false Alkermes plc. 0001520262 0001520262 2020-10-29 2020-10-29

 

 

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 29, 2020

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 29, 2020, Alkermes plc (the “Company”) announced financial results for the three and nine months ended September 30, 2020 and updated certain financial expectations for the year ending December 31, 2020. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on October 29, 2020 discussing such financial results and updated financial expectations are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively. This information, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press release issued by Alkermes plc dated October 29, 2020 announcing financial results for the three and nine months ended September 30, 2020 and updating certain financial expectations for the year ending December 31, 2020.
99.2		Investor presentation to be displayed by Alkermes plc on October 29, 2020.
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 29, 2020	By:		/s/ James M. Frates
			James M. Frates
			Senior Vice President and Chief Financial Officer (Principal Financial Officer)

 

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Exhibit 99.1

 

Alkermes plc Reports Third Quarter 2020 Financial Results and

Raises 2020 Financial Expectations

— Company Reports Third Quarter Revenues of $265.0 Million, GAAP Net Loss per Share of $0.00 and Basic and Diluted Non-GAAP Earnings per Share of $0.26 —

— ARISTADA^® Net Sales of $62.4 Million Reflect 16% Year-Over-Year Growth —

— VIVITROL^® Net Sales Increased 12% Sequentially to $80.3 Million —

 

DUBLIN, Ireland, Oct. 29, 2020 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2020 and provided updated financial expectations for full-year 2020.

 

“Over the past several months, we achieved a number of important milestones in our development programs against the backdrop of strong commercial execution and disciplined management of our expenses. The positive outcome of the ALKS 3831 FDA Advisory Committee meeting and the presentation of accumulating data for ALKS 4230, including monotherapy responses observed in melanoma, were significant achievements that underscore the potential value of these investigational medicines,” said Richard Pops, Chief Executive Officer of Alkermes. “As we look ahead, we will continue to focus on our strategic imperatives: commercial execution, including preparations for the potential launch of ALKS 3831, aggressive development of our pipeline candidates, and efficient management of our operating cost structure, as we position the company for long-term value creation.”

 

Quarter Ended Sept. 30, 2020 Financial Highlights

 

Quarter Ended Sept. 30, 2020 Financial Results

Revenues

 

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Costs and Expenses

 

Balance Sheet

 

“Our third quarter results reflect strong commercial execution, with the sequential growth of both VIVITROL and ARISTADA net sales within a complex and dynamic COVID-19 market environment. Today, we are pleased to be raising our financial guidance for 2020 to reflect this solid performance. Importantly, expectations for 2020 non-GAAP net income are back in line with the expectations provided in February prior to the impact of COVID-19, primarily due to disciplined management of our expenses,” commented James Frates, Chief Financial Officer of Alkermes. “As we approach the end of 2020, we believe we are well-positioned to execute on our strategic imperatives to drive long-term profitability and growth.”

 

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Financial Expectations for 2020

The following financial expectations for 2020 are based on recent trends and assume that treatment provider practices and patient access to the company’s commercial products continue to normalize. New COVID-19-related restrictions or a resurgence of COVID-19 could impact the company’s ability to meet these expectations. All line items are according to GAAP, except as otherwise noted.

 

 

Recent Events

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Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (12:00 p.m. GMT) on Thursday, Oct. 29, 2020, to discuss these financial results, financial expectations, 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 will be available from 11:00 a.m. ET (3:00 p.m. GMT) on Thursday, Oct. 29, 2020, through Thursday, Nov. 5, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13712082.

 

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 and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc 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 one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; changes in the fair value of the contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

 

The company’s management and the Board utilize these non-GAAP financial measures to evaluate the company’s performance. The company provides these non-GAAP 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 (loss) and non-GAAP basic and diluted earnings (loss) per share are not measures of financial performance under GAAP

