Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

OVERVIEW

The following discussion is intended to further the reader’s understanding of the consolidated financial condition and results of operations of our Company. It should be read in conjunction with our condensed consolidated financial statements and accompanying notes elsewhere in this Quarterly Report on Form 10-Q (“Form 10-Q”) as well as Management’s Discussion and Analysis of Financial Condition and Results of Operations and the consolidated financial statements and accompanying notes included in our 2024 Annual Report. Our historical financial statements may not be indicative of our future performance. This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and risks discussed in Part I, Item 1A of our 2024 Annual Report and in Part II, Item 1A of this Form 10-Q.

Throughout this section, references to “Notes” refer to the notes to our condensed consolidated financial statements (unaudited) in Part I, Item 1 of this Form 10-Q, unless otherwise indicated.

Non-U.S. GAAP Financial Measures

For the purpose of aiding the comparison of our year-over-year results, we may refer to net sales and other financial results excluding the effects of changes in foreign currency exchange rates. Organic net sales exclude the impact from acquisitions and/or divestitures and translate the current-period reported sales of subsidiaries whose functional currency is other than USD at the applicable foreign exchange rates in effect during the comparable prior-year period. We may also refer to adjusted consolidated operating profit and adjusted consolidated operating profit margin, which exclude the effects of unallocated items. The unallocated items are not representative of ongoing operations, and generally include restructuring and related charges, certain asset impairments, and other specifically-identified income or expense items. The re-measured results excluding effects from currency translation, the impact from acquisitions and/or divestitures, and excluding the effects of unallocated items are not in conformity with U.S. GAAP and should not be used as a substitute for the comparable U.S. GAAP financial measures. The non-U.S. GAAP financial measures are incorporated in our discussion and analysis as management uses them in evaluating our results of operations and believes that this information provides users with a valuable insight into our overall performance and financial position.

Our Operations

We are a leading global manufacturer in the design and production of technologically advanced, high-quality, integrated containment and delivery systems for injectable drugs and healthcare products. Our products include a variety of primary proprietary packaging, containment solutions, reconstitution and transfer systems, and drug delivery systems, as well as contract manufacturing, analytical lab services and integrated solutions. Our customers include leading biologic, generic, pharmaceutical, diagnostic, and medical device companies around the world. Our top priority is delivering quality products that meet the exact product specifications and quality standards customers require and expect. This focus on quality includes a commitment to excellence in manufacturing, scientific and technical expertise and management, which enables us to partner with our customers in order to deliver safe, effective drug products to patients quickly and efficiently.

Our business operations are organized into two global segments, Proprietary Products and Contract-Manufactured Products. Our Proprietary Products reportable segment offers proprietary packaging, containment solutions and drug delivery systems, along with analytical lab services and other integrated services and solutions, primarily to biologic, generic and pharmaceutical drug customers. Our Contract-Manufactured Products reportable segment serves as a fully integrated business, focused on the design, manufacture, and automated assembly of complex devices, primarily for pharmaceutical, diagnostic, and medical device customers. We also maintain collaborations to share technologies and market products with affiliates in Japan and Mexico.

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Macroeconomic Factors

In recent months, the U.S. government has imposed additional tariffs and trade restrictions on certain goods produced outside of the United States. In response to these actions, certain jurisdictions, including China, Mexico, Canada and the European Union, have imposed or are considering imposing tariffs and restrictions on certain goods produced in the United States. We continue to monitor this dynamic situation to assess the impact of these tariffs on our business and actions we can take to minimize their impact. Based on the information available at this time, we do not believe the impact will be material to our 2025 results.

We have operations based in Israel that conduct research and development activities and manufacture certain components for our devices. Our Israel-based facilities continue to substantially operate as they had prior to the conflict in Israel and surrounding area. We continue to monitor the impact of the conflict in Israel and surrounding areas on our operations and those of our suppliers, the possible expansion of such conflict and potential geopolitical consequences, if any, on our business and operations.

