injection to administer insulin. Of the people with diabetes globally who instead use pumps, the IDF estimates that a majority are located in the United States or in Western Europe primarily due to the significantly higher price-point of infusion delivery. As a leading producer of diabetes medication injection devices, we produce products for the vast majority of people with diabetes who treat their disease through injection.

Based on internal estimates, we believe the total addressable market for insulin administration devices (including insulin injection and infusion) is approximately $6 billion to $8 billion per year, based on the number of insulin-dependent people with diabetes worldwide. Within the U.S. market, the CDC estimates there are 27.3 million people with diabetes, of which 7.3 million are undiagnosed, 1.8 million are diagnosed with Type 1 diabetes and 25.5 million are diagnosed with Type 2 diabetes. Of U.S. adults diagnosed with any type of diabetes, 14.1% treat their disease with insulin only, and 14.9% treat their disease with insulin combined with oral medication. The incidence of diabetes is expected to continue growing, with the Type 1 diabetes population in the United States growing at 1.9% per year, and the Type 2 diabetes population in the United States growing at 4.8% per year, according to the CDC.

Our Products

We develop and manufacture products, devices and systems that promote adherence for people primarily suffering from Type 1 diabetes and Type 2 diabetes who require injections of insulin or other diabetes

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medications to help control blood glucose variability. We primarily sell our products to wholesalers and distributors, which in turn sell these products to customers through retail and acute care hospitals, clinics and other institutional channels. We have a long history of driving innovation in products used to manage diabetes. In addition to seeking to provide a superior injection experience and increased safety, we strive to provide patients and healthcare providers with sound education and support across the diabetes care journey. Today, we are a leading provider of pen needles, syringes, safety devices and accessories, complemented by our proprietary digital applications. We estimate that our products are used by nearly 30 million people in over 100 countries for insulin administration and to aid with the daily management of diabetes.    Our brands of injection products are widely recognized and valued throughout the world for their ease of use, quality, availability and compatibility with widely used insulin pens. We break our operations into two geographies: (1) the United States and (2) International.

Our sales for each of our regions are as follows:

Conventional Pen Needles

Conventional pen needles are sterile, single-use, medical devices that are designed to be used in conjunction with third-party pen injectors to inject insulin and other diabetes medications. A pen needle is made up of a resin injection-molded hub with an integrated cannula.

BD Pen Needle & Shield		Insulin Pen

Since the introduction of the first insulin pen in 1985, insulin pens and pen needles have become the standard of care for insulin delivery. Of those undergoing insulin therapy, we estimate that 95% use injection therapy. We believe that our pen needles, which include BD’s cannula technology, are widely recognized for their industry-leading comfort and form factor, which allows for reduced pain during injection. Since the introduction of our first pen needle in 1991, our business has led the industry in driving ease of use and comfort through innovations such as shorter needle lengths, thinner needles, wider inner diameters, and contoured hubs.

In 2020, conventional pen needle sales accounted for $791 million, or approximately 73%, of our total sales, with approximately 48% of such sales generated outside of the United States.

Conventional Insulin Syringes

We produce insulin syringes that are used to inject insulin. These syringes, which include BD’s cannula technology, are sterile, single-use medical devices that are used to draw insulin from a glass medication vial for administration subcutaneously to an individual. Despite the growing popularity of insulin pens and pen needles,

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insulin syringes remain important administration tools for individual use and in certain settings such as hospitals and other professional care environments due largely to cost, reimbursement and familiarity.

A conventional insulin syringe consists of a graduated barrel, plunger rod, and a cannula/hub assembly. We also manufacture and offer a variety of insulin syringes with differential features and capabilities, including safety syringes that incorporate a manually activated sliding sleeve to help to reduce needlestick exposure and injury during injection and disposal.

In 2020, insulin syringe sales accounted for $165 million, or approximately 15%, of our total sales, with approximately 55% of such sales generated outside of the United States.

