AMRX 10-K & 10-Q changes, risk factors and insider trading

If we are unable tocannot successfully develop or commercialize new products, our operating results will suffer.

Developing and commercializing a new product is time consuming, costly and subject to numerous factors that may delay or prevent such development and commercialization.obstacles. Our future results of operations will depend to a significant extent uponon our ability to successfully commercialize new products in a timely manner. We face severalKey challenges when developing and commercializing new products, includinginclude:

•our ability to developdeveloping products in a timely and cost-efficient manner and in compliance with regulatory requirements, including delays associated with the FDA review listing and approval processprocess, any policy, regulatory or other changes to FDA processes, and our ability to obtain required regulatory approvals in a timely manner, or at all, and maintain such approvals if obtained;

•the success of our clinical testing process to ensure thatthe safety and effectiveness of new products are safe and effective or bioequivalentbioequivalence to the reference listed drug;

•the risk that legal action may be brought against our generic drug products by our branded drug product competitors, including patent infringement claims among others;

•the availability,securing, on commercially reasonable terms, of raw materials, including APIs and other key ingredients necessary to the developmentdevelop of our drug products; and

•ourscaling-up abilitymanufacturing to scale-upmeet manufacturing methods to successfully manufacture commercial quantities of drug productdemand in compliance with regulatory requirements.

As a resultBecause of these andhurdles, othersome difficulties,of our products in development may or may not receive necessary regulatory approvals on a timely basis or at all, which may result in unsuccessful development or commercialization of new products.

Separately, product licensing involves inherent risks including uncertainties due to matters that may affect the achievement of milestones, as well as the possibility ofpotential contractual disagreements with regard to terms such as license scope or termination rights. If any of our products, when acquired or developed and approved, cannot be successfully or timely commercialized, our operating results could be adversely affected. We cannot guarantee that any investment we make in developing, marketing or licensing products will be recouped, even if we are successful in commercializing those products.

•a company’s ability to use and integrate artificial intelligence (“AI”);

Many of our competitors have longer operating histories and greater financial, R&D, marketing and other resources than we do. Consequently, some of our competitorsthey may be able to develop products and/or processes competitive with, or superior to, our products and/or processes.ours. Furthermore, we may not be able to (i) differentiate our products from those of our competitors,products, (ii) successfully develop or introduce new products, on a timely basis or at all, that are less costly than those of our competitors,costly, (iii) integrate new systems or technology, such as AI, as quickly or successfully as our competitors,successfully, or (iv) offer customers payment and other commercial terms as favorable as those offered by our competitors. The markets in which we compete and intend to compete are undergoing, and are expected to continue to undergo, rapid and significant change. We expect competition to intensify as technology advances and consolidation continues. New developments by other manufacturers and distributors could render our products uncompetitive or obsolete.

Our principal competitors in the U.S. generic/ and biosimilar pharmaceutical products market, where we primarily compete, are Teva Pharmaceutical Industries Ltd., Viatris Inc., Sandoz Group, Pfizer Inc., Fresenius Kabi KGaA, Hikma Pharmaceuticals PLC, Dr. Reddy’s Laboratories Ltd., Amphastar Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Inc., Zydus Pharmaceuticals USA Inc., and Aurobindo Pharma Limited. Our principal competitors in the specialty pharmaceutical products market include Supernus Pharmaceuticals, Inc., Jazz Pharmaceuticals PLC, AbbVie Inc. and Alkermes PLC. Our competitors in the AvKARE segment are other wholesalers, including Cardinal Health, Inc., Cencora, Inc., McKesson Drug Co., and manufacturers / re-packagers such as Golden State Medical Supply.

Competition in the generic drug industry has also increased due to the proliferation of authorized generic pharmaceutical products. Authorized generic drug products are generic drug products that are introduced by brand companies, either directly or through third parties, under the brand’s NDA approval. Authorized generics do not face any regulatory barriers to introduction and are not prohibited from sale during the 180-day marketing exclusivity period granted to the FTF ANDA applicant. The sale of authorized generics adversely impacts the market share of a generic drug product that has been granted 180 days of marketing exclusivity. ThisAuthorized isgeneric drug products present a significant source of competition for us,us because an authorized generic drug productand can materially decrease the profits that we could receive as an otherwise exclusive marketer of a generic drug product. Such actions have the effect of reducing the potential market share and profitability of our generic drug products and may inhibit us from developing and introducing generic pharmaceutical drug products corresponding to certain branded drugs.

If we fail to obtain exclusive marketing rights for our products or fail to introduce our products to the market on a timely basis,timely, our revenues, gross margin and operating results may decline significantly.

With respect to our generic products, ANDAs containing Paragraph IV certifications generallyoften become the subject ofto patent litigation that can be both lengthy and costly. There is no certainty that we will prevail in any such litigation, that we will be the first to file and thus granted the 180-day marketing exclusivity period,file, or, if we are granted the 180-day marketing exclusivity period, that we will not forfeit such period. Even where we are awarded marketing exclusivity, we may be required to share our exclusivity period with other first filers. In addition, branded drug product companies often authorize a generic version of the corresponding branded drug product to be sold during any period of marketing exclusivity that is awarded, which reduces gross margins during the marketing exclusivity period. Branded drug product companies may also reduce the price of their branded drug product to compete directly with generic drug products entering the market, which would similarly have the effect of reducing gross margins. Furthermore, timely commencement of the litigation by the patent owner imposes an automatic stay of ANDA approval by the FDA for 30 months, unless the case is decided in the ANDA applicant’s favor during that period. Finally, if the court decision is adverse to the ANDA applicant, the ANDA approval will be delayed until the challenged patent expires, and the applicant forfeits the 180-day marketing exclusivity.

