Repligen Corp: Form 10-Q for the period ended Sep 30, 2026

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 (“CDMOs”) and other life sciences companies (integrators) – face critical production cost, capacity, quality and time pressures. Our products help enable customers to address these concerns, both accelerating development and improving yields. We are committed to inspiring advances in bioprocessing as a trusted partner in the production of critical biologic drugs – including monoclonal antibodies (“mAbs”) and mAb derivatives like antibody drug conjugates, recombinant proteins, RNA-based therapeutics and vaccines and cell and gene therapies – that are improving human health worldwide. 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, 2025, which was filed with the Securities and Exchange Commission (“SEC”) on February 26, 2026 (“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 commercial leverage) 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.

On February 20, 2026, the U.S. Supreme Court rendered a decision invalidating tariffs imposed by the Trump administration under the International Emergency Economic Powers Act (“IEEPA”). This decision introduces uncertainty regarding future trade policy actions and could impact our cost structure and supply-chain planning. We will continue to monitor the effects of tariffs implemented by the Trump administration and the potential imposition of modified or additional tariffs.

Acquisitions

On October 6, 2026, we completed our previously announced acquisition of BioLife Solutions, Inc. (“BioLife”), a company focused on developing cell processing tools and services for the cell and gene therapy market, for approximately $1.9 billion, comprised of approximately 7.2 million shares in our common stock and approximately $564 million in cash on hand. Following the acquisition, BioLife operates as our wholly owned subsidiary under the name “BioLife Solutions, LLC.” BioLife brings a differentiated portfolio of products including a market-leading bio- preservation media platform and other cell processing tools, expanding our presence in the cell therapy market. We will account for the acquisition in the fourth quarter of 2026. See Note 14, “Subsequent Events,” included in Part I, Item 1, “Financial Statements,” in this Quarterly Report on Form 10-Q.

On March 4, 2025, we completed our acquisition of 908 Devices Inc.’s (“908 Devices”) desktop portfolio of four devices for bioprocessing process analytical technology applications (“PAT Portfolio,” together with 908 Devices, the “908 Devices PAT Portfolio”). In connection with the transaction, we 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. The addition of these desktop assets complements and strengthens our differentiated PAT Portfolio that provides its biopharmaceutical and CDMO customers with actionable insights to optimize development processes and improve manufacturing efficiencies.

Critical Accounting Policies and Estimates

The preparation of our financial statements and related disclosures require us to make estimates, assumptions and judgments. There have been no material changes to our critical accounting policies since December 31, 2025. 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 our financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and the related footnotes in this Quarterly Report on Form 10-Q. All dollar and percentage changes made herein refer to the three and nine months ended September 30, 2026, compared with the three and nine months ended September 30, 2025, unless otherwise noted. Certain prior year amounts have been reclassified to conform with the current year presentation.

Revenues

Total revenues for the three and nine months ended September 30, 2026 and 2025 were as follows:

(Amounts in thousands)

Product revenues

During the three and nine months ended September 30, 2026, product revenue increased by $20.5 million, or 10.9%, and $67.3 million, or 12.5%, respectively, as compared to the same period in 2025. This growth is widespread across our portfolio of products and includes contributions from all our franchises.

During the three months ended September 30, 2026, product revenue increased 27.9% in Europe and 6.3% in North America, and decreased 3.2% in Asia Pacific and the rest of the world. During the nine months ended September 30, 2026, product revenue increased 19.6% in Asia Pacific and the rest of the world, 13.5% in Europe and 9.5% in North America.

Product revenues were comprised of the following:

(Amounts in thousands)

Royalty and other revenues

Royalty and other revenues in the three and nine months ended September 30, 2026, and 2025 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, 2026, and 2025 were comprised of the following:

(Amounts in thousands)

Cost of goods sold

During the three and nine months ended September 30, 2026, cost of goods sold increased by $10.0 million, or 11.4%, and $22.9 million, or 9.0%, respectively, compared to the same period in 2025. Gross margin decreased to 53.0% for the three months ended September 30, 2026, compared to 53.2% for the same period in 2025. Gross margin increased to 54.2% for the nine months ended September 30, 2026, compared to 52.7% for the same period in 2025. The increase in cost of goods sold is primarily driven by higher product sales compared to the same periods in 2025, partially offset by improved leverage on indirect labor and overhead. The decrease in gross margin during the three months ended September 30, 2026, is primarily driven by unfavorable product mix, partially offset by improved leverage on indirect labor and overhead. The increase in gross margin during the nine months ended September 30, 2026, is driven by favorable product mix and improved leverage on indirect labor and overhead.

