Emergent BioSolutions Inc.: Form 10-Q for the period ended Sep 30, 2025

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and accompanying notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q includes information with respect to our plans and strategy for our business and financing, as well as forward-looking statements that involve risks and uncertainties. You should carefully review the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in this Quarterly Report on Form 10-Q for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

BUSINESS OVERVIEW

Emergent BioSolutions Inc. (“Emergent,” the “Company,” “we,” “us,” and “our”) is a global life sciences company focused on providing innovative preparedness and response solutions addressing accidental, deliberate, and naturally occurring Public Health Threats (“PHTs”). The Company’s solutions include a product portfolio, a product development portfolio, and a contract development and manufacturing services (“CDMO”) portfolio.

We are currently focused on the following four PHT categories: chemical, biological, radiological, nuclear and explosives (“CBRNE”); emerging infectious diseases (“EID”); emerging health crises; and acute, emergency and community care. We have a portfolio of 11 products, 10 of which are owned by the Company, that contribute a substantial portion of our revenue and are sold to government and commercial customers. Additionally, we have a development pipeline consisting of a diversified mix of both pre-clinical and clinical stage product candidates. Finally, we have a fully integrated portfolio of CDMO services which cover development services, drug substance manufacturing and drug product manufacturing and packaging.

The Company structures the business with a focus on markets and customers. As such, the key components of the business structure include the following four product and service categories: Anthrax - Medical Countermeasures (“MCM”) products, Naloxone commercial products, Smallpox - MCM products and Emergent Bioservices (CDMO) (“Bioservices”).

The Company manages the business with a focus on three operating segments: (1) a Commercial Products segment consisting of NARCAN® Nasal Spray and KLOXXADO® Nasal Spray, (2) a MCM Products segment consisting of Anthrax - MCM, Smallpox - MCM and Other Products and (3) a Services segment consisting of our Bioservices offerings. Commercial Products and MCM Products are our two reportable segments (see Note 17, “Segment information” in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1, of this Form 10-Q for more information on our reportable segments).

Commercial Products Segment:

The majority of our Commercial product revenue comes from the following products:

Naloxone Products

• NARCAN® (naloxone HCl) Nasal Spray, an intranasal formulation of naloxone approved by the United States Food and Drug Administration (“FDA”) (including in over-the-counter (“OTC”) form) and Health Canada for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression.
• KLOXXADO® (naloxone HCl) Nasal Spray. On January 14, 2025, the Company announced an agreement with Hikma Pharmaceuticals Inc. (“Hikma”) in which the Company obtained exclusive commercial rights for product sales and marketing in the United States and Canada to Hikma’s KLOXXADO® (naloxone HCl) Nasal Spray, an 8 mg naloxone agent.

MCM Products Segment:

The majority of our MCM product revenue comes from the following products and procured product candidates:

Anthrax - MCM Products

• Anthrasil® (Anthrax Immune Globulin Intravenous (human)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs;
• BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the for the general use prophylaxis and post-exposure prophylaxis of anthrax disease;
• CYFENDUS® (Anthrax vaccine adsorbed (AVA), adjuvanted), previously known as AV7909, which was recently approved by the FDA for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. CYFENDUS® is procured by certain authorized government buyers for their use; and
• Raxibacumab injection, the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax.

Smallpox - MCM Products

• ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live), the only single-dose smallpox vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection;
• CNJ-016® (Vaccinia Immune Globulin Intravenous (Human) (VIGIV)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination; and
• TEMBEXA®, an oral antiviral formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks which has been approved by the FDA for the treatment of smallpox disease caused by variola virus in adult and pediatric patients, including neonates.

Other Products

• BAT® (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)), the only heptavalent antitoxin licensed by the FDA and Health Canada for the treatment of symptomatic botulism; and
• Ebanga™ (ansuvimab-zykl), a monoclonal antibody with antiviral activity provided through a single IV infusion for the treatment of Ebola. Under the terms of a collaboration with Ridgeback Biotherapeutics ("Ridgeback"), Emergent will be responsible for the manufacturing, sale, and distribution of Ebanga™ in the U.S. and Canada, and Ridgeback will serve as the global access partner for Ebanga™.

Trobigard Revocation

On April 2, 2024, the Belgium Federal Agency for Medicines and Health Products (“FAMHP”) acknowledged and confirmed Emergent’s request to revoke the Market Authorization for the Trobigard Auto-Injector.

Sale of RSDL®

On July 31, 2024, the Company entered into the Stock and Asset Purchase Agreement (the “RSDL® Agreement”) with SERB Pharmaceuticals, through its wholly owned subsidiary BTG International Inc. (collectively, “SERB”), pursuant to which, among other things, the Company sold its worldwide rights to RSDL®, to SERB (the “RSDL® Transaction”). See Note 4, “Divestitures” in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1, of this Form 10-Q for more information on the sale of RSDL®.

Services Segment:

As of the first quarter of 2025, the Company’s Services operating segment no longer met the quantitative thresholds of a reportable segment and did not meet the aggregation criteria set forth in Accounting Standards Codification 280, Segment Reporting, and as such is categorized within “All other revenues” along with “Contracts and Grants”. See Note 17, “Segment information” in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1, of this Form 10-Q for more information about the Company’s reportable segments.

Other Strategic Activities

May 2024 Organizational Restructuring Plan

In May 2024, the Company initiated the May 2024 Plan. These strategic actions led to a reduction of the Company’s workforce by approximately 300 employees across all areas of the Company and the elimination of approximately 85 positions that were vacant, as well as the closure of the Company’s Baltimore-Bayview Drug Substance manufacturing facility and Rockville, Maryland Drug Product facility. Decisions regarding the elimination of positions and the closure of manufacturing facilities were subject to local law and consultation requirements in certain countries, as well as the Company’s business needs. The cumulative amount of restructuring charge related to the May 2024 Plan since inception is $18.5 million. All activities related to the May 2024 Plan were substantially completed during the third quarter of 2024. Restructuring costs are recognized as an operating expense within the Condensed Consolidated Statement of Operations and are classified based on the Company's classification policy for each category of operating expense.

Development milestone payments for CHIKV VLP

On July 18, 2024, Bavarian Nordic announced that the European Medicines Agency had validated the marketing authorization application for CHIKV VLP, which was submitted in June 2024. This approval triggered a milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $10.0 million.

On August 13, 2024, Bavarian Nordic announced that the FDA has accepted and granted priority review for the Biologics License Application for CHIKV VLP, which triggered a milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $20.0 million.

On February 14, 2025, Bavarian Nordic announced that the FDA approved CHIKV VLP under the Priority Review, which triggered a development milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $30.0 million.

On February 28, 2025, Bavarian Nordic announced that the European Commission approved CHIKV VLP, which triggered a development milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $20.0 million.

August 2024 Organizational Restructuring Plan

In August 2024, the Company initiated an organizational restructuring plan (the “August 2024 Plan”) at the Company’s Lansing facility, which reduced the Company’s workforce by approximately 70 employees, as well eliminated several open positions. The Company also implemented non-labor optimization efforts, such as reducing the Company’s external and vendor spend. The cumulative amount of restructuring charges related to the August 2024 Plan since inception is $2.5 million. All activities related to the August 2024 Plan are expected to be substantially completed during the fourth quarter of 2024. Restructuring costs are recognized as an operating expense within the Condensed Consolidated Statement of Operations and are classified based on the Company's classification policy for each category of operating expense.

Exclusive commercial rights to KLOXXADO® distribution in U.S. and Canada

On January 14, 2025, the Company announced an agreement with Hikma in which the Company obtained exclusive commercial rights for product sales and marketing in the United States and Canada to Hikma’s KLOXXADO® (naloxone HCl) Nasal Spray, an 8 mg naloxone agent.