With respect to our branded products, generic equivalents for branded pharmaceutical products are typically sold at lower prices than the branded products. The regulatory approval process in the U.S. and European Union exempts generic products from costly and time-consuming clinical trials to demonstrate their safety and efficacy and relies instead on the safety and efficacy of prior products. After the introduction of a competing generic product, a significant percentage of the prescriptions previously written for the branded product are often writtenswitch forto the generic version. In addition, legislation enacted in most U.S. states allows, or in some instances mandates, a pharmacist to dispense an available generic equivalent when filling a prescription for a branded product, in the absence of specific instructions from the prescribing physician. Pursuant to the provisions of the Hatch-Waxman Act, manufacturers of branded products often bring lawsuits to enforce their patent rights against generic products released prior to the expiration of branded products’ patents, but it is possible for generic manufacturers to offer generic products while such litigation is pending. As a result, branded products typically experience a significant loss in revenues and gross profit following the introduction of a competing generic product, even if subject to an existing patent. Our branded pharmaceutical products are or may become subject to competition from generic equivalents because either (i) there is no proprietary protection for some of the branded pharmaceutical products we sell, because(ii) our patent protection expired or because(iii) our patent protection is not sufficiently broad or enforceable. For example, in 2025, we expect to loselost exclusivity for RYTARY®, an extended-release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease.

Third parties could illegally distribute and sell counterfeit versions of our products, which do not meet the rigorous manufacturing and testing standards that our products undergo. Counterfeit products are frequently unsafe or ineffective and can be life-threatening.life-threatening Counterfeitbecause medicinesthey may contain harmful substances, the wrong dose of the API or no API at all. However, to distributors and users, counterfeit products may be visually indistinguishable from the authentic version.

Our business is highly dependent on market perceptions of us and the safety and quality of our products. Our business, products or product pricing could be subject to negative publicity, which could have a material adverse effect on our business, results of operations and financial condition.

The pharmaceutical industry hasWe also inface recentrisks yearsresulting beenfrom thepublic subjectcriticism of significant publicity regarding thedrug pricing of pharmaceutical products more generally, including publicity and pressure resulting from prices charged by competitors and peer companies for new products as well as price increases by competitors and peer companies on older products that the public has deemed excessive. Even if we may have reduced the prices we charge our customers for certain products, often consumers do not see similar reductions in the prices they paid. Any downward pricing pressure on the price of certain of our products arising from social or political pressure to lower the cost of pharmaceutical products could have a material adverse impact on our business, results of operations and financial condition.

Accompanying the press and media coverage of pharmaceutical pricing practices and public complaints about the same, has been increasing U.S. federal and state legislative and enforcement interest with respect to drug pricing. For instance, the DOJ issued subpoenas to pharmaceutical companies, including us, seeking information about the sales, marketing and pricing of certain generic drugs. See Note 20.19. Commitments and Contingencies for additional information on the DOJ investigation.investigation and other governmental inquiries. In addition to the effects of any investigations or claims brought against us, our business, results of operations and financial condition could also be adversely affected if any such inquiries, of us or of other pharmaceutical companies or the industry more generally, were to result in legislative or regulatory proposals that limit our ability to increase the prices of our products.

Even if we are able to obtainreceive regulatory approvals for our new products, such as for CREXONT®, theproducts’ success of those products is dependentdepends upon market acceptance. Levels of market acceptance for our new products could be affected by several factors, including:

•the availability and pricing of alternative products from our competitors;

Some of these factors will not be in our control, and our products may not achieve expected levels of market acceptance. Additionally, continuing and increasingly sophisticated studies of the proper utilization, safety and efficacy of pharmaceutical products are being conducted by the industry, government agencies and others which can call into question the utilization, safety and efficacy of products currently or previously marketed by us. In some cases, studies have resulted, and may in the future result, in the discontinuance of product marketing or other risk management programs such as the need for a patient registry.

We continually evaluate the performance of our products and may determine that it is in our best interest to discontinue the manufacture and distribution of certain of our products. For example, in 2023, there was a reduction in the promotional focus on LYVISPAH™, which resulted in an impairment charge of $34.1 million recorded to cost of goods sold. We cannot guarantee that we have correctly forecasted, or will correctly forecast in the future, the appropriate products to discontinue or that our decision to discontinue various products is prudent if market conditions change. In addition, we cannot assure you that the discontinuance of products will reduce our operating expenses or will not cause us to incur material charges associated with such a decision. Furthermore, the discontinuance of existing products entails various risks, including, inIn the event that we decide to sell the discontinued product, the risk that we willmay not be able to find a purchaser for such products or that the purchase price obtained willmay not be equal to at least the book value of the net assets for such products. Other risks include managing the expectations of, and maintaining good relations with, our customers who previously purchased products from among our discontinued products, which could prevent us from selling other products to them in the future. Moreover, we may incur other significant liabilities and costs associated with our discontinuance of products, which could have a material adverse effect on our business, results of operations and financial condition.

As a pharmaceutical company, we are subject to substantial regulation by various governmental authorities. For instance, weWe must comply with requirements of the FDA, DEA and other healthcare regulators with respect to the manufacture, labeling, sale, distribution, marketing, advertising, promotion and development of pharmaceutical products. We must register our facilities, whether located in the U.S. or elsewhere, with the FDA as well as regulatorsregulatory authorities outside the U.S., and our products must be made in a manner consistent with cGMP, or similar standards in each territory in which we manufacture. The failure of one of our facilities, or a facility of one of our third-party suppliers, to comply with applicable laws andor regulations may lead to breach of representations made to our customers or to regulatory or government action against us related to products made in that facility.

