ANI Pharmaceuticals Inc.

Item 1A. Risk Factors

In addition to the other information set forth in this reQuarterly Report on Form 10-Q, please carefully consider the factors described under the heading Risk Factors in our 2023 Form 10-K in Part I, Item 1A and in our Quarterly Report on Form 10-Q for the period

ended June 30, 2024 in Part II, Item 1A. The risks described are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that our management currently deems to be immaterial, also may adversely affect our business, financial condition, and/or operating results.

The following are new significant risk factors , including as related to the pending acquisition of Alimera, that could materially harm our business, financial position, or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this report.

Risks Related to our Business

Several of the Merger

The Merger is subject to a number of conditions beyond our coproducts we have acquired cannot be manufactured in our facilities and are manufactured, packaged and/or distributed by third parties, which we cannot control. Failur If we are unable to complete the Merger withinsecure or maintain qualified contract manufacturers for the expected time frame,ose products, a contract manufacturer or at all, could have a mdistributor fails to comply with federal, stateri, and local adverse effect on our business, operating resullaws and regulations, or third-party manufacturers or distributors sustain delays in production and distribution of our products, our business, financial condposition, and our share price.

On June 21, 2024, we entered inperating results could be materially, adversely affected.

We have acquired, and may continue to an Agreement and Plancquire, a variety of Merger (the Merger Agreement) with Alimera aproducts that we seek to commercialize. Some of these products, including injectables, softgel capsules, and ANIP Merger Sub INC.Purified Cortrophin Gel, a Delaware corporation and whs well as the products we acquired folly owned indirect subsidiaryowing the acquisition of us (Merger Sub), pursuant to which, and on the terms and subjeAlimera, are products that we cannot currently manufacture in our facilities. As a result, we may seek partners to contract tomanufacture the conditions set forth therein, (i) Merger Sub will be merged with and into Alimera (products on our behalf, and we rely on third parties to manufacture, package and/or distribute many of our products. Like our Company, the Merger), with Alimera surviving se companies must comply with cGMPs and othe Merger as a wholly owned subsidiary of ANI and (ii) at the effective time of the Merger, each outstr federal, state, and local laws and regulations regarding pharmaceutical manufacturing. Noncompliance by those companies may result in warning letters, fines, product recalls, anding share of Alimera common stock, par value $0.01 per sh partial or total suspension of production and distribution. If we are, will automatically be unable to find qualified converted into the right to receive (A) $5.50 in cash, without interest and less any applicabletract manufacturers or distributors or if a contract manufacturer or distributor fails to comply withholding taxesh federal, state, and (B) one contingent value right (a CVR). Capitlocal laws and regulations, we may be unable to commercialized terms used herein, but not otherwi these products, which could have a material adverse defined, have the meanings set forth in the Merger Agreement.

Consummationeffect on our business, financial position, and operating results, including an impairment of the Merger is subject to certainacquired product.

We expect our reliance on third party manufacturers to conditions,tinue to increase including the future as we receive approval by Alimeras stockholders, the absence of any legal restraints restraining, enjoining, preventing, prohibs for new products to be manufactured through our collaborative arrangements, and as we seek additional growth opportunities outside of the capabiliting or otherwisees of our current maknufacturing illegalfacilities, including following the consummaacquisition of the Merger, expiration Alimera. If we are unable to secure third-party manufacturers for terminatihese products on of the appliccommercially acceptable waiting period under the Hart-Scott-Rodino Antitrust Imterms, we may not be able to market and distribute such provemenducts Act of 1976, asat a profit.

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In amended, with such waiting period having expired on July 29, 2024ddition, manufacturers and distributors of our products may sometimes encounter difficulties in production and any other specified required regulatory approvals that may be required will have been obtained, and each partys performance of itdistribution. 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 obligations in af qualified personnel, as well material respects under the Merger Agreement.

