UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
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Identification No.) |
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(Address of principal executive offices) |
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Registrant's telephone number, including area code: +
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 15, 2024, Alkermes plc (the “Company”) announced financial results for the three months and year ended December 31, 2023 and financial expectations for the year ending December 31, 2024. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on February 15, 2024 discussing such financial results and expectations are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively. This information, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
EXHIBIT INDEX
Exhibit No. |
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Description |
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99.1 |
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99.2 |
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Investor presentation to be displayed by Alkermes plc on February 15, 2024. |
104 |
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Cover page interactive data file (embedded within the Inline XBRL document). |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ALKERMES PLC |
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Date: February 15, 2024 |
By: |
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/s/ Blair C. Jackson |
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Blair C. Jackson |
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Executive Vice President, Chief Operating Officer (Interim Principal Financial Officer) |
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Exhibit 99.1
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Alkermes Contacts: |
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For Investors: |
Sandy Coombs +1 781 609 6377 |
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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
Revenues
(In millions) |
Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2023 |
2022 |
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2023 |
2022 |
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Total Revenues |
$ |
377.5 |
$ |
304.7 |
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$ |
1,663.4 |
$ |
1,111.8 |
Total Proprietary Net Sales |
$ |
242.0 |
$ |
216.1 |
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$ |
920.0 |
$ |
777.6 |
VIVITROL® |
$ |
102.4 |
$ |
102.0 |
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$ |
400.4 |
$ |
379.5 |
ARISTADA®[i] |
$ |
83.4 |
$ |
79.2 |
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$ |
327.7 |
$ |
302.1 |
LYBALVI® |
$ |
56.2 |
$ |
34.9 |
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$ |
191.9 |
$ |
96.0 |
Profitability
(In millions) |
Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2023 |
2022 |
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2023 |
2022 |
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GAAP Net Income (Loss) |
$ |
112.8 |
$ |
(28.3) |
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$ |
355.8 |
$ |
(158.3) |
GAAP Net Income (Loss) From Continuing Operations |
$ |
160.6 |
$ |
17.2 |
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$ |
519.2 |
$ |
(33.2) |
Non-GAAP Net Income |
$ |
37.4 |
$ |
24.2 |
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$ |
243.7 |
$ |
57.9 |
Non-GAAP Net Income From Continuing Operations |
$ |
81.8 |
$ |
67.4 |
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$ |
396.5 |
$ |
174.9 |
EBITDA |
$ |
32.3 |
$ |
(1.2) |
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$ |
323.8 |
$ |
(84.0) |
EBITDA From Continuing Operations |
$ |
72.8 |
$ |
34.6 |
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$ |
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.
1
Revenue Highlights
LYBALVI
ARISTADAi
VIVITROL
Manufacturing & Royalties
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.
(In millions) |
Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2023 |
2022 |
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2023 |
2022 |
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R&D Expense – Continuing Operations |
$ |
73.9 |
$ |
73.0 |
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$ |
270.8 |
$ |
272.7 |
R&D Expense – Discontinued Operations |
$ |
21.5 |
$ |
31.6 |
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$ |
116.2 |
$ |
121.1 |
SG&A Expense – Continuing Operations |
$ |
169.8 |
$ |
152.9 |
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$ |
689.8 |
$ |
590.8 |
SG&A Expense – Discontinued Operations |
$ |
19.4 |
$ |
4.7 |
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$ |
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.
2
Balance Sheet
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 |
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2024 Expectations |
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Total Revenues a |
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$1,500 – $1,600 |
VIVITROL Net Sales |
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$410 – $430 |
ARISTADAi Net Sales |
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$340 – $360 |
LYBALVI Net Sales |
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$275– $295 |
Cost of Goods Sold |
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$230 – $250 |
R&D Expenses |
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$225 – $255 |
SG&A Expenses |
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$625 – $655 |
GAAP Net Income b |
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$350 – $390 |
Non-GAAP Net Income b |
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$465 – $505 |
EBITDA |
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$445 – $485 |
Effective Tax Rate |
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~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.
Recent Events
3
Notes and Explanations
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.
Conference Call
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.
About Alkermes plc
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.
4
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
5
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.