In addition, the FDA, DEA and other agencies periodically inspect our manufacturing facilities. Following an inspection, agencies have in the past issued, and may in the future issue, a notice listing conditions that are believed to violate cGMP or other regulations, or a warning letter for violations of “regulatory significance” that may result in enforcement action if not promptly and adequately corrected. WeFor example, in August 2025, the FDA issued a Warning Letter to our manufacturing facility in Gujarat, India, following an inspection that identified certain deficiencies. The inspection has been classified as Official Action Indicated. While we are actively implementing corrective actions and engaging with the FDA, we cannot assure that these actions will be deemed adequate or that additional enforcement actions will not occur. Further, although we remain committed to continuing to improve our quality control and manufacturing practices; however, we cannot be assured that the FDA willmay continue tonot be satisfied with our corrective actions and withor our quality control and manufacturing systems and standards. Failure to comply strictly with these regulations and requirements, or our failure to remedy any deficiencies, may damage our reputation and lead to financial penalties, compliance expenditures, the recall or seizure of products, total or partial suspension of production and/or distribution, withdrawal or suspension of the applicable regulator’s review of our submissions, enforcement actions, injunctions and criminal prosecution. Further, other federal agencies, our customers and partners in our alliance, development, collaboration and other partnership agreements with respect to our products and services may take any such FDA observations or warning letters into account when considering the award of contracts or the continuation or extension of such partnership agreements. Because regulatory approval to manufacture a drug is site-specific, the delay and cost of remedial actions, or obtaining approval to manufacture at a different facility, could negatively impact our business. Any failure by us to comply with applicable laws and regulations and/or any actions by the FDA and other agencies as described above could have a material adverse effect on our business,business and financial position and results of operations.results.

WeCustomer mayconsolidation experiencecould cause declines in the sales volume and the prices of our products as a result of the continuing trend of consolidation of certain customer groups,products, which could have a material adverse effect on our business, financial position and results of operations.

Our ability to successfully commercialize any generic or branded pharmaceutical product depends in large part upon the acceptance of the product by third parties, including pharmacies, government formularies, other retailers, physicians and patients. Therefore, our success will depend in large part on market acceptance of our products. We makerely a significant amount of our sales toon a relatively small number of drug wholesalers and retail drug chains.chains Theseto customers represent an essential part of the distribution chain ofdistribute our pharmaceutical products. Drug wholesalers and retail drug chains have undergone, and are continuing to undergo, significant consolidation. This consolidation may result in these groups gaining additional purchasing leverage and, consequently, increasing the product pricing pressures facing our business. Additionally, the emergence of large buying groups representing independent retail pharmacies and other drug distributors, and the prevalence and influence of managed care organizations and similar institutions, potentially enable such groups to demand larger price discounts on our products. For example, large wholesalers and retailer customers have formed alliances, such as Walgreens and Cencora, Inc., Rite Aid and McKesson Drug Company, and CVS Caremark and Cardinal Health. The result of these developments may have a material adverse effect on our business, financial position and results of operations.

ChangesSupply inchain tradedisruptions policy,could includinghave thea impositionmaterial ofadverse tariffseffect may adversely affecton our business, financial position and results of operations and financial condition.operations.

We generally begin our development activities forDeveloping a new generic drug product often starts several years in advance of the patent expiration date ofbefore the brand-name drug equivalent.equivalent patent expires. The development process, including drug formulation, testing, and FDA review and approval, often takes three or more years, and is informed by factors outside of our control, including but not limited to, FDA staffing and policy changes. This process requires that we expend considerable capital to pursue activities that do not yield an immediate or near-term return.returns. Also, because of the significant time necessary to develop a product, the actual market for a product at the time it is available for sale may be significantly less than the originally projected market for the product.market. If this were to occur, our potential return on our investment in developing the product, if approved for marketing by the FDA, would be adversely affected and we may never receive a return on our investment in the product. It is also possible for the manufacturer of the brand-name product for which we are developing a generic drug to obtain approvals from the FDA to switch the brand-name drug from the prescription market to the over-the counterover-the-counter (“OTC”) market. If this were to occur, we would be prohibited from marketing our product other than as an OTC drug, in which case revenues could be substantially less than we anticipated.

There are a number of risks and uncertainties associated with clinical trials. The results of clinical trials may not be indicative of results that would be obtained from large scale testing. Clinical trials are often conducted with patients having advanced stages of disease and, as a result, during the course of treatment these patients can die or suffer adverse medical effects for reasons that may not be related to the pharmaceutical agents being tested, but which nevertheless affect the clinical trial results. In addition, side effects experienced by the patients may cause delay of approval or limit the profile of an approved product. Moreover, our clinical trials may not demonstrate sufficient safety and efficacy to obtain approval from the FDA or foreign regulatory authorities. The FDA or foreign regulatory authorities may not agree with our assessment of the clinical data or they may interpret it differently. Such regulatory authorities may require additional or expanded clinical trials. Even if the FDA or foreign regulatory authorities approve certain products developed by us, we cannot provide assurance that such regulatory authorities will not subject marketing of such products to certain limits on indicated use.

Developing and commercializing branded pharmaceutical products is generally more costly than developing and commercializing generic products. To grow and achieve success in our branded product business, we must continually identify, develop, acquire and license new products that we can ultimately market. There are many difficultiesDifficulties and uncertainties inherentinherently exist in pharmaceutical R&D, andresulting there isin a high rate of failure inherent in new drug discovery and development. Failure can occur at any point in the process, including late in the process after substantial investment. New product candidates that appear promising in development may fail to reach the market or may have only limited commercial success because of efficacy or safety concerns, inability to obtain necessary regulatory approvals and payer reimbursement, limited scope of approved uses, difficulty or excessive costs to manufacture, or infringement of the patents or IP rights of others. Products that do reach the market may ultimately be subject to recalls or other suspensions in sales. Delays and uncertainties in the FDA approvalor processforeign and theregulatory approval processes in other countries can result in delays in product launches and lost market opportunity. Because there isof a high rate of failure inherent in the R&D process of new products, there is a significant risk exists that funds invested in R&D will not generate financial returns. We cannot be certain when or whether any of our products currently under development will be approved or launched or whether, once launched, such products will be commercially successful. We may be required to spend several years and incur substantial expense in completing certain clinical trials. The length of time, number of trial sites and patients required for clinical trials vary substantially, and we may have difficulty finding a sufficient number of sites and subjects to participate in our trials. Delays in planned clinical trials can result in increased development costs, delays in regulatory approvals and delays in product candidates reaching the market. We rely on independent third-party clinical investigators to recruit subjects and conduct clinical trials in accordance with applicable study protocols and laws and regulations. If regulatory authorities determine that we have not complied with regulations in the development of a product candidate, they may refuse to accept trial data from the site and/or not approve the product candidate, and we would not be able to market and sell that product. If we are not able to market and sell our products after significant expenditures to develop and test them, our business and results of operations could be materially and adversely affected.

