UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2021March 31, 2022

 

OR

 

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission File Number 001-35299

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

 

 

 

Ireland

 

98-1007018

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

Connaught House

1 Burlington Road

Dublin 4, Ireland, D04 C5Y6

(Address of principal executive offices)

 

+ 353-1-772-8000

(Registrant’s telephone number, including area code)

 

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   No 

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 

 

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

 

 

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.

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):.  Yes   No 

 

The number of the registrant’s ordinary shares, $0.01 par value, outstanding as of OctoberApril 22, 20212022 was 161,705,367163,426,943 shares.

 

 

 

 

 

 


 

 

ALKERMES PLC AND SUBSIDIARIES

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2021MARCH 31, 2022

 

 

 

 

 

Page No.

PART I - FINANCIAL INFORMATION

 

Item 1.

Condensed Consolidated Financial Statements (unaudited):

 

 

Condensed Consolidated Balance Sheets — September 30, 2021March 31, 2022 and December 31, 20202021

65

 

Condensed Consolidated Statements of Operations and Comprehensive Loss — For the Three and Nine Months Ended September 30,March 31, 2022 and 2021 and 2020

76

 

Condensed Consolidated Statements of Cash Flows — For the NineThree Months Ended September 30,March 31, 2022 and 2021 and 2020

87

 

Condensed Consolidated Statements of Shareholders’ Equity — For the Three and Nine Months Ended September 30,March 31, 2022 and 2021 and 2020

98

 

Notes to Condensed Consolidated Financial Statements

119

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

2422

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

3835

Item 4.

Controls and Procedures

3836

 

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

3937

Item 1A.

Risk Factors

3937

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

3937

Item 5.

Other Information

3937

Item 6.

Exhibits

4038

Signatures

4139

 


 

Cautionary Note Concerning Forward-Looking Statements

This document contains and incorporates by reference “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, these statements can be identified by the use of forward-looking terminology such as “may,” “will,” “could,” “should,” “would,” “expect,” “anticipate,” “continue,” “believe,” “plan,” “estimate,” “intend,” or other similar words. These statements discuss future expectations and contain projections of results of operations or of financial condition, or state trends and known uncertainties or other forward-looking information. Forward‑looking statements in this Quarterly Report on Form 10-Q (this “Form 10-Q”) may include, without limitation, statements regarding:

 

our expectations regarding our financial performance, including revenues, expenses, liquidity, capital expenditures and income taxes;

 

our expectations regarding our products, including expectations related to product development; regulatory filings, approvals and timelines; therapeutic and commercial value, scope and potential; and the costs and expenses related to such activities and expectations;

 

our expectations regarding the initiation, timing and results of clinical trials of our products;

 

our expectations regarding the competitive, payer, legislative, regulatory and policy landscape, and changes therein, related to our products, including competition from generic forms of our products or competitive products and development programs, barriers to access or coverage of our products and potential changes in reimbursement of our products, and legislation, regulations, executive orders, guidance or other measures that may impact pricing and reimbursement of, and access to, our products;

 

our expectations regarding the financial impact of currency exchange rate fluctuations and valuations;

 

our expectations regarding future amortization of intangible assets;

 

our expectations regarding collaborations, licensing arrangements and other significant agreements with third parties relating to our products and our development programs;

 

our expectations regarding the impact of new legislation, rules and regulations and the adoption of new accounting pronouncements;

 

our expectations regarding near‑term changes in the nature of our market risk exposures or in our management’s objectives and strategies with respect to managing such exposures;

 

our expectations regarding our ability to comply with restrictive covenants of our indebtedness and our ability to fund our debt service obligations;

 

our expectations regarding future capital requirements and expenditures for our operations and our ability to finance such capital requirements and expenditures;

 

our expectations regarding the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to our products and intellectual property (“IP”), including our patents;

 

our expectations regarding the impact of the ongoing novel coronavirus (“COVID-19”) pandemic on our business and operations; and

 

other expectations discussed elsewhere in this Form 10-Q.

Actual results might differ materially from those expressed or implied by these forward-looking statements because these forward-looking statements are subject to risks, assumptions and uncertainties. These risks, assumptions and uncertainties include, among others:

our business, financial condition and results of operations have been, and may continue to be, adversely affected by the ongoing COVID-19 pandemic or other similar outbreaks of contagious diseases;

we receive substantial revenue from our key proprietary products, and our success depends on our ability to successfully manufacture and commercialize such products;

we rely heavily on our licensees in the commercialization and continued development of products from which we receive revenue and, if our licensees are not effective, our revenues could be materially adversely affected;


we face competition in the biopharmaceutical industry;

our revenues may decrease or grow at a slower than expected rate due to many factors;

revenues generated by sales of our products depend on the availability from third-party payers of reimbursement for our products and the extent of cost-sharing arrangements for patients (e.g., patient co-payment, co-insurance, deductible obligations) and cost-control measures imposed, and any reductions in payment rate or reimbursement or increases in our financial obligation to payers could result in decreased sales of our products and/or decreased revenues;

clinical trials for our product candidates are expensive, may take several years to complete, and their outcomes are uncertain;

preliminary, topline or interim data from our clinical trials that we may announce, publish or report from time to time may change as more patient data become available or based on subsequent audit and verification procedures, and may not be indicative of final data from such trials;

the U.S. Food and Drug Administration (the “FDA”) or other regulatory agencies 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 and other information included in our submissions, and may not approve, or may delay approval of, our products;

the FDA or other regulatory agencies may impose limitations or post-approval requirements on approvals for our products;

we are subject to risks related to the manufacture of our products;

we rely on third parties to provide goods and services in connection with the manufacture and distribution of the products we manufacture;

our success largely depends upon our ability to attract and retain key personnel;

patent and other IP protection for our products is key to our business and our competitive position but is uncertain;

uncertainty over IP in the biopharmaceutical industry has been the source of litigation, which is inherently costly and unpredictable, could significantly delay or prevent approval or negatively impact commercialization of our products, and could adversely affect our business;

we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers;

litigation or arbitration filed against us, including securities litigation, or regulatory actions (such as citizens petitions) filed against regulatory agencies in respect of our products, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our products, or otherwise negatively impact our business;

if there are changes in, or we fail to comply with, the extensive legal and regulatory requirements affecting the healthcare industry, we could face costs, penalties and business losses;

we may not become profitable on a sustained basis;

our level of indebtedness could adversely affect our business and limit our ability to plan for or respond to changes in our business;

the business combination of Alkermes, Inc. and the drug technology business of Elan Corporation, plc may limit our ability to use our tax attributes to offset taxable income, if any, generated from such business combination;

the market price for our ordinary shares has been volatile and may continue to be volatile in the future, and could decline significantly;

our business could be negatively affected as a result of the actions of activist shareholders; and

security breaches and other disruptions could compromise our information and expose us to liability, which could cause our business and reputation to suffer.


For additional discussion regarding these risks, assumptions and uncertainties, and other material risks to our business, see “Part I, Item 1A—Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 11, 2021, as amended by Amendment No. 1 to Annual Report on Form 10-K/A, filed with the SEC on April 29, 2021 (as so amended, our “Annual Report”). In light of these risks, assumptions and uncertainties, the forward-looking eventsexpectations discussed in this Form 10-Q might not occur. You are cautioned not to place undue reliance on the forward-looking statements in this Form 10-Q, which speak only as of the date of this Form 10-Q. All subsequent written and oral forward-looking statements concerning the matters addressed in this Form 10-Q and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Except as required by applicable law or regulation, we do not undertake any obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For information about the risks, assumptions and uncertainties of our business, see “Part I, Item 1A—Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021, filed


with the United States (“U.S.”) Securities and Exchange Commission (the “SEC”) on February 16, 2022 (our “Annual Report”).

This Form 10-Q may include data that we obtained from industry publications and third-party research, surveys and studies. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe the industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. This Form 10-Q may also include data based on our own internal estimates and research. Our internal estimates and research have not been verified by any independent source and while we believe the industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. Such third-party data and our internal estimates and research are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Part I, Item 1A—Risk Factors” in our Annual Report. These and other factors could cause our results to differ materially from those expressed or implied in this Form 10-Q.

Note Regarding Company and Product References

Alkermes plc is a fully-integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. We have a portfolio of proprietary commercial products focused on addiction,alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Use of terms such as “us,” “we,” “our,” “Alkermes” or the “Company” in this Form 10-Q is meant to refer to Alkermes plc and its consolidated subsidiaries. Except as otherwise suggested by the context, (a) references to “products” or “our products” in this Form 10-Q include our marketed products, marketed products using our proprietary technologies, our licensed products, our product candidates and product candidates using our proprietary technologies, (b) references to the “biopharmaceutical industry” in this Form 10-Q are intended to include reference to the “biotechnology industry” and/or the “pharmaceutical industry” and (c) references to “licensees” in this Form 10-Q are used interchangeably with references to “partners.”

Note Regarding Trademarks

We are the owner of various United States (“U.S.”) federal trademark registrations (“®”) and other trademarks (“TM”), including ALKERMES®, ARISTADA®, ARISTADA INITIO®, LinkeRx®, LYBALVI®, NanoCrystal® and VIVITROL®.

The following are trademarks of the respective companies listed: AMPYRA® and FAMPYRA®—Acorda Therapeutics, Inc. (“Acorda”); ANJESO®—Baudax Bio, Inc.; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA®, XEPLION®, and RISPERDAL CONSTA®—Johnson & Johnson Corporation (or its affiliates); KEYTRUDA®—Merck Sharp & Dohme Corp.; and VUMERITY®—Biogen MA Inc. (together with its affiliates, “Biogen”). Other trademarks, trade names and service marks appearing in this Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Form 10-Q are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.


PART I. FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements:

ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

 

 

September 30, 2021

 

December 31, 2020

 

March 31, 2022

 

December 31, 2021

 

(In thousands, except share and per share amounts)

 

(In thousands, except share and per share amounts)

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$310,444

 

$272,961

 

$282,557

 

$337,544

Receivables, net

 

289,160

 

275,143

 

249,942

 

313,193

Investments—short-term

 

249,856

 

362,066

 

246,315

 

198,767

Inventory

 

138,696

 

125,738

 

154,786

 

150,335

Contract assets

 

3,509

 

14,401

 

20,212

 

13,363

Prepaid expenses and other current assets

 

61,341

 

60,662

 

61,018

 

48,967

Total current assets

 

1,053,006

 

1,110,971

 

1,014,830

 

1,062,169

PROPERTY, PLANT AND EQUIPMENT, NET

 

340,594

 

350,003

 

336,740

 

341,054

INVESTMENTS—LONG-TERM

 

187,855

 

24,780

 

229,825

 

229,430

RIGHT-OF-USE ASSETS

 

118,764

 

131,718

 

115,321

 

115,627

INTANGIBLE ASSETS, NET

 

83,659

 

111,191

 

65,077

 

74,043

GOODWILL

 

92,873

 

92,873

 

92,873

 

92,873

DEFERRED TAX ASSETS

 

84,498

 

86,228

 

112,515

 

81,833

CONTINGENT CONSIDERATION

 

17,411

 

24,651

OTHER ASSETS

 

16,772

 

17,315

 

10,664

 

27,455

TOTAL ASSETS

 

$1,995,432

 

$1,949,730

 

$1,977,845

 

$2,024,484

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$428,032

 

$412,171

 

$173,126

 

$208,491

Accrued sales discounts, allowances and reserves

 

265,172

 

237,216

Operating lease liabilities—short-term

 

15,548

 

15,732

 

16,144

 

16,240

Contract liabilities—short-term

 

6,404

 

7,512

 

4,919

 

6,339

Current portion of long-term debt

 

3,000

 

2,843

 

3,000

 

3,000

Total current liabilities

 

452,984

 

438,258

 

462,361

 

471,286

LONG-TERM DEBT

 

293,437

 

272,118

 

292,171

 

292,804

OPERATING LEASE LIABILITIES—LONG-TERM

 

107,860

 

119,464

 

104,014

 

104,162

CONTRACT LIABILITIES—LONG-TERM

 

12,864

 

16,397

OTHER LONG-TERM LIABILITIES

 

32,119

 

36,511

 

43,909

 

43,648

Total liabilities

 

899,264

 

882,748

 

902,455

 

911,900

COMMITMENTS AND CONTINGENT LIABILITIES (Note 14)

 

 

 

 

COMMITMENTS AND CONTINGENT LIABILITIES (Note 15)

 

 

 

 

SHAREHOLDERS’ EQUITY:

 

 

 

 

 

 

 

 

Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; 0 issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

 

Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 165,439,188 and 162,269,220 shares issued; 161,686,223 and 159,161,141 shares outstanding at September 30, 2021 and December 31, 2020, respectively

 

1,654

 

1,620

Treasury shares, at cost (3,752,965 and 3,108,079 shares at September 30, 2021 and December 31, 2020, respectively)

 

(139,720)

 

(126,087)

Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; 0 issued and outstanding at March 31, 2022 and December 31, 2021, respectively

 

 

Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 167,743,842 and 165,790,549 shares issued; 163,212,411 and 161,937,327 shares outstanding at March 31, 2022 and December 31, 2021, respectively

 

1,677

 

1,658

Treasury shares, at cost (4,531,431 and 3,853,222 shares at March 31, 2022 and December 31, 2021, respectively)

 

(159,727)

 

(142,658)

Additional paid-in capital

 

2,778,596

 

2,685,647

 

2,818,595

 

2,798,325

Accumulated other comprehensive loss

 

(2,471)

 

(1,349)

 

(8,234)

 

(3,723)

Accumulated deficit

 

(1,541,891)

 

(1,492,849)

 

(1,576,921)

 

(1,541,018)

Total shareholders’ equity

 

1,096,168

 

1,066,982

 

1,075,390

 

1,112,584

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$1,995,432

 

$1,949,730

 

$1,977,845

 

$2,024,484

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.


ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

September 30,

 

 

September 30,

 

 

March 31,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

2022

 

 

2021

 

 

(In thousands, except per share amounts)

 

 

(In thousands, except per share amounts)

 

REVENUES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

157,737

 

 

$

142,658

 

 

$

448,508

 

 

$

402,799

 

 

$

171,268

 

 

$

129,963

 

Manufacturing and royalty revenues

 

 

136,294

 

 

 

120,351

 

 

 

398,435

 

 

 

353,107

 

 

 

105,170

 

 

 

119,847

 

License revenue

 

 

 

 

 

1,050

 

 

 

1,500

 

 

 

1,050

 

 

 

2,000

 

 

 

1,500

 

Research and development revenue

 

 

110

 

 

 

953

 

 

 

845

 

 

 

1,805

 

 

 

107

 

 

 

120

 

Total revenues

 

 

294,141

 

 

 

265,012

 

 

 

849,288

 

 

 

758,761

 

 

 

278,545

 

 

 

251,430

 

EXPENSES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below)

 

 

49,561

 

 

 

43,129

 

 

 

143,705

 

 

 

135,394

 

 

 

55,159

 

 

 

41,020

 

Research and development

 

 

118,411

 

 

 

94,980

 

 

 

308,152

 

 

 

282,481

 

 

 

95,953

 

 

 

92,268

 

Selling, general and administrative

 

 

136,213

 

 

 

127,653

 

 

 

400,569

 

 

 

393,049

 

 

 

145,052

 

 

 

125,168

 

Amortization of acquired intangible assets

 

 

9,615

 

 

 

9,917

 

 

 

28,532

 

 

 

29,535

 

 

 

8,966

 

 

 

9,406

 

Total expenses

 

 

313,800

 

 

 

275,679

 

 

 

880,958

 

 

 

840,459

 

 

 

305,130

 

 

 

267,862

 

OPERATING LOSS

 

 

(19,659

)

 

 

(10,667

)

 

 

(31,670

)

 

 

(81,698

)

 

 

(26,585

)

 

 

(16,432

)

OTHER (EXPENSE) INCOME, NET:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER EXPENSE, NET:

 

 

 

 

 

 

 

 

Interest income

 

 

468

 

 

 

1,376

 

 

 

1,955

 

 

 

5,924

 

 

 

573

 

 

 

864

 

Interest expense

 

 

(2,437

)

 

 

(1,811

)

 

 

(8,814

)

 

 

(6,790

)

 

 

(2,350

)

 

 

(3,970

)

Change in the fair value of contingent consideration

 

 

(5,195

)

 

 

3,926

 

 

 

(677

)

 

 

16,626

 

 

 

(19,067

)

 

 

1,278

 

Other income (expense), net

 

 

288

 

 

 

9,368

 

 

 

(327

)

 

 

11,047

 

 

 

2,431

 

 

 

(393

)

Total other (expense) income, net

 

 

(6,876

)

 

 

12,859

 

 

 

(7,863

)

 

 

26,807

 

(LOSS) INCOME BEFORE INCOME TAXES

 

 

(26,535

)

 

 

2,192

 

 

 

(39,533

)

 

 

(54,891

)

INCOME TAX PROVISION

 

 

2,453

 

 

 

2,326

 

 

 

9,509

 

 

 

13,328

 

Total other expense, net

 

 

(18,413

)

 

 

(2,221

)

LOSS BEFORE INCOME TAXES

 

 

(44,998

)

 

 

(18,653

)

INCOME TAX (BENEFIT) PROVISION

 

 

(9,095

)

 

 

3,765

 

NET LOSS

 

$

(28,988

)

 

$

(134

)

 

$

(49,042

)

 

$

(68,219

)

 

$

(35,903

)

 

$

(22,418

)

LOSS PER ORDINARY SHARE:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.18

)

 

$

(0.00

)

 

$

(0.31

)

 

$

(0.43

)

 

$

(0.22

)

 

$

(0.14

)

WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

161,456

 

 

 

159,062

 

 

 

160,642

 

 

 

158,685

 

 

 

162,483

 

 

 

159,634

 

COMPREHENSIVE LOSS:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(28,988

)

 

$

(134

)

 

$

(49,042

)

 

$

(68,219

)

 

$

(35,903

)

 

$

(22,418

)

Holding (loss) gain, net of a tax (benefit) provision of $(72), $(193), $(325) and $303, respectively

 

 

(249

)

 

 

(659

)

 

 

(1,122

)

 

 

1,056

 

Holding loss, net of a tax benefit of $(1,382) and $(174), respectively

 

 

(4,511

)

 

 

(601

)

COMPREHENSIVE LOSS

 

$

(29,237

)

 

$

(793

)

 

$

(50,164

)

 

$

(67,163

)

 

$

(40,414

)

 

$

(23,019

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.


ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

September 30,

 

 

March 31,

 

 

2021

 

 

2020

 

 

2022

 

 

2021

 

 

(In thousands)

 

 

(In thousands)

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(49,042

)

 

$

(68,219

)

 

$

(35,903

)

 

$

(22,418

)

Adjustments to reconcile net loss to cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

57,510

 

 

 

61,525

 

 

 

19,197

 

 

 

19,643

 

Share-based compensation expense

 

 

68,603

 

 

 

65,279

 

 

 

18,343

 

 

 

15,451

 

Deferred income taxes

 

 

2,015

 

 

 

9,939

 

 

 

(29,301

)

 

 

5,255

 

Change in the fair value of contingent consideration

 

 

677

 

 

 

(16,626

)

 

 

19,067

 

 

 

(1,278

)

Loss on debt extinguishment

 

 

171

 

 

 

 

 

 

 

 

 

171

 

Payment made for debt modification

 

 

 

 

 

(248

)

Other non-cash charges

 

 

1,803

 

 

 

2,105

 

 

 

371

 

 

 

195

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Receivables

 

 

(13,991

)

 

 

(8,551

)

 

 

63,290

 

 

 

31,648

 

Contract assets

 

 

10,892

 

 

 

(6,009

)

 

 

(6,849

)

 

 

5,122

 

Inventory

 

 

(13,375

)

 

 

(20,748

)

 

 

(4,285

)

 

 

(8,652

)

Prepaid expenses and other assets

 

 

(1,507

)

 

 

5,597

 

 

 

(15,351

)

 

 

(16,807

)

Right-of-use assets

 

 

12,891

 

 

 

13,251

 

 

 

4,129

 

 

 

4,177

 

Accounts payable and accrued expenses

 

 

15,546

 

 

 

(6,222

)

 

 

(5,458

)

 

 

(71,949

)

Contract liabilities

 

 

(4,642

)

 

 

(3,045

)

 

 

(2,980

)

 

 

(1,243

)

Operating lease liabilities

 

 

(12,504

)

 

 

(11,910

)

 

 

(4,411

)

 

 

(3,996

)

Other long-term liabilities

 

 

(4,353

)

 

 

(867

)

 

 

1,819

 

 

 

(217

)

Cash flows provided by operating activities

 

 

70,694

 

 

 

15,499

 

Cash flows provided by (used in) operating activities

 

 

21,678

 

 

 

(45,146

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additions of property, plant and equipment

 

 

(19,359

)

 

 

(36,780

)

 

 

(7,791

)

 

 

(7,986

)

Proceeds from the sale of equipment

 

 

277

 

 

 

61

 

 

 

 

 

 

176

 

Proceeds from contingent consideration

 

 

7,908

 

 

 

2,819

 

 

 

501

 

 

 

6,430

 

Return of Fountain Healthcare Partners II, L.P. investment

 

 

 

 

 

2,751

 

 

 

485

 

 

 

 

Payment made for licensed IP

 

 

(1,000

)

 

 

 

Purchases of investments

 

 

(294,370

)

 

 

(151,324

)

 

 

(114,615

)

 

 

(122,545

)

Sales and maturities of investments

 

 

241,082

 

 

 

206,089

 

 

 

60,779

 

 

 

86,193

 

Cash flows (used in) provided by investing activities

 

 

(65,462

)

 

 

23,616

 

Cash flows used in investing activities

 

 

(60,641

)

 

 

(37,732

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from the issuance of ordinary shares under share-based compensation arrangements

 

 

24,810

 

 

 

7,719

 

 

 

1,795

 

 

 

2,053

 

Employee taxes paid related to net share settlement of equity awards

 

 

(13,633

)

 

 

(7,607

)

 

 

(17,069

)

 

 

(10,413

)

Proceeds from the issuance of long-term debt

 

 

23,567

 

 

 

 

 

 

 

 

 

23,567

 

Payment made for debt extinguishment

 

 

(993

)

 

 

 

 

 

 

 

 

(262

)

Principal payments of long-term debt

 

 

(1,500

)

 

 

(2,132

)

 

 

(750

)

 

 

 

Cash flows provided by (used in) financing activities

 

 

32,251

 

 

 

(2,020

)

NET INCREASE IN CASH AND CASH EQUIVALENTS

 

 

37,483

 

 

 

37,095

 

Cash flows (used in) provided by financing activities

 

 

(16,024

)

 

 

14,945

 

NET DECREASE IN CASH AND CASH EQUIVALENTS

 

 

(54,987

)

 

 

(67,933

)

CASH AND CASH EQUIVALENTS—Beginning of period

 

 

272,961

 

 

 

203,771

 

 

 

337,544

 

 

 

272,961

 

CASH AND CASH EQUIVALENTS—End of period

 

$

310,444

 

 

$

240,866

 

 

$

282,557

 

 

$

205,028

 

SUPPLEMENTAL CASH FLOW DISCLOSURE:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchased capital expenditures included in accounts payable and accrued expenses

 

$

2,698

 

 

$

2,169

 

 

$

4,058

 

 

$

995

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 


 

ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary Shares

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Treasury Stock

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

 

 

(In thousands, except share data)

 

BALANCE — December 31, 2020

 

 

162,269,220

 

 

$

1,620

 

 

$

2,685,647

 

 

$

(1,349

)

 

$

(1,492,849

)

 

 

(3,108,079

)

 

$

(126,087

)

 

$

1,066,982

 

Issuance of ordinary shares under employee stock plans

 

 

134,163

 

 

 

4

 

 

 

2,049

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,053

 

Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards

 

 

1,432,522

 

 

 

14

 

 

 

(14

)

 

 

 

 

 

 

 

 

(529,817

)

 

 

(10,413

)

 

 

(10,413

)

Share-based compensation

 

 

 

 

 

 

 

 

15,552

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15,552

 

Unrealized loss on marketable securities, net of tax (benefit) of $(174)

 

 

 

 

 

 

 

 

 

 

 

(601

)

 

 

 

 

 

 

 

 

 

 

 

(601

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,418

)

 

 

 

 

 

 

 

 

(22,418

)

BALANCE — March 31, 2021

 

 

163,835,905

 

 

$

1,638

 

 

$

2,703,234

 

 

$

(1,950

)

 

$

(1,515,267

)

 

 

(3,637,896

)

 

$

(136,500

)

 

$

1,051,155

 

Issuance of ordinary shares under employee stock plans

 

 

1,035,941

 

 

 

11

 

 

 

18,434

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18,445

 

Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards

 

 

93,928

 

 

 

1

 

 

 

(1

)

 

 

 

 

 

 

 

 

(31,752

)

 

 

(707

)

 

 

(707

)

Share-based compensation

 

 

 

 

 

 

 

 

26,917

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

26,917

 

Unrealized loss on marketable securities, net of tax (benefit) of $(79)

 

 

 

 

 

 

 

 

 

 

 

(272

)

 

 

 

 

 

 

 

 

 

 

 

(272

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,364

 

 

 

 

 

 

 

 

 

2,364

 

BALANCE — June 30, 2021

 

 

164,965,774

 

 

$

1,650

 

 

$

2,748,584

 

 

$

(2,222

)

 

$

(1,512,903

)

 

 

(3,669,648

)

 

$

(137,207

)

 

$

1,097,902

 

Issuance of ordinary shares under employee stock plans

 

 

256,718

 

 

 

2

 

 

 

4,310

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,312

 

Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards

 

 

216,696

 

 

 

2

 

 

 

(2

)

 

 

 

 

 

 

 

 

(83,317

)

 

 

(2,513

)

 

 

(2,513

)

Share-based compensation

 

 

 

 

 

 

 

 

25,704

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

25,704

 

Unrealized loss on marketable securities, net of tax (benefit) of $(72)

 

 

 

 

 

 

 

 

 

 

 

(249

)

 

 

 

 

 

 

 

 

 

 

 

(249

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(28,988

)

 

 

 

 

 

 

 

 

(28,988

)

BALANCE — September 30, 2021

 

 

165,439,188

 

 

$

1,654

 

 

$

2,778,596

 

 

$

(2,471

)

 

$

(1,541,891

)

 

 

(3,752,965

)

 

$

(139,720

)

 

$

1,096,168

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary Shares

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Treasury Stock

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

 

 

(In thousands, except share data)

 

BALANCE — December 31, 2021

 

 

165,790,549

 

 

$

1,658

 

 

$

2,798,325

 

 

$

(3,723

)

 

$

(1,541,018

)

 

 

(3,853,222

)

 

$

(142,658

)

 

$

1,112,584

 

Issuance of ordinary shares under employee stock plans

 

 

1,953,293

 

 

 

19

 

 

 

1,776

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,795

 

Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(678,209

)

 

 

(17,069

)

 

 

(17,069

)

Share-based compensation

 

 

 

 

 

 

 

 

18,494

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18,494

 

Unrealized loss on marketable securities, net of tax (benefit) of $(1,382)

 

 

 

 

 

 

 

 

 

 

 

(4,511

)

 

 

 

 

 

 

 

 

 

 

 

(4,511

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,903

)

 

 

 

 

 

 

 

 

(35,903

)

BALANCE — March 31, 2022

 

 

167,743,842

 

 

$

1,677

 

 

$

2,818,595

 

 

$

(8,234

)

 

$

(1,576,921

)

 

 

(4,531,431

)

 

$

(159,727

)

 

$

1,075,390

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary Shares

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Treasury Stock

 

 

 

 

 

 

Ordinary Shares

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Treasury Stock

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

 

(In thousands, except share data)

 

 

(In thousands, except share data)

 

BALANCE — December 31, 2019

 

 

160,489,888

 

 

$

1,602

 

 

$

2,586,030

 

 

$

(1,816

)

 

$

(1,381,988

)

 

 

(2,710,886

)

 

$

(118,386

)

 

$

1,085,442

 

BALANCE — December 31, 2020

 

 

162,269,220

 

 

$

1,620

 

 

$

2,685,647

 

 

$

(1,349

)

 

$

(1,492,849

)

 

 

(3,108,079

)

 

$

(126,087

)

 

$

1,066,982

 

Issuance of ordinary shares under employee stock plans

 

 

258,137

 

 

3

 

 

 

3,068

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,071

 

 

 

1,566,685

 

 

18

 

 

 

2,035

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,053

 

Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards

 

 

1,020,510

 

 

10

 

 

 

(10

)

 

 

 

 

 

 

 

 

(372,846

)

 

 

(7,283

)

 

 

(7,283

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(529,817

)

 

 

(10,413

)

 

 

(10,413

)

Share-based compensation

 

 

 

 

 

 

 

 

20,125

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

20,125

 

 

 

 

 

 

 

 

 

15,552

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15,552

 

Unrealized gain on marketable securities, net of tax provision of $87

 

 

 

 

 

 

 

 

 

 

 

317

 

 

 

 

 

 

 

 

 

 

 

 

317

 

Unrealized loss on marketable securities, net of tax (benefit) of $(174)

 

 

 

 

 

 

 

 

 

 

 

(601

)

 

 

 

 

 

 

 

 

 

 

 

(601

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,654

)

 

 

 

 

 

 

 

 

(38,654

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,418

)

 

 

 

 

 

 

 

 

(22,418

)

BALANCE — March 31, 2020

 

 

161,768,535

 

 

$

1,615

 

 

$

2,609,213

 

 

$

(1,499

)

 

$

(1,420,642

)

 

 

(3,083,732

)

 

$

(125,669

)

 

$

1,063,018

 

Issuance of ordinary shares under employee stock plans

 

 

327,251

 

 

3

 

 

 

3,845

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,848

 

Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards

 

 

24,175

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,874

)

 

 

(123

)

 

 

(123

)

Share-based compensation

 

 

 

 

 

 

 

 

23,136

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

23,136

 

Unrealized gain on marketable securities, net of tax provision of $409

 

 

 

 

 

 

 

 

 

 

 

1,398

 

 

 

 

 

 

 

 

 

 

 

 

1,398

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29,431

)

 

 

 

 

 

 

 

 

(29,431

)

BALANCE — June 30, 2020

 

 

162,119,961

 

 

$

1,618

 

 

$

2,636,194

 

 

$

(101

)

 

$

(1,450,073

)

 

 

(3,091,606

)

 

$

(125,792

)

 

$

1,061,846

 

Issuance of ordinary shares under employee stock plans

 

 

53,509

 

 

 

 

 

 

800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

800

 

Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards

 

 

34,675

 

 

1

 

 

 

(1

)

 

 

 

 

 

 

 

 

(11,106

)

 

 

(201

)

 

 

(201

)

Share-based compensation

 

 

 

 

 

 

 

 

22,706

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

22,706

 

Unrealized loss on marketable securities, net of tax (benefit) of $(193)

 

 

 

 

 

 

 

 

 

 

 

(659

)

 

 

 

 

 

 

 

 

 

 

 

(659

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(134

)

 

 

 

 

 

 

 

 

(134

)

BALANCE — September 30, 2020

 

 

162,208,145

 

 

$

1,619

 

 

$

2,659,699

 

 

$

(760

)

 

$

(1,450,207

)

 

 

(3,102,712

)

 

$

(125,993

)

 

$

1,084,358

 

BALANCE — March 31, 2021

 

 

163,835,905

 

 

$

1,638

 

 

$

2,703,234

 

 

$

(1,950

)

 

$

(1,515,267

)

 

 

(3,637,896

)

 

$

(136,500

)

 

$

1,051,155

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

108


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited)

 

 

1. THE COMPANY

Alkermes plc is a fully-integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas.the fields of neuroscience and oncology. Alkermes has a portfolio of proprietary commercial products focused on addiction,alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, the Company has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying condensed consolidated financial statements of the Company for the three and nine months ended September 30,March 31, 2022 and 2021 and 2020 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2020.2021. The year-end condensed consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the U.S. (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, that are necessary to state fairly the results of operations for the reported periods.

These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Company’s Annual Report. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for any full fiscal year.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies, in the “Notes to Consolidated Financial Statements” accompanying the Company’s Annual Report. Intercompany accounts and transactions have been eliminated.

Reclassification

The Company reclassified certain prior year amounts on the condensed consolidated balance sheet to conform to the current year presentation. These reclassifications had no impact on the previously reported total assets, liabilities or shareholders’ equity.

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires that Company management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including, but not limited to, those related to revenue from contracts with its customers and related allowances, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments, contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of the Company’s assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions.

9


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

Segment Information

The Company operates as 1 business segment, which is the business of developing, manufacturing and commercializing medicines.medicines designed to address unmet medical needs of patients in major therapeutic areas. The Company’s chief decision maker, the Chief Executive Officer and Chairmanchairman of the Company’s board of directors, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit.

11


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

Risks and Uncertainties

In March 2020, COVID-19 was declared a global pandemic by the World Health Organization. To date, COVID-19 has surfaced in nearly all regions around the world and resulted in travel restrictions and business slowdowns and/or shutdowns in affected areas. Ireland, all U.S. states, and many local jurisdictions and countries around the world have, at times during the pandemic, issued and implemented quarantines, vaccine and masking mandates, restrictive executive orders and other similar government orders, restrictions, and recommendations for their residents to help control the spread of COVID-19.COVID-19, and may continue to do so while the pandemic persists. Such orders, mandates, restrictions and/or recommendations, and/or the perception that additional orders, mandates, restrictions or recommendations could occur, have, at times during the pandemic, resulted in widespread interruptions and closures of businesses, including healthcare systems that serve people living with addiction and serious mental illness, work stoppages, slowdowns and/or delays, work-from-homeremote work policies and travel restrictions, among other effects.

The COVID-19 pandemic has caused, and the Company continuesexpects may continue to closely monitorcause, varying degrees of disruption to its employees and respondits business operations. While the Company has continued to operate its manufacturing facilities and supply its medicines without interruption throughout the pandemic, it has at times during the pandemic experienced labor or supply chain disruptions at its manufacturing facilities, and may continue to experience such disruptions while the pandemic persists. In addition, while the Company has continued to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has at times impacted the timelines of certain of its early-stage discovery efforts and clinical trials, and may continue to impact such timelines while the pandemic persists. The Company works with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, the potential impact of COVID-19 on its employees, communitiesmanufacturing operations and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the actual impactR&D activities.

A number of the pandemic onmarketed products from which the Company’s financial conditionCompany derives revenue, including manufacturing and operating results may differ from current projections. These uncertainties include, among others, the ultimate severity and duration of the pandemic; the emergence and prevalence of COVID-19 variants; governmental, business or other actionsroyalty revenue, are injectable medications administered by healthcare professionals. Given developments that have been, are being or will be, takentranspired to date, and may continue to transpire, in response to the pandemic, including restrictions on travel and mobility, business closures, and operatingtravel restrictions, and imposition of social distancing measures,quarantine, testing and/or vaccine mandates and/or mandatory testing policies; impactsand other protocols, labor shortages, and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees during the pandemic on the labor market and on the Company’s employees; impacts ofmay continue to be adversely impacted while the pandemic on the vendors or distribution channels in the Company’s supply chain and on the Company’s ability to continue to manufacture its products; impacts of the pandemic on the conduct of the Company’s clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder; impacts of the pandemic on the regulatory agencies with which the Company interacts in the development, review, approval and commercialization of its medicines; impacts of the pandemic on reimbursement for the Company’s products, including the Company’s Medicaid rebate liability, and for services related to the use of its products; and impacts of the pandemic on the Irish, U.S. and global economies more broadly.persists.

In addition, the Company relies upon third parties for many aspects of its business, including the provision of goods and services related to the manufacture of its clinical products and its and its partners’ marketed products, the conduct of its clinical trials, and the sale of its proprietary marketed products and the marketed products of its licensees from which the Company receives manufacturing and royalty revenue. Any prolonged material disruption to the third parties on which the Company relies could negatively impact the Company’s ability to conduct business in the manner and on the timelines presently planned, which could have a material adverse impact on the Company’s business, results of operations and financial condition.

The marketed products from whichDue to numerous uncertainties surrounding the Company derives revenue, including manufacturing and royalty revenue, are primarily injectable medications administered by healthcare professionals. Given developments that have transpired to date, and may continue to transpire, in response toongoing COVID-19 pandemic, the actual impact of the pandemic including business closures, social distancing requirementson the Company’s financial condition and operating results may differ from its current projections. These uncertainties include, among other restrictive measures, commercial salesthings, the ultimate severity and duration of these marketed products have been adversely impacted to varying degrees during the pandemic and may continue to be adversely impacted while the pandemic persists.

The Company has continued to operate its manufacturing facilities and supply its medicines throughout the pandemic. While the Companymanner in which it continues to conduct R&D activities,evolve, including its ongoing clinical trials, the emergence, prevalence and severity of new or existing COVID-19 pandemic has, at times, impacted the timelines of certainvariants, and future developments in response thereto, which are highly uncertain and cannot be predicted as of the Company’s early-stage discovery efforts and clinical trials, and may continue to impact such timelines while the pandemic persists. The Company works with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, potential adverse impactsdate of COVID-19 on its manufacturing operations and R&D activities.this Form 10-Q.

