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Alkermes Plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2019 and Provides Financial Expectations for 2020

-- Revenues of $1.17 Billion in 2019, Driven by Year-Over-Year Growth of Proprietary Product Net Sales and VUMERITY® Milestone Payment --
-- 2019 GAAP Net Loss per Share of $1.25 and Diluted Non-GAAP Earnings per Share of $0.71 --
-- Financial Expectations for 2020 Reflect Growth of Proprietary Products and Impact of Strategic Restructuring --

DUBLIN, Feb. 13, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2019 and provided financial expectations for 2020.

"2019 was an important year for Alkermes as we took active steps to shape the future of our business and continued to make a real-world impact in the treatment of serious diseases. We made significant progress on three fronts: driving growth in our proprietary product portfolio, advancing and expanding our diversified neuroscience and oncology pipeline, and positioning the business for long-term growth and future profitability," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, our priorities for 2020 are clear as we focus on commercial execution for VIVITROL® and ARISTADA®, prepare for potential approval and launch of ALKS 3831, advance the development of ALKS 4230, and continue to develop our pipeline of preclinical assets. We remain steadfast in our commitment to be a positive force for change through our science, our medicines, and our advocacy, as we advance patient-centered care."

Quarter Ended Dec. 31, 2019 Financial Highlights

  • Total revenues for the quarter were $412.7 million. This compared to $315.8 million for the same period in the prior year.
  • Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $5.4 million for the quarter, or a basic and diluted GAAP loss per share of $0.03. This compared to GAAP net loss of $9.7 million, or a basic and diluted GAAP loss per share of $0.06, for the same period in the prior year.
  • Non-GAAP net income was $131.4 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.83. This compared to non-GAAP net income of $54.8 million, or a non-GAAP basic earnings per share of $0.35 and non-GAAP diluted earnings per share of $0.34, for the same period in the prior year.
  • In October 2019, Alkermes implemented a strategic restructuring plan, which included the elimination of approximately 160 current positions across the organization, a decrease in the company's expected near-term hiring plans and the implementation of cost-saving measures related to external spend. These efforts are expected to result in cost savings of approximately $150 million in 2020.
  • In November 2019, Alkermes completed the acquisition of Rodin Therapeutics, Inc. (Rodin), a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics for synaptopathies. At the closing of the transaction, Alkermes made a cash payment of $98.1 million to Rodin's former security holders. This upfront cash payment was funded by Alkermes' available cash and was accounted for as an asset acquisition, with $86.6 million of this upfront payment recorded as research and development (R&D) expense in the quarter.

Quarter Ended Dec. 31, 2019 Financial Results

Revenues

  • Net sales of proprietary products were $149.6 million, compared to $132.7 million for the same period in the prior year.
    • Net sales of VIVITROL were $92.8 million, compared to $83.8 million for the same period in the prior year, representing an increase of approximately 11%.
    • Net sales of ARISTADAi were $56.8 million, compared to $48.8 million for the same period in the prior year, representing an increase of approximately 16%.
  • Manufacturing and royalty revenues were $107.3 million, compared to $167.4 million for the same period in the prior year.
    • Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $79.1 million, compared to $81.4 million for the same period in the prior year.
    • Manufacturing and royalty revenues from AMPYRA/FAMPYRA®ii were $7.5 million, compared to $38.8 million for the same period in the prior year, due to generic competition to AMPYRA entering the U.S. market in 2018.
    • Manufacturing and royalty revenues in the fourth quarter of 2018 included $26.7 million related to Alkermes' share of proceeds from the sale of certain royalty streams by Zealand Pharma A/S related to products using Alkermes technology.
  • Total revenues also included a $150.0 million milestone payment from Biogen related to the U.S. Food and Drug Administration (FDA) approval of VUMERITY, of which $144.8 million was recorded as license revenue and $5.2 million was recorded as R&D revenue.
  • R&D revenues were $11.1 million, primarily related to R&D reimbursement from the company's collaboration with Biogen for VUMERITY and a portion of the milestone payment noted above.

Costs and Expenses

  • Total operating expenses were $422.7 million, compared to $315.7 million for the same period in the prior year.
    • R&D expenses were $198.2 million, which included $86.6 million related to the acquisition of Rodin during the fourth quarter. Excluding this R&D charge related to Rodin, R&D expenses were $111.6 million compared to $109.0 million for the same period in the prior year.
    • Selling, General and Administrative (SG&A) expenses were $154.5 million, compared to $141.2 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of ARISTADA and VIVITROL.
    • As a result of the restructuring implemented in October 2019, the company recorded a restructuring expense charge of $13.4 million in the fourth quarter of 2019, consisting of one-time termination benefits for employee severance, benefits and related costs.

