false Alkermes plc. 0001520262 0001520262 2023-04-26 2023-04-26

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): April 26, 2023

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

Ireland		001-35299				98-1007018
(State or other jurisdiction		(Commission				(IRS Employer
of incorporation)		File Number)				Identification No.)
Connaught House, 1 Burlington Road
Dublin 4, Ireland D04 C5Y6
(Address of principal executive offices)

 

Registrant's telephone number, including area code: + 353-1-772-8000

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):

 

☐		Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐		Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐		Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐		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		Trading Symbol(s)		Name of each exchange on which registered
Ordinary shares, $0.01 par value		ALKS		Nasdaq Global Select Market

 

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).

 

		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. ☐

 

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

 

On April 26, 2023, Alkermes plc (the “Company”) announced financial results for the three months ended March 31, 2023. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on April 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.		Description
99.1		Press release issued by Alkermes plc dated April 26, 2023 announcing financial results for the three months ended March 31, 2023.
99.2		Investor presentation to be displayed by Alkermes plc on April 26, 2023.
104		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.

 

	ALKERMES PLC
Date: April 26, 2023	By:		/s/ Iain M. Brown
			Iain M. Brown
			Senior Vice President, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 

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Exhibit 99.1

 

Alkermes plc Reports First Quarter 2023 Financial Results

— First Quarter Revenues of $287.6 Million Reflect Strong Performance of Proprietary Product Portfolio —

— GAAP Loss per Share of $0.25 and Basic and Diluted Non-GAAP Earnings per Share of $0.01 —

— Planned Separation of Oncology Business Expected to be Completed in Second Half of 2023 —

— Second Favorable Interim Award Received in Janssen Arbitration —

— Financial Expectations for 2023 Reiterated —

DUBLIN, April 26, 2023 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2023.

 

“During the first quarter we made continued progress across our portfolio, including strong commercial execution driving growth for our proprietary products – LYBALVI^®, VIVITROL^® and ARISTADA^® – and important progress in the development of ALKS 2680, our orexin 2 receptor agonist, which is now poised to enter a phase 1b proof-of-concept study in patients with narcolepsy and idiopathic hypersomnia, with data expected later this year,” said Richard Pops, Chief Executive Officer of Alkermes. “In addition, we made significant operational and strategic advances in the planned separation of our oncology business, which remains on track for completion in the second half of this year. We remain sharply focused on executing our strategic priorities to create significant value for shareholders.”

 

“Our strong first quarter financial results were driven by 25% growth year-over-year in proprietary product net sales and continued focus on disciplined management of our cost structure,” commented Iain Brown, Chief Financial Officer of Alkermes. “Today, we are reiterating our financial expectations for 2023 and believe we are in a strong financial position to continue to execute our strategic priorities, including further driving the launch of LYBALVI, advancing our orexin 2 receptor agonist clinical development program and completing the planned separation of the oncology business later this year.”

 

Quarter Ended March 31, 2023 Financial Results

Revenues

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Costs and Expenses

Profitability

Balance Sheet

 

Financial Expectations for 2023

Alkermes reiterates its financial expectations for 2023, as set forth in its press release dated Feb. 16, 2023.

 

Separation of Oncology Business

Alkermes continues to make meaningful progress on the previously announced planned separation of the company’s oncology business. 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.

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Recent Events

Corporate

Neuroscience

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, April 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 (loss) and non-GAAP basic and diluted (loss) 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.

 

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Non-GAAP net (loss) 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 (loss) income and non-GAAP basic and diluted (loss) 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 (loss) income and non-GAAP basic and diluted (loss) 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 execute on its strategic priorities and create value for shareholders; the company’s expectations regarding the royalties and interest due to the company and royalty terms under the license agreements with Janssen; the company’s expectations regarding the timing, structure, anticipated benefits and other impacts of the planned separation of the oncology business; timelines, plans and expectations for development activities relating to ALKS 2680; 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 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 a potential separation of the company’s neuroscience and oncology businesses; disruption to the company’s operations resulting from the planned separation; the planned separation may adversely impact the company’s ability to attract or retain key personnel; the terms of the final award to be issued by the Tribunal may differ from the terms of the interim awards issued by the Tribunal and may be challenged by Janssen; 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; the impacts of the ongoing COVID-19 pandemic on the company’s business, results of operations or financial condition, including impacts on healthcare systems and on patient and healthcare provider access to the company’s marketed products; 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

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proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K and in subsequent filings made by the company with the SEC, which are available on the SEC’s website atwww.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)

 

 

 

 

 

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First Quarter 2023 Financial Results & Business Update April 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, including the assumptions underlying such expectations and its expected value drivers and its ability to execute on its strategy and business priorities; the Company’s expectations regarding the timing, structure, anticipated benefits and other impacts of the planned separation of the oncology business; timelines, plans and expectations for development activities relating to ALKS 2680; and the potential therapeutic and commercial value of the Company’s products and product candidates. 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 that may delay or otherwise negatively affect a potential separation of the Company’s neuroscience and oncology businesses; disruption to the Company’s operations resulting from the planned separation; 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, including the arbitration proceedings with Janssen Pharmaceutica N.V. (“Janssen”); 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 most recent annual report 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.

