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 2025 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 2025 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 West Vantage. Effective in the first quarter of 2026, the Company renamed its "Contract-Manufactured Products" reportable segment to "West Vantage™" to better align with its current strategic focus and offerings. This change in name does not affect the composition of the reportable segment, nor does it impact previously reported segment financial information. 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 West Vantage reportable segment serves as a fully integrated business, focused on the design, manufacture, and automated assembly of complex devices, as well as combination product assembly and packaging, 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

Beginning in 2025, the U.S. government imposed additional tariffs and trade restrictions on certain goods produced outside of the United States. In response to these actions, certain jurisdictions in which we operate 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 2026 results.

We continue to monitor the events and macro-economic impacts that the conflict in the Middle East has on our business model. We have raw materials and other costs in our operations that are dependent on petro-chemicals. Based on the current situation in the Middle East, we anticipate future inflationary pressures on these costs, but we do not expect those impacts to have a material impact. Additionally, our Israel-based facilities continue to operate as they had prior to the conflict, and we did not experience any disruption in business during the first quarter of 2026.

Financial Performance Summary

The following tables present a reconciliation from U.S. GAAP to non-U.S. GAAP financial measures for the three months ended March 31, 2026:

($ in millions, except per share data)			Operating Profit						Income tax expense						Net income						Diluted EPS
Three months ended March 31, 2026 U.S. GAAP			$	177.1					$	44.7					$	138.8					$	1.92
Unallocated items:
Restructuring and other charges(1)			1.4						(11.6)						13.0						0.18
SmartDose® 3.5mL sale(2)			1.9						0.4						1.5						0.02
Amortization of acquisition-related intangible assets(3)			—						—						0.5						0.01
Other			0.6						0.2						0.5						—
Three months ended March 31, 2026 adjusted amounts (non-U.S. GAAP)			$	181.0					$	33.7					$	154.3					$	2.13

The following tables present a reconciliation from U.S. GAAP to non-U.S. GAAP financial measures for the three months ended March 31, 2025:

($ in millions, except per share data)			Operating Profit						Income tax expense						Net income						Diluted EPS
Three months ended March 31, 2025 U.S. GAAP			$	107.0					$	24.1					$	89.8					$	1.23
Unallocated items:
Restructuring and other charges(1)			17.8						2.0						15.8						0.21
Amortization of acquisition-related intangible assets(3)			0.2						—						0.6						0.01
Three months ended March 31, 2025 adjusted amounts (non-U.S. GAAP)			$	125.0					$	26.1					$	106.2					$	1.45

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(1)During the three months ended March 31, 2026, the Company recorded pre-tax charges of $1.4 million related to our two existing restructuring programs: (i) $0.9 million within other expense (income), related to acceleration of depreciation and lease costs in connection with the Company's January 2025 restructuring plan and (ii) $0.5 million within selling, general and administrative expenses, for professional services relating to our 2024 plan to optimize the legal structure of the Company and its subsidiaries. In addition, we recorded a one-time tax cost of $12.0 million associated with an internal legal entity restructuring which occurred in the first quarter of 2026. During the three months ended March 31, 2025, the Company recorded pre-tax charges of $17.8 million related to our two existing restructuring programs: (i) $16.4 million within other expense (income), related to severance, acceleration of depreciation and lease costs in connection with the Company's January 2025 restructuring plan and (ii) $1.4 million within selling, general and administrative expenses, for professional services relating to our 2024 plan to optimize the legal structure of the Company and its subsidiaries. In addition, we recorded income tax charges of $2.0 million related primarily to withholding tax and capital gains incurred in executing our plan to optimize our legal structure.

(2)During the three months ended March 31, 2026, the Company recorded charges of $1.9 million related to the Company's agreement to sell its SmartDose® 3.5mL On-Body Delivery System and associated facilities to AbbVie. The Company recorded $0.9 million of the charges within other expense (income), related to employee benefit costs in connection with the sale agreement. The Company recorded the remaining $1.0 million within selling, general and administrative expenses, relating to professional services in connection with the sale agreement.

