Alkermes(ALKS) - 2024 Q3 - Quarterly Report

PART I - FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements This section presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and shareholders' equity, with detailed notes on accounting policies, discontinued operations, revenue, and investments for Q3 2024 and 2023 Condensed Consolidated Balance Sheets The balance sheets show an increase in total assets and shareholders' equity, with a decrease in total liabilities from December 31, 2023, to September 30, 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2024 | Dec 31, 2023 | | :-------------------------- | :----------- | :----------- | | Total Assets | $2,155,291 | $2,136,223 | | Total Liabilities | $863,185 | $933,537 | | Total Shareholders' Equity | $1,292,106 | $1,202,686 | | Cash and cash equivalents | $396,293 | $457,469 | | Investments—short-term | $512,571 | $316,022 | | Assets held for sale | — | $94,260 | Condensed Consolidated Statements of Operations and Comprehensive Income Total revenues showed mixed performance, decreasing for the three months but increasing for the nine months ended September 30, 2024, with net income from continuing operations increasing for the three-month period but decreasing for the nine-month period Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :-------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total Revenues | $378,143 | $380,938 | $1,127,646 | $1,285,930 | | Operating Income from Continuing Ops | $104,756 | $89,194 | $257,948 | $359,491 | | Net Income from Continuing Ops | $92,795 | $91,554 | $226,401 | $358,605 | | Loss from Discontinued Ops, Net of Tax | $(414) | $(43,796) | $(5,834) | $(115,627) | | Net Income | $92,381 | $47,758 | $220,567 | $242,978 | | Basic EPS from Continuing Ops | $0.57 | $0.55 | $1.36 | $2.16 | | Diluted EPS from Continuing Ops | $0.56 | $0.53 | $1.33 | $2.10 | Condensed Consolidated Statements of Cash Flows Operating cash flows decreased, while investing activities shifted to cash usage due to investment purchases and capital expenditures, and financing activities significantly increased cash usage due to share repurchases for the nine months ended September 30, 2024 Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :-------------------------------------- | :-------------------------- | :-------------------------- | | Net Income | $220,567 | $242,978 | | Cash flows provided by operating activities | $248,727 | $294,116 | | Cash flows (used in) provided by investing activities | $(97,433) | $74,339 | | Cash flows used in financing activities | $(212,470) | $(13,217) | | Net (Decrease) Increase in Cash and Cash Equivalents | $(61,176) | $355,238 | | Cash and Cash Equivalents—End of period | $396,293 | $647,711 | Condensed Consolidated Statements of Shareholders' Equity Shareholders' equity increased from December 31, 2023, to September 30, 2024, driven by net income and additional paid-in capital, despite significant share repurchases Shareholders' Equity Changes (in thousands) | Metric | Dec 31, 2023 | Sep 30, 2024 | | :-------------------------- | :----------- | :----------- | | Ordinary Shares (Amount) | $1,726 | $1,763 | | Treasury Shares (Amount) | $(189,336) | $(418,911) | | Additional Paid-In Capital | $2,736,934 | $2,831,790 | | Accumulated Deficit | $(1,343,528) | $(1,122,961) | | Total Shareholders' Equity | $1,202,686 | $1,292,106 | Notes to Condensed Consolidated Financial Statements These notes provide detailed explanations and disclosures for the condensed consolidated financial statements, covering operations, accounting policies, discontinued operations, revenue, investments, fair value, inventory, PPE, intangibles, leases, liabilities, debt, equity, share-based compensation, EPS, income taxes, and contingencies 1. The Company Alkermes plc is a global biopharmaceutical company focused on neuroscience, with commercial products for dependence, schizophrenia, and bipolar I disorder, and a pipeline for neurological disorders, having sold its Athlone Facility in May 2024 for $97.9 million, recording a $1.5 million gain - Alkermes plc is a global biopharmaceutical company specializing in neuroscience, with commercial products for alcohol/opioid dependence, schizophrenia, and bipolar I disorder, and a pipeline for neurological disorders[21] - The company completed the sale of its Athlone Facility in May 2024, receiving approximately $97.9 million and recording a gain of approximately $1.5 million[22] 2. Summary of Significant Accounting Policies The unaudited financial statements are prepared consistently with prior periods, reflecting management's estimates; the company operates as a single segment, early adopted ASU 2023-07 with no material impact, and is evaluating ASU 2023-09 - The company operates as one business segment, focusing on developing, manufacturing, and