12

10


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

New Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

In March 2020, the FASB issued Accounting Standards Update (“ASU”) 2020-04, Reference Rate Reform, which provides optional guidance for a limited period of time to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. This ASU applies to all entities, subject to meeting certain criteria, that have contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. This ASU became effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022. The Company believes this ASU will not have a material impact on its consolidated financial statements.

3. REVENUE FROM CONTRACTS WITH CUSTOMERS

Under FASB Accounting Standards Codification 606, Revenue from Contracts with Customers (“Topic 606”), the Company recognizes revenues when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. This approach to revenue recognition utilizes the following five-step model, as prescribed under Topic 606: (i) identify contract(s) with a customer; (ii) identify the performance obligation(s) in the contract(s); (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract(s); and (v) recognize revenues when (or as) the Company satisfies the performance obligation(s).

 

Product Sales, Net

The Company’s product sales, net consist of sales of VIVITROL and ARISTADA (together with ARISTADA INITIO) in the U.S., of VIVITROL, ARISTADA and ARISTADA INITIO and, following its commercial launch in October 2021, LYBALVI, primarily to wholesalers, specialty distributors and specialty pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the product has been received by the customer.

During the three and nine months ended September 30,March 31, 2022 and 2021, and 2020, the Company recorded product sales, net, as follows:

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

Three Months Ended March 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

2022

 

 

2021

 

VIVITROL

 

$

88,864

 

 

$

80,258

 

 

$

251,815

 

 

$

230,673

 

 

$

84,854

 

 

$

74,534

 

ARISTADA and ARISTADA INITIO

 

 

68,873

 

 

 

62,400

 

 

 

196,693

 

 

 

172,126

 

 

 

72,485

 

 

 

55,429

 

LYBALVI

 

 

13,929

 

 

 

 

Total product sales, net

 

$

157,737

 

 

$

142,658

 

 

$

448,508

 

 

$

402,799

 

 

$

171,268

 

 

$

129,963

 

 

13Manufacturing and Royalty Revenues

During the three months ended March 31, 2022 and 2021, the Company recorded manufacturing and royalty revenues as follows:

 

 

Three Months Ended March 31, 2022

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

Long-acting INVEGA products(1)

 

$

 

 

$

37,054

 

 

$

37,054

 

VUMERITY

 

 

11,395

 

 

 

19,200

 

 

 

30,595

 

RISPERDAL CONSTA

 

 

15,578

 

 

 

1,848

 

 

 

17,426

 

Other

 

 

11,854

 

 

 

8,241

 

 

 

20,095

 

 

 

$

38,827

 

 

$

66,343

 

 

$

105,170

 

 

 

Three Months Ended March 31, 2021

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

Long-acting INVEGA products(1)

 

$

 

 

$

61,570

 

 

$

61,570

 

VUMERITY

 

 

2,448

 

 

 

10,992

 

 

 

13,440

 

RISPERDAL CONSTA

 

 

10,683

 

 

 

3,479

 

 

 

14,162

 

Other

 

 

11,954

 

 

 

18,721

 

 

 

30,675

 

 

 

$

25,085

 

 

$

94,762

 

 

$

119,847

 

(1)

“Long-acting INVEGA products”: INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA HAFYERA/BYANNLI (paliperidone palmitate)  

In November 2021, the Company received notice of partial termination in the U.S. of its license agreement with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson Corporation (“Janssen Pharmaceutica”) in respect of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA, pursuant to which Janssen Pharmaceutica received access and rights to Alkermes’ small particle pharmaceutical compound technology, known as NanoCrystal Technology. When the partial termination became effective in February 2022, Janssen Pharmaceutica ceased paying royalties related to sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA in the U.S. and the Company stopped recognizing royalty revenue related to net sales of these products. In April 2022, the Company commenced binding arbitration proceedings related to, among other things, Janssen Pharmaceutica’s partial termination

11


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

Manufacturingof the license agreement in the U.S. and Royalty RevenuesJanssen Pharmaceutica’s royalty and other obligations under the agreement. Refer to Note 15, Commitments and Contingencies within the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information regarding the arbitration proceedings with Janssen Pharmaceutica.

During the three and nine months ended September 30, 2021 and 2020, the Company recorded manufacturing and royalty revenues as follows:

 

 

Three Months Ended September 30, 2021

 

 

Nine Months Ended September 30, 2021

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA

 

$

 

 

$

79,323

 

 

$

79,323

 

 

$

 

 

$

221,965

 

 

$

221,965

 

VUMERITY

 

 

8,499

 

 

 

18,250

 

 

 

26,749

 

 

 

17,671

 

 

 

42,866

 

 

 

60,537

 

RISPERDAL CONSTA

 

 

8,725

 

 

 

2,245

 

 

 

10,970

 

 

 

31,411

 

 

 

8,172

 

 

 

39,583

 

AMPYRA/FAMPYRA

 

 

4,716

 

 

 

2,828

 

 

 

7,544

 

 

 

20,343

 

 

 

15,189

 

 

 

35,532

 

Other

 

 

2,046

 

 

 

9,662

 

 

 

11,708

 

 

 

8,939

 

 

 

31,879

 

 

 

40,818

 

 

 

$

23,986

 

 

$

112,308

 

 

$

136,294

 

 

$

78,364

 

 

$

320,071

 

 

$

398,435

 

 

 

Three Months Ended September 30, 2020

 

 

Nine Months Ended September 30, 2020

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA

 

$

 

 

$

73,366

 

 

$

73,366

 

 

$

 

 

$

197,678

 

 

$

197,678

 

VUMERITY

 

 

579

 

 

 

2,134

 

 

 

2,713

 

 

 

3,211

 

 

 

3,787

 

 

 

6,998

 

RISPERDAL CONSTA

 

 

10,993

 

 

 

3,517

 

 

 

14,510

 

 

 

44,769

 

 

 

10,786

 

 

 

55,555

 

AMPYRA/FAMPYRA

 

 

6,748

 

 

 

5,592

 

 

 

12,340

 

 

 

21,724

 

 

 

18,094

 

 

 

39,818

 

Other

 

 

6,985

 

 

 

10,437

 

 

 

17,422

 

 

 

21,153

 

 

 

31,905

 

 

 

53,058

 

 

 

$

25,305

 

 

$

95,046

 

 

$

120,351

 

 

$

90,857

 

 

$

262,250

 

 

$

353,107

 

 

Contract Assets

Contract assets include unbilled amounts resulting from sales under certain of the Company’s manufacturing contracts with customers where revenue is recognized over time. Totaltime, except for $5.0 million of expected consideration from the Company’s collaboration with Biogen related to VUMERITY. The amounts included in the contract assets at September 30, 2021 included $3.5 million of assets that weretable below are classified as “Current assets” in the accompanying condensed consolidated balance sheets, as they relatedrelate to manufacturing processes that are completed in ten days to eight weeks, and, in the case of the $5.0 million that was classified as “Other assets” in the accompanying condensed consolidated balance sheets, as it consisted of consideration, from the Company’s collaboration with Biogen relatedan amount that is expected to VUMERITY, which the Company expects to receivebe received in the fourth quarter of 2022.

Total contract assets at September 30, 2021March 31, 2022 were as follows:

 

(In thousands)

 

Contract Assets

 

 

Contract Assets

 

Contract assets at December 31, 2020

 

$

19,401

 

Contract assets at December 31, 2021

 

$

13,363

 

Additions

 

 

22,384

 

 

 

11,451

 

Transferred to receivables, net

 

 

(33,276

)

 

 

(4,602

)

Contract assets at September 30, 2021

 

$

8,509

 

Contract assets at March 31, 2022

 

$

20,212

 

 

Contract Liabilities

 

Contract liabilities consist of contractual obligations related to deferred revenue.

Total contract liabilities at September 30, 2021March 31, 2022 were as follows:

 

(In thousands)

 

Contract Liabilities

 

 

Contract Liabilities

 

Contract liabilities at December 31, 2020

 

$

23,909

 

Contract liabilities at December 31, 2021

 

$

17,830

 

Additions

 

 

 

 

 

83

 

Amounts recognized into revenue

 

 

(4,641

)

 

 

(3,063

)

Contract liabilities at September 30, 2021

 

$

19,268

 

Contract liabilities at March 31, 2022

 

$

14,850

 

 

1412


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

 

4. INVESTMENTS

Investments consisted of the following (in thousands):

 

 

 

 

 

 

Gross Unrealized

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross Unrealized

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Losses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Losses

 

 

 

 

 

 

Amortized

 

 

 

 

 

 

Less than

 

 

Greater than

 

 

Allowance for

 

 

Estimated

 

 

Amortized

 

 

 

 

 

 

Less than

 

 

Greater than

 

 

Estimated

 

September 30, 2021

 

Cost

 

 

Gains

 

 

One Year

 

 

One Year

 

 

Credit Losses

 

 

Fair Value

 

March 31, 2022

 

Cost

 

 

Gains

 

 

One Year

 

 

One Year

 

 

Fair Value

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

121,003

 

 

$

388

 

 

$

(16

)

 

$

(3

)

 

$

 

 

$

121,372

 

 

$

96,729

 

 

$

16

 

 

$

(483

)

 

$

 

 

$

96,262

 

U.S. government and agency debt securities

 

 

66,064

 

 

 

83

 

 

 

 

 

 

 

 

 

 

 

 

66,147

 

 

 

83,261

 

 

 

7

 

 

 

(356

)

 

 

 

 

 

82,912

 

Non-U.S. government debt securities

 

 

62,202

 

 

 

141

 

 

 

(6

)

 

 

 

 

 

 

 

 

62,337

 

 

 

67,533

 

 

 

14

 

 

 

(406

)

 

 

 

 

 

67,141

 

Total short-term investments

 

 

249,269

 

 

 

612

 

 

 

(22

)

 

 

(3

)

 

 

 

 

 

249,856

 

 

 

247,523

 

 

 

37

 

 

 

(1,245

)

 

 

 

 

 

246,315

 

Long-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

 

78,936

 

 

 

 

 

 

(64

)

 

 

 

 

 

 

 

 

78,872

 

 

 

132,275

 

 

 

 

 

 

(3,055

)

 

 

 

 

 

129,220

 

U.S. government and agency debt securities

 

 

69,534

 

 

 

 

 

 

(53

)

 

 

 

 

 

 

 

 

69,481

 

 

 

79,824

 

 

 

 

 

 

(2,237

)

 

 

 

 

 

77,587

 

Non-U.S. government debt securities

 

 

37,728

 

 

 

 

 

 

(46

)

 

 

 

 

 

 

 

 

37,682

 

 

 

21,801

 

 

 

 

 

 

(414

)

 

 

(189

)

 

 

21,198

 

 

 

186,198

 

 

 

 

 

 

(163

)

 

 

 

 

 

 

 

 

186,035

 

 

 

233,900

 

 

 

 

 

 

(5,706

)

 

 

(189

)

 

 

228,005

 

Held-to-maturity securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

 

1,820

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,820

 

 

 

1,820

 

 

 

 

 

 

 

 

 

 

 

 

1,820

 

Total long-term investments

 

 

188,018

 

 

 

 

 

 

(163

)

 

 

 

 

 

 

 

 

187,855

 

 

 

235,720

 

 

 

 

 

 

(5,706

)

 

 

(189

)

 

 

229,825

 

Total investments

 

$

437,287

 

 

$

612

 

 

$

(185

)

 

$

(3

)

 

$

 

 

$

437,711

 

 

$

483,243

 

 

$

37

 

 

$

(6,951

)

 

$

(189

)

 

$

476,140

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

85,201

 

 

$

177

 

 

$

(39

)

 

$

 

 

$

85,339

 

U.S. government and agency debt securities

 

 

45,349

 

 

 

35

 

 

 

(24

)

 

 

 

 

 

45,360

 

Non-U.S. government debt securities

 

 

68,046

 

 

 

75

 

 

 

(53

)

 

 

 

 

 

68,068

 

Total short-term investments

 

 

198,596

 

 

 

287

 

 

 

(116

)

 

 

 

 

 

198,767

 

Long-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

176,937

 

 

$

1,105

 

 

$

(7

)

 

$

 

 

$

(977

)

 

$

177,058

 

 

 

111,793

 

 

 

 

 

 

(654

)

 

 

 

 

 

111,139

 

U.S. government and agency debt securities

 

 

103,011

 

 

 

336

 

 

 

(2

)

 

 

 

 

 

 

 

 

103,345

 

 

 

81,296

 

 

 

 

 

 

(517

)

 

 

 

 

 

80,779

 

Non-U.S. government debt securities

 

 

79,346

 

 

 

469

 

 

 

(6

)

 

 

 

 

 

 

 

 

79,809

 

 

 

35,902

 

 

 

 

 

 

(210

)

 

 

 

 

 

35,692

 

 

 

359,294

 

 

 

1,910

 

 

 

(15

)

 

 

 

 

 

(977

)

 

 

360,212

 

 

 

228,991

 

 

 

 

 

 

(1,381

)

 

 

 

 

 

227,610

 

Held-to-maturity securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fixed term deposit account

 

 

1,667

 

 

 

187

 

 

 

 

 

 

 

 

 

 

 

 

1,854

 

Total short-term investments

 

 

360,961

 

 

 

2,097

 

 

 

(15

)

 

 

 

 

 

(977

)

 

 

362,066

 

Long-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

 

7,908

 

 

 

 

 

 

(10

)

 

 

 

 

 

 

 

 

7,898

 

Non-U.S. government debt securities

 

 

15,077

 

 

 

 

 

 

(15

)

 

 

 

 

 

 

 

 

15,062

 

 

 

22,985

 

 

 

 

 

 

(25

)

 

 

 

 

 

 

 

 

22,960

 

Held-to-maturity securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

 

1,820

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,820

 

 

 

1,820

 

 

 

 

 

 

 

 

 

 

 

 

1,820

 

Total long-term investments

 

 

24,805

 

 

 

 

 

 

(25

)

 

 

 

 

 

 

 

 

24,780

 

 

 

230,811

 

 

 

 

 

 

(1,381

)

 

 

 

 

 

229,430

 

Total investments

 

$

385,766

 

 

$

2,097

 

 

$

(40

)

 

$

 

 

$

(977

)

 

$

386,846

 

 

$

429,407

 

 

$

287

 

 

$

(1,497

)

 

$

 

 

$

428,197

 

 

At September 30, 2021,March 31, 2022, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were other-than-temporary.temporary. Investments with unrealized losses consisted primarily of corporate debt securities debt securities issued by U.S. agencies and backed by the U.S. government and debt securities issued and backed by non-U.S. governments.U.S. agencies and the U.S. government. At March 31, 2022, the aggregate estimated fair value of investments in an unrealized loss position was $445.1 million. In making the determination whether the decline in fair value of these securities was other-than-temporary,were temporary, the Company evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis.

 

IfIn January 2022, the Company intends to sellpurchased a security,convertible promissory note in the amount of $0.5 million from Synchronicity Pharma, Inc., a related party, that matures on the earlier of September 30, 2022, the closing of a preferred equity financing, the closing of a merger, business combination or it is more likelysale of stock resulting in Synchronicity’s stockholders owning less than not that50% of the Company would be required to sell a security prior to recovering its amortized cost basis,surviving entity, or an other-than-temporary impairment is deemed to have occurred.event of default. The convertible promissory note was classified as an available-for-sale corporate debt instrument.

15

13


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

The amount of an other-than-temporary impairment related to a credit loss, or investments that the Company intends to sell before recovery, is recognized in earnings.

In September 2019, the Company purchased a convertible promissory note in the principal amount of $1.9 million from Synchronicity Pharma, Inc., a related party. The convertible promissory note was classified as an available-for-sale corporate debt instrument. In September 2020, the Company recorded an other-than-temporary credit loss of $1.0 million against the value of this investment. In June 2021, the Company determined that the remaining $0.9 million of the investment was impaired and recorded an additional other-than-temporary credit loss of $0.9 million. These losses were recorded within “Other (expense) income, net” in the accompanying condensed consolidated statements of operations and comprehensive loss.

 

In May 2014, the Company entered into an agreement whereby it committed to provide up to €8.3 million toinvest in a partnership, Fountain Healthcare Partners II, L.P., an Irish partnership of Ireland (“Fountain”), which was created to carry on the business of investing exclusively in companies and businesses engaged in the healthcare, pharmaceutical and life sciences sectors. TheAs of March 31, 2022, the Company’s total contribution in Fountain was equal to €7.8 million, and its commitment to Fountain representsrepresented approximately 7% of Fountain’sthe partnership’s total funding commitments. As of September 30, 2021, the Company had invested €7.7 million in Fountain.funding. The Company is accounting for its investment in Fountain under the equity method.

 

During the three months ended March 31, 2022, 1 of the companies within the Fountain portfolio was acquired by a third party. The Company’s proportional share of the proceeds from this transaction was $1.1 million, of which $1.0 million was received during the three months ended March 31, 2022 and the remaining $0.1 million was held in escrow. The transaction was accounted for under the cumulative earnings approach whereby the return on investment of $0.6 million was recorded as a gain within “Other expense, net” in the accompanying condensed consolidated statements of operations and comprehensive loss and the return of investment of $0.5 million was recorded as a reduction in the Company’s net investment in Fountain. The Company’s net investment in Fountain was $6.3$5.8 million and $6.2$6.1 million at September 30, 2021March 31, 2022 and December 31, 2020,2021, respectively, and was included within “Other assets” in the accompanying condensed consolidated balance sheets.

 

The proceeds fromDuring the three months ended March 31, 2022 and 2021, the Company recorded an increase of less than $0.1 million and a decrease of $0.3 million, respectively, in its investment in Fountain, which represented the Company’s proportional share of Fountain’s net gains or losses.

