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Alkermes plc

For the period ended Sep 30, 2024. Filed Oct 24, 2024.

View on SEC.gov

About 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, 2024 · Filed Oct 24, 2024

ALKS$45.90+3.1%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-06-30; filed 2024-07-24.

0000950170-24-085873

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-09-30; filed 2024-10-24.

0000950170-24-116872

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 99 previous paragraphs and 97 current paragraphs.

66 unchanged; 29 reworded; 1 added; 3 removed; 1 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 (1)

Current report

In April 2024, U.S. Patent No. 11,951,111 relating to LYBALVI was granted. This patent has claims to methods of treating schizophrenia and bipolar I disorder and expires in 2041.
Removed paragraphs (3)

Previous report

The decreases in net income from continuing operations during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to decreases of $256.1 million and $212.1 million, respectively, in manufacturing and royalty revenues, partially offset by increases of $37.8 million and $56.6 million, respectively, in product sales, net and decreases of $46.9 million and $38.4 million, respectively, in operating expenses.

Previous report

On May 1, 2024, we completed the sale of the Athlone Facility to Novo. We also entered into subcontracting arrangements with Novo to continue certain development and manufacturing activities currently performed at the Athlone Facility for a period of time after the closing of the transaction; these activities may continue through the end of 2025.
Reworded paragraphs (29)

Previous wording

Net income from continuing operations was $94.7 million and $133.6 million or $0.56 and 0.79 per ordinary share—basic and $0.55 and $0.78 per ordinary share—diluted, for the three months and six months ended June 30, 2024, respectively, compared to net income from continuing operations of $279.1 million and $267.1 million or $1.68 and $1.61 per ordinary share—basic and $1.63 and $1.56 per ordinary share—diluted, for the three and six months ended June 30, 2023, respectively.

Current wording

Net income from continuing operations was $92.8 million and $226.4 million or $0.57 and 1.36 per ordinary share—basic and $0.56 and $1.33 per ordinary share—diluted, for the three months and nine months ended September 30, 2024, respectively, compared to net income from continuing operations of $91.6 million and $358.6 million or $0.55 and $2.16 per ordinary share—basic and $0.53 and $2.10 per ordinary share—diluted, for the three and nine months ended September 30, 2023, respectively.

Previous wording

The decreases in manufacturing and royalty revenues during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to the receipt in June 2023 of back royalties and interest in respect of 2022 U.S. sales of the long-acting INVEGA products, following the successful outcome of the arbitration proceedings related to such products. The decreases in operating expenses during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to decreases of $27.6 million and $15.7 million, respectively, in selling, general and administrative expenses, $8.6 million and $4.7 million, respectively, in research and development expenses and $8.9 million and $16.6 million, respectively, in amortization of acquired intangible assets.

Current wording

The increase in net income from continuing operations during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023, was primarily due to an increase in product sales, net, of $41.2 million and a decrease of $18.4 million in operating expenses, partially offset by a decrease of $44.0 million in manufacturing and royalty revenue and an increase of $16.3 million in the income tax provision. The decrease in net income from continuing operations during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023 was primarily due to a decrease of $256.1 million in manufacturing and royalty revenue and an increase of $42.9 million in the income tax provision, partially offset by a decrease of $56.7 million in operating expenses and an increase of $12.2 million in other income, net. The decreases in manufacturing and royalty revenues were primarily due to the receipt in June 2023 of back royalties and interest in respect of 2022 U.S. sales of the long-acting INVEGA products, following the successful outcome of the arbitration proceedings related to such products.

Previous wording

For a discussion of legal proceedings related to certain of the patents covering INVEGA SUSTENNA and INVEGA TRINZA, see Note 17, Commitments and Contingent Liabilitiesin the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

Current wording

For a discussion of legal proceedings related to certain of the patents covering INVEGA TRINZA, see Note 17, Commitments and Contingent Liabilitiesin the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our

Previous wording

ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (“OX2R”) agonist in development as a once-daily treatment for narcolepsy. Orexin neuropeptides are important regulators of the sleep/wake cycle through OX2R activation, and loss of orexinergic neurons in the brain is associated with excessive daytime sleepiness and cataplexy in narcolepsy. ALKS 2680 was designed to address the underlying pathology of narcolepsy with the goal of improving duration of wakefulness and providing cataplexy control. Once-daily oral administration of ALKS 2680 was evaluated in a phase 1 study in healthy volunteers and patients with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia and is currently being evaluated in our Vibrance-1 phase 2 study in patients with narcolepsy type 1. We expect to initiate Vibrance-2, a phase 2 study in patients with narcolepsy type 2, in the third quarter of 2024.