We cannot predict whether and when as compliance with strictly enforced federal, state and foreign regulations. Adverse weather conditions to the Merger will be satisfied. If one oand natural disasters may also affect our more of these conditions are not satisfied,anufacturers and distributors supply chains, which could negatively impact our ability to source materials and as a result, we do not complete the Merger, we would remain liable fcomponents to make our products and, in more severe cases, such as hurricanes, earthquakes, floods, droughts, tornadoes or blizzards, eliminate the availability, or significant transactionly increase the costs, and, of the focus of our management would have been diverted from seeking other potentialcomponents to make our products, sometimes for prolonged periods of time. The response of federal, strategic opportunit and local governmental bodies, in each case without and agencies to climate change through realizgulations, mandates, reporting any benefits of the Merger. Certain costs associated with the Merger have already been incurred or may be payd disclosure requirements, taxes or levies could materially increase our or our manufacturers cost to operate or obtain product components at a reasonable even if the Merger is not cprice, resulting in a material adverse effect on our financial results.

Any of these situationsum could mated. Finrially, any disruptions tod adversely harm our business resulting fromand financial condition. We cannot assure you theat announcement and pendency ofy product quality issues relating to the Merger, including manufacture and/or distribution of our product candidate or any adverse changfuture product candidates in owill not occur relationshipsin the future. Any delays or difficulties with our third-partners, suppliy manufacturers and employees,/or distributors could continue or accelerate in adversely affect the event that we fail to consummatemarketing and distribution of the Merger.

Our shaese products, or future priceoducts, which could have a may also fluctuate significantly based onterial adverse effect on our business, financial position, announcements by Alimera, od operating results.

We may fail to realize ther third parties, or us regarding benefits expected from our acquisition of Alimera and the Merger or based on combined company may not perform as we or the market perceptions ofexpects, which could have an adverse effect on the likelihoodprice of the satisfaction of thour common stock.

On September 16, 2024, we conditions to the consummampleted our previously announced acquisition of (the Merger. Such announcements may lead to percep) of Alimera Sciences, Inc., a Delaware corporations in t (Alimera) pursuant to the market that terms of the Agreement and Plan of Merger, dated as of June 21, 2024 (the Merger may not be cAgreement), by and among the Completed, which could cause our shaany, Alimera and ANIP Merger Sub INC., a Delaware price to fluctuate or decline. Other factors outside of our control, such as a governmental entitycorporation and wholly-owned subsidiary of the Company (Merger Sub). The anticipated benefits we expect from this acquisition include, among other things, benefits relating to enacting legislation thahanced revenues, a strengthened market prohibits osition for the Merger, coulmbined cause us not to sompany and operatisfy ng efficiencies and the governmental entity condise benefits are, necessarily, based on projections and thusassumptions about the Merger would not be consumcombined businesses of our Company and Alimera, which may not mated.

If we do not consummatrialize as expected or which may prove the Merger, to be inaccurate. The pricvalue of our common stock may decline significantlycould be adversely affected if we are unable to realize the anticipated benefits from the current market price, which may reflecMerger on a timely basis or at a market assumptionll. Achieving that e benefits of the Merger will be consummated. Any of these eventsdepend, in part, on our ability to could have a material adverse effect on ourntinue to integrate the business, operating resultsons and financial condition and could cause a decline in the price of oproducts of Alimera successfully and efficiently with our common stockbusiness.

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Actions of activist stockholdersThe combined company may not perform as we or other parties may impair our ability to market expects. Risks associated with the consummatembined company following the Merger.

Activist stockholders could also take actions that disrupt the include:

integrating business of Alimera,es is a divert the timefficult, expensive, and attention oftime-consuming process, and their management and employe failure to successfully integrate our businesses away fromwith their business opf Alimerations, cause them to inc timely would adversely affect our substantfinancial adconditional expense, create perceived uncertainties among current and results of operation;

there may be inconsistencies in standards, controls, procedures and potential customers, clients, suppliers, employees and olicies that will need to be reconciled;

the Merger has materially increased ther constituencies as to their future dire size of our operations, and if we are not able to effection as a consequence thereof, whichvely manage our expanded operations, our common stock price may result in lost sales, impaired supplier relationships or other business arrangementsbe adversely affected;

it is possible that our key employees or key employees of Alimera might decide not to remain with us, and the loss of potential business opportunities, andsuch personnel could have a make it more difficult to attract and retain qualified terial adverse effect on the financial condition, results of opersonnelations, and busgrowth prospects of the combiness partners.

We have incurred, andd company;

the success of the combined company will continue to incur, directalso depend upon relationships with third parties and indirect costs as a result ofAlimeras or our pre-existing customers, which relationships may be affected by customer preferences or public attitudes about the Merger.

