Full Press Release Details
| Alkermes Contacts: | ||
| For Investors: | Sandy Coombs +1 781 609 6377 | |
| For Media: | Katie Joyce +1 781 249 8927 |
Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2023 and Provides Financial Expectations for 2024
Total Revenues of $1.66 Billion in 2023; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year
GAAP Net Income of $356 Million and Diluted GAAP Earnings per Share of $2.10 for 2023
Company Expects to Generate 30% EBITDA Margin in 2024
DUBLIN, Feb. 15, 2024 Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2023 and provided financial expectations for 2024.
We entered 2024 as a pure-play neuroscience company and are well positioned to deliver on our strategic priorities to drive growth of our proprietary commercial products, advance the clinical development of ALKS 2680 for the treatment of narcolepsy, and generate significant cash flow, said Richard Pops, Chief Executive Officer of Alkermes. Our financial expectations for 2024 reflect our sharpened strategic focus and our work to position the business for sustained profitability and growth. As we look ahead, 2024 will be an important year as we focus on maintaining strong momentum in the launch of LYBALVI and advancing and expanding our development pipeline. We look forward to sharing our progress.
Key Financial Highlights
| (In millions) | Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2023 | 2022 | 2023 | 2022 | ||||||
| Total Revenues | $ | 377.5 | $ | 304.7 | $ | 1,663.4 | $ | 1,111.8 | |
| Total Proprietary Net Sales | $ | 242.0 | $ | 216.1 | $ | 920.0 | $ | 777.6 | |
| VIVITROL | $ | 102.4 | $ | 102.0 | $ | 400.4 | $ | 379.5 | |
| ARISTADA [i] | $ | 83.4 | $ | 79.2 | $ | 327.7 | $ | 302.1 | |
| LYBALVI | $ | 56.2 | $ | 34.9 | $ | 191.9 | $ | 96.0 |
| (In millions) | Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2023 | 2022 | 2023 | 2022 | ||||||
| GAAP Net Income (Loss) | $ | 112.8 | $ | (28.3) | $ | 355.8 | $ | (158.3) | |
| GAAP Net Income (Loss) From Continuing Operations | $ | 160.6 | $ | 17.2 | $ | 519.2 | $ | (33.2) | |
| Non-GAAP Net Income | $ | 37.4 | $ | 24.2 | $ | 243.7 | $ | 57.9 | |
| Non-GAAP Net Income From Continuing Operations | $ | 81.8 | $ | 67.4 | $ | 396.5 | $ | 174.9 | |
| EBITDA | $ | 32.3 | $ | (1.2) | $ | 323.8 | $ | (84.0) | |
| EBITDA From Continuing Operations | $ | 72.8 | $ | 34.6 | $ | 486.3 | $ | 50.6 |
Please refer to Note 2 below for details related to certain tax provisions recorded during the quarter ended Dec. 31, 2023 which impacted GAAP Net Income and Non-GAAP Net Income during the quarter.
-Revenues for the fourth quarter and year-ended Dec. 31, 2023 were $56.2 million and $191.9 million, respectively.
-Fourth quarter revenues and total prescriptions grew 61% and 65%, respectively, compared to the fourth quarter of 2022.
-Revenues for the fourth quarter and year-ended Dec. 31, 2023 were $83.4 million and $327.7 million, respectively.
-Fourth quarter revenues and total prescriptions (on a months of therapy basis) grew 5% and 4%, respectively, compared to the fourth quarter of 2022.
-Revenues for the fourth quarter and year-ended Dec. 31, 2023 were $102.4 million and $400.4 million, respectively.
Manufacturing & Royalties
-Royalty revenues from INVEGA SUSTENNA /XEPLION , INVEGA TRINZA /TREVICTA and INVEGA HAFYERA /BYANNLI for the fourth quarter and year-ended Dec. 31, 2023 were $75.2 million and $486.1 million, respectively. 2023 royalty revenues included $195.4 million of back royalties and associated interest related to U.S. net sales of these products in 2022, following favorable resolution of the arbitration proceedings related to these products in the second quarter of 2023.
-VUMERITY revenues for the fourth quarter and year-ended Dec. 31, 2023 were $33.6 million and $129.3 million, respectively.