The results from early clinical trials may not be predictive of results obtained in later and larger clinical trials, and product candidates in later clinical trials may fail to show the desired safety or efficacy despite having progressed successfully through earlier clinical testing. A number of companies in the pharmaceutical industry, including us, have suffered significant setbacks in clinical trials, even in advanced clinical trials after showing positive results in earlier clinical trials. The completion of clinical trials for our product candidates may be delayed or halted for a variety of reasons in addition to the reasons noted above. In addition, our product candidates could be subject to competition for clinical study sites and patients from other therapies under development which may delay the enrollment in or initiation of our clinical trials.

We may seek to expand our business through complementary or strategic acquisitions of other businesses, products or assets, or through joint ventures, strategic agreements or other arrangements. Any such acquisitions, joint ventures or other business combinationstransactions may involve significant integration challenges, operational complexities (such as receipt of stockholder and/or regulatory approvals) and time consumption, adversely affect liquidity and require substantial resources and effort. It may also disrupt our ongoing businesses, which may adversely affect our relationships with customers, employees, regulators and others with whom we conduct business. Further, if we are unable to realize synergies or other benefits expected to result from any acquisitions,such joint ventures or other business combinations,transactions, or to generate additional revenue to offset any unanticipated inability to realize these expected synergies or benefits, our growth and ability to compete may be impaired, which would require us to focus additional resources on the integration of operations rather than other profitable areas of our business, and may otherwise cause a material adverse effect on our business, results of operations and financial condition. Acquisitions may also have hidden costs, including unforeseen pre-acquisition liabilities or the impairment of customer relationships or certain acquired assets such as goodwill. We may also incur costs and inefficiencies to the extent an acquisition expands the industries, markets or geographies in which we operate due to our limited exposure to and experience in a given industry, market or region. Finally, acquisitions can also involve litigation and/or post-transaction disputes, including with the counterparty regarding purchase price or other working capital adjustment or liabilities for which we believe we were indemnified under the relevant transaction agreements, among other matters.

We are increasingly dependentdepend on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our IT systems or breaches of information security could adversely affect our business. InWe the ordinary course of business, weregularly collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such information. Additionally, our IT systems are critical to our ability to store electronic and financial information and to manage a variety of business processes and activities, including manufacturing, financial, logistics, sales, marketing and administrative functions. We depend on our IT infrastructure to communicate internally and externally with employees, customers, suppliers and others. We also use IT networks and systems to comply with regulatory, legal and tax requirements. We have outsourced significant elements of our IT infrastructure; as a result we manage independent vendor relationships with third-parties who are responsible for maintaining significant elements of our IT systems and infrastructure and who may or could have access to our confidential information. The size and complexity of our IT systems, and those of our third-party vendors, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partnerspartners, vendors, or vendors. These systems are also vulnerable to attacks by malicious third parties,parties such asusing phishing or ransomware attacks,attacks. andOur systems may be susceptible to intentional or accidental physical damage to the infrastructure maintained by us or by third parties, including as a result of extreme weather events, such as fires, floods, hurricanes, or tornadoes or as the result of the use of AI or other new technologies. For example, in 2024, CrowdStrike Holdings, Inc., a cybersecurity vendor, distributed a faulty software update that caused widespread problems with computers running Microsoft Windows as their operating system, which impacted individual, business and government users globally. While the Company was impacted by this faulty update, affected systems were remediated within seven business days, with minimal disruption and no material impact to the Company.

Maintaining the secrecy of confidential, proprietary, and/or trade secret information is important to our competitive business position. We continually assess these threats and make investments to increase internal protection, detection, and response capabilities, as well as ensure our third-party providers have required capabilities and controls, to mitigate these risks. Like other public companies, our computer systems and those of our third-party vendors and service providers are regularly subject to, and will continue to be the target of, computer viruses, malware or other malicious code (including ransomware), unauthorized access, cyber-attacks or other computer-related penetrations, which have caused, and may continue to cause, disruptions to our operations. For example, we have been the victim of attempted phishing attempts,email attacks, some of which have been successful in evading detection and blocking. While we have experienced threats to our data and systems, to date, we are not aware that we have experienced a material cyber-security breach. Over time, however, the sophistication of these threats continues to increase. Our reliance on unsupported and vulnerable operating systems and other software in certain cases may increase both the likelihood and potential severity of cyber incidents. The preventative actions we take to reduce the risk of cyber incidents and protect our information may be insufficient. Our efforts may not prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms of deception, or for any other cause, could enable others to produce competing products, use our proprietary technology or information, and/or adversely affect our business position. Further, any such interruption, security breach, loss or disclosure of confidential information could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on our business, financial position, results of operations and/or cash flow.

AI technologies may exacerbate existing risks, including risks associated with data privacy, cybersecurity, IP, healthcare fraud and abuse, drug development and manufacturing, and risks to patients or human subjects in clinical trials. AI also introduces new risks, due to the autonomous nature of the technology, which, in some cases, may be deployed to perform tasks, inform decisions, automate decisions, and make predictions, sometimes using unverified or false information. AI may amplify biased and discriminatory decision making, perform unreliably and malfunction, generate insightsdifficult-to-interpret which are difficult to interpret and explain,insights, and cause direct harm to individuals or groups.