Agenda Introduction Sandy Coombs, SVP, Investor Relations & Corporate Affairs Opening Remarks Richard Pops, Chief Executive Officer Q1 2023 Financial Results Iain Brown, Chief Financial Officer Q1 2023 Commercial Review Todd Nichols, Chief Commercial Officer Business Update Richard Pops, Chief Executive Officer Q&A

Q1 2023 Financial Performance

In millions Q1 2023 Financial Results Summary** Total Revenue In millions GAAP Net Loss In millions Non-GAAP Net Income* *Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation. **In Q1’23, royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® (the “long-acting INVEGA products”) were $13.6 million, compared to $37.1 million in Q1’22. This decrease was driven primarily by Janssen’s partial termination of the license agreement related to sales of the long-acting INVEGA products in the U.S., effective Feb. 2, 2022. The Company and Janssen are engaged in ongoing arbitration proceedings related to, among other things, Janssen’s royalty and other obligations under the license agreement.

Q1 2023 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® **In Q1’23, royalty revenues from long-acting INVEGA products were $13.6 million, compared to $37.1 million in Q1’22. This decrease was driven primarily by Janssen’s partial termination of the license agreement related to sales of the long-acting INVEGA products in the U.S., effective Feb. 2, 2022. The Company and Janssen are engaged in ongoing arbitration proceedings related to, among other things, Janssen’s royalty and other obligations under the license agreement. †LYBALVI was commercially launched in October 2021.

Alkermes: 2023 Financial Expectations* *These expectations were initially provided by the Company on Feb. 16, 2023, are reiterated by the Company on April 26, 2023 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. 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 Assumes $40M – $45M of royalties related to sales of XEPLION®, TREVICTA® and BYANNLI® outside the U.S. through July 2023

Q1 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 *Source: IQVIA NPA Weekly Q1’23 total TRx: ~33,000 reflecting 16% sequential growth compared to Q4’22 ~9,300 prescribers had written a prescription for LYBALVI (as of 3/31/23) since launch Post-Launch TRx* (Through 4/14/23) TRx Week

LYBALVI® Performance and Expectations *These expectations were initially provided by the Company on Feb. 16, 2023, are reiterated by the Company on April 26, 2023 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) Q1’23 net sales of $38.0M reflect 9% sequential growth compared to Q4’22 Q1’23 gross-to-net deductions: ~26%, primarily reflecting the continuation of less restrictive initial commercial payer coverage Outlook: FY’23 net sales expected to range from $180M – $205M*

ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales ($M)* Q1’23 year-over-year net sales increased 10% to $80.1M 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, are reiterated by the Company on April 26, 2023 and are effective only as of such 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, are reiterated by the Company on April 26, 2023 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. VIVITROL Quarterly Net Sales ($M) Q1’23 year-over-year net sales increased 14% to $96.7M Outlook: FY’23 net sales expected to range from $380M – $410M*

Business Update

Clear Priorities to Unlock Value in 2023 2023 Business Priorities and Value Drivers Drive launch of LYBALVI® Continued execution of commercial strategy and investment in DTC campaign Advance orexin 2 receptor agonist Establish initial safety and tolerability profile and generate initial clinical proof-of-concept data for ALKS 2680 Separate oncology business Clarify value proposition for standalone neuroscience and oncology businesses DTC: Direct-to-consumer

Oncology Business Separation Updates

ALKS 2680 Clinical Development Plan Targeting Clinical Proof-of-Concept Data by Year-End 2023 Phase 1b Proof-of-Concept (POC) Study Objective: Early POC data + dose range estimation for phase 2 in lead indications Key Assessments: EEG-based maintenance of wakefulness test as primary efficacy/PD readout Drug exposure  Evaluate safety and tolerability Study initiation expected Q2 2023; Preliminary data expected by year-end Phase 1 First-in-Human (FIH) Studies Objective: Measure and model pharmacokinetics (PK)/ pharmacodynamics (PD) and evaluate safety and tolerability of single and multiple ascending doses Key Assessments: Drug exposure Evaluate safety and tolerability of single and multiple ascending doses Exploratory assessment of target engagement: qEEG trends in power of frequency bands Single-ascending dose study ongoing; Multiple-ascending dose study initiated in Q1 2023 EEG: electroencephalogram; qEEG: quantitative electroencephalogram

Appendix

Appendix: Financial Results GAAP to Non-GAAP Adjustments Amounts in the table above may not sum due to rounding.

Appendix: 2023 Guidance GAAP to Non-GAAP Adjustments 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 basic share count of approximately 166.5 million shares outstanding and a weighted average diluted share count of approximately 171.5 million shares outstanding.

www.alkermes.com