Repligen Corp: Form 10-Q for the period ended Sep 30, 2025

Overview

Repligen and its subsidiaries, collectively doing business as Repligen Corporation (“Repligen”, “we”, “our”, or the “Company”) is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that increase efficiencies and flexibility in the process of manufacturing biological drugs.

As the overall market for biologics continues to grow and expand, our customers – primarily large biopharmaceutical companies and contract development and manufacturing organizations and other life sciences companies (integrators) – face critical production cost, capacity, quality and time pressures. Built to address these concerns, our products help set new standards for the way biologics are manufactured. We are committed to inspiring advances in bioprocessing as a trusted partner in the production of critical biologic drugs – including monoclonal antibodies, recombinant proteins, vaccines and cell and gene therapies – that are improving human health worldwide. Our technologies are being implemented to overcome challenges in processing plasmid DNA (a starting material for the production of mRNA) and gene delivery vectors such as lentivirus and adeno-associated viral vectors. For more information regarding our business, products and acquisitions, see Part I, Item 1, “Business”, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the Securities and Exchange Commission (“SEC”) on March 14, 2025 (“Form 10-K”).

We currently operate as one bioprocessing business, with a comprehensive suite of products to serve both upstream and downstream processes in biological drug manufacturing. Building on over 40 years of industry expertise, we have developed a broad and diversified product portfolio that reflects our passion for innovation and the customer-first culture that drives our entire organization. We continue to capitalize on opportunities to maximize the value of our product platform through both organic growth initiatives (internal innovation and leveraging commercial opportunities) and targeted acquisitions.

Macroeconomic Trends

As a result of our global presence, a significant portion of our revenue and expenses is denominated in currencies other than the United States (“U.S.”) dollar. We are therefore subject to non-U.S. exchange exposure. Exchange rates can be volatile and a substantial weakening or strengthening of foreign currencies against the U.S. dollar could increase or reduce our revenue and gross profit margin and impact the comparability of results from period to period.

We have experienced, and expect to continue to experience, cost inflation, primarily in raw materials and other supply chain costs, as a result of global macroeconomic trends, including global geopolitical conflicts and labor shortages. Actions taken to mitigate supply chain disruptions and inflation, including price increases and productivity improvements, have generally been successful in offsetting the impact of these trends. We continue to monitor the effects of tariffs implemented by the Trump administration and the potential imposition of modified or additional tariffs.

2025 Acquisition

Acquisition of 908 Devices PAT Portfolio

On March 4, 2025, the Company completed its acquisition of 908 Devices Inc.’s (“908 Devices”) desktop portfolio of four devices for bioprocessing process analytical technology applications (“PAT Portfolio”). In connection with the transaction, Repligen also acquired facilities, employees, equipment and lease obligations for facilities in North Carolina and Braunschweig, Germany as well as certain working capital balances related to the PAT Portfolio. This transaction is referred to as the 908 Devices PAT Portfolio acquisition.

The addition of these desktop assets complements and strengthens Repligen’s differentiated PAT Portfolio that provides its biopharmaceutical and CDMO customers with actionable insights to optimize development processes and improve manufacturing efficiencies.

2024 Acquisition

Acquisition of Tantti Laboratory Inc.

On December 2, 2024, the Company's subsidiary, Repligen Sweden AB acquired Tantti Laboratory Inc. (“Tantti”) from the former shareholders of Tantti (“Tantti Seller”) pursuant to a share swap agreement, dated as of July 27, 2024 (such acquisition, the “Tantti Acquisition”), by and among Repligen Sweden AB, the Tantti Seller and the Company, in its capacity as guarantor of the obligations of Repligen Sweden AB under the Share Purchase Agreement.

Tantti, headquartered in Taoyuan City, Taiwan, has developed a unique portfolio of macroporous chromatography beads to optimize the purification of new modalities including viral vectors, viruses, nucleic acids and other large molecule biologics. The addition of Tantti further strengthens our portfolio in the new modality space.