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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 future financial and operating performance, business plans or prospects, including the anticipated ongoing impacts of COVID-19 on the company’s business and financial performance, the company’s assumptions with respect to continued normalization of patient and healthcare provider practices, and the company’s ability to drive long-term value creation and profitability; the potential therapeutic and commercial value of the company’s marketed and development products; the company’s expectations concerning future development activities for the company’s development candidates; the company’s expectations regarding the FDA’s review of the ALKS 3831 NDA, including the FDA’s PDUFA target action date for the NDA; and expectations concerning the company’s commercial activities, including the potential launch of ALKS 3831. 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 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 the vendors or distribution channels in its supply chain, and the company’s ability to continue to manufacture its products; impacts on its ability to continue its discovery activities; impacts on the conduct of its clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites and monitoring of data; impacts on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia and on patient and healthcare provider access to the company’s medicines; impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; impacts on reimbursement for the company’s products, including its Medicaid rebate liability, and for services related to the use of its products; and impacts on the U.S., Irish and/or global economies more broadly; the unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, related to any of the company’s products or products using the company’s proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company’s clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; 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, such as decisions not to approve the company’s NDAs, including the NDA for ALKS 3831; data from clinical trials may be interpreted by the FDA in different ways than the company or an advisory committee interprets it; the FDA may not agree with the company’s regulatory approval strategies or components of its ALKS 3831 NDA or other regulatory filings, including the company’s clinical trial designs, conduct and methodologies, manufacturing processes and facilities, and the adequacy of the data and other information included in its filings to meet the FDA’s requirements for approval, including the risk/benefit profile of the company’s product candidates; 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 governmental 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

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for the year ended Dec. 31, 2019, the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 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. 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.

 

Trademarks

VIVITROL^® is a registered trademark of Alkermes, Inc.; ARISTADA^® and ARISTADA INITIO^® are registered trademarks of Alkermes Pharma Ireland Limited; and RISPERDAL CONSTA^®, INVEGA SUSTENNA^®, XEPLION^®, INVEGA TRINZA^® and TREVICTA^® are registered trademarks of Johnson & Johnson.

 

(tables follow)

 

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Third Quarter 2020 Financial Results & Business Update October 29, 2020 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 and operating performance, business plans or prospects; the potential therapeutic and commercial value of the company’s marketed and development products; the company’s expectations and assumptions regarding the future impacts of COVID-19 on its business; the company’s expectations concerning future regulatory activities and interactions, including expected timing of the U.S. Food and Drug Administration’s (“FDA”) target Prescription Drug User Fee Act (“PDUFA”) action date for the new drug application (“NDA”) for ALKS 3831 and, if approved, Drug Enforcement Administration de-scheduling of ALKS 3831; the company’s expectations concerning future development activities, including with respect to the ongoing ARTISTRY clinical development program and plans to present data from the program at a medical meeting; the company’s expectations concerning its commercial activities and capabilities, including launch planning strategies and activities for the potential launch of ALKS 3831. 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: 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 the vendors or distribution channels in its supply chain and the company’s ability to continue to manufacture its products, impacts on its ability to continue its discovery activities, impacts on the conduct of its clinical trials, impacts on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia and on patient and healthcare provider access to the company’s medicines, impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines, impacts on reimbursement for its products, including its Medicaid rebate liability, and for services related to the use of its products, and impacts on the U.S., Irish and/or global economies more broadly; the unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, related to any of the company’s products, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company’s clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; 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, including decisions not to approve the company’s NDAs, including the NDA for ALKS 3831; data from clinical trials may be interpreted by the FDA in different ways than the company or an advisory committee interprets it; the FDA may not agree with the company’s regulatory approval strategies or components of the NDA for ALKS 3831 or the Company’s other regulatory filings, including clinical trial designs, conduct and methodologies, manufacturing processes and facilities, and the adequacy of the data and other information included in the company’s filings to meet the FDA’s requirements for approval, including the risk/benefit profile of the company’s product candidates; 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 governmental 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 on Form 10-K and Quarterly Report on Form 10-Q 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. 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 Report on Form 8-K filed with the SEC on Oct. 29, 2020. Note Regarding Trademarks: The company is the owner of various U.S. federal trademark registrations (®) and other trademarks (TM), including ARISTADA®, ARISTADA INITIO® and VIVITROL®. VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Any other trademarks referred to in this presentation are the property of their respective owners. Appearances of such other trademarks herein should not be construed as any indicator that their respective owners will not assert their rights thereto.

Introduction Sandy Coombs, VP, Investor Relations Q3 2020 Financial Results; 2020 Financial Expectations Jim Frates, Chief Financial Officer Q3 2020 Commercial Review Todd Nichols, Chief Commercial Officer R&D Pipeline and Business Update Richard Pops, Chief Executive Officer Agenda

Third Quarter 2020 Financial Results Summary In millions

Third Quarter 2020 Revenue Summary In millions, except % Q3’20 Q3’19 ∆ Q3’20 vs. Q3’19 VIVITROL® $80.3 $85.2 (6%) ARISTADA® $62.4 $53.6 16% Manufacturing & Royalty Revenue $120.4 $103.8 16% R&D and License Revenues $2.0 $12.7 (84%)* Total Revenue $265.0 $255.2 4% Amounts in the table above do not sum due to rounding. * R&D revenues related to reimbursement for VUMERITY® development expenses largely concluded in Q4’19 following FDA approval