Financial Performance Summary

The following tables present a reconciliation from U.S. GAAP to non-U.S. GAAP financial measures for the three and six months ended June 30, 2025:

($ in millions, except per share data)Operating ProfitIncome tax expenseNet incomeDiluted EPS
Three months ended June 30, 2025 U.S. GAAP$153.7$30.2$131.8$1.82
Unallocated items:
Restructuring and other charges (1)1.60.41.20.02
Amortization of acquisition-related intangible assets (2)——0.5—
Three months ended June 30, 2025 adjusted amounts (non-U.S. GAAP)$155.3$30.6$133.5$1.84
($ in millions, except per share data)Operating profitIncome tax expenseNet incomeDiluted EPS
Six months ended June 30, 2025 U.S. GAAP$260.7$54.3$221.6$3.05
Unallocated items:
Restructuring and other charges (1)19.42.417.00.23
Amortization of acquisition-related intangible assets (2)0.2—1.10.01
Six months ended June 30, 2025 adjusted amounts (non-U.S. GAAP)$280.3$56.7$239.7$3.29

During the three and six months ended June 30, 2025, we recorded a tax benefit of $1.2 million and $2.9 million respectively, associated with stock-based compensation.

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The following tables present a reconciliation from U.S. GAAP to non-U.S. GAAP financial measures for the three and six months ended June 30, 2024:

($ in millions, except per share data)Operating ProfitIncome tax expenseNet incomeDiluted EPS
Three months ended June 30, 2024 U.S. GAAP$126.2$21.9$111.3$1.51
Unallocated items:
Amortization of acquisition-related intangible assets (2)0.2—0.70.01
Three months ended June 30, 2024 adjusted amounts (non-U.S. GAAP)$126.4$21.9$112.0$1.52
($ in millions, except per share data)Operating ProfitIncome tax expenseNet incomeDiluted EPS
Six months ended June 30, 2024 U.S. GAAP$249.0$38.3$226.6$3.06
Unallocated items:
Amortization of acquisition-related intangible assets (2)0.4—1.40.02
Six months ended June 30, 2024 adjusted amounts (non-U.S. GAAP)$249.4$38.3$228.0$3.08

During the three and six months ended June 30, 2024, we recorded a tax benefit of $5.7 million and $16.6 million, respectively, associated with stock-based compensation.

(1)During the three and six months ended June 30, 2025, the Company recorded charges of $1.6 million and $19.4 million, respectively, related to restructuring programs. During the three and six months ended June 30, 2025, the Company recorded $0.2 million and $16.6 million, respectively, of the charges within other expense (income), related to severance and acceleration of depreciation and lease costs in connection with the Company's 2025 restructuring plan. The Company recorded the remaining $1.4 million and $2.8 million, respectively, within selling, general and administrative expenses, related to our plan to optimize the legal structure of the Company and its subsidiaries.

(2)During the six months ended June 30, 2025, the Company recorded $0.2 million of amortization expense within operating profit associated with an intangible asset acquired during the second quarter of 2020. During the three and six months ended June 30, 2025, the Company recorded $0.5 million and $0.9 million, respectively, of amortization expense in association with an acquisition of increased ownership interest in Daikyo. During the three and six months ended June 30, 2024, the Company recorded $0.2 million and $0.4 million, respectively, of amortization expense within operating profit associated with an intangible asset acquired during the second quarter of 2020. During the three and six months ended June 30, 2024, the Company recorded $0.5 million and $1.0 million, respectively, of amortization expense in association with an acquisition of increased ownership interest in Daikyo.

RESULTS OF OPERATIONS

We evaluate the performance of our segments based upon, among other things, segment net sales and operating profit. Segment operating profit excludes general corporate costs, which include executive and director compensation, stock-based compensation, certain pension and other retirement benefit costs, and other corporate facilities and administrative expenses not allocated to the segments. Also excluded are items that we consider not representative of ongoing operations. Such items are referred to as other unallocated items for which further information can be found above in the reconciliation from U.S. GAAP to non-U.S. GAAP financial measures.