Safety Injection Devices

We manufacture safety pen needles and syringes that incorporate sophisticated features designed to minimize the risks of needle stick injury and also include BD’s cannula technology. We have long been an innovator in diabetes administration and our leadership in creating safety injection products is an example of such innovation. We believe that by creating safe, easy-to-use products designed to prevent needlestick injury, our products have a reputation among healthcare professionals and end-users for industry-leading safety and ease of use. We have long served as a pioneer and thought leader in the safety space, helping to provide education, guidance, and promote adherence in diabetes management for patients and healthcare providers around the world.

In 2020, safety injection device sales accounted for $110 million, or approximately 10%, of our total sales, with approximately 43% of such sales generated outside of the United States.

BD AutoShield Duo™ Safety Pen Needle		BD SafetyGlide™ Insulin Syringe

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Accessories

We sell a variety of accessories used by people with diabetes in conjunction with injection devices when administering insulin. These accessories include sharps disposal by mail containers used for the safe disposal of used injection devices via prepaid box, alcohol swabs for the sterilization of skin at the injection site, and our BD Safe Clip^TM system for needle clipping and storage. In 2020, accessory sales accounted for $20 million, or approximately 2%, of our total sales, with approximately 45% of such sales generated outside of the United States.

Research & Development

Over its 95-year history, we believe that our business has developed a reputation as an industry leader in innovative insulin delivery solutions. As an independent entity, we expect to continue this tradition of innovation by using our increased flexibility to invest capital to better address the evolving needs of people with diabetes. We have a robust organization to execute on our current and future product development projects, comprised of highly skilled employees whom collectively hold seven PhDs, Doctorate or MD degrees and 26 employees who hold additional advanced degrees. We expect our product development efforts to focus on three main areas: injection, digital diabetes management and infusion.

Injection

We expect to continue to invest in potential improvements in safe and reliable insulin delivery, improved comfort, ease of use and simplified injection management. We also are currently investing in the development of a next-gen passive dual-ended pen needle with differentiated feature sets and additional functionality. Our goal is to include features that would differentiate this potential product from others, including features that would allow for single handed injection, reduction of environmental waste and reduction of needle stick injury compared to conventional pen needles.

Digital Diabetes Management

We are currently investing in the development of a potential integrated diabetes management system that aims to provide people with beneficial tools and support for diabetes self-management, while providing security, privacy and data management through hosting solutions, tools and components for digital health products. Since its launch in 2018, our diabetes care app is currently available in nine countries and has over 10,000 active users. We believe that this app is a potential predecessor to a larger integrated diabetes management system, and see a potential opportunity to expand our digital offerings, including areas such as integration with continuous glucose monitoring systems, safe and secure data sharing, remote patient monitoring, dosing calculators and food analyzers, among others. As an independent entity, we may pursue investments in these and other digitally enabled diabetes management tools.

Infusion

We are investing in the potential development of a continuous subcutaneous insulin infusion delivery system to provide the benefits of insulin pump therapy to a broader population, in particular those with Type 2 diabetes. We believe there is a significant unmet need for alternative treatment options for people with Type 2 diabetes who currently administer insulin via injection yet remain unable to effectively control their diabetes. Some third-party research over the last 10 years has demonstrated improved outcomes of subcutaneous insulin infusion devices over conventional injection insulin therapy. For example, a 2017 article published in Diabetes Metabolism Research and Reviews highlighted insulin pump treatment as a more physiologic method to managing insulin therapy, attaining desired glucose levels and reducing the dose requirement of insulin for people with Type 2 diabetes.

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Although insulin pump therapy has the potential to improve glycemic control and quality of life in individuals with Type 2 diabetes, it is not widely used in this population due to the complexity, extensive training requirements, total daily dose limitations and reimbursement issues associated with current insulin pump devices. As a result, we estimate that globally approximately 1% of people with Type 2 diabetes use infusion via a pump to administer insulin. We are seeking to develop a potential insulin infusion pump that can be more easily used by people with Type 2 diabetes.

Clinical Evidence and Thought Leadership

For the millions of people with diabetes who inject insulin every day, correct injection technique is critical for optimal control of diabetes and insulin use safety. We strategically collaborate with leading nonprofit organizations, advocacy groups and foundations to identify and invest in programs and initiatives that address unmet healthcare needs to minimize the burdens and complications associated with diabetes. Our products are inspired and supported by the decades of research collaborations with healthcare providers and opinion leaders around the world, which have resulted in several clinical studies and peer-reviewed publications, ultimately informing the clinical practice guidelines around the world.

