alks-10q_20220331.htm
Alkermes plc. 0001520262 false --12-31 2022 Q1 P56D 2022-02-28 P12Y P11Y P13Y 0001520262 2022-01-01 2022-03-31 xbrli:shares 0001520262 2022-04-22 iso4217:USD 0001520262 2022-03-31 0001520262 2021-12-31 iso4217:USD xbrli:shares 0001520262 us-gaap:ProductMember 2022-01-01 2022-03-31 0001520262 us-gaap:ProductMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember 2021-01-01 2021-03-31 0001520262 us-gaap:LicenseMember 2022-01-01 2022-03-31 0001520262 us-gaap:LicenseMember 2021-01-01 2021-03-31 0001520262 alks:ResearchAndDevelopmentMember 2022-01-01 2022-03-31 0001520262 alks:ResearchAndDevelopmentMember 2021-01-01 2021-03-31 0001520262 2021-01-01 2021-03-31 0001520262 2020-12-31 0001520262 2021-03-31 0001520262 us-gaap:CommonStockMember 2021-12-31 0001520262 us-gaap:AdditionalPaidInCapitalMember 2021-12-31 0001520262 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-12-31 0001520262 us-gaap:RetainedEarningsMember 2021-12-31 0001520262 us-gaap:TreasuryStockMember 2021-12-31 0001520262 us-gaap:CommonStockMember 2022-01-01 2022-03-31 0001520262 us-gaap:AdditionalPaidInCapitalMember 2022-01-01 2022-03-31 0001520262 us-gaap:TreasuryStockMember 2022-01-01 2022-03-31 0001520262 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-01-01 2022-03-31 0001520262 us-gaap:RetainedEarningsMember 2022-01-01 2022-03-31 0001520262 us-gaap:CommonStockMember 2022-03-31 0001520262 us-gaap:AdditionalPaidInCapitalMember 2022-03-31 0001520262 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-03-31 0001520262 us-gaap:RetainedEarningsMember 2022-03-31 0001520262 us-gaap:TreasuryStockMember 2022-03-31 0001520262 us-gaap:CommonStockMember 2020-12-31 0001520262 us-gaap:AdditionalPaidInCapitalMember 2020-12-31 0001520262 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-12-31 0001520262 us-gaap:RetainedEarningsMember 2020-12-31 0001520262 us-gaap:TreasuryStockMember 2020-12-31 0001520262 us-gaap:CommonStockMember 2021-01-01 2021-03-31 0001520262 us-gaap:AdditionalPaidInCapitalMember 2021-01-01 2021-03-31 0001520262 us-gaap:TreasuryStockMember 2021-01-01 2021-03-31 0001520262 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-01-01 2021-03-31 0001520262 us-gaap:RetainedEarningsMember 2021-01-01 2021-03-31 0001520262 us-gaap:CommonStockMember 2021-03-31 0001520262 us-gaap:AdditionalPaidInCapitalMember 2021-03-31 0001520262 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-03-31 0001520262 us-gaap:RetainedEarningsMember 2021-03-31 0001520262 us-gaap:TreasuryStockMember 2021-03-31 alks:segment 0001520262 alks:VivitrolMember 2022-01-01 2022-03-31 0001520262 alks:VivitrolMember 2021-01-01 2021-03-31 0001520262 alks:AristadaAndAristadaInitioMember 2022-01-01 2022-03-31 0001520262 alks:AristadaAndAristadaInitioMember 2021-01-01 2021-03-31 0001520262 alks:LYBALVIMember 2022-01-01 2022-03-31 0001520262 us-gaap:RoyaltyMember alks:LongActingINVEGAProductsMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:LongActingINVEGAProductsMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturingRevenueMember alks:VumerityMember 2022-01-01 2022-03-31 0001520262 us-gaap:RoyaltyMember alks:VumerityMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:VumerityMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturingRevenueMember alks:RISPERDALCONSTAMember 2022-01-01 2022-03-31 0001520262 us-gaap:RoyaltyMember alks:RISPERDALCONSTAMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:RISPERDALCONSTAMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturingRevenueMember alks:OtherProductsAndServicesMember 2022-01-01 2022-03-31 0001520262 us-gaap:RoyaltyMember alks:OtherProductsAndServicesMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:OtherProductsAndServicesMember 