ANIP

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How ANIP rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Below is a summary of the principal risks that could adversely affect our business, financial position and operating results : • Our approved products, including Cortrophin Gel and ILUVIEN, may not achieve commercialization at levels of market acceptance that will allow us to maintain profitability; • To the extent our ongoing and continuing efforts to commercialize Cortrophin Gel, ILUVIEN, and our other products for which we have received marketing approval are unsuccessful, our business, financial condition, and results of operations will be negatively impacted; • The limited number of suppliers for our API could result in lengthy delays in production if we need to change suppliers; • Several of the products we have acquired cannot be manufactured in our facilities and we must secure and maintain qualified and compliant contract manufacturers.
Noncompliance by these contract manufacturers or our inability to find qualified contract manufacturers could result in us being unable to commercialize these products; • Several of our products are manufactured and/or packaged by single source third parties, which we cannot control and could result in us being unable to market and distribute products; • If we fail to comply with broad and complex U.S. healthcare and other laws, as well as comparable laws and regulations in foreign jurisdictions, we could face substantial penalties and our business, operations, and financial condition could be adversely affected; • If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and business; • Any failure to comply with the complex reporting and payment obligations under the Medicaid Drug Rebate Program and other government pricing and price reporting programs may result in penalties and sanctions, which may have a material adverse effect on our business, financial position, and operating results; • Our Medicaid rebate accruals have increased and continue to increase due to our acquisitions and subsequent sales of branded products and authorized generics of branded products, and the estimates on which our accruals are based are subject to change.
Any such change could have a material adverse effect on our business, financial position, and operating results; • Our accruals for the Medicare Manufacturer Discount Program have increased due to growth and acquisitions.
Any such change could have a material adverse effect on our business, financial position and operating results; • We expect to spend significant resources on research and development efforts, and such efforts may not result in marketable products; • Production at any or all of our three current manufacturing facilities could be interrupted, which could cause us to fail to deliver product on a timely basis; • We rely on third parties to assist with our clinical trials.
If these parties do not perform or are non-compliant, it could negatively impact the clinical trial and potential of regulatory approval; further, we may be required to audit or redo previously completed trials or recall already-approved commercial products; • Clinical trials for our products may not generate the outcomes we expect, may take longer or be more costly to complete than we anticipate; • We may be adversely affected by the expiration of patents that protect key aspects of ILUVIEN and YUTIQ in the near- to medium-term; • Inability to protect our intellectual property in the U.S. and foreign countries could negatively affect sales of our branded products; • If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are material to our business; • Our success is largely dependent upon certain key employees, including members of our senior management, the loss of whom could adversely affect our operations; • We rely significantly on information technology and any failure, inadequacy, interruption, or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate the business effectively; • We are involved in and may become involved in legal proceedings from time to time, which may result in substantial losses, government enforcement actions, damage to our business and reputation, and strain on our internal resources; • We are susceptible to product liability claims that may not be covered by insurance, which, if successful, could require us to pay substantial sums; • Future acquisitions and investments could disrupt our business and harm our financial position and operating results; • Public health outbreaks, epidemics, or pandemics have adversely affected and may in the future adversely affect our business; • The continuing trend toward consolidation of customer groups could result in declines in the sales volume and prices of our products, and increased fees charged by customers; • Four of our products are marketed without approved NDAs or ANDAs and we cannot be certain that the FDA will not require us to either seek approval for these products or withdraw them from the market.
