Table of Contents

 

 

 

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 25, 2013

 

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

 

 

(Address of principal executive offices)

 

(Zip Code)

 

(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):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



Table of Contents

 

TABLE OF CONTENTS

 

Item 2.02 Results of Operations and Financial Condition

 

Item 9.01 Financial Statements and Exhibits

 

SIGNATURE

 

EXHIBIT INDEX

 

Ex-99.1 Press release issued by Alkermes plc dated July 25, 2013 announcing financial results for the quarter ended June 30, 2013.

 

 

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Table of Contents

 

Item 2.02 Results of Operations and Financial Condition

 

On July 25, 2013, Alkermes plc announced financial results for the quarter ended June 30, 2013. A copy of the press release is attached hereto as Exhibit 99.1. This information, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Securities Act 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

 

 

No.

 

Description

99.1

 

Press release issued by Alkermes plc dated July 25, 2013 announcing financial results for the quarter ended June 30, 2013.

 

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Table of Contents

 

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 25, 2013

By:

/s/ James M. Frates

 

 

James M. Frates

 

 

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

 

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Table of Contents

 

EXHIBIT INDEX

 

Exhibit

 

 

No.

 

Description

99.1

 

Press release issued by Alkermes plc dated July 25, 2013 announcing financial results for the quarter ended June 30, 2013.

 

5


Exhibit 99.1

 

 

Alkermes Contacts:

 

For Investors: Rebecca Peterson, +1 781 609 6378

 

For Media: Jennifer Snyder, +1 781 609 6166

 

ALKERMES PLC REPORTS FINANCIAL RESULTS FOR QUARTER ENDED
JUNE 30, 2013

 

— Revenues From the Company’s Five Key Commercial Products Grew 22% Year-Over-Year to $98.9 Million  —

— Company Reports Non-GAAP Diluted EPS of $0.30 —

 

DUBLIN, Ireland, July 25, 2013Alkermes plc (NASDAQ: ALKS) today reported financial results for the quarter ended June 30, 2013. This is the first quarter of the nine-month period ending Dec. 31, 2013, as the company transitions to reporting on a calendar year basis.

 

“This was another strong quarter for Alkermes. The business continues to generate strong financial results driven primarily by our portfolio of five key commercial products. The company is generating significant cash flow, and at the same time, we are advancing our robust clinical pipeline, which will be a major driver of Alkermes’ future growth,” commented James Frates, Chief Financial Officer of Alkermes. “Looking forward, our business remains on track to achieve our growth and financial expectations for the remainder of the calendar year.”

 

“Alkermes’ strong financial foundation from our commercial product portfolio, coupled with our expanding pipeline of development candidates, creates opportunities for exceptional value and growth,” commented Richard Pops, Chief Executive Officer of Alkermes. “Our pipeline now encompasses a range of promising, innovative and differentiated drug candidates, including three recently unveiled preclinical candidates that reflect our expanded research and development capabilities and productivity. Our pipeline is designed to address compelling patient needs and has become one of the most diverse and exciting CNS pipelines in the biopharmaceutical industry.”

 

1



 

Quarter Ended June 30, 2013 Highlights

 

·                  Total revenues for the quarter were $138.6 million. This compared to total revenues of $152.2 million for the same period in the prior year, which included $20.0 million of intellectual property license revenue unrelated to key development programs.

 

·                  Revenues from the company’s five key commercial products for the quarter grew 22% to $98.9 million, from $81.2 million for the same period in the prior year.

 

·                  Non-GAAP net income for the quarter was $42.9 million, or a non-GAAP diluted earnings per share (EPS) of $0.30. This compared to non-GAAP net income of $53.0 million, or a non-GAAP diluted EPS of $0.39, for the same period in the prior year, which included $20.0 million, or $0.15 per diluted share, of intellectual property license revenue.

 

·                  GAAP net income for the quarter was $7.3 million, or a basic and diluted GAAP EPS of $0.05. This compared to GAAP net income of $22.4 million, or a basic and diluted GAAP EPS of $0.17, for the same period in the prior year, which included $20.0 million, or $0.15 per diluted share, of intellectual property license revenue.

 

·                  Free cash flow for the quarter was $39.2 million. This compared to $46.2 million for the same period in the prior year, which included $20.0 million of intellectual property license revenue.