2022-01-01 2022-03-31 0001520262 alks:ManufacturingRevenueMember 2022-01-01 2022-03-31 0001520262 us-gaap:RoyaltyMember 2022-01-01 2022-03-31 0001520262 us-gaap:RoyaltyMember alks:LongActingINVEGAProductsMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:LongActingINVEGAProductsMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturingRevenueMember alks:VumerityMember 2021-01-01 2021-03-31 0001520262 us-gaap:RoyaltyMember alks:VumerityMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:VumerityMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturingRevenueMember alks:RISPERDALCONSTAMember 2021-01-01 2021-03-31 0001520262 us-gaap:RoyaltyMember alks:RISPERDALCONSTAMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:RISPERDALCONSTAMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturingRevenueMember alks:OtherProductsAndServicesMember 2021-01-01 2021-03-31 0001520262 us-gaap:RoyaltyMember alks:OtherProductsAndServicesMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturedProductAndRoyaltyMember alks:OtherProductsAndServicesMember 2021-01-01 2021-03-31 0001520262 alks:ManufacturingRevenueMember 2021-01-01 2021-03-31 0001520262 us-gaap:RoyaltyMember 2021-01-01 2021-03-31 0001520262 alks:VumerityMember alks:BiogenMember 2022-03-31 0001520262 srt:MinimumMember 2022-01-01 2022-03-31 0001520262 srt:MaximumMember 2022-01-01 2022-03-31 0001520262 us-gaap:ShortTermInvestmentsMember us-gaap:CorporateDebtSecuritiesMember 2022-03-31 0001520262 us-gaap:ShortTermInvestmentsMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2022-03-31 0001520262 us-gaap:ShortTermInvestmentsMember us-gaap:ForeignGovernmentDebtSecuritiesMember 2022-03-31 0001520262 us-gaap:ShortTermInvestmentsMember 2022-03-31 0001520262 alks:LongTermInvestmentsMember us-gaap:CorporateDebtSecuritiesMember 2022-03-31 0001520262 alks:LongTermInvestmentsMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2022-03-31 0001520262 alks:LongTermInvestmentsMember us-gaap:ForeignGovernmentDebtSecuritiesMember 2022-03-31 0001520262 alks:LongTermInvestmentsMember 2022-03-31 0001520262 us-gaap:ShortTermInvestmentsMember us-gaap:CorporateDebtSecuritiesMember 2021-12-31 0001520262 us-gaap:ShortTermInvestmentsMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2021-12-31 0001520262 us-gaap:ShortTermInvestmentsMember us-gaap:ForeignGovernmentDebtSecuritiesMember 2021-12-31 0001520262 us-gaap:ShortTermInvestmentsMember 2021-12-31 0001520262 alks:LongTermInvestmentsMember us-gaap:CorporateDebtSecuritiesMember 2021-12-31 0001520262 alks:LongTermInvestmentsMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2021-12-31 0001520262 alks:LongTermInvestmentsMember us-gaap:ForeignGovernmentDebtSecuritiesMember 2021-12-31 0001520262 alks:LongTermInvestmentsMember 2021-12-31 0001520262 alks:LongTermInvestmentsMember us-gaap:CertificatesOfDepositMember 2022-03-31 0001520262 alks:LongTermInvestmentsMember us-gaap:CertificatesOfDepositMember 2021-12-31 0001520262 alks:ConvertiblePromissoryNotesMember us-gaap:InvesteeMember alks:SynchronicityPharmaIncMember 2022-01-31 0001520262 alks:ConvertiblePromissoryNotesMember us-gaap:InvesteeMember alks:SynchronicityPharmaIncMember 2022-01-01 2022-01-31 xbrli:pure 0001520262 us-gaap:InvesteeMember alks:SynchronicityPharmaIncMember srt:MaximumMember 2022-01-31 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember 2022-03-31 iso4217:EUR alks:Portfolio 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember 2022-01-01 2022-03-31 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember 2021-01-01 2021-12-31 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember us-gaap:OtherExpenseMember 2022-01-01 2022-03-31 