0001564590-20-048665 | 10-Q | XBRL Viewer

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2020	Oct. 23, 2020
Cover [Abstract]
Entity Registrant Name	Alkermes plc.
Entity Central Index Key	0001520262
Document Type	10-Q
Document Period End Date	Sep. 30, 2020
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Shares Outstanding		159,149,785
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3
Trading Symbol	ALKS
Entity File Number	001-35299
Entity Incorporation, State or Country Code	L2
Entity Tax Identification Number	98-1007018
Entity Address, Address Line One	Connaught House
Entity Address, Address Line Two	1 Burlington Road
Entity Address, City or Town	Dublin 4
Entity Address, Country	IE
Entity Address, Postal Zip Code	D04 C5Y6
City Area Code	353
Local Phone Number	1-772-8000
Document Quarterly Report	true
Document Transition Report	false
Title of 12(b) Security	Ordinary shares, $0.01 par value
Security Exchange Name	NASDAQ

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
CURRENT ASSETS:
Cash and cash equivalents	$ 240,866	$ 203,771
Investments—short-term	328,516	331,208
Receivables, net	265,644	257,086
Contract assets	14,395	8,386
Inventory	122,823	101,803
Prepaid expenses and other current assets	52,697	59,716
Total current assets	1,024,941	961,970
PROPERTY, PLANT AND EQUIPMENT, NET	355,215	362,168
INTANGIBLE ASSETS, NET	121,108	150,643
RIGHT-OF-USE ASSETS	106,681	12,379
GOODWILL	92,873	92,873
DEFERRED TAX ASSETS	86,336	96,558
INVESTMENTS—LONG-TERM	27,774	79,391
CONTINGENT CONSIDERATION	46,200	32,400
OTHER ASSETS	15,692	17,021
TOTAL ASSETS	1,876,820	1,805,403
CURRENT LIABILITIES:
Accounts payable and accrued expenses	354,780	373,037
Operating lease liabilities—short-term	13,375	8,466
Contract liabilities—short-term	7,153	6,766
Long-term debt—short-term	2,843	2,843
Total current liabilities	378,151	391,112
LONG-TERM DEBT	272,663	274,295
OPERATING LEASE LIABILITIES—LONG-TERM	96,717	5,342
CONTRACT LIABILITIES—LONG-TERM	18,635	22,068
OTHER LONG-TERM LIABILITIES	26,296	27,144
Total liabilities	792,462	719,961
COMMITMENTS AND CONTINGENT LIABILITIES (Note 15)
SHAREHOLDERS’ EQUITY:
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at September 30, 2020 and December 31, 2019, respectively
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 162,208,145 and 160,489,888 shares issued; 159,105,433 and 157,779,002 shares outstanding at September 30, 2020 and December 31, 2019, respectively	1,619	1,602
Treasury shares, at cost (3,102,712 and 2,710,886 shares at September 30, 2020 and December 31, 2019, respectively)	(125,993)	(118,386)
Additional paid-in capital	2,659,699	2,586,030
Accumulated other comprehensive loss	(760)	(1,816)
Accumulated deficit	(1,450,207)	(1,381,988)
Total shareholders’ equity	1,084,358	1,085,442
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$ 1,876,820	$ 1,805,403

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Statement Of Financial Position [Abstract]
Preferred stock shares, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock shares, authorized	50,000,000	50,000,000
Preferred stock shares, issued	0	0
Preferred stock shares, outstanding	0	0
Ordinary shares, par value (in dollars per share)	$ 0.01	$ 0.01
Ordinary shares, shares authorized	450,000,000	450,000,000
Ordinary shares, shares issued	162,208,145	160,489,888
Ordinary shares, shares outstanding	159,105,433	157,779,002
Treasury shares	3,102,712	2,710,886

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
REVENUES:
Total revenues	$ 265,012	$ 255,243	$ 758,761	$ 758,217
EXPENSES:
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below)	43,129	42,319	135,394	133,903
Research and development	94,980	107,671	282,481	314,676
Selling, general and administrative	127,653	148,701	393,049	444,996
Amortization of acquired intangible assets	9,917	10,173	29,535	30,187
Total expenses	275,679	308,864	840,459	923,762
OPERATING LOSS	(10,667)	(53,621)	(81,698)	(165,545)
OTHER INCOME (EXPENSE), NET:
Interest income	1,376	3,509	5,924	10,785
Interest expense	(1,811)	(3,385)	(6,790)	(10,405)
Change in the fair value of contingent consideration	3,926	1,300	16,626	(27,800)
Other income (expense), net	9,368	(1,664)	11,047	(1,534)
Total other income (expense), net	12,859	(240)	26,807	(28,954)
INCOME (LOSS) BEFORE INCOME TAXES	2,192	(53,861)	(54,891)	(194,499)
INCOME TAX PROVISION (BENEFIT)	2,326	(983)	13,328	(3,233)
NET LOSS	$ (134)	$ (52,878)	$ (68,219)	$ (191,266)
LOSS PER ORDINARY SHARE:
Basic and diluted (in dollars loss per ordinary share)	$ 0.00	$ (0.34)	$ (0.43)	$ (1.22)
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING:
Basic and diluted	159,062	157,199	158,685	156,845
COMPREHENSIVE LOSS:
Net loss	$ (134)	$ (52,878)	$ (68,219)	$ (191,266)
Unrealized (loss) gain, net of a tax (benefit) provision of $(193), $(15), $303 and $479, respectively	(659)	(24)	1,056	1,642
COMPREHENSIVE LOSS	(793)	(52,902)	(67,163)	(189,624)
Product sales, net
REVENUES:
Total revenues	142,658	138,774	402,799	374,890
Manufacturing and royalty revenues
REVENUES:
Total revenues	120,351	103,783	353,107	340,595
Research and development revenue
REVENUES:
Total revenues	953	$ 12,686	1,805	41,732
License revenue
REVENUES:
Total revenues	$ 1,050		$ 1,050	$ 1,000

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (Parenthetical) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
Income Statement [Abstract]
Tax provision (benefit)	$ (193)	$ 409	$ 87	$ (15)	$ 265	$ 229	$ 303	$ 479

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (68,219)	$ (191,266)
Adjustments to reconcile net loss to cash flows from operating activities:
Share-based compensation expense	65,279	79,590
Depreciation and amortization	61,525	59,901
Deferred income taxes	9,939	(3,025)
Change in the fair value of contingent consideration	(16,626)	27,800
Other non-cash charges	2,105	90
Changes in assets and liabilities:
Receivables	(8,551)	41,988
Contract assets	(6,009)	3,207
Inventory	(20,748)	(10,324)
Prepaid expenses and other assets	5,597	2,120
Right-of-use assets	13,251	6,306
Accounts payable and accrued expenses	(6,222)	20,542
Contract liabilities	(3,045)	292
Operating lease liabilities	(11,910)	(6,845)
Other long-term liabilities	(867)	(369)
Cash flows provided by operating activities	15,499	30,007
CASH FLOWS FROM INVESTING ACTIVITIES:
Additions of property, plant and equipment	(36,780)	(58,972)
Proceeds from the sale of equipment	61	900
Proceeds from contingent consideration	2,819	10,000
Return of Fountain Healthcare Partners II, L.P. investment	2,751
Purchases of investments	(151,324)	(141,749)
Sales and maturities of investments	206,089	149,459
Cash flows provided by (used in) investing activities	23,616	(40,362)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the issuance of ordinary shares under share-based compensation arrangements	7,719	16,381
Employee taxes paid related to net share settlement of equity awards	(7,607)	(9,230)
Principal payments of long-term debt	(2,132)	(2,132)
Cash flows (used in) provided by financing activities	(2,020)	5,019
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	37,095	(5,336)
CASH AND CASH EQUIVALENTS—Beginning of period	203,771	266,762
CASH AND CASH EQUIVALENTS—End of period	240,866	261,426
Non-cash investing and financing activities:
Purchased capital expenditures included in accounts payable and accrued expenses	$ 2,169	$ 14,664