Highlights of these clinical practice guidelines and studies include the following:

Our Properties

We have three manufacturing facilities in Ireland, the United States and China. We believe that the size and location of these facilities allow us to serve a global customer base, reduce lead time and better control costs. Our Ireland manufacturing site, established in 1969, is the world’s largest manufacturer of pen needles, producing 4.6 billion pen needles and over 220 million safety pen needles in fiscal year 2020 in a 295,000 square-foot facility. The U.S. leased manufacturing site in Nebraska, established in 1966, is the world’s largest manufacturer of insulin syringes, producing over 2 billion syringes in fiscal year 2020 in a 395,000 square-foot facility. With over 50 years’ experience at each of these two large sites, we believe our technology and know-how are highly differentiated and distinguish our products in a meaningful way for end users and healthcare providers. In addition, our China manufacturing site, established in 2015, produced over 500 million pen needles in fiscal year 2020, primarily for use in China and adjacent regions in a 200,000 square-foot facility.

Sales and Marketing

We currently employ sales and marketing personnel for the direct sale and marketing of our products throughout the world with teams located around the globe, including North America, EMEA (which includes Europe, the Middle East and Africa), Greater Asia (which includes China, Japan and other countries within Asia

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Pacific) and Latin America. Our sales and marketing teams focus on healthcare providers and the people with diabetes whom they serve, with an emphasis on endocrinologists or diabetologists, general or primary care physicians, diabetes nurse educators and nurse practitioners across hospitals, clinics, long-term care facilities, and retail pharmacies. Our field-based efforts are complemented by our internal or contract inside sales teams present around the world.

Upon the separation, we expect to have over 600 employees worldwide focused on commercialization activities, including general management, sales, marketing, digital, market access & development and insights & analytics. We believe our commercialization capabilities will allow us to execute customer engagement strategies across preferred channels and aimed at healthcare providers, people with diabetes, and payors. We expect that our employees will build and maintain an integrated digital ecosystem, focus on omnichannel marketing experiences, and elevate portfolio-selling capabilities to coordinate engagement for our portfolio across all channels and geographies. Our branded engagement includes direct face-to-face selling, virtual engagement, digital marketing, social media, and our websites. In addition, we believe we have the knowledge, capabilities, and resources to achieve optimal local market access for our portfolio in a changing external environment.

Our sales and marketing efforts are diverse, with revenue generated across both hospital and retail pharmacy, and through both e-commerce and more conventional means. Within retail pharmacy, we have sales and marketing teams focused on larger national chains, local pharmacy chains and independent pharmacies as well as an online retail presence. Our sales efforts focus on self-payers and customers that benefit from reimbursement. Our distribution model varies across regions, but most frequently we distribute our products through retail pharmacies. As a result, select members of our regional sales teams are focused on managing relationships with key pharmacy customers. We also have distribution agreements with regional or national distributors (including wholesalers and medical suppliers) to ensure broad availability of our portfolio. In certain regions, we conduct business through government-related tenders, GPO contracts and business-to-business opportunities that our teams are structured to manage.

In the United States, our field-based sales representatives and inside sales team call on healthcare providers and retail pharmacies across all 50 states. We also have a dedicated sales team focused on safety products that call on major integrated delivery networks and long-term care facilities. Our retail account teams support the major national and regional retailers while our wholesale account teams focus on relationships with key distributors such as McKesson Corporation, Cardinal Health and AmerisourceBergen Drug Corporation. We also actively monitor formulary coverage, accessibility and affordability of our products on the health plans.

In EMEA, our regional commercial team partners with local country teams in select markets to ensure effective promotion of our products in approximately 70 countries where our products are sold and generally reimbursed. Country-specific business leaders and their respective sales and marketing teams are responsible for the day-to-day management of the local business and call on a range of prescribers, pharmacists, and hospital customers. We have dedicated sales representatives in select markets that focus on safety products and driving safety adoption in acute-care hospitals and other long-term care facilities. We rely upon distribution agreements in certain regions of the Middle East and Africa where we do not have a direct sales presence. We continue to seek opportunities for expansion through reimbursement in new markets and partnering with governmental authorities.