Securities and shareholder litigation

On September 12, 2024, the Company and the lead plaintiffs in stockholder litigation against the Company entered into an agreement in principle to settle the claims against the Company and each of the Company’s current and former officers and directors. On October 4, 2024, the Court granted preliminary approval of the proposed settlement, ordered notice to the settlement class and scheduled a fairness hearing for February 27, 2025. On February 27, 2025, the court granted final approval of a settlement between the Company and the lead plaintiffs. Under the settlement, the claims against the Company and its officers and directors were dismissed with prejudice and released in exchange for a payment from the Company of $40.0 million, $30.0 million of which was paid from insurance proceeds, and was funded in the fourth quarter of 2024. The Company recorded the settlement and insurance recoverable amounts as pre-tax operating expense and income, respectively, within “Selling, general and administrative” expenses on the Consolidated Statement of Operations for the year ended December 31, 2024.

Sale of Baltimore-Bayview Facility

On March 19, 2025, the Company completed the sale of its Baltimore-Bayview drug substance manufacturing facility to Syngene International (“Syngene”). At closing, Syngene paid a cash purchase price of approximately $36.5 million, which is subject to customary post-closing adjustments. Pursuant to the sale, Syngene acquired the assets and equipment associated with the Baltimore-Bayview facility. In addition, Emergent retains the rights to secure manufacturing services and capacity at the facility for future growth and pandemic response production in collaboration with Syngene. See Note 4, “Divestitures” in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1, of this Form 10-Q for further discussion.

August 2025 Settlement

On March 7, 2025, plaintiffs Lincolnshire and Pooja Sayal filed a motion in the United States District Court for the District of Maryland seeking preliminary approval of a stipulation of settlement with regard to the putative shareholder derivative lawsuits filed in 2021 and 2022 (“Proposed Settlement”). The Proposed Settlement provided that Defendants must cause their insurers to pay to the Company a settlement amount of $15.0 million, less a court-approved fee and expense amount (the “Settlement Amount”). On May 9, 2025, the United States District Court for the District of Maryland (the “Court”) issued an order granting preliminary approval of the Proposed Settlement. On August 6, 2025, the Court granted final approval of the Proposed Settlement without modification. The Company received the Settlement Amount in September 2025. Accordingly, during the three and nine months ended September 30, 2025, the Company recorded $10.5 million with respect to the Settlement Amount as a reduction of “Selling, general and administrative” expenses on the Condensed Consolidated Statement of Operations.

2025 Share Repurchase Program

On March 31, 2025, the Company announced that its Board of Directors had authorized the repurchase of up to $50.0 million of the Company’s common stock (the “2025 Share Repurchase Program”) on or before March 27, 2026. During the three and nine months ended September 30, 2025, the Company utilized $8.9 million and $15.8 million to repurchase 1.1 million and 2.3 million shares, respectively, at an average price of $7.87 and $7.00 per share, excluding commissions and excise taxes, respectively. As of September 30, 2025, the Company had $34.2 million available to repurchase shares under the 2025 Share Repurchase Program.

Senior Unsecured Note Repurchases

The Board has authorized the Company to use up to $30.0 million to repurchase Senior Unsecured Notes in open market purchases, privately negotiated transactions or otherwise. During the three and nine months ended September 30, 2025, there was $6.9 million in principal repurchases of the Company’s Senior Unsecured Notes for $5.8 million in cash, including fees, and the Company recognized a gain on extinguishment of approximately $1.1 million. As of September 30, 2025, the Company had $23.1 million available to repurchase additional Senior Unsecured Notes.

FINANCIAL OPERATIONS OVERVIEW

Revenues

We generate Commercial Product revenues through the sale of Naloxone products, primarily NARCAN® Nasal Spray, which is sold commercially over-the-counter at retail pharmacies and digital commerce websites as well as through physician-directed or standing order prescriptions at retail pharmacies, health departments, local law enforcement agencies, community-based organizations, substance abuse centers and other federal agencies, as well as KLOXXADO® Nasal Spray, which is currently being integrated into our distribution network, NARCANDirect®. We generate MCM Product revenues from the sale of our marketed products and procured product candidates. The U.S. government (“USG”) is the largest purchaser of our Government - MCM products and primarily purchases our products for the Strategic National Stockpile, a national repository of medical countermeasures including critical antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. The USG primarily purchases our products under long-term, firm fixed-price procurement contracts, generally with annual options.

We also generate revenue from our Services segment through our Bioservices portfolio, which is based on our established development and manufacturing infrastructure, technology platforms and expertise. Our services include a fully integrated molecule-to-market Bioservices business offering across development services, drug substance and drug product for small to large pharmaceutical and biotechnology industry and government agencies/non-governmental organizations. From time to time, clients require suite reservations at our various manufacturing sites, which may be considered leases depending on the facts and circumstances.

We have received contracts and grant funding from the USG and other non-governmental organizations to perform R&D activities, particularly related to programs addressing certain CBRNE threats and EIDs.

Our revenue, operating results and profitability vary quarterly based on the timing of production and deliveries, the timing of manufacturing services performed and the nature of our business, which involves providing large scale bundles of products and services as needs arise. We expect continued variability in our quarterly financial results.

Cost of Product Sales and Services

Commercial and MCM Products - The primary expenses that we incur to deliver our Naloxone and MCM products consist of fixed and variable costs. We determine the cost of product sales for products sold during a reporting period based on the average manufacturing cost per unit in the period those units were manufactured. Fixed manufacturing costs include facilities, utilities and amortization of intangible assets. Variable manufacturing costs primarily consist of costs for materials and personnel-related expenses for direct and indirect manufacturing support staff, contract manufacturing operations, sales-based royalties, shipping and logistics. In addition to the fixed and variable manufacturing costs described above, the cost of product sales depends on utilization of available manufacturing capacity. For our commercial sales, other associated expenses include sales-based royalties, shipping, and logistics.

Services - The primary expenses that we incur to deliver our Bioservices offerings consist of fixed and variable costs, including personnel, equipment, and facilities costs. Our manufacturing process includes the production of bulk material and performing drug product work for containment and distribution of biological products. For drug product customers, we receive work in process inventory to be prepared for distribution.

Research and Development ("R&D") Expenses

We expense R&D costs as incurred. Our R&D expenses consist primarily of:

• personnel-related expenses;
• fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies;
• costs associated with technology transfer and scale up activities throughout the development stage, including internally and through third-party contract manufacturers;
• costs of Bioservices for our clinical trial material; and
• costs of materials intended for use and used in clinical trials and R&D.

In many cases, we seek funding for development activities from external sources and third parties, such as governments and non-governmental organizations, or through collaborative partnerships. We expect our R&D spending will be dependent upon such factors as the results from our clinical trials, the availability of reimbursement of R&D spending, the number of product candidates under development, the size, structure and duration of any clinical programs that we may initiate, the costs associated with manufacturing and development of our product candidates on a large-scale basis for later stage clinical trials, and our ability to use or rely on data generated by government agencies.

Selling, General and Administrative Expenses

Selling, general and administrative (“SG&A”) expenses consist primarily of personnel-related costs and professional fees in support of our executives, sales and marketing, business development, government affairs, finance, accounting, information technology, legal, human resource functions and other corporate functions. Other costs include facility costs not otherwise included in cost of product sales and Bioservices or R&D expense.

Income taxes

Uncertainty in income taxes is accounted for using a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We recognize in our financial statements the impact of a tax position if that position is more likely than not of being sustained on audit, based on the technical merits of the position.

Changes in tax laws, rulings, policies, or related legal and regulatory interpretations occur frequently and may have significant favorable or adverse impacts on our effective tax rate. In 2021, the Organization for Economic Cooperation and Development released model rules for a 15% global minimum tax applied to cross-border profits of certain large multinational corporations, known as Pillar Two. Pillar Two has now been enacted by approximately 36 countries, including Ireland. This minimum tax is treated as a period cost beginning in 2024 and its impact is included on the Company's financial results of operations for the current period. The Company is monitoring legislative developments, as well as additional guidance from countries that have enacted legislation.