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Percentages in the following tables and throughout the Results of Operations section may reflect rounding adjustments.

Net Sales

The following table presents net sales, consolidated and by reportable segment, for the three months ended June 30, 2025 and 2024:

Three Months Ended June 30,Percentage Change
($ in millions)20252024As-ReportedOrganic
Proprietary Products$619.8$559.710.7%8.4%
Contract-Manufactured Products146.7142.43.0%0.5%
Consolidated net sales$766.5$702.19.2%6.8%

Consolidated net sales increased by $64.4 million, or 9.2%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $16.5 million. Excluding foreign currency translation effects, consolidated net sales for the three months ended June 30, 2025 increased by $47.9 million, or 6.8%, as compared to the same period in 2024.

Proprietary Products – Proprietary Products net sales increased by $60.1 million, or 10.7%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $12.9 million. Excluding foreign currency translation effects, net sales for the three months ended June 30, 2025 increased by $47.2 million, or 8.4%, as compared to the same period in 2024, due primarily to an increase in sales of Westar® products, NovaChoice® products and Daikyo CZ®, partially offset by a decline in sales of FluroTec® products.

Contract-Manufactured Products – Contract-Manufactured Products net sales increased by $4.3 million, or 3.0%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $3.6 million. Excluding foreign currency translation effects, net sales for the three months ended June 30, 2025 increased by $0.7 million, or 0.5%, as compared to the same period in 2024, due primarily to an increase in sales of self-injection devices for obesity and diabetes, partially offset by a decrease in sales of healthcare diagnostic devices.

The following table presents net sales, consolidated and by reportable segment, for the six months ended June 30, 2025 and 2024:

Six Months Ended June 30,Percentage Change
($ in millions)20252024As-ReportedOrganic
Proprietary Products$1,182.8$1,119.25.7%5.4%
Contract-Manufactured Products281.7278.31.2%0.6%
Consolidated net sales$1,464.5$1,397.54.8%4.5%

Consolidated net sales increased by $67.0 million, or 4.8%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $4.8 million . Excluding foreign currency translation effects, consolidated net sales for the six months ended June 30, 2025 increased by $62.2 million, or 4.5%, as compared to the same period in 2024.

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Proprietary Products – Proprietary Products net sales increased by $63.6 million, or 5.7%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $3.1 million. Excluding foreign currency translation effects, net sales for the six months ended June 30, 2025 increased by $60.5 million, or 5.4%, as compared to the same period in 2024, due primarily to an increase in sales of self-injection device platforms and Westar® products, partially offset by a decline in sales of FluroTec® products.

Contract-Manufactured Products – Contract-Manufactured Products net sales increased by $3.4 million, or 1.2%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $1.7 million. Excluding foreign currency translation effects, net sales for the six months ended June 30, 2025 increased by $1.7 million, or 0.6%, as compared to the same period in 2024, due primarily to an increase in sales of self-injection devices for obesity and diabetes, partially offset by a decrease in sales of healthcare diagnostic devices.

Gross Profit

The following table presents gross profit and related gross profit margins, consolidated and by reportable segment:

Three Months Ended June 30,Six Months Ended June 30,
($ in millions)2025202420252024
Proprietary Products:
Gross profit$248.3$207.0$458.5$414.1
Gross profit margin40.1%37.0%38.8%37.0%
Contract-Manufactured Products:
Gross profit$25.6$23.0$47.3$46.1
Gross profit margin17.5%16.2%16.8%16.6%
Consolidated gross profit$273.9$230.0$505.8$460.2
Consolidated gross profit margin35.7%32.8%34.5%32.9%

Consolidated gross profit increased by $43.9 million, or 19.1%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $6.8 million for the three months ended June 30, 2025, as compared to the same period in 2024. Consolidated gross profit margin increased by 2.9 margin points for the three months ended June 30, 2025, as compared to the same period in 2024.