Realized gains and losses on the sales and maturities of marketable securities,investments, which were identified using the specific identification method, and were primarily reinvested, were as follows:

 

 

Nine Months Ended September 30,

 

 

Three Months Ended March 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2022

 

 

2021

 

Proceeds from the sales and maturities of marketable securities

 

$

239,228

 

 

$

206,089

 

Proceeds from the sales and maturities of investments

 

$

60,779

 

 

$

86,193

 

Realized gains

 

$

34

 

 

$

52

 

 

$

 

 

$

 

Realized losses

 

$

977

 

 

$

977

 

 

$

 

 

$

 

 

The Company’s available-for-sale and held-to-maturity securities at September 30, 2021March 31, 2022 had contractual maturities in the following periods:

 

 

Available-for-sale

 

 

Held-to-maturity

 

 

Available-for-sale

 

 

Held-to-maturity

 

 

Amortized

 

 

Estimated

 

 

Amortized

 

 

Estimated

 

 

Amortized

 

 

Estimated

 

 

Amortized

 

 

Estimated

 

(In thousands)

 

Cost

 

 

Fair Value

 

 

Cost

 

 

Fair Value

 

 

Cost

 

 

Fair Value

 

 

Cost

 

 

Fair Value

 

Within 1 year

 

$

178,529

 

 

$

178,780

 

 

$

1,820

 

 

$

1,820

 

 

$

247,523

 

 

$

246,315

 

 

$

1,820

 

 

$

1,820

 

After 1 year through 5 years

 

 

256,938

 

 

 

257,111

 

 

 

 

 

 

 

 

 

233,900

 

 

 

228,005

 

 

 

 

 

 

 

Total

 

$

435,467

 

 

$

435,891

 

 

$

1,820

 

 

$

1,820

 

 

$

481,423

 

 

$

474,320

 

 

$

1,820

 

 

$

1,820

 

 

5. FAIR VALUE

The following table presents information about the Company’s assets and liabilities at September 30, 2021 and December 31, 2020 that are measured at fair value on a recurring basis and indicates the fair value hierarchy ofand the valuation techniques that the Company utilized to determine such fair value:

 

 

September 30,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31,

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

2021

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

2022

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government and agency debt securities

 

$

135,628

 

 

$

100,270

 

 

$

35,358

 

 

$

 

 

$

160,499

 

 

$

130,612

 

 

$

29,887

 

 

$

 

Corporate debt securities

 

 

200,244

 

 

 

 

 

 

200,244

 

 

 

 

 

 

225,482

 

 

 

 

 

 

224,982

 

 

 

500

 

Non-U.S. government debt securities

 

 

100,019

 

 

 

 

 

 

100,019

 

 

 

 

 

 

88,339

 

 

 

 

 

 

88,339

 

 

 

 

Contingent consideration

 

 

23,840

 

 

 

 

 

 

 

 

 

23,840

 

 

 

3,440

 

 

 

 

 

 

 

 

 

3,440

 

Total

 

$

459,731

 

 

$

100,270

 

 

$

335,621

 

 

$

23,840

 

 

$

477,760

 

 

$

130,612

 

 

$

343,208

 

 

$

3,940

 

 

1614


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

 

 

December 31,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2020

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

2021

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

41,849

 

 

$

41,849

 

 

$

 

 

$

 

U.S. government and agency debt securities

 

 

103,345

 

 

 

73,451

 

 

 

29,894

 

 

 

 

 

$

126,139

 

 

$

96,597

 

 

$

29,542

 

 

$

 

Corporate debt securities

 

 

184,956

 

 

 

 

 

 

183,979

 

 

 

977

 

 

 

196,478

 

 

 

 

 

 

196,478

 

 

 

 

Non-U.S. government debt securities

 

 

94,871

 

 

 

 

 

 

94,871

 

 

 

 

 

 

103,760

 

 

 

 

 

 

103,760

 

 

 

 

Contingent consideration

 

 

32,451

 

 

 

 

 

 

 

 

 

32,451

 

 

 

23,048

 

 

 

 

 

 

 

 

 

23,048

 

Total

 

$

457,472

 

 

$

115,300

 

 

$

308,744

 

 

$

33,428

 

 

$

449,425

 

 

$

96,597

 

 

$

329,780

 

 

$

23,048

 

 

The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period.

There were 0 transfers of any securities between the fair value hierarchieslevels during the ninethree months ended September 30, 2021.March 31, 2022. The following table is a rollforward of the fair value of the Company’s assetsinvestments with fair values that were determined using Level 3 inputs at September 30, 2021:March 31, 2022:

 

(In thousands)

 

Fair Value

 

 

Fair Value

 

Balance, January 1, 2021

 

$

33,428

 

Balance, January 1, 2022

 

$

23,048

 

Purchase of corporate debt security

 

 

500

 

Change in the fair value of contingent consideration

 

 

(677

)

 

 

(19,067

)

Milestone and royalty payments received by the Company related to contingent consideration

 

 

(7,908

)

 

 

(501

)

Impairment of corporate debt security

 

 

(977

)

Royalty payments due to the Company related to contingent consideration

 

 

(26

)

 

 

(40

)

Balance, September 30, 2021

 

$

23,840

 

Balance, March 31, 2022

 

$

3,940

 

 

The Company’s investments in U.S. government and agency debt securities, internationalnon-U.S. government agency debt securities and corporate debt securities classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active.

In April 2015, the Company sold its Gainesville, GA manufacturing facility, the related manufacturing and royalty revenue associated with certain products manufactured at the facility, and the rights to intravenous/intramuscular (“IV/IM”) and parenteral forms of Meloxicam to Recro Pharma, Inc. (“Recro”) and Recro Gainesville LLC (such transaction, the “Gainesville Transaction”). The Gainesville Transaction included in the purchase price contingent consideration tied to low double digit royalties on net sales of the IV/IM and parenteral forms of Meloxicam and any other product with the same active ingredient as Meloxicam IV/IM Meloxicam that is discovered or identified using certain of the Company’s IP to which Recro was provided a right of use, through license or transfer, pursuant to the Gainesville Transaction (such products, the “Meloxicam Products”), and milestone payments upon the achievement of certain regulatory and sales milestones related to the Meloxicam Products.

In November 2019, Recro spun out its acute care segment to Baudax Bio, Inc. (“Baudax”), a publicly-traded pharmaceutical company. As part of this transaction, Recro’s obligations to pay the Company certain contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax.

In Baudax’s Quarterly Report on Form 10-Q for the period ended June 30, 2021, Baudax included disclosures regarding its ability to continue as a going concern. At September 30, 2021,March 31, 2022, the Company determined the fair value of the contingent consideration due to the Company from Baudaxbe received as follows:

 

TheAs of December 31, 2021, the Company ishad received $7.8 million in milestone payments and was due to receive an additional $38.6 million related to the FDA approval in February 2020 of the New Drug Application (“NDA”) for ANJESO, the first Meloxicam Product, to be paidANJESO. This amount is due in 6 remaining equal, annual installments on each anniversaryfrom March 2022 through March 2027. At March 31, 2022, Baudax had paid the Company $0.5 million of such approval through 2027;the $6.4 million payment that was due in March 2022;

 

The Company is entitled to receive future royalties on future net sales of Meloxicam Products; and

1715


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

 

 

The Company is entitled to receive payments of up to $80.0 million upon achievingrelated to the achievement of certain sales milestones on future net sales of the Meloxicam Products. The fair valueAt March 31, 2022, the Company did not believe it was probable that any of the sales milestones was determined through the use of a real options approach, in which net sales are simulated in a risk-neutral world. To employ this methodology, the Company used a risk-adjusted expected growth rate based on its assessments of expected growth in net sales of ANJESO, adjusted by an appropriate factor to capture market risk.would be achieved.

In order to addressBaudax’s Annual Report on Form 10-K for the substantial doubt about Baudax’syear ended December 31, 2021, Baudax included disclosures regarding its ability to continue as a going concern the Company splitand a subsequent event note that announced a plan to reduce expenses including an approximately 80% reduction in its fair value analysis into two scenarios.workforce, effective in March 2022. In the first scenario, to which the Company applied a 45% and 50% likelihood at September 30, 2021 and December 31, 2020, respectively, the amounts above were discounted using a ratelight of 13% at each of September 30, 2021 and December 31, 2020, which the Company believes captures a market participant’s view of the risk associated with the expected payments assuming Baudax is ableBaudax’s disclosures regarding its ability to continue as a going concern. Inconcern and the second scenario, to whichfact that Baudax paid $0.5 million of the $6.4 million that was due in March 2022, the Company has applied a 55% and 50%100% likelihood at September 30, 2021 and December 31, 2020, respectively, the Company used the undiscounted values derived from the amounts summarized abovethat Baudax would default on its obligations and applied a recovery rate of 18% at each of September 30, 2021 and December 31, 2020,9% based on an analysis performed by Moody’s Investor ServiceStandard and Poor’s regarding recoveriespost-default recoveries. However, for avoidance of doubt, the Company has not waived its right to receive any portion of the payments owing by Baudax. For discussion on the calculation of the fair value of the contingent consideration at December 31, 2021, refer to Note 5, Fair Value within the “Notes to Consolidated Financial Statements” in a pandemic-driven default cycle.the Annual Report.

At September 30, 2021March 31, 2022 and December 31, 2020,2021, the Company determined that the fair value of the contingent consideration related to the Gainesville Transaction was $23.8$3.4 million and $32.5$23.0 million, respectively. At September 30, 2021March 31, 2022 and December 31, 2020, $6.42021, $3.4 million and $7.8$6.4 million, respectively, of the fair value of the contingent consideration was included within “Prepaid expenses and other current assets” in the accompanying condensed consolidated balance sheets, and $17.4 millionNaN and $24.7$16.6 million, respectively, of the fair value of the contingent consideration was included within “Contingent consideration”“Other assets” in the accompanying condensed consolidated balance sheets. The CompanyChanges in the fair value of the contingent consideration are recorded a decrease of $5.2 million and $0.7 million during the three and nine months ended September 30, 2021, respectively, and an increase of $3.9 million and $16.6 million during the three and nine months ended September 30, 2020, respectively, within “Change in the fair value of contingent consideration”consideration��� in the accompanying condensed consolidated statements of operations and comprehensive loss.

The carrying amounts reflected in the accompanying condensed consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term nature.

The estimated fair value of the Company’s long-term debt under its amended and restated credit agreement (such debt, the “2026 Term Loans”), which was based on quoted market price indications (Level 2 in the fair value hierarchy) and which may not be representative of actual values that could have been, or will be, realized in the future, was $296.6$285.1 million and $275.1$285.8 million at September 30, 2021March 31, 2022 and December 31, 2020,2021, respectively. See Note 11, Long-Term Debt in these “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information.

6. INVENTORY

Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consisted of the following:

 

 

September 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2022

 

 

2021

 

Raw materials

 

$

46,252

 

 

$

44,944

 

 

$

51,430

 

 

$

56,125

 

Work in process

 

 

50,890

 

 

 

53,243

 

 

 

64,385

 

 

 

59,105

 

Finished goods(1)

 

 

41,554

 

 

 

27,551

 

 

 

38,971

 

 

 

35,105

 

Total inventory

 

$

138,696

 

 

$

125,738

 

 

$

154,786

 

 

$

150,335

 

 

 

(1)

At September 30, 2021March 31, 2022 and December 31, 2020,2021, the Company had $25.2$34.4 million and $26.5$25.1 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider.

Beginning in September 2020, the carrying value of inventory included amounts associated with LYBALVI, which were capitalized in advance of validation of LYBALVI’s manufacturing line. The manufacturing line was validated in September 2021, and LYBALVI was launched commercially in October 2021.

1816


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

 

7. PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment consisted of the following:

 

 

September 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2022

 

 

2021

 

Land

 

$

6,560

 

 

$

6,560

 

 

$

6,560

 

 

$

6,560

 

Building and improvements

 

 

192,662

 

 

 

178,194

 

 

 

193,101

 

 

 

192,920

 

Furniture, fixtures and equipment

 

 

392,477

 

 

 

366,051

 

 

 

401,161

 

 

 

398,099

 

Leasehold improvements

 

 

52,641

 

 

 

52,508

 

 

 

52,526

 

 

 

52,526

 

Construction in progress

 

 

80,490

 

 

 

102,833

 

 

 

88,638

 

 

 

86,512

 

Subtotal

 

 

724,830

 

 

 

706,146

 

 

 

741,986

 

 

 

736,617

 

Less: accumulated depreciation

 

 

(384,236

)

 

 

(356,143

)

 

 

(405,246

)

 

 

(395,563

)

Total property, plant and equipment, net

 

$

340,594

 

 

$

350,003

 

 

$

336,740

 

 

$

341,054

 

 

8. GOODWILL AND INTANGIBLE ASSETS

 

Goodwill and intangible assets consisted of the following:

 

 

 

 

September 30, 2021

 

 

 

 

March 31, 2022

 

(In thousands)

 

Weighted Amortizable Life (Years)

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net Carrying Amount

 

 

Weighted Amortizable Life (Years)

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net Carrying Amount

 

Goodwill

 

 

 

$

92,873

 

 

$

 

 

$

92,873

 

 

 

 

$

92,873

 

 

$

 

 

$

92,873

 

Finite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration agreements

 

12

 

$

465,590

 

 

$

(399,630

)

 

$

65,960

 

 

12

 

$

465,590

 

 

$

(414,132

)

 

$

51,458

 

Capitalized IP

 

11-13

 

 

118,160

 

 

 

(100,461

)

 

 

17,699

 

 

11-13

 

 

118,160

 

 

 

(104,541

)

 

 

13,619

 

Total

 

 

 

$

583,750

 

 

$

(500,091

)

 

$

83,659

 

 

 

 

$

583,750

 

 

$

(518,673

)

 

$

65,077

 

 

Based on the Company’s most recent analysis, amortization of intangible assets included in the accompanying condensed consolidated balance sheet at September 30, 2021March 31, 2022 is expected to be approximately $40.0 million, $35.0 million, $35.0 million and $1.0 million in the years ending December 31, 20212022 through 2024, respectively. GivenAlthough the Company believes such analysis, and the available information and assumptions andunderlying such analysis, are reasonable, given the inherent risks and uncertainties underlying the Company’sits expectations regarding such future revenues, there is the potential for the Company’s actual results mayto vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets wouldwill change in proportion to the projected change in revenues.

 

9. LEASES

 

Future lease payments under non-cancelable leases at September 30, 2021March 31, 2022 and December 31, 20202021 consisted of the following:

 

 

September 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2022

 

 

2021

 

2021

 

$

4,372

 

 

$

16,882

 

2022

 

 

17,032

 

 

 

17,001

 

 

$

13,561

 

 

$

17,991

 

2023

 

 

17,266

 

 

 

17,266

 

 

 

18,271

 

 

 

17,329

 

2024

 

 

17,536

 

 

 

17,536

 

 

 

18,541

 

 

 

17,535

 

2025

 

 

17,810

 

 

 

17,810

 

 

 

18,814

 

 

 

17,808

 

2026

 

 

14,783

 

 

 

13,777

 

Thereafter

 

 

109,002

 

 

 

109,311

 

 

 

95,293

 

 

 

95,229

 

Total operating lease payments

 

$

183,018

 

 

$

195,806

 

 

$

179,263

 

 

$

179,669

 

Less: imputed interest

 

 

(59,610

)

 

 

(60,610

)

 

 

(59,105

)

 

 

(59,267

)

Total operating lease liabilities

 

$

123,408

 

 

$

135,196

 

 

$

120,158

 

 

$

120,402

 

 

At September 30, 2021,March 31, 2022, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 5.27%5.19% and 12.011.3 years, respectively. During the three and nine months ended September 30,March 31, 2022 and 2021, cash paid for lease liabilities was $4.4 million and $12.5$3.7 million, respectively, and $5.0 million and $11.9 million, respectively, during the three and nine months ended September 30, 2020.respectively. The Company recorded operating lease expense of $4.3$4.1 million and $12.9$4.2 million during the three and nine months ended September 30,March 31, 2022 and 2021, respectively, and $4.7 million and $13.3 million during the three and nine months ended September 30, 2020, respectively.

1917


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

 

 

10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

 

 

September 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2022

 

 

2021

 

Accounts payable

 

$

36,875

 

 

$

46,034

 

 

$

27,697

 

 

$

55,721

 

Accrued compensation

 

 

68,001

 

 

 

71,178

 

 

 

54,413

 

 

 

77,256

 

Accrued sales discounts, allowances and reserves

 

 

221,720

 

 

 

218,877

 

Accrued other

 

 

101,436

 

 

 

76,082

 

 

 

91,016

 

 

 

75,514

 

Total accounts payable and accrued expenses

 

$

428,032

 

 

$

412,171

 

 

$

173,126

 

 

$

208,491

 

At September 30, 2021, the Company determined that achievement

A summary of a development milestone related to submission of an investigational new drug application or equivalent for ALKS 1140 was probable and accrued $25.0 million for such milestone payment, which the company expects to pay in the fourth quarter of 2021. ALKS 1140 is the Company’s novel CoREST-selective histone deacetylase (HDAC) inhibitor candidateprovisions for the treatment of neurodegenerativesales and neurodevelopmental disorders. This accrualallowances is included within “Accounts payable and accrued expenses” in the accompanying condensed consolidated balance sheets.as follows:

 

 

March 31,

 

 

December 31,

 

(In thousands)

 

2022

 

 

2021

 

Medicaid rebates

 

$

224,216

 

 

$

195,413

 

Product discounts

 

 

13,204

 

 

 

14,951

 

Medicare Part D

 

 

17,350

 

 

 

14,348

 

Other

 

 

10,402

 

 

 

12,504

 

Total accrued sales discounts, allowances and reserves

 

$

265,172

 

 

$

237,216

 

 

11. LONG-TERM DEBT

Long-term debt consisted of the following:

 

 

September 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2022

 

 

2021

 

2026 Term Loans, due March 12, 2026

 

$

296,437

 

 

$

 

 

$

295,171

 

 

$

295,804

 

2023 Term Loans, due March 26, 2023

 

 

 

 

 

274,961

 

Less: current portion

 

 

(3,000

)

 

 

(2,843

)

 

 

(3,000

)

 

 

(3,000

)

Long-term debt

 

$

293,437

 

 

$

272,118

 

 

$

292,171

 

 

$

292,804

 

 

In March 2021, the Company amended and refinanced its existing term loans, previously referred to asresulting in the 20232026 Term Loans in order to, among other things, provide for a new class of replacement term loans equal to $300.0 million; extend(such refinancing, the due date for the loans from March 26, 2023 to“Term Loan Refinancing”). The 2026 Term Loans mature on March 12, 2026; amend the2026 and bear interest payable on the loans from LIBOR plus 2.25% with 0 LIBOR floor toat LIBOR plus 2.50% with a LIBOR floor of 0.50%; and increase covenant flexibility (such refinancing, the “Term Loan Refinancing” and the 2023 Term Loans as so amended and refinanced the “2026 Term Loans”)0.5%.

Under the 2026 Term Loans, the Company is subject to mandatory prepayments of principal if certain excess cash flow thresholds set forth in the 2026 Term Loans are met. To date, the Company has not been required to make any such mandatory prepayments. The 2026 Term Loans have an incremental facility capacity in the amount of $175.0 million plus potential additional amounts, provided that the Company meets certain conditions, including a specified leverage ratio. The 2026 Term Loans include a number of restrictive covenants that, among other things and subject to certain exceptions and baskets, impose operating and financial restrictions on the Company and certain of its subsidiaries. The 2026 Term Loans also contain customary affirmative covenants and events of default. At September 30, 2021, the Company was in compliance with its debt covenants under the 2026 Term Loans.at March 31, 2022.

