UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
|
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
|
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number
ALKERMES PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
|
|
|
|
|
|
|
|
|
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
(Address of principal executive offices)
+
(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 |
|
|
|
|
|
|
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.
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).
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.
|
|
|
|
|
|
|
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
The number of the registrant’s ordinary shares, $0.01 par value, outstanding as of April 22, 2022 was
ALKERMES PLC AND SUBSIDIARIES
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022
|
|
|
|
|
|
Page No. |
|
|
|
||
|
Item 1. |
|
|
|
|
Condensed Consolidated Balance Sheets — March 31, 2022 and December 31, 2021 |
5 |
|
|
6 |
|
|
|
Condensed Consolidated Statements of Cash Flows — For the Three Months Ended March 31, 2022 and 2021 |
7 |
|
|
8 |
|
|
|
9 |
|
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
|
Item 3. |
35 |
|
|
Item 4. |
36 |
|
|
|
|
|
|
|
||
|
Item 1. |
37 |
|
|
Item 1A. |
37 |
|
|
Item 2. |
37 |
|
|
Item 5. |
37 |
|
|
Item 6. |
38 |
|
|
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 |
|
$ |
|
$ |
|
Receivables, net |
|
|
|
|
|
Investments—short-term |
|
|
|
|
|
Inventory |
|
|
|
|
|
Contract assets |
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
Total current assets |
|
|
|
|
|
PROPERTY, PLANT AND EQUIPMENT, NET |
|
|
|
|
|
INVESTMENTS—LONG-TERM |
|
|
|
|
|
RIGHT-OF-USE ASSETS |
|
|
|
|
|
INTANGIBLE ASSETS, NET |
|
|
|
|
|
GOODWILL |
|
|
|
|
|
DEFERRED TAX ASSETS |
|
|
|
|
|
OTHER ASSETS |
|
|
|
|
|
TOTAL ASSETS |
|
$ |
|
$ |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
|
$ |
|
Accrued sales discounts, allowances and reserves |
|
|
|
|
|
Operating lease liabilities—short-term |
|
|
|
|
|
Contract liabilities—short-term |
|
|
|
|
|
Current portion of long-term debt |
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
LONG-TERM DEBT |
|
|
|
|
|
OPERATING LEASE LIABILITIES—LONG-TERM |
|
|
|
|
|
OTHER LONG-TERM LIABILITIES |
|
|
|
|
|
Total liabilities |
|
|
|
|
|
COMMITMENTS AND CONTINGENT LIABILITIES (Note 15) |
|
|
|
|
|
SHAREHOLDERS’ EQUITY: |
|
|
|
|
|
Preferred shares, par value, $ |
|
|
|
|
|
Ordinary shares, par value, $ |
|
|
|
|
|
Treasury shares, at cost ( |
|
( |
|
( |
|
Additional paid-in capital |
|
|
|
|
|
Accumulated other comprehensive loss |
|
( |
|
( |
|
Accumulated deficit |
|
( |
|
( |
|
Total shareholders’ equity |
|
|
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
|
$ |
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 |
|
$ |
|
|
|
$ |
|
|
|
|
Manufacturing and royalty revenues |
|
|
|
|
|
|
|
|
|
|
License revenue |
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
|
|
|
|
|
|
|
|
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets |
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
|
|
|
|
|
|
|
|
OPERATING LOSS |
|
|
( |
) |
|
|
( |
) |
|
|
OTHER EXPENSE, NET: |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
( |
) |
|
|
( |
) |
|
|
Change in the fair value of contingent consideration |
|
|
( |
) |
|
|
|
|
|
|
Other income (expense), net |
|
|
|
|
|
|
( |
) |
|
|
Total other expense, net |
|
|
( |
) |
|
|
( |
) |
|
|
LOSS BEFORE INCOME TAXES |
|
|
( |
) |
|
|
( |
) |
|
|
INCOME TAX (BENEFIT) PROVISION |
|
|
( |
) |
|
|
|
|
|
|
NET LOSS |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
LOSS PER ORDINARY SHARE: |
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS: |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
