Latest news with #ChintuPatel
Yahoo
08-05-2025
- Business
- Yahoo
Amneal and Apiject to Expand Sterile and Blow-Fill-Seal (BFS) Capabilities for Advanced Pharmaceutical Manufacturing in the U.S.
-Adds BFS platform technology to provide large-scale production capacity for sterile drug dosage forms, including injectables, ophthalmics and inhalation -Expands Amneal's extensive domestic pharmaceutical manufacturing footprint BRIDGEWATER, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ('Amneal' or the 'Company'), an American biopharmaceutical company, and Apiject Systems, Corp. ('Apiject'), a medical technology company focused on advanced drug delivery, today announced a strategic collaboration to expand domestic production of Apiject's BFS-based injectable platform at Amneal's Brookhaven, NY facility. The collaboration will enable large-scale capacity to produce a range of sterile drug dosage forms, including prefilled injectables, ophthalmics and inhalation. Today, Amneal has one of the largest U.S. pharmaceutical manufacturing footprints in the industry. This collaboration underscores Amneal's commitment to strengthening U.S. drug supply through domestic pharmaceutical manufacturing. Currently, the Company has approximately 2,500 employees in the U.S., with the majority focused on operations, quality, and R&D. At the Brookhaven, NY facility, Amneal has approximately 800 employees and this project is expected to create approximately 200 high-quality jobs. 'This collaboration marks a significant step in expanding our U.S. manufacturing footprint with advanced sterile pharmaceutical capabilities,' said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal Pharmaceuticals. 'We continue to invest in advanced pharmaceutical manufacturing in the United States, which reflects our commitment to producing essential and affordable medicines in America for Americans. We believe the country has an opportunity to build a more resilient U.S. pharmaceutical supply chain and to onshore critical drug production, and we are eager to lead the charge.' Amneal will install dedicated manufacturing lines to support Apiject's proprietary delivery systems across government and commercial programs, including applications for emergency preparedness and reshoring domestic pharmaceutical manufacturing, as well as Amneal's growing injectable portfolio. The new infrastructure is expected to have capacity to produce approximately 250 to 300 million units annually, with potential to scale to more than 400 million units over time. In addition, Amneal and Apiject will collaborate on the development of additional injectable product programs utilizing Apiject's BFS platform. Jay Walker, Co-Founder, Executive Chairman and CEO of Apiject, said, 'Our collaboration with Amneal is win, win, win. It provides America with an increased domestic-based capacity to manufacture a new category of prefilled drug delivery devices with supply chain, speed, scalability, and sustainability advantages over traditional offerings. It provides Amneal increased manufacturing options to serve its current and future commercial customers. And it provides Apiject a trusted company to bring a wide range of critical injectable drugs to the U.S. and global market.' Apiject's technology integrates two proven medical innovations: Blow-Fill-Seal (BFS) manufacturing and precision injection molding of pen-style needle hubs. This combination enables the creation of sterile, single-dose, prefilled injectors in a continuous, high-speed process—offering a more scalable, cost-effective, and efficient alternative to traditional glass vials and syringes. The platform's speed, efficiency, and compact supply chain make it particularly well-suited for commercial use, public health campaigns, and emergency response. Apiject's underlying technology was developed, in part, through a $180 million investment by the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) during President Trump's first term in office. The project highlights the Trump Administration's commitment to accelerate the building of new U.S.-based, high-speed, population-scale capacity for pharmaceutical manufacturing. Under the agreement with HHS-ASPR, Apiject delivered on-time and on-budget a domestic fill-finish capacity that served as a backup in the event of critical supply disruptions for traditional injection materials during the pandemic. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit and follow us on LinkedIn. About Apiject SystemsApiject Systems, Corp. is a public-benefit medical technology company that has pioneered a new category of prefilled injection devices with economic, supply chain, and sustainability advantages over traditional offerings. Our mission is to make the safety and performance benefits of prefilled injections affordable and available for most, if not all, injections around the world. The company's technology platform is anchored by a well-established manufacturing process called Blow-Fill-Seal (BFS). BFS is a widely used sterile liquid packaging technology that has been recognized by the FDA as an advanced aseptic process. For more information, visit Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as 'plans,' 'expects,' 'will,' 'anticipates,' 'estimates,' and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, 'Risk Factors' in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Amneal Investor Contact Anthony DiMeoVP, Investor Relations Amneal Media Contact Brandon SkopSr. Director, Corporate Apiject ContactSteven Hofmanshofman@
Yahoo
02-05-2025
- Business
- Yahoo
Amneal Reports First Quarter 2025 Financial Results
‒ Q1 2025 Net Revenue of $695 million; GAAP Net Income of $12 million; Diluted Income per Share of $0.04 ‒ ‒ Adjusted EBITDA of $170 million; Adjusted Diluted EPS of $0.21 ‒ ‒ Affirming 2025 Full Year Guidance ‒ BRIDGEWATER, N.J., May 02, 2025--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company") today announced its results for the first quarter ended March 31, 2025. "Amneal delivered another strong quarter to start 2025, with broad-based growth across all three segments driven by our team's outstanding execution. We are very pleased with the commercial uptake of CREXONT® for Parkinson's Disease and the momentum of our recently launched injectable products, which are delivering tremendous value to patients, caregivers and customers. As a leading U.S.