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.
| (In millions) | Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2023 | 2022 | 2023 | 2022 | ||||||
| R&D Expense Continuing Operations | $ | 73.9 | $ | 73.0 | $ | 270.8 | $ | 272.7 | |
| R&D Expense Discontinued Operations | $ | 21.5 | $ | 31.6 | $ | 116.2 | $ | 121.1 | |
| SG&A Expense Continuing Operations | $ | 169.8 | $ | 152.9 | $ | 689.8 | $ | 590.8 | |
| SG&A Expense Discontinued Operations | $ | 19.4 | $ | 4.7 | $ | 48.6 | $ | 15.0 |
Year-over-year increase in SG&A expense related to continuing operations was driven primarily by investment in the LYBALVI direct-to-consumer advertising campaign and certain one-time expenses related to the successful resolution of legal proceedings including the Janssen arbitration and VIVITROL patent litigation.
At Dec. 31, 2023, the company recorded cash, cash equivalents and total investments of $813.4 million, compared to $740.1 million at Dec. 31, 2022. The company's total debt outstanding as of Dec. 31, 2023 was $290.7 million.
Share Repurchase Program
On Feb. 15, 2024, the company's board of directors approved a new share repurchase program, authorizing the company to repurchase up to $400 million of the company's ordinary shares (exclusive of any fees, commissions or other expenses related to such repurchases). The program does not have an expiration date and can be discontinued at any time. Please refer to Note 3 below for further details.
Financial Expectations for 2024
All line items are according to GAAP, except as otherwise noted.
| In millions | 2024 Expectations | |
| Total Revenues a | $1,500 $1,600 | |
| VIVITROL Net Sales | $410 $430 | |
| ARISTADA i Net Sales | $340 $360 | |
| LYBALVI Net Sales | $275 $295 | |
| Cost of Goods Sold | $230 $250 | |
| R&D Expenses | $225 $255 | |
| SG&A Expenses | $625 $655 | |
| GAAP Net Income b | $350 $390 | |
| Non-GAAP Net Income b | $465 $505 | |
| EBITDA | $445 $485 | |
| Effective Tax Rate | ~17% |
a Expected Total Revenues reflect expiration of the U.S. royalty related to INVEGA SUSTENNA in August 2024.
b Expected 2024 weighted average basic share count of approximately 169.0 million shares outstanding and a weighted average diluted share count of approximately 173.0 million shares outstanding.
-In November 2023, the company completed the separation of its oncology business into Mural Oncology plc, a new, independent, publicly-traded company.
-In December 2023, the company announced that it had entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. Under the terms of the agreement, upon closing of the transaction, Alkermes will be entitled to a one-time cash payment of $92.5 million for the facility and related assets, subject to customary adjustments in accordance with the agreement. The transaction is expected to close in mid-2024, subject to certain closing conditions.
-In January 2024, the company announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment received in prior LYBALVI studies.
-In January 2024, the company announced that it had completed the narcolepsy type 1 cohort in its phase 1b study of ALKS 2680, the company's novel, investigational orexin 2 receptor agonist in development for the treatment of narcolepsy. The data supported dose selection of 4 mg, 6 mg, and 8 mg once daily for the planned phase 2 study in narcolepsy type 1, which the company plans to initiate in the first half of 2024.
Notes and Explanations
1.The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 205, Discontinued Operations. Accordingly, the accompanying consolidated financial statements for all periods presented have been updated to present the assets and liabilities associated with the oncology business as discontinued operations on the consolidated balance sheets, and the results of all discontinued operations reported as a separate component of loss in the consolidated statements of operations and comprehensive income (loss).
2.During the quarter ended Dec. 31, 2023, the company recorded a $102.2 million net tax benefit from continuing operations and an income tax provision of $6.9 million from discontinued operations driven by a $161.0 million tax benefit related to the partial release of a valuation allowance against certain Irish deferred tax assets, partially offset by
i.an income tax expense related to a reduced foreign derived intangible income deduction following the publication of new guidance on the application of Section 174 of the U.S. Internal Revenue Code of 1986, as amended, and
ii.a one-time charge related to the transfer of certain intellectual property in connection with the separation of the company's oncology business.
The tax benefit related to the release of the valuation allowance was excluded from non-GAAP net income due to the one-time nature of the benefit.
