QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(Exact name of registrant as specified in its charter) |
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) | ||||||||||
(Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code) | |||||
Not Applicable | |||||
(Former name, former address and former fiscal year, if changed since last report |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
☑ | Accelerated filer | ☐ | ||||||||||||||||||
Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||||||||
Emerging Growth Company |
Page | ||||||||
March 31, 2021 | December 31, 2020 | ||||||||||
Assets | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Accounts receivable, net | |||||||||||
Inventory | |||||||||||
Other current assets | |||||||||||
Assets held for sale | |||||||||||
Total current assets | |||||||||||
Property, plant and equipment, net | |||||||||||
Intangibles, net | |||||||||||
Goodwill | |||||||||||
Deferred tax assets, net | |||||||||||
Other long-term assets | |||||||||||
Total assets | $ | $ | |||||||||
Liabilities and stockholders’ equity | |||||||||||
Current liabilities | |||||||||||
Current portion of long-term debt and other borrowings | $ | $ | |||||||||
Accounts payable | |||||||||||
Accrued expenses and other liabilities | |||||||||||
Liabilities held for sale | |||||||||||
Total current liabilities | |||||||||||
Asset retirement obligations | |||||||||||
Long-term debt, net and other borrowings | |||||||||||
Other long-term liabilities | |||||||||||
Total liabilities | |||||||||||
Commitments and contingencies (See Note 18) | |||||||||||
Stockholders’ equity | |||||||||||
Preferred stock ($ | |||||||||||
Common stock ($ | |||||||||||
Additional paid-in capital | |||||||||||
Accumulated deficit | ( | ( | |||||||||
Accumulated other comprehensive loss | ( | ( | |||||||||
Total stockholders’ equity | |||||||||||
Total liabilities and stockholders’ equity | $ | $ |
Three Months Ended March 31, | |||||||||||
2021 | 2020 | ||||||||||
Revenues | $ | $ | |||||||||
Cost of goods sold | |||||||||||
Gross profit | |||||||||||
Operating expenses | |||||||||||
Sales and marketing | |||||||||||
General and administrative | |||||||||||
Research and development | |||||||||||
Total operating expenses | |||||||||||
Gain on sale of assets | |||||||||||
Operating income | |||||||||||
Interest expense | |||||||||||
Gain on extinguishment of debt | ( | ||||||||||
Other income | ( | ( | |||||||||
Income before income taxes | |||||||||||
Income tax expense | |||||||||||
Net income | $ | $ | |||||||||
Net income per common share: | |||||||||||
Basic | $ | $ | |||||||||
Diluted | $ | $ | |||||||||
Weighted-average common shares outstanding: | |||||||||||
Basic | |||||||||||
Diluted |
Three Months Ended March 31, | |||||||||||
2021 | 2020 | ||||||||||
Net income | $ | $ | |||||||||
Other comprehensive income (loss): | |||||||||||
Foreign currency translation | ( | ||||||||||
Unrealized gain (loss) on cash flow hedges, net of tax | ( | ||||||||||
Total other comprehensive income (loss) | ( | ||||||||||
Comprehensive income | $ | $ |
Three Months Ended March 31, 2021 | ||||||||||||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders’ Equity | ||||||||||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||||||||
Balance, January 1, 2021 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Net income | — | — | — | — | ||||||||||||||||||||||||||||||||||
Other comprehensive income | — | — | — | — | ||||||||||||||||||||||||||||||||||
Stock option exercises and employee stock plan purchases | — | — | ||||||||||||||||||||||||||||||||||||
Vesting of restricted stock awards and units | ( | — | — | |||||||||||||||||||||||||||||||||||
Shares withheld to cover taxes | ( | ( | ( | — | — | ( | ||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||
Balance, March 31, 2021 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Three Months Ended March 31, 2020 | ||||||||||||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders’ Equity | ||||||||||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||||||||
Balance, January 1, 2020 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Net income | — | — | — | — | ||||||||||||||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||
Stock option exercises and employee stock plan purchases | — | — | — | |||||||||||||||||||||||||||||||||||
Vesting of restricted stock awards and units | ( | — | — | |||||||||||||||||||||||||||||||||||
Shares withheld to cover taxes | ( | ( | ( | — | — | ( | ||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||
Balance, March 31, 2020 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Three Months Ended March 31, | |||||||||||
2021 | 2020 | ||||||||||
Operating activities | |||||||||||
Net income | $ | $ | |||||||||
Adjustments to reconcile net income to net cash flows from operating activities: | |||||||||||
Depreciation, amortization and accretion | |||||||||||
Impairment of long-lived assets | |||||||||||
Amortization of debt related costs | ( | ||||||||||
Changes in fair value of contingent assets and liabilities | |||||||||||
Gain on extinguishment of debt | ( | ||||||||||
Provision for excess and obsolete inventory | |||||||||||
Stock-based compensation | |||||||||||
Gain on sale of assets | ( | ||||||||||
Deferred taxes | |||||||||||
Long-term income tax receivable | ( | ( | |||||||||
Long-term income tax payable and other long-term liabilities | |||||||||||
Other | |||||||||||
Increases (decreases) in cash from operating assets and liabilities: | |||||||||||
Accounts receivable | ( | ( | |||||||||
Inventory | ( | ||||||||||
Other current assets | ( | ||||||||||
Accounts payable | ( | ||||||||||
Accrued expenses and other liabilities | ( | ( | |||||||||
Net cash provided by operating activities | |||||||||||
Investing activities | |||||||||||
Capital expenditures | ( | ( | |||||||||
Proceeds from sale of assets, net | |||||||||||
Net cash provided by provided by (used in) investing activities | ( | ||||||||||
Financing activities | |||||||||||
Payments on long-term debt and other borrowings | ( | ( | |||||||||
Proceeds from stock option exercises | |||||||||||
Proceeds from issuance of common stock | |||||||||||
Payments for minimum statutory tax withholding related to net share settlement of equity awards | ( | ( | |||||||||
Net cash used in financing activities | ( | ( | |||||||||
Effect of foreign exchange rates on cash, cash equivalents and restricted cash | ( | ( | |||||||||
Net (decrease) increase in cash, cash equivalents and restricted cash | ( | ||||||||||
Cash, cash equivalents and restricted cash, beginning of period | |||||||||||
Cash, cash equivalents and restricted cash, end of period | $ | $ |
Three Months Ended March 31, | |||||||||||
2021 | 2020 | ||||||||||
Reconciliation to amounts within the condensed consolidated balance sheets | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Restricted cash included in other long-term assets | |||||||||||
Cash, cash equivalents and restricted cash at end of period | $ | $ |
Standard | Description | Effective Date for Company | Effect on the Condensed Consolidated Financial Statements | ||||||||
Accounting Standards Adopted During the Three Months Ended March 31, 2021 | |||||||||||
ASU 2020-06, “Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40)” | This ASU provides guidance to simplify the complexity associated with accounting for convertible instruments and derivatives. For convertible instruments, the number of major separation models required were reduced. Consequently, more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion features. This ASU further amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. The ASU simplifies the diluted net income per share calculation in certain areas as well. | January 1, 2021 | The adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements. |
Three Months Ended March 31, | ||||||||||||||
Major Products/Service Lines (in thousands) | 2021 | 2020 | ||||||||||||
Product revenue, net(1) | $ | $ | ||||||||||||
License and royalty revenues | ||||||||||||||
Total revenues | $ | $ |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2021 | 2020(1) | ||||||||||||
DEFINITY | $ | $ | ||||||||||||
TechneLite | ||||||||||||||
Other precision diagnostics | ||||||||||||||
Total precision diagnostics | ||||||||||||||
Radiopharmaceutical oncology | ||||||||||||||
Strategic partnerships and other | ||||||||||||||
Total revenues | $ | $ |
March 31, 2021 | |||||||||||||||||||||||
(in thousands) | Total Fair Value | Level 1 | Level 2 | Level 3 | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Money market | $ | $ | $ | $ | |||||||||||||||||||
Contingent receivable | |||||||||||||||||||||||
Total assets | $ | $ | $ | $ | |||||||||||||||||||
Liabilities: | |||||||||||||||||||||||
Interest rate swaps | $ | $ | $ | $ | |||||||||||||||||||
Contingent consideration liabilities | |||||||||||||||||||||||
Total liabilities | $ | $ | $ | $ |
December 31, 2020 | |||||||||||||||||||||||
(in thousands) | Total Fair Value | Level 1 | Level 2 | Level 3 | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Money market | $ | $ | $ | $ | |||||||||||||||||||
Contingent receivable | |||||||||||||||||||||||
Total assets | $ | $ | $ | $ | |||||||||||||||||||
Liabilities: | |||||||||||||||||||||||
Interest rate swaps | $ | $ | $ | $ | |||||||||||||||||||
Contingent consideration liabilities | |||||||||||||||||||||||
Total liabilities | $ | $ | $ | $ |
