ALKERMES PLC First Quarter 2024
Financial Results & Business Update
May 1, 2024
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 with respect to its current and future financial, commercial and operating performance, business plans or prospects, including its expected cash and revenue generation, expectations of profitability and potential return of capital to shareholders; 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 study design and timelines and presentation of clinical data 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 for the year ended Dec. 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-GAAPFinancial 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®. 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.
2 | © 2024 Alkermes. All rights reserved. |
Q1 2024 Financial and Operational Performance
Q1 2024 Financial Results Summary
Total Revenue
In millions
$350.4 | |
$287.6 | |
Q1 2023 | Q1 2024* |
GAAP Net Income (Loss)
In millions
$36.8
($41.8)
Q1 2023 | Q1 2024 |
GAAP Earnings (Loss) Per Share
Diluted
$0.21
($0.25)
Q1 2023 | Q1 2024 |
*Reflects reinstatement of certain U.S. royalties following the successful outcome of the Company's arbitration with Janssen Pharmaceutica N.V. ("Janssen"), a subsidiary of Johnson & Johnson, announced in June 2023.
4 | © 2024 Alkermes. All rights reserved. |
Q1 2024 Profitability From Continuing Operations
GAAP Net Income (Loss)
From Continuing Operations
In millions
$38.9
($12.1)
Q1 2023 | Q1 2024 |
EBITDA*
From Continuing Operations
In millions
$51.5 | |
$7.2 | |
Q1 2023 | Q1 2024 |
Non-GAAP Net Income*
From Continuing Operations
In millions
$76.2 | |
$30.1 | |
Q1 2023 | Q1 2024 |
*Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation. EBITDA (earnings before interest, taxes, depreciation and amortization)
5 | © 2024 Alkermes. All rights reserved. |
Q1 2024 Revenue Summary
In millions, except % | Q1'24 | Q1'23 | ∆ | ||
Q1'24 vs. Q1'23 | |||||
Total Proprietary Net Sales | $233.5 | $214.7 | 9% | ||
VIVITROL® | $97.7 | $96.7 | 1% | ||
ARISTADA®* | $78.9 | $80.1 | (2%) | ||
LYBALVI® | $57.0 | $38.0 | 50% | ||
Manufacturing & Royalty Revenue** | $116.8 | $72.9 | 60% | ||
Total Revenue** | $350.4 | $287.6 | 22% | ||
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.
6 | © 2024 Alkermes. All rights reserved. |
Alkermes: 2024 Financial Expectations*
(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 - $295M
*These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on May 1, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations.
‡Reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Appendix of this presentation.
7 | © 2024 Alkermes. All rights reserved. |
Q1 2024 Commercial Review
LYBALVI® Performance and Expectations
LYBALVI Quarterly Net Sales ($M)
$60 | ||||||||
$50 | ||||||||
$40 | ||||||||
$30 | ||||||||
$20 | ||||||||
$10 | ||||||||
$0 | ||||||||
Q1'22 | Q2'22 | Q3'22 | Q4'22 | Q1'23 | Q2'23 | Q3'23 | Q4'23 | Q1'24 |
Q1'24 net sales of $57.0M reflects 1% sequential growth compared to Q4'23
- Q1'24 gross-to-net deductions: ~29%
- Inventory in the channel decreased by
~$2.3M during Q1'24
Outlook:
- FY'24 net sales expected to range from $275M - $295M*
*These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on May 1, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations.
9 | © 2024 Alkermes. All rights reserved. |
LYBALVI® Prescription Growth Trends
Post-Launch TRx*
(Through 4/19/24)
5,000 | |||||||||||||||||||||||||||||||||
4,500 | |||||||||||||||||||||||||||||||||
4,000 | |||||||||||||||||||||||||||||||||
3,500 | |||||||||||||||||||||||||||||||||
3,000 | |||||||||||||||||||||||||||||||||
TRx | 2,500 | ||||||||||||||||||||||||||||||||
2,000 | |||||||||||||||||||||||||||||||||
1,500 | |||||||||||||||||||||||||||||||||
1,000 | |||||||||||||||||||||||||||||||||
500 | |||||||||||||||||||||||||||||||||
0 | 13 | 17 | 21 | 25 | 29 | 33 | 37 | 41 | 45 | 49 | 53 | 57 | 61 | 65 | 69 | 73 | 77 | 81 | 85 | 89 | 93 | 97 | |||||||||||
1 | 5 | 9 | 101 | 105 | 109 | 113 | 117 | 121 | 125 | 129 | |||||||||||||||||||||||
By Week | 4 Week Rolling Average | ||||||||||||||||||||||||||||||||
Week |
*Source: IQVIA NPA Weekly
Q1'24 total TRx:
- ~49,600 reflecting 6% sequential growth compared to Q4'23
10 | © 2024 Alkermes. All rights reserved. |
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Alkermes plc published this content on 01 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 10:07:33 UTC.