(3)During the three months ended March 31, 2026, and 2025, the Company recorded $0.0 million and $0.2 million, respectively, of amortization expense within selling, general and administrative expenses associated with an intangible asset acquired during the second quarter of 2020. During the three months ended March 31, 2026, and 2025, the Company recorded $0.5 million and $0.4 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.

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 March 31, 2026 and 2025:

			Three Months Ended March 31,												Percentage Change
($ in millions)			2026						2025						As-Reported						Organic
Proprietary Products			$	694.3					$	563.0					23.3		%				17.5		%
West Vantage			150.6						135.0						11.6		%				6.2		%
Consolidated net sales			$	844.9					$	698.0					21.0		%				15.3		%

Consolidated net sales increased by $146.9 million, or 21.0%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $40.0 million. Excluding foreign currency translation effects, consolidated net sales for the three months ended March 31, 2026 increased by $106.9 million, or 15.3%, as compared to the same period in 2025.

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Proprietary Products – Proprietary Products net sales increased by $131.3 million, or 23.3%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $32.8 million. Excluding foreign currency translation effects, net sales for the three months ended March 31, 2026 increased by $98.5 million, or 17.5%, as compared to the same period in 2025, due primarily to an increase in sales of Westar®, NovaPure® and FluroTec® products, as well as self-injection device platforms.

West Vantage – West Vantage net sales increased by $15.6 million, or 11.6%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $7.2 million. Excluding foreign currency translation effects, net sales for the three months ended March 31, 2026 increased by $8.4 million, or 6.2%, as compared to the same period in 2025, due primarily to an increase in sales of self-injection devices for obesity and diabetes.

Gross Profit

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

			Three Months Ended March 31,
($ in millions)			2026						2025
Proprietary Products:
Gross profit			$	273.1					$	210.2
Gross profit margin			39.3		%				37.3		%
West Vantage:
Gross profit			$	23.3					$	21.7
Gross profit margin			15.5		%				16.1		%
Consolidated gross profit			$	296.4					$	231.9
Consolidated gross profit margin			35.1		%				33.2		%

Consolidated - Consolidated gross profit increased by $64.5 million, or 27.8%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $16.2 million for the three months ended March 31, 2026, as compared to the same period in 2025. Consolidated gross profit margin increased by 1.9 margin points for the three months ended March 31, 2026, as compared to the same period in 2025.

Proprietary Products - Proprietary Products gross profit increased by $62.9 million, or 29.9%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $14.9 million. Proprietary Products gross profit margin increased by 2.0 margin points for the three months ended March 31, 2026, as compared to the same periods in 2025, due primarily to increased customer demand, primarily of high value components, and sales price increases.

West Vantage - West Vantage gross profit increased by $1.6 million, or 7.4%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $1.3 million. West Vantage gross profit margin decreased by 0.6 margin points for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to increased production costs, partially offset by sales price increases.

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Research and Development (“R&D”) Costs

The following table presents consolidated R&D costs:

			Three Months Ended March 31,
($ in millions)			2026						2025
Consolidated R&D costs			$	15.8					$	16.3

Consolidated R&D costs decreased by $0.5 million, or 3.1%, for the three months ended March 31, 2026, respectively, as compared to the same period in 2025. Efforts remain focused on the continued investment in (1) primary injectables in elastomeric components, formulation development & packaging and (2) drug containment systems, self-injection systems, and drug administration consumables.

All of the R&D costs incurred in the three months ended March 31, 2026 and 2025 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 March 31,
($ in millions)			2026						2025
Proprietary Products			$	65.0					$	60.3
West Vantage			7.8						7.6
Corporate and unallocated items			26.7						20.1
Consolidated SG&A costs			$	99.5					$	88.0
SG&A as a % of net sales			11.8		%				12.6		%

Consolidated - Consolidated SG&A costs increased by $11.5 million, or 13.1%, for the three months ended March 31, 2026, as compared to the same period in 2025, including an unfavorable foreign currency translation impact of $2.2 million, due primarily to increased expense related to stock-based compensation and increased salary and wages.

Proprietary Products - Proprietary Products SG&A costs increased by $4.7 million, or 7.8%, for the three months ended March 31, 2026, as compared to the same period in 2025, including an unfavorable foreign currency translation impact of $2.0 million, due primarily to increased salary and wages.