 

The Term Loan Refinancing involved multiple lenders who were considered members of a loan syndicate. In determining whether the Term Loan Refinancing should be accounted for as a debt extinguishment or a debt modification, the Company considered whether, prior to and following the Term Loan Refinancing, creditors remained the same or changed, and whether the changes in debt terms were substantial. A change in the debt terms was considered to be substantial if the present value of the remaining cash flows under the 2026 Term Loans was at least 10% different from the present value of the remaining cash flows under the 2023 Term Loans (commonly referred to as the “10% Test”). The Company performed a separate 10% Test for each individual creditor participating in the loan syndicate.

20


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

With the exception of 3 lenders with respective holdings ranging from 2%-7% of the total outstanding principal amount of the 2023 Term Loans immediately prior to the Term Loan Refinancing whose holding amounts were accounted for as a debt extinguishment, the Term Loan Refinancing was otherwise accounted for as a debt modification.

The Term Loan Refinancing resulted in a $2.1 million charge in March 2021, which was includedIncluded in “Interest expense” in the accompanying condensed consolidated statement of operations and comprehensive loss.loss in the three months ended March 31, 2021 is $2.1 million related to the Term Loan Refinancing. Refer to Note 11, Long-Term Debt within the “Notes to Consolidated Financial Statements” in the Annual Report for a discussion on accounting for the Term Loan Refinancing.

12. SHARE-BASED COMPENSATION

The following table presents share-based compensation expense included in the accompanying condensed consolidated statements of operations and comprehensive loss:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

September 30,

 

 

September 30,

 

 

March 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

2022

 

 

2021

 

Cost of goods manufactured and sold

 

$

2,666

 

 

$

2,344

 

 

$

7,527

 

 

$

6,324

 

 

$

2,382

 

 

$

2,178

 

Research and development

 

 

7,960

 

 

 

6,762

 

 

 

19,154

 

 

 

19,400

 

 

 

5,608

 

 

 

4,063

 

Selling, general and administrative

 

 

14,974

 

 

 

13,514

 

 

 

41,922

 

 

 

39,555

 

 

 

10,353

 

 

 

9,210

 

Total share-based compensation expense

 

$

25,600

 

 

$

22,620

 

 

$

68,603

 

 

$

65,279

 

 

$

18,343

 

 

$

15,451

 

18


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

At September 30, 2021March 31, 2022 and December 31, 2020, $2.12021, $2.5 million and $2.6$2.3 million, respectively, of share-based compensation expense was capitalized and recorded as “Inventory” in the accompanying condensed consolidated balance sheets.

On June 14, 2021, the Company’s shareholders approved amendments to the Alkermes plc 2018 Stock Option and Incentive Plan that served to, among other things, increase the number of ordinary shares authorized for issuance thereunder by 8,000,000.

13. LOSS PER SHARE

Basic loss per ordinary share is calculated based upon net loss available to holders of ordinary shares divided by the weighted average number of shares outstanding. For the three and nine months ended September 30,March 31, 2022 and 2021, and 2020, as the Company was in a net loss position, the diluted loss per ordinary share calculation did not assume conversion or exercise of stock options and restricted stock unit awards, as they would have had an anti-dilutive effect on loss per ordinary share.

The following potential ordinary share equivalents havewere not been included in the net loss per ordinary share calculationscalculation because the effect would have been anti-dilutive:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

September 30,

 

 

September 30,

 

 

March 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

2022

 

 

2021

 

Stock options

 

 

11,827

 

 

 

15,322

 

 

 

15,344

 

 

 

15,352

 

 

 

13,461

 

 

 

15,451

 

Restricted stock unit awards

 

 

4,714

 

 

 

2,351

 

 

 

3,532

 

 

 

3,678

 

 

 

5,959

 

 

 

2,877

 

Total

 

 

16,541

 

 

 

17,673

 

 

 

18,876

 

 

 

19,030

 

 

 

19,420

 

 

 

18,328

 

 

21


ALKERMES PLC AND SUBSIDIARIES14. INCOME TAXES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. In determining future taxable income, the Company is responsible for assumptions utilized including the amount of Irish and non-Irish pre‑tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company is using to manage the underlying business.

During the three months ended March 31, 2022, the Company recorded an income tax benefit of $9.1 million, which was primarily due to a change to Section 174 of the Tax Cuts and Jobs Act of 2017 (as amended, the “TCJA”) which became effective on January 1, 2022. Under the TCJA, the Company is required to capitalize, and subsequently amortize R&D expenses over five years for research activities conducted in the U.S. and over fifteen years for research activities conducted outside of the U.S. The capitalization of R&D expenses resulted in an increase to the Company’s taxable income and foreign derived intangible income (“FDII”), resulting in a significant increase in the Company’s FDII deduction.

 

14.15. COMMITMENTS AND CONTINGENT LIABILITIES

Litigation

From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At September 30, 2021,March 31, 2022, there were 0 potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring.

19


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

Janssen Arbitration Proceedings

On April 19, 2022, Alkermes Pharma Ireland Limited commenced binding arbitration proceedings to settle, among other things, whether, notwithstanding Janssen Pharmaceutica’s partial termination of 2 license agreements with the Company, it has a continuing obligation to pay royalties on sales in the U.S. of INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA and CABENUVA, products developed under or enabled by these license agreements. The arbitration is to be conducted pursuant to the Institute for Conflict Prevention and Resolution (CPR) Rules for Non-Administered Arbitration. The request for arbitration seeks, among other remedies, a declaration that Janssen Pharmaceutica is in breach of the license agreements and a resumption of royalty payments for sales of the relevant products in the U.S.

INVEGA SUSTENNA ANDA Litigation

Janssen Pharmaceuticals NVPharmaceutica and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the U.S. District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc. (“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”) (such lawsuit, the “Teva Lawsuit”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”), and other Mylan Pharmaceuticals Inc. (“Mylan”entities (the “Mylan Lawsuit”), and Mylan Institutional LLC and in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC (the “Pharmascience Lawsuit”), and in the U.S. District Court for the District of Delaware in December 2021 against Tolmar Holding, Inc., Tolmar Pharmaceuticals, Inc., Tolmar Therapeutics, Inc., and Tolmar, Inc. (“Tolmar” and such lawsuit, the “Tolmar Lawsuit”), following the respective filings by each of Teva, Mylan Labs, Pharmascience and PharmascienceTolmar of an Abbreviated New Drug Application (“ANDA”) seeking approval from the FDA to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. Requested judicial remediesIn October 2021, the NJ District Court entered a judgment in eachfavor of the lawsuits include recoveryJanssen entities in the Teva Lawsuit. In December 2021, the NJ District Court entered a judgment in favor of litigation coststhe Janssen entities in the Mylan Lawsuit, based on the parties’ prior stipulation to be bound by the judgment in the Teva Lawsuit. The Teva entities and injunctive relief.Mylan Labs each filed notices of appeal of their respective judgments with the U.S. Court of Appeals for the Federal Circuit, which were consolidated in January 2022. A trial was scheduled in the Tolmar Lawsuit for October 2022. The Pharmascience Lawsuit remains pending. The Company is not a party to any of these proceedings. In October 2020, a trial was held in the lawsuit between the Janssen entities and the Teva entities and on October 8, 2021, the NJ District Court issued an order in favor of the Janssen entities.

INVEGA TRINZA ANDA Litigation

In September 2020, Janssen Pharmaceuticals NV,Pharmaceutica, Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC, initiated a patent infringement lawsuit in the NJ District Court against Mylan Labs, Mylan, and Mylan Institutional LLC following the filing by Mylan Labs of an ANDA seeking approval from the FDA to market a generic version of INVEGA TRINZA before the expiration of U.S. Patent No. 10,143,693. Requested judicial remedies include recovery of litigation costs and injunctive relief. A trial has been scheduled for October 2022. The Company is not a party to this proceeding.

RISPERDAL CONSTA European Opposition Proceedings

In December 2016, Nanjing Luye Pharmaceutical Co., Ltd., Pharmathen SA, Teva PI and Dehns Ltd (a law firm representing an unidentified opponent) filed notices of opposition with the European Patent Office (the “EPO”) in respect of the Company’s EP 2 269 577 B (the “EP ’577 Patent”), a patent directed to certain risperidone microsphere compositions, including RISPERDAL CONSTA. Following a hearing on the matter in JanuaryIn April 2019, the EPO issued a written decision revoking the EP ’577 Patent and in April 2019. TheJune 2019, the Company filed a notice of appeal of the decision to the EPO’s Technical Boards of Appeal in June 2019. Pharmathen SA submitted a reply in November 2019 and Nanjing Luye Pharmaceutical Co., Ltd. and Teva PI submitted replies in December 2019. Oral proceedings are scheduled to be held on November 29, 2022.Appeal. The Company will continue to vigorously defend the EP ’577 Patent.Patent has since expired, and in February 2022, the Company withdrew its appeal, which terminated the proceedings.

VIVITROL ANDA Litigation

In September 2020, Alkermes, Inc. and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the NJ District Court against Teva and Teva PI following the filing by Teva of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VIVITROL (naltrexone for extended-release injectable suspension) before the expiration of the Company’s U.S. Patent No. 7,919,499. Teva filed its answer in November 2020, which included counterclaims against the Company. The Company filed its reply to Teva’s counterclaims in December 2020. The Company intends to vigorously defend its IP. The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).

2220


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)

 

VUMERITY ANDA Litigation

In March 2021, Biogen Inc., Biogen Swiss Manufacturing GmbH and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the U.S. District Court for the DistrictTerm Restoration Act of Delaware (the “Delaware District Court”) against Teva Pharmaceuticals Development Inc. (“Teva PD”) following the filing by Teva PD of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VUMERITY (diroximel fumarate) before the expiration of the Company’s U.S. Patent Nos. 8,669,281, 9,090,558 and 10,080,733. The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the Hatch-Waxman Act. On October 8, 2021, the Delaware District Court granted the parties’ joint stipulation of dismissal, which terminated the litigation.1984.

Government Matters

The Company has received a subpoena and civil investigative demands from U.S. state and federal governmental authorities for documents related to VIVITROL. The Company is cooperating with the investigations.

Securities Litigation

In December 2018 and January 2019, purported stockholders of the Company filed putative class actions against the Company and certain of its officers in the U.S. District Court for the Eastern District of New York (the “EDNY District Court”) captioned Karimian v. Alkermes plc, et al., No. 1:18-cv-07410 and McDermott v. Alkermes plc, et al., No. 1:19-cv-00624, respectively. In March 2019, the EDNY District Court consolidated the two cases and appointed a lead plaintiff. The plaintiff filed an amended complaint in July 2019 naming one additional officer of the Company and one former officer of the Company as defendants. The amended complaint was filed on behalf of a putative class of purchasers of Alkermes securities during the period of July 31, 2014 through November 1, 2018 and alleges violations of Sections 10(b) and 20(a) of the Exchange Act based on allegedly false or misleading statements and omissions regarding the Company’s clinical methodologies and regulatory submission for ALKS 5461 and the FDA’s review and consideration of that submission. The lawsuit seeks, among other things, unspecified money damages, prejudgment and postjudgment interest, reasonable attorneys’ fees, expert fees and other costs. In February 2021, the EDNY District Court entered a final judgment and order dismissing the action in its entirety (the “Final Judgment and Order”). In March 2021, the plaintiff filed a notice of appeal captioned In re Alkermes Public Limited Co. Securities Litig., No. 21-801, appealing the Final Judgment and Order to the United States Court of Appeals for the Second Circuit. Oral arguments for the appeal are scheduled to be held on November 16, 2021.

Product Liability and Other Legal Proceedings

 

The Company is involved in litigation and other legal proceedings incidental to its normal business activities, including product liability cases alleging that the FDA-approved VIVITROL labeling was inadequate and caused the users of the product to suffer from opioid overdose and death. The Company intends to vigorously defend itself in these matters. While the outcome of any of these proceedings cannot be accurately predicted, the Company does not believe the ultimate resolution of any of these existing mattersproceedings would have a material adverse effect on the Company’s business or financial condition.

 


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the accompanying condensed consolidated financial statements and related notes beginning on page 6 in this Form 10-Q, and “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the audited financial statements and notes thereto included in our Annual Report.

Executive Summary

Net loss for the three and nine months ended September 30, 2021March 31, 2022 was $29.0$35.9 million, and $49.0 million, respectively, or $0.18 and $0.31$0.22 per ordinary share—basic and diluted, respectively, as compared to a net loss of $0.1$22.4 million, and $68.2 million, respectively, or $0.00 and $0.43$0.14 per ordinary share—basic and diluted, respectively, for the three and nine months ended September 30, 2020.March 31, 2021.

The increase in net loss in the three months ended September 30, 2021, as compared to the three months ended September 30, 2020, was primarily due to a $38.1$37.3 million increase in operating expenses primarily due to the $25.0 million milestone related to ALKS 1140 included within R&D expense,and a $9.1$20.3 million decrease in the fair value of our contingent consideration related to increased risk of non-payment, and a $9.1 million decrease in other income (expense), net, due to the receipt in September 2020 of our proportional share of the proceeds from the sale of two companies within the Fountain portfolio, partially offset by a $29.1$41.1 million increase in revenue.

product sales, net. The decrease in net loss in the nine months ended September 30, 2021, as compared to the nine months ended September 30, 2020, was primarily due to a $90.5 million increase in revenue, partially offset by a $40.5 million increase in operating expenses a $17.3 million decrease in the fair value of our contingent consideration, related to increased risk of non-payment and an $11.4 million decrease in other income (expense), net, primarily related to the Fountain proceeds discussed above.a $19.8 million increase in selling, general and administrative expense and a $14.1 million increase in cost of goods manufactured and sold.

These items are discussed in greater detail later in the “Results of Operations” section in this “Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q.

COVID-19 Update

In March 2020, COVID-19 was declared a global pandemic by the World Health Organization. To date, COVID-19 has surfaced in nearly all regions around the world and resulted in travel restrictions and business slowdowns and/or shutdowns in affected areas. Ireland, all U.S. states, and many local jurisdictions and countries around the world have, at times during the pandemic, issued and implemented quarantines, vaccine and masking mandates, restrictive executive orders and other similar government orders, restrictions, and recommendations for their residents to help control the spread of COVID-19, and may continue to do so while the pandemic persists. Such orders, mandates, restrictions and/or recommendations, and/or the perception that additional orders, mandates, restrictions or recommendations could occur, have, at times during the pandemic, resulted in widespread interruptions and closures of businesses, including healthcare systems that serve people living with addiction and serious mental illness, work stoppages, slowdowns and/or delays, work-from-homeremote work policies and travel restrictions, among other effects.

WeThe COVID-19 pandemic has caused, and we expect may continue to closely monitor and respondcause, varying degrees of disruption to the ongoing impact of COVID-19 on our employees our communities and our business operations, and have adopted, and adapted as needed, a series of precautionary measures in an effort to protect our employees and mitigate the potential spread of COVID-19 in a community setting. For example, at the start of the pandemic,operations. While we instituted a global remote work policy for those of our employees who were able to work remotely. At the same time, we worked to continue our critical business functions, including operation of our manufacturing facilities and our laboratories, and continued to conduct our discovery efforts and supply our medicines. For those of our employees who continued to work on-site in our laboratories and manufacturing facilities, we instituted additional safety precautions, including increased sanitization of our facilities, use of personal protective equipment, implementation of a daily health screening application and physical distancing practices. We provided employees with COVID-19 vaccine information and sponsored vaccine clinics in Massachusetts and Ohio for our employees and their families. We also took actions to support people living with opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder to help support their access to information, resources and medicines that may assist in their treatment.


In recent months, certain of our field-based employees resumed in-person interactions, and certain of our office-based employees began to return to the office, in each case on a voluntary basis and in accordance with location-specific guidance. We are planning for a larger-scale return to the office and have developed flexible work arrangement guidelines to help balance business needs, employee health, wellbeing and safety and the evolving work environment. We will continue to monitor guidance from local health authorities as we increase in-person interactions.

The marketed products from which we derive revenue, including manufacturing and royalty revenue, are primarily injectable medications administered by healthcare professionals. Given developments that have transpired to date, and may continue to transpire, in response to the pandemic, including business closures, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees during the pandemic and may continue to be adversely impacted while the pandemic persists.

We have continued to operate our manufacturing facilities and supply our medicines without interruption throughout the pandemic. Whilepandemic, we have, at times during the pandemic experienced labor or supply chain disruptions at our manufacturing facilities, and may continue to experience such disruptions while the pandemic persists. In addition, while we have continued to conduct R&D activities, including our ongoing clinical trials, the COVID-19 pandemic has at times impacted the timelines of certain of our early-stage discovery efforts and clinical trials, and may continue to impact such timelines while the pandemic persists. We work with our internal teams, our clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, the potential impact of COVID-19 on our manufacturing operations and R&D activities.

A number of the marketed products from which we derive revenue, including manufacturing and royalty revenue, are injectable medications administered by healthcare professionals. Given developments that have transpired to date, and may continue to transpire, in response to the pandemic, including business closures, travel restrictions, quarantine, testing and/or vaccine mandates and other protocols, labor shortages, and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees during the pandemic and may continue to be adversely impacted while the pandemic persists.

In addition, we rely upon third parties for many aspects of our business, including the provision of goods and services related to the manufacture of our clinical products and our and our partners’ marketed products, the conduct of our clinical trials, and the sale of our proprietary marketed products and the marketed products of our licensees from which we receive manufacturing and royalty revenue. Any prolonged material disruption to the third parties on which we


rely could negatively impact our ability to conduct business in the manner and on the timelines presently planned, which could have a material adverse impact on our business, results of operations and financial condition.

Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the actual impact of the pandemic on our financial condition and operating results may differ from our current projections. These uncertainties include, among other things, the ultimate severity and duration of the pandemic;pandemic and the manner in which it continues to evolve, including the emergence, prevalence and prevalenceseverity of new or existing COVID-19 variants; governmental, business or other actions that have been, are being, or will be, takenvariants, and future developments in response to the pandemic, including restrictions on travelthereto, which are highly uncertain and mobility, business closures and operating restrictions and imposition of social distancing measures, vaccine mandates and/or mandatory testing policies; impactscannot be predicted as of the pandemic on the labor market and on our employees; impactsdate of the pandemic on the vendors or distribution channels in our supply chain and on our ability to continue to manufacture our products; impacts of the pandemic on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with addiction and severe mental illness; impacts of the pandemic on the regulatory agencies with which we interact in the development, review, approval and commercialization of our medicines; impacts of the pandemic on reimbursement for our products, including our Medicaid rebate liability, and for services related to the use of our products; and impacts of the pandemic on the Irish, U.S. and global economies more broadly.this Form 10-Q. For additional information about risks and uncertainties related to the COVID-19 pandemic that may impact our business, our financial condition or our results of operations, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “—Our business, financial condition and results of operations have been, and may continue to be, adversely affected by the ongoing COVID-19 pandemic or other similar outbreaks of contagious diseases.”