Fair Value at | Assumptions | ||||||||||||||||||||||||||||||||||
(in thousands) | March 31, 2021 | December 31, 2020 | Valuation Technique | Unobservable Input | March 31, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||
Contingent receivable: | |||||||||||||||||||||||||||||||||||
Regulatory milestone | $ | $ | Probability adjusted discounted cash flow model | Period of expected milestone achievement | 2021 | 2021 | |||||||||||||||||||||||||||||
Probability of success | % | % | |||||||||||||||||||||||||||||||||
Discount rate | % | % | |||||||||||||||||||||||||||||||||
Royalties | Probability adjusted discounted cash flow model | ||||||||||||||||||||||||||||||||||
Probability of success | |||||||||||||||||||||||||||||||||||
Discount rate | % | % | |||||||||||||||||||||||||||||||||
Total | $ | $ |
Fair Value at | Assumptions | ||||||||||||||||||||||||||||||||||
(in thousands) | March 31, 2021 | December 31, 2020 | Valuation Technique | Unobservable Input | March 31, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||
Contingent consideration liability: | |||||||||||||||||||||||||||||||||||
Net sales targets - PyL (CVRs) | $ | $ | Monte-Carlo simulation | Period of expected milestone achievement | 2022 - 2023 | 2022 - 2023 | |||||||||||||||||||||||||||||
Discount rate | % | % | |||||||||||||||||||||||||||||||||
1095 commercialization milestone | Probability adjusted discounted cash flow model | ||||||||||||||||||||||||||||||||||
Period of expected milestone achievement | 2026 | 2026 | |||||||||||||||||||||||||||||||||
Probability of success | % | % | |||||||||||||||||||||||||||||||||
Discount rate | % | % | |||||||||||||||||||||||||||||||||
Net sales targets - AZEDRA and 1095 | Monte-Carlo simulation | ||||||||||||||||||||||||||||||||||
Probability of success | |||||||||||||||||||||||||||||||||||
Discount rate | |||||||||||||||||||||||||||||||||||
Total | $ | $ |
Financial Assets | Financial Liabilities | ||||||||||
(in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2021 | |||||||||
Fair value, beginning of period | $ | $ | |||||||||
Changes in fair value included in net income | |||||||||||
Fair value, end of period | $ | $ | |||||||||
Three Months Ended March 31, | |||||||||||
(in thousands) | 2021 | 2020 | |||||||||
Income tax expense | $ | $ |
(in thousands) | March 31, 2021 | December 31, 2020 | |||||||||
Raw materials | $ | $ | |||||||||
Work in process | |||||||||||
Finished goods | |||||||||||
Total inventory | $ | $ |
(in thousands) | March 31, 2021 | December 31, 2020 | |||||||||
Land | $ | $ | |||||||||
Buildings | |||||||||||
Machinery, equipment and fixtures | |||||||||||
Computer software | |||||||||||
Construction in progress | |||||||||||
Less: accumulated depreciation and amortization | ( | ( | |||||||||
Total property, plant and equipment, net | $ | $ |
(in thousands) | Amount | ||||
Issuance of common stock | $ | ||||
Fair value of replacement options | |||||
Fair value of bridge loan settled at close | |||||
Fair value of contingent considerations (CVRs) | |||||
Total consideration transferred(1) | $ |
(in thousands) | Amounts Recognized as of Acquisition Date (as previously reported) | Measurement Period Adjustments | Amounts Recognized as of Acquisition Date (as adjusted) | ||||||||||||||
Cash and cash equivalents | $ | $ | — | $ | |||||||||||||
Accounts receivable | — | ||||||||||||||||
Inventory | |||||||||||||||||
Other current assets | |||||||||||||||||
Property, plant and equipment | — | ||||||||||||||||
Identifiable intangible assets (weighted average useful life): | |||||||||||||||||
Currently marketed product ( | |||||||||||||||||
Licenses ( | ( | ||||||||||||||||
Developed technology ( | ( | ||||||||||||||||
IPR&D | |||||||||||||||||
Other long-term assets | — | ||||||||||||||||
Accounts payable | ( | — | ( | ||||||||||||||
Accrued expenses and other liabilities | ( | ( | ( | ||||||||||||||
Other long-term liabilities | ( | ( | ( | ||||||||||||||
Long-term debt and other borrowings | ( | — | ( | ||||||||||||||
Deferred tax liabilities | ( | ( | ( | ||||||||||||||
Goodwill | |||||||||||||||||
Total consideration transferred | $ | $ | $ |
(in thousands) | January 29, 2021 | December 31, 2020 | |||||||||
Current Assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Accounts receivable, net | |||||||||||
Inventory | |||||||||||
Other current assets | |||||||||||
Total current assets | |||||||||||
Non-Current Assets: | |||||||||||
Property, plant & equipment, net | |||||||||||
Intangibles, net | |||||||||||
Other long-term assets | |||||||||||
Total assets held for sale | $ | $ | |||||||||
Current Liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued expense and other liabilities | |||||||||||
Total current liabilities | |||||||||||
Non-Current Liabilities: | |||||||||||
Asset retirement obligations | |||||||||||
Other long-term liabilities | |||||||||||
Total liabilities held for sale | $ | $ |
(in thousands) | Amount | ||||
Balance at January 1, 2021 | $ | ||||
Accretion expense | |||||
Balance at March 31, 2021 | $ |
March 31, 2021 | |||||||||||||||||||||||
(in thousands) | Amortization Method | Cost | Accumulated Amortization | Net | |||||||||||||||||||
Trademarks | Straight-Line | $ | $ | ( | $ | ||||||||||||||||||
Customer relationships | Accelerated | ( | |||||||||||||||||||||
Currently marketed product | Straight-Line | ( | |||||||||||||||||||||
Licenses | Straight-Line | ( | |||||||||||||||||||||
Developed technology | Straight-Line | ( | |||||||||||||||||||||
IPR&D | N/A | — | |||||||||||||||||||||
Total | $ | $ | ( | $ |
December 31, 2020 | |||||||||||||||||||||||
(in thousands) | Amortization Method | Cost | Accumulated Amortization | Net | |||||||||||||||||||
Trademarks | Straight-Line | $ | $ | ( | $ | ||||||||||||||||||
Customer relationships | Accelerated | ( | |||||||||||||||||||||
Currently marketed product | Straight-Line | ( | |||||||||||||||||||||
Licenses | Straight-Line | ( | |||||||||||||||||||||
Developed technology | Straight-Line | ( | |||||||||||||||||||||
IPR&D | N/A | — | |||||||||||||||||||||
Total | $ | $ | ( | $ |
(in thousands) | Amount | ||||
Remainder of 2021 | $ | ||||
2022 | |||||
2023 | |||||
2024 | |||||
2025 | |||||
2026 and thereafter | |||||
Total | $ |
(in thousands) | Amount | ||||
Remainder of 2021 | $ | ||||
2022 | |||||
2023 | |||||
2024 | |||||
Total principal outstanding | |||||
Unamortized debt discount | ( | ||||
Unamortized debt issuance costs | ( | ||||
Finance lease liabilities | |||||
Total | |||||
Less: current portion | ( | ||||
Total long-term debt, net and other borrowings | $ |
(in thousands) | March 31, 2021 | December 31, 2020 | ||||||||||||
Derivatives type | Classification | |||||||||||||
Liabilities: | ||||||||||||||
Interest rate swap | Accrued expenses and other liabilities | $ | $ |
(in thousands) | Foreign currency translation | Unrealized loss on cash flow hedges | Accumulated other comprehensive loss | ||||||||||||||
Balance at January 1, 2021 | $ | ( | $ | ( | $ | ( | |||||||||||
Other comprehensive income before reclassifications | |||||||||||||||||
Amounts reclassified to earnings | |||||||||||||||||
Balance at March 31, 2021 | $ | ( | $ | ( | $ | ( | |||||||||||
Balance at January 1, 2020 | $ | ( | $ | $ | ( | ||||||||||||
Other comprehensive loss before reclassifications | ( | ( | ( | ||||||||||||||
Amounts reclassified to earnings | |||||||||||||||||
Balance at March 31, 2020 | $ | ( | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
(in thousands) | 2021 | 2020 | |||||||||
Cost of goods sold | $ | $ | |||||||||
Sales and marketing | |||||||||||
General and administrative | |||||||||||
Research and development | |||||||||||
Total stock-based compensation expense | $ | $ |
Three Months Ended March 31, | |||||||||||
(in thousands, except per share amounts) | 2021 | 2020 | |||||||||
Net income | $ | $ | |||||||||
Basic weighted-average common shares outstanding | |||||||||||
Effect of dilutive stock options | |||||||||||
Effect of dilutive restricted stock | |||||||||||
Diluted weighted-average common shares outstanding | |||||||||||
Basic income per common share | $ | $ | |||||||||
Diluted income per common share | $ | $ | |||||||||
Antidilutive securities excluded from diluted net income per common share |
Three Months Ended March 31, | |||||||||||
(in thousands) | 2021 | 2020 | |||||||||
Foreign currency losses | $ | $ | |||||||||
Tax indemnification income, net | ( | ( | |||||||||
Interest income | ( | ( | |||||||||
Other | ( | ||||||||||
Total other income | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||||||||||||||
(in thousands) | 2021 | 2020 | Change $ | Change % | |||||||||||||||||||
Revenues | $ | 92,509 | $ | 90,704 | $ | 1,805 | 2.0 | % | |||||||||||||||
Cost of goods sold | 51,479 | 52,702 | (1,223) | (2.3) | % | ||||||||||||||||||
Gross profit | 41,030 | 38,002 | 3,028 | 8.0 | % | ||||||||||||||||||
Operating expenses | |||||||||||||||||||||||
Sales and marketing | 14,173 | 10,130 | 4,043 | 39.9 | % | ||||||||||||||||||
General and administrative | 16,138 | 16,699 | (561) | (3.4) | % | ||||||||||||||||||
Research and development | 10,360 | 4,048 | 6,312 | 155.9 | % | ||||||||||||||||||
Total operating expenses | 40,671 | 30,877 | 9,794 | 31.7 | % | ||||||||||||||||||
Gain on sale of assets | 15,263 | — | 15,263 | N/A | |||||||||||||||||||
Operating income | 15,622 | 7,125 | 8,497 | 119.3 | % | ||||||||||||||||||
Interest expense | 2,718 | 1,946 | 772 | 39.7 | % | ||||||||||||||||||