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember us-gaap:OtherAssetsMember 2022-03-31 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember us-gaap:OtherAssetsMember 2021-12-31 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember srt:MaximumMember 2022-01-01 2022-03-31 0001520262 alks:FountainHealthcarePartnersIiLpOfIrelandMember 2021-01-01 2021-03-31 0001520262 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:ForeignGovernmentDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:ForeignGovernmentDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2022-03-31 0001520262 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:ForeignGovernmentDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:ForeignGovernmentDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-12-31 0001520262 alks:FairValueOfContingentConsiderationMember 2022-01-01 2022-03-31 0001520262 2021-01-01 2021-12-31 alks:Installment 0001520262 alks:BaudaxBioIncMember 2022-01-01 2022-03-31 0001520262 alks:BaudaxBioIncMember 2022-03-31 0001520262 alks:BaudaxBioIncMember 2021-01-01 2021-12-31 0001520262 srt:MaximumMember alks:BaudaxBioIncMember 2022-03-31 0001520262 alks:TwentyTwentySixTermLoansMember 2022-03-31 0001520262 alks:TwentyTwentySixTermLoansMember 2021-12-31 0001520262 us-gaap:LandMember 2022-03-31 0001520262 us-gaap:LandMember 2021-12-31 0001520262 us-gaap:BuildingAndBuildingImprovementsMember 2022-03-31 0001520262 us-gaap:BuildingAndBuildingImprovementsMember 2021-12-31 0001520262 alks:FurnitureFixtureAndEquipmentMember 2022-03-31 0001520262 alks:FurnitureFixtureAndEquipmentMember 2021-12-31 0001520262 us-gaap:LeaseholdImprovementsMember 2022-03-31 0001520262 us-gaap:LeaseholdImprovementsMember 2021-12-31 0001520262 us-gaap:ConstructionInProgressMember 2022-03-31 0001520262 us-gaap:ConstructionInProgressMember 2021-12-31 0001520262 us-gaap:LicensingAgreementsMember 2022-01-01 2022-03-31 0001520262 us-gaap:IntellectualPropertyMember srt:MinimumMember 2022-01-01 2022-03-31 0001520262 us-gaap:IntellectualPropertyMember srt:MaximumMember 2022-01-01 2022-03-31 0001520262 us-gaap:LicensingAgreementsMember 2022-03-31 0001520262 us-gaap:IntellectualPropertyMember 2022-03-31 0001520262 alks:MedicaidRebateMember 2022-03-31 0001520262 alks:MedicaidRebateMember 2021-12-31 0001520262 alks:ProductDiscountsMember 2022-03-31 0001520262 alks:ProductDiscountsMember 2021-12-31 0001520262 alks:MedicarePartDMember 2022-03-31 0001520262 alks:MedicarePartDMember 2021-12-31 0001520262 alks:OtherMember 2022-03-31 0001520262 alks:OtherMember 2021-12-31 0001520262 alks:TwentyTwentySixTermLoansMember 2022-01-01 2022-03-31 0001520262 alks:TwentyTwentySixTermLoansMember us-gaap:LondonInterbankOfferedRateLIBORMember 2022-01-01 2022-03-31 0001520262 us-gaap:InterestExpenseMember 2021-01-01 2021-03-31 0001520262 us-gaap:CostOfSalesMember 2022-01-01 2022-03-31 0001520262 us-gaap:CostOfSalesMember 2021-01-01 2021-03-31 0001520262 us-gaap:ResearchAndDevelopmentExpenseMember 2022-01-01 2022-03-31 0001520262 us-gaap:ResearchAndDevelopmentExpenseMember 2021-01-01 2021-03-31 0001520262 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2022-01-01 2022-03-31 0001520262 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2021-01-01 2021-03-31 0001520262 us-gaap:EmployeeStockOptionMember 2022-01-01 2022-03-31 0001520262 us-gaap:EmployeeStockOptionMember 2021-01-01 2021-03-31 0001520262 us-gaap:RestrictedStockUnitsRSUMember 2022-01-01 2022-03-31 0001520262 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-03-31 alks:Agreement 0001520262 alks:JanssenPharmaceuticaNVMember 2022-01-01 2022-03-31 0001520262 us-gaap:PatentsMember 2022-01-01 2022-03-31 0001520262 2020-09-01 2020-09-30