In either case, our business, financial position, and operating results could be materially adversely affected; • The FDA does not provide guidance on safety labeling for products that are marketed without approved NDAs or ANDAs, which could increase our potential liability with respect to failure-to-warn claims for these products; • If the DEA does not approve supply of the API we need to manufacture our controlled substances, we may be unable to manufacture controlled substances, which would eliminate our revenue on these products; • Pharmaceutical product quality standards are steadily increasing on all products as set forth by the FDA and other governmental agencies, and if we cannot meet these standards, we may be required to discontinue marketing and/or recall products from the market; • Federal and state false claims litigation brought against us by private individuals and the government could result in civil and criminal penalties, damages, fines and other related actions; • The use of legal, regulatory, and legislative strategies by competitors could result in increased costs to develop and market our products, delay new product introductions and reduce profit potential; • The successful commercialization of our products depends on adequate coverage and reimbursement from third party payors; • Our operations in an international market subject us to additional regulatory oversight both in the international market and in the U.S., as well as, social, and political uncertainties, which could cause a material adverse effect on our business, financial position, and operating results; • U.S. healthcare reform initiatives may materially and adversely affect our business, financial position, and operating results; • The international nature of our operations, including those resulting from our acquisition of Alimera and its international operations, will subject us to political and economic risks and increase our exposure to potential liability under anti-corruption, trade protection, tax, and other laws and regulations; • Our policies regarding returns, allowances and chargebacks, as well as marketing programs adopted by wholesalers, may reduce revenues in future fiscal periods; • Our indebtedness and liabilities could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and operating results; • Our 2024 Credit Agreement contains restrictive and financial covenants and if we are not in compliance with these covenants, our outstanding indebtedness under this facility could be accelerated and the lenders could terminate their commitments under the facility; • We incurred certain risks relating to the Notes and related capped call transactions; and • Raising additional funds by issuing additional equity securities may cause dilution to our current stockholders; raising additional funds by entering into additional credit or other borrowing facilities or issuing debt may subject us to covenants and other requirements that may restrict our operations.
Risks Related to our Business Our approved products, including Cortrophin Gel and ILUVIEN, may not achieve commercialization at levels of market acceptance that will allow us to maintain profitability and we may face substantial competition from competitors that discover, develop or commercialize competing products before or more successfully than we do, which could have a material adverse effect on our business, financial position, and operating results.
The commercialization of new drugs is highly competitive, and the commercial success of our products or any of our future products or product candidates will depend on several factors, including our ability to differentiate any such products or product candidates from our competitors’ current or future products, including the creation of generic competitive products.
We seek to develop, license, or acquire products that we can commercialize at levels of market acceptance that would allow us to recoup our costs, grow market share, and maintain profitability.
However, w e face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to our current products and to any future products or product candidates that we may commercialize in the future.
Even if we are able to obtain regulatory approvals for our pharmaceutical products, if we fail to predict the demand for such products accurately, or if our competitors more effectively develop competitive products, that have few or less severe adverse side effects and have higher rates of acceptance by physicians, our business, financial position, and operating results could be adversely affected.
Levels of market acceptance for our products could be impacted by several factors, including but not limited to: • relative convenience and ease of administration of our products; • our products’ pricing relative to that of our competitors; • our marketing effectiveness relative to that of our competitors; • timing of our market entry; • publicity and health authority communications concerning our products or competing products and treatments; • our ability to market our products effectively to the retail level; and • acceptance of our products by government and private formularies.
To the extent our ongoing and continuing efforts to commercialize Cortrophin Gel, ILUVIEN, and our other products for which we have received marketing approval are unsuccessful, our business, financial condition and results of operations will be negatively impacted.
We have received approval from the FDA for our Cortrophin Gel product for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to other indications.
In 2025, a significant portion of our net product revenues were derived from the sale of Cotrophin Gel, and we expect that sales of Cortrophin Gel will continue to account for a significant portion of our net product revenues in future years.
As a result, our business is dependent on our ability to sustain and grow revenues from sales of Cortrophin Gel, and we are accordingly subject to risks relating to the commercial success of Cotrophin Gel, including the risk that physicians, payors or patients will perceive the cost of Cortrophin Gel to outweigh the benefits of treatment; that we may be unable to maintain and increase sales of Cotrophin Gel or continue to gain market share from competing products; and that we may be unable to obtain and sustain favorable access and reimbursement rates.
In addition, we have received approval from the FDA for ILUVIEN for the treatment of NIU-PS in addition to DME, for which ILUVIEN was already approved.
To the extent we receive FDA approval to commercialize other products in the future, we expect to devote significant time and money towards commercialization effects in the U.S, including building out our sales force and developing a patient support program.
