Alkermes plc.
For the period ended Jun 30, 2025. Filed Jul 29, 2025.
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.
Jun 30, 2025 · Filed Jul 29, 2025
ALKS$45.90+3.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-01.
0000950170-25-061817
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-29.
0000950170-25-099409
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 88 previous paragraphs and 91 current paragraphs.
64 unchanged; 21 reworded; 5 added; 3 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 14 previous and 14 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 (5)
Current report
The decreases in net income from continuing operations of $7.6 million and $24.0 million during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, respectively, were primarily due to decreases of $8.5 million and $52.3 million, respectively, in revenues, primarily related to lower manufacturing and royalty revenues, partially offset by increases in product sales, net. During the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, total expenses increased by $8.4 million and decreased by $5.9 million, respectively, and income tax provision decreased by $4.4 million and $9.2 million, respectively.
Current report
Alixorexton (formerly referred to as ALKS 2680)
Current report
The decrease in selling and marketing expense during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to a decrease of $13.3 million in in marketing spend, primarily related to decreases in media spend for our proprietary products, partially offset by an increase of $12.1 million in employee-related expenses, primarily due to the increase in sales and marketing-related headcount noted above.
Current report
The increase in general and administrative expense during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was primarily due to an increase of $2.0 million in employee-related expenses, primarily due to a 6% increase in general and administrative-related headcount and an increase of $1.0 million in professional services fees, primarily related to an increase in legal expenses. These increases were offset by a decrease of $1.4 million related to branded prescription drug fees.
Current report
The decrease in general and administrative expense during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to a decrease of $1.4 million related to branded prescription drug fees, a decrease of $1.2 million in professional service fees and a decrease of $0.7 million in share-based compensation expense. The decrease in professional service fees was primarily related to the timing of legal expenses. The decrease in share-based compensation expense was partially offset by a $1.1 million increase in salary expense, primarily due to the increase in general and administrative-related headcount noted above.
Removed paragraphs (3)
Previous report
The decrease in net income from continuing operations during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, was primarily due to a decrease of $54.8 million in manufacturing and royalty revenue, partially offset by an increase of $11.0 million in product sales, net, a decrease of $14.4 million in operating expenses, an increase of $8.0 million in other income, net and a decrease of $4.9 million in income tax provision.
Previous report
ALKS 2680
Previous report
The decrease in general and administrative expense was primarily due to decreases of $2.2 million and $2.1 million in professional service fees and employee-related expenses, respectively. The decrease in professional service fees is primarily related to a decrease in legal expenses. The decrease in employee-related expenses is primarily related to a decrease in share-based compensation expense.
Reworded paragraphs (21)
Previous wording
Net income from continuing operations was $22.5 million or $0.14 per ordinary share—basic and $0.13 per ordinary share—diluted, for the three months ended March 31, 2025, compared to net income from continuing operations of $38.9 million or $0.23 per ordinary share—basic and $0.23 per ordinary share—diluted, for the three months ended March 31, 2024.
Current wording
Net income from continuing operations was $87.1 million and $109.6 million or $0.53 and $0.67 per ordinary share—basic and $0.52 and $0.65 per ordinary share—diluted, for the three and six months ended June 30, 2025, respectively, compared to net income from continuing operations of $94.7 million and $133.6 million or $0.56 per and $0.79 ordinary share—basic and $0.55 and $0.78 per ordinary share—diluted, for the three and six months ended June 30, 2024, respectively.
Previous wording
In March 2025, U.S. Patent No. 12,251,381 relating to ARISTADA and ARISTADA INITIO was granted. The patent has claims to a method of treating schizophrenia and expires in 2039.
Current wording
In May 2025, U.S. Patent No. 12,311,027 relating to ARISTADA was granted. The patent has claims to pharmaceutical compositions that confer long-term stability of the ARISTADA formulation and methods of treating schizophrenia and expires in 2033.
Previous wording
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy type 1 (“NT1”), narcolepsy type 2 (“NT2”) and idiopathic hypersomnia (“IH”). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. Once-daily oral administration of ALKS 2680 was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH and is currently being evaluated in the phase 2 Vibrance-1, Vibrance-2 and Vibrance-3 studies in patients with NT1, NT2 and IH, respectively.
Current wording
Alixorexton is a novel, investigational, oral, selective orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy type 1 (“NT1”), narcolepsy type 2 (“NT2”) and idiopathic hypersomnia (“IH”). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH and is currently being evaluated in the phase 2 Vibrance-1, Vibrance-2 and Vibrance-3 studies in patients with NT1, NT2 and IH, respectively. In July 2025, we announced that alixorexton achieved the primary endpoint in the Vibrance-1 study in patients with NT1 and that we are proceeding with plans for initiation of a phase 3 program in narcolepsy.