 

 

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

 

 

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

 

For the quarterly period ended March 31, 2022

 

OR

 

 

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

 

Commission File Number 001-35299

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

 

 

 

Ireland

 

98-1007018

(State or other jurisdiction of incorporation or organization)

 

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

 

Connaught House

1 Burlington Road

Dublin 4Ireland, D04 C5Y6

(Address of principal executive offices)

 

+ 353-1-772-8000

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Ordinary shares, $0.01 par value

 

ALKS

 

Nasdaq Global Select Market

 

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

 

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

 

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

 

 

 

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

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

 

The number of the registrant’s ordinary shares, $0.01 par value, outstanding as of April 22, 2022 was 163,426,943 shares.

 

 

 

 

 

 


 

 

ALKERMES PLC AND SUBSIDIARIES

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022

 

 

 

 

 

Page No.

PART I - FINANCIAL INFORMATION

 

Item 1.

Condensed Consolidated Financial Statements (unaudited):

 

 

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

5

 

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

6

 

Condensed Consolidated Statements of Cash Flows — For the Three Months Ended March 31, 2022 and 2021

7

 

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

8

 

Notes to Condensed Consolidated Financial Statements

9

Item 2.

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

22

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

35

Item 4.

Controls and Procedures

36

 

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

37

Item 1A.

Risk Factors

37

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

37

Item 5.

Other Information

37

Item 6.

Exhibits

38

Signatures

39

 

2


 

 

Cautionary Note Concerning Forward-Looking Statements

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

 

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

 

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

 

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

 

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

 

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

 

our expectations regarding future amortization of intangible assets;

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

other expectations discussed elsewhere in this Form 10-Q.

Actual results might differ materially from those expressed or implied by these forward-looking statements because these forward-looking statements are subject to risks, assumptions and uncertainties. In light of these risks, assumptions and uncertainties, the forward-looking expectations discussed in this Form 10-Q might not occur. You are cautioned not to place undue reliance on the forward-looking statements in this Form 10-Q, which speak only as of the date of this Form 10-Q. All subsequent written and oral forward-looking statements concerning the matters addressed in this Form 10-Q and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Except as required by applicable law or regulation, we do not undertake any obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For information about the risks, assumptions and uncertainties of our business, see “Part I, Item 1A—Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021, filed

3


 

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

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

Note Regarding Company and Product References

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

Note Regarding Trademarks

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

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

4


 

PART I. FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements:

ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

 

 

 

March 31, 2022

 

December 31, 2021

 

 

(In thousands, except share and per share amounts)

ASSETS

 

 

 

 

CURRENT ASSETS:

 

 

 

 

Cash and cash equivalents

 

$282,557

 

$337,544

Receivables, net

 

249,942

 

313,193

Investments—short-term

 

246,315

 

198,767

Inventory

 

154,786

 

150,335

Contract assets

 

20,212

 

13,363

Prepaid expenses and other current assets

 

61,018

 

48,967

Total current assets

 

1,014,830

 

1,062,169

PROPERTY, PLANT AND EQUIPMENT, NET

 

336,740

 

341,054

INVESTMENTS—LONG-TERM

 

229,825

 

229,430

RIGHT-OF-USE ASSETS

 

115,321

 