Management believes that the assumptions and estimates related to the provision for income taxes are critical to the Company’s results of operations.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted into law in the United States. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. These impacts did not have a material effect on the tax rate for the three and nine months ended September 30, 2025.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

The preparation of our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S., requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. Actual results may differ from these estimates. There have been no significant changes to our critical accounting policies and estimates contained in “Critical Accounting Policies and Estimates” in Management’s Discussion and Analysis of Financial Condition and Results of Operations, in Part II, Item 7, of the 2024 Form 10-K, as filed with the SEC.

New accounting standards

For a discussion of new accounting standards please see Note 2, “Summary of significant accounting policies”, in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1, of this Quarterly Report on Form 10-Q.

RESULTS OF OPERATIONS

Operating Results:

(in millions, except %)

42

Three Months Ended September 30, 2025 Compared with Three Months Ended September 30, 2024

Revenues and gross margin

(dollars in millions)

Total revenues decreased $62.7 million, or 21%, to $231.1 million for the three months ended September 30, 2025. The decrease was due to decreases in MCM Products revenue of $31.7 million, Commercial Products revenue of $20.4 million, Services revenue of $9.7 million, and Contracts and grants revenue of $0.9 million.

Intangible asset amortization was consistent at $16.3 million for the three months ended September 30, 2025 and 2024.

Gross margin decreased $25.1 million to $119.8 million for the three months ended September 30, 2025. Gross margin percentage increased 3 percentage points to 54% for the three months ended September 30, 2025. The decrease in gross margin was due to decreases in MCM Products gross margin and Commercial Products gross margin of $15.8 million each, partially offset by an increase in Services gross margin of $6.5 million. Gross margin and gross margin percentage exclude Contracts and grants revenues because the related costs are R&D expenses.

See "Reportable Segment Results" for an expanded discussion of revenues and gross margin.

Unallocated corporate operating expenses

R&D Expenses

R&D expenses decreased $0.3 million, or 2%, to $13.5 million for the three months ended September 30, 2025. The decrease was primarily due to decreases in overhead and severance related costs, partially offset by an increase in unfunded R&D project spend and in development work related to EbangaTM.

SG&A Expenses

SG&A expenses decreased $37.7 million, or 49%, to $38.9 million for the three months ended September 30, 2025. The decrease was primarily due to the absence of a one-time expense of $10.0 million recognized in the prior year period and the receipt of a one-time reimbursement of $10.5 million in the current year period related to settlements of our securities and shareholder litigation matters. These non-recurring items were coupled with decreases in compensation and other employee related expenses as a result of the restructuring initiatives that began during the first quarter of 2023, and lower marketing, professional services and legal expenses. SG&A expenses as a percentage of total revenues decreased 9 percentage points to 17% for the three months ended September 30, 2025.

Impairment of Long-Lived Assets

Impairment of long-lived assets was consistent due to no impairment recognized during the three months ended September 30, 2025 and 2024.

Interest expense

Interest expense increased $6.9 million, or 83%, to $15.2 million for the three months ended September 30, 2025. The increase was primarily due to an increase in amortization of debt service costs and higher interest expense related to our Credit Agreement with OHA Agency LLC, as administrative agent, and the lenders from time to time party thereto (the “Term Loan Agreement”), partially offset by lower interest costs related to our prior syndicated borrowings.

Gain (loss) on sale of business and assets held for sale

Gain (loss) on sale of business and assets held for sale decreased $64.3 million, or 100%, due to no sale of business or held for sale activity occurring during the three months ended September 30, 2025. The gain in the prior year was related to the sale of RSDL® to SERB, partially offset by a reduction to the loss on the sale of the Company’s drug product facility in Baltimore-Camden to Bora, which was attributable to a net working capital adjustment payable to the Company.

Other, net

Other, net went from $21.9 million in income to $3.7 million in expense for the three months ended September 30, 2025. The change of $25.6 million, or 117%, is primarily related to one-time income associated with development milestone achievements related to CHIK VLP in the prior year period and a loss on remeasurement of the Warrant liability in the current year period, partially offset by a decrease in property, plant and equipment disposals and an increase in interest income.

Income tax provision

Income tax provision decreased $21.2 million, or 77%, to $6.4 million for the three months ended September 30, 2025. The decrease was primarily due to a change in jurisdictional mix of income and losses, and a decrease of profitability in the third quarter of 2025 relative to 2024.

Nine Months Ended September 30, 2025 Compared with Nine Months Ended September 30, 2024

Revenues and gross margin

(dollars in millions)

Total revenues decreased $254.7 million, or 30%, to $594.2 million for the nine months ended September 30, 2025. The decrease was due to lower Commercial Products revenue of $146.1 million, Services revenue of $81.3 million and MCM Products revenue of $35.5 million, partially offset by an increase in Contracts and grants revenue of $8.2 million.

Intangible asset amortization was consistent at $48.8 million for the nine months ended September 30, 2025 and 2024.

Gross margin increased $59.1 million to $271.3 million for the nine months ended September 30, 2025. Gross margin percentage increased 22 percentage points to 48% for the nine months ended September 30, 2025. The increase in gross margin was due to a $158.3 million improvement in Services gross margin driven by the accounting for the Settlement Agreement with Janssen in the prior year period, partially offset by a decrease of $96.9 million in Commercial Products gross margin and a decrease of $2.3 million in MCM Products gross margin. Gross margin and gross margin percentage exclude Contracts and grants revenues because the related costs are R&D expenses.

See "Reportable Segment Results" for an expanded discussion of revenues and gross margin.

Unallocated corporate operating expenses

R&D Expenses

R&D expenses decreased $20.5 million, or 33%, to $41.1 million for the nine months ended September 30, 2025. The decrease was primarily due to write-offs related to program terminations in the second quarter of 2024 and decreases in overhead and severance related costs in the current year. This decrease was partially offset by an increase in costs associated with the development work related to EbangaTM.

SG&A Expenses

SG&A expenses decreased $112.2 million, or 45%, to $135.0 million for the nine months ended September 30, 2025. The decrease was primarily due to declines in compensation and other employee related costs as a result of the restructuring initiatives that began during the first quarter of 2023 as well as lower professional services and legal fees related to general corporate initiatives in the prior year. The decline in SG&A was also due to the absence of a one-time expense of $10.0 million recognized in the prior year period and the receipt of a one-time reimbursement of $10.5 million in the current year period related to settlements of our securities and shareholder litigation matters as well as decreases in marketing spend. SG&A expenses as a percentage of total revenues decreased 6 percentage points to 23% for the nine months ended September 30, 2025.

Impairment of Long-Lived Assets

Impairment of long-lived assets decreased $27.2 million, or 100%, due to no impairment recognized during the nine months ended September 30, 2025. The $27.2 million non-cash impairment charge in the second quarter of 2024 was related to our Bayview and Rockville asset groups within the Bioservices reporting unit.

Interest expense

Interest expense decreased $11.6 million, or 21%, to $44.6 million for the nine months ended September 30, 2025. The decrease was primarily due to lower interest costs related to our prior syndicated borrowings, partially offset by higher interest expense related to our Term Loan Agreement and an increase in amortization of debt service costs.

Gain (loss) on sale of business and assets held for sale

Gain (loss) on sale of business and assets held for sale decreased $36.5 million, or 150%, to a $12.2 million loss for the nine months ended September 30, 2025. The loss on assets held for sale in the current period is related to warehouse space in Maryland and the gain on sale of business in the prior period is related to the sale of RSDL® to SERB, partially offset by a loss the sale of the Company’s drug product facility in Baltimore-Camden to Bora.

Other, net

Other, net increased from $15.8 million in income to $62.3 million in income for the nine months ended September 30, 2025. The change of $46.5 million is primarily attributable to the $20.0 million of incremental income from milestone payments received in 2025 versus 2024 related to the sale of our travel health business to Bavarian Nordic, combined with a favorable shift from prior-year asset sale losses to asset sale gains in the current year related to our Bayview facility, as well as favorable impacts from warrant valuations, interest income and foreign currency revaluations.