In addition, we are expanding our commercialization efforts with respect to Cortrophin Gel to include a 1 mL vial, appropriate for adjunctive treatment of certain patients with acute gouty arthritis flares.
Additionally, on February 28, 2025, the FDA approved a prefilled syringe format for Cortrophin Gel.
This new presentation became available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network during the second quarter of 2025.
The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials.
The ability for us to generate significant net product revenues from ILUVIEN, our Cortrophin Gel products or any other products for which we receive marketing approval will depend upon our ability to successfully sell the product and numerous other factors, including: • successfully establishing and maintaining effective sales, marketing, and distribution systems in jurisdictions in which our approved products are approved for sale; • successfully establishing and maintaining manufacturing capabilities with our third-party suppliers and contract manufacturers and manufacturing adequate commercial quantities of our approved products at acceptable cost and quality levels, including maintaining cGMP and quality systems regulation standards required by various regulatory agencies; • broad acceptance of the products for which we have received marketing approval by physicians and patients, as well as our ability to gain market access share in the healthcare community; • the acceptance of pricing and placement of the products for which we have received marketing approval on payers’ formularies and the associated tiers; • effectively competing with other products that are approved and available to patients for the same conditions, as well as other products that are in development or may be developed in the future as treatment options; • continued demonstration of safety and efficacy of the products for which we have received marketing approval in comparison to competing products or treatment options; • our ability to comply with ongoing regulatory obligations and continued regulatory review of the products for which we have received marketing approval, which may result in significant additional expense and may require labeling changes based on new safety information, post-market studies or clinical trials to evaluate safety risks; and • obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
If we do not achieve one or more of these factors, we could experience an inability to successfully commercialize or continue to successfully commercialize ILUVIEN, Cortrophin Gel or any other products for which we receive marketing approval, which would negatively impact our business, financial condition and results of operations.
In addition, sales of our products that have received marketing approval could be negatively affected by discovery of previously unknown problems with the product, such as adverse events of unanticipated severity or frequency, problems with the facilities where the product is manufactured, or imposition of restrictions on such products, including requiring withdrawal of the product from the market by a regulatory agency if it disagrees with the promotion, marketing, or labeling of the product.
We may enter into new lines of business that offer new products and/or services and we may have limited experience in marketing such new products and/or services, which may subject us to additional risks.
For example, in September 2024 we acquired Alimera, a global pharmaceutical company that specializes in the commercialization and development of ophthalmic retinal pharmaceuticals, which for us was a new line of business.
We may experience lengthy delays if we need to change an API supplier, which could have a material adverse impact on our business and results of operations.
During the year ended December 31, 2025 , approximately 17%, of our raw materials and API purchases were from one domestic supplier.
During the year ended December 31, 2024, approximately 12% of our API purchases were from one domestic supplier.
During the year ended December 31, 2023, no single vendor represented more than 10% of our API purchases.
Any disrup tion in the supply of these ingredients or components or any problems in their quality could materially affect our ability to manufacture and distribute our products and could result in legal liabilities that could materially affect our ability to realize profits or otherwise harm our business, financial condition, and operating results.
We source the raw materials and API for our products from both domestic and international suppliers.
Any change in one of our API suppliers generally is required to be approved by the FDA through a PAS.
The process of obtaining approval of a PAS can take between six and nine months, and could take an additional eight to ten months if additional information is required to be submitted by the FDA.
From time to time, we have experienced temporary disruptions in the supply of certain of such imported API due to FDA inspections, and we may experience future disruptions in the supply of certain imported API due to trade tensions or embargoes, geopolitical tensions and macroeconomic conditions.
Any disruptions in our API supply, and particularly with respect to the API used to manufacture Cortrophin Gel and ILUVIEN, could have a material adverse effect on our business, financial condition and operating results.
Our manufacturing facilities or those of our third-party manufacturers or suppliers may fail to meet regulatory requirements.
Failure to meet cGMP requirements could increase production costs or impact supply of our products.