115,627

INTANGIBLE ASSETS, NET

 

65,077

 

74,043

GOODWILL

 

92,873

 

92,873

DEFERRED TAX ASSETS

 

112,515

 

81,833

OTHER ASSETS

 

10,664

 

27,455

TOTAL ASSETS

 

$1,977,845

 

$2,024,484

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

Accounts payable and accrued expenses

 

$173,126

 

$208,491

Accrued sales discounts, allowances and reserves

 

265,172

 

237,216

Operating lease liabilities—short-term

 

16,144

 

16,240

Contract liabilities—short-term

 

4,919

 

6,339

Current portion of long-term debt

 

3,000

 

3,000

Total current liabilities

 

462,361

 

471,286

LONG-TERM DEBT

 

292,171

 

292,804

OPERATING LEASE LIABILITIES—LONG-TERM

 

104,014

 

104,162

OTHER LONG-TERM LIABILITIES

 

43,909

 

43,648

Total liabilities

 

902,455

 

911,900

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 March 31, 2022 and December 31, 2021, respectively

 

 

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

 

1,677

 

1,658

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

 

(159,727)

 

(142,658)

Additional paid-in capital

 

2,818,595

 

2,798,325

Accumulated other comprehensive loss

 

(8,234)

 

(3,723)

Accumulated deficit

 

(1,576,921)

 

(1,541,018)

Total shareholders’ equity

 

1,075,390

 

1,112,584

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$1,977,845

 

$2,024,484

 

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

5


 

ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2022

 

 

2021

 

 

 

(In thousands, except per share amounts)

 

REVENUES:

 

 

 

 

 

 

 

 

Product sales, net

 

$

171,268

 

 

$

129,963

 

Manufacturing and royalty revenues

 

 

105,170

 

 

 

119,847

 

License revenue

 

 

2,000

 

 

 

1,500

 

Research and development revenue

 

 

107

 

 

 

120

 

Total revenues

 

 

278,545

 

 

 

251,430

 

EXPENSES:

 

 

 

 

 

 

 

 

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

 

 

55,159

 

 

 

41,020

 

Research and development

 

 

95,953

 

 

 

92,268

 

Selling, general and administrative

 

 

145,052

 

 

 

125,168

 

Amortization of acquired intangible assets

 

 

8,966

 

 

 

9,406

 

Total expenses

 

 

305,130

 

 

 

267,862

 

OPERATING LOSS

 

 

(26,585

)

 

 

(16,432

)

OTHER EXPENSE, NET:

 

 

 

 

 

 

 

 

Interest income

 

 

573

 

 

 

864

 

Interest expense

 

 

(2,350

)

 

 

(3,970

)

Change in the fair value of contingent consideration

 

 

(19,067

)

 

 

1,278

 

Other income (expense), net

 

 

2,431

 

 

 

(393

)

Total other expense, net

 

 

(18,413

)

 

 

(2,221

)

LOSS BEFORE INCOME TAXES

 

 

(44,998

)

 

 

(18,653

)

INCOME TAX (BENEFIT) PROVISION

 

 

(9,095

)

 

 

3,765

 

NET LOSS

 

$

(35,903

)

 

$

(22,418

)

LOSS PER ORDINARY SHARE:

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.22

)

 

$

(0.14

)

WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING:

 

 

 

 

 

 

 

 

Basic and diluted

 

 

162,483

 

 

 

159,634

 

COMPREHENSIVE LOSS:

 

 

 

 

 

 

 

 

Net loss

 

$

(35,903

)

 

$

(22,418

)

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

 

 

(4,511

)

 

 

(601

)

COMPREHENSIVE LOSS

 

$

(40,414

)

 

$

(23,019

)

 

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

6


 

ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2022

 

 

2021

 

 

 

(In thousands)

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(35,903

)

 

$

(22,418

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

19,197

 

 

 

19,643

 

Share-based compensation expense

 

 

18,343

 

 

 

15,451

 

Deferred income taxes

 

 

(29,301

)