Gain on extinguishment of debt | (889) | — | (889) | N/A | |||||||||||||||||||
Other income | (549) | (350) | (199) | 56.9 | % | ||||||||||||||||||
Income before income taxes | 14,342 | 5,529 | 8,813 | 159.4 | % | ||||||||||||||||||
Income tax expense | 5,334 | 2,192 | 3,142 | 143.3 | % | ||||||||||||||||||
Net income | $ | 9,008 | $ | 3,337 | $ | 5,671 | 169.9 | % |
Three Months Ended March 31, | ||||||||||||||||||||||||||
(in thousands) | 2021 | 2020(1) | Change $ | Change % | ||||||||||||||||||||||
DEFINITY | $ | 55,971 | $ | 52,505 | $ | 3,466 | 6.6 | % | ||||||||||||||||||
TechneLite | 22,800 | 22,779 | 21 | 0.1 | % | |||||||||||||||||||||
Other precision diagnostics | 6,984 | 13,057 | (6,073) | (46.5) | % | |||||||||||||||||||||
Total precision diagnostics | 85,755 | 88,341 | (2,586) | (2.9) | % | |||||||||||||||||||||
Radiopharmaceutical oncology | 1,500 | 1,968 | (468) | (23.8) | % | |||||||||||||||||||||
Strategic partnerships and other | 5,254 | 395 | 4,859 | 1,230.1 | % | |||||||||||||||||||||
Total revenues | $ | 92,509 | $ | 90,704 | $ | 1,805 | 2.0 | % |
(in thousands) | Rebates and Allowances | ||||
Balance, January 1, 2021 | $ | 9,350 | |||
Provision related to current period revenues | 5,838 | ||||
Adjustments relating to prior period revenues | 23 | ||||
Payments or credits made during the period | (5,756) | ||||
Balance, March 31, 2021 | $ | 9,455 |
Three Months Ended March 31, | ||||||||||||||
2021 | 2020 | |||||||||||||
Effective tax rate | 37.2% | 39.6% |
Three Months Ended March 31, | |||||||||||
(in thousands) | 2021 | 2020 | |||||||||
Net cash provided by operating activities | $ | 9,818 | $ | 9,408 | |||||||
Net cash provided by provided by (used in) investing activities | $ | 13,303 | $ | (2,698) | |||||||
Net cash used in financing activities | $ | (34,791) | $ | (3,732) |
2020 Amended Credit Agreement | |||||
Period | Total Net Leverage Ratio | ||||
Q1 2021 | 5.50 to 1.00 | ||||
Q2 2021 | 3.75 to 1.00 | ||||
Thereafter | 3.50 to 1.00 | ||||
Period | Interest Coverage Ratio | ||||
Q1 2021 | 2.00 to 1.00 | ||||
Thereafter | 3.00 to 1.00 | ||||
Period | Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as Part of Publicly Announced Programs | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Program | ||||||||||||||||||||||
January 2021** | 382 | $ | 13.49 | * | * | |||||||||||||||||||||
February 2021** | 17,855 | $ | 18.74 | * | * | |||||||||||||||||||||
March 2021** | 67,014 | $ | 18.79 | * | * | |||||||||||||||||||||
Total | 85,251 | * |
INCORPORATED BY REFERENCE | ||||||||||||||||||||||||||||||||
EXHIBIT NUMBER | DESCRIPTION OF EXHIBITS | FORM | FILE NUMBER | EXHIBIT | FILING DATE | |||||||||||||||||||||||||||
10.1 | 8-K | 001-36569 | 10.1 | April 1, 2021 | ||||||||||||||||||||||||||||
31.1* | ||||||||||||||||||||||||||||||||
31.2* | ||||||||||||||||||||||||||||||||
32.1** | ||||||||||||||||||||||||||||||||
101.INS* | Inline XBRL Instance Document | |||||||||||||||||||||||||||||||
101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |||||||||||||||||||||||||||||||
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||||||||||||||||||||||
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||||||||||||||||||||||||||
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||||||||||||||||||||||||||
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||||||||||||||||||||||||
104* | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
LANTHEUS HOLDINGS, INC. | ||||||||
By: | /s/ MARY ANNE HEINO | |||||||
Name: | Mary Anne Heino | |||||||
Title: | President and Chief Executive Officer (Principal Executive Officer) | |||||||
Date: | May 4, 2021 | |||||||
LANTHEUS HOLDINGS, INC. | ||||||||
By: | /s/ ROBERT J. MARSHALL, JR. | |||||||
Name: | Robert J. Marshall, Jr. | |||||||
Title: | Chief Financial Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer) | |||||||
Date: | May 4, 2021 |
/s/ MARY ANNE HEINO | ||||||||
Name: | Mary Anne Heino | |||||||
Title: | President and Chief Executive Officer | |||||||
(Principal Executive Officer) |
/s/ ROBERT J. MARSHALL, JR. | ||||||||
Name: | Robert J. Marshall, Jr. | |||||||
Title: | Chief Financial Officer and Treasurer | |||||||
(Principal Financial Officer and Principal Accounting Officer) |
/s/ MARY ANNE HEINO | ||||||||
Name: | Mary Anne Heino | |||||||
Title: | President and Chief Executive Officer | |||||||
(Principal Executive Officer) |
/s/ ROBERT J. MARSHALL, JR. | ||||||||
Name: | Robert J. Marshall, Jr. | |||||||
Title: | Chief Financial Officer and Treasurer | |||||||
(Principal Financial Officer and Principal Accounting Officer) |
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 67,434,000 | 66,875,000 |
Common stock, shares outstanding (in shares) | 67,434,000 | 66,875,000 |
Goodwill | $ 61,189 | $ 58,632 |
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended | |
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Mar. 31, 2021 |
Mar. 31, 2020 |
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Income Statement [Abstract] | ||
Revenues | $ 92,509 | $ 90,704 |
Cost of goods sold | 51,479 | 52,702 |
Gross profit | 41,030 | 38,002 |
Operating expenses | ||
Sales and marketing | 14,173 | 10,130 |
General and administrative | 16,138 | 16,699 |
Research and development | 10,360 | 4,048 |
Total operating expenses | 40,671 | 30,877 |
Gain on sale of assets | 15,263 | 0 |
Operating income | 15,622 | 7,125 |
Interest expense | 2,718 | 1,946 |
Gain on extinguishment of debt | (889) | 0 |
Other income | (549) | (350) |
Income before income taxes | 14,342 | 5,529 |
Income tax expense | 5,334 | 2,192 |
Net income | $ 9,008 | $ 3,337 |
Net income per common share: | ||
Basic (in dollars per share) | $ 0.13 | $ 0.08 |
Diluted (in dollars per share) | $ 0.13 | $ 0.08 |
Weighted-average common shares outstanding: | ||
Basic (in shares) | 67,094 | 39,433 |
Diluted (in shares) | 67,714 | 40,102 |
Condensed Consolidated Statements of Comprehensive Income - USD ($) $ in Thousands |
3 Months Ended | |
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Mar. 31, 2021 |
Mar. 31, 2020 |
|
Statement of Comprehensive Income [Abstract] | ||
Net income | $ 9,008 | $ 3,337 |
Other comprehensive income (loss): | ||
Foreign currency translation | 102 | (446) |
Unrealized gain (loss) on cash flow hedges, net of tax | 706 | (988) |
Total other comprehensive income (loss) | 808 | (1,434) |
Comprehensive income | $ 9,816 | $ 1,903 |
Basis of Presentation |
3 Months Ended |
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Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements include the accounts of Holdings and its direct and indirect wholly-owned subsidiaries, including Progenics (as of the closing date, June 19, 2020), and have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these condensed consolidated financial statements do not include all of the information and notes required by generally accepted accounting principles in the United States of America (“U.S. GAAP”) for complete financial statements. In the opinion of management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement have been included. The results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the year ended December 31, 2021 or any future period. In the first quarter of fiscal year 2021, the Company completed the evaluation of its operating and reporting structure, which resulted in a change in operating segments. Please refer to Note 19, “Segment Information”, for further details. The condensed consolidated balance sheet at December 31, 2020 has been derived from the audited consolidated financial statements at that date but does not include all of the information and notes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and notes thereto included in Item 8 of the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities Exchange Commission (“SEC”) on February 25, 2021. Progenics Acquisition On June 19, 2020 (the “Closing Date”), pursuant to the Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the “Merger Agreement”), by and among Holdings, Plato Merger Sub, Inc., a wholly-owned subsidiary of Holdings (“Merger Sub”), and Progenics, Holdings completed the previously announced acquisition of Progenics, by means of a merger of Merger Sub with and into Progenics, with Progenics surviving such merger as a wholly-owned subsidiary of Holdings (the “Progenics Acquisition”). In accordance with the Merger Agreement, at the effective time of the Progenics Acquisition (the “Effective Time”), each share of Progenics common stock, par value $0.0013 per share, issued and outstanding immediately prior to the Effective Time (other than shares of Progenics common stock owned by Holdings, Progenics or any of their wholly-owned subsidiaries) was automatically cancelled and converted into the right to receive (i) 0.31 (the “Exchange Ratio”) of a share of Holdings common stock, par value $0.01 per share, and (ii) one contingent value right (a “CVR”) tied to the financial performance of PyL (18F-DCFPyL), Progenics’ prostate-specific membrane antigen (“PSMA”) targeted imaging agent designed to visualize prostate cancer, currently a late stage clinical candidate (“PyL”). Each CVR will entitle its holder to receive a pro rata share of aggregate cash payments equal to 40% of U.S. net sales generated by PyL in 2022 and 2023 in excess of $100.0 million and $150.0 million, respectively. In no event will the Company’s aggregate payments in respect of the CVRs, together with any other