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Ordinary Shares	Additional Paid-In Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit	Treasury Stock
BALANCE at Dec. 31, 2018	$ 1,171,285	$ 1,579	$ 2,467,323	$ (3,280)	$ (1,185,368)	$ (108,969)
BALANCE (in shares) at Dec. 31, 2018		158,180,833				(2,423,489)
Issuance of ordinary shares under employee stock plans	10,554	$ 7	10,547
Issuance of ordinary shares under employee stock plans (in shares)		656,352
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards	(8,880)	$ 7	93			$ (8,980)
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares)		740,689				(269,357)
Share-based compensation expense	24,810		24,810
Unrealized gain (loss) on marketable securities, net of tax provision	770			770
Net loss	(96,398)				(96,398)
BALANCE at Mar. 31, 2019	1,102,141	$ 1,593	2,502,773	(2,510)	(1,281,766)	$ (117,949)
BALANCE (in shares) at Mar. 31, 2019		159,577,874				(2,692,846)
BALANCE at Dec. 31, 2018	1,171,285	$ 1,579	2,467,323	(3,280)	(1,185,368)	$ (108,969)
BALANCE (in shares) at Dec. 31, 2018		158,180,833				(2,423,489)
Unrealized gain (loss) on marketable securities, net of tax provision	1,642
Net loss	(191,266)
BALANCE at Sep. 30, 2019	1,068,184	$ 1,599	2,563,157	(1,638)	(1,376,634)	$ (118,300)
BALANCE (in shares) at Sep. 30, 2019		160,203,448				(2,706,458)
BALANCE at Mar. 31, 2019	1,102,141	$ 1,593	2,502,773	(2,510)	(1,281,766)	$ (117,949)
BALANCE (in shares) at Mar. 31, 2019		159,577,874				(2,692,846)
Issuance of ordinary shares under employee stock plans	2,054	$ 2	2,052
Issuance of ordinary shares under employee stock plans (in shares)		197,953
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards	(194)					$ (194)
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares)		20,289				(6,397)
Share-based compensation expense	28,261		28,261
Unrealized gain (loss) on marketable securities, net of tax provision	896			896
Net loss	(41,990)				(41,990)
BALANCE at Jun. 30, 2019	1,091,168	$ 1,595	2,533,086	(1,614)	(1,323,756)	$ (118,143)
BALANCE (in shares) at Jun. 30, 2019		159,796,116				(2,699,243)
Issuance of ordinary shares under employee stock plans	3,773	$ 3	3,770
Issuance of ordinary shares under employee stock plans (in shares)		383,957
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards	(156)	$ 1				$ (157)
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares)		23,375				(7,215)
Share-based compensation expense	26,301		26,301
Unrealized gain (loss) on marketable securities, net of tax provision	(24)			(24)
Net loss	(52,878)				(52,878)
BALANCE at Sep. 30, 2019	1,068,184	$ 1,599	2,563,157	(1,638)	(1,376,634)	$ (118,300)
BALANCE (in shares) at Sep. 30, 2019		160,203,448				(2,706,458)
BALANCE at Dec. 31, 2019	1,085,442	$ 1,602	2,586,030	(1,816)	(1,381,988)	$ (118,386)
BALANCE (in shares) at Dec. 31, 2019		160,489,888				(2,710,886)
Issuance of ordinary shares under employee stock plans	3,071	$ 3	3,068
Issuance of ordinary shares under employee stock plans (in shares)		258,137
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards	(7,283)	$ 10	(10)			$ (7,283)
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares)		1,020,510				(372,846)
Share-based compensation expense	20,125		20,125
Unrealized gain (loss) on marketable securities, net of tax provision	317			317
Net loss	(38,654)				(38,654)
BALANCE at Mar. 31, 2020	1,063,018	$ 1,615	2,609,213	(1,499)	(1,420,642)	$ (125,669)
BALANCE (in shares) at Mar. 31, 2020		161,768,535				(3,083,732)
BALANCE at Dec. 31, 2019	1,085,442	$ 1,602	2,586,030	(1,816)	(1,381,988)	$ (118,386)
BALANCE (in shares) at Dec. 31, 2019		160,489,888				(2,710,886)
Unrealized gain (loss) on marketable securities, net of tax provision	1,056
Net loss	(68,219)
BALANCE at Sep. 30, 2020	1,084,358	$ 1,619	2,659,699	(760)	(1,450,207)	$ (125,993)
BALANCE (in shares) at Sep. 30, 2020		162,208,145				(3,102,712)
BALANCE at Mar. 31, 2020	1,063,018	$ 1,615	2,609,213	(1,499)	(1,420,642)	$ (125,669)
BALANCE (in shares) at Mar. 31, 2020		161,768,535				(3,083,732)
Issuance of ordinary shares under employee stock plans	3,848	$ 3	3,845
Issuance of ordinary shares under employee stock plans (in shares)		327,251
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards	(123)					$ (123)
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares)		24,175				(7,874)
Share-based compensation expense	23,136		23,136
Unrealized gain (loss) on marketable securities, net of tax provision	1,398			1,398
Net loss	(29,431)				(29,431)
BALANCE at Jun. 30, 2020	1,061,846	$ 1,618	2,636,194	(101)	(1,450,073)	$ (125,792)
BALANCE (in shares) at Jun. 30, 2020		162,119,961				(3,091,606)
Issuance of ordinary shares under employee stock plans	800		800
Issuance of ordinary shares under employee stock plans (in shares)		53,509
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards	(201)	$ 1	(1)			$ (201)
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares)		34,675				(11,106)
Share-based compensation expense	22,706		22,706
Unrealized gain (loss) on marketable securities, net of tax provision	(659)			(659)
Net loss	(134)				(134)
BALANCE at Sep. 30, 2020	$ 1,084,358	$ 1,619	$ 2,659,699	$ (760)	$ (1,450,207)	$ (125,993)
BALANCE (in shares) at Sep. 30, 2020		162,208,145				(3,102,712)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

+ References + Details

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
Statement Of Stockholders Equity [Abstract]
Tax provision (benefit)	$ (193)	$ 409	$ 87	$ (15)	$ 265	$ 229	$ 303	$ 479

The Company

9 Months Ended

Sep. 30, 2020

Organization Consolidation And Presentation Of Financial Statements [Abstract]

The Company

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. Alkermes has a diversified portfolio of marketed products focused on CNS disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. 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.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

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, 2020 and 2019 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2019. 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 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 Annual Report. Intercompany accounts and transactions have been eliminated.

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires management to 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 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 assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.

Segment Information

The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines. The Company’s chief decision maker, the Chief Executive Officer and Chairman 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.

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. All U.S. states, and many local jurisdictions and countries around the world, including Ireland, have, at times during the pandemic, issued “shelter-in-place” orders, quarantines, executive orders and similar government orders, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and recommendations, and the perception that additional orders, restrictions or recommendations could occur, have resulted in widespread closures of businesses, including healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects. While the Company has begun to observe a gradual normalization in patient and healthcare provider practices, the impacts and extent of such normalization are not yet known, and it remains difficult to predict the nature and extent of the future impacts that the pandemic will have on such practices and, as a result, on the Company’s business.

The Company continues to closely monitor and rapidly respond to the ongoing impact of COVID-19 on its employees, communities and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the Company is unable to predict the extent of the impact that the COVID-19 pandemic may continue to have on the Company’s future financial condition and operating results. These uncertainties include, among other things, the ultimate severity and duration of the pandemic; governmental, business or other actions that have been, are being or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions, and imposition of social distancing measures; impacts of 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 and schizophrenia; 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 U.S., Irish and global economies more broadly.

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 marketed products 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 which 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 to the pandemic, including the implementation of “shelter-in-place” policies, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees and the Company expects commercial sales of these marketed products to continue to be adversely impacted while the pandemic persists.

As it relates to the Company’s proprietary marketed products, despite continuing COVID-19-related impacts on access to healthcare provider facilities and patient flow, during the three months ended September 30, 2020, the Company saw an increase of 22% in the number of VIVITROL units sold compared to the three months ended June 30, 2020. ARISTADA units sold during the three months ended September 30, 2020 increased 7% compared to the three months ended June 30, 2020. During the three months ended September 30, 2020, the Company continued to take actions to support uninterrupted access to its proprietary marketed products. However, the Company currently expects commercial sales of its marketed products, particularly VIVITROL, to continue to be impacted by the COVID-19 pandemic over the next few quarters, including, for VIVITROL, as a result of the impact that the decrease in patient volume during the previous two quarters is expected to have on overall unit demand in the fourth quarter of 2020 and beyond. These items are discussed in greater detail in the “Results of Operations” section in “Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q.

The Company continues to operate its manufacturing facilities and supply its medicines. While the Company continues to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has impacted, and may continue to impact, the timelines of certain of its early-stage discovery efforts and clinical trials. The Company is working with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, any potential adverse impacts of COVID-19 on its manufacturing operations and R&D activities.

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 June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments, to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. To achieve this objective, the amendments in this ASU replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This standard primarily impacts how firms account for credit losses and requires an impairment model, known as the current expected credit loss model, that is based on expected losses rather than incurred losses. Companies are required to carry an allowance for expected credit losses for most debt instruments (except those carried at fair value), trade receivables, lease receivables, reinsurance receivables, financial guarantee contracts and loan commitments. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The standard limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which the carrying value exceeds fair value and requires the reversal of previous recognized credit losses if fair value increases. The Company’s investment portfolio primarily consists of available-for-sale securities carried at fair value. Further, the Company’s trade receivables do not have abnormally long terms and the Company has historically rarely written off trade receivables. The Company adopted this standard on January 1, 2020 and the adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

In August 2018, the FASB issued ASU 2018-13, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which aims to improve the effectiveness of fair value measurement disclosures. The amendments in this ASU modify the disclosure requirements on fair value measurements based on the concepts in FASB Concepts Statement, Conceptual Framework for Financial Reporting - Chapter 8: Notes to Financial Statements, including the consideration of costs and benefits. The Company adopted this standard on January 1, 2020 and the adoption of this standard had no impact on the Company’s financial statement disclosures.

In August 2018, the FASB issued ASU 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This ASU also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. The Company adopted this standard on January 1, 2020 using the prospective transition method, whereby it applied the requirements to any eligible costs incurred after adoption. The Company has not incurred any material eligible costs during the nine months ended September 30, 2020.

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes, which simplifies the accounting for income taxes by removing certain exceptions to the general principles of Accounting Standards Codification (“ASC”) 740, Income Taxes (“Topic 740”). The amendments also improve consistent application of, and simplify, GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The Company adopted this standard on January 1, 2020 and the adoption of this standard had no material impact on the Company’s consolidated financial statements.

In March 2020, the FASB issued 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 amendment 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 is currently assessing the impact that this ASU may have on its consolidated financial statements.

Revenue from Contracts with Customers

9 Months Ended

Sep. 30, 2020

Revenue From Contract With Customer [Abstract]

Revenue from Contracts with Customers

3. REVENUE FROM CONTRACTS WITH CUSTOMERS

Under FASB ASC 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 the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five-step model 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., 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, 2020 and 2019, the Company recorded product sales, net, as follows:

	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands)	2020		2019		2020		2019
VIVITROL	$	80,258	$	85,164	$	230,673	$	242,546
ARISTADA/ARISTADA INITIO		62,400		53,610		172,126		132,344
Total product sales, net	$	142,658	$	138,774	$	402,799	$	374,890

Manufacturing and Royalty Revenues

During the three and nine months ended September 30, 2020 and 2019, the Company recorded manufacturing and royalty revenues as follows:

	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
RISPERDAL CONSTA		10,993		3,517		14,510		44,769		10,786		55,555
Other		14,312		18,163		32,475		46,088		53,786		99,874
	$	25,305	$	95,046	$	120,351	$	90,857	$	262,250	$	353,107

	Three Months Ended September 30, 2019						Nine Months Ended September 30, 2019
(In thousands)	Manufacturing Revenue		Royalty Revenue		Total		Manufacturing Revenue		Royalty Revenue		Total
INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA	$	—	$	68,382	$	68,382	$	—	$	188,968	$	188,968
RISPERDAL CONSTA		4,520		3,813		8,333		42,948		12,266		55,214
Other		11,562		15,506		27,068		42,460		53,953		96,413
	$	16,082	$	87,701	$	103,783	$	85,408	$	255,187	$	340,595

Research and Development Revenue

The Company recorded R&D revenue of $1.0 million and $1.8 million during the three and nine months ended September 30, 2020, respectively, of which $0.1 million and $0.3 million, respectively, related to its license and collaboration agreement with Biogen for VUMERITY. The Company recorded R&D revenue of $12.7 million and $41.7 million during the three and nine months ended September 30, 2019, respectively, of which $12.1 million and $39.5 million, respectively, related to its license and collaboration agreement with Biogen for VUMERITY.