 

Products

Marketed Products

Our portfolio ofThe key marketed products is designeddiscussed below have generated, or are expected to help address unmet medical needs of patients in major therapeutic areas.generate, significant revenues for us. See the descriptions of the marketed products below and “Part I, Item 1A—Risk Factors” in our Annual Report for important factors that could adversely affect our marketed products.  For information with respect to the IP protection for these marketed products, see the descriptions of the marketed products below andSee the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report.Report for information with respect to the IP protection for these marketed products.

 


 

The following table provides summary information regarding our FDA-approved proprietary products that we commercialize:

 

Proprietary Products

 

 

 

 

 

 

 

Product

 

Indication(s)

 

 

Territory

 

 

 

 

 

 

 

Initiation or re-initiation of

ARISTADA for the treatment of

Schizophrenia

 

 

U.S.

 

Schizophrenia

 

 

U.S.

 

 

 

 

 

 

 

 

 

 

 

 

 

Schizophrenia and

Bipolar I disorder

 

 

 

U.S.

 

 

 

 

 

 

 

 

 

 

 

 

 

Alcohol

dependence and

Opioid dependence

 

 

U.S.


 

The following table provides summary information regarding our key licensed products,product, and certain key third-party products using our proprietary technologies under license, that are commercialized by our licensees:

 

Key Third-Party Products Using Our Proprietary Technologies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

Indication(s)

 

Licensee

 

Licensed Territory

 

 

 

 

 

 

 

RISPERDAL CONSTA

 

Schizophrenia

and Bipolar I

disorder

 

Janssen

PharmaceuticaPharmaceuticals, Inc.

(“Janssen, Inc.”) and

Janssen

Pharmaceutica

International, a

division of Cilag

International AG (“Janssen

International”)

 

 

Worldwide

 

 

 

 

 

 

 

INVEGA SUSTENNASUSTENNA* / XEPLION

 

INVEGA SUSTENNA:

Schizophrenia

and Schizoaffective

disorder

 

XEPLION:

Schizophrenia

 

Janssen

Pharmaceutica N.V.

(together with

Janssen, Inc., Janssen

International and

their affiliates

“Janssen”)

 

 

Worldwide

 

 

INVEGA TRINZATRINZA* / TREVICTA

 

Schizophrenia

 

Janssen

 

Worldwide

 

INVEGA HAFYERA* / BYANNLI

Schizophrenia

Janssen

Worldwide

*

Janssen partially terminated its license agreement related to these products in the U.S., effective February 2022. See the section entitled “Products Using Our Proprietary Technologies” below and Note 15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for more information with respect to the partial termination and the arbitration proceedings we commenced related to such partial termination.

 

Our Key Licensed ProductsProduct

 

Product

 

Indication(s)

 

Licensee

 

Licensed Territory

VIVITROL

Alcohol dependence and Opioid dependence

Cilag GmbH

International (“Cilag”)

Russia and

Commonwealth of

Independent States (“CIS”)

 

 

 

 

 

 

 

VUMERITY

 

Multiple sclerosis

 

Biogen

 

Worldwide

 

Proprietary Products

We have developed and now commercialize products designed to help address the unmet needs of people living with opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for our proprietary products.


ARISTADA

 

ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injectable suspension approved in the U.S. for the treatment of schizophrenia. ARISTADA utilizes our proprietary LinkeRx technology. ARISTADA is a prodrug; once in the body, ARISTADA is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. ARISTADA is available in four dose strengths with once-monthly dosing options (441 mg, 662 mg and 882 mg), a six-week dosing option (882 mg) and a two-month dosing option (1064 mg). ARISTADA is packaged in a ready-to-use, pre-filled syringe product format. We developed ARISTADA and exclusively manufacture and commercialize it in the U.S.

In August 2021, U.S. Patent No. 11,097,006 relating to ARISTADA was granted. The patent has claims to pharmaceutical compositions that confer long-term stability of the ARISTADA formulation and expires in 2033.

ARISTADA INITIO

 

ARISTADA INITIO (aripiprazole lauroxil) leverages our proprietary LinkeRx and NanoCrystal technologies and provides an extended-release formulation of aripiprazole lauroxil in a smaller particle size compared to ARISTADA, thereby enabling faster dissolution and more rapid achievement of relevant levels of aripiprazole in the body. ARISTADA INITIO, combined with a single 30 mg dose of oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. The first ARISTADA dose may be administered on the same day as the ARISTADA INITIO regimen or up to 10 days thereafter. We developed ARISTADA INITIO and exclusively manufacture and commercialize it in the U.S.

 

In October 2021,March 2022, U.S. Patent No. 11,154,55211,273,158 relating to ARISTADA and ARISTADA INITIO was granted. The patent has composition claims to aripiprazole lauroxil in the ARISTADA INITIO formulationmethods of treating schizophrenia and expires in 2035.2039.

LYBALVI

 

LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is composed of olanzapine, an established antipsychotic agent, co-formulated with samidorphan, a new chemical entity, in a single bilayer tablet. LYBALVI was launched commercially in October 2021 and is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine. We developed LYBALVI and exclusively manufacture and commercialize it in the U.S.

In February 2022, the Company announced positive topline results from ENLIGHTEN-Early, a phase 3b study that evaluated the effect of LYBALVI compared to olanzapine on body weight in young adult patients (ages 16 to 39; mean age: 26 years) with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness.

VIVITROL (U.S.)

 

VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly, non-narcotic, injectable medication approved in the U.S., Russia and certain countries of the CISCommonwealth of Independent States for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL uses our polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through one intramuscular injection every four weeks. We developed and exclusively manufacture VIVITROL and we commercialize VIVITROLit in the U.S.

 

For a discussion of legal proceedings related to VIVITROL, see Note 14,15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the sections entitled “—Patent and other IP protection for our products is key to our business and our competitive position but is uncertain,” “—Uncertainty over IP in the biopharmaceutical industry has been the source of litigation, which is inherently costly and unpredictable, could significantly delay or prevent approval or negatively impact commercialization of our products, and could adversely affect our business” and “—Litigation or arbitration filed against Alkermes, including securities litigation, or regulatory actions (such as citizens petitions) filed against regulatory agencies in respect of our products, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our products, or otherwise negatively impact our business.”


Licensed Products and Products Using Our Proprietary Technologies

We have licensed products to third parties for commercialization and have licensed our proprietary technologies to third parties to enable them to develop, commercialize and/or manufacture products. See the “Proprietary Technology Platforms” and “Patents and Proprietary Rights” sections in “Part I, Item 1—Business” in our Annual Report for information with respect to our proprietary technologies and the IP protection for these products. We receive royalties and/or manufacturing and other revenues from the commercialization of these products.products under our collaborative arrangements with these third parties. Such arrangements include the following:

Third-Party Products Using Our Proprietary Technologies

 

INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and RISPERDAL CONSTAINVEGA HAFYERA/BYANNLI

 

In November 2021, we received notice of partial termination in the U.S. of our license agreement with Janssen in respect of INVEGA SUSTENNA/XEPLION (paliperidone palmitate),SUSTENNA, INVEGA TRINZA/TREVICTA (paliperidone palmitate 3-month injection)TRINZA and RISPERDAL CONSTA (risperidoneINVEGA HAFYERA, pursuant to which Janssen received access and rights to Alkermes’ small particle pharmaceutical compound technology, known as NanoCrystal Technology. This partial termination became effective in February 2022. In April 2022, we commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of the license agreement in the U.S. and Janssen’s royalty and other obligations under the agreement. For additional information regarding the arbitration proceedings with Janssen, see Note 15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to this notice of partial termination and our collaborative arrangements more broadly, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically that section entitled “We rely heavily on our licensees in the commercialization and continued development of products from which we receive revenue and, if our licensees are not effective, or if disputes arise in respect of our contractual arrangements, our revenues could be materially adversely affected.”

The long-acting injection)INVEGA products are long-acting atypical antipsychotics owned and commercialized worldwide by JanssenJanssen. We believe that these products were developed using, and incorporate, our proprietary technologies.

 

INVEGA SUSTENNA is approved in the U.S. for the treatment of schizophrenia and for the treatment of schizoaffective disorder as either a monotherapy or adjunctive therapy. Paliperidone palmitate extended-release injectable suspension is approved in the European Union (“EU”) and other countries outside of the U.S. for the treatment of schizophrenia and is marketed and sold under the trade name XEPLION. INVEGA SUSTENNA/XEPLION uses our nanoparticle injectable extended-release technology to increase the rate of dissolution and enable the formulation of an aqueous suspension for once-monthly intramuscular administration. INVEGA SUSTENNA/XEPLION is manufactured by Janssen.

 

INVEGA TRINZA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA SUSTENNA for at least four months. TREVICTA is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION. INVEGA TRINZA/TREVICTA is dosed once everymanufactured by Janssen.

INVEGA HAFYERA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA SUSTENNA for at least four months or INVEGA TRINZA for at least three months. BYANNLI is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION or TREVICTA. INVEGA TRINZA/TREVICTA uses our proprietary technology andHAFYERA/BYANNLI is manufactured by Janssen.

 

For a discussion of legal proceedings related to certain of the patents covering INVEGA SUSTENNA and INVEGA TRINZA, see Note 15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”


RISPERDAL CONSTA

RISPERDAL CONSTA (risperidone long-acting injection) is a long-acting atypical antipsychotic owned and commercialized worldwide by Janssen that incorporates our proprietary technologies. RISPERDAL CONSTA is approved in the U.S. for the treatment of schizophrenia and as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA is approved in numerous countries outside of the U.S. for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA uses our polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one intramuscular injection every two weeks. RISPERDAL CONSTA microspheres are exclusively manufactured by us.

 

For a discussion of legal proceedings related to certain of the patents covering INVEGA SUSTENNA, INVEGA TRINZA and RISPERDAL CONSTA, see Note 14,15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “—We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

Our Licensed Products

VIVITROL (Russia and CIS)

VIVITROL is described more fully under the heading “Proprietary Products” above in this Form 10-Q. We developed and exclusively manufacture VIVITROL for Cilag. Cilag exclusively commercializes VIVITROL in Russia and certain countries of the CIS.Product

 

VUMERITY

 

VUMERITY (diroximel fumarate) is a novel, oral fumarate with a distinct chemical structure that is approved in the U.S., the European Union and Switzerlandcertain European countries for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.


 

Under our license and collaboration agreement with Biogen, Biogen holds the exclusive, worldwide license to develop and commercialize VUMERITY. For more information about the license and collaboration agreement with Biogen, see the “Collaborative Arrangements—Biogen” section in “Part I, Item 1—Business” in our Annual Report.

For a discussion of legal proceedings related to certain of the patents covering VUMERITY, see Note 14, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “—We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

Key Development Program

 

Our R&D is focused on the development of novel, competitively advantaged medicationsinnovative medicines in the fields of neuroscience and oncology that are designed to enhanceaddress unmet patient outcomes.needs. As part of our ongoing R&D efforts, we have devoted, and will continue to devote, significant resources to conducting preclinical work and clinical studies to advance the development of new pharmaceutical products. The discussion below highlights our current key R&Ddevelopment program. Drug development involves a high degree of risk and investment, and the status, timing and scope of our development programs are subject to change. Important factors that could adversely affect our drug development efforts are discussed in “Part I, Item 1A—Risk Factors” in our Annual Report. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for our key development program.

 

Nemvaleukin alfa (formerly referred to as ALKS 4230)

 

Nemvaleukin alfa (“nemvaleukin”) is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (“IL-2”) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

 

ARTISTRY is our clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous (“IV”) and subcutaneous (“SC”) dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. ARTISTRY-1 (evaluating IV nemvaleukin) and ARTISTRY-2 (evaluating SC nemvaleukin) are ongoing phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings. ARTISTRY-3 is an ongoing phase 2 study evaluating the clinicalefficacy, safety and immunologictolerability of less frequent dosing of IV nemvaleukin and pharmacokinetic and pharmacodynamic effects of IV


nemvaleukin monotherapy onin the tumor microenvironment as a monotherapy and in combination with pembrolizumab in a variety of advanced malignant solid tumors. ARTISTRY-6 is an ongoing phase 2 study evaluating the anti-tumor activity, safety and tolerability of IV nemvaleukin monotherapy in patients with mucosal melanoma and SC nemvaleukin monotherapy in patients with advanced cutaneous melanoma. ARTISTRY-7 initiated in October 2021, is aan ongoing phase 3 study evaluating the anti-tumor activityefficacy, safety and safetytolerability of IV nemvaleukin as monotherapy and in combination with pembrolizumab compared to investigator’s choice chemotherapy in patients with platinum-resistant ovarian cancer.

 

In March 2021 and August 2021, we announced that the FDA granted Orphan Drug Designation and Fast Track designation, respectively, to nemvaleukin for the treatment of mucosal melanoma. In October 2021, we announced that the FDA granted Fast Track designation to nemvaleukin in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.


Results of Operations

 

Product Sales, Net

Our product sales, net, consist of sales of VIVITROL, ARISTADA and ARISTADA INITIO, and, following its commercial launch in the U.S., in October 2021, LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. The following table presents the adjustments deducted from product sales, gross to arrive at product sales, net, for sales of VIVITROL, ARISTADA, and ARISTADA INITIO in the U.S.and LYBALVI during the three and nine months ended September 30, 2021March 31, 2022 and 2020:2021:

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

September 30,

 

 

 

September 30,

 

 

March 31,

 

 

(In millions, except for % of Sales)

2021

 

 

% of Sales

 

 

 

2020

 

 

% of Sales

 

 

 

2021

 

 

% of Sales

 

 

 

2020

 

 

% of Sales

 

 

2022

 

 

% of Sales

 

 

 

2021

 

 

% of Sales

 

 

Product sales, gross

$

338.7

 

 

 

100.0

 

%

 

$

304.8

 

 

 

100.0

 

%

 

$

954.8

 

 

 

100.0

 

%

 

$

824.0

 

 

 

100.0

 

%

$

342.4

 

 

 

100.0

 

%

 

$

272.6

 

 

 

100.0

 

%

Adjustments to product sales, gross:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medicaid rebates

 

(86.1

)

 

 

(25.4

)

%

 

 

(83.3

)

 

 

(27.3

)

%

 

 

(245.1

)

 

 

(25.7

)

%

 

 

(210.6

)

 

 

(25.6

)

%

 

(76.5

)

 

 

(22.3

)

%

 

 

(70.9

)

 

 

(26.0

)

%

Chargebacks

 

(36.5

)

 

 

(10.8

)

%

 

 

(28.7

)

 

 

(9.4

)

%

 

 

(95.2

)

 

 

(9.9

)

%

 

 

(72.0

)

 

 

(8.7

)

%

 

(33.8

)

 

 

(9.9

)

%

 

 

(25.0

)

 

 

(9.2

)

%

Product discounts

 

(27.1

)

 

 

(8.0

)

%

 

 

(23.3

)

 

 

(7.7

)

%

 

 

(76.9

)

 

 

(8.1

)

%

 

 

(64.1

)

 

 

(7.8

)

%

 

(26.9

)

 

 

(7.9

)

%

 

 

(21.4

)

 

 

(7.9

)

%

Medicare Part D

 

(15.3

)

 

 

(4.5

)

%

 

 

(14.7

)

 

 

(4.8

)

%

 

 

(45.2

)

 

 

(4.7

)

%

 

 

(40.4

)

 

 

(4.9

)

%

 

(16.0

)

 

 

(4.7

)

%

 

 

(13.1

)

 

 

(4.8

)

%

Other

 

(16.0

)

 

 

(4.7

)

%

 

 

(12.1

)

 

 

(4.0

)

%

 

 

(43.9

)

 

 

(4.6

)

%

 

 

(34.1

)

 

 

(4.1

)

%

 

(17.9

)

 

 

(5.2

)

%

 

 

(12.2

)

 

 

(4.4

)

%

Total adjustments

 

(181.0

)

 

 

(53.4

)

%

 

 

(162.1

)

 

 

(53.2

)

%

 

 

(506.3

)

 

 

(53.0

)

%

 

 

(421.2

)

 

 

(51.1

)

%

 

(171.1

)

 

 

(50.0

)

%

 

 

(142.6

)

 

 

(52.3

)

%

Product sales, net

$

157.7

 

 

 

46.6

 

%

 

$

142.7

 

 

 

46.8

 

%

 

$

448.5

 

 

 

47.0

 

%

 

$

402.8

 

 

 

48.9

 

%

$

171.3

 

 

 

50.0

 

%

 

$

130.0

 

 

 

47.7

 

%

 

OurThe following table compares product sales, net for VIVITROL inrevenues earned during the three and nine months ended September 30, 2021 were $88.8 millionMarch 31, 2022 and $251.8 million, respectively, as compared to $80.3 million and $230.7 million in the three and nine months ended September 30, 2020, respectively. Product sales, net, for ARISTADA and ARISTADA INITIO in the three and nine months ended September 30, 2021 were $68.9 million and $196.7 million, respectively, as compared to $62.4 million and $172.1 million in the three and nine months ended September 30, 2020, respectively.2021:

 

Three Months Ended

 

 

 

 

 

 

March 31,

 

 

 

 

 

(In millions)

2022

 

 

2021

 

 

Change

 

VIVITROL

$

84.9

 

 

$

74.5

 

 

$

10.4

 

ARISTADA and ARISTADA INITIO

 

72.5

 

 

 

55.5

 

 

 

17.0

 

LYBALVI

 

13.9

 

 

 

 

 

 

13.9

 

Product sales, net

$

171.3

 

 

$

130.0

 

 

$

41.3

 

VIVITROL product sales, gross, increased by 10% and 14% in the three and nine months ended September 30, 2021, respectively, as compared to the three and nine months ended September 30, 2020,9%, primarily due to increases ofa 7% and 9%, respectively,increase in the number of VIVITROL units sold due, in part, to an improvement in the COVID-19-related disruptions that began in the second quarter of 2020. In addition, there wasand a 2% increase in the selling price of VIVITROL that went into effect in April 2021. ARISTADA and ARISTADA INITIO product sales, gross, increased by 13% and 18% in the three and nine months ended September 30, 2021, respectively, as compared to the three and nine months ended September 30, 2020,31%, primarily due to increases of 10% and 13%, respectively,a 27% increase in the number of ARISTADA and ARISTADA INITIO units sold and a 3% increase in the selling price of ARISTADA and ARISTADA INITIO that went into effect in April 2021. The increase in LYBALVI product sales, gross is due to LYBALVI’s commercial launch in October 2021. The decrease in Medicaid rebates, as a percentage of sales, was primarily due to a decrease in Medicaid utilization as rates began to normalize from pandemic levels.


