Amneal Pharmaceuticals, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
AMRX$21.28+5.7%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001723128-26-000031
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001723128-26-000040
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 146 previous paragraphs and 159 current paragraphs.
55 unchanged; 59 reworded; 44 added; 32 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (44)
Current report
On August 10, 2026, we completed the acquisition of Kashiv BioSciences, LLC (“Kashiv”), acquiring 100% of the outstanding membership interests in Kashiv (the “Kashiv Acquisition”). The transaction included the issuance of 28.9 million shares of our Class A common stock, cash consideration and contingent consideration consisting of contingent regulatory milestone and royalty payments. The acquisition was funded through a combination of existing and new borrowings under our credit facilities. Refer to Note 2. Acquisition for additional information regarding the transaction and purchase price allocation.
Current report
The Kashiv Acquisition is expected to strengthen our position in the growing biosimilars market by adding an integrated biosimilars development and manufacturing platform and expanding our portfolio of commercial and pipeline biosimilar products. We believe the acquisition enhances our Affordable Medicines business by combining Kashiv’s development and manufacturing capabilities with our commercial scale, creating opportunities to accelerate future biosimilar launches and support long-term growth.
Current report
Since the acquisition date, Kashiv’s operating results have been included in our consolidated financial statements and, for segment reporting purposes, within our Affordable Medicines segment.
Current report
On September 28, 2026, Congress passed the Lindsey Graham Russia Sanctions Act which empowers the President to place additional sanctions and tariffs on Russia as well as countries that purchase Russian energy, including India and China. On October 16, 2026, President Trump exercised his authority under the National Interest Exemption of the law to waive the imposition of sanctions both on Russia as well as countries that purchase Russian oil. The law permits the President to reverse this waiver upon good cause, which if reversed could have a product-level exposure on us if pharmaceutical products and their components are not exempted.
Current report
Net revenue for the three months ended September 30, 2026 increased 10.0% from the prior year period, primarily due to:
Current report
•Growth in our Specialty segment net revenue of $25.0 million, primarily driven by increases in sales of CREXONT® ($14.8 million), BREKIYA® autoinjector ($6.2 million), and UNITHROID® ($5.6 million), partially offset by the expected decline in sales of RYTARY®.
Current report
•A decline in our AvKARE segment net revenue of $33.2 million, primarily driven by a reduction in our government label channel due to a non-recurring cardiovascular product launch that benefited the second half of 2025.
Current report
Acquisition and Integration Costs
Current report
During the three months ended September 30, 2026, we recognized a $6.0 million gain related to the remeasurement of contingent consideration associated with the Kashiv Acquisition. The gain reflects the periodic remeasurement of the contingent consideration liability driven primarily by increases in the discount rate subsequent to the acquisition date. Refer to Note 16. Fair Value Measurements for information about the estimation of our contingent consideration liabilities.
Current report
During the third week of July 2026, severe rain caused water damage to one of our facilities in India. Operations at this facility were temporarily suspended while we assessed the damage, completed remediation and repair activities, and restored operations. We concluded that certain property and equipment and inventory were damaged. We also incurred costs related to cleanup, repair and remediation. Accordingly, we recorded $5.4 million of charges related to inventory and property losses and associated cleanup, repair and remediation costs for the three months ended September 30, 2026. For additional information, refer to Note 22. Property Losses and Associated Expenses
Current report
For the three months ended September 30, 2026, charges related to legal matters, net were $6.5 million, primarily consisting of a charge related to government investigations of $8.0 million, partially offset by immaterial net credits related to several matters. For additional information, refer to Note 18. Commitments and Contingencies.
Current report
Provision for (Benefit From) Income Taxes
Current report
During the three months ended September 30, 2026, we recognized a $6.0 million gain related to the remeasurement of contingent consideration associated with the Kashiv Acquisition. The gain reflects the periodic remeasurement of the contingent consideration liability driven primarily by increases in the discount rate subsequent to the acquisition date. Refer to Note 16. Fair Value Measurements for information about the estimation of our contingent consideration liabilities.
Current report
During the third week of July 2026, severe rain caused water damage to one of our facilities in India. Operations at this facility were temporarily suspended while we assessed the damage, completed remediation and repair activities, and restored operations. We concluded that certain property and equipment and inventory were damaged. We also incurred costs related to cleanup, repair and remediation. Accordingly, we recorded $5.3 million of charges related to inventory and property losses and associated cleanup, repair and remediation costs in our Affordable Medicines segment for the three months ended September 30, 2026. For additional information refer to Note 22. Property Losses and Associated Expenses.
Current report
For the three months ended September 30, 2026, charges related to legal matters, net were $5.5 million in the Affordable Medicines segment, primarily consisting of a charge related to government investigations of $8.0 million, partially offset by immaterial net credits related to several matters. For additional information refer to Note 18. Commitments and Contingencies.
Current report
Specialty net revenue for the three months ended September 30, 2026 increased 20.0% compared to the prior year period, primarily driven by increases in sales of CREXONT® ($14.8 million), BREKIYA® autoinjector ($6.2 million), and UNITHROID® ($5.6 million), partially offset by the expected decline in sales of RYTARY®.
Current report
Specialty gross profit as a percentage of net revenue increased to 69.2% for the three months ended September 30, 2026 as compared to 41.1%, primarily as a result of the factors noted above.