Critical Accounting Policies and Estimates

A “critical accounting policy” is one which is both important to the portrayal of our financial condition and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. There have been no material changes to our critical accounting policies since December 31, 2024. For a description of our critical accounting policies that affect our more significant judgments and estimates used in the preparation of our condensed consolidated financial statements, refer to Note 2, “Summary of Significant Accounting Policies” included in Part II, Item 8, “Financial Statements and Supplementary Data” to the Company's Form 10-K.

Recent Accounting Pronouncements

For information about recent accounting pronouncements, refer to Note 1, “Summary of Significant Accounting Policies”, included in Part I, Item 1, “Financial Statements”, in this Quarterly Report on Form 10-Q.

Results of Operations

The following discussion of the financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and the related footnotes thereto. All dollar and percentage changes made herein refer to the three and nine months ended September 30, 2025, compared with the three and nine months ended September 30, 2024, unless otherwise noted.

Revenues

Total revenue for the three and nine months ended September 30, 2025 and 2024 were as follows:

(Amounts in thousands)

Product revenues

During the three and nine months ended September 30, 2025, product revenue increased by $33.9 million, or 21.9%, and increased by $73.4 million, or 15.7%, respectively, as compared to the same period of 2024. This growth is widespread across our portfolio of products and includes significant contributions from our Analytics and Filtration franchises during the third quarter of 2025. Over the first three quarters of the year, the increase was primarily driven by our Proteins, Chromatography, and Analytics franchises. Related to our acquisitions, products acquired from 908 Devices contributed $2.9 million and $6.9 million, respectively, in revenue during the three and nine months ended September 30, 2025. In addition, the nine months ended September 30, 2024 included $11.5 million of COVID-19 related sales.

Royalty and other revenues

Royalty and other revenues in the three and nine months ended September 30, 2025 and 2024 relate to royalties received from a third-party systems manufacturer associated with our OPUS® chromatography columns. Royalty revenues are variable and are dependent on sales generated by our partners.

Costs and operating expenses

Total costs and operating expenses for the three and nine months ended September 30, 2025 and 2024 were comprised of the following:

(Amounts in thousands)

Cost of goods sold

During the three and nine months ended September 30, 2025, cost of goods sold increased by $10.9 million, or 14.1%, and increased by $26.8 million, or 11.6%, respectively, compared to the same periods of 2024. The increase in cost of goods sold is driven by the increase in product sales compared to the same period in 2024, with lower excess and obsolete and scrap costs in the current year periods.

Gross margin increased to 53.2% for the three months ended September 30, 2025 compared to 50.0% the same period in 2024. Gross margin increased to 52.3% for the nine months ended September 30, 2025 compared to 50.5% in the same period in 2024. These increases are driven by lower excess and obsolete and scrap costs and leverage on fixed overhead and indirect labor.

Research and development expenses

Research and development (“R&D”) expenses are related to the development of products supporting bioprocessing operations. The expenses include personnel compensation, supplies and other research expenses. Due to the fact that these various programs share personnel and fixed costs, we have not provided historical costs incurred by project.

R&D expenses increased by $4.5 million, or 46.0% during the three months ended September 30, 2025, as compared to the same period of 2024, and increased by $9.5 million, or 30.2%, during the nine months ended September 30, 2025, as compared to the same period of 2024. The increase in R&D costs is primarily driven by the 908 Devices PAT Portfolio and Tantti acquisitions, which have been included in our consolidated results of operations since the acquisition dates of March 2025 and December 2024, respectively.

Selling, general and administrative expenses

Selling, general and administrative (“SG&A”) expenses include the costs associated with selling our commercial products and costs required to support our marketing efforts. It also includes legal, accounting, patent, shareholder services, amortization of intangible assets and other administrative functions.

SG&A costs decreased by $1.9 million, or 2.6%, during the three months ended September 30, 2025 as compared to the same period of 2024. The primary driver of the decrease in SG&A costs is the incremental stock-based compensation expense incurred during the three months ended September 30, 2024 associated with the modification of our former Chief Executive Officer’s (“CEO”) unvested equity awards in connection with their transition from CEO to Executive Chair of our Board of Directors. This is partially offset by increased investment in personnel costs to support growth, driven by increased headcount, and incremental professional services, primarily driven by our acquisition and integration activities.