non-stock consideration treated as paid in connection with the Progenics Acquisition, exceed 19.9% (which the Company estimates could be approximately $100.0 million) of the total consideration the Company pays in the Progenics Acquisition. No fractional shares of Holdings common stock were issued in the Progenics Acquisition, and Progenics’ former stockholders have received cash in lieu of any fractional shares of Holdings common stock. As a result of the acquisition, Holdings issued 26,844,877 shares of Holdings common stock and 86,630,633 CVRs to former Progenics stockholders. Please refer to Note 8, “Business Combinations”, for further details on the acquisition. COVID-19 The Company experienced operational and financial impacts from the COVID-19 pandemic beginning late in the first quarter of 2020 and through the date of this filing, including the impact of stay-at-home mandates and advisories, and a decline in the volume of certain procedures and treatments using the Company’s products. As a result of the COVID-19 pandemic, the Company undertook a thorough analysis of all of its discretionary expenses. In the first quarter of 2020, the Company implemented certain cost reduction initiatives. For most of the second quarter, the Company reduced the Company’s work week from five days to four days and reduced the pay for employees by varying amounts depending on level of seniority. During the second quarter of 2020, Progenics also implemented certain cost reduction initiatives and paused new enrollment in the Phase 2 trial of 1095 in metastatic castrate-resistant prostate cancer (“mCRPC”) patients to minimize the risk to subjects and healthcare providers during the pandemic. New enrollment in that study restarted in October 2020. GE Healthcare Limited (“GE Healthcare”), the Company’s development and commercialization partner for flurpiridaz F 18, also delayed enrollment in the second Phase 3 clinical trial of flurpiridaz F 18 because of the pandemic and resumed enrollment in the third quarter of 2020. The on-going impact of the COVID-19 pandemic on the Company's business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, and the extent and severity of the impact on the Company's customers and suppliers, all of which remain uncertain and cannot be predicted. While the impact of COVID-19 on the Company’s results of operations and cash flows has been, and is expected to continue to be, material, given the continually evolving nature of the pandemic, the Company remains unable to accurately predict the impact of COVID-19 on its overall 2021 operations and financial results or cash flows and whether the on-going impact of COVID-19 could lead to potential future impairments.
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Summary of Significant Accounting Policies |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Reclassifications Certain immaterial reclassifications in the prior period consolidated statement of cash flows have been reclassified to conform to the current year period financial statement presentation. Reclassifications include $0.2 million from provision for bad debt to other at March 31, 2020. The Company had a reclassification in presentation related to rebates and allowances within product revenue. Please refer to Note 3, “Revenue from Contracts with Customers” for further details. Recent Accounting Pronouncements
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Revenue from Contracts with Customers |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contracts with Customers | Revenue from Contracts with Customers The following table summarizes revenue by revenue source as follows:
________________________________ (1)The Company’s principal products include DEFINITY and TechneLite and are categorized within product revenue, net. The Company applies the same revenue recognition policies and judgments for all of its principal products. The Company classifies its revenues into three product categories: precision diagnostics, radiopharmaceutical oncology, and strategic partnerships and other. Precision diagnostics includes DEFINITY, TechneLite and other imaging diagnostic products. Radiopharmaceutical oncology consists of AZEDRA and other oncologic therapeutics. Strategic partnerships and other includes partnerships related to other products, such as RELISTOR, that improve patient outcomes and care. Revenue by product category on a net basis is as follows:
________________________________ (1)The Company reclassified rebates and allowances of $4.7 million for the three months ended March 31, 2020 within each product category, which included $4.3 million for DEFINITY, $0.3 million for TechneLite and $0.1 million for other precision diagnostics. The Company’s performance obligations are typically part of contracts that have an original expected duration of one year or less. As such, the Company is not disclosing the aggregate amount of the transaction price allocated to performance obligations that are unsatisfied (or partially satisfied) as of the end of the reporting period.
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Fair Value of Financial Instruments |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability of fair value measurements, financial instruments are categorized based on a hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: •Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. •Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). •Level 3 — Unobservable inputs that reflect a Company’s estimates about the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The Company’s financial assets and liabilities measured at fair value on a recurring basis consist of money market funds, interest rate swaps, a contingent receivable and contingent consideration liabilities. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets. The fair value of the interest rate swaps are determined based on observable market-based inputs, including interest rate curves and reflects the contractual terms of these instruments, including the period to maturity. Please refer to Note 13, “Derivative Instruments”, for further details on the interest rate swaps. The Company recorded a contingent receivable and the contingent consideration liabilities resulting from the Progenics Acquisition at fair value based on inputs that are not observable in the market. Please refer to Note 8, “Business Combinations”, for further details on the acquisition. The tables below present information about the Company’s assets and liabilities measured at fair value on a recurring basis:
During the three months ended March 31, 2021, there were no transfers into or out of Level 3. As part of the Progenics Acquisition, the Company acquired the right to receive certain future milestone and royalty payments due to Progenics from CytoDyn Inc. related to a prior sale of certain intellectual property. The Company has the right to receive $5.0 million upon regulatory approval and a 5% royalty on net sales of approved products. The Company considers the contingent receivable a Level 3 instrument (one with significant unobservable inputs) in the fair value hierarchy. The estimated fair value was determined based on probability adjusted discounted cash flows that included significant estimates and assumptions pertaining to regulatory events and sales targets. The most significant unobservable inputs are the probabilities of achieving regulatory approval of the development projects and subsequent commercial success. As part of the Progenics Acquisition, the Company issued CVRs and recorded the fair value as part of consideration transferred. Refer to Note 1, “Basis of Presentation” for further details on the CVRs. Additionally, the Company assumed contingent consideration liabilities related to a previous acquisition completed by Progenics in 2013 (“2013 Acquisition”). These contingent consideration liabilities include potential payments of up to $70.0 million if the Company attains certain net sales targets primarily for AZEDRA and 1095 and a $5.0 million 1095 commercialization milestone. Additionally, there is a potential payment of up to $10.0 million related to a 1404 commercialization milestone. The Company’s total potential payments related to the 2013 Acquisition are approximately $85.0 million. The Company considers the contingent consideration liabilities a Level 3 instrument (one with significant unobservable inputs) in the fair value hierarchy. The estimated fair value was determined based on probability adjusted discounted cash flows and Monte Carlo simulation models that included significant estimates and assumptions pertaining to commercialization events and sales targets. The most significant unobservable inputs are the probabilities of achieving regulatory approval of the development projects and subsequent commercial success. Significant changes in any of the probabilities of success or the probabilities as to the periods in which milestones will be achieved would result in a significantly higher or lower fair value measurement. The Company records the contingent consideration liability at fair value with changes in estimated fair values recorded in general and administrative expenses in the condensed consolidated statements of operations. The following tables summarize quantitative information and assumptions pertaining to the fair value measurement of assets and liabilities using Level 3 inputs at March 31, 2021.