"Our 2019 results reflect volume growth of VIVITROL and ARISTADA, continued strength of our royalty and manufacturing portfolio and investment in the commercialization of our products and our research and development pipeline," commented James Frates, Chief Financial Officer of Alkermes. "We enter 2020 well positioned to drive growth of our proprietary product portfolio and advance our pipeline of novel oncology and neuroscience candidates. Our financial expectations for 2020 reflect anticipated net sales growth of our proprietary products and operating expenses in line with the predicted impact of the strategic restructuring that we implemented in the fourth quarter of 2019, reflecting our commitment to non-GAAP profitability while investing in the long-term growth of the company."

Calendar Year 2019 Financial Highlights

  • Total revenues increased 7% to $1.17 billion in 2019, which included VIVITROL net sales of $335.4 million, ARISTADA net sales of $189.1 million, and the $150.0 million milestone payment from Biogen related to the approval of VUMERITY. This compared to total revenues of $1.09 billion in 2018, which included VIVITROL net sales of $302.6 million, ARISTADA net sales of $147.7 million and license revenues of $48.4 million from Biogen. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products.
  • GAAP net loss was $196.6 million, or a basic and diluted GAAP loss per share of $1.25, for 2019. This compared to a GAAP net loss of $139.3 million, or a basic and diluted GAAP loss per share of $0.90, for 2018.
  • Non-GAAP net income was $112.2 million, or a non-GAAP basic and diluted earnings per share of $0.71, for 2019, and excludes the impact of the acquisition of Rodin and the restructuring. This compared to non-GAAP net income of $97.8 million, or a non-GAAP basic earnings per share of $0.63 and non-GAAP diluted earnings per share of $0.61, for 2018.
  • At Dec. 31, 2019, Alkermes recorded cash, cash equivalents and total investments of $614.4 million, compared to $620.0 million at Dec. 31, 2018. At Dec. 31, 2019, the company's total debt outstanding was $277.1 million, compared to $279.3 million at Dec. 31, 2018.

Recent Events:

  • ALKS 3831
    • In January 2020, the FDA accepted for review the company's New Drug Application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder, and assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.
  • VUMERITY
    • In October 2019, the FDA approved VUMERITY, a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Biogen holds the exclusive worldwide license to commercialize VUMERITY. In November 2019, Alkermes received a $150 million milestone payment from Biogen related to the approval of VUMERITY.
  • ALKS 4230
    • In November 2019, Alkermes presented preliminary clinical data from the ARTISTRY-1 phase 1/2 study investigating intravenous administration of ALKS 4230 as monotherapy and in combination with pembrolizumab in adults with advanced solid tumors, and study design details and preliminary safety data from the ARTISTRY-2 phase 1/2 study evaluating subcutaneous administration of ALKS 4230 as monotherapy and in combination with pembrolizumab at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
  • HDAC-Inhibitor Platform
    • In November 2019, Alkermes announced the acquisition of Rodin, a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics for synaptopathies, which expanded Alkermes' neuroscience development efforts into a wide range of neurodegenerative disorders.

Financial Expectations for 2020

The following outlines the company's financial expectations for 2020, which reflect the expected impact of the strategic restructuring implemented in 2019. All line items are according to GAAP, except as otherwise noted.

  • Revenues: The company expects total revenues to range from $1.03 billion to $1.08 billion. Excluding license and R&D revenues from Biogen of approximately $195 million related to the development and approval of VUMERITY recorded in 2019, this represents revenue growth of approximately 8%. Included in this total revenue expectation, Alkermes expects VIVITROL net sales to range from $340 million to $355 million, and ARISTADA net sales to range from $220 million to $235 million.
  • Cost of Goods Manufactured and Sold: The company expects cost of goods manufactured and sold to range from $185 million to $195 million.
  • Research and Development (R&D) Expenses: The company expects R&D expenses to range from $405 million to $430 million.
  • Selling, General and Administrative (SG&A) Expenses: The company expects SG&A expenses to range from $535 million to $560 million.
  • Amortization of Intangible Assets: The company expects amortization of intangibles to be approximately $40 million.
  • Net Interest Expense: The company expects interest expense and interest income to offset one another.
  • Income Tax Expense: The company expects income tax expense of up to $10 million.
  • GAAP Net Loss: The company expects GAAP net loss to range from $130 million to $160 million, or a basic and diluted loss per share of $0.82 to $1.01, based on a weighted average share count of approximately 159 million shares outstanding.
  • Non-GAAP Net Income: The company expects non-GAAP net income to range from $40 million to $70 million, or a non-GAAP basic earnings per share of $0.25 to $0.44, based on a weighted average basic share count of approximately 159 million shares outstanding and a non-GAAP diluted earnings per share of $0.25 to $0.43, based on a weighted average diluted share count of approximately 161 million shares outstanding.
  • Share-Based Compensation: The company expects share-based compensation of approximately $110 million.
  • Capital Expenditures: The company expects capital expenditures to range from $45 million to $55 million.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 13, 2020, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 13, 2020, through Thursday, Feb. 20, 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 13698323.