Income tax provision

Income tax provision decreased $17.7 million, or 40%, to $26.3 million for the nine months ended September 30, 2025. The decrease was primarily due to a change in jurisdictional mix of income and losses, reflecting a lower profitability in Ireland in the third quarter of 2025 relative to 2024.

REPORTABLE SEGMENT RESULTS

COMMERCIAL PRODUCT SEGMENT

(dollars in millions)

Three Months Ended September 30, 2025 Compared with Three Months Ended September 30, 2024

Naloxone

Naloxone sales decreased $20.4 million, or 21%, to $74.9 million for the three months ended September 30, 2025. The decrease was primarily driven by lower sales of OTC NARCAN® and Canadian sales of branded NARCAN®, driven primarily by unfavorable pricing changes and unit volumes, partially offset by an increase in KLOXXADO® sales.

Cost of Product Sales and Gross Margin

Cost of Commercial Product sales decreased $4.6 million, or 10%, to $42.6 million for the three months ended September 30, 2025. The decrease was primarily due to lower sales of OTC NARCAN® and lower Canadian sales of branded NARCAN®, partially offset by an increase in KLOXXADO® sales.

Commercial Products gross margin decreased $15.8 million, or 41%, to $22.9 million for the three months ended September 30, 2025. Commercial Products gross margin percentage decreased 10 percentage points to 31% for the three months ended September 30, 2025. The decrease was largely due to lower sales of OTC NARCAN® and lower branded NARCAN® sales, as well as an unfavorable price and volume mix, partially offset by an increase in KLOXXADO® sales. Commercial Products segment adjusted gross margin in the current year period excludes the impact of intangible asset amortization of $9.4 million.

Nine Months Ended September 30, 2025 Compared with Nine Months Ended September 30, 2024

Naloxone

Naloxone sales decreased $146.1 million, or 44%, to $187.7 million for the nine months ended September 30, 2025. The decrease was primarily driven by lower sales of OTC NARCAN® and lower Canadian sales of branded NARCAN®, primarily driven by unfavorable pricing changes and unit volumes, partially offset by an increase in KLOXXADO® sales.

Cost of Product Sales and Gross Margin

Cost of Commercial Product sales decreased $49.2 million, or 32%, to $103.5 million for the nine months ended September 30, 2025. The decrease was primarily due to lower sales of OTC NARCAN® and lower Canadian sales of branded NARCAN®, partially offset by an increase in KLOXXADO® sales.

Commercial Products gross margin decreased $96.9 million, or 63%, to $55.9 million for the nine months ended September 30, 2025. Commercial Products gross margin percentage decreased 16 percentage points to 30% for the nine months ended September 30, 2025. The decrease was largely due to lower sales of OTC NARCAN® and lower branded NARCAN® sales, as well as an unfavorable price and volume mix, partially offset by an increase in KLOXXADO® sales. Commercial Products segment adjusted gross margin in the current year period excludes the impact of intangible asset amortization of $28.3 million and restructuring costs of $0.2 million.

MCM PRODUCTS SEGMENT

(dollars in millions)

48

Three Months Ended September 30, 2025 Compared with Three Months Ended September 30, 2024

Anthrax MCM

Anthrax MCM sales decreased $10.0 million, or 88%, to $1.4 million for the three months ended September 30, 2025. The decrease primarily reflects the impact of timing of USG sales of BioThrax® as well as timing of international sales of CYFENDUS® in the prior year period. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the USG. Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow.

Smallpox MCM

Smallpox MCM sales decreased $49.1 million, or 37%, to $83.6 million for the three months ended September 30, 2025. The decrease was primarily due to lower USG ACAM2000® and CNJ-016® (VIGIV) sales due to timing, partially offset by an increase in international CNJ-016® (VIGIV), ACAM2000®, and TEMBEXA® sales. Fluctuations in revenues from Smallpox MCM result from the timing of the exercise of annual purchase options in the existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow.

Other Products

Other Products sales increased $27.4 million, or 91%, to $57.5 million for the three months ended September 30, 2025. The increase was primarily due to higher USG BAT® sales due to timing, partially offset by a decrease in international sales orders.

Cost of MCM Product Sales and Gross Margin

Cost of MCM product sales decreased $15.9 million, or 29%, to $38.1 million for the three months ended September 30, 2025. The decrease was primarily due to lower production costs of ACAM2000®, BioThrax®, and CNJ-016® (VIGIV) reflecting reduced volumes, combined with favorable manufacturing variances due to lower shut-down and severance costs, partially offset by an increase in costs related to higher BAT® sales volume.

MCM Product gross margin decreased $15.8 million, or 14%, to $97.5 million for the three months ended September 30, 2025. MCM Product gross margin percentage increased 3 percentage points to 68% for the three months ended September 30, 2025. The increase in gross margin percentage was primarily due to a favorable sales mix which was weighted more heavily towards higher margin products and a decrease in shutdown and severance related costs compared with the third quarter of 2024. MCM Product segment adjusted gross margin in the current year period excludes the impacts of intangible asset amortization of $6.9 million and restructuring costs of $0.2 million.

Nine Months Ended September 30, 2025 Compared with Nine Months Ended September 30, 2024

Anthrax MCM

Anthrax MCM sales decreased $45.1 million, or 43%, to $60.9 million for the nine months ended September 30, 2025. The decrease reflects the impact of the timing of USG sales of CYFENDUS® and BioThrax®, partially offset by increases due to timing of Canadian sales of Anthrasil® and an increase of BioThrax® international sales. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the USG. Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow.

Smallpox MCM

Smallpox MCM sales increased $29.8 million, or 15%, to $230.6 million for the nine months ended September 30, 2025. The increase was primarily due to higher ACAM2000® international sales due to foreign demand, coupled with increases in USG TEMBEXA® sales due to timing and CNJ-016® (VIGIV) international orders, partially offset by lower ACAM2000® USG sales due to timing. Fluctuations in revenues from Smallpox MCM result from the timing of the exercise of annual purchase options in the existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow.

Other Products

Other Products sales decreased $20.2 million, or 23%, to $66.0 million for the nine months ended September 30, 2025. The decrease was primarily due to no RSDL® product sales in the current year period due to the sale of RSDL® to SERB in the third quarter of 2024 and a decrease in BAT® foreign sales, partially offset by higher USG BAT® sales due to timing.

Cost of MCM Product Sales and Gross Margin

Cost of MCM product sales decreased $33.2 million, or 23%, to $114.1 million for the nine months ended September 30, 2025. The decrease was primarily due to lower production costs of CYFENDUS®, BioThrax® and ACAM2000® reflecting reduced volumes, as well as no RSDL® related costs in 2025 due to the sale of RSDL® to SERB in the third quarter of 2024, combined with favorable manufacturing variances mostly due to lower shut-down and severance costs and lower Raxibacumab inventory reserves. These decreases were partially offset by higher costs for Anthrasil®, TEMBEXA® and CNJ-016® (VIGIV) sales due to higher unit volume.

MCM Product gross margin decreased $2.3 million, or 1%, to $222.9 million for the nine months ended September 30, 2025. MCM Product gross margin percentage increased 5 percentage points to 62% for the nine months ended September 30, 2025. The increase in gross margin percentage was primarily due to a favorable sales mix which was weighted more heavily towards higher margin products and a decrease in shutdown and severance costs compared with the prior year period. MCM Product segment adjusted gross margin in the current year period excludes the impacts of intangible asset amortization of $20.5 million, inventory step-up provision of $1.8 million and restructuring costs of $(1.0) million.

ALL OTHER REVENUE

Three Months Ended September 30, 2025 Compared with Three Months Ended September 30, 2024

Services Revenues

Services revenues decreased $9.7 million, or 68%, to $4.6 million for the three months ended September 30, 2025. The decrease was primarily attributable to a decrease in revenue from the Company’s Camden facility in the current year period, which was sold to Bora in the third quarter of 2024, partially offset by an increase in production at the Company's Winnipeg facility.