(tables follow)
i |
The term “ARISTADA” as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. |
6
Alkermes plc and Subsidiaries |
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Selected Financial Information (Unaudited) |
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Condensed Consolidated Statements of Operations - GAAP |
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Three Months Ended |
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Three Months Ended |
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(In thousands, except per share data) |
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December 31, 2023 |
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December 31, 2022 |
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Revenues: |
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Product sales, net |
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$ |
241,972 |
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$ |
216,117 |
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Manufacturing and royalty revenues |
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135,500 |
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88,546 |
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Research and development revenue |
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3 |
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11 |
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Total Revenues |
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377,475 |
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304,674 |
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Expenses: |
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Cost of goods manufactured and sold |
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70,126 |
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53,954 |
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Research and development |
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73,933 |
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73,011 |
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Selling, general and administrative |
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169,789 |
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152,852 |
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Amortization of acquired intangible assets |
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8,996 |
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9,165 |
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Total Expenses |
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322,844 |
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288,982 |
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Operating Income |
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54,631 |
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15,692 |
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Other Income (Expense), net: |
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Interest income |
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9,749 |
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3,921 |
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Interest expense |
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(6,054 |
) |
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(4,769 |
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Other expense, net |
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(10 |
) |
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(258 |
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Total Other Income (Expense), net |
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3,685 |
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(1,106 |
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Income Before Income Taxes |
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58,316 |
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14,586 |
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Income Tax Benefit |
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(102,236 |
) |
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(2,589 |
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Net Income From Continuing Operations |
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160,552 |
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17,175 |
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Loss from Discontinued Operations — Net of Tax |
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$ |
(47,773 |
) |
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$ |
(45,429 |
) |
Net Income (Loss) — GAAP |
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$ |
112,779 |
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$ |
(28,254 |
) |
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GAAP Earnings (Loss) Per Share - Basic: |
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From continuing operations |
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$ |
0.96 |
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$ |
0.10 |
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From discontinued operations |
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$ |
(0.29 |
) |
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$ |
(0.28 |
) |
Earnings (loss) per share |
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$ |
0.68 |
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$ |
(0.17 |
) |
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GAAP Earnings (Loss) Per Share - Diluted: |
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From continuing operations |
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$ |
0.94 |
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$ |
0.10 |
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From discontinued operations |
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$ |
(0.28 |
) |
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$ |
(0.27 |
) |
Earnings (loss) per share |
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$ |
0.66 |
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$ |
(0.17 |
) |
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Weighted Average Number of Ordinary Shares Outstanding: |
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Basic — GAAP and Non-GAAP |
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166,898 |
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164,336 |
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Diluted — GAAP and Non-GAAP |
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170,138 |
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169,304 |
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Condensed Consolidated Statements of Operations - GAAP (Continued) |
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Three Months Ended |
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Three Months Ended |
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(In thousands, except per share data) |
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December 31, 2023 |
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December 31, 2022 |
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An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows: |
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Net Income from Continuing Operations |
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$ |
160,552 |
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$ |
17,175 |
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Adjustments: |
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Depreciation expense |
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9,225 |
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10,013 |
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Amortization expense |
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8,996 |
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9,165 |
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Interest income |
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(9,749 |
) |
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(3,921 |
) |
Interest expense |
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|
6,054 |
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4,769 |
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Income tax (benefit) provision |
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(102,236 |
) |
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(2,589 |
) |
EBITDA from Continuing Operations |
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|
72,842 |
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|
34,612 |
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EBITDA from Discontinued Operations |
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(40,537 |
) |
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(35,777 |
) |
EBITDA |
|
$ |
32,305 |
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|
$ |
(1,165 |
) |
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|
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An itemized reconciliation between net income from continuing operations on a GAAP basis and non-GAAP net income is as follows: |
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|