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; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP measures of the 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 our 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 potential cost savings that may be achieved in connection with the company's implementation of a restructuring, the company's potential to achieve profitability and long-term growth, and expectations concerning continued revenue growth from the company's commercial products and royalty streams; the potential therapeutic and commercial value of the company's marketed and development products; the FDA's target PDUFA action date for, and potential approval of, the NDA for ALKS 3831; expectations concerning future development activities, including the advancement of the ALKS 4230 clinical development program, and expansion of the company's neuroscience and oncology pipeline; and expectations concerning the company's commercial activities, including launch preparations 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 or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and  the adequacy of the data included in our filings to support the FDA's requirements for approval of the proposed indications; clinical development activities may not be completed on time or at all; the results of our 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 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 FDA or regulatory authorities outside the U.S. may make adverse decisions 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 and uncertainties described under the heading "Risk Factors" in the company's most recent Annual Report on Form 10-K 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.

VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited; RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson; VUMERITY® is a registered trademark of Biogen Inc., used by Alkermes under license; and AMPYRA® and FAMPYRA® are registered trademarks of Acorda Therapeutics, Inc. ("Acorda")

 (tables follow)

_______________
i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO, unless the context indicates otherwise.
ii AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda and outside the U.S. by Biogen Inc., under a licensing agreement with Acorda, as FAMPYRA® (prolonged-release fampridine tablets).

 

Alkermes plc and Subsidiaries

           

Selected Financial Information (Unaudited)

           
                     

 

Condensed Consolidated Statements of
Operations - GAAP

 

Three Months
Ended

 

Three Months
Ended

           
 

December 31, 

 

December 31, 

           

(In thousands, except per share data)

 

2019

 

2018

           

Revenues:

                   

Product sales, net

 

$                 149,609

 

$                  132,650

           

Manufacturing and royalty revenues

 

107,287

 

167,422

           

License revenues

 

144,750

 

120

           

Research and development revenue

 

11,084

 

15,570

           

Total Revenues

 

412,730

 

315,762

           

Expenses:

                   

Cost of goods manufactured and sold

 

46,482

 

49,117

           

Research and development

 

198,157

 

108,972

           

Selling, general and administrative

 

154,453

 

141,227

           

Amortization of acquired intangible assets

 

10,171

 

16,426

           

Restructuring expense

 

13,401

 

           

Total Expenses

 

422,664

 

315,742

           

Operating (Loss) Income

 

(9,934)

 

20

           

Other Income (Expense), net:

                   

Interest income

 

3,191

 

3,292

           

Interest expense

 

(3,196)

 

(3,478)

           

Change in the fair value of contingent consideration

 

5,000

 

(2,300)

           

Other income, net

 

2,382

 

775

           

Total Other Income (Expense), net

 

7,377

 

(1,711)

           

Loss Before Income Taxes

 

(2,557)

 

(1,691)

           

Provision for income taxes

 

2,797

 

8,022

           

Net Loss — GAAP

 

$                    (5,354)

 

$                    (9,713)

           
                     

(Loss) Earnings Per Share:

                   

GAAP loss per share — basic and diluted

 

$                      (0.03)

 

$                      (0.06)

           

Non-GAAP earnings per share — basic

 

$                       0.83

 

$                       0.35

           

Non-GAAP earnings per share — diluted

 

$                       0.83

 

$                       0.34

           
                     

Weighted Average Number of Ordinary
Shares Outstanding:

                   

Basic and diluted — GAAP

 

157,662

 

155,506

           

Basic — Non-GAAP

 

157,662

 

155,506

           

Diluted — Non-GAAP

 

159,073

 

159,518

           
                     

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

                   

Net Loss — GAAP

 

$                    (5,354)

 

$                    (9,713)