commercializing medicines for unmet medical needs in major therapeutic areas[29] - The company early adopted ASU 2023-07 (Segment Reporting) for fiscal years beginning after December 15, 2023, and determined it had no material impact on its consolidated financial statements[31] - The company is currently evaluating the impact of ASU 2023-09 (Income Taxes), effective for annual periods beginning after December 15, 2024[32] 3. Discontinued Operations The company completed the tax-free separation of its oncology business into Mural Oncology plc in November 2023, classifying it as discontinued operations, involving asset and liability transfers and post-separation agreements - On November 15, 2023, Alkermes completed the separation of its oncology business into Mural Oncology plc, an independent publicly-traded company, by distributing Mural shares to Alkermes shareholders[34] Net Assets Transferred to Mural Oncology (in thousands) | Category | Amount | | :------------------------ | :---------- | | Total Assets Transferred | $309,208 | | Total Liabilities Transferred | $15,448 | | Net Assets Transferred | $293,760 | Loss from Discontinued Operations (in thousands) | Period | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total Operating Expenses | $481 | $45,346 | $6,910 | $123,944 | | Income Tax Benefit | $(67) | $(1,550) | $(1,076) | $(8,317) | | Net Loss | $(414) | $(43,796) | $(5,834) | $(115,627) | 4. Revenue from Contracts with Customers Product sales, net, increased for both three and nine months ended September 30, 2024, driven by LYBALVI, VIVITROL, and ARISTADA, while manufacturing and royalty revenues significantly decreased due to INVEGA SUSTENNA royalty expiration and prior-year back royalties Product Sales, Net (in thousands) | Product | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | VIVITROL | $113,650 | $99,305 | $323,182 | $298,035 | | ARISTADA and ARISTADA INITIO | $84,652 | $81,834 | $249,571 | $244,320 | | LYBALVI | $74,697 | $50,683 | $203,055 | $135,671 | | Total Product Sales, Net | $272,999 | $231,822 | $775,808 | $678,026 | Manufacturing and Royalty Revenues (in thousands) | Revenue Source | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Long-acting INVEGA products | $58,448 | $76,109 | $199,860 | $410,910 | | VUMERITY | $32,574 | $34,561 | $99,062 | $95,730 | | Other | $14,122 | $38,443 | $52,913 | $101,248 | | Total Manufacturing and Royalty Revenues | $105,144 | $149,113 | $351,835 | $607,888 | Contract Assets and Liabilities (in thousands) | Metric | Sep 30, 2024 | Dec 31, 2023 | | :------------------------ | :----------- | :----------- | | Contract Assets | $2,969 | $706 | | Contract Liabilities | $2,339 | $4,775 | 5. Investments The company's investment portfolio, primarily in U.S. government and corporate debt securities, significantly increased from December 31, 2023, to September 30, 2024, with some unrealized losses due to rising interest rates, which the company intends to hold until recovery Investment Portfolio Composition (in thousands) | Investment Type | Sep 30, 2024 Estimated Fair Value | Dec 31, 2023 Estimated Fair Value | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Short-term U.S. government and agency debt securities | $306,279 | $199,819 | | Short-term Corporate debt securities | $206,292 | $112,207 | | Long-term U.S. government and agency debt securities | $12,560 | $19,050 | | Long-term Corporate debt securities | $6,215 | $19,017 | | Total Investments | $531,491 | $355,909 | - At September 30, 2024, 49 of 308 investment securities were in an unrealized loss position with an aggregate estimated fair value of $72.1 million, primarily due to fixed-rate securities acquired in a rising interest rate environment, and the company has the intent and ability to hold these investments until recovery[49] Realized Gains and Losses on Investments (in thousands) | Metric | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :-------------- | :-------------------------- | :-------------------------- | | Proceeds from sales and maturities | $224,786 | $291,944 | | Realized Gains | — | — | | Realized Losses | — | — | 6. Fair Value The company measures certain assets, primarily cash equivalents and debt securities, at fair value using Level 1 and Level 2 inputs, with no Level 3 investments or transfers between levels during the nine months ended September 30, 2024 Fair Value Hierarchy of Assets (in thousands) | Asset Category | Sep 30, 2024 Total Fair Value | Level 1 | Level 2 | Level 3 | | :---------------------------------- | :---------------------------- | :------ | :------ | :------ | | Cash equivalents | $156,976 | $156,976 | — | — | | U.S. government and agency debt securities | $318,839 | $266,392 | $52,447 | — | | Corporate debt securities | $212,507 | — | $212,507 | — | | Total | $688,322 | $423,368 | $264,954 | — | - There