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 $0.3 million, or 1.8%, and $3.1 million, or 7.6%, respectively, during the three and nine months ended September 30, 2026, as compared to the same periods in 2025. The primary driver of the increase in R&D costs during the three and nine months ended September 30, 2026, is incremental R&D personnel expenses from the 908 Devices PAT Portfolio acquisition.

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 increased by $9.9 million, or 13.5%, and $21.5 million, or 10.0%, respectively, during the three and nine months ended September 30, 2026, as compared to the same periods in 2025. The primary drivers of the increase in SG&A costs is investment in personnel costs to support growth, driven by corporate reorganization efforts, and increased professional services fees, driven by recent acquisition activities.

Restructuring activities and other charges

Restructuring activities and other charges increased by $2.0 million, or 100%, and $2.0 million, or 49.5%, respectively, during the three and nine months ended September 30, 2026, as compared to the same periods in 2025.

During the first quarter of 2026, we initiated a series of restructuring activities to simplify the global manufacturing footprint of the organization and align our workforce to support long-term company growth. These activities will include a series of site optimization phases with the purpose of improving operating efficiency and are expected to be completed by the end of 2027.

Prior period costs consist of restructuring activities we started in 2023 to simplify and streamline our organization and strengthen the overall effectiveness of operations. The activities continued into 2024 and 2025 and included consolidating a portion of the manufacturing operations between certain U.S. locations, writing-off abandoned equipment with the rationalization of excess production line capacity and discontinuing the sale of certain product SKUs. We do not expect further costs related to these actions.

Intangible asset impairment charges

Intangible asset impairment charges increased by $41.2 million, or 100%, during the three and nine months ended September 30, 2026, as compared to the same periods in 2025.

During the three months ended September 30, 2026, we identified an impairment indicator related to certain definite-lived intangible assets, specific to an intellectual property license agreement, and performed an impairment analysis. Following this analysis, these definite-lived intangible assets were determined to be a separate asset group. As a result, we determined the developed-technology intangible assets related to the intellectual property license agreement were impaired and recorded a $41.2 million impairment charge, included within intangible asset impairment charges on the condensed consolidated statements of comprehensive income or loss.

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 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 or loss.

Other income (expense), net

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

(Amounts in thousands)

Investment income

Investment income includes income earned on cash, cash equivalents and marketable securities. Our investment income increased by $0.1 million and decreased by $1.0 million for the three and nine months ended September 30, 2026, respectively, as compared to the same periods in 2025 due to changes 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 $0.9 million for the three and nine months ended September 30, 2026, respectively, as compared to the same periods in 2025. Interest expense includes contractual coupon interest on the 2023 Notes, as defined below, 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. See Note 8, “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 2023 Notes, as defined below, are amortized and recorded within amortization of debt issuance costs on the condensed consolidated statements of comprehensive income or loss.

Loss on sale of business

On March 30, 2026, we completed the sale of Polymem S.A.S. (“Polymem”) for total consideration of $3.6 million, net of cash divested. We recognized a net loss on the sale of business of $13.7 million during the nine months ended September 30, 2026.

Other income (expense), net

Other income (expense), net increased by $2.7 million and decreased by $1.5 million for the three and nine months ended September 30, 2026, respectively, as compared to the same periods in 2025. Other income (expense), 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

Income tax provision for the three and nine months ended September 30, 2026, and 2025 was as follows:

(Amounts in thousands)

For the three and nine months ended September 30, 2026, we recorded an income tax provision of $11.6 million and $14.2 million, respectively. The effective tax rate was (43.4)% and (130.6)% for the three and nine months ended September 30, 2026, respectively, and is based upon the estimated income for the year ending December 31, 2026, and the composition of income in different jurisdictions.

The difference in effective tax rates between the periods was primarily due to the Polymem divestiture and intangible asset impairment charges. Our effective tax rate for the three months ended September 30, 2026, was lower than the U.S. statutory rate of 21% primarily due to additional discrete expense related to the Polymem divestiture and intangible asset impairment charges. Our effective tax rate for the nine months ended September 30, 2026, was lower than the U.S. statutory rate of 21% primarily due to the Polymem divestiture and intangible asset impairment charges.

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. The following table shows sources of liquidity for the periods presented:

(Amounts in thousands)

On December 14, 2023, we 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”).

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.

The conditional conversion features of the 2023 Notes were not triggered during the calendar quarter ended September 30, 2026, therefore, the 2023 Notes are not convertible during the calendar quarter ended December 31, 2026, pursuant to the applicable last reported sales price conditions, as stated in the indenture governing the 2023 Notes.