We have incurred, and will continue to incur, significant costs and expenseAny adverse changes in these relationships could adversely affect the combined companys business, including fees for professional services and other transaction costs, ifinancial condition, and results of operations;

unanticipated write-offs or charges. In connection with the Merger, including costs that we may not currently expect. We must pay substantially all we recorded goodwill in the fair value amount of these costs and expenses whether or not acquisition. If we conclude the transaction is completed. Moreover, manyat some portion of the expenses that such goodwill be incurred are, byis impaired, a non-cash charge for their nature, difficult to estimate accurately. To the extent these acquisiti amount of such impairment would be recorded against earnings;

our expansion andinto integrrnation expenseal operations as are high result of the Merger than anticipated, we may experi(as discussed below);

incurrence liquidity or cash flow issues. Amoof significant costs in connection with consummating other termin Merger and integration rights, and subject to certain limitations, each of Alimerang the operations of Alimera into our business;

the potential for securities class action lawsuits and ANI may terminate derivative lawsuits the Merger Agreement iat may be brought as a result of the Merger is not, including consummsts associated by December 21, 2024,with defending such lawsuits; and each of Alimera and ANI may mutual

our failure to identify or accurately agree to terminatessess the magnitude of certain liabilities we assumed in the Merger Agreement.

The oblicould result in unexpected litigations and liabilities of Alimera, some of which may be or regulatory exposure, unfavorable accounting charges, unanticipaexpected or unknown, may be gincreater than we haveses in taxes due, a loss of anticipated, which may diminish the value of Alimera to us.

Alimeras obligations tax benefits or other known and unknown liabilities, some of s which may not have been disclosed to us or may not be reflcould result in adverse effected or reserved for in Alimeras historicals on our business, operating results or financial statcondition.

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Thements, may be gre occurrence of any of these Merger-relater than we have anticipated. The obligations and liabilities of Alimerad events individually or in combination could have a material ally and adverse ely affect on Alimerasur business or Alimeras value to us or on our busines, results of operations, financial condition, or results  and the market price of operations. Under the Merger Agreement, we have only limited indemnification with respeur common stock.

We have incurred, and will continue to incur, direct and indirect to obligations or liabilitiescosts as a result of Alimera, whe ther known or unknown. In addition, even in cases where Merger.

As a result of the Merger we are ablhave incurred, and will continue to obtain indemnincur, signification, we may discover liabilitint costs and expenses, including fees for professional services greatand other than the contractual limits or ransaction costs, in connection with the financial resources of the indemnifying party. In the event that we are responsiblMerger, including costs that we may not currently expect. These fees and costs have been, and will continue to be for liabilitiessome time, substantially in excess of any amounl, and additional unanticipated costs recovemay be incurred through rights to indemnificin our integration or alternative remedif Alimera. Moreover, many of the expenses that mightwill be available to us, or any applicable insurancincurred are, by their nature, we could suffer severe consequences that would substantially reduce our earnings and cash flows or otherwise materiallydifficult to estimate accurately. To the extent these acquisition and integration expenses are higher than and adversely affect our business, financial conticipated, we may experience liquidition,y or results of operationcash flow issues.

We willhave incurred substantial debt in order to satisfy our obligations in connection with the acquisition of Alimera.

In connection with the acquisiMerger.

We financed the cash portion, JP Morgan Chase Bank, N.A. and Blackstone Credit Insurance have committed to provide debt financing for the transaction in an aggregate principal amount equal to $280 of the Merger with borrowings of $325.0 million, on under the terms and subject the conditionsat certain senior set forth in a commitcured credit agreement letenter, dated June 21ed into on August 13, 2024 (the Debt Commitmwith JPMorgan Chase Bank, N.A. as administrative agent Letter)and other financial institutions. In order to service the debt we incurrred under the Debt Commitment LettMerger, we will require a significant amount of cash. Our ability to make scheduled payments of principal and interest depends on our future performance, which is subject to economic, financial, competitive, and other factors beyond our control. Our business may not continue to generate cash flow from operations in the future sufficient to service our debt. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt, or obtaining additional debt or equity financing on terms that may not be favorable to us or available to us at all. Our ability to refinance any such debt will depend on the capital markets and our financial condition at that time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default under our current or future indebtedness. Any event of default or inability to otherwise satisfy our obligations could have a material adverse effect on our future operating results and financial condition.