-based biopharmaceutical company, Amneal is proud to provide millions of Americans with access to affordable and innovative treatments—and we believe we are just getting started. With our diverse portfolio, expansive footprint in the U.S. and globally, and a resilient management team, we are confident in our ability to deliver sustainable growth and value creation for our stakeholders in 2025 and beyond as we embark on our exciting next chapter of growth and success," said Chirag and Chintu Patel, Co-Chief Executive Officers. First Quarter 2025 Results Net revenue in the first quarter of 2025 was $695 million, an increase of 5% compared to $659 million in the first quarter of 2024. Affordable Medicines net revenue increased 6% driven by strong performance of our complex product portfolio and new product launches. Specialty net revenue increased 3% driven by key branded products, including CREXONT® and UNITHROID®. AvKARE net revenue increased 6% driven by growth in the government label sales channel. Net income attributable to Amneal Pharmaceuticals, Inc. was $12 million in the first quarter of 2025 compared to a net loss of $92 million in the first quarter of 2024, reflecting higher revenue and gross profit, and a legal settlement charge of $94 million in the first quarter of 2024. Adjusted EBITDA in the first quarter of 2025 was $170 million, an increase of 12% compared to the first quarter of 2024, reflective of strong revenue performance, higher gross margin and operating expense leverage. Diluted income per share in the first quarter of 2025 was $0.04 compared to diluted loss per share of $0.30 for the first quarter of 2024, due to higher operating income and lower interest expense. Adjusted diluted earnings per share in the first quarter of 2025 was $0.21, an increase of 50%, compared to $0.14 for the first quarter of 2024. The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the "Non-GAAP Financial Measures" section and the accompanying GAAP to non-GAAP reconciliation tables for more information. Affirming Full Year 2025 Financial Guidance The Company is affirming its previously provided full year 2025 guidance. Net revenue $3.0 billion - $3.1 billion Adjusted EBITDA (1) $650 million - $675 million Adjusted diluted EPS (2) $0.65 - $0.70 Operating cash flow $255 million - $285 million Operating cash flow, excluding discrete items (3) $280 million - $310 million Capital expenditures (4) Approximately $100 million (1) Includes 100% of adjusted EBITDA from AvKARE. See also "Non-GAAP Financial Measures" below. (2) Accounts for 35% non-controlling interest in AvKARE. Guidance assumes approximately 330 million weighted-average diluted shares outstanding for the year ending December 31, 2025. (3) Excludes discrete items such as legal settlement payments. (4) Reflects estimated capital expenditures, net of expected contributions from an alliance partner of $20 million. Amneal's 2025 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, the timing of future product launches, the costs incurred and benefits realized of restructuring activities, and our long-term strategy. The Company's financial statements are prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP"). The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable measures in accordance with GAAP without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments, legal settlements, and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results. Conference Call Information Amneal will host a conference call and live webcast at 8:30 am Eastern Time today, May 2, 2025, to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company's website at To access the call through a conference line, dial (833) 470-1428 (in the U.S.) with access code 170097. A replay of the conference call will be posted shortly after the call. For a list of toll-free international numbers, visit this website: About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In our Affordable Medicines segment, we are expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In our Specialty segment, we have a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through our AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; statements regarding our expansion into high-growth areas and statements regarding our positioning, including our ability to drive sustainable value creation, and other non-historical statements. Words such as "plans," "expects," "will," "anticipates," "estimates," and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; the impact of illegal distribution and sale by third parties of counterfeit versions of our products or stolen products; the impact of negative market perceptions of us and the safety and quality of our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; the imposition of tariffs may adversely affect our business, results of operations and financial condition; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents, and risks associated with artificial intelligence; the impact of a prolonged business interruption within our supply chain; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to government contracting, healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, "Risk Factors" in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted diluted EPS, adjusted operating cash flow and net leverage, which are intended as supplemental measures of the Company's performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings per share based on adjusted net income (loss), which is net income (loss) adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for income taxes, (iii) amortization, (iv) stock-based compensation expense, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to certain legal matters, including interest, net, (viii) asset impairment charges, (ix) increase in tax receivable agreement liability, (x) other and (xi) net income attributable to non-controlling interests, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2025 and 2024 was calculated using the weighted average fully diluted shares outstanding of Class A common stock (inclusive of the effect of dilutive securities). EBITDA reflects net income (loss) adjusted to exclude interest expense, net, provision for income taxes and depreciation and amortization. Adjusted EBITDA reflects net income (loss) adjusted to exclude (i) interest expense, net, (ii) provision for income taxes, (iii) depreciation and amortization, (iv) stock-based compensation expense, (v) acquisition, site closure, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to legal matters, net, (viii) asset impairment charges, (ix) foreign exchange (gain) loss, (x) increase in tax receivable agreement liability, and (xi) other. Adjusted operating cash flow reflects cash flow from operations excluding discrete items such as legal settlement payments. Net leverage is calculated as net debt (total