 

·                  The company reiterated its financial expectations for the nine-month period ending Dec. 31, 2013, which were originally provided on May 23, 2013.

 

Quarter Ended June 30, 2013 Financial Results

 

Revenues

 

·                  Manufacturing and royalty revenues from the company’s long-acting atypical antipsychotic franchise, RISPERDAL® CONSTA® and INVEGA® SUSTENNA®/XEPLION®, were $56.2 million, compared to $48.6 million for the same period in the prior year. Worldwide end-market sales of RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION were approximately $627 million, compared to approximately $550 million in the same period in the prior year.

 

·                  Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®(1) were $19.9 million, compared to $17.2 million for the same period in the prior year.

 

2



 

·                  Net sales of VIVITROL® were $17.4 million, compared to $12.4 million for the same period in the prior year, representing an increase of approximately 40% year over year.

 

·                  Royalty revenue from BYDUREON® was $5.4 million, compared to $3.0 million for the same period in the prior year.

 

·                  Additionally, results for the quarter included RITALIN LA®/FOCALIN XR® revenues of $11.2 million, VERELAN® revenues of $6.5 million and TRICOR® 145 revenues of $4.1 million. This compared to RITALIN LA/FOCALIN XR revenues of $10.9 million, VERELAN revenues of $6.0 million and TRICOR 145 revenues of $12.0 million for the same period in the prior year.

 

Costs and Expenses

 

·                  Operating expenses were $125.1 million. This compared to operating expenses of $120.1 million for the same period in the prior year.

 

·                  Net interest expense was $3.3 million. This compared to net interest expense of $9.9 million for the same period in the prior year. The reduction was driven by the successful refinancing and repricing of the company’s term loans completed in 2012 and 2013, respectively.

 

Balance Sheet

 

·                  At June 30, 2013, Alkermes recorded cash and total investments of $325.0 million, compared to $304.2 million at March 31, 2013.

 

Conference Call

 

Alkermes will host a conference call at 8:30 a.m. EDT (1:30 p.m. BST) on Thursday, July 25, 2013, to discuss these financial results and provide an update on the company. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 10:30 a.m. EDT (3:30 p.m. BST) on Thursday, July 25, 2013, through 5:00 p.m. EDT (10:00 p.m. BST) on August 1, 2013, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.

 

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About Alkermes plc

 

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and 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 generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income, non-GAAP diluted earnings per share and free cash flow. 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.

 

Management defines its non-GAAP financial measures as follows:

 

·                  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; non-cash tax expense; deferred revenue; and certain other one-time or non-cash items.

 

·                  Free cash flow represents non-GAAP net income less capital expenditures.

 

Management believes that these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, better indicate underlying trends in ongoing operations and cash flows. However, non-GAAP net income, non-GAAP diluted earnings per share and free cash flow are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance.

 

4



 

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 above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to: statements concerning future financial and operating performance, business plans or prospects; the likelihood of continued revenue growth from the company’s commercial products; the therapeutic and commercial value of the company’s products; and our expectations concerning the timing and results of our clinical development activities. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond the company’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements.

 

These risks and uncertainties include, among others: clinical development activities may not be completed on time or at all and the results of such activities may not be predictive of real-world results or of results in subsequent clinical trials; the company, and its partners, may not be able to continue to successfully commercialize its products; there may occur a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to governmental payers; adverse decisions by the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. regarding the company’s products; 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 described in the company’s most recent Annual Report on Form 10-K and 10-K/A, and in other filings made by the company with the Securities and Exchange Commission (“SEC”) and which are available at 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 they are made. The information contained in this press release is provided by the company as of the date hereof and, except as required by law, the company disclaims any intention or responsibility for updating any forward-looking information contained in this press release.

 

5



 

VIVITROL® is a registered trademark of Alkermes, Inc.; RISPERDAL® CONSTA® and INVEGA® SUSTENNA® are registered trademarks of Janssen Pharmaceuticals, Inc.; XEPLION® is a registered trademark of Johnson & Johnson Corporation; AMPYRA® and FAMPYRA® are registered trademarks of Acorda Therapeutics, Inc.; BYDUREON® is a registered trademark of Amylin Pharmaceuticals, LLC; TRICOR® is a registered trademark of Fournier Industrie et Sante Corporation; RITALIN LA® and FOCALIN XR® are registered trademarks of Novartis AG Corporation; and VERELAN® is a registered trademark of Alkermes Pharma Ireland Limited.