For those financial instruments with significant Level 3 inputs, the following table summarizes the activities for the periods indicated:
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Income Taxes |
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | Income Taxes The Company provides for income taxes at the end of each interim period based on the estimated effective tax rate for the full year, adjusted for any discrete events which are recorded in the period they occur. Cumulative adjustments to the tax provision are recorded in the interim period in which a change in the estimated annual effective tax rate is determined. The Company’s income tax expense is presented below:
The Company regularly assesses its ability to realize its deferred tax assets. Assessing the realizability of deferred tax assets requires significant management judgment. In determining whether its deferred tax assets are more-likely-than-not realizable, the Company evaluated all available positive and negative evidence, and weighed the objective evidence and expected impact. The Company assessed the need for a valuation allowance against certain deferred state tax credits added through the Progenics Acquisition. The Company continues to record other valuation allowances of $1.2 million against the net deferred tax assets of its U.K. subsidiary, and $2.3 million against the net deferred tax assets of its Sweden subsidiary. In connection with the Company’s acquisition of the medical imaging business from Bristol-Myers Squibb (“BMS”) in 2008, the Company recorded a liability for uncertain tax positions related to the acquired business and simultaneously entered into a tax indemnification agreement with BMS under which BMS agreed to indemnify the Company for any payments made to settle those uncertain tax positions with the taxing authorities. Accordingly, a long-term receivable is recorded to account for the expected value to the Company of future indemnification payments, net of actual tax benefits received, to be paid on behalf of the Company by BMS. The tax indemnification receivable is recorded within other long-term assets. In accordance with the Company’s accounting policy, the change in the tax liability, penalties and interest associated with these obligations (net of any offsetting federal or state benefit) is recognized within income tax expense. As these reserves change, adjustments are included in income tax expense while the offsetting adjustment is included in other income. Assuming that the receivable from BMS continues to be considered recoverable by the Company, there will be no effect on net income and no net cash outflows related to these liabilities. On June 19, 2020, the Company completed the Progenics Acquisition in a transaction that is expected to qualify as a tax-deferred reorganization under Section 368 of the Internal Revenue Code. The transaction resulted in an ownership change of Progenics under Section 382 of the Internal Revenue Code and a limitation on the utilization of Progenics’ precombination tax attributes. All of Progenics’ precombination research credits and Orphan drug credits have been removed from the balance sheet, and the gross carrying value of the tax loss carryforwards reduced to their realizable value on the opening balance sheet, in accordance with the Section 382 limitation. Deferred tax liabilities arising from the purchase accounting basis step-up in identified intangibles were recorded at acquisition, resulting in a net overall deferred tax liability for Progenics after the application of acquisition accounting. During the current period, the Company finalized the acquisition accounting for income taxes resulting in a reduction of deferred tax assets, primarily related to state research credits and an increase to goodwill of $2.6 million.
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Inventory |
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | Inventory Inventory consisted of the following:
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Property, Plant and Equipment, Net |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment, Net | Property, Plant and Equipment, Net Property, plant and equipment, net, consisted of the following:
Depreciation and amortization expense related to property, plant and equipment, net, was $3.0 million for the three months ended March 31, 2021 and 2020. The Company tests long-lived assets for recoverability whenever events or changes in circumstances suggest that the carrying value of an asset or group of assets may not be recoverable. During the three months ended March 31, 2020, as a result of a decline in expected future cash flows and the effect of COVID-19 related to certain other nuclear legacy manufacturing assets, the Company determined certain impairment triggers had occurred. Accordingly, the Company performed an undiscounted cash flow analysis as of March 31, 2020. Based on the undiscounted cash flow analysis, the Company determined that the manufacturing assets had net carrying values that exceeded their estimated undiscounted future cash flows. The Company then estimated the fair values of the asset group based on their discounted cash flows. The carrying value exceeded the fair value and as a result, the Company recorded a non-cash impairment of $7.3 million for the three months ended March 31, 2020 in cost of goods sold in the condensed consolidated statement of operations.
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Business Combinations |
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Business Combinations [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Business Combinations | Business Combinations On June 19, 2020, the Company completed the Progenics Acquisition. Progenics is an oncology company developing innovative medicines and artificial intelligence to Find, Fight and Follow cancer. The acquisition combined the commercialization, supply chain and manufacturing expertise of the Company with the currently commercialized products and research and development (“R&D”) pipeline of Progenics. Progenics brings to the Company several commercial products and a pipeline of product candidates that will further diversify the Company’s commercial and clinical development portfolios. Under the terms of the Merger Agreement, the Company acquired all of the issued and outstanding shares of Progenics common stock for a purchase price of $419.0 million by means of an all-stock transaction, which includes options to purchase Holdings common stock (“Replacement Stock Options”) for precombination services as well as CVRs. The CVRs were accounted for as contingent consideration, the fair value of which was determined using a Monte-Carlo simulation. Additionally, the fair value of Replacement Stock Options related to precombination services was recorded as a component of consideration transferred. Finally, as a result of the acquisition, Lantheus effectively settled an existing bridge loan with Progenics at the recorded amount (principal and accrued interest) of $10.1 million, representing the effective settlement of a preexisting relationship. This effective settlement of the bridge loan was treated as a component of consideration transferred. The Company determined that the bridge loan was at market terms and no gain or loss was recorded upon settlement. The acquisition date fair value of the consideration transferred in the acquisition consisted of the following:
(1)Non-cash investing and financing activities in the condensed consolidated statements of cash flows The transaction was accounted for as a business combination which requires that assets acquired and liabilities assumed be recognized at their fair value as of the acquisition date. While the Company uses its best estimates and assumptions as part of the purchase price allocation process to value the assets acquired and liabilities assumed on the acquisition date, its estimates and assumptions are subject to refinement. Fair value estimates are based on a complex series of judgments about future events and uncertainties and rely heavily on estimates and assumptions. The judgments used to determine the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact the Company’s results of operations. The Company recorded a measurement period adjustment of $2.6 million related to deferred taxes for the three months ended March 31, 2021, which finalized all measurement period adjustments related to the Progenics Acquisition. The following table summarizes the provisional amounts recognized for assets acquired and liabilities assumed as of the acquisition date, as well as measurement period adjustments made to the amounts initially recorded in June 2020. The measurement period adjustments primarily resulted from finalizing the fair values of certain intangible assets and liabilities, deferred taxes and other changes to certain tangible assets and liability accounts. Measurement period adjustments were recognized in the reporting period in which the adjustments were determined and calculated as if the accounting had been completed at the acquisition date. The related impact to net loss that would have been recognized in previous periods if the adjustments were recognized as of the acquisition date is immaterial to the consolidated financial statements.
Intangible assets acquired consist of currently marketed products, licenses, developed technology and in-process research and development (“IPR&D”). The fair value of the acquired intangible assets was determined based on estimated future revenues, royalty rates and discount rates, among other variables and estimates. The acquired intangible assets subject to amortization were assigned useful lives based on the expected use of the assets and the regulatory and economic environment within which they are being used and are being amortized on a straight-line basis over the respective estimated useful lives. The estimated fair values of the IPR&D assets were determined based on the present values of the expected cash flows to be generated by the respective underlying assets. The Company used a discount rate of 23.0% and cash flows that have been probability adjusted to reflect the risks of product commercialization, which the Company believes are appropriate and representative of market participant assumptions. As part of the Progenics Acquisition, the Company acquired the right to receive certain future milestone and royalty payments due to Progenics, related to a prior sale of certain intellectual property. The estimated fair value of the acquired contingent receivable of $10.1 million was determined by applying a probability adjusted discounted cash flow model based on estimated future expected payments and recorded in other long-term assets. The goodwill recognized is attributable to future technologies that are not separately identifiable that could potentially add to the currently developed and pipeline products and Progenics’ assembled workforce. Future technologies did not meet the criteria for recognition separately from goodwill because they are part of the future development and growth of the business. Goodwill of $45.5 million recognized in connection with the acquisition is not deductible for tax purposes
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Sale of Puerto Rico Subsidiary |
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Discontinued Operations and Disposal Groups [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sale of Puerto Rico Subsidiary | Sale of Puerto Rico Subsidiary During the fourth quarter of 2020, the Company entered into a stock purchase agreement (the “SPA”) with one of its existing radiopharmacy customers to sell all of the stock of its Puerto Rico radiopharmacy subsidiary. The assets were classified as held for sale and the Company determined that the fair value of the net assets being sold significantly exceeded the carrying value as of December 31, 2020. The transaction was consummated on January 29, 2021. The purchase price for the stock sale was $18.0 million in cash, which includes a holdback amount of $1.8 million to be due to the Company in January 2022, and will also include a working capital adjustment once settled. The SPA contains customary representations, warranties and covenants by each of the parties. Subject to certain limitations, the buyer will be indemnified for damages resulting from breaches or inaccuracies of the Company’s representations, warranties and covenants in the SPA. As part of the transaction, the Company and the buyer also entered into a customary transition services agreement and a long-term supply contract under which the Company will supply the buyer with certain of the Company’s products on commercial terms and under which the buyer has agreed to certain product minimum purchase commitments. The Company does not believe this sale of certain net assets, reported as held for sale in the international segment prior to the change in segments in Q1 2021, constituted a strategic shift that would have a major effect on its operations or financial results. As a result, this transaction is not classified as discontinued operations in the Company’s accompanying consolidated financial statements. The following table summarizes the major classes of assets and liabilities sold as of January 29, 2021 (date of sale) and held for sale as of December 31, 2020:
The sale resulted in a pre-tax book gain of $15.3 million, which was recorded within operating income in the condensed consolidated statement of operations for the three months ended March 31, 2021.