outstanding principal on the Company's debt, less cash and cash equivalents), divided by adjusted EBITDA for the year or trailing twelve months then ended. Management uses these non-GAAP measures internally to evaluate and manage the Company's operations and to better understand its business because they facilitate a comparative assessment of the Company's operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company's operations and underlying operational performance. The compensation committee of the Company's board of directors also uses certain of these measures to evaluate management's performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company's financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company's financial performance, results of operations, cash flows, net leverage and trends while viewing the information through the eyes of management. These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company's financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company's GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company's business. A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below. Amneal Pharmaceuticals, Inc. Consolidated Statements of Operations (unaudited; $ in thousands, except per share amounts) Three Months Ended March 31, 2025 2024 Net revenue $ 695,420 $ 659,191 Cost of goods sold 439,529 421,131 Gross profit 255,891 238,060 Selling, general and administrative 118,288 112,595 Research and development 40,040 39,298 Intellectual property legal development expenses 1,767 984 Restructuring and other charges 571 1,470 Charges related to legal matters, net — 94,359 Other operating (income) expense (5,122 ) 100 Operating income (loss) 100,347 (10,746 ) Other (expense) income: Interest expense, net (56,939 ) (65,703 ) Foreign exchange gain (loss), net 4,247 (1,197 ) Increase in tax receivable agreement liability (10,687 ) (1,948 ) Other income, net 518 4,072 Total other expense, net (62,861 ) (64,776 ) Income (loss) before income taxes 37,486 (75,522 ) Provision for income taxes 12,868 6,156 Net income (loss) 24,618 (81,678 ) Less: Net income attributable to non-controlling interests (12,423 ) (9,965 ) Net income (loss) attributable to Amneal Pharmaceuticals, Inc. $ 12,195 $ (91,643 ) Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.'s Class A common stockholders: Basic $ 0.04 $ (0.30 ) Diluted $ 0.04 $ (0.30 ) Weighted-average common shares outstanding: Basic 311,054 307,279 Diluted 323,961 307,279 Amneal Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (unaudited; $ in thousands) March 31, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 59,187 $ 110,552 Restricted cash 6,583 7,868 Trade accounts receivable, net 754,236 775,731 Inventories 601,433 612,454 Prepaid expenses and other current assets 88,524 80,717 Related party receivables 487 484 Total current assets 1,510,450 1,587,806 Property, plant and equipment, net 427,231 424,908 Goodwill 597,497 597,436 Intangible assets, net 689,136 732,377 Operating lease right-of-use assets 29,103 31,388 Operating lease right-of-use assets - related party 10,447 10,964 Financing lease right-of-use assets 55,967 56,433 Other assets 45,418 60,133 Total assets $ 3,365,249 $ 3,501,445 Liabilities and Stockholders' Deficiency Current liabilities: Accounts payable and accrued expenses $ 628,572 $ 735,450 Current portion of liabilities for legal matters 43,503 31,755 Revolving credit facility 290,000 100,000 Current portion of long-term debt, net 31,790 224,213 Current portion of operating lease liabilities 8,986 9,435 Current portion of operating lease liabilities - related party 3,449 3,396 Current portion of financing lease liabilities 3,319 3,211 Related party payables - short term 66,205 22,311 Total current liabilities 1,075,824 1,129,771 Long-term debt, net 2,153,979 2,161,790 Operating lease liabilities 22,854 24,814 Operating lease liabilities - related party 8,520 9,391 Financing lease liabilities 56,604 56,889 Related party payables - long term 10,687 50,900 Liabilities for legal matters - long term 72,979 85,479 Other long-term liabilities 23,191 26,949 Total long-term liabilities 2,348,814 2,416,212 Redeemable non-controlling interests 72,611 64,974 Total stockholders' deficiency (132,000 ) (109,512 ) Total liabilities and stockholders' deficiency $ 3,365,249 $ 3,501,445 Amneal Pharmaceuticals, Inc. Consolidated Statements of Cash Flows (unaudited; $ in thousands) Three Months Ended March 31, 2025 2024 Cash flows from operating activities: Net income (loss) $ 24,618 $ (81,678 ) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Depreciation and amortization 60,159 55,528 Unrealized foreign currency (gain) loss (3,596 ) 1,511 Amortization of debt issuance costs and discount 6,811 6,803 Reclassification of cash flow hedge (6,444 ) (6,515 ) Intangible asset impairment charges — 920 Stock-based compensation 7,258 6,722 Inventory provision 23,669 22,923 Other operating charges and credits, net 1,313 1,350 Changes in assets and liabilities: Trade accounts receivable, net 21,148 (55,173 ) Inventories (13,263 ) (12,200 ) Prepaid expenses, other current assets and other assets (513 ) (11,708 ) Related party receivables (2 ) (562 ) Accounts payable, accrued expenses and other liabilities (112,626 ) 62,174 Related party payables (1,124 ) 5,495 Net cash provided by (used in) operating activities 7,408 (4,410 ) Cash flows from investing activities: Purchases of property, plant and equipment (13,162 ) (9,198 ) Acquisition of intangible assets (4,200 ) (9,700 ) Deposits for future acquisition of property, plant and equipment (960 ) (862 ) Proceeds from sale of property, plant and equipment 524 — Net cash used in investing activities (17,798 ) (19,760 ) Cash flows from financing activities: Payments of principal on debt, revolving credit facilities, financing leases and other (235,528 ) (63,377 ) Borrowings on revolving credit facilities 218,000 48,000 Proceeds from exercise of stock options 69 28 Employee payroll tax withholding on restricted stock unit and performance stock unit vesting (21,639 ) (7,212 ) Tax distributions to non-controlling interests (68 ) (594 ) Net cash used in financing activities (39,166 ) (23,155 ) Effect of foreign exchange rate on cash (470 ) (165 ) Net decrease in cash, cash equivalents, and restricted cash (50,026 ) (47,490 ) Cash, cash equivalents, and restricted cash - beginning of period 118,420 99,107 Cash, cash equivalents, and restricted cash - end of period $ 68,394 $ 51,617 Cash and cash equivalents - end of period $ 59,187 $ 46,520 Restricted cash - end of period 6,583 5,097 Long-term restricted cash included