false Alkermes plc. 0001520262 0001520262 2021-10-27 2021-10-27

 

 

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): October 27, 2021

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 October 27, 2021, Alkermes plc (the “Company”) announced financial results for the three and nine months ended September 30, 2021. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on October 27, 2021 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 October 27, 2021 announcing financial results for the three and nine months ended September 30, 2021.
99.2		Investor presentation to be displayed by Alkermes plc on October 27, 2021.
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: October 27, 2021	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 Third Quarter 2021 Financial Results

— Third Quarter Revenues of $294.1 Million Reflect 11% Growth Year-Over-Year —

— Diluted GAAP Loss per Share of $0.18 and Diluted Non-GAAP Earnings per Share of $0.14 —

— Company Reiterates Financial Expectations for 2021 —

 

DUBLIN, Oct. 27, 2021 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2021.

 

“We have made significant strides across our commercial and development portfolios over the course of 2021. With the recent commercial launch of LYBALVI^®, we have expanded our psychiatry franchise and added an important new growth opportunity that leverages our experience and capabilities in the antipsychotic market. Within our development pipeline, we initiated clinical studies designed to support potential registration of nemvaleukin in mucosal melanoma and platinum-resistant ovarian cancer. We also initiated a phase 1 study of ALKS 1140 and advanced our preclinical orexin 2 receptor agonist program. Each of these important achievements demonstrates the continued execution of our strategy to advance differentiated medicines in neuroscience and oncology,” said Richard Pops, Chief Executive Officer of Alkermes. “As we look ahead, we believe we are well-positioned to deliver long-term growth and value creation, driven by our diversified commercial business, our advancing development pipeline and our focus on profitability.”

 

Quarter Ended Sept. 30, 2021 Financial Results

Revenues

Costs and Expenses

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Profitability

 

Balance Sheet

 

Financial Expectations for 2021

Alkermes reiterates its financial expectations for 2021 set forth in its press release dated July 28, 2021. These financial expectations assume improvement in patient access to treatment providers and further normalization of the treatment system in the fourth quarter of 2021. If patient access does not improve or the treatment system does not normalize as anticipated, or if new COVID-19-related disruptions emerge, the company’s ability to meet these expectations could be negatively impacted.

 

“We are pleased to report another strong quarter that reflects our continued focus on commercial execution, with solid year-over-year growth for VIVITROL and ARISTADA, and on driving operational efficiencies,” commented Iain Brown, Chief Financial Officer of Alkermes. “As we look ahead, we believe that we are in a strong financial position to successfully launch LYBALVI and invest in our pipeline of development candidates as we seek to drive long-term value creation and profitability.”

 

Recent Events:

Psychiatry

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Oncology

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, Oct. 27, 2021, 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 addiction, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has an R&D 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 earnings (loss) 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 (loss) 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; 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 measures of the

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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 (loss) and non-GAAP basic and diluted earnings (loss) 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 (loss) and non-GAAP basic and diluted earnings (loss) 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 deliver, and the expected drivers of, growth and value creation; the company’s expectations of improvement in patient access to treatment providers and further normalization of the treatment system; the potential therapeutic and commercial value of the company’s marketed and development products; the company’s expectations concerning its future development activities, including further investment in and advancement of the company’s neuroscience and oncology development pipeline; and the company’s expectations concerning its commercial activities, including its ability to successfully launch LYBALVI and to leverage its commercial experience and capabilities in the antipsychotic market. 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 be able to achieve its targeted financial and profitability metrics in a timely manner or at all; unexpected costs or delays in the commercial launch of LYBALVI; whether LYBALVI will be commercialized successfully; whether third-party payers will cover or reimburse LYBALVI for the treatment of adults with schizophrenia or the treatment of adults with bipolar I disorder; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company’s business, results of operations or financial condition, including impacts on healthcare systems and patient and healthcare provider access to the company’s commercial products and impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; the unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, 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; data from clinical trials may be interpreted by the FDA in different ways than the company interprets it; the FDA may not agree with the company’s regulatory approval strategies or components of its filings, including its clinical trial designs, conduct and methodologies and the adequacy of the data and other information included in its submissions to support the FDA’s requirements for approval; regulatory submissions may not occur or be submitted in a timely manner; 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; 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, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s

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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; RISPERDAL CONSTA^®, INVEGA SUSTENNA^®, XEPLION^®, INVEGA TRINZA^® and TREVICTA^® are registered trademarks of Johnson & Johnson Company; and VUMERITY^® is a registered trademark of Biogen MA Inc., used by Alkermes under license.