All facilities where prescription drugs are manufactured, tested, packaged, stored, or distributed must comply with FDA cGMPs.

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Gone since FY2024

You should carefully consider all information in this Annual Rep ort on Form 10-K prior to investing in our common stock.
These risks are discussed more fully in the section titled “Risk Factors.” These risks and uncertainties include, but are not limited to, the following: • Our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, may not achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; • Cortrophin Gel is our first rare disease pharmaceutical product.
To the extent we are not able to continue to achieve commercial success with this product, including expanding the market and gaining market share, our business, financial condition, and results of operations will be negatively impacted; • We may fail to realize the benefits expected from our acquisition of Alimera and the combined company may not perform as we or the market expects; • The limited number of suppliers for our API could result in lengthy delays in production if we need to change suppliers; • Several of the products we have acquired cannot be manufactured in our facilities and we must secure and maintain qualified and compliant contract manufacturers.
Noncompliance by these contract manufacturers or our inability to find qualified contract manufacturers could result in us being unable to commercialize these products; Several of our products are manufactured and/or packaged by single-sourced third parties, which we cannot control and could result in us being unable to market and distribute products; • We are subject to United States federal and state laws related to healthcare fraud and abuse and health information privacy and security, and the failure to comply with such laws may adversely affect our business; • Failure to comply with data protection laws and regulations could subject us to government enforcement actions, private litigation and/or adverse publicity, which could negatively affect our operating results and business; • Our Medicaid rebate accruals have increased and continue to increase due to our acquisitions and subsequent sales of branded products and authorized generics of branded products; • Our accruals for the Medicare Coverage Gap Discount Program have increased due to growth and acquisitions; • We expect to spend a significant amount of resources on research and development efforts, and such efforts may not result in marketable products; • Production at any or all of our three current manufacturing facilities could be interrupted, which could cause us to fail to deliver product on a timely basis; • We rely on third parties to assist with our clinical trials.
If these parties do not perform or are non-compliant, it could negatively impact the clinical trial and potential of regulatory approval; further, we may be required to audit or redo previously completed trials or recall already-approved commercial products; • Clinical trials for our products may not generate the outcomes we expect, may take longer or be more costly to complete than we anticipate; • We may be adversely affected by the expiration of patents that protect key aspects of our products in the near- to medium-term; • Inability to protect our intellectual property in the U.S. and foreign countries could negatively affect sales of our branded products; • If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are material to our business; • Our success is largely dependent upon certain key employees, including members of our senior management, the loss of whom could adversely affect our operations; • We rely significantly on information technology and any failure, inadequacy, interruption, or security lapse of that technology could harm our ability to operate the business effectively; • We are involved in and may become involved in legal proceedings from time to time, which may result in substantial losses, government enforcement actions, damage to our business and reputation, and place a strain on our internal resources; • We are susceptible to product liability claims that may not be covered by insurance, which, if successful, could require us to pay substantial sums; • The obligations and liabilities of Alimera, some of which may be unanticipated or unknown, may be greater than we have anticipated, which may diminish the value of Alimera to us; • Our operations in an international market subject us to additional regulatory oversight both in the international market and in the U.S., as well as, social, and political uncertainties, which could cause a material adverse effect on our business, financial position, and operating results; • Our operations, including those resulting from our acquisition of Alimera, and its international operations, will subject us to political and economic risks, increase our exposure to potential liability under anti-corruption, trade protection, tax, and other laws and regulations; Ta b l e of Contents • Future acquisitions and investments could disrupt our business and harm our financial position and operating results; • Pharmaceutical product quality standards are steadily increasing on all products, and if we cannot meet these standards, we may be required to discontinue marketing and/or recall products from the market; • Federal and state false claims litigation brought against us by private individuals and the government could result in civil and criminal penalties, damages, fines and other related actions; • The use of legal, regulatory, and legislative strategies by competitors could result in increased costs to develop and market our products, delay new product introductions and reduce profit potential; • Third-party payer actions may prevent us from effectively marketing our products or cause us to decrease pricing; • Healthcare reform legislation could have a material adverse effect on our business, financial position, and operating results; • Public health outbreaks, epidemics, or pandemics (such as COVID-19) have adversely affected and may in the future adversely affect our business; • The continuing trend toward consolidation of customer groups could result in declines in the sales volume and prices of our products, and increased fees charged by customers; • The Food and Drug Administration (“FDA”) does not provide guidance on safety labeling for products that are marketed without approved New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”), which could increase our potential liability with respect to failure-to-warn claims for these products; • Four of our products are marketed without approved NDAs or ANDAs and we can offer no assurances that the FDA will not require us to either seek approval for these products or withdraw them from the market.