Holding loss, net of a tax benefit of $( |
|
|
( |
) |
|
|
( |
) |
|
|
COMPREHENSIVE LOSS |
|
$ |
( |
) |
|
$ |
( |
) |
|
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 |
|
$ |
( |
) |
|
$ |
( |
) |
|
Adjustments to reconcile net loss to cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
|
|
|
|
|
|
Deferred income taxes |
|
|
( |
) |
|
|
|
|
|
Change in the fair value of contingent consideration |
|
|
|
|
|
|
( |
) |
|
Loss on debt extinguishment |
|
|
— |
|
|
|
|
|
|
Payment made for debt modification |
|
|
— |
|
|
|
( |
) |
|
Other non-cash charges |
|
|
|
|
|
|
|
|
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
Receivables |
|
|
|
|
|
|
|
|
|
Contract assets |
|
|
( |
) |
|
|
|
|
|
Inventory |
|
|
( |
) |
|
|
( |
) |
|
Prepaid expenses and other assets |
|
|
( |
) |
|
|
( |
) |
|
Right-of-use assets |
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
( |
) |
|
|
( |
) |
|
Contract liabilities |
|
|
( |
) |
|
|
( |
) |
|
Operating lease liabilities |
|
|
( |
) |
|
|
( |
) |
|
Other long-term liabilities |
|
|
|
|
|
|
( |
) |
|
Cash flows provided by (used in) operating activities |
|
|
|
|
|
|
( |
) |
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
Additions of property, plant and equipment |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from the sale of equipment |
|
|
— |
|
|
|
|
|
|
Proceeds from contingent consideration |
|
|
|
|
|
|
|
|
|
Return of Fountain Healthcare Partners II, L.P. investment |
|
|
|
|
|
|
— |
|
|
Purchases of investments |
|
|
( |
) |
|
|
( |
) |
|
Sales and maturities of investments |
|
|
|
|
|
|
|
|
|
Cash flows used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of ordinary shares under share-based compensation arrangements |
|
|
|
|
|
|
|
|
|
Employee taxes paid related to net share settlement of equity awards |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from the issuance of long-term debt |
|
|
— |
|
|
|
|
|
|
Payment made for debt extinguishment |
|
|
— |
|
|
|
( |
) |
|
Principal payments of long-term debt |
|
|
( |
) |
|
|
— |
|
|
Cash flows (used in) provided by financing activities |
|
|
( |
) |
|
|
|
|
|
NET DECREASE IN CASH AND CASH EQUIVALENTS |
|
|
( |
) |
|
|
( |
) |
|
CASH AND CASH EQUIVALENTS—Beginning of period |
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS—End of period |
|
$ |
|
|
|
$ |
|
|
|
SUPPLEMENTAL CASH FLOW DISCLOSURE: |
|
|
|
|
|
|
|
|
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
Purchased capital expenditures included in accounts payable and accrued expenses |
|
$ |
|
|
|
$ |
|
|
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 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Unrealized loss on marketable securities, net of tax (benefit) of $( |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
BALANCE — March 31, 2022 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Unrealized loss on marketable securities, net of tax (benefit) of $( |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
BALANCE — March 31, 2021 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
|
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
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.
|
|
|
Three Months Ended March 31, |
|
|||||
|
(In thousands) |
|
2022 |
|
|
2021 |
|
||
|
VIVITROL |
|
$ |
|
|
|
$ |
|
|
|
ARISTADA and ARISTADA INITIO |
|
|
|
|
|
|
|
|
|
LYBALVI |
|
|
|
|
|
|
— |
|
|
Total product sales, net |
|
$ |
|
|
|
$ |
|
|
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) |
|
$ |
— |
|
|
$ |
|
|
|
$ |
|
|
|
VUMERITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
Three Months Ended March 31, 2021 |
|
|||||||||
|
(In thousands) |
|
Manufacturing Revenue |
|
|
Royalty Revenue |
|
|
Total |
|
|||
|
Long-acting INVEGA products(1) |
|
$ |
— |
|
|
$ |
|
|
||||