SG&A costs increased by $13.3 million, or 6.5%, during the nine months ended September 30, 2025 as compared to the same period of 2024. The primary drivers of the increase in SG&A relates to investment in personnel costs to support growth, driven by increased headcount, and incremental professional services, primarily driven by our acquisition and integration activities. These increases were partially offset by the incremental stock-based compensation expense incurred during the nine months ended September 30, 2024 related to our former CEO’s transition described above.

Change in fair value of contingent consideration

Change in fair value of contingent consideration represents the change in fair value of the obligation included in current and noncurrent contingent consideration on the condensed consolidated balance sheets as of the end of each period. Remeasurement of the contingent consideration obligation is done each quarter and the carrying value of the obligation is adjusted to the current fair value through our condensed consolidated statements of comprehensive income. The changes during the three and nine months ended September 30, 2025 were related to revisions to the amount and timing of future revenues and a change in market inputs used to calculate the discount rate. No adjustment was recorded for the three and nine months ended September 30, 2024 as management’s assessment was that the balances of the contingent consideration obligations already represented fair value.

Other income, net

The table below provides detail regarding our other income, net:

(Amounts in thousands)

Investment income

Investment income includes income earned on invested cash balances. Our investment income decreased by $2.2 million and $6.7 million, respectively, for the three and nine months ended September 30, 2025, as compared to the same period of 2024 due to a decrease in the average cash balances on hand and a reduction in interest rates. We expect investment income to vary based on changes in the amount of funds invested and fluctuation of interest rates.

Interest expense

Interest expense increased by $0.3 million and $0.7 million, respectively, for the three and nine months ended September 30, 2025 as compared to the same period of 2024. Interest expense includes contractual coupon interest on our outstanding convertible notes and the associated accretion of the discount. The discount is being accreted into interest expense using the effective interest method over the term of the 2023 Notes, as defined below. See Note 9, “Convertible Senior Notes” to our condensed consolidated financial statements included in this report for more information.

Amortization of debt issuance costs

Transaction costs related to the issuance of the 2019 Notes and the 2023 Notes, as defined below, are amortized and recorded within amortization of debt issuance costs on the condensed consolidated statements of comprehensive income.

Other (expenses) income, net

Other (expenses) income, net increased by $3.9 million for the three months ended September 30, 2025 as compared to the same period in 2024. Other income, net increased by $3.1 million for the nine months ended September 30, 2025 as compared to the same period in 2024. Other (expenses) income, net primarily includes the changes in foreign currency transaction gains and losses, revaluation impact of intercompany loans with subsidiaries and unrealized and realized impacts of foreign exchange forward contracts.

Income tax provision (benefit)

Income tax provision (benefit) for the three and nine months ended September 30, 2025 and 2024 was as follows:

(Amounts in thousands)

For the three and nine months ended September 30, 2025, we recorded an income tax provision of $2.2 million and $7.7 million, respectively. The effective tax rate was 12.9% and 17.7% for the three and nine months ended September 30, 2025, respectively, and is based upon the estimated income for the year ending December 31, 2025 and the composition of income in different jurisdictions.

The difference in effective tax rates between the periods was primarily due nontaxable contingent consideration and lower nondeductible stock-based compensation offset by lower stock windfall tax benefits. Our effective tax rate for the three and nine months ended September 30, 2025 was lower than the U.S. statutory rate of 21% primarily due to nontaxable contingent consideration.

On July 4, 2025, the United States enacted into law new tax legislation, the One Big Beautiful Bill Act (“OBBBA”), which contains several provisions modifying the corporate income tax code such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, updates to the international tax framework and the reinstatement of certain business-related provisions. The legislation has multiple effective dates, with provisions taking effect from 2025 through 2027. We do not expect the OBBBA to have a material impact on our consolidated financial statements or results of operations.