The Company expects to earn less than $0.1 million in additional R&D revenue under this agreement with Biogen through the end of 2020.

Contract Assets

Contract assets include unbilled amounts under certain of the Company’s contracts with customers where revenue is recognized over time. Total contract assets as of September 30, 2020 include $14.4 million of assets that are classified as “Current assets” in the accompanying condensed consolidated balance sheet, as they related to manufacturing processes that are completed in ten days to eight weeks, and $5.0 million that is classified as “Other assets” in the accompanying condensed consolidated balance sheet, as it consists of consideration from the Company’s collaboration with Biogen related to VUMERITY, which the Company expects to receive in approximately two years.

Total contract assets at September 30, 2020 were as follows:

(In thousands)	Contract Assets
Contract assets at December 31, 2019	$	13,386
Additions		36,569
Transferred to receivables, net		(30,560	)
Contract assets at September 30, 2020	$	19,395

Contract Liabilities

Contract liabilities consist of contractual obligations related to deferred revenue.

Total contract liabilities at September 30, 2020 were as follows:

(In thousands)	Contract Liabilities
Contract liabilities at December 31, 2019	$	28,834
Additions		—
Amounts recognized into revenue		(3,046	)
Contract liabilities at September 30, 2020	$	25,788

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI http://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 9
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

+ Details

Investments

9 Months Ended

Sep. 30, 2020

Investments Debt And Equity Securities [Abstract]

Investments

4. INVESTMENTS

Investments consisted of the following (in thousands):

			Gross Unrealized
					Losses
	Amortized				Less than			Greater than			Allowance for			Estimated
September 30, 2020	Cost		Gains		One Year			One Year			Credit Losses			Fair Value
Short-term investments:
Available-for-sale securities:
Corporate debt securities	$	163,511	$	1,484	$	(2	)	$	—		$	(977	)	$	164,016
U.S. government and agency debt securities		85,207		535		(1	)		—			—			85,741
International government agency debt securities		76,264		659		(8	)		—			—			76,915
		324,982		2,678		(11	)		—			(977	)		326,672
Held-to-maturity securities:
Fixed term deposit account		1,668		176		—			—			—			1,844
Total short-term investments		326,650		2,854		(11	)		—			(977	)		328,516
Long-term investments:
Available-for-sale securities:
Corporate debt securities		10,505		—		(21	)		—			—			10,484
U.S. government and agency debt securities		8,584		—		(1	)		—			—			8,583
International government agency debt securities		6,899		—		(12	)		—			—			6,887
		25,988		—		(34	)		—			—			25,954
Held-to-maturity securities:
Certificates of deposit		1,820		—		—			—			—			1,820
Total long-term investments		27,808		—		(34	)		—			—			27,774
Total investments	$	354,458	$	2,854	$	(45	)	$	—		$	(977	)	$	356,290

December 31, 2019
Short-term investments:
Available-for-sale securities:
Corporate debt securities	$	144,161	$	676	$	—		$	—		$	—		$	144,837
U.S. government and agency debt securities		112,948		434		(1	)		(1	)		—			113,380
International government agency debt securities		72,753		248		(10	)		—			—			72,991
Total short-term investments		329,862		1,358		(11	)		(1	)		—			331,208
Long-term investments:
Available-for-sale securities:
Corporate debt securities		51,070		—		(45	)		(7	)		—			51,018
International government agency debt securities		20,806		—		(18	)		—			—			20,788
U.S. government and agency debt securities		4,000		—		(4	)		—			—			3,996
		75,876		—		(67	)		(7	)		—			75,802
Held-to-maturity securities:
Certificates of deposit		1,820		—		—			—			—			1,820
Fixed term deposit account		1,667		102		—			—			—			1,769
		3,487		102		—			—			—			3,589
Total long-term investments		79,363		102		(67	)		(7	)		—			79,391
Total investments	$	409,225	$	1,460	$	(78	)	$	(8	)	$	—		$	410,599

At September 30, 2020, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were temporary or other-than-temporary. The investments with unrealized losses consisted primarily of corporate debt securities. In making the determination whether the decline in fair value of these securities was temporary, the Company considered various factors, including, but not limited to: the length of time each security was in an unrealized loss position; the extent to which fair value was less than cost; financial condition and near-term prospects of the issuers of the securities; the Company’s intent not to sell these securities; and the assessment that it is

more likely than not that the Company would not be required to sell these securities before the recovery of their amortized cost basis. At September 30, 2020, the Company determined that the loss on one of its corporate debt securities was other-than-temporary and recorded a $1.0 million impairment within “Other income (expense), 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 €7.4 million to Fountain Healthcare Partners II, L.P., an Irish partnership (“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. The Company’s commitment to Fountain represents approximately 7% of Fountain’s total funding. As of September 30, 2020, the Company had invested €5.8 million in Fountain. The Company is accounting for its investment in Fountain under the equity method.

During the three months ended September 30, 2020, two of the companies within the Fountain portfolio were acquired by third parties. The Company’s proportional share of the proceeds from these transactions was $11.1 million, of which $10.4 million was received in September 2020 and $0.7 million is held in escrow. 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 income (expense), 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 Company’s net investment in Fountain. The Company’s net investment in Fountain was $4.7 million and $5.9 million at September 30, 2020 and December 31, 2019, respectively, and was included within “Other assets” in the accompanying condensed consolidated balance sheets.

The proceeds from sales and maturities of marketable securities, which were identified using the specific identification method and were primarily reinvested, were as follows:

	Nine Months Ended September 30,
(In thousands)	2020		2019
Proceeds from the sales and maturities of marketable securities	$	206,089	$	149,459
Realized gains	$	8,336	$	—
Realized losses	$	977	$	497

The Company’s available-for-sale and held-to-maturity securities at September 30, 2020 had contractual maturities in the following periods:

	Available-for-sale				Held-to-maturity
	Amortized		Estimated		Amortized		Estimated
(In thousands)	Cost		Fair Value		Cost		Fair Value
Within 1 year	$	221,539	$	221,770	$	3,488	$	3,664
After 1 year through 5 years		129,431		130,856		—		—
Total	$	350,970	$	352,626	$	3,488	$	3,664

Fair Value

9 Months Ended

Sep. 30, 2020

Fair Value Disclosures [Abstract]

Fair Value

5. FAIR VALUE

The following table presents information about the Company’s assets and liabilities at September 30, 2020 and December 31, 2019 that are measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:

	September 30,
(In thousands)	2020		Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	43,089	$	43,089	$	—	$	—
U.S. government and agency debt securities		94,324		61,880		32,444		—
Corporate debt securities		174,500		—		173,523		977
International government agency debt securities		83,802		—		83,802		—
Contingent consideration		46,200		—		—		46,200
Total	$	441,915	$	104,969	$	289,769	$	47,177

	December 31,
	2019		Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	8,064	$	8,064	$	—	$	—
U.S. government and agency debt securities		117,376		73,795		43,581		—
Corporate debt securities		195,855		—		193,902		1,953
International government agency debt securities		93,779		—		93,779		—
Contingent consideration		32,400		—		—		32,400
Total	$	447,474	$	81,859	$	331,262	$	34,353

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 no transfers of any securities between the fair value hierarchies during the nine months ended September 30, 2020. The following table is a rollforward of the fair value of the Company’s assets whose fair values were determined using Level 3 inputs at September 30, 2020:

(In thousands)	Fair Value
Balance, January 1, 2020	$	34,353
Change in the fair value of contingent consideration		16,626
Payments received by the Company related to contingent consideration		(2,819	)
Payments due to the Company related to contingent consideration		(6	)
Impairment of corporate debt security		(977	)
Balance, September 30, 2020	$	47,177

The Company’s investments in U.S. government and agency debt securities, international 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.

The Company’s contingent consideration relates to the Company’s sale in April 2015 of its Gainesville, GA manufacturing facility, the related manufacturing and royalty revenue associated with certain products manufactured at the facility, and the rights to IV/IM and parenteral forms of Meloxicam (collectively, the “Gainesville Transaction”) to Recro Pharma, Inc. (“Recro”) and Recro Pharma LLC. As part of the Gainesville Transaction, the Company obtained rights to receive contingent payments upon the achievement by such Meloxicam products of certain regulatory and sales milestones and royalties on future net sales of such Meloxicam products. Additional details regarding the Gainesville Transaction can be found in Note 5, Fair Value, in the Notes to Consolidated Financial Statements in the Annual Report.

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

On February 20, 2020, ANJESO (formerly referred to as Meloxicam IV/IM), was approved by the U.S. Food and Drug Administration (the “FDA”). At September 30, 2020 and December 31, 2019, the Company determined that the value of the contingent consideration was $46.2 million and $32.4 million, respectively. The Company recorded an increase of $3.9 million and $16.6 million during the three and nine months ended September 30, 2020, respectively, and an increase of $1.3 million and a decrease of $27.8 million during the three and nine months ended September 30, 2019, respectively, within “Change in the fair value of contingent consideration” in the accompanying condensed consolidated statements of operations and comprehensive loss. The fair value of the contingent consideration was developed using the same valuation approaches as described in Note 5, Fair Value, in the Notes to Consolidated Financial Statements in the Annual Report, using a discount rate of 16% in all three valuation approaches at September 30, 2020 and December 31, 2019.

On August 17, 2020, the Company and Baudax agreed to amend the timing of payment of the $5.0 million milestone payment due to the Company in August 2020 as a result of the approval of the new drug application (“NDA”) for ANJESO, such that the Company received $2.5 million in August 2020 and will receive: (i) $1.1 million on or prior to December 20, 2020; and (ii) $1.4 million on or prior to June 20, 2021. In consideration of the amendment of the timing of this milestone payment, Baudax paid the Company an additional $0.3 million in August 2020.

