alks-8k_20200729.htm
false Alkermes plc. 0001520262 0001520262 2020-07-29 2020-07-29

 

 

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): July 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.

 

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On July 29, 2020, Alkermes plc (the “Company”) announced financial results for the three and six months ended June 30, 2020 and issued 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 July 29, 2020 discussing such financial results and 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 July 29, 2020 announcing financial results for the three and six months ended June 30, 2020 and financial expectations for the year ending December 31, 2020.

99.2

 

Investor presentation to be displayed by Alkermes plc on July 29, 2020.

104

 

Cover page interactive data file (embedded within the Inline XBRL document).

 

2


 

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: July 29, 2020

By:

 

/s/ James M. Frates

 

 

 

James M. Frates

 

 

 

Senior Vice President and Chief Financial Officer (Principal Financial Officer)

 

3

alks-ex991_6.htm

Exhibit 99.1

 

 

 

 

Alkermes Contacts:

 

 

For Investors:

Sandy Coombs     +1 781 609 6377

 

For Media:  

Katie Joyce         +1 781 249 8927

 

Alkermes plc Reports Second Quarter 2020 Financial Results and

Issues 2020 Financial Expectations

— Company Reports Second Quarter Revenues of $247.5 Million, GAAP Net Loss per Share of $0.19 and Diluted Non-GAAP Earnings per Share of $0.06

— ARISTADA® Net Sales Increased 21% Year-Over-Year to $58.8 Million

— VIVITROL® Net Sales of $71.6 Million Reflect Impact of COVID-19-Related Treatment Disruptions

Company Announces Board Declassification Proposal and Board Refreshment Process  

 

DUBLIN, Ireland, July 29, 2020 Alkermes plc (Nasdaq: ALKS) today reported financial results for the second quarter of 2020 and provided updated financial expectations for full-year 2020. The company had previously withdrawn its 2020 financial expectations due to uncertainties regarding the impact of the COVID-19 pandemic on its business.

“During the second quarter, we adapted in response to the changing conditions in a complex environment. As we enter the second half of 2020, we are focused on three strategic imperatives. The first is commercial execution, as we drive to maximize the opportunities for ARISTADA® and VIVITROL® and prepare for the potential launch of ALKS 3831. The second is aggressive development of our pipeline programs, focusing on high-value opportunities that we believe have the potential to address patient needs and drive significant value in the near- and long-term. ALKS 4230, our lead oncology candidate, is the most prominent of these opportunities. The third is efficient management of our operating structure, with a focus on rigorous expense management and careful prioritization of our investments,” said Richard Pops, Chief Executive Officer of Alkermes.

“We distinguish ourselves from other biopharmaceutical companies through our efforts in serious mental illness and addiction — chronic, highly prevalent conditions that affect millions of people and represent some of the most challenging public health issues of our time. We have built our organization with purpose and invested in specialized commercial capabilities to navigate fragmented treatment systems as we help address the complex challenges that patients with these diseases face,” continued Mr. Pops. “As the nation’s response to COVID-19 continues, it is critical that we work to mitigate the pandemic’s secondary impacts related to social isolation, economic hardship and anxiety. For many patients struggling with serious mental illness and addiction, the current environment has amplified the barriers to treatment that Alkermes has worked for many years to address. We believe it is our responsibility to help ensure that the treatment system continues to function for these patients.”

 

Quarter Ended June 30, 2020 Financial Highlights

 

Total revenues for the quarter were $247.5 million, compared to $279.9 million for the same period in the prior year.

 

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $29.4 million for the quarter, or a GAAP net loss per share of $0.19. This compared to GAAP net loss of $42.0 million, or a GAAP net loss per share of $0.27, for the same period in the prior year.

 

Non-GAAP net income was $8.9 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.06. This compared to non-GAAP net income of $13.7 million, or a non-GAAP basic and diluted earnings per share of $0.09, for the same period in the prior year.


Quarter Ended June 30, 2020 Financial Results

Revenues

 

Net sales of proprietary products were $130.4 million, compared to $136.6 million for the same period in the prior year.

 

o

Net sales of VIVITROL were $71.6 million, compared to $88.2 million for the same period in the prior year, representing a decrease of approximately 19%, driven primarily by a decline in new patient starts and more restricted access to healthcare providers that resulted from COVID-19-related disruptions.