 

 

5,255

 

Change in the fair value of contingent consideration

 

 

19,067

 

 

 

(1,278

)

Loss on debt extinguishment

 

 

 

 

 

171

 

Payment made for debt modification

 

 

 

 

 

(248

)

Other non-cash charges

 

 

371

 

 

 

195

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Receivables

 

 

63,290

 

 

 

31,648

 

Contract assets

 

 

(6,849

)

 

 

5,122

 

Inventory

 

 

(4,285

)

 

 

(8,652

)

Prepaid expenses and other assets

 

 

(15,351

)

 

 

(16,807

)

Right-of-use assets

 

 

4,129

 

 

 

4,177

 

Accounts payable and accrued expenses

 

 

(5,458

)

 

 

(71,949

)

Contract liabilities

 

 

(2,980

)

 

 

(1,243

)

Operating lease liabilities

 

 

(4,411

)

 

 

(3,996

)

Other long-term liabilities

 

 

1,819

 

 

 

(217

)

Cash flows provided by (used in) operating activities

 

 

21,678

 

 

 

(45,146

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Additions of property, plant and equipment

 

 

(7,791

)

 

 

(7,986

)

Proceeds from the sale of equipment

 

 

 

 

 

176

 

Proceeds from contingent consideration

 

 

501

 

 

 

6,430

 

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

 

 

485

 

 

 

 

Purchases of investments

 

 

(114,615

)

 

 

(122,545

)

Sales and maturities of investments

 

 

60,779

 

 

 

86,193

 

Cash flows used in investing activities

 

 

(60,641

)

 

 

(37,732

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

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

 

 

1,795

 

 

 

2,053

 

Employee taxes paid related to net share settlement of equity awards

 

 

(17,069

)

 

 

(10,413

)

Proceeds from the issuance of long-term debt

 

 

 

 

 

23,567

 

Payment made for debt extinguishment

 

 

 

 

 

(262

)

Principal payments of long-term debt

 

 

(750

)

 

 

 

Cash flows (used in) provided by financing activities

 

 

(16,024

)

 

 

14,945

 

NET DECREASE IN CASH AND CASH EQUIVALENTS

 

 

(54,987

)

 

 

(67,933

)

CASH AND CASH EQUIVALENTS—Beginning of period

 

 

337,544

 

 

 

272,961

 

CASH AND CASH EQUIVALENTS—End of period

 

$

282,557

 

 

$

205,028

 

SUPPLEMENTAL CASH FLOW DISCLOSURE:

 

 

 

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Purchased capital expenditures included in accounts payable and accrued expenses

 

$

4,058

 

 

$

995

 

 

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

 

 

7


 

 

ALKERMES PLC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary Shares

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Treasury Stock

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

 

 

(In thousands, except share data)

 

BALANCE — December 31, 2021

 

 

165,790,549

 

 

$

1,658

 

 

$

2,798,325

 

 

$

(3,723

)

 

$

(1,541,018

)

 

 

(3,853,222

)

 

$

(142,658

)

 

$

1,112,584

 

Issuance of ordinary shares under employee stock plans

 

 

1,953,293

 

 

 

19

 

 

 

1,776

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,795

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(678,209

)

 

 

(17,069

)

 

 

(17,069

)

Share-based compensation

 

 

 

 

 

 

 

 

18,494

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18,494

 

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

 

 

 

 

 

 

 

 

 

 

 

(4,511

)

 

 

 

 

 

 

 

 

 

 

 

(4,511

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,903

)

 

 

 

 

 

 

 

 

(35,903

)

BALANCE — March 31, 2022

 

 

167,743,842

 

 

$

1,677

 

 

$

2,818,595

 

 

$

(8,234

)

 

$

(1,576,921

)

 

 

(4,531,431

)

 

$

(159,727

)

 

$

1,075,390

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary Shares

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Treasury Stock

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Shares

 

 

Amount

 

 

Total

 

 

 

(In thousands, except share data)

 

BALANCE — December 31, 2020

 