Current wording

ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (“OX2R”) agonist in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia. 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 narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia and is currently being evaluated in two phase 2 studies. Vibrance-1 in patients with narcolepsy type 1 and Vibrance-2 in patients with narcolepsy type 2. We expect to initiate Vibrance-3, a phase 2 study in patients with idiopathic hypersomnia in 2025.

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 and six months ended June 30, 2024 and 2023:

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 nine months ended September 30, 2024 and 2023:

Previous wording

VIVITROL product sales, gross, increased by 9% and 6% during the three and six months ended June 30, 2024, respectively, as compared to the three and six months ended June 30, 2023, due to increases of 6% and 2%, respectively, in the number of units sold and a 3.2% increase in the selling price that went into effect in January 2024. ARISTADA and ARISTADA INITIO product sales, gross, increased by 4% and 2% during the three and six months ended June 30, 2024, respectively, as compared to the three and six months ended June 30, 2023. The increase in ARISTADA and ARISTADA INITIO during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023, was due to an increase of 2% in the number of units sold and a 3.0% increase in the selling price that went into effect in January 2024. The increase in ARISTADA and ARISTADA INITIO during the six months ended June 30, 2024, as compared to the six months ended June 30, 2023, was primarily due to the January 2024 increase in the selling price. LYBALVI product sales, gross, increased by 57% and 56% during the three and six months ended June 30, 2024, respectively, as compared to the three and six months ended June 30, 2023, due to increases of 52% and 51%, respectively, in the number of units sold and increases in the selling price of 3.8% and 3.0% that went into effect in January 2024 and July 2023, respectively.

Current wording

VIVITROL product sales, gross, increased by 12% and 8% during the three and nine months ended September 30, 2024, respectively, as compared to the three and nine months ended September 30, 2023, due to increases of 9% and 5%, respectively, in the number of units sold and a 3.2% increase in the selling price that went into effect in January 2024. ARISTADA and ARISTADA INITIO product sales, gross, increased by 4% and 3% during the three and nine months ended September 30, 2024, respectively, as compared to the three and nine months ended September 30, 2023. The increase in ARISTADA and ARISTADA INITIO during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023, was due to an increase of 2% in the number of units sold and a 3.0% increase in the selling price that went into effect in January 2024. The increase in ARISTADA and ARISTADA INITIO during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023, was primarily due to the January 2024 increase in the selling price. LYBALVI product sales, gross, increased by 59% and 57% during the three and nine months ended September 30, 2024, respectively, as compared to the three and nine months ended September 30, 2023, due to increases of 50% and 51%, respectively, in the number of units sold and increases in the selling price of 3.8% and 2.0% that went into effect in January 2024 and July 2024, respectively.

Previous wording

The following table compares product sales, net earned during the three and six months ended June 30, 2024 and 2023:

Current wording

The following table compares product sales, net earned during the three and nine months ended September 30, 2024 and 2023:

Previous wording

The following table compares manufacturing and royalty revenues earned during the three and six months ended June 30, 2024 and 2023:

Current wording

The following table compares manufacturing and royalty revenues earned during the three and nine months ended September 30, 2024 and 2023:

Previous wording

The decreases in royalty revenues related to the long-acting INVEGA products during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to the receipt in June 2023 of back royalties of $195.4 million, inclusive of $8.1 million in late-payment interest, related to 2022 U.S. sales of the long-acting INVEGA products following the successful outcome of the arbitration proceedings described above. The decreases were partially offset by increases in royalty revenue related to worldwide net sales of the long-acting INVEGA products. During the three and six months ended June 30, 2024, Janssen’s worldwide net sales of the long-acting INVEGA products were $1,054.0 million and $2,110.0 million, respectively, as compared to $1,031.0 million and $2,075.0 million during the three and six months ended June 30, 2023, respectively.