 

 

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Third Quarter 2021 Financial Results & Business Update October 27, 2021 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: the company’s expectations with respect to its future financial, commercial and operating performance, business plans or prospects, including the company’s expectations of improvement in patient access to treatment providers and further normalization of the treatment system in the fourth quarter of 2021; and the potential therapeutic and commercial value of the company’s marketed and development products. 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 be able to achieve its targeted financial and profitability metrics in a timely manner or at all; unexpected costs or delays in the commercial launch of LYBALVI; whether LYBALVI will be commercialized successfully; whether third-party payers will cover or reimburse LYBALVI for the treatment of adults with schizophrenia or the treatment of adults with bipolar I disorder; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company’s business, results of operations or financial condition; the unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, 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 (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; 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, 2020 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. 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 these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Alkermes plc Current Reports on Form 8-K filed with the SEC on July 28, 2021 and Oct. 27, 2021. Note Regarding Trademarks: The company is the owner of various U.S. federal trademark registrations (®) and other trademarks (TM), including ALKERMES®, 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, Corporate Affairs & Investor Relations Welcome Richard Pops, Chief Executive Officer Q3 2021 Financial Results Iain Brown, Chief Financial Officer Q3 2021 Commercial Review Todd Nichols, Chief Commercial Officer Q3 2021 R&D Update Craig Hopkinson, Chief Medical Officer Q&A

Q3 2021 Financial Results Summary In millions In millions In millions

Q3 2021 Revenue Summary * Inclusive of ARISTADA INITIO® Amounts in the table above do not sum due to rounding.

VIVITROL® Performance and Expectations Q3’21 year-over-year net sales increased 11% to $88.8M, driven by unit growth of 7.5% Gross-to-net deductions: 52.3% in Q3’21, compared to 52.8% in Q3’20 Inventory levels increased sequentially by ~$1.5M in line with increasing demand trends and typical seasonal patterns   FY’21 net sales expected to range from $330M - $345M* VIVITROL Quarterly Net Sales ($M) * These expectations were initially provided by Alkermes plc (the “Company”) in its Current Report on Form 8-K (“Form 8-K”) filed with the SEC on July 28, 2021. These expectations are reiterated by the Company in its Form 8-K filed with the SEC on Oct. 27, 2021 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. These expectations assume improvement in patient access to treatment providers and further normalization of the treatment system in the fourth quarter of 2021. If patient access does not improve or the treatment system does not normalize as anticipated, or if new COVID-19-related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.

ARISTADA® Performance and Expectations Q3’21 year-over-year net sales increased 10% to $68.9M, driven by unit growth of 10% Gross-to-net deductions: 54.8% in Q3’21, compared to 53.7% in Q3’20 Inventory levels decreased by ~$1M in Q3’21 following ~$6M increase in inventory levels in Q2’21 FY’21 net sales expected to range from $275M - $290M† ARISTADA Quarterly Net Sales ($M)* *Inclusive of ARISTADA INITIO® † These expectations were initially provided by the Company in its Form 8-K filed with the SEC on July 28, 2021. These expectations are reiterated by the Company in its Form 8-K filed with the SEC on Oct. 27, 2021 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. These expectations assume improvement in patient access to treatment providers and further normalization of the treatment system in the fourth quarter of 2021. If patient access does not improve or the treatment system does not normalize as anticipated, or if new COVID-19-related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.

ARISTADA®: Prescription Growth Trends Q3’21 year-over-year growth of 15% on TRx months of therapy (MOT) basis Outpaced overall atypical long-acting injectable (LAI) market Q3’21 year-over-year growth of 6% Market share: TRx MOT: 9.8% of atypical LAI market prescriptions in Q3’21 ARISTADA Quarterly TRx MOT Source: IQVIA NPA

Strong Commercial and Operational Execution Commercial Execution Drove solid VIVITROL® and ARISTADA® year-over-year growth Commenced launch of LYBALVI®, which became commercially available in October Nemvaleukin Alfa (“nemvaleukin”) Granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of mucosal melanoma in August Granted FDA Fast Track designation in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer in October Initiated ARTISTRY-7, a global phase 3 trial evaluating the anti-tumor activity and safety of intravenously administered (IV) nemvaleukin in combination with pembrolizumab compared to investigator’s choice chemotherapy in patients with platinum-resistant ovarian cancer ALKS 1140 Initiated a phase 1, first-in-human study evaluating the safety and tolerability of ALKS 1140 in healthy subjects in October; ALKS 1140 is a novel, investigational CoREST-selective (co-repressor of repressor element-1 silencing transcription factor) HDAC inhibitor candidate for the treatment of neurodegenerative and neurodevelopmental disorders Preclinical Pipeline Commenced IND-enabling activities for ALKS 2680 orexin 2 receptor agonist program

Alkermes: 2021 Financial Expectations* * These expectations were initially provided by the Company in its Form 8-K filed with the SEC on July 28, 2021. These expectations are reiterated by the Company in its Form 8-K filed with the SEC on Oct. 27, 2021 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. These expectations assume improvement in patient access to treatment providers and further normalization of the treatment system in the fourth quarter of 2021. If patient access does not improve or the treatment system does not normalize as anticipated, or if new COVID-19-related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted. ‡ Non-GAAP net income adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; certain other one-time or non-cash items; and the income tax effect of these reconciling items. Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Company’s Form 8-K filed with the SEC on July 28, 2021. Expected net sales of proprietary products: VIVITROL® net sales of $330M – $345M ARISTADA® net sales of $275M – $290M LYBALVI® net sales of <$10M

www.alkermes.com