 

o

Net sales of ARISTADA1  were $58.8 million, compared to $48.4 million for the same period in the prior year, representing an increase of approximately 21% driven primarily by increased breadth of the ARISTADA provider base and growth of the ARISTADA two-month dose.

 

Manufacturing and royalty revenues were $116.5 million, compared to $127.9 million for the same period in the prior year.

 

o

Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $83.1 million, compared to $91.9 million for the same period in the prior year, primarily driven by a decrease in manufacturing and royalty revenues related to RISPERDAL CONSTA.

 

Costs and Expenses

 

Total operating expenses were $281.2 million, compared to $315.8 million for the same period in the prior year.

 

o

Research and Development (R&D) expenses were $94.2 million, compared to $104.4 million for the same period in the prior year.

 

o

Selling, General and Administrative (SG&A) expenses were $132.0 million, compared to $155.1 million for the same period in the prior year.

 

Balance Sheet

 

At June 30, 2020, Alkermes recorded cash, cash equivalents and total investments of $539.6 million, compared to $549.7 million at March 31, 2020. Cash on hand at June 30, 2020 significantly exceeded the company’s total debt outstanding of $276.1 million under its term loan, which matures in March 2023.

 

“Our second quarter results reflect solid execution across the business. The performance of the ARISTADA product family, together with disciplined management of expenses, partially offset the negative impact on VIVITROL net sales that resulted from COVID-19-related decreases in patient visits to healthcare providers and treatment centers. With increased visibility into the expected impact of COVID-19 on our commercial portfolio, today we are issuing financial expectations for 2020 that reflect current trends and underscore our commitment to driving non-GAAP profitability,” commented James Frates, Chief Financial Officer of Alkermes. “Over the past five years, we have grown our topline while investing in the future growth drivers of our business. Directly as a result of those investments, we established VIVITROL as an important therapeutic option for patients with opioid and alcohol dependence; we secured FDA approvals for the ARISTADA product family; we developed ALKS 3831 and submitted a New Drug Application for schizophrenia and bipolar I disorder; we built commercial psychiatry capabilities that support the growth of ARISTADA and which are also fully leverageable for ALKS 3831; we successfully developed VUMERITY® and entered into a commercial collaboration that will provide 100% gross margin royalty revenues from net sales; we advanced development of ALKS 4230 while retaining optionality for strategic collaboration; and, we acquired a platform of histone deacetylase (HDAC) inhibitors that we believe will provide compelling pipeline opportunities in

2

 


neurodegeneration and oncology. We are focused on executing our business strategy and believe these investments have positioned the business to drive long-term profitability and value creation.”

 

Financial Expectations for 2020

The following financial expectations for 2020 reflect the anticipated net impacts of the COVID-19 pandemic on Alkermes’ operating and financial results.  Alkermes anticipates that the negative impact of COVID-19 on VIVITROL net sales will be partially offset by a decrease in operating expenses, notably within R&D.  The ranges provided are based on current trends and assume that treatment provider practices and patient flow will continue to normalize. Additional wide-spread COVID-19-related restrictions or resurgence of COVID-19 could negatively impact the company’s ability to meet these expectations. All line items are according to GAAP, except as otherwise noted.

 

In millions (except per share amounts)

 

Current 2020 Expectation

(Provided 7/29/20)

Pre-COVID-19 Expectation

(Provided 2/13/20; Suspended 4/29/20)

 

 

 

 

Total Revenue

 

$965 - $1,005

$1,030 - $1,080

VIVITROL Net Sales

 

$270 – $300

$340 – $355

ARISTADA Net Sales

 

$220 – $235

$220 – $235

Cost of Goods Sold

 

$180 – $190

$185 – $195

R&D Expenses

 

$370 – $395

$405 – $430

SG&A Expenses

 

$525 – $550

$535 – $560

Amortization of Intangible Assets

 

~$40

~$40

Other Income, Net

 

$10 – $15

Income Tax Expense

 

$10 – $15

$0 - $10

GAAP Net Loss

 

($145) – ($175)

($130) – ($160)

GAAP Net Loss per Share

 