Current wording

The decrease in royalty revenues related to the long-acting INVEGA products during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023, was primarily due to the expiration of our royalty on net sales in the U.S. of INVEGA SUSTENNA on August 20, 2024. The decrease in royalty revenues related to the long-acting INVEGA products during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023, related to the expiration of the INVEGA SUSTENNA royalty and receipt in June 2023 of back royalties of $195.4 million, inclusive of $8.1 million in late-payment interest, related to 2022 U.S. sales of the long-acting INVEGA products following the successful outcome of the arbitration proceedings described above. The decreases were partially offset by increases in royalty revenue related to worldwide net sales of the long-acting INVEGA products. During the three and nine months ended September 30, 2024, Janssen’s worldwide net sales of the long-acting INVEGA products were $1,049.0 million and $3,159.0 million, respectively, as compared to $1,029.0 million and $3,104.0 million during the three and nine months ended September 30, 2023, respectively.

Previous wording

We expect royalty revenues from net sales of the long-acting INVEGA products to decrease in the near-term, as the royalty revenues related to net sales of INVEGA SUSTENNA are expected to end on August 20, 2024, which we anticipate will have a significant impact on our INVEGA SUSTENNA royalty revenues during 2024. In addition, each of INVEGA SUSTENNA and INVEGA TRINZA are currently subject to Paragraph IV litigation in response to companies seeking to market generic versions of such products. Increased competition from new products or generic versions of these products may lead to reduced unit sales of such products and increased pricing pressure. For a discussion of these legal proceedings, see Note 17, 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 “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

Current wording

We expect royalty revenues from net sales of the long-acting INVEGA products to decrease in the near-term, as the royalty revenues related to net sales of INVEGA SUSTENNA ended on August 20, 2024. 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 17, Commitments and Contingent Liabilitiesin the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to Paragraph IV legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report, and specifically the section entitled “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

Previous wording

We receive a 15% royalty on worldwide net sales of VUMERITY manufactured and packaged by us, subject to increases in such royalty rate for VUMERITY manufactured and/or packaged by Biogen or its designees, in the period that the end-market sales of VUMERITY occur. We also recognize manufacturing revenue related to VUMERITY at cost plus 15%, upon making available bulk batches of VUMERITY to Biogen and, to the extent we package such product, then also when packaged batches of VUMERITY are made available to Biogen. Manufacturing revenue from VUMERITY decreased by $0.5 million and $1.0 million during the three and six months ended June 30, 2024, respectively, as compared to the three and six months ended June 30, 2023. The decreases were primarily due to reductions in the sales price. The reduction in the sales price related to our manufacturing revenue was primarily due to the removal of depreciation expense from the manufacturing cost base as the assets used to manufacture VUMERITY were classified as held for sale and transferred to Novo in connection with the sale of the Athlone Facility in the six months ended June 30, 2024. Royalty revenue related to VUMERITY increased by $3.4 million and $6.4 million during the three and six months ended June 30, 2024, respectively, as compared to the three and six months ended June 30, 2023. The increases in royalty revenue were due to increases in end-market net sales of VUMERITY from $146.2 million and $254.3 million during the three and six months ended June 30, 2023, respectively, to $166.8 million and $293.3 million during the three and six months ended June 30, 2024, respectively.

Current wording

The decrease in VUMERITY revenue in the three months ended September 30, 2024, as compared to the three months ended September 30, 2023, was due to a $1.0 million decrease in manufacturing revenue and a $0.9 million decrease in royalty revenue. The decrease in manufacturing revenue was primarily due to a reduction in the sales price, which was primarily due to the removal of depreciation expense from the manufacturing cost base as the assets used to manufacture VUMERITY were classified as held for sale and transferred to Novo in connection with the sale of the Athlone Facility. The decrease in royalty revenue was due to a decrease in the end-market sales of VUMERITY. The increase in VUMERITY revenue in the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023, was due to an increase in royalty revenue of $5.3 million, due to an increase in end-market sales of VUMERITY, partially offset by a decrease in manufacturing revenue of $2.1 million, primarily due to the reduction in sales price previously discussed.

Previous wording

The decrease in the cost of goods manufactured and sold during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023, was primarily due to a decrease of $2.6 million in the cost of goods manufactured for VIVITROL, primarily due to decreases in costs related to out-of-specification batches and investigation costs, and decreases in the cost of goods manufactured for certain legacy products due to reduced sales of such products. These decreases were partially offset by an increase in the number of units manufactured and sold for VIVITROL, as discussed above, and by an increase of $1.1 million in the cost of goods manufactured for ARISTADA and ARISTADA INITIO, primarily due to an increase in the number of units manufactured and sold, as discussed above.