In Greater Asia, our products are sold across 19 countries through a variety of go-to-market models from direct to distributor-led markets. In countries where we have direct presence, country business leaders and their commercial teams call on healthcare providers and key retail pharmacies and work closely with our distribution partners to support the broader hospital / retail base. We rely on distribution partners in some of the emerging economies where we do not have a direct presence. Country teams are supported by a regional commercial team that provides omnichannel marketing expertise, insights & analytics, commercial excellence and market access support, while China has its own country commercial team to support sales execution. Expansion into new markets and omnichannel marketing activities, including direct-to-consumer engagement and e-commerce, are also aspects of the commercial model in Greater Asia.

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In Latin America, Newco has a variety of go-to-market models across 16 countries where our products are sold. In the countries where we have local operations, our business is typically generated through retail channels where our field-based representatives focus on marketing, selling and distributing our products across retail pharmacies and private hospitals across the region. The majority of our non-retail business is generated through annual or bi-annual tenders and contracts. In countries where we do not have local operations or a direct presence, we operate through distributors and other intermediaries who distribute our products to our end customers. Our teams in Latin America are also expanding into direct-to-consumer engagement and e-commerce.

As the number of people with diabetes continues to expand, we believe our scale, diverse in-market knowledge and world-class injection devices position us to continue growing our global franchises and provide high-quality products. As one of the largest pure-play diabetes companies in the world, our relationships span the continuum of stakeholders in the diabetes market, from partnerships with major insulin producers to deep recognition with prescribers, nurses, payors, and retailers that offer our products to our estimated 30 million users living around the world with diabetes.

Competition

The diabetes care industry is highly competitive, subject to rapid change and significantly affected by new product introductions and innovation. Although most people who use diabetes medications are on injection therapy, our products compete across a continuum of therapies and administration modalities designed to manage diabetes. We face competition and innovation from both new and existing companies pursuing new delivery devices, injection technologies, drugs, and therapeutics for the treatment of diabetes. For example, GLP-1s, sodium-glucose cotransporter SGLT-2 inhibitors and other novel diabetes therapies do not always require injections (or require fewer injections) using pen needles and insulin syringes and are prescribed to certain people with diabetes to help manage their disease. The impact of these therapies in most cases has been to defer insulin injection therapy for certain people with diabetes, although in many cases the diabetes will progress with time such that insulin injection therapy will ultimately be required.

We currently compete with other providers of diabetes drug injection devices. Companies with whom we currently compete in the diabetes drug injection business include Novo Nordisk, HTL-Strefa, Terumo Medical Corporation and Ypsomed. We also compete with providers of insulin pumps and other insulin administration devices. We compete in the marketplace based on a number of factors, including product quality and efficacy, price, service and reputation.

Intellectual Property

Intellectual property is a strategic priority for our business. We use a combination of patents, copyrights, trademarks, trade secrets, nondisclosure agreements and other measures to establish and protect our proprietary rights. In many cases, we own this intellectual property directly, but in other cases, we access technologies through a combination of license and supply arrangements.

Our pen needle and syringe products incorporate numerous technologies protected by patents and trade secrets, including pen needle and syringe designs directed toward safety, comfort and ease of use. Our products also incorporate important cannula technologies under our cannula supply arrangement with BD, including EasyFlow^™ Technology and PentaPoint^™ Comfort technology. Technologies relating to our Type 2 patch pump in development are similarly protected by patents and trade secrets. We also have patents directed toward software for systems and methods for managing diabetes and, in particular, to systems and methods that provide smart, connected, end-to-end solutions for delivering personalized insights to users based on decades of experience interacting with people with diabetes and caregivers. Our business also leverages technologies relating to our expertise in manufacturing processes, including molding, material handling, assembly, inspection and sterilization.