($0.91) – ($1.10)

($0.82) – ($1.01)

Non-GAAP Net Income

 

$0 – $30

$40 – $70

Non-GAAP Basic EPS

 

$0.00 – $0.19

$0.25 – $0.44

Non-GAAP Diluted EPS

 

$0.00 – $0.19

$0.25 – $0.43

Capital Expenditures

 

~$35

$45 – $55

 

Governance Update

“Over the past 12 months, we conducted extensive shareholder outreach and engaged with shareholders representing approximately 60% in value of our outstanding ordinary shares. The Board values the views of our shareholders and, after considering their feedback, is taking actions to further strengthen our business and corporate governance practices. The Board believes these actions will help to position the company for long-term growth as we execute on our strategy,” said David Anstice, Lead Independent Director of the Alkermes Board of Directors (the Board).

 

The company announced today that it plans to take a series of actions as part of its commitment to corporate governance best practices and regular Board refreshment.

 

First, the Board will recommend that shareholders approve, at the company’s 2021 Annual General Meeting of Shareholders, an amendment to the company’s Articles of Association to declassify the Board. Currently, the Board has three classes of directors, with directors in each class elected to three-year terms. Once the Board is declassified, the directors will be combined into a single class elected annually.

3

 


 

Second, the Board has engaged a leading recruitment firm to identify independent director candidates whose experience and expertise offer valuable insights and strategic leadership at this stage in Alkermes’ evolution. As part of this process, the company expects certain of its longer-serving directors will retire from the Board.  This Board refreshment process will continue and build on the efforts undertaken by the company in the fall of 2019 that led to the addition of two highly-qualified, independent directors, Dr. Richard Gaynor and Mr. Andy Wilson, to the Board.

 

Recent Events

 

Schizophrenia portfolio

 

o

In May 2020, presented new research from the company’s schizophrenia portfolio at the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting, including data from patient-reported evaluations relating to treatment with ALKS 3831 and satisfaction data relating to treatment with ARISTADA.

 

o

In July 2020, announced a new survey conducted by The Harris Poll for Alkermes, which explored the current use and future potential of telepsychiatry services during and after the COVID-19 pandemic.

 

ALKS 4230

 

o

In June 2020, presented positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes’ investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis Oncology, Inc.’s investigational angiogenesis inhibitor, at the American Association for Cancer Research (AACR) Virtual Annual Meeting II.

 

Corporate citizenship

 

o

In June 2020, announced that 10 nonprofit organizations were awarded grants from the company’s COVID-19 Relief Fund, a special edition of the company’s signature Alkermes Inspiration Grants® program, that was established to assist nonprofit organizations in their work to rapidly address pandemic-related needs for people living with addiction, serious mental illness, or cancer.

 

o

In July 2020, published Alkermes’ latest Corporate Responsibility Report which outlines how the company integrates environmental, social and governance considerations into all aspects of its business. A copy of the report is available on the Responsibility section of Alkermes’ website.

 

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 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 (4:00 p.m. BST) on Wednesday, July 29, 2020, through Wednesday, Aug. 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 13707215.

 

4

 


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 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 normalization of patient and healthcare provider practices, the expected growth drivers of the company’s business, and the company’s ability to drive significant value creation and long-term growth and profitability; the potential therapeutic and commercial value of the company’s marketed and development products and the company’s potential contributions to supporting patient access to such products; the company’s plans for, and expectations relating to, corporate governance changes, including the proposed declassification and refreshment of the Board; expectations concerning future development activities for the company’s development candidates; and expectations and timelines concerning the company’s commercial activities and capabilities, including in relation to the potential launch of ALKS 3831 following U.S. Food and Drug Administration’s (“FDA”) review and potential approval of the new drug application (“NDA”) for 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

5

 


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, including decisions not to approve the company’s NDAs; 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 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; 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 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. 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; VUMERITY® is a registered trademark of Biogen Inc., used by Alkermes under license; and RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson.

 

(tables follow)

 

 

1 

The term “ARISTADA” as used in this press release refers to ARISTADA and ARISTADA INITIO, unless the context indicates otherwise.