Current wording

The increases in the cost of goods manufactured and sold during the three and nine months ended September 30, 2024, as compared to the three and nine months ended September 30, 2023, were primarily related to increases in the cost of goods sold for certain of our proprietary products due to increases in the number of units sold as discussed above, and increases in costs related to out-of-specification batches and investigation costs. These increases were partially offset by decreases in the cost of goods manufactured for certain legacy products that we manufacture, due to a decrease in volume of such products.

Previous wording

The following table sets forth our external R&D expenses for the three and six months ended June 30, 2024 and 2023 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 nine months ended September 30, 2024 and 2023 relating to our then-current development programs and our internal R&D expenses, listed by the nature of such expenses:

Previous wording

The increases in expenses related to ALKS 2680 during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to increases in spend related to the advancement of the development program for the product, including completion of our phase 1b proof-of-concept study and activities to prepare for the initiation of our phase 2 clinical studies for the product, the first of which was announced in April 2024 in patients with narcolepsy type 1, and the second of which we expect to initiate in patients with narcolepsy type 2 in the third quarter of 2024. The increases in expenses related to LYBALVI during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to increased spend on the pediatric studies related to the product, partially offset by decreased spend following the completion of the long-term safety and tolerability studies for the product. The decreases in other external R&D expenses during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to disciplined prioritization of R&D spend and activities associated with our research programs.

Current wording

The increases in expenses related to ALKS 2680 during the three and nine months ended September 30, 2024, as compared to the three and nine months ended September 30, 2023, were primarily due to increases in spend related to the advancement of the development program for the product, including completion of our phase 1b proof-of-concept study and initiation of our first two phase 2 clinical studies for the product. The increases in expenses related to LYBALVI during the three and nine months ended September 30, 2024, as compared to the three and nine months ended September 30, 2023, were primarily due to increased spend on the pediatric studies related to the product, partially offset by decreased spend following the completion of the long-term safety and tolerability studies for the product. The decreases in other external R&D expenses during the three and nine months ended September 30, 2024, as compared to the three and nine months ended September 30, 2023, were primarily due to disciplined prioritization of R&D spend and activities associated with our research programs. The decreases in employee-related expenses during the three and nine months ended September 30, 2024, as compared to the three and nine months ended September 30, 2023, were primarily due to a decrease in labor and benefits expense related to a 2% decrease in R&D-related headcount.

Previous wording

The decreases in selling and marketing expense during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to decreases of $15.3 million and $10.6 million, respectively, in marketing expense and decreases of $3.1 million and $1.2 million, respectively, in employee-related expenses. The decreases in marketing expense primarily related to disciplined prioritization of selling and marketing expense, partially offset in the six months ended June 30, 2024 by an increase in marketing expense related to the timing and mix of commercial activities, and the decreases in employee-related expenses were primarily due to decreases in salaries and benefits related to a 7% reduction in sales and marketing headcount.

Current wording

The decreases in selling and marketing expense during the three and nine months ended September 30, 2024, as compared to the three and nine months ended September 30, 2023, were primarily due to decreases of $11.2 million and $21.6 million, respectively, in marketing expense and decreases of $1.7 million and $2.9 million, respectively, in employee-related expenses. The decreases in marketing expense primarily related to disciplined expense prioritization and the decreases in employee-related expenses were primarily due to decreases in salaries and benefits related to an 8% reduction in sales and marketing headcount.

Previous wording

The decreases in general and administrative expense during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to decreases in legal expenses of $9.1 million and $11.1 million, respectively. The decrease during the six months ended June 30, 2024, as compared to the six months ended June 30, 2023, was partially offset by an increase of $2.3 million in employee-related expenses, primarily due to increases in certain payroll-related taxes and in share-based compensation expense related to the vesting of certain performance-based restricted stock unit awards in February 2024, as described in Note 14, Share-based Compensationin the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q.

Current wording

The increase in general and administrative expense during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023, was primarily due to an increase of $2.0 million related to share-based compensation expense and an increase of $1.5 million related to the branded prescription drug fee. The increase in general and administrative expense during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023, was primarily due to an increase of $4.4 million in employee-related expenses due to increases in certain payroll-related taxes and in share-based compensation expense related to the vesting of certain performance-based restricted stock unit awards in February 2024, as described in Note 14, Share-based Compensationin the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q. These increases were partially offset by a $7.9 million decrease in professional service fees, primarily related to a decrease in legal expenses during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023.

