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Amneal Pharmaceuticals, Inc.

AMRX
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Business Summary

Amneal Pharmaceuticals, Inc. is a diversified, global biopharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines . The company operates principally in the United States, India, and Ireland . Its core business model revolves around three reportable segments: Affordable Medicines, Specialty, and AvKARE . The company generates revenue by supplying finished pharmaceutical products to customers, including major wholesalers, distributors, retail pharmacies, managed care organizations, purchasing co-ops, hospitals, government agencies, institutions, and other pharmaceutical companies . Revenue is recognized when control of products is transferred to customers, typically upon shipment or delivery . The company also enters into licensing arrangements for intellectual property (IP) rights and provides research and development (R&D) and contract manufacturing services .

The Affordable Medicines segment includes over 280 product families in the United States, covering a wide range of dosage forms and delivery systems such as oral solids, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmics, films, transdermal patches, and topicals . This segment focuses on developing products with substantial barriers-to-entry due to complex formulations, manufacturing, or legal/regulatory challenges, aiming for first-to-file (FTF), first-to-market (FTM), and other high-value products . As of December 31, 2025, the Affordable Medicines segment had 61 products with a pending Abbreviated New Drug Application (ANDA) and 43 products in various stages of development, with 95% being non-oral solid products . In 2025, products manufactured in U.S. facilities contributed 46% of Affordable Medicines product net revenue, while those manufactured in India contributed 24% . Approximately 30% of Affordable Medicines net revenue for the year ended December 31, 2025, was supplied by third-party manufacturers . Key developments in 2025 included tentative FDA approval for beclomethasone dipropionate HFA inhalation aerosol (generic QVAR®) and FDA approval for albuterol sulfate inhalation aerosol (generic ProAir® HFA), both manufactured in the Ireland facility . The company also received FDA approval for two denosumab biosimilars, Boncresa™ and Oziltus™, in December 2025, bringing its total commercially available biosimilars in the U.S. to five .

The Specialty segment is dedicated to the development, promotion, sale, and distribution of proprietary branded pharmaceutical products, primarily targeting central nervous system disorders, including Parkinson's disease, and endocrine disorders . Significant products in this segment include CREXONT® (combination of carbidopa and levodopa extended release capsules), RYTARY® (extended release oral capsule formulation of carbidopa-levodopa), UNITHROID® (levothyroxine sodium), and Brekiya® (dihydroergotamine mesylate) injection . Brekiya® autoinjector, approved by the FDA in May 2025, was launched in the U.S. in October 2025 . In 2025, an authorized generic version of RYTARY® was launched . CREXONT® expanded its U.S. insurance coverage from approximately 30% of covered lives at the end of 2024 to over 50% at the end of 2025 .

The AvKARE segment distributes pharmaceuticals primarily to governmental agencies, with a focus on the U.S. Department of Defense and the U.S. Department of Veterans Affairs . AvKARE also re-packages bottle and unit dose pharmaceuticals and vitamins under the names AvKARE and AvPAK, and acts as a wholesale distributor of pharmaceuticals, over-the-counter drugs, and medical supplies to retail and institutional customers across the U.S., particularly those serving low-income and uninsured patients . Operating results for the sale of Amneal products by AvKARE are included in the Affordable Medicines segment .

For the year ended December 31, 2025, total net revenue increased by 8.0% to $3.018 billion from $2.793 billion in the prior year . Cost of goods sold increased by 7.4% to $1.905 billion from $1.773 billion . Gross profit rose to $1.113 billion from $1.020 billion , with gross margin increasing to 36.9% from 36.5% . Selling, general and administrative (SG&A) expenses increased by 10.6% to $526.8 million from $476.4 million . Research and development (R&D) expenses decreased by 2.4% to $186.2 million from $190.7 million . Operating income increased by 58.1% to $394.1 million from $249.3 million . Net income was $127.9 million compared to a net loss of $73.9 million in the prior year . Diluted EPS was $0.22 compared to $(0.38) in the prior year . Cash and cash equivalents were $282.0 million as of December 31, 2025, up from $110.6 million in the prior year. Total indebtedness was $2.7 billion , comprising $2.1 billion in Term Loan Due 2032 and $600.0 million in Senior Notes Due 2032. Free cash flow is not explicitly stated, but net cash provided by operating activities was $339.992 million .