Contracts and Grants

Contracts and grants revenue decreased $0.9 million, or 9%, to $9.1 million for the three months ended September 30, 2025. The decrease was due to declines in overall funded R&D projects, partially offset by an increase in development work in connection with EbangaTM.

Nine Months Ended September 30, 2025 Compared with Nine Months Ended September 30, 2024

Services Revenues

Services revenues decreased $81.3 million, or 83%, to $16.2 million for the nine months ended September 30, 2025. The decrease was primarily attributable to the one time $50.0 million arbitration settlement with Janssen related to the Settlement Agreement, coupled with a decrease in revenue from the Company’s Camden facility in the current year period, which was sold to Bora in the third quarter of 2024, partially offset by an increase in production at the Company's Winnipeg facility.

Contracts and Grants

Contracts and grants revenue increased $8.2 million, or 33%, to $32.8 million for the nine months ended September 30, 2025. The increase was due to development work in connection with EbangaTM, partially offset by a decrease in overall funded R&D projects.

Three Months Ended September 30, 2024 Compared with Three Months Ended September 30, 2023

Revenues and gross margin

(dollars in millions)

Total revenues increased $23.3 million, or 9%, to $293.8 million for the three months ended September 30, 2024. The increase was due to an increase in MCM Products revenue of $66.5 million and an increase in Services revenue of $0.1 million, partially offset by a decrease in Commercial Products revenue of $46.8 million.

Intangible asset amortization was consistent with the prior year period at $16.3 million for the three months ended September 30, 2024.

Gross margin increased $74.0 million, or 104%, to $144.9 million for the three months ended September 30, 2024. Gross margin percentage increased 24 percentage points to 51% for the three months ended September 30, 2024. The increase in gross margin was due to increases in Services gross margin of $23.0 million and MCM Products gross margin of $85.0 million, partially offset by a decrease in Commercial Products gross margin of $34.0 million. Gross margin and gross margin percentage exclude Contracts and grants revenues because the related costs are R&D expenses.

See "Reportable Segment Results" for an expanded discussion of revenues and gross margin.

Unallocated corporate operating expenses

R&D Expenses

R&D expenses decreased $1.5 million, or 10%, to $13.8 million for the three months ended September 30, 2024. The decrease was driven by a reduction in spend for certain funded and unfunded projects, excluding EbangaTM. The decrease was partially offset by an increase in funded R&D related to EbangaTM.

SG&A Expenses

SG&A expenses decreased $9.4 million, or 11%, to $76.6 million for the three months ended September 30, 2024. The decrease was primarily due to lower employee related expenses and compensation as a result of restructuring initiatives during 2023 and 2024, coupled with a decrease in legal services fees for disputes and other corporate initiatives. The decrease was partially offset by the settlement charge related to the stockholder litigation matter, net of expected insurance proceeds. SG&A expenses as a percentage of total revenues decreased 6 percentage points to 26% for the three months ended September 30, 2024.

Goodwill Impairment

Goodwill impairment decreased $218.2 million, or 100%, for the three months ended September 30, 2024. The decrease was due to a $218.2 million impairment charge to goodwill in the MCM Products segment in the third quarter of 2023, which reduced the goodwill balance of the reporting unit and segment to zero as of September 30, 2024 and 2023.

Interest expense

Interest expense decreased $11.4 million, or 58%, to $8.3 million for the three months ended September 30, 2024. The decrease was primarily due to lower amortization of debt service costs coupled with lower interest costs related to our syndicated borrowings, partially offset by higher interest expense related to the termination of our interest rate swap hedging agreements and interest related to our Term Loan Agreement.

Gain (loss) on sale of business and assets held for sale

Gain (loss) on sale of business and assets held for sale was a gain of $64.3 million for the three months ended September 30, 2024, compared with a loss of $0.7 million for the three months ended September 30, 2023. The gain on sale of business in the current year is related to the sale of RSDL® to SERB coupled with a reduction to the loss on the sale of the Company’s drug product facility in Baltimore-Camden to Bora, which is attributable to a net working capital adjustment payable to the Company. The loss on sale of business in the prior year is attributable to a net working capital adjustment, payable to Bavarian Nordic, related to the sale of our travel health business to Bavarian Nordic during the second quarter of 2023.

Other, net

Other, net was $21.9 million in income for the three months ended September 30, 2024 compared with $3.4 million in expense for the three months ended September 30, 2023. The change of $25.3 million was primarily attributable to income associated with development milestone achievements related to CHIK VLP, partially offset by a loss on the sale of a building at our Canton facility.

Income tax provision

Income tax provision increased $30.1 million, to $27.6 million for the three months ended September 30, 2024. The increase was primarily due to an increase in taxable income in the Company’s profitable jurisdictions.

Nine Months Ended September 30, 2024 Compared with Nine Months Ended September 30, 2023

Revenues and gross margin

(dollars in millions)

Total revenues increased $76.2 million, or 10%, to $848.9 million for the nine months ended September 30, 2024. The increase was due increases in Services revenue of $39.8 million and MCM Products revenue of $83.8 million, partially offset by a decrease Commercial Products revenue of $52.4 million.

Intangible asset amortization decreased $0.6 million, or 1%, to $48.8 million for the nine months ended September 30, 2024. The decrease was due to a decrease in amortization expense resulting from the intangibles sold with our travel health business to Bavarian Nordic, partially offset by an increase in amortization expense for the intangible asset related to EbangaTM.

Gross margin increased $28.8 million, or 16%, to $212.2 million for the nine months ended September 30, 2024. Gross margin percentage increased 2 percentage points to 26% for the nine months ended September 30, 2024. The increase in gross margin was due to an increase in MCM Products gross margin of $144.6 million, partially offset by decreases in Services gross margin of $71.8 million and Commercial Products gross margin of $44.0 million. Gross margin and gross margin percentage exclude Contracts and grants revenues because the related costs are R&D expenses.

See "Reportable Segment Results" for an expanded discussion of revenues and gross margin.

Unallocated corporate operating expenses

R&D Expenses

R&D expenses decreased $20.4 million, or 25%, to $61.6 million for the nine months ended September 30, 2024. The decrease was primarily due to the sale of our development program for CHIKV VLP to Bavarian Nordic in the second quarter of 2023 and lower overhead costs driven by headcount reductions. The decrease was also driven by the wind-down of funded projects, excluding EbangaTM. The decrease was partially offset by write-offs related to program terminations during the period and increases in the allocation of R&D overhead costs and funded R&D related to EbangaTM.

SG&A Expenses

SG&A expenses decreased $31.5 million, or 11%, to $247.2 million for the nine months ended September 30, 2024. The decrease was primarily due to lower employee related expenses and compensation as a result of restructuring initiatives during 2023 and 2024, lower professional services fees related to corporate initiatives, including organizational transformation consulting fees, and lower legal fees due to the wind-down of various legal matters. This decrease was partially offset by the settlement charge related to the stockholder litigation matter, net of expected insurance proceeds. SG&A expenses as a percentage of total revenues decreased 7 percentage points to 29% for the nine months ended September 30, 2024.

Goodwill Impairment

Goodwill impairment decreased $218.2 million, or 100%, for the nine months ended September 30, 2024. The decrease was due to the $218.2 million impairment charge to goodwill in the MCM Products segment in the third quarter of 2023, which reduced the goodwill balance of the reporting unit and segment to zero as of September 30, 2024 and 2023.

Impairment of Long-Lived Assets

Impairment of long-lived assets decreased $279.5 million, or 91%, to $27.2 million for the nine months ended September 30, 2024. The decrease was due to a $27.2 million non-cash impairment charge in the second quarter of 2024 related to our Bayview and Rockville asset groups within the Bioservices reporting unit, compared with a $306.7 million non-cash impairment charge recorded in the second quarter of 2023 related to our Camden, Bayview and Rockville asset groups within the Bioservices reporting unit.