 


(1)AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda Therapeutics, Inc. and outside the U.S. by Biogen Idec Inc., under a licensing agreement with Acorda Therapeutics, as FAMPYRA® (prolonged-release fampridine tablets).

 

(tables follow)

 

6



 

Alkermes plc and Subsidiaries

Selected Financial Information (Unaudited)

 

 

 

Three Months

 

Three Months

 

 

 

Ended

 

Ended

 

Condensed Consolidated Statements of Operations - GAAP

 

June 30,

 

June 30,

 

(In thousands, except per share data)

 

2013

 

2012

 

Revenues:

 

 

 

 

 

Manufacturing and royalty revenues

 

$

119,788

 

$

138,380

 

Product sales, net

 

17,379

 

12,372

 

Research and development revenue

 

1,464

 

1,487

 

Total Revenues

 

138,631

 

152,239

 

Expenses:

 

 

 

 

 

Cost of goods manufactured and sold

 

45,991

 

42,070

 

Research and development

 

33,462

 

37,806

 

Selling, general and administrative

 

32,933

 

29,784

 

Amortization of acquired intangible assets

 

12,716

 

10,434

 

Total Expenses

 

125,102

 

120,094

 

Operating Income

 

13,529

 

32,145

 

Other (Expense), net:

 

 

 

 

 

Interest income

 

161

 

299

 

Interest expense

 

(3,468

)

(10,170

)

Other (expense) income, net

 

(170

)

923

 

Total Other (Expense), net

 

(3,477

)

(8,948

)

Income Before Income Taxes

 

10,052

 

23,197

 

Provision for Income Taxes

 

2,718

 

764

 

Net Income — GAAP

 

$

7,334

 

$

22,433

 

 

 

 

 

 

 

Earnings Per Share:

 

 

 

 

 

GAAP earnings per share — basic and diluted

 

$

0.05

 

$

0.17

 

Non-GAAP earnings per share — basic

 

$

0.32

 

$

0.41

 

Non-GAAP earnings per share — diluted

 

$

0.30

 

$

0.39

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

Basic — GAAP and Non-GAAP

 

134,602

 

130,434

 

Diluted — GAAP and Non-GAAP

 

143,369

 

134,945

 

 

 

 

 

 

 

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

 

 

 

 

 

Net Income — GAAP

 

$

7,334

 

$

22,433

 

Adjustments:

 

 

 

 

 

Non-cash net interest expense

 

268

 

1,528

 

Non-cash taxes

 

2,814

 

(145

)

Depreciation expense

 

11,011

 

7,584

 

Amortization expense

 

12,716

 

10,434

 

Share-based compensation

 

8,809

 

8,162

 

Deferred revenue

 

(97

)

2,970

 

Non-GAAP Net Income

 

$

42,855

 

$

52,966

 

Capital expenditure

 

3,625

 

6,733

 

Free Cash Flow

 

$

39,230

 

$

46,233

 

 



 

Alkermes plc and Subsidiaries

Selected Financial Information (Unaudited)

 

Condensed Consolidated Balance Sheets

 

June 30,

 

March 31,

 

(In thousands)

 

2013

 

2013

 

Cash, cash equivalents and total investments

 

$

324,990

 

$

304,179

 

Receivables

 

130,578

 

124,620

 

Inventory

 

39,128

 

43,483

 

Prepaid expenses and other current assets

 

23,838

 

19,133

 

Property, plant and equipment, net

 

281,253

 

288,435

 

Intangible assets, net and goodwill

 

656,017

 

668,733

 

Other assets

 

22,050

 

21,708

 

Total Assets

 

$

1,477,854

 

$

1,470,291

 

Long-term debt — current portion

 

$

6,750

 

$

6,750

 

Other current liabilities

 

65,848

 

79,180

 

Long-term debt

 

360,690

 

362,258

 

Deferred revenue - long-term

 

8,911

 

8,866

 

Other long-term liabilities

 

53,715

 

60,863

 

Total shareholders’ equity

 

981,940

 

952,374

 

Total Liabilities and Shareholders’ Equity

 

$

1,477,854

 

$

1,470,291

 

 

 

 

 

 

 

Ordinary shares outstanding (in thousands)

 

135,262

 

133,752

 

 

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 months ended June 30, 2013, which the company intends to file in July 2013.