Year-over-year, Affordable Medicines net revenue increased by 3.6% to $1.745 billion , driven by $122.6 million in new product launches and strong volume growth, partially offset by price erosion . Specialty net revenue increased by 18.6% to $528.5 million , primarily due to increases of $58.1 million from CREXONT® and $23.7 million from UNITHROID®, partially offset by a $6.0 million decrease in IPX203 out-licensing revenue . AvKARE net revenue increased by 12.3% to $744.7 million , driven by growth in the government label channel from new product introductions, partially offset by a decline in the lower margin distribution channel . Affordable Medicines gross profit as a percentage of net revenue decreased to 39.2% from 40.0% , while Specialty gross profit as a percentage of net revenue decreased to 53.5% from 54.5% . AvKARE gross profit as a percentage of net revenue increased to 19.7% from 15.6% .

Significant operational developments in 2025 included the FDA approval and U.S. launch of Brekiya® autoinjector in October , and the FDA approvals of Boncresa™ and Oziltus™ denosumab biosimilars in December . The company also received tentative FDA approval for generic QVAR® and FDA approval for generic ProAir® HFA, marking the first commercial approvals for products manufactured in its Ireland facility . In December 2025, the company entered into a distribution agreement with Valorum Oncology, LLC for ALYMSYS® . In September 2025, a Biologics License Application (BLA) was submitted to the FDA for the omalizumab biosimilar candidate . The company also began a multi-year enterprise resource planning (ERP) system implementation for certain parts of its business .

Business Outlook

For the upcoming period, the company expects to make $21.0 million in principal payments on the Term Loan Due 2032 during 2026, with no principal due on the Senior Notes Due 2032 until maturity . Interest payments totaling $193.9 million , excluding the impact of the interest rate swap, are expected during 2026 related to the Term Loan Due 2032 and Senior Notes Due 2032 . The company anticipates investing approximately $110.0 million during 2026 for capital expenditures to support and grow existing operations, primarily for manufacturing equipment, IT, and facilities, net of expected contributions from Metsera, Inc. .

A major growth area for the company is its injectable portfolio, with R&D prioritizing new product innovations such as drug/device combinations, peptides, long-acting injectables, and large volume parenteral bags . The company has expanded its manufacturing capabilities and infrastructure to support this expanding business, focusing on development, commercialization, and scaling a differentiated injectables portfolio . The strategic collaboration agreement with ApiJect Systems, Corp., entered into on May 8, 2025, is a 15-year agreement where the company will install and operate manufacturing equipment leased from ApiJect at its Brookhaven, New York facility to support production of ApiJect’s proprietary blow fill seal (BFS) delivery systems and the company's growing injectable portfolio . The company will pay a low-digit royalty to ApiJect for commercial products manufactured using this equipment and has the right to purchase the equipment for a nominal amount at the end of the term . The collaboration also includes development of additional injectable product programs utilizing ApiJect’s BFS platform, for which the company is entitled to receive consideration for development work .

Another significant growth vector is the biosimilar portfolio. The company received FDA approval for two denosumab biosimilars, Boncresa™ and Oziltus™, in December 2025, reinforcing its position in this fast-growing category and underscoring biosimilars as a key long-term growth driver within the Affordable Medicines segment . These products were developed by mAbxience S.L. . In September 2025, the company submitted a BLA to the FDA for its omalizumab biosimilar candidate . The collaboration agreement with Metsera, Inc., entered into on September 30, 2024, designates the company as Metsera’s preferred global supply partner for its portfolio of weight loss medicines and grants an exclusive license to commercialize certain Metsera products in select emerging markets, including India, certain Southeast Asian countries, Africa, and the Middle East . The company is constructing two manufacturing facilities in India for API production and fill-finish manufacturing, with Metsera funding an agreed-upon percentage of these costs, up to $100 million . Following Pfizer's acquisition of Metsera and exercise of a change-in-control provision on January 30, 2026, the agreement's term was shortened from seven to four years from the date of first commercial sale, eliminating the company's rebate and construction cost reimbursement obligations, while Metsera's cost sharing commitment of up to $100 million remains unchanged .