Previous wording
Our product sales, net, consist of sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. The following table presents the adjustments deducted from product sales, gross to arrive at product sales, net, for sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI during the three months ended March 31, 2025 and 2024:
Current wording
Our product sales, net, consist of sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. The following table presents the adjustments deducted from product sales, gross to arrive at product sales, net, for sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI during the three and six months ended June 30, 2025 and 2024:
Previous wording
The increase in product sales, gross was due to a 21% increase in the number of LYBALVI units sold and a 3% price increase for each of our proprietary products that went into effect on January 1, 2025. These increases were partially offset by 5% and 9% decreases in the number of units sold for VIVITROL and ARISTADA/ARISTADA INITIO, respectively.
Current wording
The increase in product sales, gross during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was due to increases of 14% and 2% in the number of units sold for LYBALVI and ARISTADA/ARISTADA INITIO, respectively, and a 3% price increase for each of our proprietary products that went into effect on January 1, 2025. These increases were partially offset by a 1% decrease in the number of units sold for VIVITROL.
Previous wording
The decrease in Medicaid rebates, as a percentage of sales, was primarily due to actual Medicaid utilization rebates related to VIVITROL, which were lower than original estimates by approximately $8.7 million.
Current wording
The decreases in Medicaid rebates, as a percentage of sales, during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to actual Medicaid rebates related to VIVITROL and ARISTADA/ARISTADA INITIO, which were lower than original estimates by approximately $9.0 million and $17.7 million for VIVITROL during the three and six months ended June 30, 2025, respectively, and by approximately $7.2 million for ARISTADA/ARISTADA INITIO during the three months ended June 30, 2025.
Previous wording
The following table compares product sales, net earned during the three months ended March 31, 2025 and 2024:
Current wording
The following table compares product sales, net earned during the three and six months ended June 30, 2025 and 2024:
Previous wording
The following table compares manufacturing and royalty revenues earned during the three months ended March 31, 2025 and 2024:
Current wording
The following table compares manufacturing and royalty revenues earned during the three and six months ended June 30, 2025 and 2024:
Previous wording
The decrease in royalty revenues related to the long-acting INVEGA products was primarily due to the expiration of our royalty on net sales of INVEGA SUSTENNA in the U.S. in August 2024. We expect royalty revenues from net sales of the long-acting INVEGA products to continue to be lower in 2025, as the royalty revenues related to net sales of INVEGA SUSTENNA in the U.S. comprised a significant portion of the overall royalty revenues for the long-acting INVEGA products. In addition, each of INVEGA SUSTENNA and INVEGA TRINZA is currently subject to Paragraph IV litigation in response to companies seeking to market generic versions of such product. Increased competition from new products or generic versions of any one or more of the long-acting INVEGA products may lead to reduced unit sales of the long-acting INVEGA products, including those not yet genericized, and increased pricing pressure. For a discussion of the legal proceedings related to INVEGA TRINZA, see Note 16, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to these legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report, and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
Current wording
The decreases in royalty revenues related to the long-acting INVEGA products during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to the expiration of our royalty on net sales of INVEGA SUSTENNA in the U.S. in August 2024. We expect royalty revenues from net sales of the long-acting INVEGA products to continue to be lower for the remainder of 2025, as the royalty revenues related to net sales of INVEGA SUSTENNA in the U.S. comprised a significant portion of the overall royalty revenues for the long-acting INVEGA products. In addition, each of INVEGA SUSTENNA and INVEGA TRINZA is currently subject to Paragraph IV litigation in response to companies seeking to market generic versions of such product. Increased competition from new products or generic versions of any one or more of the long-acting INVEGA products may lead to reduced unit sales of the long-acting INVEGA products, including those not yet genericized, and increased pricing pressure. For a discussion of the legal proceedings related to INVEGA TRINZA, see Note 16, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to these legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report, and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
Previous wording
The decrease in VUMERITY revenue was due to a $6.2 million decrease in manufacturing revenue, offset by a $2.7 million increase in royalty revenue. The decrease in VUMERITY manufacturing revenue was primarily due to a reduction in the number of batches manufactured for sale to Biogen, and the increase in VUMERITY royalty revenue was due to an increase in the end-market sales of the product. The increase in RISPERDAL CONSTA revenue was due to a $6.5 million increase in manufacturing revenue, primarily due to an increase in the number of batches made available to Janssen for sale in the U.S., which has a higher selling price than product sold outside of the U.S. The decrease in Other manufacturing and royalty revenue was primarily due to a $10.5 million decrease in revenue from FAMPYRA, as our manufacturing obligations for FAMPYRA concluded on December 31, 2024.