3.Under the share repurchase program, the company may repurchase ordinary shares of the company from time to time in an aggregate amount of up to $400 million (exclusive of any fees, commissions or other expenses related to such repurchases), subject to general business and market conditions and other investment opportunities, through open market purchases, conducted through Rule 10b5-1 plans or 10b-18 plans pursuant to the Securities Exchange Act of 1934, as amended, or through other mechanisms permitted by the company's constitution.
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Thursday, Feb. 15, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website.
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.
Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense.
The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects, including its ability to grow its proprietary commercial products, generate cash and sustain profitability; the company's expectations regarding advancement of its development pipeline, including plans and expected timelines for the ALKS 2680 clinical development program, including initiation of the phase 2 study; the company's expectations regarding its share repurchase program; and the company's expectations regarding the sale of its development and manufacturing facility in Athlone, Ireland. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to sustain profitability; the unfavorable outcome of arbitration or litigation, including so-called Paragraph IV litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company's products or products using the company's proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company's regulatory approval strategies; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to government payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading Risk Factors in the company's Annual Report on Form 10-K and in subsequent filings made by
the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
VIVITROL is a registered trademark of Alkermes, Inc.; ARISTADA , ARISTADA INITIO and LYBALVI are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI , INVEGA , INVEGA HAFYERA , INVEGA SUSTENNA , INVEGA TRINZA , TREVICTA and XEPLION are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY is a registered trademark of Biogen MA Inc., used by Alkermes under license.
| Alkermes plc and Subsidiaries | ||||||||
| Selected Financial Information (Unaudited) | ||||||||
| Condensed Consolidated Statements of Operations - GAAP | Three Months Ended | Three Months Ended | ||||||
| (In thousands, except per share data) | December 31, 2023 | December 31, 2022 | ||||||
| Revenues: | ||||||||
| Product sales, net | $ | 241,972 | $ | 216,117 | ||||
| Manufacturing and royalty revenues | 135,500 | 88,546 | ||||||
| Research and development revenue | 3 | 11 | ||||||
| Total Revenues | 377,475 | 304,674 | ||||||
| Expenses: | ||||||||
| Cost of goods manufactured and sold | 70,126 | 53,954 | ||||||
| Research and development | 73,933 | 73,011 | ||||||
| Selling, general and administrative | 169,789 | 152,852 | ||||||
| Amortization of acquired intangible assets | 8,996 | 9,165 | ||||||
| Total Expenses | 322,844 | 288,982 | ||||||
| Operating Income | 54,631 | 15,692 | ||||||
| Other Income (Expense), net: | ||||||||
| Interest income | 9,749 | 3,921 | ||||||
| Interest expense | (6,054 | ) | (4,769 | ) | ||||
| Other expense, net | (10 | ) | (258 | ) | ||||
| Total Other Income (Expense), net | 3,685 | (1,106 | ) | |||||
| Income Before Income Taxes | 58,316 | 14,586 | ||||||
| Income Tax Benefit | (102,236 | ) | (2,589 | ) | ||||