Liquidity and Capital Resources

We have financed our operations primarily through revenues derived from product sales and the issuance of notes and public offerings. Our revenue for the foreseeable future will primarily be limited to our bioprocessing product revenue.

At September 30, 2025, we held cash and cash equivalents of $748.7 million compared to cash and cash equivalents of $757.4 million at December 31, 2024. Working capital increased by $26.1 million to $965.3 million at September 30, 2025 from $939.3 million at December 31, 2024 primarily due to the various changes noted below in “Cash Flows”.

On December 14, 2023, the Company issued $600.0 million aggregate principal amount of 1.00% Convertible Senior Notes due 2028 (the “2023 Notes”) in a private placement pursuant to separate, privately negotiated exchange and subscription agreements (the “Exchange and Subscription Agreements”) with a limited number of holders of the 0.375% Convertible Notes due 2024 (the “2019 Notes”) and certain other qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (“Securities Act”). Pursuant to the Exchange and Subscription Agreements, the Company exchanged $217.7 million of its 2019 Notes for $309.9 million aggregate principal amount of the 2023 Notes (the “Exchange Transaction”) and issued $290.1 million aggregate principal amount of the 2023 Notes (the “Subscription Transactions”) for $290.1 million in cash. Proceeds from the Subscription Transactions amounted to $276.1 million after debt issuance costs of $13.9 million.

The 2023 Notes are senior, unsecured obligations of the Company, and bear interest at a rate of 1.00% per year and have an effective interest rate of 4.39%. Interest is payable semi-annually in arrears on each of June 15 and December 15, which commenced on June 15, 2024. The 2023 Notes will mature on December 15, 2028, unless earlier redeemed, repurchased or converted. During the third quarter of 2025, the closing price of the Company’s common stock did not exceed 130% of the conversion price of the 2023 Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the 2023 Notes are not convertible at the option of the holders of the 2023 Notes during the fourth quarter of 2025, the quarter immediately following the quarter when the conditions are met, as stated in the indenture governing the 2023 Notes.

Cash Flows

(Amounts in thousands)

Operating activities

For the nine months ended September 30, 2025, our operating activities provided cash of $91.7 million reflecting net income of $35.6 million and non-cash charges totaling $82.6 million primarily related to depreciation and intangible amortization, stock-based compensation, operating lease right of use asset amortization and amortization of debt discount and issuance costs, partially offset by net unrealized foreign exchange gains, changes in the fair value of contingent consideration and deferred income taxes, net. The non-cash charges were partially offset by unfavorable changes in working capital of $26.5 million. This is primarily driven by decreases in operating lease liabilities of $12.1 million, primarily due to normal course rent payments, an increase in accounts receivable of $7.3 million due to timing of sales and receipts from customers, an increase in prepaid expenses and other current assets of $5.5 million, an increase in inventories of $5.3 million and a net increase in accounts payable and accrued liabilities of $4.5 million due to timing of payments to vendors. The remaining cash provided by operating activities resulted from net favorable changes in various other working capital accounts.

For the nine months ended September 30, 2024, our operating activities provided cash of $136.2 million reflecting net income of $8.4 million and non-cash charges totaling $113.3 million primarily related to depreciation and intangible amortization, amortization of debt discount and issuance costs, stock-based compensation, deferred income taxes and operating lease right of use asset amortization. Accounts receivable increased by $4.6 million, while inventory manufactured decreased by $20.1 million. Accounts payable and accrued liabilities had a net increase of $7.1 million, primarily due to an increase in unearned revenue and accrued employee payroll and bonuses, and there was a net increase in operating lease liability of $5.8 million, due to new operating leases entered into during 2024. Prepaid expenses increased by $1.8 million, primarily related to prepayment of corporate taxes. The remaining cash used in operating activities resulted from unfavorable changes in various other working capital accounts.

Investing activities

Our investing activities consumed $89.7 million of cash during the nine months ended September 30, 2025, which was primarily driven by the acquisitions of 908 Devices and Tantti, of $70.0 million, net of cash acquired. Capital expenditures during the nine months ended September 30, 2025, consumed $17.4 million, inclusive of $2.1 million of capitalized costs related to our internal-use software.