Manufacturing and Royalty Revenues

The following table compares manufacturing and royalty revenues earned induring the three and nine months ended September 30, 2021March 31, 2022 and 2020:2021:

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

Three Months Ended

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

March 31,

 

 

 

 

 

(In millions)

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

2022

 

 

2021

 

 

Change

 

Manufacturing and royalty revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA

$

79.4

 

 

$

73.4

 

 

$

6.0

 

 

$

222.0

 

 

$

197.7

 

 

$

24.3

 

Long-acting INVEGA products

$

37.1

 

 

$

61.6

 

 

$

(24.5

)

VUMERITY

 

26.7

 

 

 

2.7

 

 

 

24.0

 

 

 

60.5

 

 

 

7.0

 

 

 

53.5

 

 

30.6

 

 

 

13.4

 

 

 

17.2

 

RISPERDAL CONSTA

 

11.0

 

 

 

14.5

 

 

 

(3.5

)

 

 

39.6

 

 

 

55.5

 

 

 

(15.9

)

 

17.4

 

 

 

14.2

 

 

 

3.2

 

AMPYRA/FAMPYRA

 

7.5

 

 

 

12.3

 

 

 

(4.8

)

 

 

35.5

 

 

 

39.8

 

 

 

(4.3

)

Other

 

11.7

 

 

 

17.5

 

 

 

(5.8

)

 

 

40.8

 

 

 

53.1

 

 

 

(12.3

)

 

20.1

 

 

 

30.6

 

 

 

(10.5

)

Manufacturing and royalty revenues

$

136.3

 

 

$

120.4

 

 

$

15.9

 

 

$

398.4

 

 

$

353.1

 

 

$

45.3

 

$

105.2

 

 

$

119.8

 

 

$

(14.6

)

 

We earnOur agreements with Janssen related to the long-acting INVEGA products provide for tiered royalty payments, for INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA, which consist of a patent royalty and a know-how royalty, both of which are determined on a country-by-country basis. The patent royalty, which equals 1.5% of net sales, is payable in each country until the expiration of the last of the royalty-bearing patents with valid claims applicable to the product in such country. The know-how royalty is a tiered royalty of


3.5% on calendar year net sales up to $250 million; 5.5% on calendar year net sales of between $250 million and $500 million; and 7.5% on calendar year net sales exceeding $500 million. The know-how royalty rate resets to 3.5% at the beginning of each calendar year and is payable until 15 years from the first commercial sale of a product in each individual country, subject to the expiry of the license agreement.country.

 

The increasedecrease in INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA royalty revenues infrom the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020,long-acting INVEGA products was primarily due to the partial termination in the U.S. of our license agreement with Janssen. When the termination of the license agreement became effective in February 2022, we stopped recognizing royalty revenue related to net sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA in the U.S. The decrease in royalty revenue was partially offset by an increase in Janssen’s end-marketnon-U.S. net sales of these products. During the three months ended March 31, 2022, Janssen’s rest of world net sales were $387.0 million, as compared to $376.0 million during the three months ended March 31, 2021.

We expect revenues from net sales of XEPLION, TREVICTA and BYANNLI to decrease over time. The amount and timing of revenues from sales of INVEGA SUSTENNA/XEPLIONSUSTENNA, INVEGA TRINZA and INVEGA TRINZA/TREVICTA. DuringHAFYERA depend upon the threeoutcome of our dispute with Janssen related to the basis for its partial termination of our license agreement in respect of these products. In November 2021, we received notice of partial termination of our license agreement with Janssen in respect of INVEGA SUSTENNA, INVEGA TRINZA and nine months ended September 30, 2021, Janssen’s end-marketINVEGA HAFYERA, pursuant to which Janssen received access and rights to Alkermes’ small particle pharmaceutical compound technology, known as NanoCrystal Technology. When the partial termination became effective in February 2022, Janssen ceased paying royalties related to sales of INVEGA SUSTENNA/XEPLIONSUSTENNA, INVEGA TRINZA and INVEGA TRINZA/TREVICTA were $1,004.0 millionHAFYERA in the U.S. and $2,994.0 million, respectively, as comparedthe Company stopped recognizing royalty revenue related to $926.0 millionnet sales of these products.  In April 2022, we commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of the license agreement in the U.S. and $2,688.0 million, respectively, duringJanssen’s royalty and other obligations under the threeagreement. For additional information regarding the arbitration proceedings with Janssen, see Note 15, Commitments and nine months ended September 30, 2020.Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q. For more information about the license agreement with Janssen in respect of the long-acting INVEGA products, see the “Collaborative Arrangements—Janssen” section in “Part I, Item 1—Business” in our Annual Report. For information about risks relating to the notice of partial termination and our collaborative arrangements more broadly, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically that section entitled “We rely heavily on our licensees in the commercialization and continued development of products from which we receive revenue and, if our licensees are not effective, or if disputes arise in respect of our contractual arrangements, our revenues could be materially adversely affected.”

In addition, each of INVEGA SUSTENNA and INVEGA TRINZA are currently subject to Paragraph IV litigation in response to companies seeking to market generic versions of such products. Increased competition from new products or generic versions of these products may lead to reduced unit sales of such products and increased pricing pressure. For a discussion of these legal proceedings, see Note 15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to these legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report, and specifically the section entitled “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”


We recognize manufacturing revenue for RISPERDAL CONSTA at the point in time when RISPERDAL CONSTA has been fully manufactured, which is deemed to have occurred when the product is approved for shipment by both us and Janssen. We record royalty revenue, equal to 2.5% of Janssen’s end-market net sales, in the period that the end-market sale of RISPERDAL CONSTA occurs. The decreaseincrease in revenue from RISPERDAL CONSTA in the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, was due to decreasesan increase of $2.3$4.9 million and $13.4 million, respectively, in manufacturing revenue, and decreasespartially offset by a decrease of $1.3$1.6 million and $2.6 million, respectively, in royalty revenue. The decreasesincrease in manufacturing revenue during the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, werewas primarily due to decreases of 8% and 39%, respectively,an increase in Janssen’s net selling price for units sold in the amount of RISPERDAL CONSTA manufactured for Janssen. This wasU.S., partially offset by an increasea decrease in our manufacturing fee from 7.5%8.6% to 8.6%8.3% pursuant to the terms of our manufacturing and supply agreement with Janssen due to a decreasean increase in forecasted manufacturing units. The decreasesdecrease in royalty revenue during the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, werewas due to decreasesa decrease in end-market sales of RISPERDAL CONSTA, which were $140.0 million and $452.0$129.0 million during the three and nine months ended September 30, 2021, respectively,March 31, 2022, as compared to $152.0 million and $475.0$157.0 million during the three and nine months ended September 30, 2020, respectively.March 31, 2021.

We expect revenuesrevenue from our long‑acting, atypical franchiseRISPERDAL CONSTA to decrease over time. While we expect continued growth from sales of INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTAThe latest to expire patent covering RISPERDAL CONSTA expired in 2021 in the near term,EU and will expire in 2023 in the U.S., and we are aware of potential generic competition for RISPERDAL CONSTA that may lead to reduced unit sales and increased pricing pressure in 2021. We are also aware of generic challenges to INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA.pressure. For a discussion of legal proceedings related to patents covering RISPERDAL CONSTA, INVEGA SUSTENNA and INVEGA TRINZA, see Note 14,15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q. In addition, a number of companies are working10-Q, and for risks relating to develop newsuch legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “We or our licensees may face claims against IP rights covering our products to treat schizophrenia and/or bipolar disorder that may compete with INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and RISPERDAL CONSTA. Increased competition from new products or generic versions of INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA or RISPERDAL CONSTA may lead to reduced unit sales of INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and RISPERDAL CONSTA, and increased pricing pressure.drug manufacturers.”

We receive a 15% royalty on worldwide net sales of VUMERITY. We also recognize manufacturing revenue related to VUMERITY at cost plus 15%, upon release for bulk batches of VUMERITY and upon shipment for packaged lots of VUMERITY. The increasesincrease in revenue from VUMERITY in the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, werewas due to increasesan increase of $16.1$9.0 million and $39.1 million, respectively, in royalty revenue and increases of $8.0 million and $14.5 million, respectively, in manufacturing revenue. The increases in royalty revenue were due to increases in net sales of VUMERITY, which were $120.9 million and $285.0 million during the three and nine months ended September 30, 2021, respectively, as compared to $14.3 million and $25.3 million during the three and nine months ended September 30, 2020, respectively. The increases in manufacturing revenue during the three and nine months ended September 30, 2021, as comparedan increase of $8.2 million in royalty revenue. The increase in manufacturing revenue was primarily due to the three and nine months ended September 30, 2020, were primarily the result of increased manufacturing activity to satisfy increased demand for the product. For a discussionThe increase in royalty revenue was due to an increase in net sales of legal proceedings relatedVUMERITY, which were $128.0 million during the three months ended March 31, 2022, as compared to VUMERITY, see Note 14, Commitments and Contingent Liabilities in$73.3 million during the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q.three months ended March 31, 2021.


Costs and Expenses

Cost of Goods Manufactured and Sold

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

Three Months Ended

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

March 31,

 

 

 

 

 

(In millions)

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

2022

 

 

2021

 

 

Change

 

Cost of goods manufactured and sold

$

49.6

 

 

$

43.1

 

 

$

6.5

 

 

$

143.7

 

 

$

135.4

 

 

$

8.3

 

$

55.2

 

 

$

41.0

 

 

$

14.2

 

The increasesincrease in cost of goods manufactured and sold in the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, werewas primarily due to increases of $6.0$6.6 million and $11.8$3.9 million, respectively, in the cost of goods manufactured for VUMERITY and RISPERDAL CONSTA and increases of $4.8$4.5 million and $5.0$4.4 million, respectively, in the cost of goods sold for VIVITROL and LYBALVI. These increases were all related to an increase in the number of units manufactured for VUMERITY and the number of units sold for VIVITROL, as discussed above. These increases were partially offset by decreases in the three and nine months ended, September 30, 2021each of $1.8 million and $4.3 million, respectively, in the cost of goods manufactured for RISPERDAL CONSTA, related to decreases in the number of units manufactured for RISPERDAL CONSTA,these products, as discussed above.

Research and Development ExpenseExpenses

For each of our R&D programs, we incur both external and internal expenses. External R&D expenses include fees for clinical and non-clinical activities performed by contract research organizations, consulting fees, and costs related to laboratory services, the purchase of drug product materials and third-party manufacturing development activities. Internal R&D expenses include employee-related expenses, occupancy costs, depreciation and general overhead. We track external R&D expenses for each of our development programs; however, internal R&D expenses are not tracked by individual program as they can benefit multiple programs or our technologies in general.

The following table sets forth our external R&D expenses for the three and nine months ended September 30,March 31, 2022 and 2021 and 2020 relating to our then current key development programs and all other development programs and our internal R&D expenses, listed by the nature of such expenses:


 

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

March 31,

 

 

 

 

 

(In millions)

 

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

 

2022

 

 

2021

 

 

Change

 

External R&D expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Development programs:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

nemvaleukin

 

$

19.8

 

 

$

16.9

 

 

$

2.9

 

 

$

61.1

 

 

$

46.6

 

 

$

14.5

 

 

$

19.5

 

 

$

18.6

 

 

$

0.9

 

LYBALVI

 

 

6.8

 

 

 

7.5

 

 

 

(0.7

)

 

 

21.3

 

 

 

20.3

 

 

 

1.0

 

 

 

5.8

 

 

 

6.8

 

 

 

(1.0

)

ALKS 1140

 

 

25.5

 

 

 

0.3

 

 

 

25.2

 

 

 

27.7

 

 

 

1.1

 

 

 

26.6

 

 

 

1.7

 

 

 

1.3

 

 

 

0.4

 

Other external R&D expenses

 

 

15.2

 

 

 

17.2

 

 

 

(2.0

)

 

 

43.4

 

 

 

53.6

 

 

 

(10.2

)

 

 

15.7

 

 

 

14.1

 

 

 

1.6

 

Total external R&D expenses

 

 

67.3

 

 

 

41.9

 

 

 

25.4

 

 

 

153.5

 

 

 

121.6

 

 

 

31.9

 

 

 

42.7

 

 

 

40.8

 

 

 

1.9

 

Internal R&D expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee-related

 

 

37.9

 

 

 

39.5

 

 

 

(1.6

)

 

 

114.7

 

 

 

120.2

 

 

 

(5.5

)

 

 

40.1

 

 

 

37.9

 

 

 

2.2

 

Occupancy

 

 

4.9

 

 

 

5.8

 

 

 

(0.9

)

 

 

14.7

 

 

 

15.8

 

 

 

(1.1

)

 

 

4.2

 

 

 

4.8

 

 

 

(0.6

)

Depreciation

 

 

2.9

 

 

 

4.1

 

 

 

(1.2

)

 

 

9.2

 

 

 

11.5

 

 

 

(2.3

)

 

 

2.8

 

 

 

3.4

 

 

 

(0.6

)

Other

 

 

5.4

 

 

 

3.7

 

 

 

1.7

 

 

 

16.1

 

 

 

13.4

 

 

 

2.7

 

 

 

6.2

 

 

 

5.4

 

 

 

0.8

 

Total internal R&D expenses

 

 

51.1

 

 

 

53.1

 

 

 

(2.0

)

 

 

154.7

 

 

 

160.9

 

 

 

(6.2

)

 

 

53.3

 

 

 

51.5

 

 

 

1.8

 

Research and development expenses

 

$

118.4

 

 

$

95.0

 

 

$

23.4

 

 

$

308.2

 

 

$

282.5

 

 

$

25.7

 

 

$

96.0

 

 

$

92.3

 

 

$

3.7

 

These amounts are not necessarily predictive of future R&D expenses. In an effort to allocate our spending most effectively, we continually evaluate our products under development, based on the performance of such products in pre-clinicalpreclinical and/or clinical trials, our expectations regarding the likelihood of their regulatory approval and our view of their future potential commercial viability, among other factors.

The increasesincrease in expenses related to nemvaleukin in the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, werewas primarily due to the advancement of the ARTISTRY development program for the product, including increased patient enrollment in ongoing clinical studies and initiation ofspend on the ARTISTRY-6ARTISTRY-7 study. For additional details on the status of the ARTISTRY development program, see the “Key Development Program” section of this “Part I, Item 2—Management’s Discussion and Analysis of Financial


Condition and Results of Operations” in this Form 10-Q. The increasesincrease in other external R&D expenses was primarily due to a $1.4 million increase related to nonclinical studies for early stage development programs and a $1.8 million increase in general clinical operations and medical affairs support. The decrease in expenses related to ALKS 1140, our novel CoREST-selective HDAC inhibitor candidate for the treatment of neurodegenerative and neurodevelopmental disorders, in the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, wereLYBALVI was primarily due to the accrualproduct’s commercial launch in the three months ended September 30, 2021 of a $25.0 million development milestone to be paid to the former shareholders of Rodin Therapeutics, Inc. related to the submission of an investigational new drug application or equivalent for ALKS 1140 as we determined this milestone was probable of achievement. The amount is expected to be paid in the fourth quarter ofOctober 2021.

The decreasesincrease in employee-related expenses in the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020, wereexpense was primarily duerelated to a $2.3$1.5 million and $4.9 million decrease in labor and benefits, respectively, resulting from a 13.5% reduction increase in R&D headcount from September 30, 2020 to September 30, 2021.&D-related share-based compensation expense.

Selling, General and Administrative Expense

 

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

March 31,

 

 

 

 

 

(In millions)

 

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

 

2022

 

 

2021

 

 

Change

 

Selling and marketing expense

 

$

88.0

 

 

$

79.0

 

 

$

9.0

 

 

$

253.4

 

 

$

249.7

 

 

$

3.7

 

 

$

96.2

 

 

$

79.7

 

 

$

16.5

 

General and administrative expense

 

 

48.2

 

 

 

48.6

 

 

 

(0.4

)

 

 

147.2

 

 

 

143.3

 

 

 

3.9

 

 

 

48.9

 

 

 

45.5

 

 

 

3.4

 

Selling, general and administrative expense

 

$

136.2

 

 

$

127.6

 

 

$

8.6

 

 

$

400.6

 

 

$

393.0

 

 

$

7.6

 

 

$

145.1

 

 

$

125.2

 

 

$

19.9

 

 

The increase in selling and marketing expense in the three months ended September 30, 2021, as compared to the three months ended September 30, 2020, was primarily due to a $7.1$7.9 million increase in employee-related expenses, a $6.4 million increase in marketing expense and a $1.5$2.4 million increase in professional service fees. The increase in employee-related expenses was primarily due to a 4% increase in selling and marketing headcount from March 31, 2021 to March 31, 2022. The increases in marketing expense and professional service fees were primarily related to pre-launch commercial launch activities for LYBALVI.

 

The increase in sellinggeneral and marketingadministrative expense during the nine months ended September 30, 2021, as compared to the nine months ended September 30, 2020, was primarily due to a $4.1$2.0 million increase in professional service fees, and a $3.4 million increase in marketing expenses, partially offset by a $5.0 million decrease in employee-related expenses. The increases in marketing expense and professional service fees were primarily related to pre-launch commercial activities for LYBALVI. The decrease in employee-related expenses was primarily due to a decrease in salary expense resulting from a 1.5% reduction in selling and marketing headcount from September 30, 2020 to September 30, 2021.

The increases in general and administrative expense during the nine months ended September 30, 2021, as compared to the nine months ended September 30, 2020, was primarily due to a $5.0 million increase in professional service fees and a $2.5 million increase in employee-related expenses, partially offset by a $1.9 million decrease in the timing of spend related to new product planning. The increase in professional service fees was primarily related to increased spend on legal fees. The increase in employee-related expense was primarily related tofees, and a $2.0$1.4 million increase in general and administrative-related share-based compensation expense.