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Asset Retirement Obligations |
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||
Asset Retirement Obligation Disclosure [Abstract] | |||||||||||||||||||||||||||||||
Asset Retirement Obligations | Asset Retirement Obligations The Company considers its legal obligation to remediate its facilities upon a decommissioning of its radioactive-related operations as an asset retirement obligation. The Company has production facilities which manufacture and process radioactive materials at its North Billerica, Massachusetts site. As of March 31, 2021, the liability is measured at the present value of the obligation expected to be incurred, of approximately $26.4 million. The Company previously operated a production facility which manufactured and processed radioactive materials at its San Juan, Puerto Rico site. As of December 31, 2020, the liability for the San Juan, Puerto Rico site was recorded in liabilities held for sale and the sale was consummated on January 29, 2021. The following table provides a summary of the changes in the Company’s asset retirement obligations:
The Company is required to provide the U.S. Nuclear Regulatory Commission and Massachusetts Department of Public Health financial assurance demonstrating the Company’s ability to fund the decommissioning of its North Billerica, Massachusetts production facility upon closure, although the Company does not intend to close the facility. The Company has provided this financial assurance in the form of a $28.2 million surety bond.
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Intangibles, Net |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangibles, Net | Intangibles, Net Intangibles, net, consisted of the following:
The Company recorded amortization expense for its intangible assets of $4.7 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively. The below table summarizes the estimated aggregate amortization expense expected to be recognized on the above intangible assets:
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Long-Term Debt, Net, and Other Borrowings |
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Long-Term Debt, Net, and Other Borrowings | Long-Term Debt, Net, and Other Borrowings As of March 31, 2021, the Company’s maturities of principal obligations under its long-term debt and other borrowings are as follows:
At March 31, 2021, the Company’s interest rate under the five-year secured term loan facility, which matures on June 30, 2024 (the “2019 Term Facility”) was 3.4%. On March 31, 2021, the Company voluntarily repaid in full the entire outstanding principal on the original $50.0 million loan agreement (the “Royalty-Backed Loan”) with a fund managed by HealthCare Royalty Partners III, L.P. in the amount of $30.9 million, which included a prepayment amount of $0.5 million, and terminated the agreement governing the Royalty-Backed Loan. The Company recorded a gain on extinguishment of debt of $0.9 million related to the write-off of an unamortized debt premium offset by the prepayment amount.
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Derivative Instruments |
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Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Derivative Instruments | Derivative Instruments The Company uses interest rate swaps to reduce the variability in cash flows associated with a portion of the Company’s forecasted interest payments on its variable rate debt. In March 2020, the Company entered into interest rate swap contracts to fix the LIBOR rate on a notional amount of $100.0 million through May 31, 2024. The average fixed LIBOR rate on the interest rate swaps is approximately 0.82%. This agreement involves the receipt of floating rate amounts in exchange for fixed rate interest payments over the life of the agreement without an exchange of the underlying principal amount. The interest rate swaps were designated as cash flow hedges. In accordance with hedge accounting, the interest rate swaps are recorded on the Company’s condensed consolidated balance sheets at fair value, and changes in the fair value of the swap agreements are recorded to other comprehensive loss and reclassified to interest expense in the period during which the hedged transaction affected earnings or it will become probable that the forecasted transaction would not occur. At March 31, 2021, accumulated other comprehensive loss included $0.6 million of pre-tax deferred losses that are expected to be reclassified to earnings during the next 12 months. The following table presents the location and fair value amounts of derivative instruments reported in the condensed consolidated balance sheet:
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Accumulated Other Comprehensive Loss |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss The components of accumulated other comprehensive loss, net of tax of $0.2 million and $0.3 million for the three months ended March 31, 2021 and 2020, respectively, consisted of the following:
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Stock-Based Compensation |
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Share-based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | Stock-Based Compensation The following table presents stock-based compensation expense recognized in the Company’s accompanying condensed consolidated statements of operations:
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Net Income Per Common Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income Per Common Share | Net Income Per Common Share A summary of net income per common share is presented below:
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Other Income |
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Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income | Other Income Other income consisted of the following:
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Commitments and Contingencies |
3 Months Ended |
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Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Legal Proceedings From time to time, the Company is a party to various legal proceedings arising in the ordinary course of business. In addition, the Company has in the past been, and may in the future be, subject to investigations by governmental and regulatory authorities, which expose it to greater risks associated with litigation, regulatory or other proceedings, as a result of which the Company could be required to pay significant fines or penalties. The costs and outcome of litigation, regulatory or other proceedings cannot be predicted with certainty, and some lawsuits, claims, actions or proceedings may be disposed of unfavorably to the Company and could have a material adverse effect on the Company’s results of operations or financial condition. In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations. If a matter is both probable to result in material liability and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible material loss or range of loss. If such loss is not probable or cannot be reasonably estimated, a liability is not recorded in its condensed consolidated financial statements. As of March 31, 2021, the Company had the following material ongoing litigation in which the Company was a party: RELISTOR European Opposition Proceedings In October 2015, Progenics received notices of opposition to three European patents relating to methylnaltrexone: EP1615646, EP2368553 and EP2368554. Notices of opposition were filed separately by each of Actavis Group PTC ehf and Fresenius Kabi Deutschland GmbH. Between May 11, 2017 and July 4, 2017, the opposition division provided notice that the three European patents would be revoked. Each of these matters were appealed to with the European Patent Office. On November 13, 2020, Progenics withdrew the appeal for EP2368553 and EP2368554. Notices of termination of the proceedings with revocation of the patent were issued on November 23, 2020 for both patents. Oral proceedings for the third patent, EP1615646 were held on September 22, 2020. The decision under appeal was set aside and the case was remitted to the opposition division for further prosecution. The deadline for written submissions prior to an oral hearing is July 27, 2021. The oral hearing is set for September 27, 2021. Because the outcome of litigation is uncertain, the Company cannot predict how or when this matter will ultimately be resolved. German PSMA-617 Litigation On November 8, 2018, Molecular Insight Pharmaceuticals, Inc., a subsidiary of Progenics (“MIP”), filed a complaint against the University of Heidelberg (the “University”) in the District Court in Mannheim, Germany (the “German District Court”). In this Complaint, MIP claimed that the discovery and development of PSMA-617 was related to work performed under a research collaboration sponsored by MIP. MIP alleged that the University breached certain contracts with MIP and that MIP is the co-owner of inventions embodied in certain worldwide patent filings related to PSMA-617 that were filed by the University. On February 27, 2019, Endocyte, Inc., a wholly owned subsidiary of Novartis AG, filed a motion to intervene in the German litigation. Endocyte is the exclusive licensee of the patent rights that are the subject of the German proceedings. On November 27, 2018, MIP requested that the European Patent Office (“EPO”) stay the examination of a certain European Patent (EP) and related Divisional Applications, pending a decision from the German District Court on MIP’s Complaint. On December 10, 2018, the EPO granted MIP’s request and stayed the examination of the patent and patent applications effective November 27, 2018. MIP filed a Confirmation of Ownership with the United States Patent and Trademark Office (“USPTO”) in corresponding U.S. patent applications (U.S. Serial Nos. 15/131,118; 15/805,900; 16/038,729, 16/114,988, 16/510,495, 16/551,198, and 17/110,558). MIP’s filing with the USPTO takes the position that, in light of the collaboration and contracts between MIP and the University, MIP is the co-owner of these pending U.S. patent applications (U.S. Serial Nos. 16/510,495, 16/551,198). On March 6, 2020, MIP filed with the USPTO a notice stating that the Power of Attorney in certain pending U.S. patent applications was signed by less than all applicants or owners of the applications. On February 27, 2019, the German District Court set €0.4 million as the amount MIP must deposit with the German District Court as security in the event of an unfavorable final decision on the merits of the dispute. The German District Court held the first oral hearing in the case on August 6, 2019. The German District Court considered procedural matters and granted the parties the right to make further submissions. A further oral hearing occurred July 23, 2020, during which the German District Court heard live testimony from several witnesses, testifying on behalf of the defendants. On August 24, 2020, the German District Court issued its decision dismissing MIP’s claims, stating that MIP failed to discharge its burden of proof in the matter. MIP filed a Notice of Appeal of the German District Court’s decision on September 24, 2020 and filed its appeal brief on November 26, 2020. The University and Endocyte each filed oppositions to MIP’s Notice of Appeal on March 12, 2021. MIP is also considering its legal and procedural alternatives against the defendants in other jurisdictions and proceedings. If MIP is not successful in its appeal, it will be responsible for the German court fees and fees and disbursements of defendant’s and intervenor’s counsel, both at first instance and on appeal. Most of such fees and disbursements at first instance are covered by the aforementioned cash security deposited with the German District Court. Because the outcome of litigation is uncertain, the Company cannot predict how or when this matter will ultimately be resolved. Petition for Post-Grant Review On February 4, 2021, Advanced Accelerator Applications USA, Inc. (“AAA”) filed a petition for post-grant review of U.S. Patent No. 10,640,461 (the “’461 patent”) with the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office. The ’461 patent is owned by MIP. In the petition, AAA challenges the patentability of claims 1, 45, and 47 of the ’461 patent under 35 U.S.C. §§ 112 and 102(a)(1). On February 9, 2021, the PTAB mailed a Notice of Filing Date Accorded to Petition and Time for Filing Patent Owner Preliminary Response. The PTAB set a three (3) month deadline for MIP to file a preliminary response. The filing of a preliminary response to the petition is optional for the patent owner (MIP). Should the PTAB decide to institute post-grant review, a schedule will be set and MIP will be afforded three months from the date of institution to formally respond to the petition. Because the outcome of litigation is uncertain, the Company cannot predict how or when this matter will be ultimately resolved.