Our investing activities consumed $21.6 million of cash during the nine months ended September 30, 2024, which was primarily due to capital expenditures, including costs capitalized related to our internal-use software.

Financing activities

Our financing activities consumed $15.4 million of cash for the nine months ended September 30, 2025, which was driven by $8.0 million of cash disbursed related to the tax withholding obligation on vesting of restricted stock units and $9.5 million to settle the cash portions of the contingent consideration earnout obligations related to acquisitions from previous years. These cash outflows are partially offset by proceeds received from stock option exercises of $2.1 million.

Our financing activities consumed $84.4 million of cash for the nine months ended September 30, 2024, driven by the settlement of the 2019 Notes of $69.9 million, $9.4 million was disbursed in cash for shares withheld to cover employee income tax due upon the vesting and release of restricted stock units and the payments of $7.4 million to settle the cash portion of the contingent earnout obligations related to our acquisition of FlexBiosys in April 2023 and Avitide in September 2021. These payments were partially offset by proceeds received of $2.4 million from stock option exercises during the period.

Off-balance sheet arrangements

We do not have any special purpose entities or off-balance sheet financing arrangements.

Effect of exchange rate changes on cash and cash equivalents

The effect of exchange rate changes on cash during the three and nine months ended September 30, 2025, is a result of using multiple currencies across the group, with the Euro and Swedish Krona being significant currencies for the group outside of the US Dollar.

Future capital requirements

Our future capital requirements will depend on many factors, including the following:

• the expansion of our bioprocessing business;
• the ability to sustain sales and profits of our bioprocessing products and successfully integrate them into our business;
• our ability to acquire additional bioprocessing products;
• the scope of and progress made in our R&D activities;
• the scope of investment in our intellectual property portfolio;
• contingent consideration earnout payments resulting from our acquisitions;
• the extent of any share repurchase activity;
• the success of any proposed financing efforts;
• general economic and capital markets;
• change in accounting standards;
• the impact of inflation on our operations, including our expenditures on raw materials and freight charges;
• fluctuations in foreign currency exchange rates; and
• costs associated with our ability to comply with, emerging environmental, social and governance standards.

Absent acquisitions of additional products, product candidates or intellectual property and absent the need to satisfy any debt conversions, we believe our current cash balances are adequate to meet our cash needs for at least the next 24 months from the date of this filing. We expect operating expenses for the remainder of the fiscal year to increase as we continue to expand our bioprocessing business. We expect to incur continued spending related to the development and expansion of our bioprocessing product lines and expansion of our commercial capabilities for the foreseeable future. Our future capital requirements may include, but are not limited to, purchases of property, plant and equipment, the acquisition of additional bioprocessing products and technologies to complement our existing manufacturing capabilities and continued investment in our intellectual property portfolio.

We plan to continue to invest in our bioprocessing business and in key R&D activities associated with the development of new bioprocessing products. We actively evaluate various strategic transactions on an ongoing basis, including acquiring products, technologies or businesses that would complement our existing portfolio. We continue to seek to acquire such potential assets that may offer us the best opportunity to create value for our shareholders. In order to acquire such assets, we may need to seek additional financing to fund these investments. If our available cash balances and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, due to any such acquisition-related financing needs, the need to fund debt conversions, or due to lower demand for our products, we may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt funding. The sale of equity and convertible debt securities may result in dilution to our shareholders, and those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights. We may require additional capital beyond our currently anticipated amounts. Additional capital may not be available on reasonable terms, if at all.

Net Operating Loss Carryforwards

At December 31, 2024, we had federal net operating loss carryforwards of $19.3 million, state net operating loss carryforwards of $11.9 million, and foreign net operating loss carryforwards of $26.0 million. The federal net operating loss carryforwards have unlimited carryforward periods and do not expire. The state net operating loss carryforwards will expire at various dates through 2044. Approximately $4.8 million of the foreign net operating loss carryforwards have unlimited carryforward periods and do not expire, while $21.2 million of the foreign net operating loss carryforwards will expire at various dates through 2034. We had federal and state business tax credit carryforwards of $6.6 million available to reduce future federal and state income taxes. The business tax credit carryforwards will expire at various dates through 2044. Net operating loss carryforwards and available tax credits are subject to review and possible adjustment by the Internal Revenue Service, state and foreign jurisdictions and may be limited in the event of certain changes in the ownership interest of significant stockholders.

