– Acquisition Positions Amneal to Capitalize on $300B+ Global Biologics LOE Opportunity –
– Transaction Accelerates Growth Profile and Diversification –
– Preliminary Q1 Results Reflect Continued Growth and Raising 2026 Full Year Guidance –
– Company to Host Investor Conference Call Today at
Kashiv is among a select group of
“As biosimilar adoption accelerates and the industry enters an unprecedented period of biologic loss of exclusivity, we see a compelling opportunity to establish leadership and scale in a rapidly expanding market,” said
“This acquisition establishes Amneal as a fully integrated global biosimilar platform at scale,” said
“We are thrilled to combine Kashiv’s highly complementary portfolio and capabilities with Amneal at this critical inflection point for the biosimilar market, particularly in the U.S.,” said Dr.
The transaction is subject to approval by Amneal shareholders, receipt of regulatory approvals and satisfaction of customary closing conditions, and is expected to close in the second half of 2026.
Compelling Strategic and Financial Benefits:
- Highly strategic and complementary transaction at a pivotal moment of market inflection. More than
$300 billion of global biologics are expected to lose exclusivity over the next decade. As biosimilars expand access to biologics and deliver meaningful savings, adoption is accelerating across physicians, patients and payers. Kashiv’s R&D and manufacturing capabilities complement Amneal’s commercial scale, creating an integrated leader well positioned to lead in the next wave of affordable medicines. - Establishes an integrated biosimilar platform enabling multiple new biosimilars launches each year. The combination enhances speed to market, enables parallel development and commercialization, and enhances Amneal’s competitiveness. By 2030, Amneal expects to have more than 12 commercial biosimilars and over 20 more products in the pipeline.
- Diversifies and extends Amneal’s strong, durable growth profile into the 2030s. The transaction expands biosimilars long-term growth within Affordable Medicines, alongside Specialty and
AvKARE . - Transaction is highly synergistic, with
$400M to$500M in expected financial benefits. The transaction reflects a balanced mix of upfront cash and equity, as well as potential success-based consideration over time. There is a minimal impact to the leverage profile and a clear path to deleveraging to below 3x net leverage by 2028. The transaction is expected to provide substantial financial synergies through the elimination of upcoming milestone and royalty obligations through 2030 and unlocks incremental tax and structural benefits over time.
Amneal Reports Preliminary First Quarter 2026 Results and Raises 2026 Full Year Guidance
In connection with announcing the transaction, Amneal is reporting certain unaudited preliminary financial results for the first quarter ended
“Amneal delivered a very strong start to 2026, reflecting the strength of our diversified business and multiple growth drivers across the portfolio. Our Specialty business continues to perform exceptionally well, led by CREXONT® and the recent launch of BREKIYA® autoinjector, alongside a strong cadence of key launches in Affordable Medicines. We are entering the Kashiv transaction from a position of strength, at a time when we see an extended period of accelerated growth ahead with no shortage of opportunities across our core businesses. Combined with our very strong first quarter results, we are pleased to increase our full year 2026 guidance,” said Chirag and
Unaudited Financial Results for the Three Months Ended
($ in millions, except per share amounts in the table below)
| 2026 (Preliminary) | 2025 | Change | |||
| Consolidated net revenue | 4% | ||||
| Affordable Medicines net revenue | 2% | ||||
| Specialty net revenue | 23% | ||||
| (4)% | |||||
| Gross margin | 44.3% | 36.8% | 750 bps | ||
| Adjusted gross margin (1) | 48.2% | 43.1% | 510 bps | ||
| Net income | 217% | ||||
| Adjusted EBITDA (1) | 19% | ||||
| Diluted EPS | 375% | ||||
| Adjusted diluted EPS (1) | 29% |
| (1) | Refer to “Non-GAAP Financial Measures” section and accompanying GAAP to non-GAAP reconciliation tables for more information. | |
First quarter 2026 Affordable Medicines net revenue of
Amneal’s preliminary financial results are based on the most recent information available to the Company’s management. Such preliminary financial results are forward-looking statements. Actual results may differ from these preliminary financial results due to the completion of the Company’s financial close procedures, final accounting adjustments and other developments that may arise between the date of this press release and the time that financial results for the first quarter of 2026 are finalized, and such differences may be material. The preliminary financial results for the first quarter of 2026 are not necessarily indicative of the results to be achieved in any future period. 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.