Regulators are proposing, adopting, and implementing new AI laws and regulations. WeSuch laws and regulations may berequire requiredus to change our business practices and policies as a result of such laws and regulations and may incurcreate substantial compliance-related costs. Regulators are also using existing laws and regulations to take enforcement actions related to the deployment of AI in ways that result in non-compliance with current laws and regulations.non-compliance. If we fail to comply with AI laws and regulations, we may be subject to sanctions, fines, and reputational damage, orders to stop certain processing of personal data, orders to delete certain data or destroy AI algorithms derived from data collects, legal action on behalf of impacted individuals or other enforcement or other actions. If we or our vendors using AI technologies fail to take steps to protect our confidential data, trade secrets, IP and personal data, we may be subject to legal, regulatory, financial, and reputational risks.

AI technologies present significant opportunities and risks to our business. Harnessing AI’s transformative potential may enable us to speed up the discovery and development of new drugs, optimize our manufacturing processes, and drive efficiencies. Our failure to use AI technologies in a way that maintains trust, qualityquality, and control in our business activities and to capitalize on opportunities presented by AI may also place us at a competitive disadvantage. Failure to address AI risks will reduce our ability to deliver strategic objectives. Also, investmentsInvestments in AI may not realize the benefits that were anticipated. Failure to address AI risks could reduce our ability to deliver strategic objectives.

We produce the majority of the products that we manufacture at our manufacturing facilities in New York, New Jersey and India, as well as at certain third-party suppliers, one of which is located in Taiwan. Disruptions at these facilities or within our supply chain can occur for many reasons, including events unrelated to us or beyond our control, such as fires and other industrial accidents, floods and other severe weather events, natural disasters, environmental incidents or other catastrophes, utility and transportation infrastructure disruptions, shortages of raw materials, pandemic diseases or viral contagions, and acts of war or terrorism. For example, in November 2023, the Houthi movement, which controls parts of Yemen, began attacking merchant ships in the Red Sea disrupting global supply chains;chains. whileAlthough theconditions improved at times during 2024, attacks haveand largelythreats abatedcontinued sinceinto late2025, 2024,and itshipping isdisruptions possiblecould theyresume willor resume.worsen. Natural disasters and adverse weather conditions can be caused or exacerbated by climate change, and the spate of extreme weather events experienced over the past several years presents an alarming trend. Extreme weather events have compromised our facilities in the past and may do so in the future. Furthermore, work stoppages, whether union-organized or not, can also disrupt operations. Business interruption could also be caused by compliance failures. A significant disruption at any of these facilities or otherwise within our supply chain, even on a short-term basis, could impair our ability to produce and ship products to the market on a timely basis or at all, which could have a material adverse effect on our business, financial position and results of operations.

Amneal Pharmaceuticals, Inc. (the “Company”, “we,” “us,” or “our”) is a diversified, global pharmaceuticalbiopharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines. Our Affordable Medicines segment includes retail generics, injectables, and biosimilars. In our Specialty segment, we offer a portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through our AvKARE segment, we are a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. We operate principally in the United States (“U.S.”),U.S., India, and Ireland. Refer to the section “Segments” below for an overview of our segments, including the change in name of the Affordable Medicines segment.segments.

Prior to the Reorganization (as defined herein), we were a holding company, whose principal assets were common units (the “Amneal Common Units”) of Amneal Pharmaceuticals, LLC (“Amneal”). As of September 30, 2023, we held 50.4% of the Amneal Common Units and the group, together with their affiliates and certain assignees, who owned Amneal when it was a private company (the “Members” or the “Amneal Group”) held the remaining 49.6%. On November 7, 2023, we implemented a plan pursuant to which we and Amneal reorganized and simplified our corporate structure by eliminating our umbrella partnership-C-corporation structure and converting to a more traditional structure whereby all stockholders hold their voting and economic interests directly through the public company (the “Reorganization”). Effective with the Reorganization, we hold 100% of the Amneal Common Units and consolidate the financial statements of Amneal and its subsidiaries. Refer to Note 1. Nature of Operations in our consolidated financial statements for additional information about the Reorganization.

For a discussion of our financial condition and results of operations for the year ended December 31, 20232024 compared to the year ended December 31, 2022,2023, see “Results of Operations” and “Liquidity and Capital Resources” under Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 20232024 Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission on MarchFebruary 14,28, 2024.2025.

We have three reportable segments: Affordable Medicines (formerly known as Generics),Medicines, Specialty, and AvKARE.

Our Affordable Medicines segment includes approximatelyover 270280 product families covering an extensive range of dosage forms and delivery systems, including both immediate and extended-release oral solids, powders, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmics, films, transdermal patches and topicals. We focus on developing products that have substantial barriers-to-entry due to complex drug formulations or manufacturing, or legal or regulatory challenges.

Our Specialty segment is engaged in the development, promotion, sale and distribution of proprietary branded pharmaceutical products, with a focus on products addressing central nervous system disorders, including Parkinson’s disease, and endocrine disorders. Our portfolio ofSignificant products includeswithin our Specialty segment include CREXONT® (combination of carbidopa and levodopa extended release capsules), RYTARY® (extended release oral capsule formulation of carbidopa-levodopa), UNITHROID® (levothyroxine sodium), and ONGENTYSBrekiya® (opicapone).dihydroergotamine On August 7, 2024, the FDA approved our new drug application (“NDA”mesylate) for CREXONT®, previously referred to as IPX203.injection. In September 2024, we began selling CREXONT®, which is indicated for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults. RYTARY® is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. ONGENTYS® is an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing “Off” episodes, which we commenced selling in early 2024 under a license agreement with BIAL-Portela & Ca., S.A. UNITHROID®, indicated for the treatment of hypothyroidism, is sold under a license and distribution agreement with Jerome Stevens Pharmaceuticals, Inc.

Our Specialty products are marketed through skilled specialty sales and marketing teams, who call on neurologists, movement disorder specialists, endocrinologists and primary care physicians in key markets throughout the U.S. Our Specialty segment also has a number ofother product candidates that are in varying stages of development.