The carrying amounts reflected in the 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 “2023 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 $274.0 million and $277.9 million at September 30, 2020 and December 31, 2019, respectively. Please refer to Note 11, Long-Term Debt in these “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Inventory

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

Inventory

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,
(In thousands)	2020		2019
Raw materials	$	42,163	$	34,577
Work in process		53,336		54,061
Finished goods⁽¹⁾		27,324		13,165
Total inventory	$	122,823	$	101,803

(1)

At September 30, 2020 and December 31, 2019, the Company had $27.2 million and $7.6 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider.

As of September 30, 2020 and December 31, 2019, the carrying value of inventory includes $15.3 million and none, respectively, associated with the Company’s ALKS 3831 development program, which was capitalized in advance of potential regulatory approval.

Property, Plant and Equipment

9 Months Ended

Sep. 30, 2020

Property Plant And Equipment [Abstract]

Property, Plant and Equipment

7. PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment consisted of the following:

	September 30,			December 31,
(In thousands)	2020			2019
Land	$	6,560		$	6,560
Building and improvements		178,193			177,087
Furniture, fixtures and equipment		362,936			340,146
Leasehold improvements		52,438			20,737
Construction in progress		103,917			134,683
Subtotal		704,044			679,213
Less: accumulated depreciation		(348,829	)		(317,045	)
Total property, plant and equipment, net	$	355,215		$	362,168

Goodwill and Intangible Assets

9 Months Ended

Sep. 30, 2020

Goodwill And Intangible Assets Disclosure [Abstract]

Goodwill and Intangible Assets

8. GOODWILL AND INTANGIBLE ASSETS

Goodwill and intangible assets consisted of the following:

		September 30, 2020
(In thousands)	Weighted Amortizable Life (Years)	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Goodwill		$	92,873	$	—		$	92,873
Finite-lived intangible assets:
Collaboration agreements	12	$	465,590	$	(370,404	)	$	95,186
NanoCrystal technology	13		74,600		(52,476	)		22,124
OCR⁽¹⁾ technologies	12		42,560		(38,762	)		3,798
Total		$	582,750	$	(461,642	)	$	121,108

(1)

OCR refers to the Company’s oral controlled release technologies.

Based on the Company’s most recent analysis, amortization of intangible assets included within its condensed consolidated balance sheet at September 30, 2020 is expected to be approximately $40.0 million, $40.0 million, $35.0 million, $35.0 million and $1.0 million in the years ending December 31, 2020 through 2024, respectively. Although the Company believes such available information and assumptions are reasonable, given the inherent risks and uncertainties underlying its expectations regarding such future revenues, there is the potential for the Company’s actual results to vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets will change in proportion to the change in revenues.

Leases

9 Months Ended

Sep. 30, 2020

Leases [Abstract]

Leases

9. LEASES

In March 2018, the Company entered into a lease agreement for approximately 220,000 square feet of office and laboratory space at 900 Winter Street, Waltham, Massachusetts (“900 Winter Street”). The initial term of the operating lease for 900 Winter Street commenced on January 20, 2020 and expires in 2035, with an option to extend for an additional 10 years. The Company did not assume this option would be exercised in the calculation of its right-of-use asset and lease liability amounts.

The Company has determined that the identified operating lease did not contain non-lease components and required no further allocation of the total lease cost. Additionally, the agreement in place did not contain information to determine the rate implicit in the lease.

At September 30, 2020, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 5.58% and 14.0 years, respectively. During the three and nine months ended September 30, 2020, cash paid for amounts included for the measurement of lease liabilities was $5.0 million and $11.9 million, respectively, compared to $2.2 million and $6.8 million during the three and nine months ended September 30, 2019, respectively. The Company recorded operating lease expense of $4.7 million and $13.3 million, during the three and nine months ended September 30, 2020, respectively, compared to $2.1 million and $6.3 million during the three and nine months ended September 30, 2019, respectively.

Future lease payments under non-cancelable leases as of September 30, 2020 and December 31, 2019 consisted of the following:

	September 30,			December 31,
(In thousands)	2020			2019 ⁽¹⁾
2020	$	4,335		$	9,053
2021		12,948			2,727
2022		10,788			500
2023		10,913			509
2024		11,040			520
Thereafter		117,994			2,579
Total lease payments		168,018			15,888
Less: imputed interest		(57,926	)		(2,080	)
Total operating lease liabilities	$	110,092		$	13,808

(1)

As of December 31, 2019, the term of the 900 Winter Street lease had not commenced and the Company (a) did not have the right to obtain or control the leased premises during the construction period; (b) did not have the right of payment for the partially constructed assets, and thus, the partially constructed assets could have potentially been leased to another tenant; and (c) did not legally own or control the land on which the property improvements were being constructed. As such, the lease assets were not included as right-of-use assets at December 31, 2019. The future lease payments outlined above do not include the 900 Winter Street lease payments as of December 31, 2019 under ASU 2016-02, Leases (“Topic 842”).

In July 2020, the Company entered into an amendment to its existing lease at 852 Winter Street, Waltham, Massachusetts (as amended, the “852 Winter Street Lease”). The amendment became effective on October 7, 2020. The 852 Winter Street Lease governs approximately 180,000 square feet of corporate office space, administrative areas and laboratories. The amendment served to, among other things, extend the term of the 852 Winter Street Lease for a period of approximately five years, to commence in March 2021 and expire in April 2026 with respect to approximately 163,000 square feet of the 852 Winter Street Lease premises (the “Base Premises”) and to commence in September 2021 and expire in October 2026 with respect to approximately 17,000 square feet of the 852 Winter Street Lease premises (the “Additional Premises”). The Company expects to make annual lease payments of approximately $5.7 million for the Base Premises and $0.5 million for the Additional Premises, subject to annual increases. Under the terms of the 852 Winter Street Lease, the Company will have the option to extend for an additional five-year term. The Company determined that the amendment did not grant an additional right-of-use and therefore was not deemed to be a separate new lease and that the 852 Winter Street Lease should be reassessed and remeasured as of the effective date of the amendment. The Company will account for the amendment prospectively.

Accounts Payable and Accrued Expenses

9 Months Ended

Sep. 30, 2020

Payables And Accruals [Abstract]

Accounts Payable and Accrued Expenses

10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

	September 30,		December 31,
(In thousands)	2020		2019
Accounts payable	$	82,835	$	54,261
Accrued compensation		72,832		72,072
Accrued sales discounts, allowances and reserves		145,347		153,902
Accrued other		53,766		92,802
Total accounts payable and accrued expenses	$	354,780	$	373,037

Long-term Debt

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

Long-term Debt

11. LONG-TERM DEBT

Long-term debt consisted of the following:

	September 30,			December 31,
(In thousands)	2020			2019
2023 Term Loans, due March 26, 2023	$	275,506		$	277,138
Less: current portion		(2,843	)		(2,843	)
Long-term debt	$	272,663		$	274,295

The 2023 Term Loans have a due date of March 26, 2023 and interest payable of LIBOR plus 2.25% with a LIBOR floor of 0%. As of September 30, 2020, the Company was in compliance with its debt covenants.

Share-based Compensation

9 Months Ended

Sep. 30, 2020

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Share-based Compensation

12. SHARE-BASED COMPENSATION

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

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands)	2020		2019		2020		2019
Cost of goods manufactured and sold	$	2,344	$	2,912	$	6,324	$	7,395
Research and development		6,762		8,195		19,400		24,076
Selling, general and administrative		13,514		15,622		39,555		48,119
Total share-based compensation expense	$	22,620	$	26,729	$	65,279	$	79,590

At September 30, 2020 and December 31, 2019, $2.2 million and $1.5 million, respectively, of share-based compensation expense was capitalized and recorded as “Inventory” in the accompanying condensed consolidated balance sheets.

In February 2017, the compensation committee of the Company’s board of directors approved awards of restricted stock units (“RSUs”) to all employees employed by the Company during 2017, in each case subject to vesting on the achievement of three specified performance criteria over a performance period of three years from the date of the grant.

The Company achieved one of the three performance criteria in December 2018, resulting in the vesting of a portion of the performance-based RSUs. In February 2020, the compensation committee of the Company’s board of directors acknowledged that the two remaining performance criteria had not been achieved prior to the expiration of the three-year performance period and the unvested portion of the awards expired.

Loss Per Share

9 Months Ended

Sep. 30, 2020

Earnings Per Share [Abstract]

Loss Per Share

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, 2020 and 2019, 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 units, as they would have had an anti-dilutive effect on loss per ordinary share.

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

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands)	2020		2019		2020		2019
Stock options		15,322		13,867		15,352		14,077
Restricted stock units		2,351		3,344		3,678		3,110
Total		17,673		17,211		19,030		17,187

Restructuring

9 Months Ended

Sep. 30, 2020

Restructuring And Related Activities [Abstract]

Restructuring

14. RESTRUCTURING

In October 2019, the Company approved a restructuring plan following a review of its operations, cost structure and growth opportunities (the “Restructuring”). The Restructuring included a reduction in headcount of approximately 160 employees across the Company. The Company recorded a charge of $13.4 million in the fourth quarter of 2019 as a result of the Restructuring, which consisted of one-time termination benefits for employee severance, benefits and related costs, all of which were expected to result in cash expenditures and substantially all of which would be paid out within one year. Restructuring activity during the nine months ended September 30, 2020 was as follows:

(In thousands)
Balance, December 31, 2019	$	9,201
Amounts paid during the period:
Severance		(6,714	)
Outplacement services		(108	)
Benefits		(1,224	)
Balance, September 30, 2020	$	1,155

At September 30, 2020 and December 31, 2019, $1.2 million and $9.0 million of the restructuring accrual, respectively, was included within “Accounts payable and accrued expenses” and none and $0.2 million of the restructuring accrual, respectively, was included within “Other long-term liabilities” in the accompanying condensed consolidated balance sheets.

Commitments and Contingent Liabilities

9 Months Ended

Sep. 30, 2020

Commitments And Contingencies Disclosure [Abstract]

Commitments and Contingent Liabilities

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, 2020, there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring.