Effects of Inflation

Our assets are primarily monetary, consisting mainly of cash and cash equivalents. Because of their liquidity, these assets are not directly affected by inflation. Since we intend to retain and continue to use our equipment, furniture, fixtures and office equipment, computer hardware and software and leasehold improvements, we believe that the incremental inflation related to replacement costs of such items will not materially affect our operations. However, the rate of inflation affects our expenses, such as those for employee compensation and contract services, which could increase our level of expenses and the rate at which we use our resources.

Cautionary Statement Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended

(the “Exchange Act”). The forward-looking statements in this Quarterly Report on Form 10-Q do not constitute guarantees of future performance. Investors are cautioned that statements in this Quarterly Report on Form 10-Q which are not strictly historical statements, including, without limitation, express or implied statements or guidance regarding current or future financial performance and position, potential impairment of future earnings, management’s strategy, plans and objectives for future operations or acquisitions, expectations and beliefs for recently-completed acquisitions, product development and sales, restructuring activities and the expected results thereof, product candidate research, development and regulatory approval, SG&A expenditures, intellectual property, development and manufacturing plans, availability of materials and product and adequacy of capital resources, and our financing plans. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates, and management’s beliefs and assumptions. The Company undertakes no obligation to publicly update or revise the statements in light of future developments. In addition, other written and oral statements that constitute forward-looking statements may be made by the Company or on the Company’s behalf. Words such as “expect,” “seek,” “anticipate,” “intend,” “plan,” “believe,” “could,” “estimate,” “may,” “target,” “project,” or variations of such words and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with the following: the success of current and future collaborative or supply relationships; our ability to successfully grow our bioprocessing business, including as a result of acquisitions, commercialization or partnership opportunities, and our ability to develop and commercialize products; our ability to obtain required regulatory approvals; our compliance with all U.S. Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products; the risk of litigation regarding our patent and other intellectual property rights; the risk of litigation with collaborative partners; our manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers; our ability to hire and retain skilled personnel; the market acceptance of our products, reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; our ability to integrate acquired businesses successfully into our business and achieve the expected benefits of the acquisitions; projections of tariff impacts; our ability to compete with larger, better financed life sciences companies; our history of losses and expectation of incurring losses; our ability to generate future revenues; our ability to successfully integrate acquired businesses; our ability to raise additional capital to fund potential acquisitions; our plans to mitigate our material weaknesses in our internal controls over financial reporting; our volatile stock price; and the effects of our anti-takeover provisions. Further information on potential risk factors that could affect our financial results are included in the filings made by us from time to time with the SEC including under the sections entitled “Risk Factors” in our Form 10-K.

There have been no material changes to our market risk exposures since December 31, 2024. For information regarding our exposure to certain market risks, see “Quantitative and Qualitative Disclosures About Market Risk”, included in Part II, Item 7A, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the Securities and Exchange Commission on March 14, 2025.

Disclosure Controls and Procedures

The Company’s management is responsible for establishing and maintaining adequate disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Disclosure controls and procedures (“DCPs”) are those controls and procedures that are designed to ensure that information required to be disclosed in the Company’s reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions’ rules and forms, and that such information is accumulated and communicated to the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

Under the supervision and with the participation of the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, the Company carried out an evaluation as of September 30, 2025 of the effectiveness of the design and operation of the Company’s DCPs pursuant to Exchange Act Rules 13a-15(b) and 15d-15(b). Based on such evaluation, the principal executive officer and principal financial officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were not effective because of the previously reported material weaknesses in our internal control over financial reporting, which are described in Part II, Item 9A, “Controls and Procedures” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the Securities and Exchange

Commission on March 14, 2025 (“Form 10-K”) for the year. Notwithstanding the material weaknesses, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q are fairly stated in all material respects in accordance with generally accepted accounting principles in the United States for each of the periods presented.