Raising Full Year 2026 Financial Guidance
The Company is raising its previously provided full year 2026 standalone guidance.
| 2026 Updated Guidance | 2026 Prior Guidance | |
| Net revenue | ||
| Adjusted EBITDA (1) | ||
| Adjusted diluted EPS (2) | ||
| Operating cash flow (3) | ||
| Operating cash flow, excluding discrete items (4) | ||
| Capital expenditures (5) |
| (1) | Includes 100% of adjusted EBITDA from | |
| (2) | Accounts for 35% non-controlling interest in | |
| (3) | Represents cash provided by operating activities. | |
| (4) | Excludes discrete items such as legal settlement payments. | |
| (5) | Reflects estimated capital expenditures, net of expected contributions from an alliance party. | |
Amneal’s 2026 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
Investor Call Today
Amneal will host a conference call and live webcast at
The previously scheduled
Investor Presentation
Amneal has made available on its website a presentation designed to accompany the foregoing announced acquisition and preliminary first quarter 2026 results, along with certain supplemental financial information and other data. Interested parties may access this information through the Amneal Investor Relations website at https://investors.amneal.com.
Advisors
About Amneal
About Kashiv BioSciences
Cautionary Statement on Forward-Looking Statements
The foregoing contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements are often identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “hope,” “hopeful,” “likely,” “may,” “optimistic,” “possible,” “potential,” “preliminary,” “project,” “should,” “will,” “would” or the negative or plural of these words or similar expressions or variations.
Forward-looking statements are made based upon management’s current expectations and beliefs and are not guarantees of future performance, and include statements regarding the transaction agreement and the transaction, including the expected time period to consummate the transaction, the anticipated benefits (including synergies) of the transaction and integration and transition plans, the transaction’s closing date, opportunities and anticipated future performance (including pro forma combined performance), expectations regarding non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted diluted EPS, adjusted gross margin, net debt, gross leverage and net leverage, our ability to become America’s top affordable medicines company, statements regarding the global biosimilars and affordable medicines markets and the company’s position and opportunities therein and our ability to expand internationally, and statements regarding our business and results of operations.
Such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. These factors include, among others (i) the completion of the proposed transaction on the anticipated terms and timing; (ii) the satisfaction of other conditions to the completion of the proposed transaction, including obtaining required shareholder and regulatory approvals; (iii) the risk that the Company’s stock price may fluctuate during the pendency of the proposed transaction and may decline if the proposed transaction is not completed; (iv) potential litigation relating to the proposed transaction that could be instituted against the Company or its directors, managers or officers, including the effects of any outcomes related thereto; (v) the risk that disruptions from the proposed transaction will harm the Company’s business, including current plans and operations, including during the pendency of the proposed transaction; (vi) the diversion of management’s time and attention from ordinary course business operations to completion of the proposed transaction and integration matters; (vii) legislative, regulatory and economic developments; (viii) unpredictability and severity of catastrophic events, including but not limited to acts of terrorism, outbreaks of war or hostilities or global pandemics, as well as management’s response to any of the aforementioned factors; (ix) the possibility that the proposed transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; (x) unexpected costs, liabilities or delays associated with the transaction; (xi) the response of competitors to the transaction; (xii) the occurrence of any event, change or other circumstance that could give rise to the termination of the proposed transaction; and (xiii) other risks set forth under the heading “Risk Factors,” of our Annual Report on Form 10-K for the year ended
You should not rely upon forward-looking statements as predictions of future events. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Additional Information and Where to Find It
This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. This communication relates to a proposed acquisition of
Participants in Solicitation
Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the
Investor Relations
invest@amneal.com
amneal.com
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted diluted EPS, adjusted gross margin, net debt, gross leverage 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.