Current report
AvKARE net revenue for the three months ended September 30, 2026 decreased 16.7% as compared to the prior year period, primarily driven by a reduction in our government label channel due to a non-recurring cardiovascular product launch that benefited the second half of 2025.
Current report
Gross profit as a percentage of net revenue was 21.3% for both the three months ended September 30, 2026 and 2025, reflecting a proportional decline in cost of goods sold alongside the decrease in revenue during the current year period.
Current report
Comparison of Nine Months Ended September 30, 2026 to Nine Months Ended September 30, 2025
Current report
Net revenue for the nine months ended September 30, 2026 increased 8.0% from the prior year period primarily due to:
Current report
•Growth in our Specialty segment net revenue of $71.2 million, primarily driven by increases in sales of CREXONT® ($44.7 million), BREKIYA® autoinjector ($16.3 million), and UNITHROID® ($14.0 million), partially offset by the expected decline in sales of RYTARY®.
Current report
Cost of goods sold for the nine months ended September 30, 2026 was flat compared to the prior year period. Cost of goods sold was impacted by a favorable mix of revenues and manufacturing efficiencies, partially offset by increases in sales volume, plant and freight costs, and inventory obsolescence. In addition, the prior year period included impairment charges related to non-promoted products of $22.8 million.
Current report
Gross profit as a percentage of net revenue increased to 41.5% for the nine months ended September 30, 2026 from 37.0% in the prior year period, primarily as a result of the factors noted above.
Current report
Acquisition and Integration Costs
Current report
During the nine months ended September 30, 2026, we recognized a $6.0 million gain related to the remeasurement of contingent consideration associated with the Kashiv Acquisition. The gain reflects the periodic remeasurement of the contingent consideration liability driven primarily by increases in the discount rate subsequent to the acquisition date. Refer to Note 16. Fair Value Measurements for information about the estimation of our contingent consideration liabilities.
Current report
During the third week of July 2026, severe rain caused water damage to one of our facilities in India. Operations at this facility were temporarily suspended while we assessed the damage, completed remediation and repair activities, and restored operations. We concluded that certain property and equipment and inventory were damaged. We also incurred costs related to cleanup, repair and remediation. Accordingly, we recorded $5.4 million of charges related to inventory and property losses and associated cleanup, repair and remediation costs in our Affordable Medicines and Specialty segments for the nine months ended September 30, 2026. For additional information, refer to Note 22. Property Losses and Associated Expenses.
Current report
Charges (Credit) Related to Legal Matters, Net
Current report
Provision for Income Taxes
Current report
The following table sets forth results of operations for our Affordable Medicines segment for the nine months ended September 30, 2026 and 2025 (in thousands):
Current report
During the nine months ended September 30, 2026, we recognized a $6.0 million gain related to the remeasurement of contingent consideration associated with the Kashiv Acquisition. The gain reflects the periodic remeasurement of the contingent consideration liability driven primarily by increases in the discount rate subsequent to the acquisition date. Refer to Note 16. Fair Value Measurements for information about the estimation of our contingent consideration liabilities.
Current report
During the third week of July 2026, severe rain caused water damage to one of our facilities in India. Operations at this facility were temporarily suspended while we assessed the damage, completed remediation and repair activities, and restored operations. We concluded that certain property and equipment and inventory were damaged. We also incurred costs related to cleanup, repair and remediation. Accordingly, we recorded $5.3 million of charges related to inventory and property losses and associated cleanup, repair and remediation costs in our Affordable Medicines segment for the nine months ended September 30, 2026. For additional information, refer to Note 22. Property Losses and Associated Expenses.
Current report
Charges (Credit) Related to Legal Matters, Net
Current report
Other Operating Income
Current report
Specialty net revenue for the nine months ended September 30, 2026 increased 19.7% as compared to the prior year period, primarily driven by increases in sales of CREXONT® ($44.7 million), BREKIYA® autoinjector ($16.3 million), and UNITHROID® ($14.0 million), partially offset by the expected decline in sales of RYTARY®.
Current report
Specialty gross profit as a percentage of net revenue increased to 68.2% for the nine months ended September 30, 2026 as compared to 49.5%, primarily as a result of the factors noted above.
Current report
AvKARE net revenue for the nine months ended September 30, 2026 decreased 8.6% as compared to the prior year period, primarily driven by a reduction in our low margin distribution sales.
Current report
Gross profit as a percentage of net revenue increased to 20.6% for the nine months ended September 30, 2026 from 19.5% in the prior year period, primarily as a result of the factors noted above.
Current report
On August 10, 2026, we entered into Amendment No. 4 to our Term Loan Credit Agreement. Pursuant to the amendment, we incurred an additional $350.0 million of incremental borrowings under the Term Loan Due 2032 (the “Incremental Term Loans”) with substantially the same terms. The proceeds of the Incremental Term Loans were used primarily to finance a portion of the consideration paid in connection with the Kashiv Acquisition with any remaining proceeds available for general corporate purposes. We will begin making quarterly principal payments of 0.25% of the aggregate outstanding balance of the Incremental Term Loans beginning December 31, 2026.