| Net Income From Continuing Operations | 160,552 | 17,175 | ||||||
| Loss from Discontinued Operations Net of Tax | $ | (47,773 | ) | $ | (45,429 | ) | ||
| Net Income (Loss) GAAP | $ | 112,779 | $ | (28,254 | ) | |||
| GAAP Earnings (Loss) Per Share - Basic: | ||||||||
| From continuing operations | $ | 0.96 | $ | 0.10 | ||||
| From discontinued operations | $ | (0.29 | ) | $ | (0.28 | ) | ||
| Earnings (loss) per share | $ | 0.68 | $ | (0.17 | ) | |||
| GAAP Earnings (Loss) Per Share - Diluted: | ||||||||
| From continuing operations | $ | 0.94 | $ | 0.10 | ||||
| From discontinued operations | $ | (0.28 | ) | $ | (0.27 | ) | ||
| Earnings (loss) per share | $ | 0.66 | $ | (0.17 | ) | |||
| Weighted Average Number of Ordinary Shares Outstanding: | ||||||||
| Basic GAAP and Non-GAAP | 166,898 | 164,336 | ||||||
| Diluted GAAP and Non-GAAP | 170,138 | 169,304 |
| Condensed Consolidated Statements of Operations - GAAP (Continued) | Three Months Ended | Three Months Ended | ||||||
| (In thousands, except per share data) | December 31, 2023 | December 31, 2022 | ||||||
| An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows: | ||||||||
| Net Income from Continuing Operations | $ | 160,552 | $ | 17,175 | ||||
| Adjustments: | ||||||||
| Depreciation expense | 9,225 | 10,013 | ||||||
| Amortization expense | 8,996 | 9,165 | ||||||
| Interest income | (9,749 | ) | (3,921 | ) | ||||
| Interest expense | 6,054 | 4,769 | ||||||
| Income tax (benefit) provision | (102,236 | ) | (2,589 | ) | ||||
| EBITDA from Continuing Operations | 72,842 | 34,612 | ||||||
| EBITDA from Discontinued Operations | (40,537 | ) | (35,777 | ) | ||||
| EBITDA | $ | 32,305 | $ | (1,165 | ) | |||
| An itemized reconciliation between net income from continuing operations on a GAAP basis and non-GAAP net income is as follows: | ||||||||
| Net Income from Continuing Operations | $ | 160,552 | $ | 17,175 | ||||
| Adjustments: | ||||||||
| Share-based compensation expense | 22,776 | 24,692 | ||||||
| Depreciation expense | 9,225 | 10,013 | ||||||
| Amortization expense | 8,996 | 9,165 | ||||||
| Separation expense | 19,084 | 1,355 | ||||||
| Income tax effect related to reconciling items | 22,011 | 4,847 | ||||||
| Deferred tax valuation release | (160,953 | ) | ||||||
| Non-cash net interest expense | 115 | 116 | ||||||
| Non-GAAP Net Income from Continuing Operations | 81,806 | 67,363 | ||||||
| Non-GAAP Net Loss from Discontinued Operations | (44,383 | ) | (43,142 | ) | ||||
| Non-GAAP Net Income | $ | 37,423 | $ | 24,221 | ||||
| Non-GAAP diluted earnings per share from continuing operations | $ | 0.48 | $ | 0.40 | ||||
| Non-GAAP diluted loss per share from discontinued operations | $ | (0.26 | ) | $ | (0.25 | ) | ||
| Non-GAAP diluted earnings per share | $ | 0.22 | $ | 0.14 |
| Alkermes plc and Subsidiaries | ||||||||
| Selected Financial Information (Unaudited) | ||||||||
| Condensed Consolidated Statements of Operations - GAAP | Year Ended | Year Ended | ||||||
| (In thousands, except per share data) | December 31, 2023 | December 31, 2022 | ||||||
| Revenues: | ||||||||
| Product sales, net | $ | 919,998 | $ | 777,552 | ||||
| Manufacturing and royalty revenues | 743,388 | 331,983 | ||||||
| License revenue | 2,000 | |||||||
| Research and development revenue | 19 | 260 | ||||||
| Total Revenues | 1,663,405 | 1,111,795 | ||||||
| Expenses: | ||||||||
| Cost of goods manufactured and sold | 253,037 | 218,068 | ||||||
| Research and development | 270,806 | 272,702 | ||||||
| Selling, general and administrative | 689,751 | 590,751 | ||||||
| Amortization of acquired intangible assets | 35,689 | 36,363 | ||||||