Cash Flows

(Amounts in thousands)

Operating activities

For the nine months ended September 30, 2026, our operating activities provided cash of $104.2 million reflecting net loss of $25.1 million and non-cash charges totaling $164.2 million primarily related to depreciation and intangible amortization, intangible asset impairment charges, loss on sale of Polymem, stock-based compensation, operating lease right of use asset amortization and amortization of debt discount and issuance costs, partially offset by changes in deferred income taxes, net and other non-cash items.

The non-cash charges were partially offset by unfavorable changes in working capital of $35.0 million. This is primarily driven by increases in inventories of $16.1 million, increases in prepaid expenses and other current assets of $3.7 million, decreases in operating lease liabilities of $18.8 million, primarily due to normal course rent payments and net decreases in accounts payable and accrued liabilities of $3.0 million due to timing of payments to vendors and compensation. These are partially offset by decreases in accounts receivable of $3.4 million due to timing of sales and receipts from customers. 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, 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, increases in accounts receivable of $7.3 million due to timing of sales and receipts from customers, increases in prepaid expenses and other current assets of $5.5 million, and increases in inventories of $5.3 million. These are partially offset by net increases 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 unfavorable changes in various other working capital accounts.

Investing activities

Our investing activities provided cash of $57.9 million during the nine months ended September 30, 2026, which was primarily driven by increased maturities and sales of marketable securities of $271.1 million, compared to purchases of marketable securities of $200.5 million and proceeds received, net of cash divested from our sale of Polymem of $3.6 million. These are partially offset by capital expenditures of $16.3 million, inclusive of $1.3 million of capitalized costs related to our internal-use software.

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

Financing activities

Our financing activities provided cash of $2.9 million for the nine months ended September 30, 2026, which was primarily driven by proceeds received from exercise of stock options of $15.9 million, partially offset by cash disbursed related to the tax withholding obligation on vesting of restricted stock units of $7.8 million and cash payments for a portion of the contingent earnout obligation related to the acquisition of Tantti of $5.2 million.

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.

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;
• conversion or refinancing efforts related to the 2023 Notes or other forms of indebtedness;
• the extent of any share repurchase activity;
• the success of any proposed financing efforts;
• general economic and capital markets;
• 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.

On October 29, 2026, we entered into privately negotiated exchange and subscription agreements with certain holders of our outstanding 1.00% Convertible Senior Notes due 2028 and certain new investors. Pursuant to the agreements, we expect to issue $1.0 billion aggregate principal amount of 0.25% Convertible Senior Notes due 2031 (the “New Notes”). Approximately $541.4 million principal amount of the New Notes will be issued in exchange for approximately $456.8 million principal amount of 2028 Notes (the “Exchange Transactions”) and approximately $458.6 million principal amount of the New Notes will be issued for cash (the “Subscription Transactions”, and together with the Exchange Transactions, the “Transactions”). In connection with the issuance of the New Notes, we intend to use approximately $120.0 million of the net proceeds from the Subscription Transactions to repurchase shares of its common stock from certain purchasers of the New Notes. The transactions are expected to close in November 2026, subject to customary closing conditions.

On October 6, 2026, we completed the acquisition of BioLife pursuant to the Merger Agreement entered into on July 21, 2026, for approximately $1.9 billion, comprised of approximately 7.2 million shares in our common stock and approximately $564 million in cash. We funded the cash portion of the consideration with cash and cash equivalents on hand.

Aside from items discussed herein, there have been no other material changes to our future capital requirements or contractual obligations disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 26, 2026.

Absent acquisitions of additional businesses, products, product candidates or intellectual property not reflected herein, we believe our current liquidity and future cash flow from operations are adequate to meet our cash needs for at least one year from this Quarterly Report on 10-Q. We expect operating expenses in 2026 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, continued investment in our intellectual property portfolio and financing activities to service our outstanding convertible notes.

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 licensing, acquiring or investing in products, technologies or businesses that would complement our existing portfolio. We continue to seek to acquire or invest in such potential assets that may offer us the best opportunity to create value for our shareholders. In order to do so, 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, for example, due to acquisition-related financing needs, servicing of our outstanding indebtedness or lower demand for our products, among potential other events, 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.

Our future capital requirements and the adequacy of available funds will depend on many factors, including those described herein and in our other filings with the SEC, including those set forth in Part I, Item 1A, Risk Factors in our 10-K for the year ended December 31, 2025.

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, cash equivalents and restricted cash

The effect of exchange rate changes on cash during the three and nine months ended September 30, 2026, 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.