in other assets - end of period 2,624 — Cash, cash equivalents, and restricted cash - end of period $ 68,394 $ 51,617 Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited, $ in thousands) Reconciliation of Net Income (Loss) to EBITDA and Adjusted EBITDA Three Months Ended March 31, Year Ended December 31, 2025 2024 2024 Net income (loss) $ 24,618 $ (81,678 ) $ (73,876 ) Adjusted to add: Interest expense, net 56,939 65,703 258,595 Provision for income taxes 12,868 6,156 18,863 Depreciation and amortization 60,159 55,528 236,191 EBITDA (Non-GAAP) $ 154,584 $ 45,709 $ 439,773 Adjusted to add (deduct): Stock-based compensation expense 7,128 6,506 27,552 Acquisition, site closure, and idle facility expenses (1) 1,241 444 2,112 Restructuring and other charges 571 1,470 2,265 Charges related to legal matters, net (2) — 94,359 96,692 Asset impairment charges 68 1,015 1,372 Foreign exchange (gain) loss (4,247 ) 1,197 6,846 Increase in tax receivable agreement liability 10,687 1,948 50,680 Other (3) (54 ) (297 ) 150 Adjusted EBITDA (Non-GAAP) $ 169,978 $ 152,351 $ 627,442 Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited, $ in thousands) Calculation of Net Leverage March 31, 2025 December 31, 2024 Term Loan Due 2025 $ — $ 191,979 Term Loan Due 2028 2,278,158 2,292,856 Amended New Revolving Credit Facility 290,000 100,000 Gross debt $ 2,568,158 $ 2,584,835 Less: Cash and cash equivalents 59,197 110,552 Net debt (Non-GAAP) (4) $ 2,508,961 $ 2,474,283 Adjusted EBITDA (Non-GAAP) Year ended December 31, 2024 $ 627,442 Less: Three months ended March 31, 2024 152,351 Add: Three months ended March 31, 2025 169,978 Last twelve months ended March 31, 2025 $ 645,069 Net leverage (Non-GAAP) (5) 3.9x 3.9x Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited; $ in thousands, except per share amounts) Reconciliation of Net Income (Loss) to Adjusted Net Income and Calculation of Adjusted Diluted Earnings Per Share Three Months Ended March 31, 2025 2024 Net income (loss) $ 24,618 $ (81,678 ) Adjusted to add (deduct): Non-cash interest 334 82 GAAP provision for income taxes 12,868 6,156 Amortization 44,274 38,671 Stock-based compensation expense 7,128 6,506 Acquisition, site closure expenses, and idle facility expenses (1) 1,227 444 Restructuring and other charges 571 1,453 Charges related to legal matters, including interest, net (2) — 94,486 Asset impairment charges 68 1,015 Increase in tax receivable agreement liability 10,687 1,948 Other (3) (44 ) (297 ) Provision for income taxes (6) (22,765 ) (14,341 ) Net income attributable to non-controlling interests (12,423 ) (9,965 ) Adjusted net income (Non-GAAP) $ 66,543 $ 44,480 Weighted average diluted shares outstanding (Non-GAAP) (7) 323,961 316,559 Adjusted diluted earnings per share (Non-GAAP) $ 0.21 $ 0.14 Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited) Explanations for Non-GAAP Reconciliations (1) Acquisition, site closure, and idle facility expenses for the three months ended March 31, 2025 primarily included costs related to a planned facility closure and rent for vacated properties. Acquisition, site closure, and idle facility expenses for the three months ended March 31, 2024 and year ended December 31, 2024 primarily included rent for vacated properties. (2) For the three months ended March 31, 2024 and year ended December 31, 2024, charges related to legal matters, net 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 the Company by political subdivisions and Native American tribes across the United States. (3) System implementation expense of $0.9 million and change in the fair value of contingent consideration of $0.1 million, formerly included in their own captions in the non-GAAP reconciliations, for the three months ended March 31, 2024 have been reclassified to the caption "other" to conform to the current period presentation. System implementation expense of $2.4 million and change in the fair value of contingent consideration of ($0.9 million), formerly included in their own captions in the non-GAAP reconciliations, for the year ended December 31, 2024 have been reclassified to the caption "other" to conform to the current period presentation. System implementation expense was immaterial and there was no change in the fair of contingent consideration for the three months ended March 31, 2025. (4) Net debt was calculated as the total outstanding principal on the Company's debt less cash and cash equivalents. (5) Net leverage was calculated by dividing net debt as of March 31, 2025 and December 31, 2024 by adjusted EBITDA for the last twelve months ended March 31, 2025 and year ended December 31, 2024, respectively. (6) The non-GAAP effective tax rates for the three months ended March 31, 2025 and 2024 were 25.5% and 24.4%, respectively. (7) Weighted average diluted shares outstanding for the three months ended March 31, 2025 and 2024 consisted of fully diluted Class A common stock (inclusive of the effect of dilutive securities). Amneal Pharmaceuticals, Inc. Affordable Medicines Segment Reconciliation of GAAP to Non-GAAP Operating Results (1) (unaudited; $ in thousands) Three Months Ended March 31, 2025 Three Months Ended March 31, 2024 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 414,708 $ — $ 414,708 $ 391,294 $ — $ 391,294 Cost of goods sold (2) 242,633 (10,875 ) 231,758 239,922 (12,268 ) 227,654 Gross profit 172,075 10,875 182,950 151,372 12,268 163,640 Gross margin % 41.5 % 44.1 % 38.7 % 41.8 % Selling, general and administrative (3) 33,715 (1,816 ) 31,899 33,085 (1,729 ) 31,356 Research and development (4) 30,980 (689 ) 30,291 34,371 (655 ) 33,716 Intellectual property legal development expenses 1,713 — 1,713 960 — 960 Charges related to legal matters, net (5) — — — 94,359 (94,359 ) — Other operating income (5,122 ) — (5,122 ) — — — Operating income (loss) $ 110,789 $ 13,380 $ 124,169 $ (11,403 ) $ 109,011 $ 97,608 (1) Revenue, cost of goods sold, and gross profit from the sale of Amneal products by AvKARE were included in our Affordable Medicines segment. (2) Adjustments for the three months ended March 31, 2025 and 2024, respectively, were comprised of stock-based compensation expense ($0.9 million in each period), amortization expense ($9.9 million and $10.4 million), and asset impairment charges ($0.1 million and $1.0 million). (3) Adjustments for the three months ended March 31, 2025 and 2024, respectively, were comprised of stock-based compensation expense ($1.3 million in each period) and site closure costs ($0.5 million and $0.4 million). (4) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of stock-based compensation expense. (5) Adjustment for the