Consolidated gross profit increased by $45.6 million, or 9.9%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $3.2 million for the six months ended June 30, 2025, as compared to the same period in 2024. Consolidated gross profit margin increased by 1.6 margin points for the six months ended June 30, 2025, as compared to the same period in 2024.

Proprietary Products - Proprietary Products gross profit increased by $41.3 million, or 20.0%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $6.2 million. Proprietary Products gross profit margin increased by 3.1 margin points for the three months ended June 30, 2025, as compared to the same periods in 2024, due primarily to higher plant absorption from increased customer demand and sales price increases.

Proprietary Products gross profit increased by $44.4 million, or 10.7%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $3.0 million. Proprietary Products gross profit margin increased by 1.8 margin points for the six months ended June 30, 2025, as compared to the same periods in 2024, due primarily to higher plant absorption from increased customer demand and sales price increases.

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Contract-Manufactured Products - Contract-Manufactured Products gross profit increased by $2.6 million, or 11.3%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $0.6 million. Contract-Manufactured Products gross profit margin increased by 1.3 margin points for the three months ended June 30, 2025, as compared to the same period in 2024, due primarily to sales price increases and product mix.

Contract-Manufactured Products gross profit increased by $1.2 million, or 2.6%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $0.2 million. Contract-Manufactured Products gross profit margin increased by 0.2 margin points for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to sales price increases and product mix.

Research and Development (“R&D”) Costs

The following table presents consolidated R&D costs:

Three Months Ended June 30,Six Months Ended June 30,
($ in millions)2025202420252024
Consolidated R&D costs$19.1$17.5$35.4$35.1

Consolidated R&D costs increased by $1.6 million, or 9.1%, and $0.3 million, or 0.9% for the three and six months ended June 30, 2025, respectively, as compared to the same period in 2024. Efforts remain focused on the continued investment in elastomeric packaging components, formulation development, drug containment systems, self-injection systems and drug administration consumable.

All of the R&D costs incurred in the three and six months ended June 30, 2025 and 2024 related to Proprietary Products.

Selling, General and Administrative (“SG&A”) Costs

The following table presents SG&A costs, consolidated and by reportable segment and corporate and unallocated items:

Three Months Ended June 30,Six Months Ended June 30,
($ in millions)2025202420252024
Proprietary Products$61.5$56.1$121.8$116.8
Contract-Manufactured Products7.06.214.612.4
Corporate and unallocated items27.420.747.540.5
Consolidated SG&A costs$95.9$83.0$183.9$169.7
SG&A as a % of net sales12.5%11.8%12.6%12.1%

Consolidated SG&A costs increased by $12.9 million, or 15.5%, for the three months ended June 30, 2025, as compared to the same period in 2024, including an unfavorable foreign currency translation impact of $0.9 million, due primarily to higher annual incentive compensation, increased expense related to stock-based compensation and increased salary and wages.

Consolidated SG&A costs increased by $14.2 million, or 8.4%, for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to increased salary and wages and higher annual incentive compensation, partially offset by decreased costs related to professional services.

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Proprietary Products - Proprietary Products SG&A costs increased by $5.4 million, or 9.6%, for the three months ended June 30, 2025, as compared to the same period in 2024, including an unfavorable foreign currency translation impact of $0.8 million. Proprietary Products SG&A costs increased due primarily to higher annual incentive compensation and increased salary and wages, partially offset by decreased costs related to professional services.

Proprietary Products SG&A costs increased by $5.0 million, or 4.3%, for the six months ended June 30, 2025, as compared to the same period in 2024. Proprietary Products SG&A costs increased due primarily to increased salary and wages and higher annual incentive compensation, partially offset by decreased costs related to professional services.

Contract-Manufactured Products - Contract-Manufactured Products SG&A costs increased by $0.8 million, or 12.9%, for the three months ended June 30, 2025, as compared to the same period in 2024, including an unfavorable foreign currency translation impact of $0.1 million, due primarily to increased salary and wages and higher annual incentive compensation.