Interest expense

Interest expense decreased $10.0 million, or 15%, to $56.2 million for the nine months ended September 30, 2024. The decrease was primarily due to a decrease in interest expense related to our syndicated borrowings and a decrease in amortization of debt service costs, partially offset by higher interest expense related to the termination of our interest rate swap hedging agreements and interest related to our Term Loan Agreement.

Gain (loss) on sale of business and assets held for sale

Gain (loss) on sale of business and assets held for sale decreased $49.9 million, or 67%, to $24.3 million for the nine months ended September 30, 2024 The gain on sale of business in the current year is related to the sale of RSDL® to SERB, partially offset by a loss the sale of the Company’s drug product facility in Baltimore-Camden to Bora. The gain on sale of business in the prior year is attributable to the sale of our travel health business to Bavarian Nordic during the second quarter of 2023.

Other, net

Other, net was $15.8 million in income for the for the nine months ended September 30, 2024 compared to $2.1 million in expense for the nine months ended September 30, 2023. The change of $17.9 million was primarily due to income associated with development milestone achievements related to CHIK VLP, partially offset by a loss on the sale of a building at our Canton facility, lower interest income, due to lower balances in our money market accounts, and a write-off of an equity method investment.

Income tax provision

Income tax provision increased $9.7 million, or 28%, to $44.0 million for the nine months ended September 30, 2024. The increase largely due to the jurisdictional mix of income and losses. The effective tax rate was (38)% for the nine months ended September 30, 2024 as compared with (5)% in 2023. The effective annual tax rate increased largely due the jurisdictional mix of income and losses and the prior year impairment loss.

REPORTABLE SEGMENT RESULTS

COMMERCIAL PRODUCT SEGMENT

(dollars in millions)

Three Months Ended September 30, 2024 Compared with Three Months Ended September 30, 2023

Naloxone

NARCAN® sales decreased $46.8 million, or 33%, to $95.3 million for the three months ended September 30, 2024. The decrease was primarily driven by the discontinuation of prescription NARCAN® due to the launch of over-the-counter (“OTC”) NARCAN® in the third quarter of 2023 and lower Canadian retail sales, partially offset by higher sales of OTC NARCAN®.

Cost of Product Sales and Gross Margin

Cost of Commercial Product sales decreased $12.8 million, or 21%, to $47.2 million for the three months ended September 30, 2024. The decrease was primarily due to lower prescription NARCAN® unit volume, partially offset by higher OTC NARCAN® unit volume.

Commercial Products gross margin decreased $34.0 million, or 47%, to $38.7 million for the three months ended September 30, 2024. Commercial Products gross margin percentage decreased 10 percentage point to 41% for the three months ended September 30, 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products. Commercial Products segment adjusted gross margin in the current year period excludes the impact of intangible asset amortization of $9.4 million.

Nine Months Ended September 30, 2024 Compared with Nine Months Ended September 30, 2023

Naloxone

NARCAN® sales decreased $42.6 million, or 11%, to $333.8 million for the nine months ended September 30, 2024. The decrease was primarily driven by the discontinuation of prescription NARCAN® due to the launch of OTC NARCAN® in the third quarter of 2023 and lower Canadian retail sales, partially offset by higher sales of OTC NARCAN®.

Other Commercial Products

Other Commercial Products sales decreased $9.8 million, or 100%, to no sales for the nine months ended September 30, 2024. During the second quarter of 2023, we sold Vivotif® and Vaxchora® to Bavarian Nordic as part of our travel health business.

Cost of Product Sales and Gross Margin

Cost of Commercial Product sales decreased $7.5 million, or 5%, to $152.7 million for the nine months ended September 30, 2024. The decrease was primarily due to no current period costs related to Vivotif® and Vaxchora®, which were sold to Bavarian Nordic as part of our travel health business, and lower prescription NARCAN® unit volume, partially offset by the higher OTC NARCAN® unit volume.

Commercial Products gross margin decreased $44.9 million, or 22%, to $152.8 million for the nine months ended September 30, 2024. Commercial Products gross margin percentage decreased 5 percentage point to 46% for the nine months ended September 30, 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products, partially offset by the sale of the products associated with our travel health business to Bavarian Nordic. Commercial Products segment adjusted gross margin in the current year period excludes the impact of intangible asset amortization of $28.3 million.

MCM PRODUCTS SEGMENT

(dollars in millions)

Three Months Ended September 30, 2024 Compared with Three Months Ended September 30, 2023

Anthrax MCM

Anthrax MCM sales decreased $21.5 million, or 65%, to $11.4 million for the three months ended September 30, 2024. The decrease reflects the impact of timing of sales related to CYFENDUS® and Anthrasil®, partially offset by an increase in BioThrax® sales, due to timing. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the USG. Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and the Company’s delivery of orders that follow.

Smallpox MCM

Smallpox MCM sales increased $108.0 million to $132.7 million for the three months ended September 30, 2024. The increase was primarily due to timing of USG purchases of ACAM2000® and VIGIV. Fluctuations in revenues from Smallpox MCM result from the timing of the exercise of annual purchase options in the existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow.

Other Products

Other Products sales decreased $20.0 million, or 40%, to $30.1 million for the three months ended September 30, 2024. The decrease was due to lower product sales of BAT®, due to timing of deliveries, and lower product sales of RSDL®, which was sold to SERB during the third quarter of 2024.

Cost of MCM Product Sales and Gross Margin

Cost of MCM product sales decreased $18.5 million, or 26%, to $54.0 million for the three months ended September 30, 2024. The decrease was primarily due to lower sales of BAT® and CYFENDUS®, coupled with lower allocations to Cost of MCM Product sales at our Bayview facility. This decrease was partially offset by higher sales of BioThrax® and ACAM2000®.

MCM Product gross margin increased $85.0 million to $113.3 million for the three months ended September 30, 2024. MCM Product gross margin percentage increased 39 percentage points to 65% for the three months ended September 30, 2024. MCM Product segment adjusted gross margin in the current year period excludes the impacts of intangible asset amortization of $6.9 million, non-cash items related to restructuring costs of $4.9 million and inventory step-up provision of $1.2 million.

Nine Months Ended September 30, 2024 Compared with Nine Months Ended September 30, 2023

Anthrax MCM

Anthrax MCM sales increased $30.0 million, or 39%, to $106.0 million for the nine months ended September 30, 2024. The increase was due to the impact of timing of sales related to CYFENDUS® and BioThrax®, partially offset by a decrease in Anthrasil® sales, due to timing. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the USG. Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and the Company’s delivery of orders that follow.

Smallpox MCM

Smallpox MCM sales increased $45.0 million, or 29%, to $200.8 million for the nine months ended September 30, 2024. The increase was due to higher VIGIV sales, primarily related to USG, and higher ACAM2000® sales to non-U.S. customers, partially offset by lower USG purchases of ACAM2000®, due to timing. Fluctuations in revenues result from the timing of the exercise of annual purchase options in existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow.

Other Products

Other Products sales increased $8.8 million, or 11%, to $86.2 million for the nine months ended September 30, 2024. The increase was primarily due to higher BAT® product sales to USG and non-U.S. customers, partially offset by lower sales of RSDL®, which was sold to SERB during the third quarter of 2024.

Cost of MCM Product Sales and Gross Margin

Cost of MCM product sales decreased $61.1 million, or 29%, to $147.3 million for the nine months ended September 30, 2024. The decrease was primarily due to lower allocations to Cost of MCM Product sales at our Bayview facility, lower shutdown costs, and a reduction in Trobigard®-related costs due to the Belgium FAMHP’s approval of the Trobigard® revocation, partially offset by higher BioThrax® and VIGIV sales.