 

162,269,220

 

 

$

1,620

 

 

$

2,685,647

 

 

$

(1,349

)

 

$

(1,492,849

)

 

 

(3,108,079

)

 

$

(126,087

)

 

$

1,066,982

 

Issuance of ordinary shares under employee stock plans

 

 

1,566,685

 

 

18

 

 

 

2,035

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,053

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(529,817

)

 

 

(10,413

)

 

 

(10,413

)

Share-based compensation

 

 

 

 

 

 

 

 

15,552

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15,552

 

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

 

 

 

 

 

 

 

 

 

 

 

(601

)

 

 

 

 

 

 

 

 

 

 

 

(601

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,418

)

 

 

 

 

 

 

 

 

(22,418

)

BALANCE — March 31, 2021

 

 

163,835,905

 

 

$

1,638

 

 

$

2,703,234

 

 

$

(1,950

)

 

$

(1,515,267

)

 

 

(3,637,896

)

 

$

(136,500

)

 

$

1,051,155

 

 

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

 

 

 

8


ALKERMES PLC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited)

 

 

1. THE COMPANY

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

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

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

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

Principles of Consolidation

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

Reclassification

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

Use of Estimates

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

9


ALKERMES PLC AND SUBSIDIARIES

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

 

Segment Information

The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed to address unmet medical needs of patients in major therapeutic areas. 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. Ireland, all U.S. states, and many local jurisdictions and countries around the world have, at times during the pandemic, issued and implemented quarantines, vaccine and masking mandates, restrictive executive orders and other similar government orders, restrictions, and recommendations for their residents to help control the spread of COVID-19, and may continue to do so while the pandemic persists. Such orders, mandates, restrictions and/or recommendations, and/or the perception that additional orders, mandates, restrictions or recommendations could occur, have, at times during the pandemic, resulted in widespread interruptions and closures of businesses, including healthcare systems that serve people living with addiction and serious mental illness, work stoppages, slowdowns and/or delays, remote work policies and travel restrictions, among other effects.

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

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

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

Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the actual impact of the pandemic on the Company’s financial condition and operating results may differ from its current projections. These uncertainties include, among other things, the ultimate severity and duration of the pandemic and the manner in which it continues to evolve, including the emergence, prevalence and severity of new or existing COVID-19 variants, and future developments in response thereto, which are highly uncertain and cannot be predicted as of the date of this Form 10-Q.

 

10


ALKERMES PLC AND SUBSIDIARIES

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

 

 

New Accounting Pronouncements

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

3. REVENUE FROM CONTRACTS WITH CUSTOMERS

 

Product Sales, Net

The Company’s product sales, net consist of sales in the U.S. of VIVITROL, ARISTADA and ARISTADA INITIO and, following its commercial launch in October 2021, LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. During the three months ended March 31, 2022 and 2021, the Company recorded product sales, net, as follows:

 

 

 

Three Months Ended March 31,

 

(In thousands)

 

2022

 

 

2021

 

VIVITROL

 

$

84,854

 

 

$

74,534

 

ARISTADA and ARISTADA INITIO

 

 

72,485

 

 

 

55,429

 

LYBALVI

 

 

13,929

 

 

 

 

Total product sales, net

 

$

171,268

 

 

$

129,963

 

 

Manufacturing and Royalty Revenues

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

 

 

 

Three Months Ended March 31, 2022

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

Long-acting INVEGA products(1)

 

$

 

 

$

37,054

 

 

$

37,054

 

VUMERITY

 

 

11,395

 

 

 

19,200

 

 

 

30,595

 

RISPERDAL CONSTA

 

 

15,578

 

 

 

1,848

 

 

 

17,426

 

Other

 

 

11,854

 

 

 

8,241

 

 

 

20,095

 

 

 

$

38,827

 

 

$

66,343

 

 

$

105,170

 

 

 

 

Three Months Ended March 31, 2021

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

Long-acting INVEGA products(1)

 

$

 

 

$

61,570