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Raw Materials and Components

We use a broad range of raw materials in the manufacture of our products. We purchase all our raw materials and certain components from third-party suppliers. The primary materials that comprise our pen needles and insulin syringes are cannula, plastic resin, adhesive, needle lubricants, rubber stoppers and packaging material. We purchase some of these and other materials from a single or limited number of sources for reasons for quality assurance, cost-effectiveness and other reasons. In connection with the separation and prior to the distribution, we will enter into a cannula supply agreement with BD, whereby BD will sell to us cannulas for incorporation into our pen needles and syringes for sale within the diabetes care sector, as described in greater detail in “Certain Relationships and Related Party Transactions—Cannula Supply Agreement.” After the separation, BD will retain ownership of all cannula production activities and all intellectual property rights of BD and its subsidiaries relating to cannula, the manufacture thereof and other critical cannula-related technology.

The design and formulation of certain of these materials and components is proprietary and the intellectual property rights may be owned exclusively by one party. In the case of sole sourced parts, we manage risk through holding inventory ourselves and at the supplier to ensure continuity of supply and low risk of disruption. We expect that, if necessary or appropriate, we will be able to enter into new arrangements with alternative suppliers. We work closely with all suppliers to ensure continuity of supply while maintaining high-quality and reliability, although no assurance can be given that these efforts will be successful. See “Description of Material Indebtedness” and “Risk Factors—Risks Related to Newco’s Business—Newco will obtain components and raw materials for its products from third parties, including BD.” These third parties may fail to perform under their agreements with Newco, or there may be a reduction or interruption in the manufacturing and supply of these components and raw materials. Any such failure to perform or a reduction or interruption in supply could have a material adverse effect on Newco’s business and operations.”

We have written agreements with a variety of suppliers that provide the resins, rubber stoppers, packaging, plungers, barrel rods, hubs and other components used in the manufacture of pen needles and our other products. We rely on sole suppliers for certain of these components, but, subject to pre-qualification of a new supplier as required by applicable law, we expect we would be able to engage another supplier in the event one of our existing supply agreements were terminated.

Regulatory Matters

We distribute our products around the world. Changes in legislation or government policies, including with respect to licensing, health information privacy and data privacy and healthcare costs and access, can have a material impact on our worldwide operations.

In particular, our operations are subject to, and affected by, regulations of medical devices promulgated by federal, state and local authorities in the United States, including the FDA, and other regulatory authorities with jurisdiction over our foreign operations. FDA regulations govern, among other things, product design and development, preclinical and clinical testing, pre-market clearance and approval, manufacturing, labeling, product storage, advertising and promotion, sales and distribution, post-market adverse event reporting, post-market surveillance, complaint handling, repair or recall of products and record keeping. Failure to comply with regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies, which may include warning letters that require corrective action, fines, injunctions, rescissions of previously granted approvals and other penalties.

We maintain a robust FDA Quality System Regulation and ISO Quality Systems that establish standards for our product design, manufacturing, and distribution processes, inclusive of Current Good Manufacturing Practices. The FDA and other regulatory agencies engage in periodic reviews and inspections of our quality systems, as well as product performance. As a medical device manufacturer and distributor, our manufacturing facilities and the facilities of our suppliers are subject to periodic inspection by the FDA, certain corresponding

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state agencies, and other regulatory bodies. Prior to marketing or selling most of our products, we must secure approval from the FDA and counterpart non-U.S. regulatory agencies. Following the introduction of a product, these agencies engage in periodic reviews and inspections of our quality systems, as well as product performance and advertising and promotional materials. These regulatory controls, as well as any changes in agency policies, can affect the time and cost associated with the development, introduction and continued availability of new and existing products. Where possible, we anticipate these factors in our product development and planning processes.

International sales of our products are subject to foreign government regulations, which may vary substantially from country to country. The time required to obtain approval by a foreign regulatory authority may be longer or shorter than that required for FDA approval, and the requirements may differ significantly, particularly outside of the European Union, Canada and other industrialized countries. In addition, other jurisdictions continue to update requirements for marketing and sale of products in their geography, often becoming more stringent. As we operate in other regions and continue to expand into emerging markets, new requirements may require updates to our quality management system. These global changes are monitored and reviewed as part of the overall quality lifecycle.

For further discussion of risks related to government regulations, see “Risk Factors” and “Legal Proceedings”.