were no transfers of any securities between fair value levels during the nine months ended September 30, 2024, and no investments were determined using Level 3 inputs[53] 7. Inventory Total inventory slightly increased from December 31, 2023, to September 30, 2024, driven by raw materials and work in process, while finished goods decreased Inventory Composition (in thousands) | Inventory Category | Sep 30, 2024 | Dec 31, 2023 | | :----------------- | :----------- | :----------- | | Raw materials | $78,341 | $71,416 | | Work in process | $77,006 | $68,843 | | Finished goods | $35,740 | $46,147 | | Total Inventory | $191,087 | $186,406 | 8. Property, Plant and Equipment Net property, plant and equipment remained stable, with increased construction in progress and decreased accumulated depreciation from December 31, 2023, to September 30, 2024 Property, Plant and Equipment (in thousands) | Category | Sep 30, 2024 | Dec 31, 2023 | | :-------------------------------- | :----------- | :----------- | | Land | $957 | $957 | | Building and improvements | $134,315 | $132,735 | | Furniture, fixtures and equipment | $246,188 | $237,728 | | Leasehold improvements | $40,114 | $39,893 | | Construction in progress | $52,918 | $45,791 | | Less: accumulated depreciation | $(249,070) | $(230,161) | | Total Property, Plant and Equipment, Net | $225,422 | $226,943 | 9. Intangible Assets and Goodwill Goodwill remained at $83.0 million, while finite-lived intangible assets, primarily capitalized IP, had a net carrying amount of $0.9 million as of September 30, 2024 Intangible Assets and Goodwill (in thousands) | Category | Sep 30, 2024 Net Carrying Amount | | :---------------------------- | :------------------------------- | | Goodwill | $83,027 | | Finite-lived intangible assets: | | | Collaboration agreements | — | | Capitalized IP | $904 | | Total | $904 | 10. Leases Total operating lease liabilities were $77.2 million as of September 30, 2024, with a 7.5-year weighted average remaining lease term and a 4.1% incremental borrowing rate, while cash paid for lease liabilities and operating lease expense decreased for the nine months ended September 30, 2024 Future Lease Payments (in thousands) | Year | Total Operating Lease Payments | | :-------- | :----------------------------- | | 2024 | $2,547 | | 2025 | $10,262 | | 2026 | $10,333 | | 2027 | $9,510 | | 2028 | $9,574 | | Thereafter | $59,695 | | Total | $101,921 | | Less: imputed interest | $(24,741) | | Total Operating Lease Liabilities | $77,180 | - At September 30, 2024, the weighted average incremental borrowing rate for operating leases was 4.1%, and the weighted average remaining lease term was 7.5 years[58] Lease-Related Cash Flows and Expenses (in thousands) | Metric | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Cash paid for lease liabilities | $2,500 | $2,500 | $7,600 | $7,800 | | Operating lease expense | $1,800 | $2,800 | $5,400 | $8,400 | 11. Accounts Payable and Accrued Expenses Total accounts payable and accrued expenses significantly decreased from December 31, 2023, to September 30, 2024, primarily due to reductions in accounts payable, accrued compensation, and other accrued expenses, despite an increase in accrued sales discounts, allowances, and reserves Accounts Payable and Accrued Expenses (in thousands) | Category | Sep 30, 2024 | Dec 31, 2023 | | :-------------------------------- | :----------- | :----------- | | Accounts payable | $37,037 | $65,649 | | Accrued compensation | $55,904 | $83,107 | | Accrued other | $67,257 | $91,805 | | Total Accounts Payable and Accrued Expenses | $160,198 | $240,561 | Accrued Sales Discounts, Allowances and Reserves (in thousands) | Category | Sep 30, 2024 | Dec 31, 2023 | | :-------------------------------- | :----------- | :----------- | | Medicaid rebates | $223,007 | $213,845 | | Product discounts | $15,528 | $15,121 | | Medicare Part D | $24,073 | $20,569 | | Other | $19,410 | $14,106 | | Total Accrued Sales Discounts, Allowances and Reserves | $282,018 | $263,641 | 12. Long-Term Debt The company's long-term debt, primarily 2026 Term Loans, had a principal balance of $288.8 million as of September 30, 2024, with the company in compliance with its debt covenants Long-Term Debt (in thousands) | Debt Category | Sep 30, 2024 | Dec 31, 2023 | | :-------------------------------- | :----------- | :----------- | | 2026 Term Loans, due March 12, 2026 | $288,823 | $290,730 | | Less: current portion | $(3,000) | $(3,000) | | Long-term debt | $285,823 | $287,730 | - The 2026 Term Loans bear interest at the Secured Overnight Financing Rate plus a credit spread adjustment and an applicable margin of 2.50% with a floor of 0.50%[62] - The company was in compliance with its debt covenants at September 30, 2024[62] 13. Shareholders' Equity In February 2024, the company approved a new $400.0 million