For Specialty products, the majority of thesuch product’sproducts’ commercial value is usually realized during the period in which the product has market exclusivity. In the U.S., when market exclusivity expires and generic versions of a product are approved and marketed, there can often be very substantial and rapid declines in the branded product’s sales. In 2025, an authorized generic version of RYTARY® was launched, and the Company anticipates multiple generic versions of RYTARY® to be introduced in the future.

Our AvKARE segment provides pharmaceuticals, medical and surgical products and servicespharmaceuticals primarily to governmental agencies, predominantly focused on serving the U.S. Department of Defense and the U.S. Department of Veterans Affairs. AvKARE is also a re-packager of bottle and unit dose pharmaceuticals and vitamins under the registered names of AvKARE and AvPAK. AvKARE is also a wholesale distributor of pharmaceuticals, over the counter drugs and medical supplies to its retail and institutional customers that are located throughout the U.S. focused primarily on entities that provide care to low-income and uninsured patients. Operating results for the sale of Amneal products by AvKARE are included in our Affordable Medicines reportable segment.

•Growth in our Affordable Medicines segment of $213.9$60.3 million, primarily due to new products launched in 20242025 and 2023,2024, which included biosimilars that contributed $59.7 million of year-over-year growth and other new products that contributed $144.1$122.6 million of year-over-year growth, and strong volume growth, partially offset by price erosion. Net revenue for the year ended December 31, 2023 included a non-recurring customer order of $21.0 million.

•Growth in our AvKARE segment of $131.2$81.8 millionmillion, primarily driven by growth in our distribution and government channelslabel channel resulting from new product introductions.introductions, partially offset by a decline in our lower margin distribution channel.

Gross profit as a percentage of net revenue increased to 36.5%36.9% for the year ended December 31, 20242025 from 34.3%36.5% in the prior year, primarily as a result of the factors noted above.above and favorable product mix, as low margin distribution sales decreased.

Selling, general and administrative (“SG&A”) expenses for the year ended December 31, 20242025 increased 10.9%10.6% as compared to the prior year primarily due to increases in employee compensation,compensation promotionand launch costs associated with ONGENTYSCREXONT® and CREXONTthe Brekiya®, increased expenses associated with our growing biosimilars, and annual fees assessed on branded prescription drug manufacturers, which are also applicable to certain of our Affordable Medicines products.autoinjector.

Research and development (“R&D”) expenses for the year ended December 31, 20242025 increaseddecreased 16.3%2.4% from the prior year primarily due to ana increasedecrease in in-licensing and upfront milestone payments of $30.0$7.5 million, including $20.0 million associated with our exclusive license of Omalizumab (refer to Note 23. Related Party Transactions for additional information), partially offset by operatingan efficienciesincrease in ouremployee infrastructure.compensation.

(Credit) Charges Related to Legal Matters, Net

For the year ended December 31, 2024, (credit) charges related to legal matters, net of $96.7 million were primarily associated with an Affordable Medicines settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against us by political subdivisions and Native American tribes across the U.S. Refer to Note 19. Commitments and Contingencies for additional information.

The provision for income taxes was $18.9$11.3 million and $8.5$18.9 million for the years ended December 31, 20242025 and 2023,2024, respectively. The effective tax rates for the years ended December 31, 20242025 and 20232024 were (34.3)%8.1% and (21.034.3)%, respectively. The changeyear-over-year changes in the effectiveprovision for income taxes and effective tax rate forprimarily reflected differences in income by jurisdiction, the yearimpact endedof DecemberOBBBA, 31,and 2024items as comparedrelated to theshare priorbased yearcompensation was primarily due toin the timingcurrent and jurisdictional mix of income and the Reorganization, which resulted in allocating all of Amneal’s income to the Company.year. Refer to Note 6.5. Income Taxes for additional information.

Affordable Medicines net revenue for the year ended December 31, 20242025 increased 14.5%3.6% as compared to the prior year, primarily due to new products launched in 20242025 and 2023,2024, which included biosimilars that contributed $59.7 million of year-over-year growth and other new products that contributed $144.1$122.6 million of year-over-year growth, and strong volume growth, partially offset by price erosion. Net revenue for the year ended December 31, 2023 included a non-recurring customer order of $21.0 million.

Affordable Medicines cost of goods sold for the year ended December 31, 20242025 increased 10.7%5.0% compared to the prior year primarily due to costs associated with increased sales volume and increased plant and freight costs and an increased inventory provision,costs, partially offset by efficienciesmanufacturing in our supply costs. Cost of goods sold for the year ended December 31, 2023 included $11.0 million associated with the non-recurring customer order discussed above.efficiencies.

Affordable Medicines gross profit as a percentage of net revenue increaseddecreased to 40.0%39.2% for the year ended December 31, 20242025 from 37.9%40.0% in the prior year as a result of the factors described above.

Affordable Medicines SG&A for the year ended December 31, 20242025 increased by 8.1%9.9% compared to the prior year primarily due to increases in employee compensationcompensation, driven by infrastructure expansion and promotion associated with our biosimilar launches and the annual fees assessed on branded prescription drug manufacturers, which are also applicable to certaincosts of our affordableinternational medicineexpansion, products,and partiallyshipping offset by reduced legal fees.costs.

Affordable Medicines R&D expense for the year ended December 31, 20242025 increaseddecreased 29.9%9.2% as compared to the prior year primarily due to an increasedecreases in in-licensing and upfront milestone payments of $30.0 million, including $20.0$13.5 million associatedand withreduced ourproject exclusive license of Omalizumab (refer to Note 23. Related Party Transactions for additional information),spend, partially offset by operatingincreased efficiencies.employee compensation.

Charges (Credit) Charges Related to Legal Matters, Net

For the year ended December 31, 2024, the Affordable Medicines charges related to legal matters, net of $96.7 millionmillion, were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against us by political subdivisions and Native American tribes across the U.S. Refer to Note 20.19. Commitments and Contingencies for additional information.

Other than as set forth below, there have been no material changes to the disclosures presented in our 2025 Annual Report on Form 10-K under Item 1A. Risk Factors.Factors, as supplemented by the disclosure presented in our Quarterly Report on Form 10-Q for the period ended March 31, 2026, filed with the SEC on May 7, 2026.