Net Operating Loss Carryforwards

At December 31, 2025, we had federal net operating loss carryforwards of $7.5 million, state net operating loss carryforwards of $15 million, and foreign net operating loss carryforwards of $27.4 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 2045. Approximately $5.7 million of the foreign net operating loss carryforwards have unlimited carryforward periods and do not expire, while $21.7 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 $7.1 million available to reduce future federal and state income taxes. The business tax credit carryforwards will expire at various dates through 2045. 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 federal securities laws, including 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 the Company’s acquisitions and divestitures, 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, constitute forward-looking statements. 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, including the anticipated synergies and other benefits of the BioLife transaction; our ability to complete pending acquisitions; 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 and in Part II, Item 1A of this Quarterly Report on Form 10-Q. We assume no obligation to update any forward-looking information contained in this Form 10-Q, except as required by law.

There have been no material changes to our market risk exposures since December 31, 2025. 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, 2025, which was filed with the Securities and Exchange Commission on February 26, 2026.

Disclosure Controls and Procedures

The Company’s management is responsible for establishing and maintaining adequate disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934 (“Exchange Act”)). Disclosure controls and procedures 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, 2026, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures 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, 2025, which was filed with the Securities and Exchange Commission on February 26, 2026 (“Form 10-K”). 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:

• 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.

• 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, 2026, the Company has not remediated these material weaknesses. In connection with the remediation plan previously disclosed in the Form 10-K, the Company performed remediation activities during the nine months ended September 30, 2026, as detailed below.

Remediation Plans

IT General Controls - During the nine months ended September 30, 2026, our remediation activities included the following with respect to IT general controls:

• Continued execution of controls that we worked to improve during fiscal year 2025 that did not have a sufficient period of time to demonstrate operating effectiveness as of December 31, 2025;
• Engaging third-party experts to assist in certain aspects of the remediation plan;
• Redesigning certain existing controls with additional attributes to mitigate the presumed IT risk relevant to the control;
• Evaluating, enhancing, and adding personnel in the IT organization with a focus on the requisite experience in the areas of internal control compliance; and
• Assessing and identifying areas within logical access where supplemental tools can be implemented to enhance role security and logical access controls compliance.

Business process-level controls related to inventory valuation and the financial statement close process - During the nine months ended September 30, 2026, our remediation activities included the following with respect to certain business process-level controls related to inventory valuation and the financial statement close process:

• Continued execution of controls that we worked to improve during fiscal year 2025 that did not have a sufficient period of time to demonstrate operating effectiveness as of December 31, 2025;
• Redesigning and executing enhanced controls related to inventory valuation;
• Engaging third-party experts to assist in certain aspects of the remediation plan;
• Initiating the implementation of software tools in fiscal year 2026 to support control monitoring activities and the retention of control documentation; and
• Provided ongoing training related to internal control over financial reporting for control owners.

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, 2026, 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, 2025, and in subsequent filings, could cause our actual results to differ materially from those in the forward-looking statements. The information presented below supplements the risks and uncertainties identified under the caption “Risk Factors” in Part I, Item 1A of our Form 10-K for the period ended December 31, 2025.

We may be unable to successfully and efficiently integrate BioLife’s business into the Repligen enterprise, which could adversely affect our business, financial condition and results of operations.

Our ability to realize the anticipated benefits of the acquisition of BioLife depends on the successful and efficient integration of BioLife’s business into our existing business. The integration process may require significant management attention and resources and could result in unforeseen difficulties, delays or costs. We may also be unable to retain key employees or realize the anticipated cost savings or synergies from the acquisition. Such integration efforts, whether successful or not, could divert BioLife and Repligen management’s attention from ongoing business operations and other opportunities and could give rise to adverse reactions or changes to business or employee relationships. If we are unable to successfully integrate BioLife’s operations and realize the anticipated benefits of the acquisition, our business, financial condition and results of operations could be materially adversely affected.

Our assumptions around the size and trajectory of the cell therapy market and BioLife’s market position may prove to be incorrect, which, along with other risks and uncertainties related to the BioLife transaction, could materially and adversely affect our business and financial results.

Other risks and uncertainties related to the BioLife transaction that could materially and adversely affect our business and financial results include the risk that the parties have overestimated the size or trajectory of the cell therapy market and BioLife’s market position, as well as the possibility that the anticipated financial impact and revenue growth of the transaction will not be realized when expected or at all, including as a result of the impact of, or problems arising from, the integration of the two companies or as a result of the strength of the economy and competitive factors in the areas where we and BioLife do business; the outcome of any legal proceedings that may be instituted against us or BioLife in connection with the transaction or otherwise; and the potential for increased regulatory scrutiny and the impact on the clinical pipeline, global approvals and expanded indications.