share repurchase program, under which approximately 7.9 million shares were repurchased for $200.0 million during the nine months ended September 30, 2024, with $200.0 million remaining authorized - In February 2024, the company approved a new share repurchase program authorizing up to $400.0 million[62] Share Repurchase Program Activity (9 Months Ended Sep 30, 2024) | Metric | Amount | | :------------------------------------ | :----------- | | Shares Repurchased | 7.9 million | | Total Cost (exclusive of fees) | $200.0 million | | Average Purchase Price per Share | $25.33 | | Remaining Authorized under Program | $200.0 million | | Shares Repurchased (3 Months Ended Sep 30, 2024) | 4.4 million | | Total Cost (3 Months Ended Sep 30, 2024) | $115.3 million | | Average Purchase Price per Share (3 Months Ended Sep 30, 2024) | $26.22 | 14. Share-Based Compensation Total share-based compensation expense from continuing operations increased for both three and nine months ended September 30, 2024, partly due to a $6.8 million modification charge and a $2.6 million incremental expense from achieving performance criteria for restricted stock unit awards in February 2024 Share-Based Compensation Expense (in thousands) | Category | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :-------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Share-based compensation expense from continuing operations | $22,533 | $21,733 | $75,889 | $69,943 | | Share-based compensation expense from discontinued operations | — | $2,182 | — | $5,119 | | Total share-based compensation expense | $22,533 | $23,915 | $75,889 | $75,062 | - In February 2024, a modification charge of approximately $6.8 million was recognized due to partial achievement of financial performance criteria for performance-based restricted stock unit awards[65] - An additional $2.6 million incremental share-based compensation expense was recognized in February 2024 due to the achievement of pipeline performance criteria for these awards[65] 15. Earnings (Loss) Per Ordinary Share Basic and diluted EPS from continuing operations increased for the three months but decreased for the nine months ended September 30, 2024, compared to the prior year, with calculations including dilutive securities like stock options and restricted stock unit awards Earnings (Loss) Per Ordinary Share (in thousands, except per share amounts) | Metric | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :-------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net income from continuing operations | $92,795 | $91,554 | $226,401 | $358,605 | | Weighted average number of ordinary shares outstanding (Basic) | 163,368 | 166,607 | 166,546 | 165,996 | | Dilutive ordinary share equivalents | 3,657 | 5,296 | 3,650 | 4,985 | | Shares used in calculating diluted EPS | 167,025 | 171,903 | 170,196 | 170,981 | Anti-Dilutive Potential Ordinary Share Equivalents (in thousands) | Category | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Stock options | 11,047 | 12,029 | 12,311 | 12,422 | | Restricted stock unit awards | 1,276 | 1,317 | 2,401 | 2,389 | | Total | 12,323 | 13,346 | 14,712 | 14,811 | 16. Income Taxes Income tax provisions significantly increased for both three and nine months ended September 30, 2024, primarily due to Irish income taxes, resulting in a 17.3% effective tax rate for the nine months, exceeding the 12.5% Irish statutory rate, with no material impact expected from Pillar Two Income Tax Provision (in millions) | Period | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Income tax provision | $17.4 | $1.2 | $47.5 | $4.6 | - The income tax provisions for the three and nine months ended September 30, 2024, were primarily due to taxes on income earned in Ireland[69] - The effective tax rate for the nine months ended September 30, 2024, was 17.3%, exceeding the Irish statutory tax rate of 12.5% due to non-deductible expenses and income taxable at higher rates, with the global minimum tax rate (Pillar Two) not expected to have a material impact for the current year[70] 17. Commitments and Contingent Liabilities The company is involved in various legal proceedings, including patent infringement lawsuits for INVEGA TRINZA and VUMERITY, a VIVITROL product liability case, government investigations, and an arbitration appeal with Acorda Therapeutics, while also maintaining a guarantee for the 852 Winter Street Lease assigned to Mural US - The company is involved in a patent infringement lawsuit regarding INVEGA TRINZA, initiated by Janssen entities against Mylan Labs, with an appeal pending[72] - A patent infringement lawsuit was filed against Zydus concerning VUMERITY, triggering a 30-month stay of FDA approval for a generic version, with a bench trial scheduled for July 28, 2025[73] - The company is cooperating with U.S. state and federal governmental