Material Weaknesses in Internal Control Over Financial Reporting

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company's annual or interim financial statements will not be prevented or detected on a timely basis. As previously disclosed in the Form 10-K, the Company identified the following material weaknesses in internal control over financial reporting:

1. Management identified deficiencies related to the design and operating effectiveness of controls related to revenue recognition specific to the evaluation of accounting for contract terms.

2. Management did not maintain effective information technology (“IT”) general controls for information systems that are relevant to the preparation of our financial statements. Specifically, we did not maintain logical access controls and program change management controls to ensure that access to programs and data are appropriately restricted and program and data changes are identified, tested, authorized and implemented appropriately. As a result, automated and business process controls that rely on information from the systems were also deemed ineffective because they could have been adversely affected.

3. Irrespective of the effects of the IT general controls deficiencies, management did not perform certain business process-level controls related to inventory valuation and the financial statement close process either in a timely manner or with an appropriate precision threshold.

As of September 30, 2025, the Company has not remediated these material weaknesses. See below for a description of our remediation plan and activities.

Remediation Plans

Revenue Recognition - During the nine months ended September 30, 2025, we took steps to remediate the material weakness described above, including:

• Designing and implementing new internal controls to validate there is a complete listing of revenue contracts that have non-standard terms, which require incremental accounting analysis under Accounting Standards Codification (“ASC”) 606 “Revenue from contracts with Customers”;
• Designing and implementing new internal controls evaluating the accounting for contract amendments, including amendments accounted for as contract modifications;
• Enhancing and expanding our existing revenue recognition control procedures and attributes when evaluating the accounting impact of non-standard contract terms and contract modifications; and
• Increasing education for internal resources on accounting for contracts within the scope of ASC 606 and deploying enablers to facilitate documentation of accounting analyses and conclusions.

IT General Controls - During the nine months ended September 30, 2025, we took steps to remediate the material weakness described above, including:

• Designing and implementing new internal controls related to the program and data change management and user access processes; and
• Expanding the management and governance over IT system controls.

Business process-level controls - During the nine months ended September 30, 2025, our remediation activities included the following with respect to certain business process-level controls:

• Reassessing the operating effectiveness of these controls, including precision thresholds, timely execution, and documentation requirements for control owners;
• Assessing the frequency of our control monitoring activities to ensure that they are conducted in a timely manner; and
• Hiring additional staff, including external experts, to enhance the performance, documentation and monitoring of such controls. This includes providing training for control owners setting out expectations as it relates to the control risk and

design, execution and monitoring of such controls, including enhancements to the documentation to evidence the execution of the control.

We believe we are making progress toward achieving effectiveness of our internal control over financial reporting. The actions that we are taking are subject to ongoing management review and audit committee oversight. We will not be able to conclude whether the steps we are taking will fully remediate the material weaknesses in our internal control over financial reporting until we have completed our remediation efforts and subsequently evaluated their design and effectiveness over a sufficient period of time, and management concludes, through testing, that these controls are operating effectively. We may also conclude that additional measures are required to remediate the material weaknesses in our internal control over financial reporting.

Changes in Internal Control

Except for the material weaknesses described above, there have been no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Exchange Act Rule 13a-15 or Rule 15d-15 that occurred in the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

The matters discussed in this Quarterly Report on Form 10-Q include forward-looking statements that involve risks or uncertainties. These statements are neither promises nor guarantees, but are based on various assumptions by management regarding future circumstances, over many of which Repligen has little or no control. A number of important risks and uncertainties, including those identified under the caption “Risk Factors” in Part I, Item 1A of our Form 10-K for the period ended December 31, 2024 and in subsequent filings, could cause our actual results to differ materially from those in the forward-looking statements. There are no material changes to the risk factors described in our Form 10-K for the period ended December 31, 2024.