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Segment Information |
3 Months Ended |
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Mar. 31, 2021 | |
Segment Reporting [Abstract] | |
Segment Information | Segment InformationIn the first quarter of fiscal year 2021, the Company completed the evaluation of its operating and reporting structure, including the impact on the Company’s business of the acquisition of Progenics described in Note 8, and the sale of the Puerto Rico subsidiary in the current quarter, which resulted in a change in operating and reportable segments. As of the first quarter of fiscal year 2021, the Company operates as one business segment: the development, manufacture and sale of innovative diagnostic and therapeutic agents and products that assist clinicians in the diagnosis and treatment of heart disease, cancer and other diseases. This conclusion reflects the Company’s focus on the performance of the business on a consolidated worldwide basis. The results of this operating segment are regularly reviewed by the Company’s chief operating decision maker, the President and Chief Executive Officer. The Company’s chief operating decision maker does not manage any part of the Company separately, and the allocation of resources and assessment of performance are based on the Company’s consolidated operating results. |
Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Basis of Presentation | The accompanying unaudited condensed consolidated financial statements include the accounts of Holdings and its direct and indirect wholly-owned subsidiaries, including Progenics (as of the closing date, June 19, 2020), and have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these condensed consolidated financial statements do not include all of the information and notes required by generally accepted accounting principles in the United States of America (“U.S. GAAP”) for complete financial statements. In the opinion of management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement have been included. The results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the year ended December 31, 2021 or any future period. In the first quarter of fiscal year 2021, the Company completed the evaluation of its operating and reporting structure, which resulted in a change in operating segments. Please refer to Note 19, “Segment Information”, for further details. The condensed consolidated balance sheet at December 31, 2020 has been derived from the audited consolidated financial statements at that date but does not include all of the information and notes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and notes thereto included in Item 8 of the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities Exchange Commission (“SEC”) on February 25, 2021.
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Reclassifications | Reclassifications Certain immaterial reclassifications in the prior period consolidated statement of cash flows have been reclassified to conform to the current year period financial statement presentation. Reclassifications include $0.2 million from provision for bad debt to other at March 31, 2020. The Company had a reclassification in presentation related to rebates and allowances within product revenue. Please refer to Note 3, “Revenue from Contracts with Customers” for further details.
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Recent Accounting Pronouncements | Recent Accounting Pronouncements
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Summary of Significant Accounting Policies (Tables) |
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Recent Accounting Pronouncements |
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Revenue from Contracts with Customers (Tables) |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of disaggregation of revenue | The following table summarizes revenue by revenue source as follows:
________________________________ (1)The Company’s principal products include DEFINITY and TechneLite and are categorized within product revenue, net. The Company applies the same revenue recognition policies and judgments for all of its principal products. The Company classifies its revenues into three product categories: precision diagnostics, radiopharmaceutical oncology, and strategic partnerships and other. Precision diagnostics includes DEFINITY, TechneLite and other imaging diagnostic products. Radiopharmaceutical oncology consists of AZEDRA and other oncologic therapeutics. Strategic partnerships and other includes partnerships related to other products, such as RELISTOR, that improve patient outcomes and care. Revenue by product category on a net basis is as follows:
________________________________ (1)The Company reclassified rebates and allowances of $4.7 million for the three months ended March 31, 2020 within each product category, which included $4.3 million for DEFINITY, $0.3 million for TechneLite and $0.1 million for other precision diagnostics.
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Fair Value of Financial Instruments (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of assets and liabilities measured at fair value on a recurring basis | The tables below present information about the Company’s assets and liabilities measured at fair value on a recurring basis:
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Fair Value Measurement Inputs and Valuation Techniques | The following tables summarize quantitative information and assumptions pertaining to the fair value measurement of assets and liabilities using Level 3 inputs at March 31, 2021.
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Schedule of financial instruments with significant Level 3 inputs | For those financial instruments with significant Level 3 inputs, the following table summarizes the activities for the periods indicated:
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Income Taxes (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of income tax expense | The Company’s income tax expense is presented below:
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Inventory (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of inventory | Inventory consisted of the following:
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Property, Plant and Equipment, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of property, plant, and equipment, net | Property, plant and equipment, net, consisted of the following:
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Business Combinations (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Business Combinations [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of business acquisition | The acquisition date fair value of the consideration transferred in the acquisition consisted of the following:
(1)Non-cash investing and financing activities in the condensed consolidated statements of cash flows
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Schedule of fair value disclosure of asset and liability | The following table summarizes the provisional amounts recognized for assets acquired and liabilities assumed as of the acquisition date, as well as measurement period adjustments made to the amounts initially recorded in June 2020. The measurement period adjustments primarily resulted from finalizing the fair values of certain intangible assets and liabilities, deferred taxes and other changes to certain tangible assets and liability accounts. Measurement period adjustments were recognized in the reporting period in which the adjustments were determined and calculated as if the accounting had been completed at the acquisition date. The related impact to net loss that would have been recognized in previous periods if the adjustments were recognized as of the acquisition date is immaterial to the consolidated financial statements.