The following discussion and analysis for the three and six months ended MarchJune 31,30, 2026 should also be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements for the year ended December 31, 2025 included in our 2025 Annual Report on Form 10-K.

On April 21, 2026, we entered into a definitive agreement to acquire 100% of the outstanding membership interests in Kashiv BioSciences, LLC (a related party, as described in Note 20.18. SubsequentRelated EventsParty Transactions in this Quarterly Report on Form 10-Q and Note 22. Related Party Transactions in our 2025 Annual Report on Form 10-K) (“Kashiv”) in a transaction (the “Transaction”) with consideration that includes $375 million of cash and 28,942,108 shares of Class A common stock of the Company at closing, subject to certain purchase price adjustments for cash, and the funding of operations between signing and closing, among others. Consideration also includes up to $350 million in potential contingent payments based on the achievement of certain regulatory milestones in the United States and potential contingent royalties equal to 25% of the amount by which annual aggregate gross profits for certain products exceed specified gross profit hurdle amounts for the corresponding annual royalty periods during the twelve-year period following the closing of the transaction.

The transaction iswas subject to approvalapproved by a vote of the holders of the Company’s common stock not party to the transaction, and the issuance of Class A common stock as consideration iswas subject to approvalapproved by a vote of the Company’s common shareholders.shareholders on July 31, 2026. Closing of the transaction, which is expected in the secondthird halfquarter of 2026, isremains subject to the receipt of regulatory approvals and the satisfaction of customary closing conditions.

IfUpon closing of the pending acquisition is consummated,transaction, we will issue 28,942,108 shares of our Class A common stock. As a result, our stockholders will own a smaller percentage of the Company after the acquisition and will thereafter have a reduced voting and economic interest in the Company.

Since 2025, the U.S. government has taken a number of actions affecting trade policy for pharmaceuticals, including initiating investigations into pharmaceutical imports and announcing various tariff measures, as discussed in Part II., Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our 2025 Annual Report on Form 10-K. These actions have included the imposition and subsequent invalidation of certain tariffs under the International Emergency Economic Powers Act by the U.S. Supreme Court, as well as the establishment of additional tarifftariffs pursuant to several other authorities that include product‑specific exemptions.

On AprilMay 2,13, 2026, the President announced the findings of a Section 232 investigation into pharmaceutical imports and the imposition of tariffs on certain FDF and API.API, Accordingunder towhich the announcement, generic and biosimilar products, as well as their associated APIs, are exempt from the Section 232 tariffs. Certaincertain branded pharmaceutical products and their APIs are subject to tariffs of up to 100%, with the potential for tariff reductions and various product-, company-, and country-specific exceptions. TheWe Administration has indicated that it intends to issue a Federal Register notice providing additional information regarding the scope and applicability of the exceptions. The Company isare currently evaluating the potential impact of these measures, the ultimate effect of which will depend on the final scope of the tariffs, the availability and terms of any applicable exceptions, and any additional guidance or actions taken by the Administration. Generic and biosimilar products, as well as their associated APIs, were exempted from this action.

Comparison of Three Months Ended MarchJune 31,30, 2026 to Three Months Ended MarchJune 31,30, 2025

The following table sets forth our summarized, consolidated results of operations for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Net revenue for the three months ended MarchJune 31,30, 2026 increased 3.9%9.9% from the prior year periodperiod, primarily due to:

•Growth in our Affordable Medicines segment net revenue of $8.5$56.5 million, primarily due to increasesnew products launched in 2026 and 2025, which contributed $44.8 million of year-over-year growth, as well as an increase in sales of women’s health and attention deficit hyperactivity disorder medicines due to market conditions, partially offset by price erosion and a decline in biosimilar sales.erosion.

•Growth in our Specialty segment net revenue of $25.0$21.3 million, primarily driven by increases in sales of CREXONT® ($12.2$17.6 million), BREKIYA® autoinjector ($4.6$5.5 million), and UNITHROID® ($2.6$5.9 million), partially offset by the expected decline in sales of RYTARY®.

•DeclineA decline in our AvKARE segment net revenue of $6.4$6.1 million, primarily driven by a reduction in our low margin distribution sales, partially offset by expansion in our government label channel from new product introductions.

Cost of goods sold increased 5.3% for the three months ended MarchJune 31,30, 2026 decreased 8.4%as compared to the prior year period. The decreaseincrease in cost of goods sold was primarily due to the mix of revenues, including a reductionincreases in lowsales marginvolume, distributionplant sales,and increasedfreight manufacturingcosts, efficiencies, including a reduction inand inventory obsolescence, andpartially offset by a reduction in amortization expense of $15.2 million, partially offset by increased plant costs.expense.

Gross profit as a percentage of net revenue increased to 44.3%42.0% for the three months ended MarchJune 31,30, 2026 from 36.8%39.5% in the prior year period,period primarily asdue ato resultlower ofamortization theexpense factorsand notedoperating above.leverage from higher sales volume.

Selling, general, and administrative (“SG&A”) expenses for the three months ended MarchJune 31,30, 2026 increased 17.4%19.7% as compared to the prior year period, primarily due to increases in employee compensation and launch costs associated with CREXONT® and BREKIYA® autoinjector.

Research and Developmentdevelopment (“R&D”) expenses for the three months ended MarchJune 31,30, 2026 decreased 4.1%18.7% as compared to the prior year period, primarily duedriven toby decreaseda $2.9 million decrease in in-licensing and upfront milestone payments and lower employee compensation costs as a result of $2.8operational million, partially offset by increased project spend.efficiencies.

Acquisition costs for the three months ended MarchJune 31,30, 2026 were primarily related to professional services fees (e.g., legal, duefinancial diligence,advisory, accounting, and consulting) associated with the previously announced agreement to acquire Kashiv Biosciences, LLC (see Note 20.18. SubsequentRelated EventsParty Transactions).