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Net Income from Continuing Operations |
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$ |
160,552 |
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|
$ |
17,175 |
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Adjustments: |
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|
|
|
|
|
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Share-based compensation expense |
|
|
22,776 |
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|
|
24,692 |
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Depreciation expense |
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|
9,225 |
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|
|
10,013 |
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Amortization expense |
|
|
8,996 |
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|
|
9,165 |
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Separation expense |
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|
19,084 |
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|
1,355 |
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Income tax effect related to reconciling items |
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|
22,011 |
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|
|
4,847 |
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Deferred tax valuation release |
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(160,953 |
) |
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|
— |
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Non-cash net interest expense |
|
|
115 |
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|
|
116 |
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Non-GAAP Net Income from Continuing Operations |
|
|
81,806 |
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|
67,363 |
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Non-GAAP Net Loss from Discontinued Operations |
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(44,383 |
) |
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|
(43,142 |
) |
Non-GAAP Net Income |
|
$ |
37,423 |
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$ |
24,221 |
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|
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|
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Non-GAAP diluted earnings per share from continuing operations |
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$ |
0.48 |
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$ |
0.40 |
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Non-GAAP diluted loss per share from discontinued operations |
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$ |
(0.26 |
) |
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$ |
(0.25 |
) |
Non-GAAP diluted earnings per share |
|
$ |
0.22 |
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|
$ |
0.14 |
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Alkermes plc and Subsidiaries |
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Selected Financial Information (Unaudited) |
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|||||||
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Condensed Consolidated Statements of Operations - GAAP |
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Year Ended |
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Year Ended |
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(In thousands, except per share data) |
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December 31, 2023 |
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|
December 31, 2022 |
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Revenues: |
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|
|
|
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|
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Product sales, net |
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$ |
919,998 |
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|
$ |
777,552 |
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Manufacturing and royalty revenues |
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|
743,388 |
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331,983 |
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License revenue |
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|
— |
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|
2,000 |
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Research and development revenue |
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|
19 |
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|
|
260 |
|
Total Revenues |
|
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1,663,405 |
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|
|
1,111,795 |
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Expenses: |
|
|
|
|
|
|
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Cost of goods manufactured and sold |
|
|
253,037 |
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|
|
218,068 |
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Research and development |
|
|
270,806 |
|
|
|
272,702 |
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Selling, general and administrative |
|
|
689,751 |
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|
|
590,751 |
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Amortization of acquired intangible assets |
|
|
35,689 |
|
|
|
36,363 |
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Total Expenses |
|
|
1,249,283 |
|
|
|
1,117,884 |
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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 |
|
|
Three Months |
|
|
Three Months |
|
|
Three Months |
|
|
Year |
|
|||||
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 |
|
|
Three Months |
|
|
Three Months |
|
|
Three Months |
|
|
Year |
|
|||||
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 |
|
|
Three Months |
|
|
Three Months |
|
|
Three Months |
|
|
Year |
|
|||||
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 |
|
|
Three Months |
|
|
Three Months |
|
|
Three Months |
|
|
Year |
|
|||||
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 |
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Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance. |
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Fourth Quarter and Year-End 2023 Financial Results & Business Update February 15, 2024 Exhibit 99.2
Forward-Looking Statements Certain statements set forth in this presentation 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: Alkermes plc’s (the “Company”) expectations with respect to its current and future financial and operating performance, business plans or prospects, including its expected cash generation, revenue and growth drivers, expectations of profitability, potential return of capital to shareholders and potential transactions; the potential therapeutic and commercial value of the Company’s marketed products and development candidates; the Company’s expectations regarding plans and timelines for further clinical development activities, including for ALKS 2680; and the Company’s plans to advance and expand its neuroscience pipeline. The Company cautions that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks, assumptions and uncertainties. These risks, assumptions 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 or 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; the Company’s commercial activities may not result in the benefits that the Company anticipates; clinical development activities may not be completed on time or at all; the results of the Company’s development activities, including those related to ALKS 2680, may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; potential changes in the cost, scope, design or duration of the Company’s development activities, including the ALKS 2680 development program; the U.S. Food and Drug Administration (“FDA”) or other regulatory authorities may not agree with the Company’s regulatory approval strategies or components of the Company’s marketing applications and 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 growth of 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, assumptions 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, and on the Company’s website at www.alkermes.com in the ‘Investors – SEC filings’ section. 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 presentation. Non-GAAP Financial Measures: This presentation 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, EBITDA (earnings before interest, taxes, depreciation and amortization) and non-GAAP earnings per share. 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. 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. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures, to the extent reasonably determinable, can be found in the Appendix of this presentation. Note Regarding Trademarks: The Company and its affiliates are the owners of various U.S. federal trademark registrations (®) and other trademarks (TM), including ARISTADA®, ARISTADA INITIO® , LYBALVI® and VIVITROL®. VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Any other trademarks referred to in this presentation are the property of their respective owners. Appearances of such other trademarks herein should not be construed as any indicator that their respective owners will not assert their rights thereto.
2023 Accomplishments Enabled Repositioning of Alkermes and Established Strong Foundation for Growth *Based on twelve months ended Dec. 31, 2023 compared to the prior year Generated ALKS 2680 initial clinical proof-of-concept data in patients with narcolepsy type 1 Completed separation of the oncology business Continued focus on operational efficiency, including recent agreement to divest Athlone, Ireland manufacturing facility Grew proprietary commercial product portfolio net sales by 18%* year-over-year Successfully settled VIVITROL® patent litigation Prevailed in Janssen arbitration; Raised 2023 financial expectations
Alkermes 2024: Profitable, Pure-play Neuroscience Company >$1B commercial business driven primarily by 4 core products* Proven development capabilities with advancing neuroscience pipeline Positioned for sustained profitability and significant cash generation *Based on revenues from VIVITROL®, ARISTADA®, VUMERITY® and LYBALVI® for twelve months ended Dec. 31, 2023
Q4 & FY 2023 Financial and Operational Performance
In millions FY 2023 Financial Results Summary Total Revenue In millions GAAP Net Income (Loss) GAAP Earnings (Loss) Per Share (Diluted)
In millions FY 2023 Profitability From Continuing Operations GAAP Net Income (Loss) From Continuing Operations In millions Non-GAAP Net Income From Continuing Operations* EBITDA From Continuing Operations* In millions *Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation.
Q4 2023 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® **Reflects reinstatement of certain U.S. royalties following the successful outcome of the Company’s arbitration with Janssen announced in June 2023. In millions, except % Q4’23 Q4’22 ∆ Q4’23 vs. Q4’22 Total Proprietary Net Sales $242.0 $216.1 12% VIVITROL® $102.4 $102.0 - ARISTADA®* $83.4 $79.2 5% LYBALVI® $56.2 $34.9 61% Manufacturing & Royalty Revenue** $135.5 $88.5 53% Research & Development Revenue $0.0 $0.0 - Total Revenue** $377.5 $304.7 24%
FY 2023 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® **Reflects reinstatement of certain U.S. royalties following the successful outcome of the Company’s arbitration with Janssen announced in June 2023. In millions, except % FY’23 FY’22 ∆ FY’23 vs. FY’22 Total Proprietary Net Sales $920.0 $777.6 18% VIVITROL® $400.4 $379.5 6% ARISTADA®* $327.7 $302.1 8% LYBALVI® $191.9 $96.0 100% Manufacturing & Royalty Revenue** $743.4 $332.0 124% License Revenue - $2.0 (100%) Research & Development Revenue $0.0 $0.3 - Total Revenue** $1,663.4 $1,111.8 50%
Alkermes: 2024 Financial Expectations* *These expectations are provided by the Company on Feb. 15, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. ‡Reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Appendix of this presentation. (in millions) Financial Expectations for Year Ending Dec. 31, 2024 Total Revenues $1,500 – $1,600 COGS $230 – $250 R&D Expense $225 – $255 SG&A Expense $625 – $655 GAAP Net Income $350 – $390 EBITDA‡ $445 – $485 Non-GAAP Net Income‡ $465 – $505 Effective Tax Rate ~17% Expected net sales of proprietary products: VIVITROL® net sales of $410M – $430M ARISTADA® net sales of $340M – $360M LYBALVI® net sales of $275M – $295M
2023 Commercial Review
Topline Growth and Diversification Reflect Evolving Business *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing revenue) Key Product Revenues ($M) $574 $715 $893 $1,049
LYBALVI® Performance and Expectations *These expectations are provided by the Company on Feb. 15, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. LYBALVI Quarterly Net Sales ($M) Q4’23 net sales of $56.2M reflect 11% sequential growth compared to Q3’23 Q4’23 gross-to-net deductions: ~29% Outlook: FY’24 net sales expected to range from $275M – $295M*
LYBALVI® Prescription Growth Trends Q4’23 total TRx: ~46,700 reflecting 11% sequential growth compared to Q3’23 *Source: IQVIA NPA Weekly Post-Launch TRx* (Through 2/2/24) TRx Week
ARISTADA® Performance and Expectations ARISTADA Annual Net Sales* ($M) *Inclusive of ARISTADA INITIO® † These expectations are provided by the Company on Feb. 15, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. $241 $275 $302 $328 Q4’23 year-over-year net sales increased 5% to $83.4M FY’23 year-over-year net sales increased 8% to $327.7M Outlook: FY’24 net sales expected to range from $340M – $360M†*
VIVITROL® Performance and Expectations VIVITROL Annual Net Sales ($M) $311 $344 $380 $400 Q4’23 net sales of $102.4M were flat year-over-year FY’23 year-over-year net sales increased 6% to $400.4M Outlook: FY’24 net sales expected to range from $410M – $430M* *These expectations are provided by the Company on Feb. 15, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations.
2024 Outlook
Capital Allocation Strategy Maximize the potential of proprietary commercial products with primary focus on LYBALVI® Pursue external opportunities to expand portfolio with assets that are a strong strategic fit Invest in internal development pipeline to advance new neuroscience candidates Return excess cash to shareholders
2024 Strategic Priorities Driven by 4 core products and streamlined operating structure Initiate phase 2 program Advance internal development candidates and explore external pipeline opportunities Deliver strong commercial growth and profitability Advance orexin 2 receptor agonist program Expand neuroscience pipeline Plan for significant cash generation Continue focus on capital allocation, including potential opportunities to return capital to shareholders
Appendix
Appendix: Amounts Included in Discontinued Operations (In thousands) Year Ended December 31, 2023 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 provision (benefit) $ (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) Year Ended December 31, 2023 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 provision (benefit) $ (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
Appendix: Financial Results GAAP to Non-GAAP Adjustments (In millions) Year Ended December 31, 2023 Year Ended December 31, 2022 Net Income (Loss) from Continuing Operations — GAAP $ 519.2 $ (33.2) Adjustments: Share-based compensation expense 92.7 87.7 Depreciation expense 36.9 40.0 Amortization expense 35.7 36.4 Separation expense 38.4 1.4 Income tax effect related to reconciling items 25.3 2.3 Final award in the Janssen arbitration (2022 back royalties and interest) (197.1) -- Deferred tax valuation release (161.0) -- Restructuring 5.9 -- Non-cash net interest expense 0.5 0.5 Reduction in the fair value of contingent consideration and other related assets -- 24.0 Legal settlement -- 15.9 Non-GAAP Net Income from Continuing Operations $ 396.5 $ 174.9 Non-GAAP Net Loss from Discontinued Operations $ (152.9) $ (117.0) Non-GAAP Net Income $ 243.7 $ 57.9 Amounts in the table above may not sum due to rounding.
Appendix: Financial Results GAAP to EBITDA (In millions) Year Ended December 31, 2023 Year Ended December 31, 2022 Net Income from Continuing Operations — GAAP $ 519.2 $ (33.2) Adjustments: Depreciation expense 36.9 40.0 Amortization expense 35.7 36.4 Interest income (30.9) (7.6) Interest expense 23.0 13.0 Income tax (benefit) provision (97.6) 2.0 EBITDA from Continuing Operations $ 486.3 $ 50.6 EBITDA from Discontinued Operations $ (162.5) $ (134.6) EBITDA $ 323.8 $ (84.0)
Appendix: 2024 Guidance GAAP to Non-GAAP Adjustments (In millions, except per share data) Year Ended December 31, 2023 Year Ending December 31, 2024 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 the mid-points within the Company’s financial expectations ranges. +2024 per share expectations are calculated based on a weighted average diluted share count of approximately 173.0 million shares outstanding.
Appendix: 2024 Guidance GAAP to EBITDA (In millions) Year Ended December 31, 2023 Year Ending December 31, 2024 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 GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges.
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