Previous wording

Interest income consists primarily of interest earned on our cash and available-for-sale investments. The increases in interest income in the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily related to increases in interest rates, due to the rising interest rate environment. Interest expense consists of interest incurred on our 2026 Term Loans.

Current wording

Interest income consists primarily of interest earned on our cash and available-for-sale investments. The increases in interest income in the three and nine months ended September 30, 2024, as compared to the three and nine months ended September 30, 2023, were primarily related to increases in interest rates, due to the rising interest rate environment. Interest expense consists of interest incurred on our 2026 Term Loans.

Previous wording

The increases in other income (expense), net, during the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023, were primarily due to the gain on the sale of the Athlone Facility of approximately $1.5 million, following the completion of the sale in May 2024.

Current wording

The increase in other income (expense), net, during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023, were primarily due to the gain on the sale of the Athlone Facility of approximately $1.5 million, following the completion of the sale in May 2024.

Previous wording

The income tax provision in the three and six months ended June 30, 2024 were primarily attributable to taxes on income earned in Ireland. The income tax provision in the three and six months ended June 30, 2023 were primarily due to U.S. federal and state taxes on income earned in the U.S.

Current wording

The income tax provisions in the three and nine months ended September 30, 2024, were primarily due to taxes on income earned in Ireland. The income tax provisions in the three and nine months ended September 30, 2023, were primarily due to U.S. federal and state taxes on income earned in the U.S.

Previous wording

We generated $167.1 million and $194.4 million of cash from operating activities during the six months ended June 30, 2024 and 2023, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, such as capital expenditures and principal and interest payments on our long-term debt, for at least the 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 additional financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures. In addition, the 2026 Term Loans have an incremental facility capacity in an amount of $175.0 million, plus additional potential amounts, provided that we meet certain conditions, including a specified leverage ratio.

Current wording

We generated $248.7 million and $294.1 million of cash from operating activities during the nine months ended September 30, 2024 and 2023, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, such as capital expenditures and principal and interest payments on our long-term debt, for at least the 12 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 additional financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures. In addition, the 2026 Term Loans have an incremental facility capacity in an amount of $175.0 million, plus additional potential amounts, provided that we meet certain conditions, including a specified leverage ratio.

Previous wording

We classify available-for-sale investments in an unrealized loss position that do not mature within twelve months as long-term investments. We have the intent and ability to hold these investments until recovery, which may be at maturity, and it is more-likely-than-not that we would not be required to sell these securities before recovery of their amortized cost.

Current wording

We classify available-for-sale investments in an unrealized loss position that do not mature within 12 months as long-term investments. We have the intent and ability to hold these investments until recovery, which may be at maturity, and it is more-likely-than-not that we would not be required to sell these securities before recovery of their amortized cost.

Previous wording

We have no off-balance sheet arrangements that are reasonably likely to have a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources in the next twelve months.

Current wording

We have no off-balance sheet arrangements that are reasonably likely to have a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources in the next 12 months.

Previous wording

In February 2024, we announced approval by our board of directors of the Repurchase Program, as described in Note 13, Shareholders’ Equity in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q. During the three months ended June 30, 2024, we repurchased approximately 3.5 million of our ordinary shares under the Repurchase Program at a total cost of $84.7 million. As of June 30, 2024, the remaining amount authorized under the Repurchase Program was $315.3 million.

Current wording

In February 2024, we announced approval by our board of directors of the Repurchase Program, as described in Note 13, Shareholders’ Equity in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q. During the three months ended September 30, 2024, we repurchased approximately 4.4 million of our ordinary shares under the Repurchase Program at a total cost of $115.3 million, exclusive of any fees, commissions or other expenses related to such repurchases. As of September 30, 2024, the remaining amount authorized under the Repurchase Program was $200.0 million.

Previous wording

Information about our cash flows, by category, is presented in the accompanying 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, 2024 and 2023:

Current wording

Information about our cash flows, by category, is presented in the accompanying 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 nine months ended September 30, 2024 and 2023:

Previous wording

Cash flows provided by operating activities for the six months ended June 30, 2024 were $167.1 million and primarily consisted of net income of $128.2 million, adjusted for non-cash items including share-based compensation of $53.4 million, depreciation and amortization of $14.7 million, deferred income taxes of $21.7 million and gain on the sale of the Athlone Facility of $1.5 million, partially offset by changes in working capital of $51.5 million.