For the three months ended MarchJune 31,30, 2026, charges related to legal matters, net were $0.7$8.1 million, primarily comprisedconsisting of acharges $21.2related millionto chargeantitrust associatedclass withaction certainlitigation. statesFor electingadditional ainformation 25% cash conversion in lieu of product underregarding the Nationwideantitrust Opioidsclass Settlementaction Agreement,litigation, partially offset by a $20.8 million discount recorded on the expected settlement payments as of the agreement’s effective date. Referrefer to Note 16. Commitments and Contingencies for additional information.Contingencies.

Other operating income for the three months ended 2025June 30, 2026 was primarily comprised of income earned from the India Production Linked Incentive Scheme for the Pharmaceutical Sector (the “PLI Scheme”).

Total other expense, net for the three months ended MarchJune 31,30, 2026 decreased 2.0%1.5% as compared to the prior year period. The decrease was primarily driven by a period-over-period decrease in the tax receivable agreement charge of $13.0 million (refer to Note 4. Income Taxes) and a $3.6$10.1 million period-over-period decrease in interest expense due to lower interest rates and lower amounts outstanding on our variable-rate debt,debt and a $2.0 million period-over-period decrease in the tax receivable agreement charge (refer to Note 4. Income Taxes), partially offset by a $3.5 million loss on refinancing in the first quarter of 2026 and unfavorable foreign currency movements.

For the three months ended MarchJune 31,30, 2026, our provision for income taxes and effective tax rate were $2.2$1.4 million and 2.7%,1.9%, respectively, as compared to $12.9$16.1 million and 34.3%,31.1%, respectively, for the three months ended MarchJune 31,30, 2025. The period-over-period change in the provision for income taxes was primarily reflecteddue differencesto the tax impacts from changes in the level and jurisdictional mix of income, the impact of the OBBBA,One Big Beautiful Bill Act (enacted in July 2025), and discrete items related to share-based compensation in the current period.

The following table sets forth results of operations for our Affordable Medicines segment for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Affordable Medicines net revenue for the three months ended MarchJune 31,30, 2026 increased 2.1%13.0% as compared to the prior year period, primarily due to increasesnew products launched in 2026 and 2025, which contributed $44.8 million of year-over-year growth, as well as an increase in sales of women’s health and attention deficit hyperactivity disorder medicines due to market conditions, partially offset by price erosion and a decline in biosimilar sales.erosion.

Affordable Medicines SG&Acost expenseof goods sold for the three months ended MarchJune 31,30, 2026 increased 22.6%11.9% as compared to the prior year period, primarily due to increases in employeesales compensation,volume, regulatory fees,plant and costsfreight ofcosts, ourand internationalinventory expansion.obsolescence.

Affordable Medicines R&Dgross expensesprofit as a percentage of net revenue increased to 42.3% for the three months ended MarchJune 31,30, 2026 increasedfrom 7.4%41.7% as compared toin the prior year period, primarily due to increasedfavorable projectproduct spend,mix from recently launched products and higher sales volumes, partially offset by declinesincreased in depreciationplant and employeefreight compensation.costs and inventory obsolescence.

For the three months ended MarchJune 31,30, 2026, charges related to legal matters, net were $0.7$8.1 million, primarily comprisedconsisting of acharges $21.2related millionto chargeantitrust associatedclass withaction certainlitigation. statesFor electingadditional ainformation 25% cash conversion in lieu of product underregarding the Nationwideantitrust Opioidsclass Settlementaction Agreement,litigation, partially offset by a $20.8 million discount recorded on the expected settlement payments as of the agreement’s effective date. Referrefer to Note 16. Commitments and Contingencies for additional information.Contingencies.

Other operating income for the three months ended 2025June 30, 2026 was primarily comprised of income earned from the PLI Scheme.

The following table sets forth results of operations for our Specialty segment for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Specialty net revenue for the three months ended MarchJune 31,30, 2026 increased 23.1% as16.6% compared to the prior year period, primarily driven by increases in sales of CREXONT® ($12.2$17.6 million), BREKIYA® autoinjector ($4.6$5.5 million), and UNITHROID® ($2.6$5.9 million), partially offset by the expected decline in sales of RYTARY®.

Specialty cost of goods sold for the three months ended MarchJune 31,30, 2026 decreased 19.0% as13.5% compared to the prior year period, primarily due to a reduction in amortization expense of $13.9$14.1 million and revenue mix, partially offset by increased sales volume.

Specialty gross profit as a percentage of net revenue increased to 67.7% for the three months ended MarchJune 31,30, 2026 as compared to 51.0%,56.4%, primarily as a result of the factors noted above.

Specialty SG&A expense for the three months ended MarchJune 31,30, 2026 increased 12.0%32.3% as compared to the prior year period, primarily due to increased launch costs associated with CREXONT® and BREKIYA® autoinjector, as well as increased employee compensation.

Specialty R&D expensesexpense for the three months ended MarchJune 31,30, 2026 decreased 43.7%1.2% as compared to the prior year period, primarily due to decreasedincreased in-licensingoperational and upfront milestone payments of $3.0 million.efficiencies.

The following table sets forth results of operations for our AvKARE segment for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

AvKARE net revenue for the three months ended MarchJune 31,30, 2026 decreased 3.7% as compared to the prior year periodperiod, primarily driven by a reduction in our low margin distribution sales, partially offset by expansion in our government label channel from new product introductions.

AvKARE cost of goods sold for the three months ended MarchJune 31,30, 2026 decreasedincreased 11.7%0.7% as compared to the prior year periodperiod, primarily due to aan reductionincrease in inventory obsolescence of $6.5$5.6 million and higher sales in our government label channel, partially offset by reduced sales in our low margin distribution channel, partially offset by higher sales in our government label channel.

Gross profit as a percentage of net revenue increaseddecreased to 23.5%16.7% for the three months ended MarchJune 31,30, 2026 from 16.6%20.4% in the prior year period, primarily as a result of the factors noted above.