The company does not expect a material impact related to inflation for the year ending December 31, 2026 . However, rising inflationary pressures due to higher input costs, including higher material, transportation, labor, and other costs, could exceed expectations and adversely impact operating results in future periods . The company is closely monitoring tariff and trade developments and will take actions to reduce or minimize any material negative impact .

Planned capital allocation for 2026 includes approximately $110.0 million for capital expenditures, primarily for investments in manufacturing equipment, IT, and facilities, net of expected contributions from Metsera, Inc. . The company’s current policy is to retain all earnings, if any, for use in business operations or to reduce debt, and it has no present plans to pay cash dividends on common stock in the foreseeable future .

The company is subject to certain trade and tariff requirements imposed by the U.S. and various foreign governments . On February 1, 2025, the Administration imposed a 10% tariff on all products from China under the International Emergency Economic Powers Act (IEEPA) , though this was invalidated by a Supreme Court ruling on February 20, 2026 . On April 14, 2025, the Department of Commerce Bureau of Industry and Security (DOCBIS) initiated a Section 232 investigation into the effects on national security of pharmaceutical imports, including whether tariffs should be imposed . A separate Section 232 investigation was initiated on September 26, 2025, for imports of personal protective equipment, medical consumables, and medical equipment . On February 20, 2026, President Trump imposed a 10% global tariff for 150 days under Section 122 of the Trade Act of 1974, with FDF and API exempt as of the filing date . The recently enacted One Big Beautiful Bill Act (OBBBA) on July 4, 2025, introduces significant changes to U.S. healthcare programs, including Medicaid, Medicare, and Affordable Care Act marketplaces, which may reduce federal healthcare spending, alter eligibility requirements, and potentially lead to lower prescription volumes and decreased demand for products . OBBBA also includes provisions that may increase compliance obligations and administrative complexity for manufacturers participating in government programs .

Risk Factors

The company faces intense competition in the pharmaceutical industry from both brand and generic drug product companies, which could significantly limit growth and materially adversely affect financial results . The illegal distribution and sale of counterfeit or stolen products by third parties could negatively impact the company's reputation and financial condition . The company's business is highly dependent on market perceptions of its safety and quality, and adverse events or public criticism of drug pricing could cause sales to decline . A substantial portion of total revenues is derived from sales of a limited number of products, making the company vulnerable to market conditions and regulatory actions affecting these products . Manufacturing or quality control problems, such as the Warning Letter issued by the FDA to its Gujarat, India facility in August 2025, may damage the company's reputation, demand costly remedial activities, and negatively impact business . The company's profitability depends on major customers, with the four largest accounting for approximately 71% of consolidated net revenue for the year ended December 31, 2025, and the loss of any one could materially affect operating results . Supply chain disruptions, including reliance on single suppliers for raw materials and geopolitical events like the Red Sea attacks or tensions between China and Taiwan, could have a material adverse effect . Changes in trade policy, including the imposition of tariffs, may increase costs, affect product availability, and disrupt supply chains . A U.S. government shutdown could adversely impact regulatory, operational, and financial performance due to delays in FDA and DEA interactions and interruptions in government contracting for the AvKARE segment . The company has a substantial amount of indebtedness, totaling $2.7 billion as of December 31, 2025, which could increase vulnerability to adverse economic conditions and limit financial flexibility . Obligations under a tax receivable agreement (TRA) may be substantial, with an unrecorded contingent TRA liability of $129.1 million as of December 31, 2025, which could significantly impact future results if realized . The Amneal Group controls approximately 48% of the voting power of outstanding Class A Common Stock, potentially leading to conflicts of interest with other stockholders . The company's international operations in India and Ireland, and potential expansion into new geographies, expose it to increased regulatory, economic, social, and political uncertainties . Global economic conditions, including inflation and efforts to contain healthcare costs, could harm the business . The recently enacted One Big Beautiful Bill Act (OBBBA) in July 2025 may reduce future Medicare reimbursement rates and Medicaid participation, potentially decreasing demand for products and increasing compliance costs .