Current report
As discussed in the section titled “Overview” in Item 2., Management’s Discussion and Analysis of Financial Condition and Results of Operationsin this Quarterly Report on Form 10-Q, on August 10, 2026, we completed the acquisition of Kashiv BioSciences, LLC. The cash portion of the Kashiv Acquisition was funded through borrowings under our credit facilities. We also expect to incur post-closing integration costs. Refer to Note 2. Acquisition and Note 14. Debtin this Quarterly Report on Form 10-Qfor additional information.
Showing the first 40 of 44 passages. Open the source sections for the rest.
Removed paragraphs (32)
Previous report
On April 21, 2026, we entered into a definitive agreement to acquire 100% of the outstanding membership interests in Kashiv BioSciences, LLC (a related party, as described in Note 18. Related Party Transactions in this Quarterly Report on Form 10-Q and Note 22. Related Party Transactionsin our 2025 Annual Report on Form 10-K) (“Kashiv”) in a transaction (the “Transaction”) with consideration that includes $375 million of cash and 28,942,108 shares of Class A common stock of the Company at closing, subject to certain purchase price adjustments for cash, and the funding of operations between signing and closing, among others. Consideration also includes up to $350 million in potential contingent payments based on the achievement of certain regulatory milestones in the United States and potential contingent royalties equal to 25% of the amount by which annual aggregate gross profits for certain products exceed specified gross profit hurdle amounts for the corresponding annual royalty periods during the twelve-year period following the closing of the transaction.
Previous report
The transaction was approved by a vote of the holders of the Company’s common stock not party to the transaction, and the issuance of Class A common stock as consideration was approved by a vote of the Company’s common shareholders on July 31, 2026. Closing of the transaction, which is expected in the third quarter of 2026, remains subject to the satisfaction of customary closing conditions.
Previous report
Upon closing of the transaction, we will issue 28,942,108 shares of our Class A common stock. As a result, our stockholders will own a smaller percentage of the Company after the acquisition and will thereafter have a reduced voting and economic interest in the Company.
Previous report
Kashiv is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars.
Previous report
Water Damage to India Facility
Previous report
During the third week of July 2026, severe rain caused water damage to one of our facilities in India. We are currently undertaking remediation efforts and completing repairs. As of the date of this Quarterly Report, we estimate that inventory losses, property damage, remediation costs, and other incremental expenses could range from approximately $10 million to $15 million before any potential insurance recoveries, with most of the impact expected during the second half of 2026. We maintain property and business interruption insurance. The amount and timing of any potential insurance recoveries have not yet been determined. These estimates are preliminary and may change as the assessment and remediation activities continue.
Previous report
Since the severe rain and resulting water damage occurred subsequent to June 30, 2026, no amounts related to this event have been recognized in our consolidated financial statements as of and for the three and six months ended June 30, 2026.
Previous report
We expect production volumes and operating results to be adversely affected during the second half of 2026. In addition, separate from the estimated direct losses and costs described above, we currently estimate that this event could result in approximately $20 million of lost pre-tax profit during the same period. The magnitude of the impact will depend on the timing of repairs and the availability of alternative manufacturing capacity.
Previous report
Net revenue for the three months ended June 30, 2026 increased 9.9% from the prior year period, primarily due to:
Previous report
•Growth in our Specialty segment net revenue of $21.3 million, primarily driven by increases in sales of CREXONT® ($17.6 million), BREKIYA® autoinjector ($5.5 million), and UNITHROID® ($5.9 million), partially offset by the expected decline in sales of RYTARY®.
Previous report
•A decline in our AvKARE segment net revenue of $6.1 million, primarily driven by a reduction in our low margin distribution sales, partially offset by expansion in our government label channel from new product introductions.
Previous report
Acquisition Costs
Previous report
Other operating income for the three months ended June 30, 2026 was primarily comprised of income earned from the India Production Linked Incentive Scheme for the Pharmaceutical Sector (the “PLI Scheme”).
Previous report
Affordable Medicines gross profit as a percentage of net revenue increased to 42.3% for the three months ended June 30, 2026 from 41.7% in the prior year period, primarily due to favorable product mix from recently launched products and higher sales volumes, partially offset by increased plant and freight costs and inventory obsolescence.
Previous report
For the three months ended June 30, 2026, charges related to legal matters, net were $8.1 million, primarily consisting of charges related to antitrust class action litigation. For additional information regarding the antitrust class action litigation, refer to Note 16. Commitments and Contingencies.
Previous report
Specialty net revenue for the three months ended June 30, 2026 increased 16.6% compared to the prior year period, primarily driven by increases in sales of CREXONT® ($17.6 million), BREKIYA® autoinjector ($5.5 million), and UNITHROID® ($5.9 million), partially offset by the expected decline in sales of RYTARY®.
Previous report
Specialty gross profit as a percentage of net revenue increased to 67.7% for the three months ended June 30, 2026 as compared to 56.4%, primarily as a result of the factors noted above.
Previous report
AvKARE net revenue for the three months ended June 30, 2026 decreased 3.7% as compared to the prior year period, primarily driven by a reduction in our low margin distribution sales, partially offset by expansion in our government label channel from new product introductions.
Previous report
Comparison of Six Months Ended June 30, 2026 to Six Months Ended June 30, 2025
Previous report
Net revenue for the six months ended June 30, 2026 increased 7.0% from the prior year period primarily due to:
Previous report
•Growth in our Specialty segment net revenue of $46.2 million, primarily driven by increases in sales of CREXONT® ($29.8 million), BREKIYA® autoinjector ($10.1 million), and UNITHROID® ($8.5 million), partially offset by the expected decline in sales of RYTARY®.