INVEGA SUSTENNA ANDA Litigation

Janssen Pharmaceuticals NV 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”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”), Mylan Pharmaceuticals Inc. (“Mylan”), and Mylan Institutional LLC and in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC, following the respective filings by each of Teva, Mylan Labs, and Pharmascience 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 remedies in each of the lawsuits included recovery of litigation costs and injunctive relief. The Company is not a party to any of these proceedings.

INVEGA TRINZA ANDA Litigation

In September 2020, Janssen Pharmaceuticals NV, 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. 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 EP 2 269 577 B (the “EP ’577 Patent”), which is a patent directed to certain risperidone microsphere compositions, including RISPERDAL CONSTA. Following a hearing on the matter in January 2019, the EPO issued a written decision revoking the EP’577 Patent in April 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 on November 5, 2019 and Nanjing Luye Pharmaceutical Co Ltd. and Teva Pharmaceutical Industries Ltd. submitted replies on December 20, 2019. The Company will continue to vigorously defend the EP ’577 Patent.

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. The Company intends to vigorously defend its intellectual property. 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).

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 on July 9, 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 August 2019, the defendants filed a pre-motion letter (in respect of a requested motion to dismiss filing) with the EDNY District Court and plaintiff filed a response. On November 27, 2019, the defendants served the plaintiff with a motion to dismiss, and on December 27, 2019, the plaintiff served the defendants with its opposition to such motion. On January 17, 2020, the defendants filed the fully-briefed motion, including a reply to the plaintiff’s opposition, with the EDNY District Court.

Product Liability and Other Legal Proceedings

The Company is also involved in product liability cases 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 matters would have a material adverse effect on the Company’s business or financial condition.

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2020
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three and nine months ended September 30, 2020 and 2019 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2019. 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 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	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 Annual Report. Intercompany accounts and transactions have been eliminated.
Use of Estimates	Use of Estimates The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires management to 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 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 assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.
Segment Information	Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines. The Company’s chief decision maker, the Chief Executive Officer and Chairman 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.
Risks and Uncertainties	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. All U.S. states, and many local jurisdictions and countries around the world, including Ireland, have, at times during the pandemic, issued “shelter-in-place” orders, quarantines, executive orders and similar government orders, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and recommendations, and the perception that additional orders, restrictions or recommendations could occur, have resulted in widespread closures of businesses, including healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects. While the Company has begun to observe a gradual normalization in patient and healthcare provider practices, the impacts and extent of such normalization are not yet known, and it remains difficult to predict the nature and extent of the future impacts that the pandemic will have on such practices and, as a result, on the Company’s business. The Company continues to closely monitor and rapidly respond to the ongoing impact of COVID-19 on its employees, communities and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the Company is unable to predict the extent of the impact that the COVID-19 pandemic may continue to have on the Company’s future financial condition and operating results. These uncertainties include, among other things, the ultimate severity and duration of the pandemic; governmental, business or other actions that have been, are being or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions, and imposition of social distancing measures; impacts of 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 and schizophrenia; 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 U.S., Irish and global economies more broadly. 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 marketed products 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 which 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 to the pandemic, including the implementation of “shelter-in-place” policies, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees and the Company expects commercial sales of these marketed products to continue to be adversely impacted while the pandemic persists. As it relates to the Company’s proprietary marketed products, despite continuing COVID-19-related impacts on access to healthcare provider facilities and patient flow, during the three months ended September 30, 2020, the Company saw an increase of 22% in the number of VIVITROL units sold compared to the three months ended June 30, 2020. ARISTADA units sold during the three months ended September 30, 2020 increased 7% compared to the three months ended June 30, 2020. During the three months ended September 30, 2020, the Company continued to take actions to support uninterrupted access to its proprietary marketed products. However, the Company currently expects commercial sales of its marketed products, particularly VIVITROL, to continue to be impacted by the COVID-19 pandemic over the next few quarters, including, for VIVITROL, as a result of the impact that the decrease in patient volume during the previous two quarters is expected to have on overall unit demand in the fourth quarter of 2020 and beyond. These items are discussed in greater detail in the “Results of Operations” section in “Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q. The Company continues to operate its manufacturing facilities and supply its medicines. While the Company continues to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has impacted, and may continue to impact, the timelines of certain of its early-stage discovery efforts and clinical trials. The Company is working with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, any potential adverse impacts of COVID-19 on its manufacturing operations and R&D activities.
New Accounting Pronouncements	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 June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments, to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. To achieve this objective, the amendments in this ASU replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This standard primarily impacts how firms account for credit losses and requires an impairment model, known as the current expected credit loss model, that is based on expected losses rather than incurred losses. Companies are required to carry an allowance for expected credit losses for most debt instruments (except those carried at fair value), trade receivables, lease receivables, reinsurance receivables, financial guarantee contracts and loan commitments. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The standard limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which the carrying value exceeds fair value and requires the reversal of previous recognized credit losses if fair value increases. The Company’s investment portfolio primarily consists of available-for-sale securities carried at fair value. Further, the Company’s trade receivables do not have abnormally long terms and the Company has historically rarely written off trade receivables. The Company adopted this standard on January 1, 2020 and the adoption of this standard did not have a material impact on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which aims to improve the effectiveness of fair value measurement disclosures. The amendments in this ASU modify the disclosure requirements on fair value measurements based on the concepts in FASB Concepts Statement, Conceptual Framework for Financial Reporting - Chapter 8: Notes to Financial Statements, including the consideration of costs and benefits. The Company adopted this standard on January 1, 2020 and the adoption of this standard had no impact on the Company’s financial statement disclosures. In August 2018, the FASB issued ASU 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This ASU also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. The Company adopted this standard on January 1, 2020 using the prospective transition method, whereby it applied the requirements to any eligible costs incurred after adoption. The Company has not incurred any material eligible costs during the nine months ended September 30, 2020. In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes, which simplifies the accounting for income taxes by removing certain exceptions to the general principles of Accounting Standards Codification (“ASC”) 740, Income Taxes (“Topic 740”). The amendments also improve consistent application of, and simplify, GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The Company adopted this standard on January 1, 2020 and the adoption of this standard had no material impact on the Company’s consolidated financial statements. In March 2020, the FASB issued 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 amendment 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 is currently assessing the impact that this ASU may have on its consolidated financial statements.

- Definition

Disclosure of accounting policy for segment reporting.

+ References + Details

Revenue from Contracts with Customers (Tables)

9 Months Ended

Sep. 30, 2020

Schedule of Contract Assets and Contract Liabilities

Total contract assets at September 30, 2020 were as follows:

(In thousands)	Contract Assets
Contract assets at December 31, 2019	$	13,386
Additions		36,569
Transferred to receivables, net		(30,560	)
Contract assets at September 30, 2020	$	19,395

Total contract liabilities at September 30, 2020 were as follows:

(In thousands)	Contract Liabilities
Contract liabilities at December 31, 2019	$	28,834
Additions		—
Amounts recognized into revenue		(3,046	)
Contract liabilities at September 30, 2020	$	25,788

Product sales, net

Schedule of Disaggregation of Revenues

During the three and nine months ended September 30, 2020 and 2019, the Company recorded product sales, net, as follows:

	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands)	2020		2019		2020		2019
VIVITROL	$	80,258	$	85,164	$	230,673	$	242,546
ARISTADA/ARISTADA INITIO		62,400		53,610		172,126		132,344
Total product sales, net	$	142,658	$	138,774	$	402,799	$	374,890

Manufacturing and royalty revenues

Schedule of Disaggregation of Revenues

During the three and nine months ended September 30, 2020 and 2019, the Company recorded manufacturing and royalty revenues as follows:

	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
RISPERDAL CONSTA		10,993		3,517		14,510		44,769		10,786		55,555
Other		14,312		18,163		32,475		46,088		53,786		99,874
	$	25,305	$	95,046	$	120,351	$	90,857	$	262,250	$	353,107

	Three Months Ended September 30, 2019						Nine Months Ended September 30, 2019
(In thousands)	Manufacturing Revenue		Royalty Revenue		Total		Manufacturing Revenue		Royalty Revenue		Total
INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA	$	—	$	68,382	$	68,382	$	—	$	188,968	$	188,968
RISPERDAL CONSTA		4,520		3,813		8,333		42,948		12,266		55,214
Other		11,562		15,506		27,068		42,460		53,953		96,413
	$	16,082	$	87,701	$	103,783	$	85,408	$	255,187	$	340,595

Investments (Tables)

9 Months Ended

Sep. 30, 2020

Investments Debt And Equity Securities [Abstract]

Schedule of Investments

Investments consisted of the following (in thousands):

			Gross Unrealized
					Losses
	Amortized				Less than			Greater than			Allowance for			Estimated
September 30, 2020	Cost		Gains		One Year			One Year			Credit Losses			Fair Value
Short-term investments:
Available-for-sale securities:
Corporate debt securities	$	163,511	$	1,484	$	(2	)	$	—		$	(977	)	$	164,016
U.S. government and agency debt securities		85,207		535		(1	)		—			—			85,741
International government agency debt securities		76,264		659		(8	)		—			—			76,915
		324,982		2,678		(11	)		—			(977	)		326,672
Held-to-maturity securities:
Fixed term deposit account		1,668		176		—			—			—			1,844
Total short-term investments		326,650		2,854		(11	)		—			(977	)		328,516
Long-term investments:
Available-for-sale securities:
Corporate debt securities		10,505		—		(21	)		—			—			10,484
U.S. government and agency debt securities		8,584		—		(1	)		—			—			8,583
International government agency debt securities		6,899		—		(12	)		—			—			6,887
		25,988		—		(34	)		—			—			25,954
Held-to-maturity securities:
Certificates of deposit		1,820		—		—			—			—			1,820
Total long-term investments		27,808		—		(34	)		—			—			27,774
Total investments	$	354,458	$	2,854	$	(45	)	$	—		$	(977	)	$	356,290