West Vantage - West Vantage SG&A costs increased by $0.2 million, or 2.6%, for the three months ended March 31, 2026, as compared to the same period in 2025, including an unfavorable foreign currency translation impact of $0.2 million.

Corporate and unallocated items - Corporate SG&A costs increased by $6.6 million, or 32.8%, for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to an increase in expense related to stock-based compensation and increased salary and wages.

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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 March 31,
($ in millions)			2026						2025
Proprietary Products			$	3.1					$	3.0
West Vantage			(0.1)						0.6
Corporate and unallocated			1.0						17.0
Consolidated other expense (income)			$	4.0					$	20.6

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

Consolidated - Consolidated other expense (income) changed by $16.6 million for the three months ended March 31, 2026, as compared to the same period in 2025, due to the factors described below.

Proprietary Products - Proprietary Products other expense (income) changed by $0.1 million for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to increased contingent consideration expense and foreign exchange losses being recorded in the three months ended March 31, 2026, as compared to the same period in 2025. This was partially offset by gains being recorded on oil hedges in the three months ended March 31, 2026, as compared to losses being recorded in the same period in 2025.

West Vantage - West Vantage other expense (income) changed by $0.7 million for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to foreign exchange gains being recorded in the three months ended March 31, 2026, as compared to foreign exchange losses being recorded in the same period in 2025.

Corporate and unallocated items - Corporate and unallocated items changed by $16.0 million for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to the Company recording restructuring and other charges of $1.8 million within the three months ended March 31, 2026, as compared to $16.4 million being recorded during the same period in 2025. The Company's 2026 restructuring and other charges within other expense (income) were (i) $0.9 million related to acceleration of depreciation and lease costs in connection with the Company's January 2025 restructuring plan and (ii) $0.9 million related to employee benefit costs in connection with the Company's agreement to sell its SmartDose® 3.5mL On-Body Delivery System and associated facilities to AbbVie. The Company's 2025 restructuring and other charges of $16.4 million related to severance, acceleration of depreciation and lease costs in connection with the Company's January 2025 restructuring plan.

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Operating Profit

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

			Three Months Ended March 31,
($ in millions)			2026						2025
Proprietary Products			$	189.2					$	130.6
West Vantage			15.6						13.5
Corporate and unallocated items			(27.7)						(37.1)
Consolidated operating profit			$	177.1					$	107.0
Consolidated operating profit margin			21.0		%				15.3		%
Unallocated items			3.9						18.0
Adjusted consolidated operating profit			$	181.0					$	125.0
Adjusted consolidated operating profit margin			21.4		%				17.9		%

Consolidated - Consolidated operating profit increased by $70.1 million, or 65.5%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $13.4 million for the three months ended March 31, 2026, as compared to the same period in 2025.

Proprietary Products - Proprietary Products operating profit increased by $58.6 million, or 44.9%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $12.4 million, due to the factors described above, most notably increased customer demand, primarily of high value components, and sales price increases.

West Vantage - West Vantage operating profit increased by $2.1 million, or 15.6%, for the three months ended March 31, 2026, as compared to the same period in 2025, including a favorable foreign currency translation impact of $1.0 million, due to the factors described above, most notably sales price increases and foreign exchange gains, partially offset by increased production costs.

Corporate and unallocated - Excluding the unallocated items, Corporate costs increased by $4.7 million, or 24.6%, for the three months ended March 31, 2026, as compared to the same period in 2025, due to the factors described above, most notably the increase in expense related to stock-based compensation.

Interest Expense, Net and Interest Income

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

			Three Months Ended March 31,
($ in millions)			2026						2025
Interest expense			$	3.7					$	4.2
Capitalized interest			(1.8)						(3.8)
Interest expense, net			$	1.9					$	0.4
Interest income			$	(5.1)					$	(4.1)

Interest expense, net, increased by $1.5 million, for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to a decline in interest rates on the Company's Term Loan in three months ended March 31, 2026, as compared to the same period in 2025, as well as a decrease in capitalized interest.