           

Adjustments:

                   

Share-based compensation expense

 

21,387

 

29,314

           

Amortization expense

 

10,171

 

16,426

           

Depreciation expense

 

10,340

 

9,476

           

Income tax effect related to reconciling items

 

592

 

1,533

           

Non-cash net interest expense

 

168

 

169

           

Change in the fair value of warrants and equity
method investments

 

(930)

 

(410)

           

Change in the fair value of contingent consideration

 

(5,000)

 

2,300

           

Acquisition of IPR&D

 

86,595

 

           

Restructuring expense

 

13,401

 

           

Fixed asset impairment

 

 

5,746

           

Non-GAAP Net Income

 

$                  131,370

 

$                    54,841

           
                     
                     
                     
                     
                     

 

Condensed Consolidated Statements of
Operations - GAAP

 

Year Ended

 

Year Ended

           
 

December 31, 

 

December 31, 

           

(In thousands, except per share data)

 

2019

 

2018

           

Revenues:

                   

Product sales, net

 

$                  524,499

 

$                  450,334

           

Manufacturing and royalty revenues

 

447,882

 

526,675

           

License revenues

 

145,750

 

48,370

           

Research and development revenue

 

52,816

 

68,895

           

Total Revenues

 

1,170,947

 

1,094,274

           

Expenses:

                   

Cost of goods manufactured and sold

 

180,385

 

176,420

           

Research and development

 

512,833

 

425,406

           

Selling, general and administrative

 

599,449

 

526,408

           

Amortization of acquired intangible assets

 

40,358

 

65,168

           

Restructuring expense

 

13,401

 

0

           

Total Expenses

 

1,346,426

 

1,193,402

           

Operating Loss

 

(175,479)

 

(99,128)

           

Other Expense, net:

                   

  Interest income

 

13,976

 

9,238

           

  Interest expense

 

(13,601)

 

(15,437)

           

  Change in the fair value of contingent consideration

 

(22,800)

 

(19,600)

           

  Other income (expense), net

 

848

 

(2,040)

           

Total Other Expense, net

 

(21,577)

 

(27,839)

           

Loss Before Income Taxes

 

(197,056)

 

(126,967)

           

(Benefit) Provision for income taxes

 

(436)

 

12,344

           

Net Loss — GAAP

 

$                (196,620)

 

$                (139,311)

           
                     

(Loss) Earnings Per Share:

                   

GAAP net loss per share — basic and diluted

 

$                      (1.25)

 

$                      (0.90)

           

Non-GAAP earnings per share — basic

 

$                        0.71

 

$                        0.63

           

Non-GAAP earnings per share — diluted

 

$                        0.71

 

$                        0.61

           
                     

Weighted Average Number of Ordinary
Shares Outstanding:

                   

Basic and diluted — GAAP

 

157,051

 

155,112

           

Basic — Non-GAAP

 

157,051

 

155,112

           

Diluted — Non-GAAP

 

159,056

 

160,363

           
                     

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

                   

Net Loss — GAAP

 

$                (196,620)

 

$                (139,311)

           

Adjustments:

                   

Share-based compensation expense

 

100,977

 

105,357

           

Amortization expense

 

40,358

 

65,168

           

Depreciation expense

 

40,055

 

38,492

           

Income tax effect related to reconciling items

 

5,762

 

(4,002)

           

Non-cash net interest expense

 

673

 

700

           

Change in the fair value of warrants and equity
method investments

 

(1,837)

 

190

           

Change in the fair value of contingent consideration

 

22,800

 

19,600

           

Acquisition of IPR&D

 

86,595

 

           

Restructuring expense

 

13,401

 

3,598

           

Fixed asset impairment

 

 

5,746

           

Debt refinancing charge

 

 

2,298

           

Non-GAAP Net Income

 

$                  112,164

 

$                    97,836

           
                     
                     
                     

Condensed Consolidated Balance Sheets

 

December 31, 

 

December 31, 

           

(In thousands)

 

2019

 

2018

           

Cash, cash equivalents and total investments

 

$                  614,370

 

$                  620,039

           

Receivables

 

257,086

 

292,223

           

Contract assets

 

8,386

 

8,230

           

Inventory

 

101,803

 

90,196

           

Prepaid expenses and other current assets

 

59,716

 

53,308

           

Property, plant and equipment, net

 

362,168

 

309,987

           

Intangible assets, net and goodwill

 

243,516

 

283,874

           

Other assets

 

158,358

 

167,150

           

Total Assets

 

$               1,805,403

 