investigations related to VIVITROL and is defending a product liability case alleging VIVITROL caused opioid overdose and death[74][75] - An appeal by Acorda Therapeutics regarding an arbitral award is pending decision in the Federal Circuit Court[76] - The company ratified its guarantor obligations for the 852 Winter Street Lease, which was assigned to Mural US, with the guarantee's fair value not material at September 30, 2024[77] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on financial performance, condition, and results of operations, highlighting key drivers of revenue and expense changes, product performance, liquidity, the impact of the oncology business separation, and future outlook Executive Summary Net income from continuing operations increased for the three months ended September 30, 2024, due to higher product sales and lower operating expenses, but decreased for the nine-month period due to a significant drop in manufacturing and royalty revenue and increased income tax provision Net Income from Continuing Operations (in millions) | Period | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net Income from Continuing Operations | $92.8 | $91.6 | $226.4 | $358.6 | | Basic EPS from Continuing Operations | $0.57 | $0.55 | $1.36 | $2.16 | | Diluted EPS from Continuing Operations | $0.56 | $0.53 | $1.33 | $2.10 | - The increase in net income from continuing operations for the three months ended September 30, 2024, was primarily due to a $41.2 million increase in product sales, net, and an $18.4 million decrease in operating expenses, partially offset by a $44.0 million decrease in manufacturing and royalty revenue and a $16.3 million increase in income tax provision[80] - The decrease in net income from continuing operations for the nine months ended September 30, 2024, was primarily due to a $256.1 million decrease in manufacturing and royalty revenue (driven by 2023 back royalties from INVEGA products) and a $42.9 million increase in income tax provision, partially offset by a $56.7 million decrease in operating expenses and a $12.2 million increase in other income, net[80] Products Alkermes commercializes proprietary products like ARISTADA, LYBALVI, and VIVITROL for U.S. neuroscience disorders, and licenses technologies for third-party products such as the INVEGA family and VUMERITY globally, with its key development program, ALKS 2680, in Phase 2 studies for narcolepsy and idiopathic hypersomnia - Alkermes' proprietary commercial products include ARISTADA (schizophrenia), LYBALVI (schizophrenia, bipolar I disorder), and VIVITROL (alcohol and opioid dependence), all exclusively manufactured and commercialized in the U.S[85][90][91] - Key third-party products using Alkermes' proprietary technologies include the long-acting INVEGA products (INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI) for schizophrenia, commercialized worldwide by Janssen[86][92][93] - VUMERITY, a licensed product for multiple sclerosis, is commercialized worldwide by Biogen[87][95] - ALKS 2680, a novel, investigational, oral, selective orexin 2 receptor agonist, is in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia, currently being evaluated in two Phase 2 studies (Vibrance-1 and Vibrance-2), with Vibrance-3 planned for 2025[97] Results of Operations The company's results show increased product sales from volume and price increases, while manufacturing and royalty revenues declined due to INVEGA SUSTENNA royalty expiration and prior-year arbitration proceeds; operating expenses saw mixed changes, with R&D increasing for ALKS 2680 but decreasing overall, and SG&A decreasing due to marketing and headcount reductions Product Sales, Net Product sales, net, increased by $41.3 million (17.8%) for the three months and $97.9 million (14.4%) for the nine months ended September 30, 2024, driven by increased unit sales and selling price adjustments across VIVITROL, ARISTADA, and LYBALVI Product Sales, Net (in millions) | Product | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | Change | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | Change | | :------------------------ | :-------------------------- | :-------------------------- | :----- | :-------------------------- | :-------------------------- | :----- | | VIVITROL | $113.7 | $99.3 | $14.4 | $323.2 | $298.0 | $25.2 | | ARISTADA and ARISTADA INITIO | $84.7 | $81.8 | $2.9 | $249.6 | $244.3 | $5.3 | | LYBALVI | $74.7 | $50.7 | $24.0 | $203.1 | $135.7 | $67.4 | | Total Product Sales, Net | $273.0 | $231.8 | $41.3 | $775.8 | $678.0 | $97.9 | - VIVITROL product sales, gross, increased by 12% (3 months) and 8% (9 months) due to increases in units sold (9% and 5%) and a 3.2% price increase in January 2024[99] - LYBALVI product sales, gross, increased by 59% (3 months) and 57% (9 months) due to increases in units sold (50% and 