Contract-Manufactured Products SG&A costs increased by $2.2 million, or 17.7%, for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to increased salary and wages.

Corporate and unallocated items - Corporate SG&A costs increased by $6.7 million, or 32.4%, for the three months ended June 30, 2025, as compared to the same period in 2024, due primarily to increase in expense related to stock-based compensation, higher annual incentive compensation and increased costs related to professional services.

Corporate SG&A costs increased by $7.0 million, or 17.3%, for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to expenses in connection with a plan to optimize the legal structure of the Company and its subsidiaries, higher annual incentive compensation and increased costs related to professional services.

Other Expense (Income)

The following table presents other income and expense items, consolidated and by reportable segment, corporate and unallocated items:

Expense (Income)Three Months Ended June 30,Six Months Ended June 30,
($ in millions)2025202420252024
Proprietary Products$6.0$2.4$9.0$4.9
Contract-Manufactured Products0.8(0.4)1.4(0.6)
Corporate and unallocated(1.6)1.315.42.1
Consolidated other expense (income)$5.2$3.3$25.8$6.4

Other expense and income items consist of restructuring and related charges, foreign exchange transaction gains and losses, contingent consideration, asset impairments and miscellaneous income and charges.

Consolidated other expense (income) changed by $1.9 million for the three months ended June 30, 2025, as compared to the same period in 2024, and changed by $19.4 million for the six months ended June 30, 2025, as compared to the same period in 2024, due to the factors described below.

Proprietary Products - Proprietary Products other expense (income) changed by $3.6 million for the three months ended June 30, 2025, as compared to the same period in 2024, due primarily to increased contingent consideration expense being recorded in the three months ended June 30, 2025, as compared to the same period in 2024.

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Proprietary Products other expense (income) changed by $4.1 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to increased contingent consideration expense being recorded in the six months ended June 30, 2025, as compared to the same period in 2024.

Contract-Manufa****ctured Products - Contract-Manufactured Products other expense (income) changed by $1.2 million for the three months ended June 30, 2025, as compared to the same period in 2024, due primarily to increased foreign exchange losses in the three months ended June 30, 2025, as compared to the same period in 2024.

Contract-Manufactured Products other expense (income) changed by $2.0 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to increased foreign exchange losses in the six months ended June 30, 2025, as compared to the same period in 2024.

Corporate and unallocated items - Corporate and unallocated items changed by $2.9 million for the three months ended June 30, 2025, as compared to the same period in 2024, due primarily to gains on foreign exchange being recorded in the three months ended June 30, 2025, as compared to losses on foreign exchange being recorded in the same period in 2024. This was partially offset by the Company recording restructuring and other charges of $0.2 million in the three months ended June 30, 2025 that did not occur in the same period in 2024.

Corporate and unallocated items changed by $13.3 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to the Company recording restructuring and other charges of $16.6 million in the six months ended June 30, 2025 that did not occur in the same period in 2024.

Operating Profit

The following table presents adjusted operating profit, consolidated and by reportable segment, corporate and unallocated items:

Three Months Ended June 30,Six Months Ended June 30,
($ in millions)2025202420252024
Proprietary Products$161.7$131.0$292.3$257.3
Contract-Manufactured Products17.817.231.334.3
Corporate and unallocated items(25.8)(22.0)(62.9)(42.6)
Consolidated operating profit$153.7$126.2$260.7$249.0
Consolidated operating profit margin20.1%18.0%17.8%17.8%
Unallocated items1.60.219.60.4
Adjusted consolidated operating profit$155.3$126.4$280.3$249.4
Adjusted consolidated operating profit margin20.3%18.0%19.1%17.8%

Consolidated operating profit increased by $27.5 million, or 21.8%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $6.0 million for the three months ended June 30, 2025, as compared to the same period in 2024.

Consolidated operating profit increased by $11.7 million, or 4.7%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $3.3 million for the six months ended June 30, 2025, as compared to the same period in 2024.