December 31, 2019
Short-term investments:
Available-for-sale securities:
Corporate debt securities	$	144,161	$	676	$	—		$	—		$	—		$	144,837
U.S. government and agency debt securities		112,948		434		(1	)		(1	)		—			113,380
International government agency debt securities		72,753		248		(10	)		—			—			72,991
Total short-term investments		329,862		1,358		(11	)		(1	)		—			331,208
Long-term investments:
Available-for-sale securities:
Corporate debt securities		51,070		—		(45	)		(7	)		—			51,018
International government agency debt securities		20,806		—		(18	)		—			—			20,788
U.S. government and agency debt securities		4,000		—		(4	)		—			—			3,996
		75,876		—		(67	)		(7	)		—			75,802
Held-to-maturity securities:
Certificates of deposit		1,820		—		—			—			—			1,820
Fixed term deposit account		1,667		102		—			—			—			1,769
		3,487		102		—			—			—			3,589
Total long-term investments		79,363		102		(67	)		(7	)		—			79,391
Total investments	$	409,225	$	1,460	$	(78	)	$	(8	)	$	—		$	410,599

Schedule of Proceeds from Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses

The proceeds from sales and maturities of marketable securities, which were identified using the specific identification method and were primarily reinvested, were as follows:

	Nine Months Ended September 30,
(In thousands)	2020		2019
Proceeds from the sales and maturities of marketable securities	$	206,089	$	149,459
Realized gains	$	8,336	$	—
Realized losses	$	977	$	497

Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities

The Company’s available-for-sale and held-to-maturity securities at September 30, 2020 had contractual maturities in the following periods:

	Available-for-sale				Held-to-maturity
	Amortized		Estimated		Amortized		Estimated
(In thousands)	Cost		Fair Value		Cost		Fair Value
Within 1 year	$	221,539	$	221,770	$	3,488	$	3,664
After 1 year through 5 years		129,431		130,856		—		—
Total	$	350,970	$	352,626	$	3,488	$	3,664

Fair Value (Tables)

9 Months Ended

Sep. 30, 2020

Fair Value Disclosures [Abstract]

Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis

	September 30,
(In thousands)	2020		Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	43,089	$	43,089	$	—	$	—
U.S. government and agency debt securities		94,324		61,880		32,444		—
Corporate debt securities		174,500		—		173,523		977
International government agency debt securities		83,802		—		83,802		—
Contingent consideration		46,200		—		—		46,200
Total	$	441,915	$	104,969	$	289,769	$	47,177

	December 31,
	2019		Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	8,064	$	8,064	$	—	$	—
U.S. government and agency debt securities		117,376		73,795		43,581		—
Corporate debt securities		195,855		—		193,902		1,953
International government agency debt securities		93,779		—		93,779		—
Contingent consideration		32,400		—		—		32,400
Total	$	447,474	$	81,859	$	331,262	$	34,353

Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs

The following table is a rollforward of the fair value of the Company’s assets whose fair values were determined using Level 3 inputs at September 30, 2020:

(In thousands)	Fair Value
Balance, January 1, 2020	$	34,353
Change in the fair value of contingent consideration		16,626
Payments received by the Company related to contingent consideration		(2,819	)
Payments due to the Company related to contingent consideration		(6	)
Impairment of corporate debt security		(977	)
Balance, September 30, 2020	$	47,177

Inventory (Tables)

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

Schedule of Inventories

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,
(In thousands)	2020		2019
Raw materials	$	42,163	$	34,577
Work in process		53,336		54,061
Finished goods⁽¹⁾		27,324		13,165
Total inventory	$	122,823	$	101,803

(1)

Property, Plant and Equipment (Tables)

9 Months Ended

Sep. 30, 2020

Property Plant And Equipment [Abstract]

Schedule of Property, Plant and Equipment

Property, plant and equipment consisted of the following:

	September 30,			December 31,
(In thousands)	2020			2019
Land	$	6,560		$	6,560
Building and improvements		178,193			177,087
Furniture, fixtures and equipment		362,936			340,146
Leasehold improvements		52,438			20,737
Construction in progress		103,917			134,683
Subtotal		704,044			679,213
Less: accumulated depreciation		(348,829	)		(317,045	)
Total property, plant and equipment, net	$	355,215		$	362,168

Goodwill and Intangible Assets (Tables)

9 Months Ended

Sep. 30, 2020

Goodwill And Intangible Assets Disclosure [Abstract]

Schedule of Goodwill and Intangible Assets

Goodwill and intangible assets consisted of the following:

		September 30, 2020
(In thousands)	Weighted Amortizable Life (Years)	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Goodwill		$	92,873	$	—		$	92,873
Finite-lived intangible assets:
Collaboration agreements	12	$	465,590	$	(370,404	)	$	95,186
NanoCrystal technology	13		74,600		(52,476	)		22,124
OCR⁽¹⁾ technologies	12		42,560		(38,762	)		3,798
Total		$	582,750	$	(461,642	)	$	121,108

(1)

OCR refers to the Company’s oral controlled release technologies.

Leases (Tables)

9 Months Ended

Sep. 30, 2020

Leases [Abstract]

Summary of Future Lease Payments Under Non-Cancelable Leases

Future lease payments under non-cancelable leases as of September 30, 2020 and December 31, 2019 consisted of the following:

	September 30,			December 31,
(In thousands)	2020			2019 ⁽¹⁾
2020	$	4,335		$	9,053
2021		12,948			2,727
2022		10,788			500
2023		10,913			509
2024		11,040			520
Thereafter		117,994			2,579
Total lease payments		168,018			15,888
Less: imputed interest		(57,926	)		(2,080	)
Total operating lease liabilities	$	110,092		$	13,808

(1)

Accounts Payable and Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2020

Payables And Accruals [Abstract]

Schedule of Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following:

	September 30,		December 31,
(In thousands)	2020		2019
Accounts payable	$	82,835	$	54,261
Accrued compensation		72,832		72,072
Accrued sales discounts, allowances and reserves		145,347		153,902
Accrued other		53,766		92,802
Total accounts payable and accrued expenses	$	354,780	$	373,037

Long-term Debt (Tables)

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

Schedule of Long-term Debt

Long-term debt consisted of the following:

	September 30,			December 31,
(In thousands)	2020			2019
2023 Term Loans, due March 26, 2023	$	275,506		$	277,138
Less: current portion		(2,843	)		(2,843	)
Long-term debt	$	272,663		$	274,295

Share-based Compensation (Tables)

9 Months Ended

Sep. 30, 2020

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Schedule of Share-based Compensation Expense

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

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands)	2020		2019		2020		2019
Cost of goods manufactured and sold	$	2,344	$	2,912	$	6,324	$	7,395
Research and development		6,762		8,195		19,400		24,076
Selling, general and administrative		13,514		15,622		39,555		48,119
Total share-based compensation expense	$	22,620	$	26,729	$	65,279	$	79,590

Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2020

Earnings Per Share [Abstract]

Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share

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

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands)	2020		2019		2020		2019
Stock options		15,322		13,867		15,352		14,077
Restricted stock units		2,351		3,344		3,678		3,110
Total		17,673		17,211		19,030		17,187

Restructuring (Tables)

9 Months Ended

Sep. 30, 2020

Restructuring And Related Activities [Abstract]

Schedule of Restructuring Activity

Restructuring activity during the nine months ended September 30, 2020 was as follows:

(In thousands)
Balance, December 31, 2019	$	9,201
Amounts paid during the period:
Severance		(6,714	)
Outplacement services		(108	)
Benefits		(1,224	)
Balance, September 30, 2020	$	1,155

Summary of Significant Accounting Policies - Additional Information (Details)	3 Months Ended	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2020 segment
Summary Of Significant Accounting Policies [Line Items]
Number of business segments		1
ASU 2016-13
Summary Of Significant Accounting Policies [Line Items]
Change in accounting principle, accounting standards update, adopted	true	true
Change in accounting principle, accounting standards update, adoption date	Jan. 01, 2020	Jan. 01, 2020
Change in accounting principle, accounting standards update, immaterial effect	true	true
ASU 2018-13
Summary Of Significant Accounting Policies [Line Items]
Change in accounting principle, accounting standards update, adopted	true	true
Change in accounting principle, accounting standards update, adoption date	Jan. 01, 2020	Jan. 01, 2020
Change in accounting principle, accounting standards update, immaterial effect	true	true
ASU 2018-15
Summary Of Significant Accounting Policies [Line Items]
Change in accounting principle, accounting standards update, adopted	true	true
Change in accounting principle, accounting standards update, adoption date	Jan. 01, 2020	Jan. 01, 2020
Change in accounting principle, accounting standards update, immaterial effect	true	true
Change in accounting principle, accounting standards update, transition option elected		us-gaap:AccountingStandardsUpdate201815ProspectiveMember
ASU 2019-12
Summary Of Significant Accounting Policies [Line Items]
Change in accounting principle, accounting standards update, adopted	true	true
Change in accounting principle, accounting standards update, adoption date	Jan. 01, 2020	Jan. 01, 2020
Change in accounting principle, accounting standards update, immaterial effect	true	true
VIVITROL
Summary Of Significant Accounting Policies [Line Items]
Increase (decrease) in units sold due to COVID19 pandemic, percentage	22.00%
ARISTADA
Summary Of Significant Accounting Policies [Line Items]
Increase (decrease) in units sold due to COVID19 pandemic, percentage	7.00%

Revenue from Contracts with Customers - Schedule of Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Disaggregation Of Revenue [Line Items]
Total revenues	$ 265,012	$ 255,243	$ 758,761	$ 758,217
VIVITROL
Disaggregation Of Revenue [Line Items]
Total revenues	80,258	85,164	230,673	242,546
ARISTADA/ARISTADA INITIO
Disaggregation Of Revenue [Line Items]
Total revenues	62,400	53,610	172,126	132,344
Product sales, net
Disaggregation Of Revenue [Line Items]
Total revenues	$ 142,658	$ 138,774	$ 402,799	$ 374,890