6

 


 

 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP

 

Three Months Ended

 

 

Three Months Ended

 

(In thousands, except per share data)

 

June 30, 2020

 

 

June 30, 2019

 

Revenues:

 

 

 

 

 

 

 

 

Product sales, net

 

$

130,415

 

 

$

136,635

 

Manufacturing and royalty revenues

 

 

116,505

 

 

 

127,897

 

Research and development revenue

 

 

609

 

 

 

14,340

 

License revenue

 

 

 

 

 

1,000

 

Total Revenues

 

 

247,529

 

 

 

279,872

 

Expenses:

 

 

 

 

 

 

 

 

Cost of goods manufactured and sold

 

 

45,053

 

 

 

46,223

 

Research and development

 

 

94,222

 

 

 

104,435

 

Selling, general and administrative

 

 

132,025

 

 

 

155,075

 

Amortization of acquired intangible assets

 

 

9,890

 

 

 

10,062

 

Total Expenses

 

 

281,190

 

 

 

315,795

 

Operating Loss

 

 

(33,661

)

 

 

(35,923

)

Other Income (Expense), net:

 

 

 

 

 

 

 

 

Interest income

 

 

1,788

 

 

 

3,706

 

Interest expense

 

 

(2,122

)

 

 

(3,520

)

Change in the fair value of contingent consideration

 

 

5,900

 

 

 

(6,500

)

Other income, net

 

 

2,337

 

 

 

1,851

 

Total Other Income (Expense), net

 

 

7,903

 

 

 

(4,463

)

Loss Before Income Taxes

 

 

(25,758

)

 

 

(40,386

)

Income Tax Provision

 

 

3,673

 

 

 

1,604

 

Net Loss — GAAP

 

$

(29,431

)

 

$

(41,990

)

 

 

 

 

 

 

 

 

 

(Loss) Earnings Per Share:

 

 

 

 

 

 

 

 

GAAP loss per share — basic and diluted

 

$

(0.19

)

 

$

(0.27

)

Non-GAAP earnings per share — basic and diluted

 

$

0.06

 

 

$

0.09

 

 

 

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

 

 

Basic and diluted — GAAP

 

 

158,895

 

 

 

156,991

 

Basic — Non-GAAP

 

 

158,895

 

 

 

156,991

 

Diluted — Non-GAAP

 

 

159,275

 

 

 

158,987

 

 

 

 

 

 

 

 

 

 

An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:

 

Net Loss — GAAP

 

$

(29,431

)

 

$

(41,990

)

Adjustments:

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

22,846

 

 

 

28,245

 

Depreciation expense

 

 

10,447

 

 

 

9,852

 

Amortization expense

 

 

9,890

 

 

 

10,062

 

Income tax effect related to reconciling items

 

 

877

 

 

 

2,043

 

Non-cash net interest expense

 

 

167

 

 

 

168

 

Change in the fair value of contingent consideration

 

 

(5,900

)

 

 

6,500

 

Change in the fair value of warrants and equity method investments

 

 

 

 

 

(1,134

)

Non-GAAP Net Income

 

$

8,896

 

 

$

13,746

 

 

 

 

 


 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP

 

Six Months Ended

 

 

Six Months Ended

 

(In thousands, except per share data)

 

June 30, 2020

 

 

June 30, 2019

 

Revenues:

 

 

 

 

 

 

 

 

Product sales, net

 

$

260,141

 

 

$

236,116

 

Manufacturing and royalty revenues

 

 

232,756

 

 

 

236,812

 

Research and development revenue

 

 

852

 

 

 

29,046

 

License Revenue

 

 

 

 

 

1,000

 

Total Revenues

 

 

493,749

 

 

 

502,974

 

Expenses:

 

 

 

 

 

 

 

 

Cost of goods manufactured and sold

 

 

92,264

 

 

 

91,584

 

Research and development

 

 

187,501

 

 

 

207,005

 

Selling, general and administrative

 

 

265,397

 

 

 

296,295

 

Amortization of acquired intangible assets

 

 

19,618

 

 

 

20,014

 

Total Expenses

 

 

564,780

 

 

 

614,898

 

Operating Loss

 

 

(71,031

)

 

 

(111,924

)

Other Income (Expense), net:

 

 

 

 

 

 