$               1,825,007

           

Long-term debt — current portion

 

$                      2,843

 

$                      2,843

           

Other current liabilities

 

388,269

 

336,931

           

Long-term debt   

 

274,295

 

276,465

           

Contract liabilities — long-term 

 

22,068

 

9,525

           

Other long-term liabilities

 

32,486

 

27,958

           

Total shareholders' equity

 

1,085,442

 

1,171,285

           

Total Liabilities and Shareholders' Equity

 

$               1,805,403

 

$               1,825,007

           
                     

Ordinary shares outstanding (in thousands)

 

157,779

 

155,757

           
                     

This selected financial information should be read in conjunction with the consolidated financial
statements and notes thereto included in Alkermes plc's Annual Report on Form 10-K for the year
ended December 31, 2019, which the company intends to file in February 2020.

           
                     
                     

Alkermes plc and Subsidiaries

Revenues for Calendar Year 2019 and 2018

                     
   

Three Months

 

Three Months

 

Three Months

 

Three Months

 

Year 

   

Ended

 

Ended

 

Ended

 

Ended

 

Ended

   

March 31,

 

June 30,

 

September 30,

 

December 31,

 

December 31,

(In thousands)

 

2019

 

2019

 

2019

 

2019

 

2019

Revenues:

                   

PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)

 

$                    75,605

 

$                    91,863

 

$                76,716

 

$                  79,147

 

$             323,331

VIVITROL

 

69,183

 

88,199

 

85,164

 

92,818

 

335,364

ARISTADA

 

30,298

 

48,436

 

53,610

 

56,791

 

189,135

Key Commercial Product Revenues

 

175,086

 

228,498

 

215,490

 

228,756

 

847,830

                     

Legacy Product Revenues

 

33,310

 

36,034

 

27,067

 

28,140

 

124,551

License Revenue(2)

 

 

1,000

 

 

144,750

 

145,750

Research and Development Revenues

 

14,706

 

14,340

 

12,686

 

11,084

 

52,816

Total Revenues

 

$                223,102

 

$                279,872

 

$             255,243

 

$             412,730

 

$          1,170,947

                     
                     
                     
   

Three Months

 

Three Months

 

Three Months

 

Three Months

 

Year 

   

Ended

 

Ended

 

Ended

 

Ended

 

Ended

   

March 31,

 

June 30,

 

September 30,

 

December 31,

 

December 31,

(In thousands)

 

2018

 

2018

 

2018

 

2018

 

2018

Revenues:

                   

PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)

 

$                    68,790

 

$                    85,181

 

$                77,202

 

$                  81,372

 

$             312,545

VIVITROL

 

62,682

 

76,203

 

79,893

 

83,831

 

302,609

ARISTADA

 

29,160

 

33,604

 

36,142

 

48,819

 

147,725

Key Commercial Product Revenues

 

160,632

 

194,988

 

193,237

 

214,022

 

762,879

                     

Legacy Product Revenues

 

45,811

 

43,060

 

39,209

 

86,050

 

214,130

License Revenue(3)

 

 

48,250

 

 

120

 

48,370

Research and Development Revenues

 

18,707

 

18,344

 

16,274

 

15,570

 

68,895

Total Revenues

 

$                225,150

 

$                304,642

 

$             248,720

 

$             315,762

 

$          1,094,274

                     
                     

(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA.

(2) - Includes a milestone payment received in the fourth quarter of 2019 which was allocated to the license sold to Biogen in connection with the VUMERITY collaboration.

(3) - Includes a milestone payment received in the second quarter of 2018 which was allocated to the license sold to Biogen in connection with the VUMERITY collaboration.

                     
                     

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

 

$               (145.0)

 

159

 

$                   (0.91)

       

   Adjustments:

                   

Share-based compensation expense

 

110.0

               

Amortization expense

 

40.0

               

Depreciation expense

 

44.0

               

Non-cash net interest expense

 

1.0

               

Income tax effect related to reconciling items 

 

5.0

               

Projected Net Income — Non-GAAP

 

$                  55.0

 

161

 

$                    0.34

       
                     

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

       

 

 

Alkermes Contacts:
For Investors: Sandy Coombs      +1 781 609 6377
For Media:      Eva Stroynowski   +1 781 609 6823

Cision View original content:http://www.prnewswire.com/news-releases/alkermes-plc-reports-financial-results-for-the-fourth-quarter-and-year-ended-dec-31-2019-and-provides-financial-expectations-for-2020-301004133.html

SOURCE Alkermes plc