51%) and price increases of 3.8% (Jan 2024) and 2.0% (Jul 2024)[99] Manufacturing and Royalty Revenues Manufacturing and royalty revenues decreased by $44.0 million (29.5%) for the three months and $256.1 million (42.1%) for the nine months ended September 30, 2024, primarily due to the expiration of INVEGA SUSTENNA royalties and the non-recurring $195.4 million in back royalties received in June 2023 Manufacturing and Royalty Revenues (in millions) | Revenue Source | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | Change | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | Change | | :------------------------ | :-------------------------- | :-------------------------- | :-------- | :-------------------------- | :-------------------------- | :---------- | | Long-acting INVEGA products | $58.5 | $76.1 | $(17.6) | $199.9 | $410.9 | $(211.0) | | VUMERITY | $32.6 | $34.5 | $(1.9) | $99.1 | $95.7 | $3.4 | | Other | $14.0 | $38.5 | $(24.5) | $52.8 | $101.3 | $(48.5) | | Total Manufacturing and Royalty Revenues | $105.1 | $149.1 | $(44.0) | $351.8 | $607.9 | $(256.1) | - The decrease in INVEGA royalty revenues was primarily due to the expiration of royalties on U.S. net sales of INVEGA SUSTENNA on August 20, 2024, and the receipt of $195.4 million in back royalties in June 2023 related to 2022 U.S. sales[104] - Royalty revenues from net sales of long-acting INVEGA products are expected to decrease in the near-term due to the INVEGA SUSTENNA royalty expiration and potential generic competition[105] Costs and Expenses Total expenses decreased for both three and nine months ended September 30, 2024, with a slight increase in cost of goods manufactured and sold, while R&D expenses decreased due to prioritization and headcount reduction, and SG&A expenses also decreased due to lower marketing spend and headcount, partially offset by increases in general and administrative expenses Cost of Goods Manufactured and Sold Cost of goods manufactured and sold increased slightly by $1.6 million (2.6%) for the three months and $0.3 million (0.2%) for the nine months ended September 30, 2024, primarily due to higher proprietary product sales volumes and increased costs from out-of-specification batches Cost of Goods Manufactured and Sold (in millions) | Metric | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | Change | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :----- | :-------------------------- | :-------------------------- | :----- | | Cost of goods manufactured and sold | $63.1 | $61.5 | $1.6 | $183.2 | $182.9 | $0.3 | - Increases were primarily related to higher cost of goods sold for proprietary products due to increased units sold and costs from out-of-specification batches and investigations, partially offset by decreased manufacturing costs for certain legacy products[108] Research and Development Expenses Total R&D expenses decreased by $5.1 million (7.9%) for the three months and $9.8 million (5.0%) for the nine months ended September 30, 2024, driven by increased ALKS 2680 and LYBALVI pediatric study spending, offset by decreases in other external R&D and internal employee-related expenses due to headcount reduction Research and Development Expenses (in millions) | Category | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | Change | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------- | :-------------------------- | :-------------------------- | :-------- | | External R&D expenses: | | | | | | | | ALKS 2680 | $11.9 | $5.5 | $6.4 | $34.9 | $17.8 | $17.1 | | LYBALVI | $5.5 | $4.2 | $1.3 | $14.3 | $10.8 | $3.5 | | Other external R&D expenses | $8.6 | $11.4 | $(2.8) | $27.4 | $37.7 | $(10.3) | | Total external R&D expenses | $26.0 | $21.1 | $4.9 | $76.6 | $66.3 | $10.3 | | Internal R&D expenses: | | | | | | | | Employee-related | $26.8 | $32.6 | $(5.8) | $87.6 | $96.8 | $(9.2) | | Total internal R&D expenses | $33.8 | $43.8 | $(10.0) | $110.5 | $130.6 | $(20.1) | | Total Research and development expenses | $59.8 | $64.9 | $(5.1) | $187.1 | $196.9 | $(9.8) | - Increased expenses for ALKS 2680 were due to advancement of the development program, including completion of a phase 1b study and initiation of two phase 2 clinical studies[110] - Decreases in employee-related expenses were primarily due to a 2% decrease in R&D-related headcount[110] Selling, General and Administrative Expense Selling, general and administrative (SG&A) expense decreased by $6.1 million (3.9%) for the three months and $21.8 million (4.2%) for the nine months ended September 30, 2024, primarily due to reduced marketing expenses and an 8% reduction in sales and marketing headcount, partially offset by increases in general and administrative expenses related to share-based compensation and branded prescription drug fees Selling, General and Administrative Expense (in millions) | Category | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | Change | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------- | :-------------------------- | :-------------------------- | :-------- | | Selling and marketing expense | $102.1 | $114.8 | $(12.7) | $347.4 | $371.2 | $(23.8) | | General and administrative expense | $48.2 | $41.6 | $6.6 | $150.8 | $148.8 | $2.0 | | Total Selling, General and Administrative expense | $150.3 | $156.4 | $(6.1) | $498.2 | $520.0 | $(21.8) | - Decreases in selling and marketing expense were primarily due to $11.2 million (3 months) and $21.6 million (9 months) reductions in marketing expense and decreases in employee-related expenses due to an 8% reduction in sales and marketing headcount[112] - The increase in general and administrative expense for the three months was due to a $2.0 million increase in share-based compensation and a $1.5 million increase in the branded prescription drug fee; for the nine months, it was due to a $4.4 million increase in employee-related expenses (payroll taxes, share-based compensation), partially offset by a $7.9 million decrease in professional service fees[113] Other Income, Net Total other income, net, increased by $2.0 million (57.1%) for the three months and $12.2 million (329.7%) for the nine months ended September 30, 2024, primarily driven by higher interest income due to rising interest rates and a $1.5 million gain from the Athlone Facility sale Other Income, Net (in millions) | Category | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | Change | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | Change | | :------------------------ | :-------------------------- | :-------------------------- | :----- | :-------------------------- | :-------------------------- | :----- | | Interest income | $10.9 | $9.4 | $1.5 | $31.0 | $21.1 | $9.9 | | Interest expense | $(6.0) | $(6.0) | — | $(17.9) | $(17.0) | $(0.9) | | Other income (expense), net | $0.6 | $0.1 | $0.5 | $2.8 | $(0.4) | $3.2 | | Total Other Income, Net | $5.5 | $3.5 | $2.0 | $15.9 | $3.7 | $12.2 | - Increases in interest income were primarily related to rising interest rates[115] - The increase in other income (expense), net, for the nine months was primarily due to a $1.5 million gain on the sale of the Athlone Facility[115] Income Tax Provision Income tax provisions significantly increased for both three and nine months ended September 30, 2024, primarily due to taxes on income earned in Ireland, contrasting with prior year's provisions mainly from U.S. federal and state taxes Income Tax Provision (in millions) | Period | 3 Months Ended Sep 30, 2024 | 3 Months Ended Sep 30, 2023 | Change | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | Change | | :------------------------ | :-------------------------- | :-------------------------- | :----- | :-------------------------- | :-------------------------- | :----- | | Income tax provision | $17.4 | $1.2 | $16.2 | $47.5 | $4.6 | $42.9 | - Income tax provisions for the three and nine months ended September 30, 2024, were primarily due to taxes on income earned in Ireland[116] Liquidity and Financial Condition Total cash and investments increased to $927.8 million as of September 30, 2024; operating activities generated $248.7 million, while investing activities used $97.4 million and financing activities used $212.5 million, largely due to share repurchases, with sufficient liquidity expected for the next 12 months Cash and Investments (in millions) | Category | Sep 30, 2024 | Dec 31, 2023 | | :------------------------ | :----------- | :----------- | | Cash and cash equivalents | $396.3 | $457.5 | | Investments—short-term | $512.6 | $316.0 | | Investments—long-term | $18.9 | $39.9 | | Total Cash and Investments | $927.8 | $813.4 | | Outstanding borrowings—short and long-term | $288.8 | $290.7 | Summary of Cash Flows (in millions) | Cash Flow Category | 9 Months Ended Sep 30, 2024 | 9 Months Ended Sep 30, 2023 | | :-------------------------------------- | :-------------------------- | :-------------------------- | | Cash flows provided by operating activities | $248.7 | $294.1 | | Cash flows (used in) provided by investing activities | $(97.4) | $74.3 | | Cash flows used in financing activities | $(212.5) | $(13.2) | | Net (Decrease) Increase in Cash and Cash Equivalents | $(61.2) | $355.2 | | Cash and cash equivalents, end of period | $396.3 | $647.7 | - Cash flows used in financing activities for the nine months ended September 30, 2024, primarily related to $200.0 million used to repurchase ordinary shares under the Repurchase Program[127] - The company expects existing cash, cash equivalents, and investments to be sufficient to finance anticipated working capital and other cash requirements for at least the next 12 months[120] Critical Accounting Estimates This section refers to the