Current wording

Cash flows provided by operating activities for the nine months ended September 30, 2024 were $248.7 million and primarily consisted of net income of $220.6 million, adjusted for non-cash items including share-based compensation of $75.9 million, depreciation and amortization of $21.7 million, deferred income taxes of $32.3 million and gain on the sale of the Athlone Facility of $1.5 million, partially offset by changes in working capital of $105.1 million.

Previous wording

Cash flows provided by operating activities for the six months ended June 30, 2023 were $194.4 million and primarily consisted of net income of $195.2 million, adjusted for non-cash items including share-based compensation of $51.1 million and depreciation and amortization of $37.7 million, partially offset by changes in working capital of $52.2 million and deferred income taxes of $38.1 million. During the six months ended June 30, 2023, net income included receipt of $195.4 million from Janssen, inclusive of $8.1 million in late-payment interest, related to 2022 U.S. net sales of the long-acting INVEGA products following the successful outcome of the arbitration proceedings in respect of such products.

Current wording

Cash flows provided by operating activities for the nine months ended September 30, 2023 were $294.1 million and primarily consisted of net income of $243.0 million, adjusted for non-cash items including share-based compensation of $75.1 million and depreciation and amortization of $56.4 million, partially offset by changes in working capital of $34.3 million and deferred income taxes of $47.4 million. During the nine months ended September 30, 2023, net income included receipt of $195.4 million from Janssen, inclusive of $8.1 million in late-payment interest, related to 2022 U.S. net sales of the long-acting INVEGA products following the successful outcome of the arbitration proceedings in respect of such products.

Previous wording

Cash flows provided by investing activities for the six months ended June 30, 2024 were primarily due to proceeds related to the sale of the Athlone Facility of approximately $97.9 million, 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. Cash flows provided by investing activities for the six months ended June 30, 2023 were primarily due to $210.3 million in net sales of investments, offset by the purchase of $16.6 million of property, plant and equipment.

Current wording

Cash flows used in investing activities for the nine months ended September 30, 2024 were primarily due to $172.1 million in net purchases of investments and $23.7 million in the purchase of property, plant and equipment, partially offset by proceeds related to the sale of the Athlone Facility of approximately $97.9 million, which included a payment of approximately $91.0 million for the facility and certain related assets. Cash flows provided by investing activities for the nine months ended September 30, 2023 were primarily due to $105.4 million in net sales of investments, offset by the purchase of $31.0 million of property, plant and equipment.

Previous wording

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. Cash flows used in financing activities for the six months ended June 30, 2023 primarily related to $25.3 million of employee taxes paid related to the net share settlement of equity awards, partially offset by $12.0 million of cash that we received upon exercises of employee stock options.

Current wording

Cash flows used in financing activities for the nine months ended September 30, 2024 primarily related to $200.0 million (exclusive of any fees, commissions or other related expenses) used to repurchase our ordinary shares under the Repurchase Program and $29.3 million of employee taxes paid related to the net share settlement of equity awards, partially offset by $19.4 million of cash that we received upon exercises of employee stock options. Cash flows used in financing activities for the nine months ended September 30, 2023 primarily related to $26.1 million of employee taxes paid related to the net share settlement of equity awards, partially offset by $15.1 million of cash that we received upon exercises of employee stock options.

Previous wording

At June 30, 2024, the principal balance of our borrowings consisted of $290.3 million outstanding under our 2026 Term Loans. See Note 12, Long-Term Debt in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for further discussion of our 2026 Term Loans.

Current wording

At September 30, 2024, the principal balance of our borrowings consisted of $289.5 million outstanding under our 2026 Term Loans. See Note 12, Long-Term Debt in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for further discussion of our 2026 Term Loans.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Annual Report and specifically the section entitled “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

The decrease in the cost of goods manufactured and sold during the six months ended June 30, 2024, as compared to the six months ended June 30, 2023, was primarily due to decreases in the cost of goods manufactured for certain legacy products due to a decrease in sales of such products, as discussed above, partially offset by an increase of $1.3 million in the cost of goods manufactured for VIVITROL, primarily due to an increase in the number of units manufactured and sold, as discussed above.