In either case, our business, financial position, and operating results could be materially adversely affected; • If the Drug Enforcement Administration (“DEA”) does not approve supply of the API we need to manufacture our controlled substances, we may be unable to manufacture controlled substances, which would eliminate our revenue on these products; • Our policies regarding returns, allowances and chargebacks, and marketing programs adopted by wholesalers may reduce revenues in future fiscal periods; • Our indebtedness and liabilities could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operation; • To service our indebtedness, we will be required to generate a significant amount of cash; • Our New Credit Agreement contain restrictive and financial covenants and if are not in compliance with these covenants, our outstanding indebtedness under this facility could be accelerated and the lenders could terminate their commitments under the facility; • Certain risks relating to our 2.25% Convertible Senior Notes due 2029 and related capped call transactions; and • Raising additional funds by issuing additional equity securities may cause dilution to our current stockholders.
Risks Related to our Business Our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, may not achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability and we may face substantial competition from competitors that discover, develop or commercialize competing products before or more successfully than we do, which could have a material adverse effect on our business, financial position, and operating results.
The development and commercialization of new drugs is highly competitive, and the commercial success of our products or any of our future products or product candidates will depend on several factors, including our ability to differentiate any such products or product candidates from our competitors’ current or future products, including the creation of generic competitive products.
We seek to develop, license, or acquire products that we can commercialize at levels of market acceptance that would allow us to recoup our costs, grow market share, and achieve profitability.
However, w e face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to our current products and to any future products or product candidates that we may develop or commercialize in the future.
Ta b l e of Contents Even if we are able to obtain regulatory approvals for our pharmaceutical products, if we fail to predict accurately demand for such products, or our competitors more effectively develop competitive products, that have few or less severe adverse side effects and have higher rates of acceptance by physicians, our business, financial position, and operating results could be adversely affected.
Levels of market acceptance for our products could be impacted by several factors, including but not limited to: • our products’ pricing relative to that of our competitors; • our marketing effectiveness relative to that of our competitors; • timing of our market entry; • our ability to market our products effectively to the retail level; and • acceptance of our products by government and private formularies.
Cortrophin Gel is our first rare disease pharmaceutical product.
To the extent our ongoing and continuing efforts to commercialize this product are unsuccessful, our business, financial condition and results of operations will be negatively impacted.
On October 29, 2021, we received approval from the FDA for our Cortrophin Gel product for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to excess urinary protein due to nephrotic syndrome.
We have devoted significant time and money to the development of this product since we acquired the rights to the product in 2016.
We have invested and continue to invest significantly in the commercialization of this product in the U.S, including building out a sales force and developing a patient support program, with a full-scale launch in January 2022.
In October 2023, we announced FDA approval and commercial availability of a 1-mLvial of Cortrophin Gel, appropriate for adjunctive treatment of certain patients with acute gouty arthritis flares.