As a result of

In connection with the Merger, we will recorded goodwill in connection with our acquisition of Alimera, anand if it becomes impaired, our earnings could be significantly impacted. 

Under current accounting methods, goodwill is not amortized but, instead, is subject to impairment tests on at least an annual basis and more frequently if an event occurs or circumstances change that reduce the fair value of a reporting unit below its carrying amount. In connection with our acquisition of Alimerathe Merger, we will recorded goodwill in the fair value amount of such acquisition. Although we do not anticipate impairment charges, if we conclude that some portion of such goodwill is impaired, a non-cash charge for the amount of such impairment would be recorded against earnings.

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A goodwill impairment charge could be caused by a decline in our stock price or the occurrence of a triggering event that compounds negative financial results. Therefore, following the Merger, and ourif goodwill recording of goodwilled in connection therewith, if such goodwill the Merger becomes impaired, our earnings could be significantly and adversely affected.

The Merger may become the target of securities class action and dderivative lawsuits that could result in substantial costs and may delay or prevent the Merger from being completed. 

Securities class actiin connection lawsuits and derivative lawsuits are often brought against public companies that have entered into merwith the Merger agreements. The outcome of any litigation is uncertain, but regardless of the outcome of any such lawsuits, they could delay or prevent the Merger or otherwise adversely affect us financially.

If the acquisition of Alimera is consummated, the combined company may not perform as we or the market expects, which could have an adverse effect on the price of our common stock.

Even if the Merger is consummated, the combined.

We may incur significant, non-recurring costs in company may not perform as we or the market expects. Risks associatednnection with the combined company followconsummating the Merger include:

and integrating businesses is a difficult, expensive, and time-consuming process, and tthe failure to successfully integoperate our businesses with the businessions of Alimera in the expected time frame would adversely affect to our financial condition and results ofbusiness operation;

there may be inconsistencies in standards, controls, procedures and policies that will need to be reconciled;

the Merger will materially increase the size of our operations, and if we as. Derivative lawsuits are not able to effectively manage our expanded operations, ouroften brought against public common stock price may be adversely affected;

it is possible that our key employees or key employees of Alimera might decide not to remain with us after the Alimera acquisition is completed, panies that have entered into merger agreements and the loss of such personnel could have a have consummaterial adverse effect on the financial condd acquisition, results of operations, and growth prospects of the s. The outcombined company;

the success of the combined compe of any will also depend upon relationships with third parties and Alimeras or our pre-existing customers, which relationships may be affected by customer preferences or public attitudes ablitigation is uncertain, but regardless of the out the Merger. Acome of any adverse changes in these relationships could adversely affect the combined companys business, financial condition, and results of operations;such lawsuits, we may incur significant fees and

if government agenci expenses or regurelatory bodies impose requirements, limitations, costs, divestitures or restrictions on the consummation of the Merger, the combineding to legal services (including any companys ability to realize the anticipated benefits of the acquisition may sts that would be impaired.

Further, we intend to enter into the Merger with the expectation that the acquisition will result in, among other things, benefits relating to enhanced revenues, a strengthened market position for the combinedincurred in defending against any potential derivative lawsuits in company and operating efficiencies. Achieving the benefits of tnnection with the Merger isf any subject to a number of uncertainties, incluch proceeding whether we integrate Alimera in an efficient manner, and general competitive factors in the marketplace. The occurrence ofs are brought), accounting any of these Merger-related events individually or in combination could materially and adversely affect our businesd other fees and costs, results of operations, finanassocial condition and the market price of our common stock.

Following the closted with consummating of the Merger, i.

If we fail to successfully manage our international operations, our business, operating results and financial condition could suffer.

Alimera hasd, and we have acquired, direct operations and are markets itsing products outside the United States, with international operations that cover the United Kingdom and much of Europe and the Middle East. We have not historically conducted any operations or marketed any of our products outside the United States. As a result, following of the closing of the Merger, the percentage of our revenues generated outside of the United States will iincreased materially, and our new international operations will require significant management attention and financial resources.

There is a high level of regulation in all markets where Alimerasthe products are we acquired from Alimera have been sold and great diversity in how those markets operate. Consequently, experience and expertise will be required in understanding the market dynamics of each country, the rules and regulations in place governing the sale of medicines, the codes of practice governing promotion of medicines, different currencies, the financial frameworks applying to taxation (both corporate and

 value-added tax) and the need to communicate in different languages.