Third-Party Agreements

We distribute a significant portion of our pen needles, syringes and other products through independent distributors. McKesson Corporation, Cardinal Health and AmerisourceBergen Drug Corporation, our three largest distributors, together represented approximately 39% of our worldwide sales in fiscal 2020. These distributors purchase our products on a purchase order basis under standard written agreements. Newco also makes direct sales to pharmacies and other organizations, which sales are generally done under standard terms and conditions negotiated by our sales representatives. Outside of the United States, sales are made either directly to end users or through distributors, depending on the region served.

Employees

We expect that upon the separation, we will have approximately 2,327 employees worldwide. Approximately 956 employees are employed in the United States. Only certain employees, all outside of the United States and representing approximately 27% of our headcount, are represented by various collective bargaining groups.

Our human resources organization is led by an experienced team that monitors our employee base and sets annual targets for managing our human capital, including employee retention, engagement and training targets. Newco will develop diversity and inclusion initiatives and will regularly review our strategies and programs for leadership development. We will establish benefit and incentive compensation plans, including comprehensive medical and life insurance coverage, 401(k) matching programs and other incentive compensation programs that we believe align employee incentives directly with our future performance.

Legal Proceedings

The diabetes care business is subject from time to time to claims and litigation arising in the ordinary course of business. These claims and litigation may include, among other things, allegations of violations of U.S. and foreign health regulation and privacy laws and related regulations, as well as claims or litigation relating to product liability, intellectual property, breach of contract and tort. The diabetes care business operates in multiple jurisdictions and, as a result, claims in one jurisdiction may lead to claims or regulatory penalties in other jurisdictions.

Subject to certain specified matters, Newco generally will assume liability for all pending, threatened and unasserted legal matters related to the diabetes care business and will indemnify BD for any liability to the extent arising out of or resulting from such liabilities.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

Certain Factors Affecting Forward-Looking Statements

The following discussion and analysis should be read in conjunction with the other sections of this information statement, including “Risk Factors,” “Cautionary Statement Concerning Forward-Looking Statements,” “Selected Historical Combined Financial Data of the Diabetes Care Business,” “Unaudited Pro Forma Condensed Combined Financial Information of the Diabetes Care Business” and the Diabetes Care Business’ historical combined financial information included elsewhere in this information statement. This discussion contains a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and other factors described throughout this information statement and particularly in the sections entitled “Risk Factors” and “Cautionary Statement Concerning Forward-Looking Statements.”

References in this section to the “Diabetes Care Business” refer to the Diabetes Care Business as defined in the historical combined financial statements included in this information statement.

All amounts discussed are in millions of U.S. dollars, unless otherwise indicated.

Company Overview

We are a leading global medical device company focused on providing solutions to improve the health and wellbeing of people living with diabetes. Over the 95-year history of our business, we believe that our products have become one of the most widely recognized and respected brands in diabetes management in the world. We estimate that our products are used by nearly 30 million people in over 100 countries for insulin administration and to aid with the daily management of diabetes. Our business traces its origins to 1924, when BD developed the first dedicated insulin syringe. Since then, we have built a world-class organization with a unique manufacturing supply chain and commercial footprint, delivering over 7.5 billion units of diabetes injection devices globally in 2020. We generated revenues of $1,086 million and $1,109 million in 2020 and 2019, respectively.

We have a broad portfolio of marketed products, including a variety of pen needles, syringes and safety devices, which are complemented by our proprietary digital applications designed to assist people with managing their diabetes. Our pen needles are sterile, single-use, medical devices, designed to be used in conjunction with insulin pens and are used to inject insulin or other diabetes medications. We also sell safety pen needles, which includes resin injection-molded shields on both ends of the cannula that automatically deploy to help prevent needlestick exposure and injury during injection and disposal. Our traditional and safety pen needles are compatible and frequently used with widely available pen injectors in the market today. In addition to pen needles, we sell sterile, single-use insulin syringes, which are used to inject insulin drawn from insulin vials. We also sell safety insulin syringes, which incorporate a manually activated sliding sleeve to help prevent needlestick exposure and injury during injection and disposal.

We primarily sell our products to wholesalers and distributors, which in turn sell such products to customers in primarily retail and institutional channels.