Interest income increased by $1.0 million, for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to the Company having a higher average cash balance in three months ended March 31, 2026, as compared to the same period in 2025.

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Other Nonoperating Expense (Income)

Other nonoperating expense (income) was $0.2 million and $0.2 million for the three months ended March 31, 2026 and 2025, respectively.

Income Tax Expense

The provision for income taxes was $44.7 million and $24.1 million for the three months ended March 31, 2026 and 2025, respectively, and the effective tax rate was 24.8% and 21.8%, respectively. The increase in the effective tax rate is due primarily to a one-time tax cost of $12.0 million associated with an internal legal entity restructuring which occurred in the first quarter of 2026.

Equity in Net Income of Affiliated Companies

Equity in net income of affiliated companies was $3.4 million and $3.4 million for the three months ended March 31, 2026 and 2025, respectively.

FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES

Cash Flows

The following table presents cash flow data for the three months ended March 31:

($ in millions)			2026						2025
Net cash provided by operating activities			$	89.9					$	129.4
Net cash used in investing activities			$	(42.7)					$	(71.3)
Net cash used in financing activities			$	(308.7)					$	(147.0)

Net Cash Provided by Operating Activities – Net cash provided by operating activities decreased by $39.5 million for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to fluctuations in working capital and increased incentive payments, partially offset by improved operating results.

Net Cash Used in Investing Activities – Net cash used in investing activities decreased by $28.6 million for the three months ended March 31, 2026, as compared to the same period in 2025, due to a decrease in capital expenditures.

Net Cash Used in Financing Activities – Net cash used in financing activities increased by $161.7 million for the three months ended March 31, 2026, as compared to the same period in 2025, due primarily to an increase in purchases under our share repurchase programs.

Liquidity and Capital Resources

The table below presents selected liquidity and capital measures:

($ in millions)			March 31, 2026						December 31, 2025
Cash and cash equivalents			$	521.4					$	791.3
Accounts receivable, net			$	685.6					$	574.4
Inventories			$	452.6					$	443.9
Accounts payable			$	252.3					$	253.7
Debt			$	202.8					$	202.8
Equity			$	2,990.4					$	3,176.0
Working capital			$	1,152.8					$	1,323.3

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.

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Cash and cash equivalents – Our cash and cash equivalents balance at March 31, 2026 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 March 31, 2026 included $98.4 million of cash held by subsidiaries within the U.S., and $423.0 million of cash held by subsidiaries outside of the U.S. During the three months ended March 31, 2026, we purchased 1,222,019 shares of our common stock under the share repurchase program at a cost of $297.6 million, or an average price of $243.57 per share.

Working capital – Working capital at March 31, 2026 decreased by $170.5 million, or 12.9%, as compared to December 31, 2025, which includes a decrease of $6.5 million due to foreign currency translation. Excluding the impact of currency exchange rates, cash and cash equivalents decreased by $261.4 million, while accounts receivable increased by $115.6 million.

The decrease in cash and cash equivalents was due to share repurchases and capital expenditures during the three months ended March 31, 2026, partially offset by cash from operations. The increase in accounts receivable was due to increased net sales leading up to the March 31, 2026 balance sheet date as compared to the December 31, 2025 balance sheet date.

Debt and credit facilities – The total debt balance of $202.8 million at March 31, 2026 is consistent with the total debt balance at December 31, 2025.

Our sources of liquidity include our multi-currency revolving credit facility. At March 31, 2026, we had no outstanding borrowings under the multi-currency revolving credit facility. At March 31, 2026, 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 March 31, 2026, 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.

Commitments and Contractual Obligations

A summary of future material cash payments resulting from commitments and contractual obligations was provided in our 2025 Annual Report. During the three months ended March 31, 2026, there were no material changes outside of the ordinary course of business to our commitments and contractual obligations.

OFF-BALANCE SHEET ARRANGEMENTS

At March 31, 2026, 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 2025 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 2025 Annual Report.

NEW ACCOUNTING STANDARDS

For information on new accounting standards see Note 2, New Accounting Standards, within Item 1 of this report.

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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;

• 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;

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• 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 2025 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.