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Moreover, Alimeras international operations relyied on distributors in many countries to provide adequate levels of experience and expertise on its behalf. W, and we will need ow rely on those distributors. We need to monitor and manage these relationships appropriately to address risks in these markets.

Conducting extensive international operations subjects us to risks that are inherent in international operations, including:

extended collection timelines for accounts receivable and greater working capital requirements;

multiple, conflicting legal systems and unexpected changes in legal requirements such as privacy and data protection laws and regulations, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

tariffs, export restrictions, trade barriers and other regulatory or contractual limitations on our ability to sell or develop our products in certain foreign markets, including China and certain other parts of Asia;

changes in currency exchange rates;

currency transfer and other restrictions and regulations that may limit our ability to sell our products internationally or repatriate profits to the United States;

difficulties adapting to new cultures, business customs, and legal systems;

trade laws and business practices favoring local competition;

potential tax issues, including restrictions on repatriating earnings, resulting from multiple, conflicting and complex tax laws and regulations;

weaker intellectual property protection in some countries;

natural disasters, political, economic, and social instability, including the effects of ongoing U.S.-China diplomatic and trade friction, social unrest in China, the recent conflicts between Russia and Ukraine, Israel and Hamaswithin the Middle East, and global sanctions imposed in response thereto, the possibility of a wider European or global conflict, or other war or terrorist activities or the threat of war and terrorism; and

adverse economic conditions, including increasing inflation and the stability and solvency of business financial markets, financial institutions and sovereign nations.

In particular, regulatory oversight of pharmaceutical products, including production, marketing and sales, can vary significantly among countries and will require additional oversight by our compliance and marketing teams. We will need to spend significantly more time and invest in additional resources to ensure compliance with regulatory regimes outside the United States. Similarly, there are often supply chain risks that are specific to a given region, and our expansion outside the United States will exposes us to additional risks and expenses related thereto.

In addition, compliance with foreign and U.S. laws and regulations that are applicable to our international operations is complex and may increase our cost of doing business in international jurisdictions, and our international operations could expose us to fines and penalties if we fail to comply with these regulations. These laws and regulations include import and export requirements, U.S. laws such as the Foreign Corrupt Practices Act, and local laws prohibiting corrupt payments to governmental officials. Although we intend to implement policies and procedures designed to help ensure compliance with these laws, there can There can be no assurance that our employees, partners and other persons with whom we do business will not take actions in violation of our policies or these laws. Any violations of these laws could subject us to civil or criminal penalties, including substantial fines or prohibitions on our ability to offer our products in one or more countries, and could also materially and adversely harm our business and financial condition.

Following The Merger magnifies the operational risks that we face.

Alimera was subject to many of the same operational risks as our business prior to the closing oMerger, which are described in our 2023 Form 10-K and in our Quarterly Report on Form 10-Q for the period ended June 30, 2024. Given the substantial size of Alimera and associated complexities, many of the risk factors that we faced prior to the Merger, we  will only become more magnified and substantial and the expanded business will need to meet only pose additional challenges for management, including those that relate to management and monitoring of new operations.

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As a result of the certonsummation of the Merger, we need to meet certain additional requirements for our international operations, including adequate levels of reimbursement and various regulatory approvals, and our inability to meet these requirements could adversely affect our results of operations.

Following the closingonsummation of the Merger, we willnow have certain additional requirements that we will need to meet in order to engage in international operations. For example, in the European Economic Area (EEA) and the United Kingdom, each country has a different reviewing body that evaluates reimbursement dossiers submitted by marketing authorization holders of new

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drugs and then makes recommendations as to whether or not the drug should be reimbursed. Limitations on reimbursement could be imposed at the national, regional or local level or by fiscal intermediaries in each country, either through the initial authorization process or at some point in the future. In addition, due to price referencing within the EEA, the United Kingdom and certain other countries, existing pricing in our current markets could be negatively affected by a change in pricing in a country where Alimera currenthistorically has reimbursement or by a new price in a country where we or Alimera obtain reimbursement approval in the future.