| Total Expenses | 1,249,283 | 1,117,884 | ||||||
| Operating Income (Loss) | 414,122 | (6,089 | ) | |||||
| Other Income (Expense), net: | ||||||||
| Interest income | 30,854 | 7,629 | ||||||
| Interest expense | (23,032 | ) | (13,040 | ) | ||||
| Change in the fair value of contingent consideration | (21,750 | ) | ||||||
| Other (expense) income, net | (425 | ) | 2,122 | |||||
| Total Other Income (Expense), net | 7,397 | (25,039 | ) | |||||
| Income (Loss) Before Income Taxes | 421,519 | (31,128 | ) | |||||
| Income Tax (Benefit) Provision | (97,638 | ) | 2,024 | |||||
| Net Income (Loss) From Continuing Operations | 519,157 | (33,152 | ) | |||||
| Discontinued Operations Net of Tax | (163,400 | ) | (125,115 | ) | ||||
| Net Income (Loss) GAAP | $ | 355,757 | $ | (158,267 | ) | |||
| GAAP Earnings (Loss) Per Share - Basic: | ||||||||
| From continuing operations | $ | 3.12 | $ | (0.20 | ) | |||
| From discontinued operations | $ | (0.98 | ) | $ | (0.76 | ) | ||
| Earnings (loss) per share | $ | 2.14 | $ | (0.97 | ) | |||
| GAAP Earnings (Loss) Per Share - Diluted: | ||||||||
| From continuing operations | $ | 3.06 | $ | (0.20 | ) | |||
| From discontinued operations | $ | (0.96 | ) | $ | (0.76 | ) | ||
| Earnings (loss) per share | $ | 2.10 | $ | (0.97 | ) | |||
| Weighted Average Number of Ordinary Shares Outstanding: | ||||||||
| Basic GAAP and Non-GAAP | 166,223 | 163,742 | ||||||
| Diluted GAAP | 169,730 | 163,742 | ||||||
| Diluted Non-GAAP | 169,730 | 168,362 | ||||||
| An itemized reconciliation between net income (loss) from continuing operations on a GAAP basis and EBITDA is as follows: | ||||||||
| Net Income (Loss) from Continuing Operations | $ | 519,157 | $ | (33,152 | ) | |||
| Adjustments: | ||||||||
| Depreciation expense | 36,921 | 39,959 | ||||||
| Amortization expense | 35,689 | 36,363 | ||||||
| Interest income | (30,854 | ) | (7,629 | ) | ||||
| Interest expense | 23,032 | 13,040 | ||||||
| Income tax (benefit) provision | (97,638 | ) | 2,024 | |||||
| EBITDA from Continuing Operations | 486,307 | 50,605 | ||||||
| EBITDA from Discontinued Operations | (162,484 | ) | (134,637 | ) | ||||
| EBITDA | $ | 323,823 | $ | (84,032 | ) |
| Condensed Consolidated Statements of Operations - GAAP (Continued) | Year Ended | Year Ended | ||||||
| (In thousands, except per share data) | December 31, 2023 | December 31, 2022 | ||||||
| An itemized reconciliation between net income (loss) from continuing operations on a GAAP basis and non-GAAP net income is as follows: | ||||||||
| Net Income (Loss) from Continuing Operations | $ | 519,157 | $ | (33,152 | ) | |||
| Adjustments: | ||||||||
| Share-based compensation expense | 92,719 | 87,676 | ||||||
| Depreciation expense | 36,921 | 39,959 | ||||||
| Amortization expense | 35,689 | 36,363 | ||||||
| Separation expense | 38,364 | 1,355 | ||||||
| Income tax effect related to reconciling items | 25,343 | 2,254 | ||||||
| Final award in the Janssen arbitration (2022 back royalties and interest) | (197,092 | ) | ||||||
| Deferred tax valuation release | (160,953 | ) | ||||||
| Restructuring | 5,938 | |||||||
| Non-cash net interest expense | 461 | 466 | ||||||
| Reduction in the fair value of contingent consideration and other related assets | 24,032 | |||||||
| Legal settlement | 15,905 | |||||||
| Non-GAAP Net Income from Continuing Operations | 396,547 | 174,858 | ||||||
| Non-GAAP Net Loss from Discontinued Operations | (152,894 | ) | (116,999 | ) | ||||
| Non-GAAP Net Income | $ | 243,653 | $ | 57,859 | ||||
| Non-GAAP diluted earnings per share from continuing operations | $ | 2.34 | $ | 1.04 | ||||