Management Priorities

Management's message to shareholders emphasizes the company's position as a diversified, global biopharmaceutical company focused on essential medicines across its Affordable Medicines, Specialty, and AvKARE segments. They highlight the strategic importance of new product launches and pipeline development, particularly in complex generics, injectables, and biosimilars, as well as branded products for central nervous system and endocrine disorders. Management notes the growth in the Specialty segment, with CREXONT® expanding U.S. insurance coverage to over 50% of covered lives by the end of 2025, and the launch of Brekiya® autoinjector in October 2025 . The company also achieved significant regulatory milestones in 2025, including FDA approvals for generic QVAR® and generic ProAir® HFA from its Ireland facility, and the approval of two denosumab biosimilars, Boncresa™ and Oziltus™ . For the upcoming year, management expects to make $21.0 million in principal payments on the Term Loan Due 2032 and $193.9 million in interest payments, excluding the interest rate swap impact, during 2026 . They plan to invest approximately $110.0 million in capital expenditures for 2026, net of Metsera, Inc. contributions . Strategic priorities include continued investment in R&D for high-value products, expanding manufacturing capabilities for injectables and biosimilars, and leveraging strategic collaborations like those with ApiJect and Metsera to drive future growth. Management also acknowledges the potential impacts of the One Big Beautiful Bill Act (OBBBA) and ongoing trade policy developments, while stating no material impact from inflation is expected for 2026 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 1, Business — Segments of the Business
  4. [4] Item 3, Revenue Recognition — Pharmaceutical Product Sales Performance Obligations
  5. [5] Item 3, Revenue Recognition — Pharmaceutical Product Sales Performance Obligations
  6. [6] Item 3, Revenue Recognition — Revenue Recognition
  7. [7] Item 1, Business — Affordable Medicines
  8. [8] Item 1, Business — Affordable Medicines
  9. [9] Item 1, Business — Affordable Medicines
  10. [10] Item 1, Business — Manufacturing and Distribution
  11. [11] Item 1, Business — Manufacturing and Distribution
  12. [12] Item 1, Business — Affordable Medicines
  13. [13] Item 1, Business — Affordable Medicines
  14. [14] Item 1, Business — Specialty
  15. [15] Item 1, Business — Specialty
  16. [16] Item 1, Business — Specialty
  17. [17] Item 7, MD&A — Specialty
  18. [18] Item 7, MD&A — Specialty
  19. [19] Item 1, Business — AvKARE
  20. [20] Item 1, Business — AvKARE
  21. [21] Item 1, Business — AvKARE
  22. [22] Item 7, MD&A — Consolidated Results
  23. [23] Item 7, MD&A — Consolidated Results
  24. [24] Item 7, MD&A — Consolidated Results
  25. [25] Item 7, MD&A — Consolidated Results
  26. [26] Item 7, MD&A — Consolidated Results
  27. [27] Item 7, MD&A — Consolidated Results
  28. [28] Item 7, MD&A — Consolidated Results
  29. [29] Item 7, MD&A — Consolidated Results
  30. [30] Item 7, MD&A — Consolidated Results
  31. [31] Item 7, MD&A — Consolidated Results
  32. [32] Item 7, MD&A — Consolidated Results
  33. [33] Item 7, MD&A — Consolidated Results
  34. [34] Item 7, MD&A — Consolidated Results
  35. [35] Item 7, MD&A — Consolidated Results
  36. [36] Item 7, MD&A — Consolidated Results
  37. [37] Item 7, MD&A — Consolidated Results
  38. [38] Item 8, Consolidated Statements of Operations
  39. [39] Item 8, Consolidated Statements of Operations
  40. [40] Item 8, Consolidated Balance Sheets
  41. [41] Item 8, Consolidated Balance Sheets
  42. [42] Item 1A, Risk Factors — Risks Relating to Our Indebtedness
  43. [43] Item 1A, Risk Factors — Risks Relating to Our Indebtedness
  44. [44] Item 1A, Risk Factors — Risks Relating to Our Indebtedness
  45. [45] Item 7, MD&A — Cash Flows
  46. [46] Item 7, MD&A — Affordable Medicines
  47. [47] Item 7, MD&A — Net Revenue
  48. [48] Item 7, MD&A — Net Revenue
  49. [49] Item 7, MD&A — Specialty
  50. [50] Item 7, MD&A — Specialty
  51. [51] Item 7, MD&A — Specialty
  52. [52] Item 7, MD&A — Specialty
  53. [53] Item 7, MD&A — Specialty