Following the closing of the Merger, oOur business could also be adversely affected if governments, private insurers or other reimbursing bodies or payers limit the indications for reimbursement approval to a smaller subset than we believe our products are effective in treating or establish a limit on the frequency with which our products may be administered that is less often than we believe would be effective. Those actions could limit our revenues and harm our business.

We will also need to maintain current or obtain marketing authorization and commercialization rights in countries outside the United States. Certain countries, such as those in the EEA, require minimum sales within three years or licenses may be revoked if extensions are not negotiated. Alimera does id not and we do not currently have rights in China and certain other parts of Asia. Following the closingAs a result of the Merger,  in order to market our products in foreign jurisdictions, we will bare required to obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. We may not receive the necessary approvals to commercialize our products in any additional market.

The process of obtaining regulatory approvals and clearances in jurisdictions where our products are not approved will require us to expend substantial time and capital. Despite the time and expense incurred, regulatory approval is never guaranteed. The number of preclinical and clinical tests that will be required for regulatory approval varies depending on the drug candidate, the disease or condition for which the drug candidate is in development, the jurisdiction in which we are seeking approval and the regulations applicable to that particular drug candidate. The applicable regulatory authorities may make requests or suggestions regarding our clinical trials, resulting in an increased risk of difficulties or delays in obtaining regulatory approval. For example, the regulatory authorities may not approve of certain of our methods for analyzing our trial data, including how we evaluate the relationship between risk and benefit. Additionally, the foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. For all of these reasons, following the closing of the Merger, we we may not obtain additional foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or jurisdictions or by the FDA.

Fol

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As a resulowingt of the closingonsummation of the Merger, our reliance on third parties to manufacture and test certain of our products will increase, and if any of these third parties is unable to satisfy our demand, our business, operating results and financial condition could suffer.

Alimera doesid not have in-house manufacturing capability and dependsed entirely on single source third-party manufacturers for the manufacture of its products, incl; following the consummation of the Merger, we rely on these third-party manufacturers for the manufacture of the products we acquired from Alimera, including for supply of active pharmaceutical ingredients, the product applicator, the product implants, and the final assembly of the injectors with the implants. In addition, Alimera relies d, and we now rely, on third parties for the quality release testing. If any of these third-party manufacturers breaches its agreement, is unable to meet its contractual or quality requirements or becomes unwilling to perform for any reason, we may be unable, in a timely manner or at all, to locate alternative acceptable manufacturers or testing facilities, as applicable, enter into favorable agreements with them and ensure that they are approved by the applicable regulatory authorities, such as the FDA. For example, Alimera relies od, and we now rely, on (subject to certain exceptions) an agreement with an exclusive supplier for the manufacturing and supply of YUTIQ, which has an initial term of two years through May 2025. Following the Merger, iIf the supplier is unwilling to extend the supply agreement, and we are unable to timely transfer manufacturing to a replacement supplier or make other arrangements to supply product, we may not be able to fulfill demand for YUTIQ. In addition, on July 12, 2024, the supplier of YUTIQ received a warning letter from the FDA alleging violations of current good manufacturing practice (CGMP) requirements in connection with a February 2024 FDA inspection and associated February 2024 Form FDA-483 specifically related to the manufacturing of YUTIQ at the suppliers facility (the "Warning Letter"). The Warning Letter requires the supplier to implement certain corrective and preventive actions. Any failure by the supplier to remediate to the FDAs satisfaction these findings or any future findings the FDA may have, could result in the supply of YUTIQ being adversely effected or terminated, and, if such findings remain unresolved following the Merger, our abili our ability to fulfill demand for YUTIQ could be materially impaired. Additionally, we may experience lengthy delays if we need to change a third-party to fulfill demandsupplier or manufacturer, including for YUTIQ, which could be have a materiallyl impaired.

ct on business and results of operations. Further, Alimeras ssuppliers and manufacturers relfor the products we acquired from Alimera rely on additional third parties for the manufacture of component parts. Any inability of Alimerasthese contract manufacturers to acquire sufficient quantities of the active pharmaceutical ingredients and other component parts in a timely manner from these third parties could delay commercial production of YUTIQ or ILUVIEN. 

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Any of these events could adversely affect our ability following the Merger tto fulfill demand for the acquired products. In addition, any of these events could in turn have a material adverse effect on our business, financial position, and operating results, including an impairment of the acquired assets, or cause a decline in the price of our common stock.