Previous report
Cost of goods sold for the six months ended June 30, 2026 decreased 1.6% compared to the prior year period. The decrease in cost of goods sold was primarily due to the mix of revenues, including a reduction in low margin distribution sales, increased manufacturing efficiencies, and a reduction in amortization expense of $26.0 million, partially offset by increases in sales volume, plant and freight costs, and inventory obsolescence.
Previous report
Gross profit as a percentage of net revenue increased to 43.1% for the six months ended June 30, 2026 from 38.2% in the prior year period, primarily as a result of the factors noted above.
Previous report
Acquisition Costs
Previous report
The following table sets forth results of operations for our Affordable Medicines segment for the six months ended June 30, 2026 and 2025 (in thousands):
Previous report
Specialty net revenue for the six months ended June 30, 2026 increased 19.6% as compared to the prior year period, primarily driven by increases in sales of CREXONT® ($29.8 million), BREKIYA® autoinjector ($10.1 million), and UNITHROID® ($8.5 million), partially offset by the expected decline in sales of RYTARY®.
Previous report
Specialty gross profit as a percentage of net revenue increased to 67.7% for the six months ended June 30, 2026 as compared to 53.9%, primarily as a result of the factors noted above.
Previous report
AvKARE net revenue for the six months ended June 30, 2026 decreased 3.7% as compared to the prior year period primarily driven by a reduction in our low margin distribution sales, partially offset by expansion in our government label channel from new product introductions.
Previous report
Gross profit as a percentage of net revenue increased to 20.2% for the six months ended June 30, 2026 from 18.4% in the prior year period, primarily as a result of the factors noted above.
Previous report
As discussed in the section titled “Overview” in Item 2., Management’s Discussion and Analysis of Financial Condition and Results of Operationsin this Quarterly Report on Form 10-Q, on April 21, 2026, we entered into a definitive agreement to acquire Kashiv, which is expected to close in the third quarter of 2026. At closing, we expect to fund the cash portion of the purchase price of$375 million, subject to certain adjustments including for cash, the funding of operations between signing and closing (subject to a specified cap, calculated on the basis of the period from the date of the purchase agreement until the closing), indebtedness, transaction expenses and working capital fluctuations (relative to a target). In addition, we expect to incur post-closing integration costs.
Previous report
Although these amounts had not been incurred as of June 30, 2026, they represent known cash requirements that are reasonably likely to be incurred in connection with the closing of the acquisition and the integration of Kashiv. We currently expect to fund these requirements through a combination of cash on hand and long-term borrowings.
Previous report
Rondo Redeemable Non-Controlling Interests
Reworded paragraphs (59)
Previous wording
The following discussion and analysis for the three and six months ended June 30, 2026 should also be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements for the year ended December 31, 2025 included in our 2025 Annual Report on Form 10-K.
Current wording
The following discussion and analysis for the three and nine months ended September 30, 2026 should also be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements for the year ended December 31, 2025 included in our 2025 Annual Report on Form 10-K.
Previous wording
On July 21, 2026, the President announced a preliminary proposal that generic drugs imported into the U.S. would remain subject to no tariffs through July 31, 2028, after which tariffs would increase to 100% for one year and 200% thereafter. As of the date of this Quarterly Report on Form 10-Q, the announced policy has not been formally implemented and significant uncertainties remain regarding its scope, including the treatment of APIs, biosimilars, global supply chains and potential exemptions. Based on the announced timing, we do not expect a material direct impact on our 2026 results; however, if implemented as announced, the tariffs could materially increase the cost of products manufactured by us or third parties outside the U.S., adversely affecting gross margins, product availability and our competitive position. We are evaluating our product-level exposure and potential mitigation actions, including expanding U.S. manufacturing, alternative sourcing, supplier arrangements, pricing actions and portfolio changes, but we cannot currently estimate the impact on our future financial condition, results of operations or cash flows.
Current wording
On July 21, 2026, the President announced a preliminary proposal that generic drugs imported into the U.S. would remain subject to no tariffs through July 31, 2028, after which tariffs would increase to 100% for one year and 200% thereafter. As of the date of this Quarterly Report on Form 10-Q, the announced policy has not been formally implemented and significant uncertainties remain regarding its scope, including the treatment of APIs, biosimilars, global supply chains and potential exemptions. Based on the announced timing, we do not expect a material direct impact on our 2026 results; however, if implemented as announced, the tariffs could materially increase the cost of products manufactured by us or third parties outside the U.S., adversely affecting gross margins, product availability and our competitive position.
Previous wording
•Growth in our Affordable Medicines segment net revenue of $56.5 million, primarily due to new products launched in 2026 and 2025, which contributed $44.8 million of year-over-year growth, as well as an increase in sales of women’s health medicines due to market conditions, partially offset by price erosion.
Current wording
•Growth in our Affordable Medicines segment net revenue of $86.4 million, primarily due to new products launched in 2026 and 2025, which contributed $53.7 million of year-over-year growth, as well as an increase in sales of women’s health medicines due to market conditions, and a $60.7 million increase in biosimilar revenue, partially offset by price erosion.