 

 

  Interest income

 

 

4,548

 

 

 

7,276

 

  Interest expense

 

 

(4,979

)

 

 

(7,020

)

  Change in the fair value of contingent consideration

 

 

12,700

 

 

 

(29,100

)

  Other income, net

 

 

1,679

 

 

 

130

 

Total Other Income (Expense), net

 

 

13,948

 

 

 

(28,714

)

Loss Before Income Taxes

 

 

(57,083

)

 

 

(140,638

)

Provision (Benefit) for Income Taxes

 

 

11,002

 

 

 

(2,250

)

Net Loss — GAAP

 

$

(68,085

)

 

$

(138,388

)

 

 

 

 

 

 

 

 

 

(Loss) Earnings Per Share:

 

 

 

 

 

 

 

 

GAAP loss per share — basic and diluted

 

$

(0.43

)

 

$

(0.88

)

Non-GAAP earnings (loss) per share — basic and diluted

 

$

0.07

 

 

$

(0.08

)

 

 

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

 

 

Basic and diluted — GAAP

 

 

158,495

 

 

 

156,665

 

Basic — Non-GAAP

 

 

158,495

 

 

 

156,665

 

Diluted — Non-GAAP

 

 

159,151

 

 

 

156,665

 

 

 

 

 

 

 

 

 

 

An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows:

 

Net Loss — GAAP

 

$

(68,085

)

 

$

(138,388

)

Adjustments:

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

42,659

 

 

 

52,861

 

Depreciation expense

 

 

21,328

 

 

 

19,542

 

Amortization expense

 

 

19,618

 

 

 

20,014

 

Income tax effect related to reconciling items

 

 

6,797

 

 

 

5,015

 

Non-cash net interest expense

 

 

334

 

 

 

337

 

Change in the fair value of contingent consideration

 

 

(12,700

)

 

 

29,100

 

Acquisition of IPR&D

 

 

674

 

 

 

 

Change in the fair value of warrants and equity method investments

 

 

 

 

 

(701

)

Non-GAAP Net Income (Loss)

 

$

10,625

 

 

$

(12,220

)

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

June 30,

 

 

December 31,

 

(In thousands)

 

2020

 

 

2019

 

Cash, cash equivalents and total investments

 

$

539,596

 

 

$

614,370

 

Receivables

 

 

237,393

 

 

 

257,086

 

Contract assets

 

 

9,240

 

 

 

8,386

 

Inventory

 

 

116,458

 

 

 

101,803

 

Prepaid expenses and other current assets

 

 

51,705

 

 

 

59,716

 

Property, plant and equipment, net

 

 

361,807

 

 

 

362,168

 

Intangible assets, net and goodwill

 

 

223,898

 

 

 

243,516

 

Other assets

 

 

262,240

 

 

 

158,358

 

Total Assets

 

$

1,802,337

 

 

$

1,805,403

 

Long-term debt — current portion

 

$

2,843

 

 

$

2,843

 

Other current liabilities

 

 

318,571

 

 

 

388,269

 

Long-term debt

 

 

273,207

 

 

 

274,295

 

Contract liabilities — long-term

 

 

18,881

 

 

 

22,068

 

Other long-term liabilities

 

 

126,989

 

 

 

32,486

 

Total shareholders' equity

 

 

1,061,846

 

 

 

1,085,442

 

Total Liabilities and Shareholders' Equity

 

$

1,802,337

 

 

$

1,805,403

 

 

 

 

 

 

 

 

 

 

Ordinary shares outstanding (in thousands)

 

 

159,028

 

 

 

157,779

 

 

 

 

 

 

 

 

 

 

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, 2020, which the company intends to file in July 2020.