Proprietary Products - Proprietary Products operating profit increased by $30.7 million, or 23.4%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $5.5 million, due to the factors described above, most notably higher plant absorption from increased customer demand and sales price increases.

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Proprietary Products operating profit increased by $35.0 million, or 13.6%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $3.1 million, due to the factors described above, most notably higher plant absorption from increased customer demand and sales price increases.

Contract-Manufactured Products - Contract-Manufactured Products operating profit increased by $0.6 million, or 3.5%, for the three months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $0.5 million, due to the factors described above, most notably sales price increases.

Contract-Manufactured Products operating profit decreased by $3.0 million, or 8.7%, for the six months ended June 30, 2025, as compared to the same period in 2024, including a favorable foreign currency translation impact of $0.2 million, due to the factors described above, most notably increased salary and wage expense.

Corporate and unallocated - Excluding the unallocated items, Corporate costs increased by $2.4 million, or 11.0%, for the three months ended June 30, 2025, as compared to the same period in 2024, due to the factors described above, most notably the increase in expense related to stock-based compensation.

Excluding the unallocated items, Corporate costs increased by $1.1 million, or 2.6%, for the six months ended June 30, 2025, as compared to the same period in 2024, due to the factors described above, most notably the higher annual incentive compensation and increased costs related to professional services.

For unallocated items, please refer to the Financial Performance Summary section above for details.

Interest Expense, Net and Interest Income

The following table presents interest expense, net, by significant component:

Three Months Ended June 30,Six Months Ended June 30,
($ in millions)2025202420252024
Interest expense$4.1$3.6$8.3$7.2
Capitalized interest(4.0)(2.1)(7.8)(4.1)
Interest expense, net$0.1$1.5$0.5$3.1
Interest income$(3.6)$(4.0)$(7.7)$(10.2)

Interest expense, net, decreased by $1.4 million, for the three months ended June 30, 2025, as compared to the same period in 2024, and decreased by $2.6 million, for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to an increase in capitalized interest, offset by an increase in interest expense driven by an increase in the Company's Term Loan balance.

Interest income decreased by $0.4 million for the three months ended June 30, 2025, as compared to the same period in 2024, and decreased by $2.5 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to the Company having a lower average cash balance during 2025 and a decline in interest rates in 2025, as compared to the same periods in 2024.

Other Nonoperating Expense (Income)

Other nonoperating expense (income) was $0.2 million and $0.0 million for the three months ended June 30, 2025 and 2024, respectively, and $0.4 million and $0.0 million for the six months ended June 30, 2025 and 2024, respectively.

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Income Tax Expense

The provision for income taxes was $30.2 million and $21.9 million for the three months ended June 30, 2025 and 2024, respectively, and the effective tax rate was 19.2% and 17.0%, respectively. The increase in the effective tax rate is due primarily to a decrease in the tax benefit related to stock-based compensation in the three months ended June 30, 2025 as compared to the same period in 2024.

The provision for income taxes was $54.3 million and $38.3 million for the six months ended June 30, 2025 and 2024, respectively, and the effective tax rate was 20.3% and 15.0%, respectively. The increase in the effective tax rate is due primarily to a decrease in the tax benefit related to stock-based compensation in the six months ended June 30, 2025 as compared to the same period in 2024.

Equity in Net Income of Affiliated Companies

Equity in net income of affiliated companies was $5.0 million and $4.5 million for the three months ended June 30, 2025 and 2024, respectively. Equity in net income of affiliated companies increased by $0.5 million for the three months ended June 30, 2025, as compared to the same period in 2024, due primarily to more favorable operating results at the Mexico affiliates, partially offset by less favorable operating results at Daikyo.

Equity in net income of affiliated companies was $8.4 million and $8.8 million for the six months ended June 30, 2025 and 2024, respectively. Equity in net income of affiliated companies decreased by $0.4 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to less favorable operating results at Daikyo, partially offset by more favorable operating results at the Mexico affiliates.

FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES

Cash Flows

The following table presents cash flow data for the six months ended June 30:

($ in millions)20252024
Net cash provided by operating activities$306.5$283.2
Net cash used in investing activities$(146.5)$(191.8)
Net cash used in financing activities$(161.9)$(489.3)

Net Cash Provided by Operating Activities – Net cash provided by operating activities increased by $23.3 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to favorable working capital management.

Net Cash Used in Investing Activities – Net cash used in investing activities decreased by $45.3 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to a decrease in capital expenditures.

Net Cash Used in Financing Activities – Net cash used in financing activities decreased by $327.4 million for the six months ended June 30, 2025, as compared to the same period in 2024, due primarily to a decrease in purchases under our share repurchase programs.

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Liquidity and Capital Resources

The table below presents selected liquidity and capital measures:

($ in millions)June 30, 2025December 31, 2024
Cash and cash equivalents$509.7$484.6
Accounts receivable, net$582.4$552.5
Inventories$421.1$377.0
Accounts payable$239.0$239.3
Debt$202.6$202.6
Equity$2,929.1$2,682.3
Working capital$1,076.3$987.7

Cash and cash equivalents include all instruments that have maturities of ninety days or less when purchased. Working capital is defined as current assets less current liabilities.

Cash and cash equivalents – Our cash and cash equivalents balance at June 30, 2025 consisted of cash held in depository accounts with banks around the world and cash invested in high-quality, short-term investments. The cash and cash equivalents balance at June 30, 2025 included $97.9 million of cash held by subsidiaries within the U.S., and $411.8 million of cash held by subsidiaries outside of the U.S. During the six months ended June 30, 2025, we purchased 552,593 shares of our common stock under the share repurchase program at a cost of $134.0 million, or an average price of $242.55 per share.

Working capital – Working capital at June 30, 2025 increased by $88.6 million, or 9.0%, as compared to December 31, 2024, which includes a favorable foreign currency translation impact of $57.5 million. Excluding the impact of currency exchange rates, other current assets, inventories and total current liabilities increased by $36.4 million, $18.4 million and $19.8 million, respectively, while cash and cash equivalents decreased by $2.8 million.

The increase in other current assets was primarily driven by an increase in the asset value of our short-term hedges associated with foreign currency risk and prepaid expenses. The increase in inventories was to ensure we have sufficient inventory on hand to support the needs of our customers. The increase in total current liabilities was driven by an increase in the liability value of our short-term hedges associated with foreign currency risk and an increase in the salaries, wages and benefits accrual. The decrease in cash and cash equivalents was due to share repurchases and capital expenditures, offset by cash from operations during the six months ended June 30, 2025.

Debt and credit facilities – The total debt balance of $202.6 million at June 30, 2025 is consistent with the total debt balance at December 31, 2024.

Our sources of liquidity include our multi-currency revolving credit facility. At June 30, 2025, we had no outstanding borrowings under the multi-currency revolving credit facility. At June 30, 2025, the borrowing capacity available under the multi-currency revolving credit facility, including outstanding letters of credit of $2.3 million, was $497.7 million. We do not expect any significant limitations on our ability to access this source of funds.

Pursuant to the financial covenants in our debt agreements, we are required to maintain established interest coverage ratios and not to exceed established leverage ratios. In addition, the agreements contain other customary covenants, none of which we consider restrictive to our operations. At June 30, 2025, we were in compliance with all of our debt covenants.

We believe that cash on hand and cash generated from operations, together with availability under our multi-currency revolving credit facility, will be adequate to address our foreseeable liquidity needs based on our current expectations of our business operations, capital expenditures and scheduled payments of debt obligations.

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Commitments and Contractual Obligations

A summary of future material cash payments resulting from commitments and contractual obligations was provided in our 2024 Annual Report. During the three months ended June 30, 2025, there were no material changes outside of the ordinary course of business to our commitments and contractual obligations.