three months ended March 31, 2024 was 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 the Company by political subdivisions and Native American tribes across the United States. Amneal Pharmaceuticals, Inc. Specialty Segment Reconciliation of GAAP to Non-GAAP Operating Results (unaudited; $ in thousands) Three Months Ended March 31, 2025 Three Months Ended March 31, 2024 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 108,297 $ — $ 108,297 $ 105,234 $ — $ 105,234 Cost of goods sold (1) 53,083 (32,640 ) 20,443 44,800 (25,978 ) 18,822 Gross profit 55,214 32,640 87,854 60,434 25,978 86,412 Gross margin % 51.0 % 81.1 % 57.4 % 82.1 % Selling, general and administrative (2) 30,978 (345 ) 30,633 25,196 (271 ) 24,925 Research and development (3) 9,060 (791 ) 8,269 4,927 (284 ) 4,643 Intellectual property legal development expenses 54 — 54 24 — 24 Restructuring and other charges 130 (130 ) — 946 (946 ) — Other operating expense — — — 100 (100 ) — Operating income $ 14,992 $ 33,906 $ 48,898 $ 29,241 $ 27,579 $ 56,820 (1) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of amortization expense. (2) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of stock-based compensation expense. (3) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of stock-based compensation expense ($0.1 million and $0.3 million) and site closure costs ($0.7 million and none). Amneal Pharmaceuticals, Inc. AvKARE Segment Reconciliation of GAAP to Non-GAAP Operating Results (1) (unaudited; $ in thousands) Three Months Ended March 31, 2025 Three Months Ended March 31, 2024 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 172,415 $ — $ 172,415 $ 162,663 $ — $ 162,663 Cost of goods sold 143,813 — 143,813 136,409 — 136,409 Gross profit 28,602 — 28,602 26,254 — 26,254 Gross margin % 16.6 % 16.6 % 16.1 % 16.1 % Selling, general and administrative (2) 15,694 (2,700 ) 12,994 14,907 (3,545 ) 11,362 Operating income $ 12,908 $ 2,700 $ 15,608 $ 11,347 $ 3,545 $ 14,892 (1) Revenue, cost of goods sold, and gross profit from the sale of Amneal products by AvKARE were included in our Affordable Medicines segment. (2) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of amortization expense. View source version on Contacts Contact Anthony DiMeoVP, Investor
Business Wire
02-05-2025
- Business
- Business Wire
Amneal Reports First Quarter 2025 Financial Results
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ('Amneal' or the 'Company') today announced its results for the first quarter ended March 31, 2025. 'Amneal delivered another strong quarter to start 2025, with broad-based growth across all three segments driven by our team's outstanding execution. We are very pleased with the commercial uptake of CREXONT® for Parkinson's Disease and the momentum of our recently launched injectable products, which are delivering tremendous value to patients, caregivers and customers. As a leading U.S.-based biopharmaceutical company, Amneal is proud to provide millions of Americans with access to affordable and innovative treatments—and we believe we are just getting started. With our diverse portfolio, expansive footprint in the U.S. and globally, and a resilient management team, we are confident in our ability to deliver sustainable growth and value creation for our stakeholders in 2025 and beyond as we embark on our exciting next chapter of growth and success,' said Chirag and Chintu Patel, Co-Chief Executive Officers. First Quarter 2025 Results Net revenue in the first quarter of 2025 was $695 million, an increase of 5% compared to $659 million in the first quarter of 2024. Affordable Medicines net revenue increased 6% driven by strong performance of our complex product portfolio and new product launches. Specialty net revenue increased 3% driven by key branded products, including CREXONT® and UNITHROID®. AvKARE net revenue increased 6% driven by growth in the government label sales channel. Net income attributable to Amneal Pharmaceuticals, Inc. was $12 million in the first quarter of 2025 compared to a net loss of $92 million in the first quarter of 2024, reflecting higher revenue and gross profit, and a legal settlement charge of $94 million in the first quarter of 2024. Adjusted EBITDA in the first quarter of 2025 was $170 million, an increase of 12% compared to the first quarter of 2024, reflective of strong revenue performance, higher gross margin and operating expense leverage. Diluted income per share in the first quarter of 2025 was $0.04 compared to diluted loss per share of $0.30 for the first quarter of 2024, due to higher operating income and lower interest expense. Adjusted diluted earnings per share in the first quarter of 2025 was $0.21, an increase of 50%, compared to $0.14 for the first quarter of 2024. The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the 'Non-GAAP Financial Measures' section and the accompanying GAAP to non-GAAP reconciliation tables for more information. Affirming Full Year 2025 Financial Guidance The Company is affirming its previously provided full year 2025 guidance. (1) Includes 100% of adjusted EBITDA from AvKARE. See also 'Non-GAAP Financial Measures' below. (2) Accounts for 35% non-controlling interest in AvKARE. Guidance assumes approximately 330 million weighted-average diluted shares outstanding for the year ending December 31, 2025. (3) Excludes discrete items such as legal settlement payments. (4) Reflects estimated capital expenditures, net of expected contributions from an alliance partner of $20 million. Expand Amneal's 2025 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, the timing of future product launches, the costs incurred and benefits realized of restructuring activities, and our long-term strategy. The Company's financial statements are prepared in accordance with accounting principles generally accepted in the United States of America ('GAAP'). The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable measures in accordance with GAAP without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments, legal settlements, and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results. Conference Call Information Amneal will host a conference call and live webcast at 8:30 am Eastern Time today, May 2, 2025, to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company's website at To access the call through a conference line, dial (833) 470-1428 (in the U.S.) with access code 170097. A replay of the conference call will be posted shortly after the call. For a list of toll-free international numbers, visit this website: About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In our Affordable Medicines segment, we are expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In our Specialty segment, we have a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through our AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; statements regarding our expansion into high-growth areas and statements regarding our positioning, including our ability to drive sustainable value creation, and other non-historical statements. Words such as 'plans,' 'expects,' 'will,' 'anticipates,' 'estimates,' and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; the impact of illegal distribution and sale by third parties of counterfeit versions of our products or stolen products; the impact of negative market perceptions of us and the safety and quality of our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; the imposition of tariffs may adversely affect our business, results of operations and financial condition; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents, and risks associated with artificial intelligence; the impact of a prolonged business interruption within our supply chain; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to government contracting, healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, 'Risk Factors' in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted diluted EPS, adjusted operating cash flow and net leverage, which are intended as supplemental measures of the Company's performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings per share based on adjusted net income (loss), which is net income (loss) adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for income taxes, (iii) amortization, (iv) stock-based compensation expense, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to certain legal matters, including interest, net, (viii) asset impairment charges, (ix) increase in tax receivable agreement liability, (x) other and (xi) net income attributable to non-controlling interests, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2025 and 2024 was calculated using the weighted average fully diluted shares outstanding of Class A common stock (inclusive of the effect of dilutive securities). EBITDA reflects net income (loss) adjusted to exclude interest expense, net, provision for income taxes and depreciation and amortization. Adjusted EBITDA reflects net income (loss) adjusted to exclude (i) interest expense, net, (ii) provision for income taxes, (iii) depreciation and amortization, (iv) stock-based compensation expense, (v) acquisition, site closure, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to legal matters, net, (viii) asset impairment charges, (ix) foreign exchange (gain) loss, (x) increase in tax receivable agreement liability, and (xi) other. Adjusted operating cash flow reflects cash flow from operations excluding discrete items such as legal settlement payments. Net leverage is calculated as net debt (total outstanding principal on the Company's debt, less cash and cash equivalents), divided by adjusted EBITDA for the year or trailing twelve months then ended. Management uses these non-GAAP measures internally to evaluate and manage the Company's operations and to better understand its business because they facilitate a comparative assessment of the Company's operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company's operations and underlying operational performance. The compensation committee of the Company's board of directors also uses certain of these measures to evaluate management's performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company's financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company's financial performance, results of operations, cash flows, net leverage and trends while viewing the information through the eyes of management. These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company's financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company's GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company's business. A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below. Amneal Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (unaudited; $ in thousands) March 31, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 59,187 $ 110,552 Restricted cash 6,583 7,868 Trade accounts receivable, net 754,236 775,731 Inventories 601,433 612,454 Prepaid expenses and other current assets 88,524 80,717 Related party receivables 487 484 Total current assets 1,510,450 1,587,806 Property, plant and equipment, net 427,231 424,908 Goodwill 597,497 597,436 Intangible assets, net 689,136 732,377 Operating lease right-of-use assets 29,103 31,388 Operating lease right-of-use assets - related party 10,447 10,964 Financing lease right-of-use assets 55,967 56,433 Other assets 45,418 60,133 Total assets $ 3,365,249 $ 3,501,445 Liabilities and Stockholders' Deficiency Current liabilities: Accounts payable and accrued expenses $ 628,572 $ 735,450 Current portion of liabilities for legal matters 43,503 31,755 Revolving credit facility 290,000 100,000 Current portion of long-term debt, net 31,790 224,213 Current portion of operating lease liabilities 8,986 9,435 Current portion of operating lease liabilities - related party 3,449 3,396 Current portion of financing lease liabilities 3,319 3,211 Related party payables - short term 66,205 22,311 Total current liabilities 1,075,824 1,129,771 Long-term debt, net 2,153,979 2,161,790 Operating lease liabilities 22,854 24,814 Operating lease liabilities - related party 8,520 9,391 Financing lease liabilities 56,604 56,889 Related party payables - long term 10,687 50,900 Liabilities for legal matters - long term 72,979 85,479 Other long-term liabilities 23,191 26,949 Total long-term liabilities 2,348,814 2,416,212 Redeemable non-controlling interests 72,611 64,974 Total stockholders' deficiency (132,000 ) (109,512 ) Total liabilities and stockholders' deficiency $ 3,365,249 $ 3,501,445 Expand Amneal Pharmaceuticals, Inc. Consolidated Statements of Cash Flows (unaudited; $ in thousands) Three Months Ended March 31, 2025 2024 Cash flows from operating activities: Net income (loss) $ 24,618 $ (81,678 ) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Depreciation and amortization 60,159 55,528 Unrealized foreign currency (gain) loss (3,596 ) 1,511 Amortization of debt issuance costs and discount 6,811 6,803 Reclassification of cash flow hedge (6,444 ) (6,515 ) Intangible asset impairment charges — 920 Stock-based compensation 7,258 6,722 Inventory provision 23,669 22,923 Other operating charges and credits, net 1,313 1,350 Changes in assets and liabilities: Trade accounts receivable, net 21,148 (55,173 ) Inventories (13,263 ) (12,200 ) Prepaid expenses, other current assets and other assets (513 ) (11,708 ) Related party receivables (2 ) (562 ) Accounts payable, accrued expenses and other liabilities (112,626 ) 62,174 Related party payables (1,124 ) 5,495 Net cash provided by (used in) operating activities 7,408 (4,410 ) Cash flows from investing activities: Purchases of property, plant and equipment (13,162 ) (9,198 ) Acquisition of intangible assets (4,200 ) (9,700 ) Deposits for future acquisition of property, plant and equipment (960 ) (862 ) Proceeds from sale of property, plant and equipment 524 — Net cash used in investing activities (17,798 ) (19,760 ) Cash flows from financing activities: Payments of principal on debt, revolving credit facilities, financing leases and other (235,528 ) (63,377 ) Borrowings on revolving credit facilities 218,000 48,000 Proceeds from exercise of stock options 69 28 Employee payroll tax withholding on restricted stock unit and performance stock unit vesting (21,639 ) (7,212 ) Tax distributions to non-controlling interests (68 ) (594 ) Net cash used in financing activities (39,166 ) (23,155 ) Effect of foreign exchange rate on cash (470 ) (165 ) Net decrease in cash, cash equivalents, and restricted cash (50,026 ) (47,490 ) Cash, cash equivalents, and restricted cash - beginning of period 118,420 99,107 Cash, cash equivalents, and restricted cash - end of period $ 68,394 $ 51,617 Cash and cash equivalents - end of period $ 59,187 $ 46,520 Restricted cash - end of period 6,583 5,097 Long-term restricted cash included in other assets - end of period 2,624 — Cash, cash equivalents, and restricted cash - end of period $ 68,394 $ 51,617 Expand Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited, $ in thousands) Three Months Ended March 31, Year Ended December 31, 2025 2024 2024 Net income (loss) $ 24,618 $ (81,678 ) $ (73,876 ) Adjusted to add: Interest expense, net 56,939 65,703 258,595 Provision for income taxes 12,868 6,156 18,863 Depreciation and amortization 60,159 55,528 236,191 EBITDA (Non-GAAP) $ 154,584 $ 45,709 $ 439,773 Adjusted to add (deduct): Stock-based compensation expense 7,128 6,506 27,552 Acquisition, site closure, and idle facility expenses (1) 1,241 444 2,112 Restructuring and other charges 571 1,470 2,265 Charges related to legal matters, net (2) — 94,359 96,692 Asset impairment charges 68 1,015 1,372 Foreign exchange (gain) loss (4,247 ) 1,197 6,846 Increase in tax receivable agreement liability 10,687 1,948 50,680 Other (3) (54 ) (297 ) 150 Adjusted EBITDA (Non-GAAP) $ 169,978 $ 152,351 $ 627,442 Expand Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited, $ in thousands) Calculation of Net Leverage March 31, 2025 December 31, 2024 Term Loan Due 2025 $ — $ 191,979 Term Loan Due 2028 2,278,158 2,292,856 Amended New Revolving Credit Facility 290,000 100,000 Gross debt $ 2,568,158 $ 2,584,835 Less: Cash and cash equivalents 59,197 110,552 Net debt (Non-GAAP) (4) $ 2,508,961 $ 2,474,283 Adjusted EBITDA (Non-GAAP) Year ended December 31, 2024 $ 627,442 Less: Three months ended March 31, 2024 152,351 Add: Three months ended March 31, 2025 169,978 Last twelve months ended March 31, 2025 $ 645,069 Net leverage (Non-GAAP) (5) 3.9x 3.9x Expand Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited; $ in thousands, except per share amounts) Three Months Ended March 31, 2025 2024 Net income (loss) $ 24,618 $ (81,678 ) Adjusted to add (deduct): Non-cash interest 334 82 GAAP provision for income taxes 12,868 6,156 Amortization 44,274 38,671 Stock-based compensation expense 7,128 6,506 Acquisition, site closure expenses, and idle facility expenses (1) 1,227 444 Restructuring and other charges 571 1,453 Charges related to legal matters, including interest, net (2) — 94,486 Asset impairment charges 68 1,015 Increase in tax receivable agreement liability 10,687 1,948 Other (3) (44 ) (297 ) Provision for income taxes (6) (22,765 ) (14,341 ) Net income attributable to non-controlling interests (12,423 ) (9,965 ) Adjusted net income (Non-GAAP) $ 66,543 $ 44,480 Weighted average diluted shares outstanding (Non-GAAP) (7) 323,961 316,559 Adjusted diluted earnings per share (Non-GAAP) $ 0.21 $ 0.14 Expand Amneal Pharmaceuticals, Inc. Non-GAAP Reconciliations (unaudited) Explanations for Non-GAAP Reconciliations (1) Acquisition, site closure, and idle facility expenses for the three months ended March 31, 2025 primarily included costs related to a planned facility closure and rent for vacated properties. Acquisition, site closure, and idle facility expenses for the three months ended March 31, 2024 and year ended December 31, 2024 primarily included rent for vacated properties. (2) For the three months ended March 31, 2024 and year ended December 31, 2024, charges related to legal matters, net 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 the Company by political subdivisions and Native American tribes across the United States. (3) System implementation expense of $0.9 million and change in the fair value of contingent consideration of $0.1 million, formerly included in their own captions in the non-GAAP reconciliations, for the three months ended March 31, 2024 have been reclassified to the caption 'other' to conform to the current period presentation. System implementation expense of $2.4 million and change in the fair value of contingent consideration of ($0.9 million), formerly included in their own captions in the non-GAAP reconciliations, for the year ended December 31, 2024 have been reclassified to the caption 'other' to conform to the current period presentation. System implementation expense was immaterial and there was no change in the fair of contingent consideration for the three months ended March 31, 2025. (4) Net debt was calculated as the total outstanding principal on the Company's debt less cash and cash equivalents. (5) Net leverage was calculated by dividing net debt as of March 31, 2025 and December 31, 2024 by adjusted EBITDA for the last twelve months ended March 31, 2025 and year ended December 31, 2024, respectively. (6) The non-GAAP effective tax rates for the three months ended March 31, 2025 and 2024 were 25.5% and 24.4%, respectively. (7) Weighted average diluted shares outstanding for the three months ended March 31, 2025 and 2024 consisted of fully diluted Class A common stock (inclusive of the effect of dilutive securities). Expand (1) Revenue, cost of goods sold, and gross profit from the sale of Amneal products by AvKARE were included in our Affordable Medicines segment. (2) Adjustments for the three months ended March 31, 2025 and 2024, respectively, were comprised of