The ability for us to generate significant net product revenues from our Cortrophin Gel products will depend upon our ability to successfully sell the product and numerous other factors, including: • successfully establishing and maintaining effective sales, marketing, and distribution systems in jurisdictions in which Cortrophin Gel is approved for sale; • successfully establishing and maintaining manufacturing capabilities with our third-party suppliers and CMOs and manufacturing adequate commercial quantities of Cortrophin Gel at acceptable cost and quality levels, including maintaining current good manufacturing practice (“cGMP”) and quality systems regulation standards required by various regulatory agencies; • broad acceptance of Cortrophin Gel by physicians, patients, and gaining market access share in the healthcare community; • the acceptance of pricing and placement of Cortrophin Gel on payers’ formularies and the associated tiers; • effectively competing with the only other competitor that has an approved adrenocorticotropic hormone (“ACTH”) therapy product on the market, as well as other products that are in development or may be developed in the future as a treatment option; • continued demonstration of safety and efficacy of Cortrophin Gel in comparison to competing products or treatment options; • our ability to comply with ongoing regulatory obligations and continued regulatory review which may result in significant additional expense and may require labeling changes based on new safety information, post-market studies or clinical trials to evaluate safety risks related to the use of Cortrophin Gel; and • obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
If we do not achieve one or more of these factors, we could experience an inability to successfully commercialize Cortrophin Gel, which would negatively impact our business, financial condition and results of operations.
In addition, sales of Cortrophin Gel could be negatively affected by discovery of previously unknown problems with the product, such as adverse events of unanticipated severity or frequency, problems with the facilities where the product is manufactured, or imposition of restrictions on Cortrophin Gel, including requiring withdrawal of the product from the market, by a regulatory agency if it disagrees with the promotion, marketing, or labeling of the product.
Ta b l e of Contents We may enter into new lines of business that offer new products and/or services and we may have limited experience in marketing such new products and/or services, which may subject us to additional risks.
For example, in September 2024 we acquired Alimera, a global pharmaceutical company that specializes in the commercialization and development of ophthalmic retinal pharmaceuticals, which for us is a new line of business.
We may experience lengthy delays if we need to change an API supplier, which could have a material impact on business and results of operations.
During the year ended December 31, 2024, approximately 12%, of our raw material inventory purchases were from one domestic supplier.
During the year ended December 31, 2023, no single vendor represented more than 10% of our raw ma terial inventory purchases.
During the year ended December 31, 2022 approximately 19% , of our raw material inventory purchases were from one domestic supplier.
Any disruption in the supply of these ingredients or components or any problems in their quality could materially affect our ability to manufacture and distribute our products and could result in legal liabilities that could materially affect our ability to realize profits or otherwise harm our business, financial, and operating results.
We source the raw materials for our products from both domestic and international suppliers.
Any change in one of our API suppliers must usually be approved through a Prior Approval Supplement (“PAS”) by the FDA.
The process of obtaining an approval of such a PAS can require between four and 18 months.
Certain of the API for our drug products, including those that are marketed without approved NDAs or ANDAs, are sourced from international suppliers.
From time to time, we have experienced temporary disruptions in the supply of certain of such imported API due to FDA inspections.
Ta b l e of Contents Several of the products we have acquired cannot be manufactured in our facilities and are manufactured, packaged and/or distributed by third parties, which we cannot control.
If we are unable to secure or maintain qualified contract manufacturers for those products, a contract manufacturer or distributor fails to comply with federal, state, and local laws and regulations, or third-party manufacturers or distributors sustain delays in production and distribution of our products, our business, financial position, and operating results could be materially, adversely affected.
We have acquired, and may continue to acquire, a variety of products that we seek to commercialize.
Some of these products, including injectables, softgel capsules, and Cortrophin Gel, as well as ILUVIEN and YUTIQ, are products that we cannot currently manufacture in our facilities.
As a result, we may seek partners to contract manufacture the products on our behalf, and we rely on single-source third parties to manufacture, package and/or distribute many of our products.
These problems include failure to meet target production costs and yields, failure to meet product release specifications, including stability of the product, quality assurance system failures, operator error and shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations.
Adverse weather conditions and natural disasters may also affect our manufacturers’ and distributors’ supply chains, which could negatively impact our ability to source materials and components to make our products and, in more severe cases, such as hurricanes, earthquakes, floods, droughts, tornadoes or blizzards, eliminate the availability, or significantly increase the cost, of the components to make our products, sometimes for prolonged periods of time.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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