| Non-GAAP diluted loss per share from discontinued operations | $ | (0.90 | ) | $ | (0.69 | ) | ||
| Non-GAAP diluted earnings per share | $ | 1.44 | $ | 0.34 |
| Alkermes plc and Subsidiaries | ||||||||
| Selected Financial Information (Unaudited) | ||||||||
| Condensed Consolidated Balance Sheets | December 31, | December 31, | ||||||
| (In thousands) | 2023 | 2022 | ||||||
| Cash, cash equivalents and total investments | $ | 813,378 | $ | 740,075 | ||||
| Receivables | 332,477 | 287,967 | ||||||
| Inventory | 186,406 | 181,418 | ||||||
| Contract assets | 706 | 8,929 | ||||||
| Prepaid expenses and other current assets | 98,166 | 41,203 | ||||||
| Property, plant and equipment, net | 226,943 | 222,919 | ||||||
| Intangible assets, net and goodwill | 85,018 | 120,707 | ||||||
| Assets held for sale | 94,260 | 93,871 | ||||||
| Assets from discontinued operations | 40,087 | |||||||
| Other assets | 298,869 | 226,802 | ||||||
| Total Assets | $ | 2,136,223 | $ | 1,963,978 | ||||
| Long-term debt current portion | $ | 3,000 | $ | 3,000 | ||||
| Other current liabilities | 512,678 | 488,898 | ||||||
| Long-term debt | 287,730 | 290,270 | ||||||
| Liabilities from discontinued operations | 4,542 | 19,386 | ||||||
| Other long-term liabilities | 125,587 | 118,671 | ||||||
| Total shareholders' equity | 1,202,686 | 1,043,753 | ||||||
| Total Liabilities and Shareholders' Equity | $ | 2,136,223 | $ | 1,963,978 | ||||
| Ordinary shares outstanding (in thousands) | 166,980 | 164,377 | ||||||
| This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Annual Report on Form 10-K for the year ended December 31, 2023, which the company intends to file in February 2024. |
| Alkermes plc and Subsidiaries | ||||||||||||||||||||
| Amounts included in Discontinued Operations | ||||||||||||||||||||
| (In thousands) | Three Months Ended March 31, 2023 | Three Months Ended June 30, 2023 | Three Months Ended September 30, 2023 | Three Months Ended December 31, 2023 | Year Ended December 31, 2023 | |||||||||||||||
| Cost of goods manufactured and sold | $ | 11 | $ | 11 | $ | 11 | $ | 6 | $ | 39 | ||||||||||
| Research and development | 29,867 | 32,563 | 32,262 | 21,485 | 116,177 | |||||||||||||||
| Selling, general and administrative | 6,644 | 9,502 | 13,073 | 19,368 | 48,587 | |||||||||||||||
| Income tax (benefit) provision | (6,727 | ) | (40 | ) | (1,550 | ) | 6,914 | (1,403 | ) | |||||||||||
| Loss from discontinued operations, net of tax | $ | 29,795 | $ | 42,036 | $ | 43,796 | $ | 47,773 | $ | 163,400 | ||||||||||
| (In thousands) | Three Months Ended March 31, 2022 | Three Months Ended June 30, 2022 | Three Months Ended September 30, 2022 | Three Months Ended December 31, 2022 | Year Ended December 31, 2022 | |||||||||||||||
| Cost of goods manufactured and sold | $ | 10 | $ | 10 | $ | 10 | $ | 10 | $ | 40 | ||||||||||
| Research and development | 29,161 | 27,475 | 32,929 | 31,575 | 121,140 | |||||||||||||||
| Selling, general and administrative | 3,201 | 3,488 | 3,618 | 4,689 | 14,996 | |||||||||||||||
| Income tax (benefit) provision | (22,883 | ) | 1,374 | 1,293 | 9,155 | (11,061 | ) | |||||||||||||
| Loss from discontinued operations, net of tax | $ | 9,489 | $ | 32,347 | $ | 37,850 | $ | 45,429 | $ | 125,115 |
| Alkermes plc and Subsidiaries | ||||||||||||||||||||
| Revenues for Calendar Year 2023 and 2022 | ||||||||||||||||||||
| (In thousands) | Three Months Ended March 31, 2023 | Three Months Ended June 30, 2023 | Three Months Ended September 30, 2023 | Three Months Ended December 31, 2023 | Year Ended December 31, 2023 | |||||||||||||||
| Revenues: | ||||||||||||||||||||
| VIVITROL | $ | 96,659 | $ | 102,070 | $ | 99,305 | $ | 102,385 | $ | 400,419 | ||||||||||
| ARISTADA | 80,077 | 82,410 | 81,834 | 83,369 | 327,690 | |||||||||||||||
| LYBALVI | 37,991 | 46,997 | 50,683 | 56,218 | 191,889 | |||||||||||||||
| Total Proprietary Sales | 214,727 | 231,477 | 231,822 | 241,972 | 919,998 | |||||||||||||||
| PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) | 24,543 | 326,380 | 90,993 | 81,461 | 523,377 | |||||||||||||||
| VUMERITY | 28,874 | 32,295 | 34,561 | 33,596 | 129,326 | |||||||||||||||
| Key Commercial Product Revenues | 268,144 | 590,152 | 357,376 | 357,029 | 1,572,701 | |||||||||||||||
| Legacy Product Revenues | 19,445 | 27,238 | 23,559 | 20,443 | 90,685 | |||||||||||||||
| Research and Development Revenues | 6 | 7 | 3 | 3 | 19 | |||||||||||||||
| Total Revenues | $ | 287,595 | $ | 617,397 | $ | 380,938 | $ | 377,475 | $ | 1,663,405 | ||||||||||
| (In thousands) | Three Months Ended March 31, 2022 | Three Months Ended June 30, 2022 | Three Months Ended September 30, 2022 | Three Months Ended December 31, 2022 | Year Ended December 31, 2022 | |||||||||||||||
| Revenues: | ||||||||||||||||||||
| VIVITROL | $ | 84,854 | $ | 96,105 | $ | 96,534 | $ | 101,985 | $ | 379,478 | ||||||||||
| ARISTADA | 72,485 | 74,622 | 75,719 | 79,226 | 302,052 | |||||||||||||||
| LYBALVI | 13,929 | 20,060 | 27,127 | 34,906 | 96,022 | |||||||||||||||
| Total Proprietary Sales | 171,268 | 190,787 | 199,380 | 216,117 | 777,552 | |||||||||||||||
| PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) | 54,480 | 37,039 | 36,965 | 37,085 | 165,569 | |||||||||||||||
| VUMERITY | 30,595 | 26,170 | 26,250 | 32,481 | 115,496 | |||||||||||||||
| Key Commercial Product Revenues | 256,343 | 253,996 | 262,595 | 285,683 | 1,058,617 | |||||||||||||||
| Legacy Product Revenues | 20,095 | 22,117 | (10,274 | ) | 18,980 | 50,918 | ||||||||||||||
| License Revenue | 2,000 | 2,000 | ||||||||||||||||||
| Research and Development Revenues | 107 | 106 | 36 | 11 | 260 | |||||||||||||||
| Total Revenues | $ | 278,545 | $ | 276,219 | $ | 252,357 | $ | 304,674 | $ | 1,111,795 | ||||||||||
| (1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI. |
| Alkermes plc and Subsidiaries | ||||
| 2024 Guidance GAAP to EBITDA | ||||
| An itemized reconciliation between projected net income on a GAAP basis and EBITDA is as follows: | ||||
| (In millions, except per share data) | Amount | |||
| Projected Net Income GAAP | $ | 370.0 | ||
| Adjustments: | ||||
| Net interest income | (16.0 | ) | ||
| Depreciation expense | 35.0 | |||
| Amortization expense | 1.0 | |||
| Provision for income taxes | 75.0 | |||
| Projected EBITDA | $ | 465.0 | ||
| Projected Net Income on a GAAP basis and Projected EBITDA reflect mid-points within ranges of estimated guidance. |
| Alkermes plc and Subsidiaries | ||||||||||||
| 2024 Guidance GAAP to Non-GAAP Adjustments | ||||||||||||
| An itemized reconciliation between projected earnings per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows: | ||||||||||||
| (In millions, except per share data) | Amount | Shares | Earnings Per Share | |||||||||
| Projected Net Income GAAP | $ | 370.0 | 173.0 | $ | 2.14 | |||||||
| Adjustments: | ||||||||||||
| Share-based compensation expense | 86.0 | |||||||||||
| Depreciation expense | 35.0 | |||||||||||
| Amortization expense | 1.0 | |||||||||||
| Non-cash net interest expense | 0.5 | |||||||||||
| Income tax effect related to reconciling items | (7.5 | ) | ||||||||||
| Projected Net Income Non-GAAP | $ | 485.0 | 173.0 | $ | 2.80 | |||||||
| Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance. |