Previous wording
Cost of goods sold increased 5.3% for the three months ended June 30, 2026 as compared to the prior year period. The increase in cost of goods sold was primarily due to increases in sales volume, plant and freight costs, and inventory obsolescence, partially offset by a reduction in amortization expense.
Current wording
Cost of goods sold increased 3.5% for the three months ended September 30, 2026 as compared to the prior year period. The increase in cost of goods sold was primarily due to increases in sales volume and plant and freight costs. In addition, the prior year period included impairment charges related to non-promoted products of $22.8 million.
Previous wording
Gross profit as a percentage of net revenue increased to 42.0% for the three months ended June 30, 2026 from 39.5% in the prior year period primarily due to lower amortization expense and operating leverage from higher sales volume.
Current wording
Gross profit as a percentage of net revenue increased to 38.7% for the three months ended September 30, 2026 from 34.9% in the prior year period, primarily due to impairment charges recognized in the prior year period that did not recur in 2026, as well as lower amortization expense and operating leverage from higher sales volume.
Previous wording
Selling, general, and administrative (“SG&A”) expenses for the three months ended June 30, 2026 increased 19.7% as compared to the prior year period, primarily due to increases in employee compensation and launch costs associated with CREXONT® and BREKIYA® autoinjector.
Current wording
Selling, general, and administrative (“SG&A”) expenses for the three months ended September 30, 2026 increased 1.3% as compared to the prior year period, primarily due to increases in employee compensation, launch costs associated with CREXONT® and BREKIYA® autoinjector, and an impact of $2.3 million for the Kashiv Acquisition, partially offset by a non-recurring benefit in freight spend.
Previous wording
Research and development (“R&D”) expenses for the three months ended June 30, 2026 decreased 18.7% as compared to the prior year period, primarily driven by a $2.9 million decrease in in-licensing and upfront milestone payments and lower employee compensation costs as a result of operational efficiencies.
Current wording
Research and development (“R&D”) expenses for the three months ended September 30, 2026 increased 7.9% as compared to the prior year period, primarily driven by a $13.8 million impairment charge related to certain equipment used in research and development activities as a result of a change in the expected future utilization of the assets and a $19.6 million impact from the Kashiv Acquisition, partially offset by a $22.5 million decrease in in-licensing and upfront milestone payments and operational efficiencies.
Previous wording
Acquisition costs for the three months ended June 30, 2026 were primarily related to professional services fees (e.g., legal, financial advisory, accounting, and consulting) associated with the previously announced agreement to acquire Kashiv (see Note 18. Related Party Transactions).
Current wording
Acquisition and integration costs for the three months ended September 30, 2026 were primarily related to professional services fees (e.g., legal, financial advisory, accounting, and consulting) associated with the Kashiv Acquisition (see Note 20. Related Party Transactions and Note 2. Acquisition).
Previous wording
For the three months ended June 30, 2026, charges related to legal matters, net were $8.1 million, primarily consisting of charges related to antitrust class action litigation. For additional information regarding the antitrust class action litigation, refer to Note 16. Commitments and Contingencies.
Current wording
Charges Related to Legal Matters, Net
Previous wording
Total other expense, net for the three months ended June 30, 2026 decreased 1.5% as compared to the prior year period. The decrease was primarily driven by a $10.1 million period-over-period decrease in interest expense due to lower interest rates on our variable-rate debt and a $2.0 million period-over-period decrease in the tax receivable agreement charge (refer to Note 4. Income Taxes), partially offset by unfavorable foreign currency movements.
Current wording
Total other expense, net for the three months ended September 30, 2026 increased 6.3% as compared to the prior year period. The increase was primarily driven by a $33.8 million period-over-period increase in the tax receivable agreement expense (refer to Note 5. Income Taxes), partially offset by a $3.9 million period-over-period decrease in interest expense due to lower interest rates on our variable-rate debt and a $25.6 million period-over-period decrease in loss on refinancing expense, primarily due to lower refinancing-related costs in the current year period as compared to costs incurred in connection with the refinancing of our long-term debt during the third quarter of 2025. For additional information, refer to Note 14. Debt.
Previous wording
For the six months ended June 30, 2026, our provision for income taxes and effective tax rate were $3.6 million and 2.3%, respectively, as compared to $29.0 million and 32.5%, respectively, for the six months ended June 30, 2025. The period-over-period change in the provision for income taxes was primarily due to the tax impacts from changes in the level and jurisdictional mix of income, the impact of the One Big Beautiful Bill Act, and discrete items related to share-based compensation in the current period.
Current wording
For the three months ended September 30, 2026, our provision for (benefit from) income taxes and effective tax rate was $2.8 million and 18.3%, respectively, as compared to a provision for (benefit from) income taxes $(23.4) million and 447.2%, respectively, for the three months ended September 30, 2025. The period-over-period change in the provision for income taxes and effective tax rate was primarily driven by the tax effects of changes in the level and jurisdictional mix of earnings and the impact of the One Big Beautiful Bill Act (enacted in July 2025).
Previous wording
Affordable Medicines net revenue for the three months ended June 30, 2026 increased 13.0% as compared to the prior year period, primarily due to new products launched in 2026 and 2025, which contributed $44.8 million of year-over-year growth, as well as an increase in sales of women’s health medicines due to market conditions, partially offset by price erosion.