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 Contacts
VP, Investor Relations
anthony.dimeo@amneal.com
Sr. Director,
brandon.skop@amneal.com
Kashiv Contact
Chief Legal Officer
ross.oehler@kashivbio.com
Non-GAAP Reconciliations (unaudited, in thousands) | |||||||
| Reconciliation of Net Income to EBITDA and Adjusted EBITDA | |||||||
| Three Months Ended | |||||||
| 2026 (Preliminary) | 2025 | ||||||
| Net income | $ | 78,000 | $ | 24,618 | |||
| Adjusted to add: | |||||||
| Interest expense, net | 53,361 | 56,939 | |||||
| Provision for income taxes | 2,176 | 12,868 | |||||
| Depreciation and amortization | 43,191 | 60,159 | |||||
| EBITDA (Non-GAAP) | $ | 176,728 | $ | 154,584 | |||
| Adjusted to add (deduct): | |||||||
| Stock-based compensation expense | 8,816 | 7,128 | |||||
| Acquisition, site closure, and idle facility expenses (1) | 5,682 | 1,241 | |||||
| Restructuring and other charges | 499 | 571 | |||||
| Loss on refinancing | 3,510 | — | |||||
| Charges related to legal matters, net | 694 | — | |||||
| Asset impairment charges | — | 68 | |||||
| Foreign exchange loss (gain) | 7,800 | (4,247 | ) | ||||
| (Decrease) increase in tax receivable agreement liability | (2,333 | ) | 10,687 | ||||
| Other | 614 | (54 | ) | ||||
| Adjusted EBITDA (Non-GAAP) | $ | 202,010 | $ | 169,978 | |||
Non-GAAP Reconciliations (unaudited, in thousands, except per share amounts) | |||||||
| Reconciliation of Net Income to Adjusted Net Income and Calculation of Adjusted Diluted Earnings Per Share | |||||||
| Three Months Ended | |||||||
| 2026 (Preliminary) | 2025 | ||||||
| Net income | $ | 78,000 | $ | 24,618 | |||
| Adjusted to add (deduct): | |||||||
| Non-cash interest | 6,737 | 334 | |||||
| GAAP provision for income taxes | 2,176 | 12,868 | |||||
| Amortization | 29,021 | 44,274 | |||||
| Stock-based compensation expense | 8,816 | 7,128 | |||||
| Acquisition, site closure, and idle facility expenses (1) | 5,682 | 1,227 | |||||
| Restructuring and other charges | 499 | 571 | |||||
| Loss on refinancing | 3,510 | — | |||||
| Charges related to legal matters, including interest, net | 1,450 | — | |||||
| Asset impairment charges | — | 68 | |||||
| (Decrease) increase in tax receivable agreement liability | (2,333 | ) | 10,687 | ||||
| Other | 614 | (44 | ) | ||||
| Provision for income taxes (2) | (28,755 | ) | (22,765 | ) | |||
| Net income attributable to non-controlling interests | (15,744 | ) | (12,423 | ) | |||
| Adjusted net income (Non-GAAP) | $ | 89,673 | $ | 66,543 | |||
| Weighted average diluted shares outstanding (Non-GAAP) (3) | 328,933 | 323,961 | |||||
| Diluted earnings per share (GAAP) | $ | 0.19 | $ | 0.04 | |||
| Adjusted diluted earnings per share (Non-GAAP) | $ | 0.27 | $ | 0.21 | |||
Non-GAAP Reconciliations (unaudited) |
| Explanations for Reconciliation of Net Income to EBITDA and Adjusted EBITDA and Reconciliation of Net Income to Adjusted Net Income and Calculation of Adjusted Diluted Earnings Per Share |
| (1) | Acquisition, site closure, and idle facility expenses for the three months ended | |
| (2) | The non-GAAP effective tax rates for the three months ended | |
| (3) | Weighted average diluted shares outstanding for the three months ended |
Non-GAAP Reconciliations (unaudited, in thousands, except leverage) | |||||
| Calculation of Net Debt, Gross Leverage, and Net Leverage | |||||
| Term Loan Due 2032 | $ | 2,089,500 | $ | 2,094,750 | |
| Senior Notes Due 2032 | 600,000 | 600,000 | |||
| Gross debt (1) | $ | 2,689,500 | $ | 2,694,750 | |
| Less: Cash and cash equivalents | 197,656 | 282,029 | |||
| Net debt (Non-GAAP) | $ | 2,491,844 | $ | 2,412,721 | |
| Last Twelve Months Ended (Preliminary) | Year Ended 2025 | ||||
| Adjusted EBITDA (Non-GAAP) (2) | $ | 720,447 | $ | 688,415 | |
| Gross leverage (Non-GAAP) (3) | 3.7x | 3.9x | |||
| Net leverage (Non-GAAP) (4) | 3.5x | 3.5x | |||
| (1) | See “Note 14. Debt” in the Company’s 2025 Annual Report on Form 10-K for additional information. | |
| (2) | See “Reconciliation of Net Income to EBITDA and adjusted EBITDA” below. | |