  54. [54] Item 7, MD&A — AvKARE
  55. [55] Item 7, MD&A — AvKARE
  56. [56] Item 7, MD&A — Affordable Medicines
  57. [57] Item 7, MD&A — Affordable Medicines
  58. [58] Item 7, MD&A — Specialty
  59. [59] Item 7, MD&A — Specialty
  60. [60] Item 7, MD&A — AvKARE
  61. [61] Item 7, MD&A — AvKARE
  62. [62] Item 1, Business — Specialty
  63. [63] Item 1, Business — Affordable Medicines
  64. [64] Item 1, Business — Affordable Medicines
  65. [65] Item 1, Business — Affordable Medicines
  66. [66] Item 1, Business — Affordable Medicines
  67. [67] Item 1A, Risk Factors — Failure to successfully implement a new enterprise resource planning system could have a material adverse effect on our business, results of operations and financial condition.
  68. [68] Item 1A, Risk Factors — Our ability to make scheduled payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing economic and competitive conditions and to certain financial, business, legislative, regulatory and other factors which may be beyond our control.
  69. [69] Item 1A, Risk Factors — Our ability to make scheduled payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing economic and competitive conditions and to certain financial, business, legislative, regulatory and other factors which may be beyond our control.
  70. [70] Item 1A, Risk Factors — Our ability to make scheduled payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing economic and competitive conditions and to certain financial, business, legislative, regulatory and other factors which may be beyond our control.
  71. [71] Item 1A, Risk Factors — Our ability to make scheduled payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing economic and competitive conditions and to certain financial, business, legislative, regulatory and other factors which may be beyond our control.
  72. [72] Item 7, MD&A — Liquidity and Capital Resources
  73. [73] Item 7, MD&A — Liquidity and Capital Resources
  74. [74] Item 1, Business — Affordable Medicines
  75. [75] Item 1, Business — Affordable Medicines
  76. [76] Item 1, Business — ApiJect Systems Collaboration Agreement
  77. [77] Item 1, Business — ApiJect Systems Collaboration Agreement
  78. [78] Item 1, Business — ApiJect Systems Collaboration Agreement
  79. [79] Item 1, Business — Affordable Medicines
  80. [80] Item 1, Business — Affordable Medicines
  81. [81] Item 1, Business — Affordable Medicines
  82. [82] Item 1, Business — Metsera, Inc. Collaboration Agreement
  83. [83] Item 1, Business — Metsera, Inc. Collaboration Agreement
  84. [84] Item 1, Business — Metsera, Inc. Collaboration Agreement
  85. [85] Item 1, Business — Metsera, Inc. Collaboration Agreement
  86. [86] Item 7, MD&A — Inflation
  87. [87] Item 7, MD&A — Inflation
  88. [88] Item 7, MD&A — Trade Policy and Tariffs
  89. [89] Item 7, MD&A — Liquidity and Capital Resources
  90. [90] Item 7, MD&A — Liquidity and Capital Resources
  91. [91] Item 5, Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities — Dividends
  92. [92] Item 7, MD&A — Trade Policy and Tariffs
  93. [93] Item 7, MD&A — Trade Policy and Tariffs
  94. [94] Item 7, MD&A — Trade Policy and Tariffs
  95. [95] Item 7, MD&A — Trade Policy and Tariffs
  96. [96] Item 7, MD&A — Trade Policy and Tariffs
  97. [97] Item 7, MD&A — Trade Policy and Tariffs
  98. [98] Item 7, MD&A — One Big Beautiful Bill Act
  99. [99] Item 7, MD&A — One Big Beautiful Bill Act
  100. [100] Item 1A, Risk Factors — We face intense competition in the pharmaceutical industry from both brand and generic drug product companies, which could significantly limit our growth and materially adversely affect our financial results.
  101. [101] Item 1A, Risk Factors — The illegal distribution and sale by third parties of counterfeit versions of our products or of stolen products could have a negative impact on our reputation and a material adverse effect on our business, results of operations and financial condition.
  102. [102] Item 1A, Risk Factors — Our business is highly dependent on market perceptions of us and the safety and quality of our products.
  103. [103] Item 1A, Risk Factors — A substantial portion of our total revenues is expected to be derived from sales of a limited number of products.