stock-based compensation expense ($0.9 million in each period), amortization expense ($9.9 million and $10.4 million), and asset impairment charges ($0.1 million and $1.0 million). (3) Adjustments for the three months ended March 31, 2025 and 2024, respectively, were comprised of stock-based compensation expense ($1.3 million in each period) and site closure costs ($0.5 million and $0.4 million). (4) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of stock-based compensation expense. (5) Adjustment for the three months ended March 31, 2024 was 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 the Company by political subdivisions and Native American tribes across the United States. Expand (1) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of amortization expense. (2) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of stock-based compensation expense. (3) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of stock-based compensation expense ($0.1 million and $0.3 million) and site closure costs ($0.7 million and none). Expand (1) Revenue, cost of goods sold, and gross profit from the sale of Amneal products by AvKARE were included in our Affordable Medicines segment. (2) Adjustments for the three months ended March 31, 2025 and 2024 were comprised of amortization expense. Expand
Associated Press
26-03-2025
- Business
- Associated Press
UK Medicines and Healthcare Products Regulatory Agency has Validated and Accepted the Marketing Authorization Application for ADL-018, a Proposed Biosimilar of Xolair® (omalizumab)
Kashiv BioSciences, LLC ('Kashiv' or the 'Company') today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application (MAA) for ADL-018, the Company's proposed biosimilar for Xolair® (omalizumab). The acceptance marks a critical milestone in our commitment to developing cost-effective therapies to patients with moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria. The MAA is supported by a comprehensive data package, including extensive analytical, preclinical, pharmacokinetic, pharmacodynamic, safety, and immunogenicity studies demonstrating that ADL-018 is highly similar to the reference product, Xolair®, in terms of quality, safety, and efficacy. 'The MHRA's acceptance of the MAA for ADL-018 brings us one step closer to offering patients in the UK a cost-effective alternative to Xolair ®,' said Chirag and Chintu Patel, Executive Chairman and Co-Founders of Kashiv Biosciences. 'This acknowledgement by the MHRA underscores our dedication to expanding access to vital biologic therapies and addressing unmet medical needs.' 'This represents an important step in the development of our proposed biosimilar to Xolair, with the key goal to increase patient access to an important biologic,' said Joseph McClellan, Chief Scientific Officer of Alvotech. 'We are pleased to see the MHRA's acceptance of the MAA for ADL-018, which reflects the strength of our scientific collaboration and the shared vision to increase access to high-quality, affordable biologics,' said Dr. Nick Warwick, Chief Medical Officer at ADVANZ PHARMA. 'This is a significant step forward in our mission to bringing biosimilar medicines to more patients across the UK and beyond.' Kashiv Biosciences has a robust pipeline of biosimilar products, reflecting their deep commitment to delivering high-quality therapeutic options. The acceptance for ADL-018 aligns with the Company's strategic goal to broaden the portfolio on a global scale. About Kashiv: Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together 'Kashiv BioSciences') operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL MANAGED CARE GENERAL HEALTH HEALTH CLINICAL TRIALS SOURCE: Kashiv BioSciences, LLC Copyright Business Wire 2025. PUB: 03/26/2025 08:45 AM/DISC: 03/26/2025 08:47 AM
Yahoo
03-03-2025
- Business
- Yahoo
Amneal's BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
Denosumab biosimilar candidates reference Prolia® and XGEVA® Amneal looks to expand portfolio to six biosimilars across eight product presentations by 2027 BRIDGEWATER, N.J., March 03, 2025--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and mAbxience ("mAbxience") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia® and XGEVA®. mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius. The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. Under the terms of the agreement, mAbxience is responsible for the development and manufacturing of the biosimilars while Amneal will pursue regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience currently partner on ALYMSYS®, a bevacizumab biosimilar, which was launched in 2022. "Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics. Building on our first three successful biosimilar launches, we look to expand our portfolio next with denosumab, which is an important therapy across multiple indications, including oncology. We are pleased to expand our partnership with mAbxience as we advance our biosimilars pipeline," said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. "We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization strategy and applying innovation and cutting-edge R&D technology to create high quality, affordable medicines for underserved patients," said Jurgen Van Broeck, Chief Executive Officer of mAbxience. Prolia®: In patients with postmenopausal osteoporosis, the most frequently reported adverse reactions included back musculoskeletal and extremity pain; hypercholesterolemia; and cystitis. Among male patients with osteoporosis, back pain, arthralgia, and nasopharyngitis were reported. Prolia also carries a Boxed Warning for patients with advanced chronic kidney disease. XGEVA®: The most frequently reported serious adverse reaction was dyspnea. Other reported adverse reactions observed included fatigue, asthenia, hypophosphatemia, and nausea. Discontinuation was reported in patients with osteonecrosis and hypocalcemia. According to IQVIA®, U.S. annual sales for Prolia® and XGEVA® for the 12 months ended December 2024 were approximately $5.0 billion. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit and follow us on LinkedIn. About mAbxiencemAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website ( or connect with us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as "plans," "expects," "will," "anticipates," "estimates," and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, "Risk Factors" in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. View source version on Contacts Investor Contact Anthony DiMeoVP, Investor mAbxience Contact Miguel Martínez-CavaGlobal External Communication Sign in to access your portfolio