Separation from BD

In May 2021, BD announced its plan to separate its diabetes care business into an independent public company. The separation will occur through a distribution by BD of all of the outstanding shares of a newly formed company named Berra Newco, Inc., which will hold BD’s diabetes care business.

Completion of the distribution is subject to certain conditions which are described more fully under “The Separation and Distribution—Conditions to the Distribution,” including receipt of an opinion of BD’s outside counsel, satisfactory to the BD Board of Directors, regarding the qualification of the distribution, together with certain related transactions, as a “reorganization” within the meaning of Sections 355 and 368(a)(1)(D) of the Code.

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Basis of Presentation of Our Financial Information

The accompanying historical combined financial statements included in this information statement were derived from the consolidated financial statements and accounting records of BD. These combined financial statements reflect the combined historical results of operations, financial position and cash flows of BD’s diabetes care business as they were historically managed in conformity with U.S. generally accepted accounting principles (“GAAP”). Therefore, the historical combined financial information may not be indicative of our future performance and does not necessarily reflect what our combined results of operations, financial condition and cash flows would have been had the Diabetes Care Business operated as a separate, publicly traded company during the periods presented, particularly because of changes that we expect to experience in the future as a result of our separation from BD, including changes in the financing, cash management, operations, cost structure and personnel needs of our business.

The combined financial statements include certain assets and liabilities that have historically been held at the BD corporate level but are specifically identifiable or otherwise allocable to the diabetes care business. Cash has not been assigned to the diabetes care business for any of the periods presented because those cash balances are not directly attributable to the diabetes care business. BD uses a centralized approach to cash management and financing of its operations. These arrangements are not reflective of the manner in which the Diabetes Care Business would have financed its operations had it been a standalone company separate from BD during the periods presented. Cash pooling, related interest and intercompany arrangements are excluded from the asset and liability balances in the combined balance sheets. These amounts have instead been reported as Net parent investment as a component of Parent’s Equity.

Additionally, BD provides certain services, such as legal, accounting, information technology, human resources and other infrastructure support to the diabetes care business. The cost of these services has been allocated to the diabetes care business on the basis of the proportion of net sales, headcount, and other drivers. The Diabetes Care Business and BD consider these allocations to be a reasonable reflection of the benefits received by the diabetes care business. Actual costs that would have been incurred if the Diabetes Care Business had been a standalone company would depend on multiple factors, including organizational structure and strategic decisions made in various areas, including information technology and infrastructure.

Subsequent to the completion of the separation, we expect that Newco will incur expenditures consisting of employee-related costs, costs to start up certain standalone functions and information technology systems and other one-time transaction related costs. Recurring standalone costs include establishing the internal audit, treasury, investor relations, tax and corporate secretary functions as well as the annual expenses associated with running an independent publicly traded company, including listing fees, compensation of non-employee directors, related board of director fees and other fees and expenses related to insurance, legal and external audit.

Percentages presented are calculated from the underlying amounts. References to years throughout this discussion relate to our fiscal years, which end on September 30.

Relationship with BD

Following the distribution, certain functions that BD provided to the diabetes care business prior to the distribution will either continue to be provided to Newco by BD under a transition services agreement or will be performed using Newco’s own resources or third-party service providers. Additionally, under manufacturing and supply agreements, BD will manufacture certain products for Newco and its subsidiaries following the distribution.

Concurrent with the distribution, we will enter into certain agreements with BD. See “Certain Relationships and Related Party Transactions—Agreements with BD.”

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Key Trends Affecting Our Results of Operations

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COVID-19 Pandemic Impacts and Response

A novel strain of coronavirus disease (“COVID-19”) was officially declared a pandemic by the World Health Organization in March 2020 and governments around the world have been implementing various measures to slow and control the spread of COVID-19. These government measures have led to a shift in healthcare priorities and disruptions of economic activities worldwide, which unfavorably affected the demand for our products. Disruptions resulting from the ongoing COVID-19 pandemic unfavorably impacted our revenues in 2020 to some extent, as is further discussed below. Due to the significant uncertainty with respect to the duration and overall impact of the COVID-19 pandemic, our future operating performance may be subject to volatility. The impacts of the COVID-19 pandemic on our business, results of operations, financial condition and cash flows is dependent on certain factors including: