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) |
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 July 26, 2023, Alkermes plc (the “Company”) announced financial results for the three and six months ended June 30, 2023. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on July 26, 2023 discussing such financial results 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 July 26, 2023. |
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: July 26, 2023 |
By: |
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/s/ Iain M. Brown |
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Iain M. Brown |
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Senior Vice President, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
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Exhibit 99.1
ale |
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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 Second Quarter 2023 Financial Results
— Second Quarter Revenues of $617.4 Million Reflect Strong Performance of Proprietary Product Portfolio and Reinstatement of Long-Acting INVEGA® Product Royalties —
— Net Sales of Proprietary Products Increased Approximately 21% Year-Over-Year —
— Prevailed in Janssen Arbitration; Recorded $248.4 Million in Back Royalties and Interest —
— GAAP Net Income of $237.1 Million and Non-GAAP Net Income of $94.3 Million —
— Financial Expectations for Full-Year 2023 Reiterated —
DUBLIN, July 26, 2023 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the second quarter of 2023.
“The second quarter clearly demonstrated Alkermes’ strong execution against our strategic priorities. We generated double-digit growth of our proprietary commercial products, advanced our development pipeline, and progressed the planned separation of our oncology business,” said Richard Pops, Chief Executive Officer of Alkermes. “As we enter the second half of the year, we are well positioned to continue to make meaningful progress across the business and drive shareholder value.”
“Our second quarter results reflect solid execution across our portfolio, highlighted by 21% year-over-year growth of our proprietary commercial products and reinstatement of the long-acting INVEGA product royalties in the U.S.,” commented Iain Brown, Chief Financial Officer of Alkermes. “We are in a strong financial position with more than $907 million of cash and total investments and, today, we are reiterating our financial expectations for 2023 that were provided in June following receipt of the favorable final award in our arbitration with Janssen. We continue to expect royalty revenues from Janssen for these long-acting INVEGA products to be incrementally accretive to Alkermes’ bottom line in 2023 and beyond, as we continue to manage our business to drive profitability for the benefit of Alkermes’ shareholders.”
Quarter Ended June 30, 2023 Financial Results
Revenues
1
Costs and Expenses
Profitability
Balance Sheet
2
Financial Expectations for 2023
Alkermes reiterated its financial expectations for 2023, as set forth in its press release dated June 6, 2023.
Separation of Oncology Business
Alkermes continues to make meaningful progress on the previously announced planned separation of its oncology business into a new, independent publicly-traded company. The separation would allow Alkermes to maintain its focus on researching, developing and commercializing therapies for people living with complex neurological conditions and is expected to accelerate and enhance the profitability of the remaining neuroscience business.
Recent Events
Corporate
Neuroscience
Oncology
3
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 26, 2023, 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 fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurological disorders and cancer. 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 GAAP, including non-GAAP net income and non-GAAP basic and diluted earnings per share. 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.
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 non-GAAP basic and diluted earnings per share 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 non-GAAP basic and diluted earnings per share 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 drive profitability and create value for shareholders; the company’s expectations regarding the future royalties to be received from Janssen; the company’s expectations regarding the timing, structure, anticipated benefits and other impacts of the planned separation of its oncology business; and the therapeutic and commercial potential of the company’s products. 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
4
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: the company may not ultimately separate its oncology business during 2023 or at all; unanticipated developments, costs or difficulties that may delay or otherwise negatively affect the planned separation of the company’s oncology business; the planned separation may adversely impact the company’s ability to attract or retain key personnel; 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 or components of the company’s marketing applications; 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 for the year ended Dec. 31, 2022 and the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 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; CABENUVA® is a registered trademark of ViiV Healthcare UK (No.3) Limited; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license.
(tables follow)
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The term “ARISTADA” as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. |
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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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June 30, 2023 |
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June 30, 2022 |
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Revenues: |
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Product sales, net |
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$ |
231,477 |
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$ |
190,787 |
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Manufacturing and royalty revenues |
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385,913 |
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85,326 |
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Research and development revenue |
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7 |
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106 |
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Total Revenues |
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617,397 |
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276,219 |
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Expenses: |
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Cost of goods manufactured and sold |
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63,260 |
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58,360 |
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Research and development |
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100,788 |
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92,873 |
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Selling, general and administrative |
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205,258 |
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150,377 |
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Amortization of acquired intangible assets |
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8,898 |
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9,066 |
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Total Expenses |
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378,204 |
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310,676 |
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Operating Income (Loss) |
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239,193 |
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(34,457 |
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Other Income, net: |
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Interest income |
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6,769 |
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896 |
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Interest expense |
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(5,684 |
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(2,369 |
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Other (expense) income, net |
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(525 |
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1,810 |
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Change in the fair value of contingent consideration |
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— |
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870 |
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Total Other Income, net |
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560 |
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1,207 |
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Income (Loss) Before Income Taxes |
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239,753 |
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(33,250 |
) |
Income Tax Provision (Benefit) |
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2,688 |
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(3,114 |
) |
Net Income (Loss) — GAAP |
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$ |
237,065 |
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$ |
(30,136 |
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Earnings (Loss) Per Share: |
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GAAP earnings (loss) per share — basic |
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$ |
1.43 |
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$ |
(0.18 |
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GAAP earnings (loss) per share — diluted |
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$ |
1.38 |
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$ |
(0.18 |
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Non-GAAP earnings per share — basic |
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$ |
0.57 |
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$ |
0.06 |
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Non-GAAP earnings per share — diluted |
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$ |
0.55 |
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$ |
0.06 |
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Weighted Average Number of Ordinary Shares Outstanding: |
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Basic — GAAP and Non-GAAP |
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166,279 |
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163,839 |
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Diluted — GAAP |
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171,553 |
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163,839 |
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Diluted — Non-GAAP |
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171,553 |
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168,706 |
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An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows: |
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Net Income (Loss) — GAAP |
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$ |
237,065 |
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$ |
(30,136 |
) |
Adjustments: |
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Share-based compensation expense |
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28,504 |
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23,377 |
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Depreciation expense |
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10,114 |
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10,326 |
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Amortization expense |
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8,898 |
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9,066 |
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Final award in the Janssen arbitration (2022 back royalties and interest) |
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(197,092 |
) |
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— |
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Separation expense |
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5,857 |
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|
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— |
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Income tax effect related to reconciling items |
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816 |
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(1,383 |
) |
Non-cash net interest expense |
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115 |
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117 |
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Change in the fair value of contingent consideration and other related assets |
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— |
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(870 |
) |
Non-GAAP Net Income |
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$ |
94,277 |
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$ |
10,497 |
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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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Six Months Ended |
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Six Months Ended |
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(In thousands, except per share data) |
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June 30, 2023 |
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June 30, 2022 |
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Revenues: |
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Product sales, net |
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$ |
446,204 |
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$ |
362,055 |
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Manufacturing and royalty revenues |
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458,775 |
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190,496 |
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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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13 |
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213 |
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Total Revenues |
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904,992 |
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554,764 |
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Expenses: |
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Cost of goods manufactured and sold |
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121,435 |
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113,519 |
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Research and development |
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194,425 |
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188,826 |
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Selling, general and administrative |
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379,735 |
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295,429 |
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Amortization of acquired intangible assets |
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17,698 |
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18,032 |
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Total Expenses |
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713,293 |
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615,806 |
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Operating Income (Loss) |
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191,699 |
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(61,042 |
) |
Other Income (Expense), net: |
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Interest income |
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11,735 |
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1,469 |
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Interest expense |
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(10,972 |
) |
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(4,719 |
) |
Other (expense) income, net |
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(564 |
) |
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4,241 |
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Change in the fair value of contingent consideration |
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— |
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(18,197 |
) |
Total Other Income (Expense), net |
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199 |
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(17,206 |
) |
Income (Loss) Before Income Taxes |
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191,898 |
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(78,248 |
) |
Income Tax Benefit |
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(3,322 |
) |
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(12,209 |
) |
Net Income (Loss) — GAAP |
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$ |
195,220 |
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$ |
(66,039 |
) |
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Earnings (Loss) Per Share: |
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GAAP earnings (loss) per share — basic |
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$ |
1.18 |
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$ |
(0.40 |
) |
GAAP earnings (loss) per share — diluted |
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$ |
1.14 |
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$ |
(0.40 |
) |
Non-GAAP earnings per share — basic |
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$ |
0.58 |
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$ |
0.18 |
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Non-GAAP earnings per share — diluted |
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$ |
0.57 |
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$ |
0.18 |
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Weighted Average Number of Ordinary Shares Outstanding: |
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|
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Basic — GAAP and Non-GAAP |
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165,686 |
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|
|
163,165 |
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Diluted — GAAP |
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|
170,747 |
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|
|
163,165 |
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Diluted — Non-GAAP |
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170,747 |
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|
|
167,372 |
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|
|
|
|
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An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows: |
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Net Income (Loss) — GAAP |
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$ |
195,220 |
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|
$ |
(66,039 |
) |
Adjustments: |
|
|
|
|
|
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Share-based compensation expense |
|
|
51,147 |
|
|
|
41,720 |
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Depreciation expense |
|
|
20,028 |
|
|
|
20,557 |
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Amortization expense |
|
|
17,698 |
|
|
|
18,032 |
|
Final award in the Janssen arbitration (2022 back royalties and interest) |
|
|
(197,092 |
) |
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|
0 |
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Separation expense |
|
|
9,640 |
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|
|
— |
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Income tax effect related to reconciling items |
|
|
(179 |
) |
|
|
(2,576 |
) |
Non-cash net interest expense |
|
|
231 |
|
|
|
234 |
|
Reduction in the fair value of contingent consideration and other related assets |
|
|
— |
|
|
|
18,197 |
|
Non-GAAP Net Income |
|
$ |
96,693 |
|
|
$ |
30,125 |
|
Alkermes plc and Subsidiaries |
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Selected Financial Information (Unaudited) |
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|
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|
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Condensed Consolidated Balance Sheets |
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June 30, |
|
|
December 31, |
|
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(In thousands) |
|
2023 |
|
|
2022 |
|
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Cash, cash equivalents and total investments |
|
$ |
907,176 |
|
|
$ |
740,075 |
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Receivables |
|
|
334,478 |
|
|
|
287,967 |
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Inventory |
|
|
189,372 |
|
|
|
181,418 |
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Contract assets |
|
|
— |
|
|
|
8,929 |
|
Prepaid expenses and other current assets |
|
|
44,452 |
|
|
|
43,527 |
|
Property, plant and equipment, net |
|
|
323,801 |
|
|
|
325,361 |
|
Intangible assets, net and goodwill |
|
|
112,855 |
|
|
|
130,553 |
|
Deferred tax assets |
|
|
153,152 |
|
|
|
115,602 |
|
Other assets |
|
|
121,898 |
|
|
|
130,546 |
|
Total Assets |
|
$ |
2,187,184 |
|
|
$ |
1,963,978 |
|
Accounts payable and accrued expenses |
|
$ |
465,691 |
|
|
$ |
472,204 |
|
Long-term debt — current portion |
|
|
3,000 |
|
|
|
3,000 |
|
Other current liabilities |
|
|
18,494 |
|
|
|
22,538 |
|
Long-term debt |
|
|
289,001 |
|
|
|
290,270 |
|
Other long-term liabilities |
|
|
130,561 |
|
|
|
132,213 |
|
Total shareholders' equity |
|
|
1,280,437 |
|
|
|
1,043,753 |
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Total Liabilities and Shareholders' Equity |
|
$ |
2,187,184 |
|
|
$ |
1,963,978 |
|
|
|
|
|
|
|
|
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Ordinary shares outstanding (in thousands) |
|
|
166,498 |
|
|
|
164,377 |
|
|
|
|
|
|
|
|
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This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the three and six months ended June 30, 2023, which the company intends to file in July 2023. |
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Second Quarter 2023 Financial Results & Business Update July 26, 2023 Exhibit 99.2
Forward-Looking Statements and Non-GAAP Financial Information 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 concerning its future financial, commercial and operating performance, business plans or prospects and the Company’s expectations regarding the timing of the planned separation of its oncology business. The Company cautions that forward-looking statements are inherently uncertain. The forward-looking statements contained in this presentation 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, assumptions and uncertainties. These risks, assumptions and uncertainties include, among others: the Company may not ultimately separate its oncology business during 2023 or at all; unanticipated developments, costs or difficulties may delay or otherwise negatively affect the planned separation of the Company’s oncology business; the planned separation may adversely impact the Company’s ability to attract or retain key personnel; 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; 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 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; 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 for the year ended Dec. 31, 2022 and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 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 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®. 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.
Q2 2023 Financial Performance
In millions Q2 2023 Financial Results Summary Total Revenue* In millions GAAP Net Income (Loss) In millions Non-GAAP Net Income** *Following the successful outcome of the Company’s arbitration with Janssen Pharmaceutica N.V. (“Janssen”), a subsidiary of Johnson & Johnson, the Company recorded related revenues of $325.3 million, which included $197.1 million of back royalties and associated interest on late payments related to 2022, and $51.3 million of royalties related to the first quarter of 2023. **Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation. Non-GAAP net income excludes Janssen back royalties and associated interest on late payments related to 2022 of $197.1 million.
Q2 2023 Janssen Revenues* (millions) Long-acting INVEGA® Product** Revenues CABENUVA® Revenues Total Revenues FY'22 royalties on U.S. net sales $187.3 $1.7 $189.0 FY'22 interest on late payments $8.1 $0.1 $8.1 FY'23 Q1 royalties on U.S. net sales $50.2 $1.1 $51.3 FY'23 Q2 royalties on WW net sales $75.7 $1.3 $76.9 Total revenues included in Q2 GAAP results $321.2 $4.1 $325.3 FY'22 royalties and interest on late payments $195.4 $1.7 $197.1 Total revenues included in Q2 non-GAAP results $125.9 $2.4 $128.3 Amounts in the table above may not sum due to rounding. *Following the successful outcome of the Company’s arbitration with Janssen announced June 6, 2023. **Long-acting INVEGA Products: INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI®
Q2 2023 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® **Following the successful outcome of the Company’s arbitration with Janssen, the Company recorded related revenues of $325.3 million, which included $197.1 million of back royalties and associated interest on late payments related to 2022, and $51.3 million of royalties related to the first quarter of 2023. LYBALVI was commercially launched in October 2021. In millions, except % Q2’23 Q2’22 ∆Q2’23 vs. Q2’22 Total Proprietary Net Sales $231.5 $190.8 21% VIVITROL® $102.1 $96.1 6% ARISTADA®* $82.4 $74.6 10% LYBALVI® $47.0 $20.1 134% Manufacturing & Royalty Revenue** $385.9 $85.3 352% Research & Development Revenue $0.0 $0.1 - Total Revenue** $617.4 $276.2 124%
Alkermes: 2023 Financial Expectations1 1 “Financial Expectations for Year Ending Dec. 31, 2023” and “Janssen royalty expectations”, on the one hand, and “Expected net sales of proprietary products”, on the other hand, were initially provided by the Company on June 6, 2023 and Feb. 16, 2023, respectively. The Company reiterates these expectations as of July 26, 2023, and such expectations are effective only as of this 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, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2023 Total Revenues $1,550 – $1,680 COGS $230 – $250 R&D Expense $370 – $400 SG&A Expense $695 – $725 Amortization of Intangible Assets ~$35 Interest Expense, net $5 – $10 Income Tax Benefit $5 – $10 GAAP Net Income $225 – $265 GAAP Earnings Per Share (Diluted) $1.31 – $1.54 Non-GAAP Net Income $230 – $270 Non-GAAP Earnings Per Share (Diluted) $1.34 – $1.57 The Company’s 2023 financial expectations continue to reflect Alkermes’ combined neuroscience and oncology business for the full year. The Company continues to work toward the planned separation of its oncology business, which it continues to expect to complete in the second half of 2023. Total Revenues Breakdown: Expected net sales of proprietary products: VIVITROL® net sales of $380M – $410M ARISTADA® net sales of $315M – $345M LYBALVI® net sales of $180M – $205M Janssen royalty expectations: Long-acting INVEGA® franchise back royalties and interest on late payments related to 2022: ~$197M INVEGA® franchise royalties related to 2023: $265M – $280M
Q2 2023 Commercial Review
Topline Growth and Diversification Reflect Evolving Business *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing revenue) R12M = Rolling Twelve Months Key Product Revenues ($M)
LYBALVI® Prescription Growth Trends Q2’23 total TRx: ~38,300 reflecting 16% sequential growth compared to Q1’23 ~11,150 prescribers had written a prescription for LYBALVI (as of 6/30/23) since launch *Source: IQVIA NPA Weekly Post-Launch TRx* (Through 7/14/23) TRx Week
LYBALVI® Performance and Expectations *These expectations were initially provided by the Company on Feb. 16, 2023. The Company reiterates these expectations as of July 26, 2023 and such expectations are effective only as of this date. The Company expressly disclaims any obligation to update or reaffirm these expectations. LYBALVI Quarterly Net Sales ($M) Q2’23 net sales of $47.0M reflect 24% sequential growth compared to Q1’23 Q2’23 gross-to-net deductions: ~26%, reflecting the Company’s commercial access strategy to limit rebates at this stage of launch Outlook: FY’23 net sales expected to range from $180M – $205M*
ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales ($M)* Q2’23 year-over-year net sales increased 10% to $82.4M Outlook: FY’23 net sales expected to range from $315M – $345M* *Inclusive of ARISTADA INITIO® These expectations were initially provided by the Company on Feb. 16, 2023. The Company reiterates these expectations as of July 26, 2023 and such expectations are effective only as of this date. The Company expressly disclaims any obligation to update or reaffirm these expectations.
VIVITROL® Performance and Expectations *These expectations were initially provided by the Company on Feb. 16, 2023. The Company reiterates these expectations as of July 26, 2023 and such expectations are effective only as of this date. The Company expressly disclaims any obligation to update or reaffirm these expectations. VIVITROL Quarterly Net Sales ($M) Q2’23 year-over-year net sales increased 6% to $102.1 Outlook: FY’23 net sales expected to range from $380M – $410M*
Appendix
Appendix: Financial Results GAAP to Non-GAAP Adjustments (In millions) Three Months Ended June 30, 2023 Net Income — GAAP $ 237.1 Adjustments: Share-based compensation expense 28.5 Depreciation expense 10.1 Amortization expense 8.9 Final award in the Janssen arbitration (2022 back royalties and interest on late payments) (197.1) Separation expense 5.9 Income tax effect related to reconciling items 0.8 Non-cash net interest expense 0.1 Non-GAAP Net Income $ 94.3
Appendix: 2023 Guidance GAAP to Non-GAAP Adjustments (In millions, except per share data) Year Ended December 31, 2023 Year Ending December 31, 2023 Shares+ Earnings Per Share Projected Net Income — GAAP $ 245.0 171.5 $ 1.43 Adjustments: Share-based compensation expense 97.5 Depreciation expense 42.5 Amortization expense 35.0 Separation expense 21.0 Income tax effect related to reconciling items 3.5 Non-cash net interest expense 0.5 Final award in the Janssen arbitration (2022 back royalties and interest on late payments)* (195.0) Projected Net Income — Non-GAAP $ 250.0 171.5 $ 1.46 Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges. +2023 per share expectations are calculated based on a weighted average diluted share count of approximately 171.5 million shares outstanding. *Back royalties and interest on late payments related to 2022 pursuant to final award related to arbitration proceedings with Janssen.
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