| (3) | Gross leverage was calculated by dividing gross debt by adjusted EBITDA. | |
| (4) | Net leverage was calculated by dividing net debt by adjusted EBITDA. |
Non-GAAP Reconciliations (unaudited, in thousands) | |||||||||||||||||||
| Reconciliation of Net Income to EBITDA and Adjusted EBITDA | |||||||||||||||||||
| Three Months Ended | Last Twelve Months Ended | ||||||||||||||||||
| Net income | $ | 35,610 | $ | 18,132 | $ | 49,573 | $ | 78,000 | $ | 181,315 | |||||||||
| Adjusted to add: | |||||||||||||||||||
| Interest expense, net | 65,101 | 62,814 | 56,237 | 53,361 | 237,513 | ||||||||||||||
| Provision for (benefit from) income taxes | 16,101 | (23,355 | ) | 5,662 | 2,176 | 584 | |||||||||||||
| Depreciation and amortization | 60,113 | 54,073 | 49,227 | 43,191 | 206,604 | ||||||||||||||
| EBITDA (Non-GAAP) | $ | 176,925 | $ | 111,664 | $ | 160,699 | $ | 176,728 | $ | 626,016 | |||||||||
| Adjusted to add (deduct): | |||||||||||||||||||
| Stock-based compensation expense | 8,274 | 8,219 | 8,202 | 8,816 | 33,511 | ||||||||||||||
| Acquisition, site closure, and idle facility expenses (1) | 1,203 | 2,318 | 539 | 5,682 | 9,742 | ||||||||||||||
| Restructuring and other charges | 1,024 | 143 | 2,470 | 499 | 4,136 | ||||||||||||||
| Loss on refinancing (2) | — | 31,365 | — | 3,510 | 34,875 | ||||||||||||||
| (Credit) charges related to legal matters, net | (390 | ) | — | — | 694 | 304 | |||||||||||||
| Asset impairment charges (3) | 36 | 22,784 | 134 | — | 22,954 | ||||||||||||||
| Foreign exchange (gain) loss | (8,256 | ) | 3,431 | 1,437 | 7,800 | 4,412 | |||||||||||||
| Increase (decrease) in tax receivable agreement liability | 4,420 | (20,808 | ) | 12,289 | (2,333 | ) | (6,432 | ) | |||||||||||
| Other (4) | 424 | 459 | (10,568 | ) | 614 | (9,071 | ) | ||||||||||||
| Adjusted EBITDA (Non-GAAP) | $ | 183,660 | $ | 159,575 | $ | 175,202 | $ | 202,010 | $ | 720,447 | |||||||||
Non-GAAP Reconciliations (unaudited, in thousands) | |||
| Reconciliation of Net Income to EBITDA and Adjusted EBITDA | |||
| Year Ended | |||
| Net income | $ | 127,933 | |
| Adjusted to add: | |||
| Interest expense, net | 241,091 | ||
| Provision for income taxes | 11,276 | ||
| Depreciation and amortization | 223,572 | ||
| EBITDA (Non-GAAP) | $ | 603,872 | |
| Adjusted to add: | |||
| Stock-based compensation expense | 31,823 | ||
| Acquisition, site closure, and idle facility expenses (1) | 5,301 | ||
| Restructuring and other charges | 4,208 | ||
| Loss on refinancing (2) | 31,365 | ||
| Credit related to legal matters, net | (390 | ) | |
| Asset impairment charges (3) | 23,022 | ||
| Foreign exchange gain | (7,635 | ) | |
| Increase in tax receivable agreement liability | 6,588 | ||
| Other (4) | (9,739 | ) | |
| Adjusted EBITDA (Non-GAAP) | $ | 688,415 | |
Non-GAAP Reconciliations (unaudited) |
| Explanations for Reconciliation of Net Income to EBITDA and Adjusted EBITDA |
| (1) | For all 2025 periods presented, acquisition, site closure, and idle facility expenses 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 | |
| (2) | For the three months ended | |
| (3) | For the three months ended | |
| (4) | For the three months and year ended | |
Non-GAAP Reconciliations (unaudited, $ in thousands) | |||||||||||||||||||||||
| Reconciliation of Consolidated Adjusted Cost of Goods Sold, Adjusted Gross Profit and Adjusted Gross Margin | |||||||||||||||||||||||
| Three Months Ended (Preliminary) | Three Months Ended | ||||||||||||||||||||||
| GAAP | Adjustments | Non-GAAP | GAAP | Adjustments | Non-GAAP | ||||||||||||||||||
| Net revenue | $ | 722,519 | $ | — | $ | 722,519 | $ | 695,420 | $ | — | $ | 695,420 | |||||||||||
| Cost of goods sold (1) | 402,406 | (28,311 | ) | 374,095 | 439,529 | (43,515 | ) | 396,014 | |||||||||||||||
| Gross profit | $ | 320,113 | $ | 28,311 | $ | 348,424 | $ | 255,891 | $ | 43,515 | $ | 299,406 | |||||||||||
| Gross margin % | 44.3 | % | 48.2 | % | 36.8 | % | 43.1 | % | |||||||||||||||
| (1) | Adjustments for the three months ended |