(in millions, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2020 Revenues $1,010 – $1,035 COGS $180 – $190 R&D Expense $375 – $390 SG&A Expense $530 – $545 Amortization of Intangible Assets ~$40 Other Income, Net ~$30 Income Tax Expense $10 – $15 GAAP Net Loss ($95) – ($115) GAAP Net Loss Per Share ($0.60) – ($0.72) Non-GAAP Net Income‡ $50 – $70 Non-GAAP Earnings Per Share (Diluted) $0.31 – $0.43 † These expectations are provided by Alkermes plc (the “Company”) in its Current Report on Form 8-K filed with the SEC on Oct. 29, 2020 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm this guidance. The Company only provides financial expectations in a Regulation FD compliant manner. * Ranges provided are based on recent trends and assume that treatment provider practices and patient flow will continue to normalize. Additional COVID-19-related restrictions or resurgence of COVID-19 could negatively impact the Company’s ability to meet these expectations. ‡ Non-GAAP net income adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization expense; depreciation expense; non-cash net interest expense; change in the fair value of contingent consideration; change in the fair value of warrants; the income tax effect of these reconciling items; and certain other one-time or non-cash items. Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Company’s Current Report on Form 8-K filed with the SEC on Oct. 29, 2020. Expected net sales of proprietary products: VIVITROL® net sales of $305M – $315M† ARISTADA® net sales of $230M – $240M Alkermes: 2020 Financial Expectations†*

VIVITROL® Performance Q3 year-over-year net sales decline of 6% to $80.3M, driven by unit decline of 3% Sequential net sales increased 12% driven by unit growth of 22% Gross-to-net deductions: 53% in Q3’20, compared to 49% in Q3’19 and 46% in Q2’20 Inventory levels rebounded by ~6,500 units in Q3’20 to a normal range Expect gross-to-net adjustments in Q4’20 to increase to 54%, driven by expected increased Medicaid utilization* VIVITROL Quarterly Net Sales ($M) * These expectations are provided by the Company in its Current Report on Form 8-K filed with the SEC on Oct. 29, 2020 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm this guidance. The Company only provides financial expectations in a Regulation FD compliant manner.

ARISTADA® Performance Q3 year-over-year net sales growth of 16% to $62.4M, driven by unit growth of 20% Gross-to-net deductions: 54% in Q3’20, compared to 48% in Q3’19 and 53% in Q2’20 Increased gross-to-net adjustments in Q3’20 reflect increased Medicaid utilization Inventory levels increased ~1,900 units; within normal levels at 9/30/20 ARISTADA Quarterly Net Sales ($M)* *Inclusive of ARISTADA INITIO®

ARISTADA®: Prescription Growth Trends Q3 year-over-year growth of 22% on TRx months of therapy (MOT) basis Outpaced overall atypical long-acting injectable (LAI) market Q3 year-over-year growth of 5% Market share: TRx MOT: 9% of atypical LAI market prescriptions in August 2020 Utilization of two-month dose drove 37% of ARISTADA Q3’20 volume in terms of MOT ARISTADA Quarterly TRx MOT Source: IMS NPA

ALKS 3831 Update Payer engagement strategy Expect that access will improve throughout first year of launch as formulary decisions are made Plan to implement patient access programs designed to mitigate payer restrictions early in launch Sales force planning Focus on leveraging existing commercial organization Hybrid promotional model permanently incorporates both in-person and virtual engagements to efficiently target a broader footprint of prescribers for oral antipsychotics Well-defined healthcare provider call universe Plan to target healthcare providers that represent ~ 70% of the oral antipsychotic market, and ~ 80% of the branded oral antipsychotic market Commercial launch pending FDA approval and DEA de-scheduling Launch Planning Activities Regulatory Review Positive outcome of Advisory Committee meeting Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020

ALKS 4230: Advancing the Clinical Development Program ARTISTRY-1 data presented at the European Society for Medical Oncology (ESMO) Virtual Congress included evidence of ALKS 4230 antitumor activity, both as monotherapy and in combination with pembrolizumab, with durable and deepening responses observed in a diverse set of difficult-to-treat tumor types ARTISTRY-2 dose escalation is ongoing for both once-weekly and once-every-three-week subcutaneous dosing regimens Data to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November will include pharmacokinetic, pharmacodynamic, safety and tolerability data from the initial dose escalation cohorts

www.alkermes.com