OFF-BALANCE SHEET ARRANGEMENTS

At June 30, 2025, we had no off-balance sheet financing arrangements other than unconditional purchase obligations incurred in the ordinary course of business and outstanding letters of credit related to various insurance programs, as noted in our 2024 Annual Report.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

There have been no changes to the Critical Accounting Policies and Estimates disclosed in Part II, Item 7 of our 2024 Annual Report.

NEW ACCOUNTING STANDARDS

For information on new accounting standards see Note 2, New Accounting Standards.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Our disclosure and analysis in this Form 10-Q contains some forward-looking statements that are based on management’s beliefs and assumptions, current expectations, estimates and forecasts. We also provide forward-looking statements in other materials we release to the public, as well as oral forward-looking statements. Such statements provide our current expectations or forecasts of future events. They do not relate strictly to historical or current facts. We have attempted, wherever possible, to identify forward-looking statements by using words such as “plan,” “expect,” “believe,” “intend,” “will,” “estimate,” “continue” and other words of similar meaning in conjunction with, among other things, discussions of future operations and financial performance, as well as our strategy for growth, product development, market position and expenditures. All statements that address operating performance or events or developments that we expect or anticipate will occur in the future - including statements relating to sales and earnings per share growth, cash flows or uses, and statements expressing views about future operating results - are forward-looking statements.

Forward-looking statements are based on current expectations of future events. The forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance, and speak only as of their dates. Investors should realize that, if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements.

The following are some important factors that could cause our actual results to differ from our expectations in any forward-looking statements:

  • sales demand and our ability to meet that demand;

  • competition from other providers in our businesses, including customers’ in-house operations, and from lower-cost producers in emerging markets, which can impact unit volume, price and profitability;

  • customers’ changing inventory requirements and manufacturing plans that alter existing orders or ordering patterns for the products we supply to them;

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  • interruptions or weaknesses in our supply chain, including from reasons beyond our control such as extreme weather, longer-term climate changes, natural disasters, pandemic, war, accidental damage, or unauthorized access to our or our customers’ information and systems, which could cause delivery delays or restrict the availability of raw materials, key purchased components and finished products;

  • the timing, regulatory approval and commercial success of customer products that incorporate our products and systems;

  • whether customers agree to incorporate our products and delivery systems with their new and existing drug products, the ultimate timing and successful commercialization of those products and systems, which involves substantial evaluations of the functional, operational, clinical and economic viability of our products, and the rate, timing and success of regulatory approval for the drug products that incorporate our components and systems;

  • the timely and adequate availability of filling capacity, which is essential to conducting definitive stability trials and the timing of first commercialization of customers’ products in Crystal Zenith prefilled syringes;

  • profitability, or mix, of the products sold in any reporting period, including lower-than-expected sales growth of our high-value proprietary product offerings;

  • maintaining or improving production efficiencies and overhead absorption;

  • dependence on third-party suppliers and partners, some of which are single-source suppliers of critical materials and products, including our Japanese partner and affiliate, Daikyo;

  • the loss of key personnel or highly-skilled employees;

  • the availability and cost of skilled employees required to meet increased production, managerial, research and other needs, including professional employees and persons employed under collective bargaining agreements;

  • the successful and timely implementation of price increases necessary to offset rising production costs, including raw material prices, particularly petroleum-based raw materials;

  • the cost and progress of development, regulatory approval and marketing of new products;

  • our ability to obtain and maintain licenses in any jurisdiction in which we do business;

  • the relative strength of USD in relation to other currencies, particularly the Euro, SGD, the Danish Krone, Yen, Colombian Peso, Brazilian Real, and the South Korean Won; and

  • the potential adverse effects of global healthcare legislation on customer demand, product pricing and profitability.

This list sets forth many, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. Investors should understand that it is not possible to predict or identify all of the factors and should not consider this list to be a complete statement of all potential risks and uncertainties. For further discussion of these and other factors, see the risk factors disclosed in Part I, Item 1A of our 2024 Annual Report as well as Part II, section 1A of this quarterly report.

Except as required by law or regulation, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

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