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Sale of Puerto Rico Subsidiary (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Discontinued Operations and Disposal Groups [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disposal groups including discontinued operations | The following table summarizes the major classes of assets and liabilities sold as of January 29, 2021 (date of sale) and held for sale as of December 31, 2020:
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Asset Retirement Obligations (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||
Asset Retirement Obligation Disclosure [Abstract] | |||||||||||||||||||||||||||||||
Summary of changes in asset retirement obligations | The following table provides a summary of the changes in the Company’s asset retirement obligations:
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Intangibles, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of intangibles | Intangibles, net, consisted of the following:
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Schedule of intangibles | Intangibles, net, consisted of the following:
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Schedule of expected future amortization expense | The below table summarizes the estimated aggregate amortization expense expected to be recognized on the above intangible assets:
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Long-Term Debt, Net, and Other Borrowings (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of maturities of principal obligations | As of March 31, 2021, the Company’s maturities of principal obligations under its long-term debt and other borrowings are as follows:
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Derivative Instruments (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of derivative instruments | The following table presents the location and fair value amounts of derivative instruments reported in the condensed consolidated balance sheet:
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Accumulated Other Comprehensive Loss (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of accumulated other comprehensive income | The components of accumulated other comprehensive loss, net of tax of $0.2 million and $0.3 million for the three months ended March 31, 2021 and 2020, respectively, consisted of the following:
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Stock-Based Compensation (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of stock-based compensation expense recognized | The following table presents stock-based compensation expense recognized in the Company’s accompanying condensed consolidated statements of operations:
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Net Income Per Common Share (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of net (loss) income per common share | A summary of net income per common share is presented below:
|
Other Income (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of other income | Other income consisted of the following:
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Summary of Significant Accounting Policies - Narrative (Details) $ in Millions |
3 Months Ended |
---|---|
Mar. 31, 2020
USD ($)
| |
Revision of Prior Period, Reclassification, Adjustment | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |
Provision for bad debt | $ (0.2) |
Fair Value Measures and Disclosures - Financial Instruments With Significant Level 3 Inputs (Details) $ in Thousands |
3 Months Ended |
---|---|
Mar. 31, 2021
USD ($)
| |
Financial Assets | |
Fair value, beginning of period | $ 11,300 |
Changes in fair value included in net income | 900 |
Fair value, end of period | 12,200 |
Financial Liabilities | |
Fair value, beginning of period | 15,800 |
Changes in fair value included in net income | 1,200 |
Fair value, end of period | 17,000 |
Change in fair value of the contingent financial asset and contingent financial liabilities | $ 300 |
Income Taxes (Detail) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Valuation Allowance [Line Items] | ||
Income tax expense | $ 5,334 | $ 2,192 |
Goodwill acquired | 2,600 | |
UNITED KINGDOM | ||
Valuation Allowance [Line Items] | ||
Deferred tax asset, valuation allowance | 1,200 | |
SWEDEN | ||
Valuation Allowance [Line Items] | ||
Deferred tax asset, valuation allowance | $ 2,300 |
Inventory (Detail) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 15,297 | $ 16,000 |
Work in process | 8,606 | 11,212 |
Finished goods | 6,454 | 8,532 |
Inventory | $ 30,357 | $ 35,744 |
Property, Plant and Equipment, Net (Detail) - USD ($) $ in Thousands |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
Dec. 31, 2020 |
|
Property, Plant & Equipment [Line Items] | |||
Property, plant & equipment, gross | $ 197,921 | $ 196,583 | |
Less: accumulated depreciation and amortization | (79,540) | (76,412) | |
Total property, plant and equipment, net | 118,381 | 120,171 | |
Depreciation and amortization expense | 3,000 | ||
Impairment of long-lived assets | 0 | $ 7,275 | |
Land | |||
Property, Plant & Equipment [Line Items] | |||
Property, plant & equipment, gross | 13,450 | 13,450 | |
Buildings | |||
Property, Plant & Equipment [Line Items] | |||
Property, plant & equipment, gross | 71,622 | 70,381 | |
Machinery, equipment and fixtures | |||
Property, Plant & Equipment [Line Items] | |||
Property, plant & equipment, gross | 79,460 | 77,854 | |
Computer software | |||
Property, Plant & Equipment [Line Items] | |||
Property, plant & equipment, gross | 23,751 | 23,644 | |
Construction in progress | |||
Property, Plant & Equipment [Line Items] | |||
Property, plant & equipment, gross | $ 9,638 | $ 11,254 |
Business Combinations - Narrative (Details) $ in Thousands |
3 Months Ended | ||
---|---|---|---|
Jun. 19, 2020
USD ($)
|
Mar. 31, 2021
USD ($)
|
Dec. 31, 2020
USD ($)
|
|
Business Acquisition [Line Items] | |||
Goodwill | $ 61,189 | $ 58,632 | |
Progenics | |||
Business Acquisition [Line Items] | |||
Purchase price | $ 419,009 | ||
Fair value of bridge loan settled at close | 10,074 | ||
Measurement period adjustment | $ 2,600 | ||
Acquired contingent receivable | 10,100 | ||
Goodwill | $ 45,475 | ||
Progenics | Discount rate | |||
Business Acquisition [Line Items] | |||
Measurement input | 0.230 |
Business Combinations - Fair Value of the Consideration Transferred in the Acquisition (Details) - USD ($) $ in Thousands |
Jun. 19, 2020 |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|---|
Business Acquisition [Line Items] | |||
Fair value of contingent considerations (CVRs) | $ 17,000 | $ 15,800 | |
Progenics | |||
Business Acquisition [Line Items] | |||
Issuance of common stock | $ 398,110 | ||
Fair value of replacement options | 7,125 | ||
Fair value of bridge loan settled at close | 10,074 | ||
Fair value of contingent considerations (CVRs) | 3,700 | ||
Total consideration transferred | $ 419,009 |
Asset Retirement Obligations (Detail) $ in Thousands |
3 Months Ended |
---|---|
Mar. 31, 2021
USD ($)
| |
Asset Retirement Obligation Disclosure [Abstract] | |
Asset retirement obligation liabilities expected, present value | $ 26,400 |
Asset Retirement Obligation, Roll Forward Analysis [Roll Forward] | |
Asset retirement obligations, beginning balance | 14,020 |
Accretion expense | 388 |
Asset retirement obligations, ending balance | 14,408 |
Financial assurance in form of surety bond | $ 28,200 |
Intangibles, Net - Additional Information (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization expense | $ 4.7 | $ 0.4 |
Intangibles, Net - Schedule of Expected Future Amortization Expense Related to Intangible Assets (Details) $ in Thousands |
Mar. 31, 2021
USD ($)
|
---|---|
Goodwill and Intangible Assets Disclosure [Abstract] | |
Remainder of 2021 | $ 14,051 |
2022 | 18,477 |
2023 | 17,878 |
2024 | 17,808 |
2025 | 17,753 |
2026 and thereafter | 136,924 |
Total | $ 222,891 |
Long-Term Debt, Net, and Other Borrowings (Details) - USD ($) |
3 Months Ended | |||
---|---|---|---|---|
Mar. 31, 2021 |
Mar. 31, 2021 |
Mar. 31, 2020 |
Dec. 31, 2020 |
|
Debt Instrument [Line Items] | ||||
Remainder of 2021 | $ 7,500,000 | $ 7,500,000 | ||
2022 | 11,250,000 | 11,250,000 | ||
2023 | 15,000,000 | 15,000,000 | ||
2024 | 148,750,000 | 148,750,000 | ||
Total principal outstanding | 182,500,000 | 182,500,000 | ||
Unamortized debt discount | (647,000) | (647,000) | ||
Unamortized debt issuance costs | (559,000) | (559,000) | ||
Finance lease liabilities | 431,000 | 431,000 | ||
Total | 181,725,000 | 181,725,000 | ||
Less: current portion | (10,251,000) | (10,251,000) | $ (20,701,000) | |
Total long-term debt, net and other borrowings | $ 171,474,000 | 171,474,000 | $ 197,699,000 | |
Gain on extinguishment of debt | $ 889,000 | $ 0 | ||
2019 Term Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Debt instrument term | 5 years | |||
Interest rate | 3.40% | 3.40% | ||
Royalty-Backed Loan | ||||
Debt Instrument [Line Items] | ||||
Debt instrument face amount | $ 50,000,000.0 | $ 50,000,000.0 | ||
Extinguishment of debt | 30,900,000 | |||
Prepayment of debt | 500,000 | |||
Gain on extinguishment of debt | $ 900,000 |
Derivative Instruments (Detail) - USD ($) |
Mar. 31, 2021 |
Dec. 31, 2020 |
Mar. 31, 2020 |
---|---|---|---|
Derivative [Line Items] | |||
Pre-tax deferred losses expected to be reclassified to earnings during the next 12 months | $ 600,000 | ||
Cash Flow Hedge | Interest Rate Swaps | |||
Derivative [Line Items] | |||
Notional amount | $ 100,000,000.0 | ||
Average fixed interest rate | 0.82% | ||
Cash Flow Hedge | Interest Rate Swaps | Accrued expenses and other liabilities | |||
Derivative [Line Items] | |||
Liabilities | $ 960,000 | $ 1,908,000 |
Stock-Based Compensation (Detail) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 3,317 | $ 3,075 |
Cost of goods sold | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 622 | 618 |
Sales and marketing | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 350 | 253 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 1,920 | 1,815 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 425 | $ 389 |
Net Income Per Common Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Earnings Per Share [Abstract] | ||
Net income | $ 9,008 | $ 3,337 |
Basic weighted-average common shares outstanding (in shares) | 67,094 | 39,433 |
Effect of dilutive stock options (in shares) | 82 | 28 |
Effect of dilutive restricted stock (in shares) | 538 | 641 |
Diluted weighted-average common shares outstanding (in shares) | 67,714 | 40,102 |
Basic income per common share (in dollars per share) | $ 0.13 | $ 0.08 |
Diluted income per common share (in dollars per share) | $ 0.13 | $ 0.08 |
Antidilutive securities excluded from diluted net income per common share (in shares) | 1,349 | 604 |
Other Income (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Other Income and Expenses [Abstract] | ||
Foreign currency losses | $ 42 | $ 314 |
Tax indemnification income, net | (573) | (555) |
Interest income | (17) | (109) |
Other | (1) | 0 |
Total other income | $ (549) | $ (350) |
Commitments and Contingencies (Details) |
Feb. 27, 2019
EUR (€)
|
---|---|
MIP | |
Loss Contingencies [Line Items] | |
Court deposit | € 400,000 |
Segment Information (Details) |
3 Months Ended |
---|---|
Mar. 31, 2021
segment
| |
Segment Reporting [Abstract] | |
Operating segments | 1 |
Label | Element | Value |
---|---|---|
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 0 |
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 2,142,000 |
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