Current wording
The increases in VUMERITY revenue during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were due to increases of $6.6 million and $9.4 million, respectively, in royalty revenue, offset by decreases of $2.5 million and $8.6 million, respectively, in manufacturing revenue. The increases in VUMERITY royalty revenue were primarily due to increases in end-market sales of the product. The decreases in VUMERITY manufacturing revenue were primarily due to reductions in the number of batches manufactured for sale to Biogen. The increase in RISPERDAL CONSTA revenue during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was due to a $6.9 million increase in manufacturing revenue, primarily due to an increase in the number of batches made available to Janssen for sale in the U.S., which has a higher selling price than product sold outside of the U.S. The decreases in Other manufacturing and royalty revenue during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to decreases of $3.1 million and $13.6 million, respectively, in revenue from FAMPYRA, as our manufacturing obligations for FAMPYRA concluded on December 31, 2024.
Previous wording
The decrease in the cost of goods manufactured and sold was primarily related to decreases in the cost of goods sold for VIVITROL and ARISTADA and ARISTADA INITIO due to decreases in the number of units sold, as discussed above, and decreases in costs related to out-of-specification batches and investigations. In addition, following the sale of the Athlone Facility in May 2024, the cost of goods manufactured for certain legacy products that are manufactured at the Athlone Facility decreased. These decreases were partially offset by an increase in the cost of goods sold for LYBALVI due to an increase in the number of units sold, as discussed above.
Current wording
The decreases in the cost of goods manufactured and sold during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily related to decreases of $13.7 million and $20.7 million, respectively, in the cost of goods manufactured for certain legacy products following the sale of the Athlone Facility in May 2024 and decreases in the cost of goods sold for VIVITROL during each period due to decreases in the number of units sold, as discussed above. These decreases were partially offset by increases in the cost of goods sold for LYBALVI due to increases in the number of units sold in each period, as discussed above.
Previous wording
The following table sets forth our external R&D expenses for the three months ended March 31, 2025 and 2024 relating to our then-current development programs and our internal R&D expenses, listed by the nature of such expenses:
Current wording
The following table sets forth our external R&D expenses for the three and six months ended June 30, 2025 and 2024 relating to our then-current development programs and our internal R&D expenses, listed by the nature of such expenses:
Previous wording
The increase in expenses related to ALKS 2680 was primarily due to increased spend related to the advancement of the development program for the product, including initiation of our Vibrance-3 phase 2 clinical study and costs related to our long-term extension study for the product, partially offset by the completion of our first-in-human phase 1 clinical study for the product in the first half of 2024. The decrease in expenses related to LYBALVI was primarily due to the timing of spend on our pediatric studies for the product. The increase in other external R&D expenses was primarily due to activities associated with our preclinical development programs. The decrease in employee-related expenses was primarily due to a decrease in labor and benefits expense related to a 9% decrease in R&D-related headcount following the completion of the sale of the Athlone Facility in May 2024.
Current wording
The increases in expenses related to alixorexton during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to increased spend related to the advancement of the development program for the product, including initiation of our Vibrance-3 phase 2 clinical study and costs related to our long-term extension study for the product, partially offset by the completion of our first-in-human phase 1 clinical study for the product in the first half of 2024. The increase in expenses related to LYBALVI during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was primarily due to increased spend on our pediatric program related to the product. The increase in other external R&D expenses during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to activities associated with our preclinical development programs. The increases in employee-related expenses during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to increases in labor and benefits expense related to a 10% increase in R&D-related headcount. The increase in employee-related expenses during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was partially offset by a decrease in share-based compensation expense.
Previous wording
The decrease in selling and marketing expense was primarily due to a decrease of $9.2 million in media spend for our proprietary products, partially offset by a $4.2 million increase in sales and marketing-related materials and training and a $1.7 million increase in employee-related expenses, primarily due to a 14% increase in sales and marketing-related headcount.
Current wording
The increase in selling and marketing expense during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was primarily due to an increase of $10.4 million in employee-related expenses, primarily due to a 13% increase in sales and marketing-related headcount, partially offset by a decrease of $8.9 million in marketing spend, primarily related to decreases in media spend for our proprietary products.
Previous wording
The income tax provisions in the three months ended March 31, 2025 and 2024 were primarily attributable to taxes on income earned in Ireland.
Current wording
The income tax provisions in each of the three and six months ended June 30, 2025 and 2024 were primarily attributable to taxes on income earned in Ireland.