MCM Product gross margin increased $144.6 million, or 179%, to $225.2 million for the nine months ended September 30, 2024. MCM Product gross margin percentage increased 31 percentage points to 57% for the nine months ended September 30, 2024. In addition to the MCM Product revenue and Cost of MCM Products items as discussed above, the increase was largely due to overall higher sales volumes with a favorable product mix weighted more heavily to higher margin products coupled with a realization of previously adjusted inventory values. MCM Product segment adjusted gross margin in the current year period excludes the impacts of intangible asset amortization of $20.5 million, non-cash items related to changes in the fair value of financial instruments of $0.6 million, restructuring costs of $7.5 million and inventory step-up provision of $1.2 million.

ALL OTHER REVENUES

Three Months Ended September 30, 2024 Compared with Three Months Ended September 30, 2023

Services

Services revenues increased $0.1 million, or 1%, to $14.3 million for the three months ended September 30, 2024. The increase was primarily attributable to an increase in production at the Company’s Camden facility, prior to the sale of the facility to Bora, partially offset by lower production at the Company’s Canton and Winnipeg facilities. The increase was further offset by Bioservices lease revenues which decreased $0.6 million related to the completion of a lease for a Bioservices customer at our Canton facility, partially offset by new lease revenue associated with SERB at our Winnipeg facility.

Contracts and Grants

Contracts and grants revenue increased $3.5 million, or 54%, to $10.0 million for the three months ended September 30, 2024. The increase was primarily due to timing of funding as well as an increase related to work under the EbangaTM program.

Nine Months Ended September 30, 2024 Compared with Nine Months Ended September 30, 2023

Services

Services revenues increased $39.8 million, or 69%, to $97.5 million for the nine months ended September 30, 2024. The increase was primarily attributable to the $50.0 million arbitration settlement with Janssen related to the Settlement Agreement, coupled with increased production at our Camden facility. The increase was partially offset by reduced production activities at the Company's Canton and Winnipeg facilities and the completion of a lease for a Bioservices customer at our Canton facility.

Contracts and Grants

Contracts and grants revenue increased $5.0 million, or 26%, to $24.6 million for the nine months ended September 30, 2024. The increase was related to work under the EbangaTM program, partially offset by the wind-down of our other funded development initiatives.

FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES

Our financial condition is summarized as follows:

(dollars in millions)

Principal Sources of Capital Resources

We have historically financed our operating and capital expenditures through existing cash and cash equivalents, cash from operations, development contracts and grant funding and borrowings under various credit agreements, including our Term Loan Agreement and other lines of credit we have established from time to time. We also occasionally obtain financing from the sale of our common stock upon exercise of stock options. As of September 30, 2025, we had unrestricted cash and cash equivalents of $245.5 million and available borrowing capacity of up to $100.0 million under the Revolving Credit Agreement. As of September 30, 2025, the Company believes that its sources of liquidity, including debt and cash flows from operating activities, are adequate to fund its operations for at least the next twelve months from the issuance of these condensed consolidated financial statements.

2025 Share Repurchase Program

On March 31, 2025, the Company announced that its Board of Directors had authorized the repurchase of up to $50.0 million of the Company’s common stock (the “2025 Share Repurchase Program”) on or before March 27, 2026. Repurchases under the 2025 Share Repurchase Program may be made from time to time on the open market or in privately negotiated transactions. The timing and amount of any shares repurchased will be determined by the Company’s management based on its evaluation of market conditions and other factors, including the market price of the Company’s common shares, macroeconomic environment and other investment opportunities, consistent with the Company’s insider trading policy. The 2025 Share Repurchase Program may be suspended or discontinued at any time. The Inflation Reduction Act of 2022, which was enacted on August 16, 2022, imposed a nondeductible 1% excise tax on the net value of certain stock repurchases made after December 31, 2022. Excise tax accrued during the three and nine months ended September 30, 2025 was $0.2 million.

During the three and nine months ended September 30, 2025, the Company utilized $8.9 million and $15.8 million to repurchase 1.1 million and 2.3 million shares, respectively, at an average price of $7.87 and $7.00 per share, excluding commissions and excise taxes, respectively. As of September 30, 2025, the Company had $34.2 million available to repurchase shares under the 2025 Share Repurchase Program.

Senior Unsecured Note Repurchase

On May 7, 2025, the Board of Directors authorized the Company to repurchase up to $30.0 million aggregate principal amount of the Company’s Senior Unsecured Notes. The Company may seek to opportunistically use this authority to repurchase its Senior Unsecured Notes in open market purchases, privately negotiated transactions or otherwise. Any such repurchases will depend upon prevailing market conditions, our liquidity requirements, contractual restrictions, applicable securities law and other factors. During the three and nine months ended September 30, 2025, we repurchased $6.9 million aggregate principal amount of the Company’s Senior Unsecured Notes for $5.8 million in cash, including fees, and recognized a gain on extinguishment of approximately $1.1 million. As of September 30, 2025, we had $23.1 million available to repurchase additional Senior Unsecured Notes.

Cash Flows

The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024:

(in millions)

Operating Activities:

Net cash provided by operating activities for the nine months ended September 30, 2025 decreased $45.7 million as compared with the nine months ended September 30, 2024. The decrease in net cash provided by operating activities was primarily driven by unfavorable changes in working capital, including significantly lower sources of cash contributions from prepaids and other assets, accounts receivable and inventories. Higher cash payments related to our accrued expenses, compensation and income taxes also contributed to the decrease. These working capital changes, combined with less favorable non-cash adjustments, offset the higher net income in 2025.

Investing Activities:

Net cash provided by investing activities for the nine months ended September 30, 2025 decreased $23.3 million as compared with the nine months ended September 30, 2024. The decrease in net cash provided by investing activities was primarily attributable to the significant cash inflows in 2024 related to the RSDL® Transaction and the sale of the Baltimore-Camden facility, partially offset in 2025 by the $50.0 million in aggregate milestone payments received in connection with the sale of the Company’s travel health business to Bavarian Nordic, proceeds from the sale of property, plant and equipment, including the sale of our Baltimore-Bayview facility to Syngene, and a reduction in capital expenditures compared to the prior year.

Financing Activities:

Net cash used in financing activities for the nine months ended September 30, 2025 decreased $167.8 million as compared with the nine months ended September 30, 2024. The decrease in net cash used in financing activities was primarily driven by significant financing outflows in 2024, including principal repayments on the Company’s former revolving and term loan facilities and associated debt issuance costs. The reduction in cash outflows was partially offset by 2024 inflows related to the issuance of a new term loan, warrants, and common stock issued in connection with the debt restructuring. Additionally, 2025 financing outflows included repurchases under the Company’s 2025 Share Repurchase Program and Senior Unsecured Note repurchases, which partially offset the year-over-year decrease.

Debt

As of September 30, 2025, the Company has $693.1 million of fixed and variable rate debt with varying maturities. See Note 10, “Debt” in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1, of this Form 10-Q for further discussion.

Uncertainties and Trends Affecting Funding Requirements

We expect to continue to fund our short-term and long-term anticipated operating expenses, capital expenditures, debt service requirements, any potential debt repurchases and any future repurchase of our common stock from the following sources:

• existing cash and cash equivalents;
• net proceeds from the sale of our products and Bioservices;
• development contracts and grant funding;
• proceeds from potential asset sales; and
• our Term Loan Agreement and Revolving Loans.

There are numerous risks and uncertainties associated with product sales and with the development and commercialization of our product candidates. We may seek additional external financing to provide additional financial flexibility. Our future capital requirements will depend on many factors, including (but not limited to):

• the level, timing and cost of product and services sales;
• the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
• the acquisition of new facilities and capital improvements to new or existing facilities;
• the payment obligations under our indebtedness;
• the scope, progress, results and costs of our development activities;
• our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs; and
• the costs of commercialization activities, including product marketing, sales and distribution.

If our capital resources are insufficient to meet our future capital requirements, we will need to finance our cash needs through public or private equity or debt offerings, bank loans, collaboration and licensing arrangements, cost reductions, assets sales or a combination of these options.