 

 


 

 


 

Alkermes plc and Subsidiaries

 

2020 Guidance — GAAP to Non-GAAP Adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In millions, except per share data)

 

Amount

 

 

Shares

 

 

(Loss) Earnings Per Share

 

Projected Net Loss — GAAP

 

$

(160.0

)

 

 

159

 

 

$

(1.01

)

   Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

97.5

 

 

 

 

 

 

 

 

 

Depreciation expense

 

 

44.0

 

 

 

 

 

 

 

 

 

Amortization expense

 

 

40.0

 

 

 

 

 

 

 

 

 

Income tax effect related to reconciling items

 

 

5.0

 

 

 

 

 

 

 

 

 

Non-cash net interest expense

 

 

1.0

 

 

 

 

 

 

 

 

 

Change in the fair value of contingent consideration

 

 

(12.5

)

 

 

 

 

 

 

 

 

Projected Net Income — Non-GAAP

 

$

15.0

 

 

 

161

 

 

$

0.09

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

 

 

 

 

alks-ex992_7.pptx.htm

Slide 1

Second Quarter 2020 Financial Results & Business Update July 29, 2020 Exhibit 99.2

Slide 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, including the company’s strategic imperatives of commercial execution and efficient expense management and its belief in its ability to drive significant short- and long-term value; the potential therapeutic and commercial value of the company’s marketed and development products, including with respect to ALKS 4230’s differentiation from other IL-2 programs; 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 the related advisory committee meeting; the company’s expectations concerning future development activities, including with respect to the ongoing ARTISTRY clinical development program and plans to present ARTISTRY-1 data at a medical meeting; the company’s expectations concerning its commercial activities and capabilities, including plans for a new potential promotional model and sales force planning for the potential launch of ALKS 3831; and the company’s planned actions relating to corporate governance, including declassification and refreshment of the company’s Board. 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; 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 the company’s filings for its products, including its 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; 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 July 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.

Slide 3

Introduction Sandy Coombs, VP, Investor Relations Opening Remarks Richard Pops, Chief Executive Officer Q2 2020 Financial Results; 2020 Financial Expectations Jim Frates, Chief Financial Officer Q2 2020 Commercial Review Todd Nichols, Chief Commercial Officer R&D Pipeline and Governance Update Richard Pops, Chief Executive Officer Agenda

Slide 4

Focus on Three Strategic Imperatives Commercial execution Maximizing the opportunities for both ARISTADA® and VIVITROL® and preparing to leverage commercial infrastructure with the potential launch of ALKS 3831 Aggressive development of pipeline programs Focus on high-value opportunities that we believe have the potential to drive significant value in both the near- and long-term, including ALKS 4230 in oncology Efficient management of operating structure and corporate governance Focus on rigorous expense management and careful prioritization of investments Planned actions as part of commitment to corporate governance best practices and board refreshment

Slide 5

Q2 2020 Financial Results Summary In millions

Slide 6

Second Quarter 2020 Revenue Summary In millions, except % Q2’20 Q2’19 ∆ Q2’20 vs. Q2’19 VIVITROL® $71.6 $88.2 (19%) ARISTADA® $58.8 $48.4 21% Manufacturing & Royalty Revenue $116.5 $127.9 (9%) R&D and License Revenues $0.6 $15.3 (96%)* Total Revenue $247.5 $279.9 (12%) 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

Slide 7

(in millions, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2020 Revenues $965 – 1,005 COGS $180 – 190 R&D Expense $370 – 395 SG&A Expense $525 – 550 Amortization of Intangible Assets ~$40 Other Income, Net $10 – 15 Income Tax Expense $10 – 15 GAAP Net Loss $(145) – (175) GAAP Loss Per Share (Basic & Diluted) $(0.91) – (1.10) Non-GAAP Net Income‡ $0 – 30 Non-GAAP Earnings Per Share (Basic & Diluted) $0.00 – 0.19 * Ranges provided are based on current 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 our ability to meet these expectations. † These expectations are provided by Alkermes plc (the “Company”) in its Current Report on Form 8-K filed with the SEC on July 29, 2020 and is 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. ‡ 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; certain other one-time or non-cash items; change in the fair value of contingent consideration; change in the fair value of warrants and equity method investments; 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 Current Report on Form 8-K filed with the SEC on July 29, 2020. Expected net sales of proprietary products: VIVITROL® net sales of $270M – $300M† ARISTADA® net sales of $220M – $235M Alkermes: 2020 Financial Expectations*†