Amortization of Acquired Intangible Assets

 

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

(In millions)

 

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

Amortization of acquired intangible assets

 

$

9.6

 

 

$

9.9

 

 

$

(0.3

)

 

$

28.5

 

 

$

29.5

 

 

$

(1.0

)

We amortizeexpenses related to our amortizable intangible assets using the economic-use method, which reflects the pattern that the economic benefits of the intangible assets are consumed as revenue is generated from the underlying patent or contract. Based on our most recent analysis, amortization of intangible assets included within our condensed consolidated balance sheet at September 30, 2021 is expected to be approximately $40.0 million, $35.0 million, $35.0 million and $1.0 million in the years ending December 31, 2021 through 2024, respectively.branded prescription drug fee.


Other (Expense) Income,Expense, Net

 

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

March 31,

 

 

 

 

 

(In millions)

 

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

 

2022

 

 

2021

 

 

Change

 

Interest income

 

$

0.5

 

 

$

1.4

 

 

$

(0.9

)

 

$

2.0

 

 

$

5.9

 

 

$

(3.9

)

 

$

0.6

 

 

$

0.9

 

 

$

(0.3

)

Interest expense

 

 

(2.4

)

 

 

(1.8

)

 

 

(0.6

)

 

 

(8.8

)

 

 

(6.8

)

 

 

(2.0

)

 

 

(2.4

)

 

 

(4.0

)

 

 

1.6

 

Change in the fair value of contingent consideration

 

 

(5.2

)

 

 

3.9

 

 

 

(9.1

)

 

 

(0.7

)

 

 

16.6

 

 

 

(17.3

)

 

 

(19.1

)

 

 

1.3

 

 

 

(20.4

)

Other income (expense), net

 

 

0.2

 

 

 

9.4

 

 

 

(9.2

)

 

 

(0.4

)

 

 

11.1

 

 

 

(11.5

)

 

 

2.5

 

 

 

(0.4

)

 

 

2.9

 

Total other (expense) income, net

 

$

(6.9

)

 

$

12.9

 

 

$

(19.8

)

 

$

(7.9

)

 

$

26.8

 

 

$

(34.7

)

Total other expense, net

 

$

(18.4

)

 

$

(2.2

)

 

$

(16.2

)

 

The decreasesincrease in interest income during the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, weretotal other expense, net was primarily due to a decrease in interest rates. Interest income consists of interest earned on our available-for-sale investments.

The increases in interest expense during the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, were due to the Term Loan Refinancing completed in March 2021. The Term Loan Refinancing is discussed in greater detail in Note 11, Long-Term Debt in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q.

The changeschange in the fair value of contingent consideration in the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, were primarily due toa result of an increase in the risk of non-payment. In Baudax’s Quarterly Report on Form 10-QThe reasons for the period ended June 30, 2021, Baudax included disclosures regarding its ability to continue as a going concern. As a resultincrease in the risk of this disclosure, we updatednon-payment and the model used to determine the fair value of the contingent consideration. The valuation approach used to determine the fair value of the contingent consideration isare discussed in greater detail in Note 5, Fair Value, in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q.

The decreases This was partially offset by a decrease in other income (expense), net in the three and nine months ended September 30, 2021, as compared to the three and nine months ended September 30, 2020, were primarilyinterest expense due to the receipt of $11.1 million, of which $10.4 million wasTerm Loan Refinancing completed in March 2021 and proceeds received in September 2020, representing our proportional share of the proceeds from the sale of two companies withinconnection with the Fountain portfolio.transaction in March 2022. The transactions were accounted for under the cumulative earnings approach whereby the return on investment of $8.3 million was recorded as a gain within “Other (expense) income, net” in the accompanying condensed consolidated statements of operations and comprehensive loss and the return of investment of $2.8 million was recorded as a reduction in the our net investment in Fountain. Our investment in FountainTerm Loan Refinancing is discussed in greater detailNote 11, Long-Term Debt in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q. The Fountain transaction is discussed in Note 4, Investments, in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q.

Income Tax (Benefit) Provision

 

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

March 31,

 

 

 

 

 

(In millions)

 

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

 

2022

 

 

2021

 

 

Change

 

Income tax provision

 

 

2.5

 

 

 

2.3

 

 

$

0.2

 

 

$

9.5

 

 

$

13.3

 

 

$

(3.8

)

Income tax (benefit) provision

 

$

(9.1

)

 

 

3.8

 

 

$

(12.9

)

 

The income tax (benefit) provision in the three months ended March 31, 2022 and 2021 primarily related to U.S. federal and state taxes. The favorable change in the income tax (benefit) provision was primarily due to an enhanced FDII deduction as a result of a change to Section 174 of the TCJA in relation to capitalization and amortization of R&D expenses. The income tax provision in the three months ended September 30, 2021 and 2020 primarily related to U.S. federal and state taxes. The unfavorable change in the income tax provision in the three months ended September 30, 2021, as compared to the three months ended September 30, 2020, was primarily due to an increase in income taxes for income earned in the U.S.

The income tax provision in the nine months ended September 30,March 31, 2021 primarily related to a $3.9 million tax expense on income earned in the U.S. and a $6.8$3.8 million discrete tax expense related to employee equity activity during the period. The income tax provision in the nine months ended September 30, 2020 primarily related to a $5.1 million tax expense on income earned in the U.S. and an $8.0 million discrete tax expense related to employee equity activity during the period.activity. 


 

Liquidity and Financial Condition

Our financial condition is summarized as follows:

 

 

September 30, 2021

 

 

December 31, 2020

 

 

March 31, 2022

 

 

December 31, 2021

 

(In millions)

 

U.S.

 

 

Ireland

 

 

Total

 

 

U.S.

 

 

Ireland

 

 

Total

 

 

U.S.

 

 

Ireland

 

 

Total

 

 

U.S.

 

 

Ireland

 

 

Total

 

Cash and cash equivalents

 

$

91.9

 

 

$

218.5

 

 

$

310.4

 

 

$

152.8

 

 

$

120.2

 

 

$

273.0

 

 

$

134.5

 

 

$

148.1

 

 

$

282.6

 

 

$

88.6

 

 

$

248.9

 

 

$

337.5

 

Investments—short-term

 

 

200.0

 

 

 

49.9

 

 

 

249.9

 

 

 

293.5

 

 

 

68.5

 

 

 

362.0

 

 

 

146.5

 

 

 

99.8

 

 

 

246.3

 

 

 

144.5

 

 

 

54.3

 

 

 

198.8

 

Investments—long-term

 

 

132.5

 

 

 

55.4

 

 

 

187.9

 

 

 

23.2

 

 

 

1.6

 

 

 

24.8

 

 

 

142.6

 

 

 

87.2

 

 

 

229.8

 

 

 

163.0

 

 

 

66.4

 

 

 

229.4

 

Total cash and investments

 

$

424.4

 

 

$

323.8

 

 

$

748.2

 

 

$

469.5

 

 

$

190.3

 

 

$

659.8

 

 

$

423.6

 

 

$

335.1

 

 

$

758.7

 

 

$

396.1

 

 

$

369.6

 

 

$

765.7

 

Outstanding borrowings—short and long-term

 

$

296.4

 

 

$

 

 

$

296.4

 

 

$

275.0

 

 

$

 

 

$

275.0

 

 

$

295.2

 

 

$

 

 

$

295.2

 

 

$

295.8

 

 

$

 

 

$

295.8

 

 

At September 30, 2021March 31, 2022 our investments consisted of the following:

 

 

 

 

 

 

Gross

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross

 

 

 

 

 

 

 

 

 

 

Amortized

 

 

Unrealized

 

 

Allowance for

 

 

Estimated

 

 

Amortized

 

 

Unrealized

 

 

Allowance for

 

 

Estimated

 

(In millions)

 

Cost

 

 

Gains

 

 

Losses

 

 

Credit Losses

 

 

Fair Value

 

 

Cost

 

 

Gains

 

 

Losses

 

 

Credit Losses

 

 

Fair Value

 

Investments—short-term available-for-sale

 

$

249.3

 

 

$

0.6

 

 

$

 

 

$

 

 

$

249.9

 

 

$

247.5

 

 

$

 

 

$

(1.2

)

 

$

 

 

$

246.3

 

Investments—long-term available-for-sale

 

 

186.2

 

 

 

 

 

 

(0.2

)

 

 

 

 

 

186.0

 

 

 

233.9

 

 

 

 

 

 

(5.9

)

 

 

 

 

 

228.0

 

Investments—long-term held-to-maturity

 

 

1.8

 

 

 

 

 

 

 

 

 

 

 

 

1.8

 

 

 

1.8

 

 

 

 

 

 

 

 

 

 

 

 

1.8

 

Total

 

$

437.3

 

 

$

0.6

 

 

$

(0.2

)

 

$

 

 

$

437.7

 

 

$

483.2

 

 

$

 

 

$

(7.1

)

 

$

 

 

$

476.1

 


Sources and Uses of Cash

We generated $21.7 million and used $45.1 million of cash from operating activities during the three months ended March 31, 2022 and 2021, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, such as capital expenditures and principal and interest payments on our long‑term debt, for at least the twelve months following the date from which our financial statements were issued. Subject to market conditions, interest rates and other factors, we may pursue opportunities to obtain additional financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures. In addition, the 2026 Term Loans have an incremental facility capacity in an amount of $175.0 million, plus additional amounts provided that we meet certain conditions, including a specified leverage ratio.

 

Our investment objectives are, first, to preserve liquidity and conserve capital and, second, to generate investment income. We mitigate credit risk in our cash reserves by maintaining a well-diversified portfolio that limits the amount of investment exposure as to institution, maturity and investment type. However, the value of these securities may be adversely affected by the instability of the global financial markets, which could, in turn, adversely impact our financial position and our overall liquidity. Our available-for-sale investments consist primarily of short-short and long-term U.S. government and agency debt securities, corporate debt securities and debt securities issued and backed by non-U.S. governments. Our held-to-maturity investments consist of investments that are held as collateral under certain letters of credit related to certain of our lease agreements.

 

We classify available‑for‑sale investments in an unrealized loss position that do not mature within 12twelve months as long‑term investments. We have the intent and ability to hold these investments until recovery, which may be at maturity, and it is more‑likely‑than‑not that we would not be required to sell these securities before recovery of their amortized cost. At September 30, 2021,March 31, 2022, we performed an analysis of our investments with unrealized losses for impairment and determined that the lossthey were not impaired.

We have no off-balance sheet arrangements that are reasonably likely to have a material effect on oneour financial condition, changes in financial condition, revenues or expenses, results of our corporate debt securities was other-than-temporary and, during the nine months ended September 30, 2021, recorded a $0.9 million impairment charge within “Other (expense) income, net”operations, liquidity, capital expenditures, or capital resources in the accompanying condensed consolidated statements of operations and comprehensive loss.


Sources and Uses of Cash

We expect that our existing cash and investments balance will be sufficient to finance our anticipated working capital and other cash requirements, such as capital expenditures and principal and interest payments, for at least 12 months following the date on which this Form 10-Q is filed. Subject to market conditions, interest rates and other factors, we may pursue opportunities to obtain additional financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, debt refinancings, arrangements relating to assets or other financing methods or structures. We are closely monitoring ongoing developments in connection with the COVID-19 pandemic that may have an adverse impact on our commercial prospects and projected cash position.next twelve months.

Information about our cash flows, by category, is presented in “Part I, Item 1—Condensed Consolidated Financial Statements of Cash Flows” in this Form 10-Q. The following table summarizes our cash flows for the ninethree months ended September 30, 2021March 31, 2022 and 2020:2021:

 

 

Nine Months Ended

 

 

September 30,

 

 

Three Months Ended March 31,

 

(In millions)

 

2021

 

 

2020

 

 

2022

 

 

2021

 

Cash and cash equivalents, beginning of period

 

$

273.0

 

 

$

203.8

 

 

$

337.5

 

 

$

273.0

 

Cash flows provided by operating activities

 

 

70.7

 

 

 

15.5

 

Cash flows (used in) provided by investing activities

 

 

(65.5

)

 

 

23.6

 

Cash flows provided by (used in) financing activities

 

 

32.2

 

 

 

(2.0

)

Cash flows provided by (used in) operating activities

 

 

21.7

 

 

 

(45.1

)

Cash flows used in investing activities

 

 

(60.6

)

 

 

(37.8

)

Cash flows (used in) provided by financing activities

 

 

(16.0

)

 

 

14.9

 

Cash and cash equivalents, end of period

 

$

310.4

 

 

$

240.9

 

 

$

282.6

 

 

$

205.0

 

 

Cash flows from operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash operating items such as depreciation, amortization and share-based compensation and changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in our results of operations.

The change in cash flows from operating activities was primarily due to an increase in cash flows provided by operating activities in the nine months ended September 30, 2021, as compared to the nine months ended September 30, 2020, is primarily due to a decreaseworking capital, offset by an increase in our net loss, net of adjustments to reconcile net loss to cash flows from operating activities and a decreaseactivities. The increase in cash used forfrom working capital was primarily duerelated to an increase in cash flows from accounts receivable and decreases in cash flows used forin accounts payable and accrued expenses, contract assetsliabilities and inventory,operating lease liabilities, partially offset by increases in cash flows used for receivablescontract assets, inventory and prepaid expenses and other current assets.


The changeincrease in cash flows fromused in investing activities in the nine months ended September 30, 2021, as compared to the nine months ended September 30, 2020, was primarily due to a $108.1$17.5 million increase in net purchase of investments partially offset by a $17.4 million decrease in cash paid for property, plant and equipment and a $5.1$5.9 million increasedecrease in payments received in connection with the contingent consideration resulting from the Gainesville Transaction.

The change in cash flows from financing activities in the nine months ended September 30, 2021, as compared to the nine months ended September 30, 2020, was primarily due to $23.6 million in proceeds from the Term Loan Refinancing and an $11.1a $6.9 million increase in the amount of cash we received upon exercises of employee stock options, net of employee taxes.

BorrowingsDebt

At September 30, 2021,March 31, 2022, the principal balance of our borrowings consisted of $298.5$297.0 million outstanding under our 2026 Term Loans. See Note 11, Long-Term Debt, in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for further discussion of our 2026 Term Loans.

Contractual Obligations

See the “Contractual Obligations” section in “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report for a discussion of our contractual obligations.

Off-Balance Sheet Arrangements

At September 30, 2021, we were not party to any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources material to investors.


Critical Accounting Estimates

The discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates under different conditions or using different assumptions. See the “Critical Accounting Estimates” section in “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report for a discussion of our critical accounting estimates.

In relation to our contingent consideration and in light of Baudax’s disclosures regarding its ability to continue as a going concern, we increased the likelihood that Baudax would default on its obligations to us to 100% at March 31, 2022 from 55% at December 31, 2021 and adjusted the recovery rate to 9% at March 31, 2022 from 18% at December 31, 2021. For further information regarding the calculation of the fair value of the contingent consideration, refer to Note 5, Fair Value in this Form 10-Q.

New Accounting Standards

See the “New Accounting Pronouncements” section in Note 2, Summary of Significant Accounting Policies in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for discussion of certain recent accounting standards applicable to us.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Market risks related to our investment portfolio, and the ways we manage such risks, are summarized in “Part II, Item 7A—Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report. We regularly review our marketable securities holdings and shift our investment holdings to those that best meet our investment objectives, which are to preserve capital, provide sufficient liquidity to satisfy operating requirements and generate investment income. Apart from such adjustments to our investment portfolio, there have been no material changes to our market risks since December 31, 2020,2021, and we do not anticipate any near-term changes in the nature of our market risk exposures or in our management’s objectives and strategies with respect to managing such exposures.

We are exposed to non-U.S. currency exchange risk related to manufacturing and royalty revenues we receive on certain of our products, partially offset by certain operating costs arising from expenses and payables in connection with our Irish operations that are settled predominantly in Euro. These non-U.S. currency exchange rate risks are summarized in “Part II, Item 7A—Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report. There has been no material change in our assessment of our sensitivity to non-U.S. currency exchange rate risk since December 31, 2020.2021.


Item 4. Controls and Procedures

a) Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of September 30, 2021.March 31, 2022. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that our disclosure controls and procedures were effective as of September 30, 2021March 31, 2022 to provide reasonable assurance that the information required to be disclosed by us in the reports that we file under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

b) Change in Internal Control Over Financial Reporting

During the period covered by this report, there have been no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


PART II. OTHER INFORMATION

For information regarding legal proceedings, see the discussion of legal proceedings in Note 14,15, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, which discussion is incorporated into this Part II, Item 1 by reference.

Item 1A. Risk Factors

For a discussion of our risk factors, see “Part I, Item 1A—Risk Factors” in our Annual Report. There have been no material changes from the risk factors disclosed in our Annual Report.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

On September 16, 2011, our board of directors authorized the continuation of the Alkermes, Inc. program to repurchase up to $215.0 million of our ordinary shares at the discretion of management from time to time in the open market or through privately negotiated transactions. We did not purchase any shares under this program during the ninethree months ended September 30, 2021.March 31, 2022. As of September 30, 2021,March 31, 2022, we had purchased a total of 8,866,342 shares under this program at an aggregate cost of $114.0 million.

During the three months ended September 30, 2021March 31, 2022, we acquired 83,317678,209 of our ordinary shares, at an average price of $30.17$25.17 per share, to satisfy withholding tax obligations related to the vesting of employee equity awards.

Item 5. Other Information

Our policy governing transactions in our securities by our directors, officers and employees permits our directors, officers and employees to enter into trading plans in accordance with Rule 10b5-1 under the Exchange Act. During the three months ended September 30, 2021,March 31, 2022, Mr. Blair C. Jackson, an executive officerShane M. Cooke, a director of the Company, entered into a trading plan in accordance with Rule 10b5-1 and our policy governing transactions in our securities by our directors, officers and employees. We undertake no obligation to update or revise the information provided herein, including for any revision or termination of an established trading plan.


Item 6. Exhibits

The following exhibits are filed or furnished as part of this Form 10-Q:

EXHIBIT INDEX

 

Exhibit No.

 

Description of Exhibit

  31.1 #

 

Rule 13a-14(a)/15d-14(a) Certification.

  31.2 #

 

Rule 13a-14(a)/15d-14(a) Certification.

  32.1 ‡

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

  101.SCH #

 

Inline XBRL Taxonomy Extension Schema Document.

  101.CAL #

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

  101.LAB #

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

  101.PRE #

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

  101.DEF #

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

  104 #

 

Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101)

 

#

Filed herewith.

Furnished herewith.


 

SIGNATURES

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 thereunto duly authorized.

 

 

 

 

 

 

ALKERMES PLC

 

 

 

 

 

 

(Registrant)

 

 

 

 

 

 

 

 

 

 

By:

/s/ Richard F. Pops

 

 

 

Chairman and Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

By:

/s/ Iain M. Brown

 

 

 

Senior Vice President, Chief Financial Officer

 

 

 

(Principal Financial Officer and Principal Accounting Officer)

 

 

Date: OctoberApril 27, 20212022

 

4139