If we raise funds by issuing equity securities, our stockholders may experience dilution. Public or bank debt financing, if available, may involve agreements that include covenants, like those contained in our Senior Unsecured Notes, our Term Loan Agreement and our Revolving Credit Agreement, which could limit or restrict our ability to take specific actions, such as incurring additional debt, making capital expenditures, pursuing acquisition opportunities, buying back shares or declaring dividends. If we raise funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies or product candidates or grant licenses on terms that may not be favorable to us.

Economic conditions, including market volatility and adverse impacts on financial markets, may make it more difficult to obtain financing on attractive terms, or at all. Any new debt funding, if available, may be on terms less favorable to us than our Senior Unsecured Notes, our Term Loan Agreement or our Revolving Credit Agreement. If financing is unavailable or lost, our business, operating results, financial condition and cash flows would be adversely affected, and we could be forced to delay, reduce the scope of or eliminate many of our planned activities.

Unused Credit Capacity

Available room under the Revolving Loans as of September 30, 2025 and December 31, 2024 was:

(in millions)

61

For a discussion of additional risks arising from our operations, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, under the heading “Item 1A. Risk Factors” in addition to updates contained in “Item 1A. Risk Factors” of this Quarterly Report on Form 10-Q.

Market risk

We have interest rate and foreign currency market risk. Because of the short-term maturities of our cash and cash equivalents, we believe that an increase in market rates would likely not have a significant impact on the realized value of our investments.

Interest rate risk

We have debt with a mix of fixed and variable rates of interest and we are satisfied with the current fix-float mix of the Company's debt portfolio. Floating rate debt carries interest based generally on the eurocurrency rate, as defined in the Prior Credit Agreement, as amended from time to time, plus an applicable margin. Increases in interest rates could result in an increase in interest payments for our floating rate debt. See Note 10, "Debt" in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1, of this Form 10-Q.

From time to time, we may use derivative instruments to manage our interest rate risk and market risk exposure.

We have assessed our exposure to changes in interest rates by analyzing the sensitivity to our operating results assuming various changes in market interest rates. A hypothetical increase of one percentage point in the eurocurrency rate as of September 30, 2025 would increase our interest expense by approximately $2.5 million annually.

Foreign currency exchange rate risk

We have exposure to foreign currency exchange rate fluctuations worldwide and primarily with respect to the Euro, Canadian dollar, Swiss franc and British pound. We manage our foreign currency exchange rate risk primarily by either entering into foreign currency hedging transactions or incurring operating expenses in the local currency in the countries in which we operate, to the extent practical. We currently do not hedge all of our foreign currency exchange exposure and the movement of foreign currency exchange rates could have an adverse or positive impact on our results of operations.

Evaluation of disclosure controls and procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2025. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the "Exchange Act"), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2025, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in internal control over financial reporting

There have not been any changes in our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act that occurred during 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 Company’s Annual Report on Form 10-K for the year ended December 31, 2024 contains disclosure regarding the risks and uncertainties related to the Company’s business under the heading Item 1A. Risk Factors. There have been no material changes to the Company’s risk factors as presented in the Company’s 2024 Form 10-K, except as described below:

Divestitures and sales of assets could negatively impact our business, and retained liabilities from businesses or assets that we have sold could adversely affect our financial results.

In connection with the execution of our multi-year strategic plan to stabilize, turnaround and transform the Company, we have completed several divestitures and sales of assets. These divestitures and asset sales pose risks and challenges that could negatively impact our business, including retained liabilities related to divested businesses and sold assets, obligations to indemnify buyers against contingent liabilities and potential disputes with buyers.

If post-completion liabilities and obligations related to divestitures and asset sales are substantial and exceed our expectations, our financial position, results of operations and cash flows could be negatively impacted. Any divestiture or asset sale may result in a dilutive impact to our future earnings if we are unable to offset the dilutive impact from the loss of revenue and profits associated with the divestiture or sold asset, as well as significant write-offs, including those related to goodwill and other intangible assets, which could have a material adverse effect on our results of operations and financial condition.

We may not realize the expected benefits of the sale of our travel health business to Bavarian Nordic, the sale of RSDL® to SERB, the sale of our drug product facility in Baltimore-Camden to Bora, and the sale of our Baltimore-Bayview drug substance manufacturing facility to Syngene.

On May 15, 2023, pursuant to the Purchase and Sale Agreement, we completed the previously announced sale to Bavarian Nordic of our travel health business, including rights to Vaxchora® and Vivotif®, as well as our development-stage chikungunya vaccine candidate CHIKV VLP, our manufacturing site in Bern, Switzerland and certain of our development facilities in San Diego, California for a cash purchase price of $270.2 million, subject to certain customary adjustments. In addition, we may receive milestone payments of up to $80.0 million related to the development of CHIKV VLP and receipt of marketing approval and authorization in the U.S. and Europe, and sales-based milestone payments of up to $30.0 million based on aggregate net sales of Vaxchora® and Vivotif® in calendar year 2026.

On June 20, 2024, Cangene bioPharma LLC (“Cangene”), a subsidiary of the Company (together with Cangene, the “Seller”), entered into an Asset Purchase Agreement with Bora, under which the Seller sold its drug product facility in Baltimore-Camden for a cash purchase price of approximately $35.0 million. The transaction closed on August 20, 2024.

On July 31, 2024, we entered into the Stock and Asset Purchase Agreement with SERB Pharmaceuticals, through its wholly owned subsidiary BTG International Inc. (collectively, “SERB”), pursuant to which, among other things, we sold our worldwide rights to RSDL®, to SERB (the “RSDL® Transaction”) for a cash purchase price of $75.0 million, exclusive of customary closing adjustments related to inventory. In addition, SERB will pay us a $5.0 million payment upon achievement of a milestone relating to sourcing of a certain component of RSDL® decontamination lotion. The Transaction also included the sale to SERB of all the outstanding capital stock of Emergent Protective Products USA Inc. (“EPPU”), a wholly owned subsidiary of the Company, which leases a manufacturing facility in Hattiesburg, Mississippi, as well as certain assets related to RSDL®, including intellectual property rights, contract rights, inventory and marketing authorizations. In addition, the employees of EPPU joined SERB in connection with the RSDL® Transaction.

On March 19, 2025, we sold our Baltimore-Bayview Drug Substance manufacturing facility to Syngene International (“Syngene”) for a cash purchase price of approximately $36.5 million. Pursuant to the sale, Syngene acquired the assets and equipment associated with the Baltimore-Bayview facility. We retained rights to secure manufacturing services and capacity at the facility for future growth and pandemic response production in collaboration with Syngene.

There can be no assurance that we will be able to realize in full the expected benefits of these transactions, including as to whether any milestone payments will be received. If we are unable to or do not realize the expected strategic, economic, or other benefits of these transactions, it could adversely affect our business and financial position.

We cannot guarantee that our 2025 Share Repurchase Program will be utilized in full, or at all, or that our 2025 Share Repurchase Program will enhance long-term stockholder value.

Our Board of Directors authorized the 2025 Share Repurchase Program for up to $50.0 million of the Company’s common stock through March 27, 2026, and through September 30, 2025 we have repurchased approximately $15.8 million under the Share Repurchase Program. Any share repurchases will depend upon, among other factors, market conditions, the market price of the Company’s common shares, macroeconomic environment and other investment opportunities. The existence of the 2025 Share Repurchase Program could cause our stock price, in certain cases, to be higher or lower than it otherwise would be and could potentially reduce the market liquidity or have other unintended consequences for our stock. We can provide no assurance that we will repurchase shares of our common stock at favorable prices, if at all. Although the 2025 Share Repurchase Program is intended to enhance long-term stockholder value, we can provide no assurance it will do so. The 2025 Share Repurchase Program does not obligate the Company to acquire any particular amount of common stock and it may be suspended or discontinued, or the amount to be spent by the Company to repurchase shares could be reduced, at any time at the Company’s discretion. Any decision to reduce or discontinue repurchasing shares of our common stock pursuant to our 2025 Share Repurchase Program could cause the market price for our common stock to decline and may negatively impact our reputation and investor confidence in us.