  104. [104] Item 1A, Risk Factors — Manufacturing or quality control problems may damage our reputation for quality production, demand costly remedial activities and negatively impact our business, results of operations and financial condition.
  105. [105] Item 1A, Risk Factors — Our profitability depends on our major customers. If these relationships do not continue as expected, our business, condition (financial and otherwise), prospects and results of operations could materially suffer.
  106. [106] Item 1A, Risk Factors — Our profitability depends on our major customers. If these relationships do not continue as expected, our business, condition (financial and otherwise), prospects and results of operations could materially suffer.
  107. [107] Item 1A, Risk Factors — Supply chain disruptions could have a material adverse effect on our business, financial position and results of operations.
  108. [108] Item 1A, Risk Factors — Changes in trade policy, including the imposition of tariffs may affect our business, results of operations and financial condition.
  109. [109] Item 1A, Risk Factors — A U.S. government shutdown could adversely impact our regulatory, operational and financial performance.
  110. [110] Item 1A, Risk Factors — We have a substantial amount of indebtedness, which could adversely affect our financial health.
  111. [111] Item 1A, Risk Factors — We have a substantial amount of indebtedness, which could adversely affect our financial health.
  112. [112] Item 1A, Risk Factors — We are required under a tax receivable agreement to make cash payments in respect of certain tax benefits to which we may become entitled, and we expect that the payments we will be required to make will be substantial.
  113. [113] Item 1A, Risk Factors — We are required under a tax receivable agreement to make cash payments in respect of certain tax benefits to which we may become entitled, and we expect that the payments we will be required to make will be substantial.
  114. [114] Item 1A, Risk Factors — The Amneal Group owns nearly a majority of our outstanding Class A Common Stock. The interests of the Amneal Group may differ from the interests of our other stockholders.
  115. [115] Item 1A, Risk Factors — The Amneal Group owns nearly a majority of our outstanding Class A Common Stock. The interests of the Amneal Group may differ from the interests of our other stockholders.
  116. [116] Item 1A, Risk Factors — Our current operations in, and potential expansion into additional international markets subjects us to increased regulatory oversight both in those international markets and domestically as well as regulatory, economic, social and political uncertainties, which could cause a material adverse effect on our business, financial position and results of operations.
  117. [117] Item 1A, Risk Factors — Global economic conditions could harm us.
  118. [118] Item 1A, Risk Factors — Changes in tax laws could have a material adverse effect on our business, results of operations, or financial condition.
  119. [119] Item 7, MD&A — Specialty
  120. [120] Item 7, MD&A — Specialty
  121. [121] Item 1, Business — Affordable Medicines
  122. [122] Item 1A, Risk Factors — Our ability to make scheduled payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing economic and competitive conditions and to certain financial, business, legislative, regulatory and other factors which may be beyond our control.
  123. [123] Item 1A, Risk Factors — Our ability to make scheduled payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing economic and competitive conditions and to certain financial, business, legislative, regulatory and other factors which may be beyond our control.
  124. [124] Item 1A, Risk Factors — Our ability to make scheduled payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing economic and competitive conditions and to certain financial, business, legislative, regulatory and other factors which may be beyond our control.
  125. [125] Item 7, MD&A — Liquidity and Capital Resources
  126. [126] Item 7, MD&A — Liquidity and Capital Resources
  127. [127] Item 7, MD&A — Inflation

Analysis on 5/19/2026