Current wording
Affordable Medicines net revenue for the three months ended September 30, 2026 increased 18.7% as compared to the prior year period, primarily due to new products launched in 2026 and 2025, which contributed $53.7 million of year-over-year growth, as well as an increase in sales of women’s health medicines due to market conditions, and a $60.7 million increase in biosimilar revenue, partially offset by price erosion.
Previous wording
Affordable Medicines cost of goods sold for the three months ended June 30, 2026 increased 11.9% as compared to the prior year period, primarily due to increases in sales volume, plant and freight costs, and inventory obsolescence.
Current wording
Affordable Medicines cost of goods sold for the three months ended September 30, 2026 increased 25.6% as compared to the prior year period, primarily due to increases in sales volume and plant and freight costs.
Previous wording
Gross profit as a percentage of net revenue decreased to 16.7% for the three months ended June 30, 2026 from 20.4% in the prior year period, primarily as a result of the factors noted above.
Current wording
Affordable Medicines gross profit as a percentage of net revenue decreased to 35.6% for the three months ended September 30, 2026 from 39.1% in the prior year period, primarily as a result of the factors noted above, as well as the current year period being impacted by the timing of lower margin contract distribution revenues.
Previous wording
Affordable Medicines SG&A expense for the three months ended June 30, 2026 increased 23.8% as compared to the prior year period, primarily due to increases in employee compensation, regulatory fees, and freight costs.
Current wording
Affordable Medicines SG&A expense for the three months ended September 30, 2026 decreased 13.7% as compared to the prior year period, primarily due to the current year period being impacted by a non-recurring benefit in freight spend, partially offset by increases in employee compensation and regulatory fees.
Previous wording
Affordable Medicines R&D expenses for the three months ended June 30, 2026 decreased 21.2% as compared to the prior year period, primarily driven by a $2.9 million decrease in in-licensing and upfront milestone payments and lower employee compensation costs as a result of operational efficiencies.
Current wording
Affordable Medicines R&D expenses for the three months ended September 30, 2026 increased 15.0% as compared to the prior year period, primarily driven by a $13.8 million impairment charge related to certain equipment used in research and development activities as a result of a change in the expected future utilization of the assets and a $19.6 million impact from the Kashiv Acquisition, partially offset by a $22.5 million decrease in in-licensing and upfront milestone payments and operational efficiencies.
Previous wording
Specialty cost of goods sold for the three months ended June 30, 2026 decreased 13.5% compared to the prior year period, primarily due to a reduction in amortization expense of $14.1 million and revenue mix, partially offset by increased sales volume.
Current wording
Specialty cost of goods sold for the three months ended September 30, 2026 decreased 37.4% compared to the prior year period, primarily due to a reduction in amortization expense of $7.6 million and revenue mix, partially offset by increased sales volume in the current year period. In addition, the prior year period included impairment charges related to non-promoted products of $22.8 million.
Previous wording
Specialty SG&A expense for the three months ended June 30, 2026 increased 32.3% as compared to the prior year period, primarily due to increased launch costs associated with CREXONT® and BREKIYA® autoinjector, as well as increased employee compensation.
Current wording
Specialty SG&A expense for the three months ended September 30, 2026 increased 10.1% as compared to the prior year period, primarily due to increased launch costs associated with CREXONT® and BREKIYA® autoinjector, as well as increased employee compensation.
Previous wording
Specialty R&D expense for the three months ended June 30, 2026 decreased 1.2% as compared to the prior year period, primarily due to increased operational efficiencies.
Current wording
Specialty R&D expense for the three months ended September 30, 2026 decreased 39.8% as compared to the prior year period, primarily due to increased operational efficiencies and reduced project spend due to timing.
Previous wording
AvKARE cost of goods sold for the six months ended June 30, 2026 decreased 5.8% as compared to the prior year period primarily due to reduced sales in our low margin distribution channel, partially offset by higher sales in our government label channel.
Current wording
AvKARE cost of goods sold for the three months ended September 30, 2026 decreased 16.8% as compared to the prior year period, primarily due to reduced sales and a decrease in inventory obsolescence in the current year period of $3.5 million.
Previous wording
AvKARE SG&A expense for the three months ended June 30, 2026 increased 12.2% as compared to the prior year period, primarily due to increased employee compensation.
Current wording
AvKARE SG&A expense for the three months ended September 30, 2026 increased 17.6% as compared to the prior year period, primarily due to increased employee compensation.
Previous wording
The following table sets forth our summarized, consolidated results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table sets forth our summarized, consolidated results of operations for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
•Growth in our Affordable Medicines segment net revenue of $65.0 million, primarily due to new products launched in 2026 and 2025, which contributed $45.2 million of year-over-year growth, as well as increases in sales of women’s health and attention deficit hyperactivity disorder medicines due to market conditions, partially offset by price erosion.
Current wording
•Growth in our Affordable Medicines segment net revenue of $151.4 million, primarily due to new products launched in 2026 and 2025, which contributed $98.9 million of year-over-year growth as well as increases in sales of women’s health due to market conditions, and timing of Biosimilar revenues, which grew $58.3 million, partially offset by price erosion.
Previous wording
•Decline in our AvKARE segment net revenue of $12.4 million, primarily driven by a reduction in our low margin distribution sales, partially offset by expansion in our government label channel from new product introductions.
Current wording
•Decline in our AvKARE segment net revenue of $45.7 million, primarily driven by a reduction in our low margin distribution sales.