Previous wording
We generated $98.8 million and $21.1 million of cash from operating activities during the three months ended March 31, 2025 and 2024, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, including capital expenditures, for not less than twelve months following the date from which our financial statements were issued. Subject to market conditions, interest rates and other factors, we may pursue opportunities to obtain financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures.
Current wording
We generated $249.0 million and $167.1 million of cash from operating activities during the six months ended June 30, 2025 and 2024, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, including capital expenditures, for not less than twelve months following the date from which our financial statements were issued. Subject to market conditions, interest rates and other factors, we may pursue opportunities to obtain financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures.
Previous wording
Information about our cash flows, by category, is presented in the accompanying condensed consolidated statements of cash flows. The discussion of our cash flows that follows does not include the impact of any adjustments to remove discontinued operations and is stated on a total company consolidated basis. The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024:
Current wording
Information about our cash flows, by category, is presented in the accompanying condensed consolidated statements of cash flows. The discussion of our cash flows that follows does not include the impact of any adjustments to remove discontinued operations and is stated on a total company consolidated basis. The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:
Previous wording
Cash flows provided by operating activities for the three months ended March 31, 2025 were $98.8 million and primarily consisted of net income of $22.5 million, adjusted for non-cash items, including share-based compensation of $22.8 million, depreciation and amortization of $7.4 million, deferred income taxes of $2.5 million and changes in working capital of $43.3 million.
Current wording
Cash flows provided by operating activities for the six months ended June 30, 2025 primarily consisted of $109.6 million of net income, adjusted for non-cash items, including $47.8 million of share-based compensation, $15.2 million of depreciation and amortization and changes of $74.1 million in working capital.
Previous wording
Cash flows provided by operating activities for the three months ended March 31, 2024 were $21.1 million and primarily consisted of a net income of $38.9 million adjusted for non-cash items, including share-based compensation of $32.8 million, depreciation and amortization of $8.1 million and deferred income taxes of $7.5 million, partially offset by changes in working capital of $66.3 million.
Current wording
Cash flows provided by operating activities for the six months ended June 30, 2024 primarily consisted of $128.2 million of net income, adjusted for non-cash items, including $53.4 million of share-based compensation, $14.7 million of depreciation and amortization, $21.7 million of deferred income taxes and a gain of $1.5 million on the sale of the Athlone Facility, partially offset by changes of $51.5 million in working capital.
Previous wording
Cash flows provided by investing activities for the three months ended March 31, 2025 were primarily due to $17.5 million in net sales of investments, partially offset by the purchase of $10.1 million of property, plant and equipment. Cash flows used in investing activities for the three months ended March 31, 2024 were primarily due to $32.0 million in net purchase of investments and the purchase of $8.3 million of property, plant and equipment.
Current wording
Cash flows used in investing activities for the six months ended June 30, 2025 were primarily due to the purchase of $23.1 million of property, plant and equipment, partially offset by $1.3 million in net sales of investments. Cash flows provided by investing activities for the six months ended June 30, 2024 were primarily due to proceeds of approximately $97.9 million related to the sale of the Athlone Facility, which included a payment of approximately $91.0 million for the facility and certain related assets, partially offset by $71.0 million in net purchase of investments and the purchase of $15.5 million of property, plant and equipment.
Previous wording
Cash flows provided by financing activities for the three months ended March 31, 2025 were primarily due to $29.5 million of cash that we received upon exercises of employee stock options, partially offset by $28.8 million of employee taxes paid related to the net share settlement of equity awards. Cash flows used in financing activities for the three months ended March 31, 2024 primarily related to $28.3 million of employee taxes paid related to the net share settlement of equity awards, partially offset by $11.2 million of cash that we received upon exercises of employee stock options.
Current wording
Cash flows provided by financing activities for the six months ended June 30, 2025 were due to $31.6 million of cash that we received upon exercises of employee stock options, offset by $30.4 million of employee taxes paid related to the net share settlement of equity awards. Cash flows used in financing activities for the six months ended June 30, 2024 primarily related to $84.7 million used to repurchase our ordinary shares under the Repurchase Program and $29.0 million of employee taxes paid related to the net share settlement of equity awards, partially offset by $13.8 million of cash that we received upon exercises of employee stock options.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The increase in product sales, gross during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to a 17% increase in the number of LYBALVI units sold and the 3% price increase for each of our proprietary products that went into effect on January 1, 2025. These increases were partially offset by 3% decreases in the number of units sold for each of VIVITROL and ARISTADA/ARISTADA INITIO.