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
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-Paragraph 32
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Paragraph 22
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-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Revenue from Contracts with Customers - Schedule of Manufacturing and Royalty Revenues (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Disaggregation Of Revenue [Line Items]
Total revenues	$ 265,012	$ 255,243	$ 758,761	$ 758,217
Manufacturing Revenue
Disaggregation Of Revenue [Line Items]
Total revenues	25,305	16,082	90,857	85,408
Royalty
Disaggregation Of Revenue [Line Items]
Total revenues	95,046	87,701	262,250	255,187
Manufacturing and royalty revenues
Disaggregation Of Revenue [Line Items]
Total revenues	120,351	103,783	353,107	340,595
INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA \| Royalty
Disaggregation Of Revenue [Line Items]
Total revenues	73,366	68,382	197,678	188,968
INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA \| Manufacturing and royalty revenues
Disaggregation Of Revenue [Line Items]
Total revenues	73,366	68,382	197,678	188,968
RISPERDAL CONSTA \| Manufacturing Revenue
Disaggregation Of Revenue [Line Items]
Total revenues	10,993	4,520	44,769	42,948
RISPERDAL CONSTA \| Royalty
Disaggregation Of Revenue [Line Items]
Total revenues	3,517	3,813	10,786	12,266
RISPERDAL CONSTA \| Manufacturing and royalty revenues
Disaggregation Of Revenue [Line Items]
Total revenues	14,510	8,333	55,555	55,214
Other \| Manufacturing Revenue
Disaggregation Of Revenue [Line Items]
Total revenues	14,312	11,562	46,088	42,460
Other \| Royalty
Disaggregation Of Revenue [Line Items]
Total revenues	18,163	15,506	53,786	53,953
Other \| Manufacturing and royalty revenues
Disaggregation Of Revenue [Line Items]
Total revenues	$ 32,475	$ 27,068	$ 99,874	$ 96,413

- Definition

+ References

+ Details

Revenue from Contracts with Customers - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2020	Dec. 31, 2019
Disaggregation Of Revenue [Line Items]
Revenues	$ 265,012	$ 255,243	$ 758,761	$ 758,217
Contract asset, current	14,395		$ 14,395			$ 8,386
Consideration expects to receive			2 years
Other Assets
Disaggregation Of Revenue [Line Items]
Contract asset, non-current	5,000		$ 5,000			$ 5,000
Maximum
Disaggregation Of Revenue [Line Items]
Manufacturing Process period			56 days
Minimum
Disaggregation Of Revenue [Line Items]
Manufacturing Process period			10 days
Research and development revenue
Disaggregation Of Revenue [Line Items]
Revenues	953	12,686	$ 1,805	41,732
Research and development revenue \| Biogen
Disaggregation Of Revenue [Line Items]
Revenues	$ 100	$ 12,100	$ 300	$ 39,500
Research and development revenue \| Biogen \| Forecast \| Maximum
Disaggregation Of Revenue [Line Items]
Additional revenue expected					$ 100

Revenue from Contracts with Customers - Schedule of Contract Assets and Contract Liabilities (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2020 USD ($)
Contract Asset [Abstract]
Contract assets at beginning of period	$ 13,386
Additions	36,569
Transferred to receivables, net	(30,560)
Contract assets at end of period	19,395
Contract Liabilities [Abstract]
Contract liabilities at beginning of the period	28,834
Amounts recognized into revenue	(3,046)
Contract liabilities at end of the period	$ 25,788

Investments - Schedule of Investments (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Available-for-sale securities:
Amortized Cost	$ 350,970
Estimated Fair Value	352,626
Held-to-maturity securities:
Gross Unrealized Losses, Less than One Year	(11)
Estimated Fair Value	3,664
Long-term Investments
Amortized Cost	27,808	$ 79,363
Gross Unrealized Gains		102
Gross Unrealized Losses, Less than One Year	(34)	(67)
Gross Unrealized Losses, Greater than One Year		(7)
Total long-term investments	27,774	79,391
Total investments
Amortized Cost	354,458	409,225
Gross Unrealized Gains	2,854	1,460
Gross Unrealized Losses, Less than One Year	(45)	(78)
Gross Unrealized Losses, Greater than One Year		(8)
Allowance for Credit Losses	(977)
Estimated Fair Value	356,290	410,599
Short-term Investments
Amortized Cost	326,650	329,862
Gross Unrealized Gains	2,854	1,358
Gross Unrealized Losses, Less than One Year	(11)	(11)
Gross Unrealized Losses, Greater than One Year		(1)
Allowance for Credit Losses	(977)
Total short-term investments	328,516	331,208
Short-term investments
Available-for-sale securities:
Amortized Cost	324,982
Gross Unrealized Gains	2,678
Gross Unrealized Losses, Less than One Year	(11)
Allowance for Credit Losses	(977)
Estimated Fair Value	326,672
Short-term investments \| Corporate debt securities
Available-for-sale securities:
Amortized Cost	163,511	144,161
Gross Unrealized Gains	1,484	676
Gross Unrealized Losses, Less than One Year	(2)
Allowance for Credit Losses	(977)
Estimated Fair Value	164,016	144,837
Short-term investments \| U.S. government and agency debt securities
Available-for-sale securities:
Amortized Cost	85,207	112,948
Gross Unrealized Gains	535	434
Gross Unrealized Losses, Less than One Year	(1)	(1)
Gross Unrealized Losses, Greater than One Year		(1)
Estimated Fair Value	85,741	113,380
Short-term investments \| International government agency debt securities
Available-for-sale securities:
Amortized Cost	76,264	72,753
Gross Unrealized Gains	659	248
Gross Unrealized Losses, Less than One Year	(8)	(10)
Estimated Fair Value	76,915	72,991
Short-term investments \| Fixed Term Deposit Account
Held-to-maturity securities:
Amortized Cost	1,668
Gross Unrealized Gains	176
Estimated Fair Value	1,844
Long-term investments
Available-for-sale securities:
Amortized Cost	25,988	75,876
Gross Unrealized Losses, Less than One Year	(34)	(67)
Gross Unrealized Losses, Greater than One Year		(7)
Estimated Fair Value	25,954	75,802
Held-to-maturity securities:
Amortized Cost		3,487
Gross Unrealized Gains		102
Estimated Fair Value		3,589
Long-term investments \| Certificates of deposit
Held-to-maturity securities:
Amortized Cost	1,820	1,820
Estimated Fair Value	1,820	1,820
Long-term investments \| Corporate debt securities
Available-for-sale securities:
Amortized Cost	10,505	51,070
Gross Unrealized Losses, Less than One Year	(21)	(45)
Gross Unrealized Losses, Greater than One Year		(7)
Estimated Fair Value	10,484	51,018
Long-term investments \| U.S. government and agency debt securities
Available-for-sale securities:
Amortized Cost	8,584	4,000
Gross Unrealized Losses, Less than One Year	(1)	(4)
Estimated Fair Value	8,583	3,996
Long-term investments \| International government agency debt securities
Available-for-sale securities:
Amortized Cost	6,899	20,806
Gross Unrealized Losses, Less than One Year	(12)	(18)
Estimated Fair Value	$ 6,887	20,788
Long-term investments \| Fixed Term Deposit Account
Held-to-maturity securities:
Amortized Cost		1,667
Gross Unrealized Gains		102
Estimated Fair Value		$ 1,769

Investments - Additional Information (Details) $ in Thousands	1 Months Ended	3 Months Ended	9 Months Ended
	Sep. 30, 2020 USD ($)	Sep. 30, 2020 USD ($) Portfolio	Sep. 30, 2020 USD ($)	Sep. 30, 2020 EUR (€)	Dec. 31, 2019 USD ($)	May 31, 2014 EUR (€)
Investment Holdings [Line Items]
Other-than-temporary impairment charge	$ 1,000
Return of Fountain Healthcare Partners II, L.P. investment			$ 2,751
Fountain Healthcare Partners II
Investment Holdings [Line Items]
Funding commitment as percentage of partnership's total funding	7.00%	7.00%	7.00%	7.00%
Equity method commitment \| €				€ 5,800,000
Number of portfolio sold \| Portfolio		2
Proceeds from sale of portfolio	$ 10,400	$ 11,100
Gain on sale of investment		8,300
Return of Fountain Healthcare Partners II, L.P. investment		2,800
Fountain Healthcare Partners II \| Other Assets
Investment Holdings [Line Items]
Carrying value of equity investment	4,700	$ 4,700	$ 4,700		$ 5,900
Fountain Healthcare Partners II \| Held-in Escrow
Investment Holdings [Line Items]
Proceeds from sale of portfolio	$ 700
Fountain Healthcare Partners II \| Maximum
Investment Holdings [Line Items]
Commitment on equity method investment \| €						€ 7,400,000

Investments - Schedule of Proceeds from Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Investments Debt And Equity Securities [Abstract]
Proceeds from the sales and maturities of marketable securities	$ 206,089	$ 149,459
Realized gains	8,336
Realized losses	$ 977	$ 497

Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands	Sep. 30, 2020 USD ($)
Available-for-sale, Amortized Cost
Within 1 year	$ 221,539
After 1 year through 5 years	129,431
Amortized Cost	350,970
Available-for-sale, Estimated Fair Value
Within 1 year	221,770
After 1 year through 5 years	130,856
Total	352,626
Held-to-maturity, Amortized Cost
Within 1 year	3,488
Total	3,488
Held-to-maturity, Estimated Fair Value
Within 1 year	3,664
Total	$ 3,664

Fair Value - Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Fair value
Debt securities	$ 352,626
Contingent consideration	46,200	$ 32,400
Recurring Basis
Fair value
Cash equivalents	43,089	8,064
Contingent consideration	46,200	32,400
Assets, Total	441,915	447,474
Recurring Basis \| Level 1
Fair value
Cash equivalents	43,089	8,064
Assets, Total	104,969	81,859
Recurring Basis \| Level 2
Fair value
Assets, Total	289,769	331,262
Recurring Basis \| Level 3
Fair value
Contingent consideration	46,200	32,400
Assets, Total	47,177	34,353
U.S. government and agency debt securities \| Recurring Basis
Fair value
Debt securities	94,324	117,376
U.S. government and agency debt securities \| Recurring Basis \| Level 1
Fair value
Debt securities	61,880	73,795
U.S. government and agency debt securities \| Recurring Basis \| Level 2
Fair value
Debt securities	32,444	43,581
Corporate debt securities \| Recurring Basis
Fair value
Debt securities	174,500	195,855
Corporate debt securities \| Recurring Basis \| Level 2
Fair value
Debt securities	173,523	193,902
Corporate debt securities \| Recurring Basis \| Level 3
Fair value
Debt securities	977	1,953
International government agency debt securities \| Recurring Basis
Fair value
Debt securities	83,802	93,779
International government agency debt securities \| Recurring Basis \| Level 2
Fair value
Debt securities	$ 83,802	$ 93,779