Previous wording
SG&A expenses for the six months ended June 30, 2026 increased 18.6% as compared to the prior year period, primarily due to increases in employee compensation and launch costs associated with CREXONT® and BREKIYA® autoinjector.
Current wording
SG&A expenses for the nine months ended September 30, 2026 increased 12.3% as compared to the prior year period, primarily due to increases in employee compensation, regulatory fees, and launch costs associated with CREXONT® and BREKIYA® autoinjector.
Previous wording
R&D expenses for the six months ended June 30, 2026 decreased 12.0% as compared to the prior year period, primarily driven by a $5.6 million reduction in in-licensing and upfront milestone payments, lower employee compensation costs and other overhead reductions due to operational efficiencies, partially offset by increased project spend.
Current wording
R&D expenses for the nine months ended September 30, 2026 decreased 3.7% as compared to the prior year period, primarily driven by a $28.1 million reduction in in-licensing and upfront milestone payments, a decrease in employee compensation, and other overhead reductions due to operational efficiencies, partially offset by a $13.8 million impairment charge related to certain equipment used in research and development activities as a result of a change in the expected future utilization of the assets and an impact of $19.6 million for the Kashiv Acquisition.
Previous wording
Acquisition costs for the six months ended June 30, 2026 were primarily related to professional services fees (e.g., legal, due diligence, financial advisory, accounting, and consulting) associated with the previously announced agreement to acquire Kashiv (see Note 18. Related Party Transactions).
Current wording
Acquisition and integration costs for the nine months ended September 30, 2026 were primarily related to professional services fees (e.g., legal, due diligence, financial advisory, accounting, and consulting) associated with the acquisition and integration of Kashiv. For additional information, refer to Note 2. Acquisition.
Previous wording
For the six months ended June 30, 2026, charges related to legal matters, net were $8.8 million, primarily consisting of (i) a $21.2 million charge associated with certain states electing a 25% cash conversion in lieu of product under the Nationwide Opioids Settlement Agreement, partially offset by a $20.8 million discount recorded on the expected settlement payments as of the agreement’s effective date and (ii) charges associated with antitrust class action litigation. For additional information regarding the Nationwide Opioids Settlement Agreement and antitrust class action litigation, refer to Note 16. Commitments and Contingencies.
Current wording
For the nine months ended September 30, 2026, charges related to legal matters, net were $15.2 million, primarily consisting of (i) a $21.2 million charge associated with certain states electing a 25% cash conversion in lieu of product under the Nationwide Opioids Settlement Agreement, partially offset by a $20.8 million discount recorded on the expected settlement payments as of the agreement’s effective date, (ii) net charges associated with antitrust class action litigation of $7.5 million, and (iii) a charge related to government investigations of $8.0 million, partially offset by immaterial net credits related to several matters. For additional information refer to Note 18. Commitments and Contingencies.
Previous wording
Other operating income for the three months ended June 30, 2026 was primarily comprised of income earned from the PLI Scheme.
Current wording
Other Operating Income
Previous wording
Other operating income for the six months ended June 30, 2026 was primarily comprised of a $6.9 million gain recognized during the first quarter of 2026 from the derecognition of the financing obligation associated with a contract with Pfizer and income earned from the PLI Scheme. Refer to Note 3. Alliance and Collaborationfor additional information about our contract with Pfizer.
Current wording
Other operating income for the nine months ended September 30, 2026 was primarily comprised of a $6.9 million gain recognized during the first quarter of 2026 from the derecognition of the financing obligation associated with a contract with Pfizer and income earned from the PLI Scheme. Refer to Note 4. Alliance and Collaborationfor additional information about our contract with Pfizer.
Previous wording
Other operating income for the six months ended 2025 was comprised of income earned from the PLI Scheme.
Current wording
Other operating income for the nine months ended 2025 was comprised of income earned from the PLI Scheme.
Previous wording
Total other expense, net for the six months ended June 30, 2026 decreased 1.8% as compared to the prior year period. The decrease was driven by a period-over-period decrease in the tax receivable agreement charge of $15.0 million (refer to Note 4. Income Taxes)and a $13.6 million period-over-period decrease in interest expense due to lower rates on our variable-rate debt, partially offset by a $3.5 million loss on refinancing in the first quarter of 2026 and unfavorable foreign currency movements.
Current wording
Total other expense, net for the nine months ended September 30, 2026 increased 1.3% as compared to the prior year period. The increase was driven by a period-over-period change in the tax receivable agreement charge of $18.8 million (refer to Note 5. Income Taxes)and unfavorable foreign currency movements, partially offset by a $17.5 million period-over-period decrease in interest expense due to lower rates on our variable-rate debt, and a $22.1 million period-over-period decrease in loss on refinancing, primarily due to lower refinancing-related costs in the current year period as compared to costs incurred in connection with the refinancing of our long-term debt during the third quarter of 2025.
Previous wording
For the three months ended June 30, 2026, our provision for income taxes and effective tax rate were $1.4 million and 1.9%, respectively, as compared to $16.1 million and 31.1%, respectively, for the three months ended June 30, 2025. The period-over-period change in the provision for income taxes was primarily due to the tax impacts from changes in the level and jurisdictional mix of income, the impact of the One Big Beautiful Bill Act (enacted in July 2025), and discrete items related to share-based compensation in the current period.
