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The Company’s Annual Report on Form 10-K for the year ended December 31, 2025 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 2025 Form 10-K, except as described below:
We are currently dependent on third-party manufacturers for the manufacture of all or part of most Emergent products. Failure of such manufacturers to maintain regulatory compliance may be expensive and time-consuming and may cause interruptions to our supply of our products to customers.
We are currently dependent on third-party manufacturers for the manufacture of all or part of most Emergent products. Certain of our third-party manufacturers constitute the sole source of manufacture of drug product, drug substance, components and raw materials. We have a limited ability to control the costs or the manufacturing process related to the third-party manufacture of our products. Increases in the prices we pay our manufacturers, interruptions in the supply of our products, lapses in quality, or the inability to supply finished product could adversely impact our margins, profitability and cash flows. In addition, we are reliant on our third-party manufacturers to maintain the facilities at which they manufacture our products in compliance with all FDA and other applicable regulatory requirements. If these manufacturers fail to maintain compliance with FDA or other applicable regulatory requirements, they could be ordered to cease manufacturing, which could have a materially adverse impact on our revenues and operating results, including the inability to supply products for sale to our customers. We may be forced to consider entering into additional or replacement manufacturing arrangements with other third-party manufacturers. Because of contractual restraints and the lead-time necessary to obtain FDA approval of a new manufacturer, replacement of any of our current manufacturers may be expensive and time-consuming and may cause interruptions to our supply of these products to our customers.
Political or social factors may delay or impair our ability to market and sell our products and may require us to spend significant management time and financial resources to address these issues.
Products developed to counter the potential impact of PHTs are subject to changing political and social environments. The political responses and social awareness of the risks of these threats on military personnel or civilians and the level of emphasis placed on such risks by the USG may vary over time. If the threat of terrorism were to decline, then the public perception of the risk on public health and safety may be reduced. This perception, as well as political or social pressures (including as a result of negative publicity we have received based on our longstanding ties to the USG), could delay or cause resistance to bringing our products in development to market or limit pricing or purchases of our products, any of which could negatively affect our revenues and our business, financial condition, operating results and cash flows.
In addition, substantial delays or cancellations of purchases could result from protests or challenges from third parties. Lawsuits brought against us by third parties or activists, even if not successful, could require us to spend significant management time and financial resources defending the related litigation and could potentially damage the public's perception of us and our products. Any publicity campaigns or other negative publicity may adversely affect the degree of market acceptance of our MCMs and thereby limit the demand for our products, which would adversely affect our business, financial condition, operating results and cash flows. Further, to the extent the USG exerts a preference for U.S. made products, the USG may elect to reduce or eliminate purchases of products that we currently make in our Winnipeg facility.
NARCAN® (naloxone HCl) Nasal Spray is currently subject to generic and branded competition and may be subject to additional generic and branded competition in the future. As our competitors introduce their own generic and branded equivalents of our branded drug products, our revenues and gross margin from such products generally decline.
NARCAN® Nasal Spray faces increased competition from the addition of new naloxone agents, including generic competition from Teva Pharmaceuticals Industries Limited and Teva Pharmaceuticals USA (collectively, “Teva”), Padagis LLC (“Padagis”) and Amneal Pharmaceuticals, Inc. (“Amneal”). Sales of generic versions of NARCAN® Nasal Spray at prices lower than our branded product or provided at no cost by Teva, Padagis and Amneal have the potential to erode our sales and could impact our product revenue related to NARCAN® Nasal Spray.
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NARCAN® Nasal Spray also faces branded competition from prescription products, such as Zimhi™ (naloxone), a branded injectable product developed by Adamis Pharmaceuticals Corporation, RextovyTM, (naloxone HCL nasal spray 4 mg), a branded product marketed by Amphastar Pharmaceuticals, Inc., Teleflex Medical Inc.'s Intranasal Mucosal Atomization Device, and Rezenopy® (naloxone HCL nasal spray 10mg), a branded product manufactured by Summit Biosciences Inc., as well as OTC products, such as RiViveTM (naloxene HCl nasal spray 3mg), a branded product developed by Harm Reduction Therapeutics. Competition that NARCAN® Nasal Spray faces from generic and branded versions has adversely affected sales of NARCAN® Nasal Spray and the revenue, profitability and cash flows that we derive from its sale and ongoing competition could continue to exert downward price pressure on our branded drug prices, which could materially and adversely affect our results of operations and financial condition.
We may not successfully execute or realize some or all of the expected benefits of our restructuring plans and our restructuring may adversely affect our business.
On August 5, 2026, we announced an organizational restructuring plan intended to reduce operating costs, improve operating margins, and continue advancing the Company’s ongoing commitment to profitable growth. Our restructuring efforts involve workforce reductions and closure of wet laboratories to enhance productivity and maintain operational efficiency, and may require additional investments in technology, infrastructure and related capabilities. We will incur costs in connection with the execution of this restructuring plan, including charges related to employee transition, severance payments, employee benefits, and share-based compensation. These charges and others that we may incur in connection with the restructuring plan may exceed our estimates. In addition, we may be unable to obtain the costs savings and other benefits that were initially anticipated in connection with our decision to implement the restructuring plan. Furthermore, even if we are successful with our cost control efforts, we may not see the benefits of such efforts on our financial condition, results of operations and cash flows due to other factors. We also may experience a loss of continuity, loss of accumulated knowledge and/or inefficiency during transitional periods. Restructuring actions could also increase the risk of operational disruptions, delivery issues, internal control weaknesses or other operational challenges, especially during periods of organizational transition, as responsibilities are reassigned and processes are adjusted. Reorganization and restructuring can require a significant amount of management and other employees’ time and focus, which may divert attention from operating and growing our business. Furthermore, restructuring measures require compliance with numerous laws and regulations, including local labor laws. We may face wrongful termination, discrimination or other legal claims from affected employees that require us to incur substantial costs to defend against, and such claims may significantly increase our severance costs.
If we fail to achieve some or all of the expected benefits of restructuring, it could have a material adverse effect on our competitive position, business, financial condition, results of operations and cash flows. For more information about our restructuring plans, see Note 17, “Subsequent Events”, in the notes to the Condensed Consolidated Financial Statements in Part I, Item 1, of this quarterly report on this Form 10-Q.
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