discussion of critical accounting estimates in the company's Annual Report on Form 10-K for the year ended December 31, 2023 New Accounting Standards This section refers to the discussion of new accounting pronouncements in Note 2, Summary of Significant Accounting Policies, within the Notes to Condensed Consolidated Financial Statements Item 3. Quantitative and Qualitative Disclosures about Market Risk The company's market risks, primarily related to its investment portfolio and non-U.S. currency exchange rates, have not materially changed since December 31, 2023, and are managed through portfolio diversification and currency monitoring - No material changes to market risks related to the investment portfolio or management's objectives and strategies have occurred since December 31, 2023[130] - The company is exposed to non-U.S. currency exchange risk from manufacturing and royalty revenues, partially offset by Irish operating costs settled in Euro[131] Item 4. Controls and Procedures Management, including the principal executive and interim principal financial officers, concluded that the company's disclosure controls and procedures were effective as of September 30, 2024, with no material changes in internal control over financial reporting during the quarter a) Evaluation of Disclosure Controls and Procedures%20Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, including the principal executive and interim principal financial officers, concluded that disclosure controls and procedures were effective as of September 30, 2024, ensuring reasonable assurance for timely and accurate reporting - Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2024, providing reasonable assurance for timely and accurate reporting of information[132] b) Change in Internal Control Over Financial Reporting%20Change%20in%20Internal%20Control%20Over%20Financial%20Reporting) No material changes in the company's internal control over financial reporting occurred during the three months ended September 30, 2024 - No material changes in internal control over financial reporting occurred during the three months ended September 30, 2024[133] PART II - OTHER INFORMATION Item 1. Legal Proceedings This section incorporates by reference the discussion of legal proceedings from Note 17, Commitments and Contingent Liabilities, in the Notes to Condensed Consolidated Financial Statements Item 1A. Risk Factors This section refers to the discussion of risk factors in the company's Annual Report on Form 10-K for the year ended December 31, 2023 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds During the three months ended September 30, 2024, the company repurchased over 4.4 million ordinary shares under its publicly announced Repurchase Program at an average price of $26.22 per share, with $200.0 million remaining authorized Ordinary Share Purchases (Three Months Ended Sep 30, 2024) | Period | Total Number of Ordinary Shares Purchased | Average Price Paid per Ordinary Share | Total Number of Ordinary Shares Purchased as Part of Publicly Announced Program | Maximum Dollar Value that May Yet Be Purchased Under the Program | | :-------------------------- | :---------------------------------------- | :------------------------------------ | :-------------------------------------------------------------- | :--------------------------------------------------------------- | | July 1, 2024 – July 31, 2024 | 1,857,101 | $24.83 | 1,854,375 | $269.3 million | | August 1, 2024 – August 31, 2024 | 1,668,522 | $27.09 | 1,664,844 | $224.2 million | | September 1, 2024 – September 30, 2024 | 883,759 | $27.81 | 879,011 | $200.0 million | | Totals | 4,409,382 | $26.22 | 4,398,230 | | - The difference between total shares purchased and shares purchased under the publicly announced program consists of 11,152 ordinary shares acquired to satisfy withholding tax obligations related to equity awards[137] - The Repurchase Program, approved in February 2024, authorized up to $400.0 million in share repurchases and has no set expiration date[137] Item 5. Other Information During the three months ended September 30, 2024, two officers adopted Rule 10b5-1 plans for the sale of company securities, with no other officers or directors adopting, modifying, or terminating such plans - Christian Todd Nichols, Senior Vice President Chief Commercial Officer, adopted a Rule 10b5-1 plan on August 23, 2024, for the sale of up to 5,208 ordinary shares, expiring December 31, 2024[138] - Samuel Parisi, VP, Finance and Interim Chief Accounting Officer, adopted a Rule 10b5-1 plan on September 11, 2024, for the sale of up to 10,177 ordinary shares, expiring February 20, 2026[138] Item 6. Exhibits This section lists the exhibits filed or furnished as part of this Form 10-Q, including certifications, XBRL taxonomy documents, and the interactive data file