Current wording
For the nine months ended September 30, 2026, our provision for income taxes and effective tax rate were $6.3 million and 3.8%, respectively, as compared to $5.6 million and 6.7%, respectively, for the nine months ended September 30, 2025. The period-over-period change in the provision for income taxes and effective tax rate was primarily driven by the tax effects of changes in the level and jurisdictional mix of earnings, the impact of the One Big Beautiful Bill Act (enacted in July 2025), and discrete items related to share-based compensation in the current period.
Previous wording
Affordable Medicines net revenue for the six months ended June 30, 2026 increased 7.7% as compared to the prior year period, primarily due to new products launched in 2026 and 2025, which contributed $45.2 million of year-over-year growth, as well as increases in sales of women’s health and attention deficit hyperactivity disorder medicines due to market conditions, partially offset by price erosion.
Current wording
Affordable Medicines net revenue for the nine months ended September 30, 2026 increased 11.6% as compared to the prior year period, primarily due to new products launched in 2026 and 2025, which contributed $98.9 million of year-over-year growth as well as increases in sales of women’s health due to market conditions, and timing of Biosimilar revenues, which grew $58.3 million, partially offset by price erosion.
Previous wording
Affordable Medicines cost of goods sold for the six months ended June 30, 2026 increased 4.0% as compared to the prior year period, primarily due to increases in sales volume, plant and freight costs, and inventory obsolescence, partially offset by favorable product mix and manufacturing efficiencies.
Current wording
Affordable Medicines cost of goods sold for the nine months ended September 30, 2026 increased 11.8% as compared to the prior year period, primarily due to increases in sales volume, plant and freight costs, and inventory obsolescence, partially offset by manufacturing efficiencies.
Previous wording
Affordable Medicines gross profit as a percentage of net revenue increased to 43.6% for the six months ended June 30, 2026 from 41.6% in the prior year period, primarily as a result of the factors noted above.
Current wording
Affordable Medicines gross profit as a percentage of net revenue decreased to 40.6% for the nine months ended September 30, 2026 from 40.7%, primarily as a result of product mix and the factors noted above.
Previous wording
Affordable Medicines SG&A expense for the six months ended June 30, 2026 increased 23.2% as compared to the prior year period, primarily due to increases in employee compensation, regulatory fees, freight costs, and costs related to our international expansion.
Current wording
Affordable Medicines SG&A expense for the nine months ended September 30, 2026 increased 10.1% as compared to the prior year period, primarily due to increases in employee compensation, regulatory fees, and costs related to our international expansion, partially offset by the current year period being impacted by a non-recurring benefit in freight spend.
Previous wording
Affordable Medicines R&D expenses for the six months ended June 30, 2026 decreased 9.0% as compared to the prior year period, primarily driven by a $2.6 million reduction in in-licensing and upfront milestone payments, lower employee compensation costs and other overhead reductions due to operational efficiencies, partially offset by increased project spend.
Current wording
Affordable Medicines R&D expenses for the nine months ended September 30, 2026 increased 1.3% as compared to the prior year period, primarily driven by a $13.8 million impairment charge related to certain equipment used in research and development activities as a result of a change in the expected future utilization of the assets and an impact of $19.6 million for the Kashiv Acquisition, partially offset by a $25.1 million reduction in in-licensing and upfront milestone payments and other overhead reductions due to operational efficiencies.
Previous wording
For the six months ended June 30, 2026, charges related to legal matters, net were $8.8 million, primarily consisting of (i) a $21.2 million charge associated with certain states electing a 25% cash conversion in lieu of product under the Nationwide Opioids Settlement Agreement, partially offset by a $20.8 million discount recorded on the expected settlement payments as of the agreement’s effective date and (ii) charges associated with antitrust class action litigation. For additional information regarding the Nationwide Opioids Settlement Agreement and antitrust class action litigation, refer to Note 16. Commitments and Contingencies.
Current wording
For the nine months ended September 30, 2026, charges (credit) related to legal matters, net were $14.3 million, primarily consisting of (i) a $21.2 million charge associated with certain states electing a 25% cash conversion in lieu of product under the Nationwide Opioids Settlement Agreement, partially offset by a $20.8 million discount recorded on the expected settlement payments as of the agreement’s effective date, (ii) net charges associated with antitrust class action litigation of $7.5 million, and (iii) a charge related to government investigations of $8.0 million, partially offset by immaterial net credits related to several matters. For additional information regarding the Nationwide Opioids Settlement Agreement, antitrust class action litigation, and government investigations, refer to Note 18. Commitments and Contingencies.
Previous wording
Other operating income for the six months ended June 30, 2026 was primarily comprised of a $6.9 million gain recognized during the first quarter of 2026 from the derecognition of the financing obligation associated with a contract with Pfizer, and income earned from the PLI Scheme. Refer to Note 3. Alliance and Collaborationfor additional information about our contract with Pfizer.
Current wording
Other operating income for the nine months ended September 30, 2026 was primarily comprised of a $6.9 million gain recognized during the first quarter of 2026 from the derecognition of the financing obligation associated with a contract with Pfizer, and income earned from the PLI Scheme. Refer to Note 4. Alliance and Collaborationfor additional information about our contract with Pfizer.
Showing the first 40 of 59 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Charges Related to Legal Matters, Net