Fair Value - Additional Information (Details)	1 Months Ended	3 Months Ended		9 Months Ended
Fair Value - Additional Information (Details)	Aug. 31, 2020 USD ($)	Sep. 30, 2020 USD ($) item	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) item	Sep. 30, 2019 USD ($)	Jun. 20, 2021 USD ($)	Dec. 20, 2020 USD ($)	Aug. 17, 2020 USD ($)	Dec. 31, 2019 USD ($) item
Fair Value
Transfers between the levels				$ 0
Contingent consideration		$ 46,200,000		46,200,000					$ 32,400,000
Increase (decrease) in the fair value of contingent consideration		3,926,000	$ 1,300,000	16,626,000	$ (27,800,000)
Milestone payments receivable								$ 5,000,000.0
Milestone payments received	$ 2,500,000
Additional milestone payments received	$ 300,000
2023 Term Loan
Fair Value
Amount to be realized in future		$ 274,000,000.0		$ 274,000,000.0					$ 277,900,000
Forecast
Fair Value
Milestone payments receivable						$ 1,400,000	$ 1,100,000
Discount Rate
Fair Value
Discount rate (as a percent) \| item		16		16					16

Fair Value - Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2020 USD ($)
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs
Balance at the beginning of the period	$ 34,353
Payments received by the Company related to contingent consideration	(2,819)
Payments due to the Company related to contingent consideration	(6)
Impairment of corporate debt security	(977)
Balance at the end of the period	47,177
Change In The Fair Value Of Contingent Consideration
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs
Change in the fair value	$ 16,626

Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Inventory Disclosure [Abstract]
Raw materials	$ 42,163	$ 34,577
Work in process	53,336	54,061
Finished goods	27,324	13,165
Total inventory	$ 122,823	$ 101,803

Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions	Sep. 30, 2020	Dec. 31, 2019
Inventory Disclosure [Abstract]
Finished goods inventory located at third-party warehouse and shipping service provider	$ 27.2	$ 7.6

Inventory - Additional Information (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Inventory Disclosure [Abstract]
Inventory capitalized in advance of potential regulatory approval	$ 15,300,000	$ 0

Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Property, plant and equipment
Property, plant and equipment, gross	$ 704,044	$ 679,213
Less: accumulated depreciation	(348,829)	(317,045)
Total property, plant and equipment, net	355,215	362,168
Land
Property, plant and equipment
Property, plant and equipment, gross	6,560	6,560
Building and Improvements
Property, plant and equipment
Property, plant and equipment, gross	178,193	177,087
Furniture, Fixtures and Equipment
Property, plant and equipment
Property, plant and equipment, gross	362,936	340,146
Leasehold Improvements
Property, plant and equipment
Property, plant and equipment, gross	52,438	20,737
Construction in Progress
Property, plant and equipment
Property, plant and equipment, gross	$ 103,917	$ 134,683

Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Goodwill
Gross Carrying Amount	$ 92,873
Net Carrying Amount	92,873	$ 92,873
Finite-lived intangible assets:
Gross Carrying Amount	582,750
Accumulated Amortization	(461,642)
Net Carrying Amount	$ 121,108	$ 150,643
Collaboration agreements
Finite-lived intangible assets:
Weighted Amortizable Life	12 years
Gross Carrying Amount	$ 465,590
Accumulated Amortization	(370,404)
Net Carrying Amount	$ 95,186
NanoCrystal technology
Finite-lived intangible assets:
Weighted Amortizable Life	13 years
Gross Carrying Amount	$ 74,600
Accumulated Amortization	(52,476)
Net Carrying Amount	$ 22,124
OCR technologies
Finite-lived intangible assets:
Weighted Amortizable Life	12 years
Gross Carrying Amount	$ 42,560
Accumulated Amortization	(38,762)
Net Carrying Amount	$ 3,798

Goodwill and Intangible Assets - Additional Information (Details) $ in Millions	Sep. 30, 2020 USD ($)
Expected amortization of intangible assets
2020	$ 40.0
2021	40.0
2022	35.0
2023	35.0
2024	$ 1.0

Leases - Additional Information (Details)
$ in Thousands

1 Months Ended

3 Months Ended

9 Months Ended

Oct. 07, 2020

USD ($)

ft²

Mar. 31, 2018

ft²

Sep. 30, 2020

USD ($)

Sep. 30, 2019

USD ($)

Sep. 30, 2020

USD ($)

Sep. 30, 2019

USD ($)

Dec. 31, 2019

USD ($)

^[1]

Lessee Lease Description [Line Items]

Area of real estate property | ft²

220,000

Lessee operating lease term of option to extend

10 years

Operating lease, existence of option to extend

true

Lease, commencement date

Jan. 20, 2020

Lease, expiration year

2035

Weighted average incremental borrowing rate

5.58%

Weighted average remaining lease term

14 years

Payments for operating leases

$ 5,000

$ 2,200

$ 11,900

$ 6,800

Operating lease expense

4,700

$ 2,100

13,300

$ 6,300

Annual lease payments

$ 168,018

$ 15,888

Subsequent Event

Lessee Lease Description [Line Items]

Area of real estate property | ft²

180,000

Lessee operating lease term of option to extend

5 years

Subsequent Event | Base Premises

Lessee Lease Description [Line Items]

Area of real estate property | ft²

163,000

Lease period

5 years

Lease agreement commencement period

2021-03

Lease, expiration period

2026-04

Annual lease payments

$ 5,700

Subsequent Event | Additional Premises

Lessee Lease Description [Line Items]

Area of real estate property | ft²

17,000

Lease agreement commencement period

2021-09

Lease, expiration period

2026-10

Annual lease payments

$ 500

[1]

Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) - USD ($)
$ in Thousands

Sep. 30, 2020

Dec. 31, 2019

Leases [Abstract]

Remainder of fiscal year

$ 4,335

Year 1

12,948

$ 9,053

^[1]

Year 2

10,788

2,727

^[1]

Year 3

10,913

500

^[1]

Year 4

11,040

509

^[1]

Thereafter

117,994

Year 5

^[1]

520

Thereafter

^[1]

2,579

Total lease payments

168,018

15,888

^[1]

Less: imputed interest

(57,926)

(2,080)

^[1]

Total operating lease liabilities

$ 110,092

$ 13,808

^[1]

[1]

Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Payables And Accruals [Abstract]
Accounts payable	$ 82,835	$ 54,261
Accrued compensation	72,832	72,072
Accrued sales discounts, allowances and reserves	145,347	153,902
Accrued other	53,766	92,802
Total accounts payable and accrued expenses	$ 354,780	$ 373,037

Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Long-term debt
Less: current portion	$ (2,843)	$ (2,843)
Long-term debt	272,663	274,295
2023 Term Loans
Long-term debt
2023 Term Loans, due March 26, 2023	275,506	277,138
Less: current portion	(2,843)	(2,843)
Long-term debt	$ 272,663	$ 274,295

Long-term Debt - Additional Information (Details) - 2023 Term Loans	9 Months Ended
	Sep. 30, 2020
Long-term debt
Due date of loan	Mar. 26, 2023
Variable interest rate base	LIBOR
LIBOR
Long-term debt
Interest rate added to base rate (as a percent)	2.25%
Interest rate, variable interest rate floor (as a percent)	0.00%

Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Share-based compensation Expense
Total share-based compensation expense	$ 22,620	$ 26,729	$ 65,279	$ 79,590
Cost of goods manufactured and sold
Share-based compensation Expense
Total share-based compensation expense	2,344	2,912	6,324	7,395
Research and development
Share-based compensation Expense
Total share-based compensation expense	6,762	8,195	19,400	24,076
Selling, general and administrative
Share-based compensation Expense
Total share-based compensation expense	$ 13,514	$ 15,622	$ 39,555	$ 48,119

Share-based Compensation - Additional Information (Details) - USD ($) $ in Millions	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Performance-based RSUs
Share-based compensation Expense
Number of years from the date of the grant	3 years
Expiration period	3 years
Inventory
Share-based compensation Expense
Share based compensation cost capitalized	$ 2.2	$ 1.5

Loss Per Share - Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Denominator:
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share	17,673	17,211	19,030	17,187
Stock Options
Denominator:
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share	15,322	13,867	15,352	14,077
Restricted Stock Units
Denominator:
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share	2,351	3,344	3,678	3,110

Restructuring - Additional Information (Details)	1 Months Ended	9 Months Ended
Restructuring - Additional Information (Details)	Oct. 31, 2019 USD ($) Position	Sep. 30, 2020 USD ($)	Dec. 31, 2019 USD ($)
Restructuring Cost And Reserve [Line Items]
Restructuring and related activities initiation month and year		October 2019
Expected number of positions eliminated \| Position	160
Restructuring and related charges	$ 13,400,000
Restructuring and related activities description		The Restructuring included a reduction in headcount of approximately 160 employees across the Company. The Company recorded a charge of $13.4 million in the fourth quarter of 2019 as a result of the Restructuring, which consisted of one-time termination benefits for employee severance, benefits and related costs, all of which were expected to result in cash expenditures and substantially all of which would be paid out within one year.
Restructuring accrual		$ 1,155,000	$ 9,201,000
Accounts payable and accrued expenses
Restructuring Cost And Reserve [Line Items]
Restructuring accrual		1,200,000	9,000,000.0
Other long-term liabilities
Restructuring Cost And Reserve [Line Items]
Restructuring accrual		$ 0	$ 200,000

Restructuring - Schedule of Restructuring Activity (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2020 USD ($)
Restructuring And Related Activities [Abstract]
Balance, December 31, 2019	$ 9,201
Amounts paid during the period:
Severance	(6,714)
Outplacement services	(108)
Benefits	(1,224)
Balance, September 30, 2020	$ 1,155

Commitments and Contingent Liabilities - Additional Information (Details) - USD ($)	1 Months Ended	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2020
Commitments And Contingencies Disclosure [Abstract]
Potential losses from claims, legal proceedings probable of occurring		$ 0
Maximum number of months before FDA can approve patent request	30 months