Slide 8

VIVITROL® Performance and Expectations Q2 year-over-year net sales decline of 19% to $71.6M, driven by unit decline of 22% Gross-to-net deductions: 46% in Q2’20, compared to 48% in Q2’19 and 49% in Q1’20 $6.5M favorable impact of lower gross-to-nets in Q2’20 reflect lower return rate and favorable state Medicaid true-ups Inventory levels decreased by ~5,100 units in Q2’20 Q3’20 net sales expected to be in the range of $60M to $65M*† VIVITROL Quarterly Net Sales ($M) * Range provided is based on current trends and assumes that treatment provider practices and patient flow will continue to normalize. Additional COVID-19-related restrictions or resurgence of COVID-19 could negatively impact our ability to meet this expectation. † This expectation is provided by the Company in its Current Report on Form 8-K filed with the SEC on July 29, 2020 and is 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.

Slide 9

ARISTADA® Performance Q2 year-over-year net sales growth of 21% to $58.8M, driven by unit growth of 25% Growth reflects resilient underlying demand Gross-to-net deductions: 53% in Q2’20, compared to 48% in Q2’19 and 52% in Q1’20 Increased gross-to-nets reflect increased Medicaid utilization Inventory levels increased ~1,000 units in Q2’20 ARISTADA Quarterly Net Sales ($M)* *Inclusive of ARISTADA INITIO®

Slide 10

ARISTADA®: Prescription Growth Trends Q2 year-over-year growth of 29% on TRx months of therapy (MOT) basis Compared to overall atypical long-acting injectable (LAI) market growth of 7% Market share: NRx: 10% of atypical LAI market prescriptions (MOT) in June 2020 Utilization of two-month dose drove 37% of ARISTADA Q2’20 volume in terms of MOT ARISTADA Quarterly TRx MOT Source: IMS NPA

Slide 11

ALKS 4230: Advancing the Clinical Development Program ALKS 4230 is differentiated from other IL-2 variant programs in active clinical development Stable fusion protein molecular structure Potential for subcutaneous administration Current evaluation in the clinic as a monotherapy ARTISTRY clinical development program ongoing ARTISTRY-1: Resilient enrollment trends in H1’20 despite COVID-19 ARTISTRY-2: Dose escalation ongoing for both once-weekly and once-every-three week subcutaneous dosing regimens ARTISTRY-1 data recently accepted for oral presentation at the European Society for Medical Oncology (ESMO) annual meeting in September 2020

Slide 12

ALKS 3831 Activities Awareness through scientific exchange Presented new datasets from ENLIGHTEN pivotal program at spring virtual medical meetings Payer engagement Conducted preliminary engagement with payers that represent more than half of the potential class volume, as well as key federal and regional accounts Sales force planning Potential for new hybrid promotional model that permanently incorporates virtual engagements and builds on existing commercial infrastructure Launch Planning Activities Regulatory Review Advisory Committee meeting scheduled for October 2020 Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020

Slide 13

Governance and Corporate Responsibility Updates Governance Updates Declassification of Alkermes’ Board of Directors (the Board) The Board will recommend that shareholders approve a proposal at the company’s 2021 Annual General Meeting of Shareholders to declassify the Board Currently, the Board has three classes of directors, with directors in each class elected to three-year terms; Upon declassification, directors will be combined into a single class elected annually Board refreshment Leading recruitment firm engaged to identify independent director candidates Refreshment process to build on Board refreshment efforts undertaken by company in fall 2019 Certain longer-serving directors expected to retire in connection with refreshment efforts Corporate Responsibility Recently published updated Corporate Responsibility Report, available on the Responsibility section of Alkermes’ website

Slide 14

www.alkermes.com

v3.20.2
Document And Entity Information
Jul. 29, 2020
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jul. 29, 2020
Entity Registrant Name Alkermes plc.
Entity Central Index Key 0001520262
Entity Emerging Growth Company false
Entity File Number 001-35299
Entity Incorporation, State or Country Code L2
Entity Tax Identification Number 98-1007018
Entity Address, Address Line One Connaught House
Entity Address, Address Line Two 1 Burlington Road
Entity Address, City or Town Dublin 4
Entity Address, Country IE
Entity Address, Postal Zip Code D04 C5Y6
City Area Code 353
Local Phone Number 1-772-8000
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Ordinary shares, $0.01 par value
Trading Symbol(s) ALKS
Security Exchange Name NASDAQ