(Mark One) | |||||
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
or | |||||
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the transition period from to |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | ||||||||||
(Address of Principal Executive Offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Large accelerated filer | ☐ | ☒ | ||||||||||||
Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||
Emerging growth company |
March 31, 2020 | December 31, 2019 | ||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Marketable securities | |||||||||||
Accounts receivable, net | |||||||||||
Inventories | |||||||||||
Prepaid and other current assets | |||||||||||
Total current assets | |||||||||||
Property and equipment, net | |||||||||||
Goodwill | |||||||||||
Intangible assets, net | |||||||||||
Operating lease right-of-use asset | |||||||||||
Deferred tax assets | |||||||||||
Restricted cash | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued expenses | |||||||||||
Current portion of operating lease liability | |||||||||||
Current portion of acquisition-related contingent consideration | |||||||||||
Total current liabilities | |||||||||||
Long-term liabilities: | |||||||||||
Convertible notes, net | |||||||||||
Long-term operating lease liability | |||||||||||
Other long-term liabilities | |||||||||||
Total liabilities | |||||||||||
Commitments and contingencies (Note O) | |||||||||||
Stockholders’ equity: | |||||||||||
Preferred stock, par value $ | |||||||||||
Common stock, par value $ | |||||||||||
Additional paid-in capital | |||||||||||
Accumulated other comprehensive loss | ( | ( | |||||||||
Accumulated deficit | ( | ( | |||||||||
Total stockholders’ equity | |||||||||||
Total liabilities and stockholders’ equity | $ | $ |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Revenues: | |||||||||||
Product sales, net | $ | $ | |||||||||
Other revenues | |||||||||||
Total revenues | |||||||||||
Costs and expenses: | |||||||||||
Cost of product sales | |||||||||||
Research and development expenses | |||||||||||
Acquired in-process research and development | |||||||||||
Selling, general and administrative expenses | |||||||||||
Restructuring expenses | |||||||||||
Total costs and expenses | |||||||||||
Operating loss | ( | ( | |||||||||
Other income (expense): | |||||||||||
Interest expense | ( | ( | |||||||||
Interest and dividend income | |||||||||||
Other income | |||||||||||
Total other expense, net | ( | ( | |||||||||
Loss before income taxes | ( | ( | |||||||||
Income tax expense (benefit) | ( | ||||||||||
Net loss | $ | ( | $ | ( | |||||||
Basic and diluted net loss per share | $ | ( | $ | ( | |||||||
Weighted average shares outstanding used to compute net loss per share (basic and diluted) |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Net loss | $ | ( | $ | ( | |||||||
Other comprehensive loss: | |||||||||||
Holding (losses) gains associated with marketable securities arising during period, net of tax | ( | ||||||||||
Total comprehensive loss | $ | ( | $ | ( |
Common Stock | |||||||||||||||||||||||||||||||||||
Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders' Equity | ||||||||||||||||||||||||||||||
Balance at December 31, 2019 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Net shares issued in connection with the vesting of restricted stock units, net of withholdings | ( | — | — | ( | |||||||||||||||||||||||||||||||
Non-cash equity based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
Unrealized losses on securities, net of tax | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at March 31, 2020 | $ | $ | $ | ( | $ | ( | $ |
Common Stock | |||||||||||||||||||||||||||||||||||
Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders' Equity | ||||||||||||||||||||||||||||||
Balance at December 31, 2018 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | ( | — | — | ( | |||||||||||||||||||||||||||||||
Repurchase of common stock pursuant to the share repurchase program | ( | ( | ( | — | — | ( | |||||||||||||||||||||||||||||
Non-cash equity based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
Unrealized gains on securities, net of tax | — | — | — | — | |||||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at March 31, 2019 | $ | $ | $ | ( | $ | ( | $ |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | |||||||||||
Depreciation and amortization | |||||||||||
Provision for bad debt expense | ( | ||||||||||
Amortization of premium/discount on purchased securities | ( | ||||||||||
Write-down of inventory | |||||||||||
Non-cash equity-based compensation expense | |||||||||||
Non-cash IPR&D expense | |||||||||||
Amortization of debt discount and debt issuance costs | |||||||||||
Gains on marketable securities, net | ( | ||||||||||
Change in fair value of contingent consideration | ( | ||||||||||
Deferred income taxes | |||||||||||
Non-cash lease expense | |||||||||||
Gain on sale of assets | ( | ||||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable, net | ( | ( | |||||||||
Inventories | ( | ( | |||||||||
Prepaid and other current assets | ( | ( | |||||||||
Accounts payable and accrued expenses | ( | ||||||||||
Other assets and liabilities | |||||||||||
Net cash used in operating activities | ( | ( | |||||||||
Cash flows from investing activities: | |||||||||||
Proceeds from sales or maturities of marketable securities | |||||||||||
Purchase of marketable securities | ( | ( | |||||||||
Net proceeds from the sale of assets | |||||||||||
Capital expenditures | ( | ( | |||||||||
Net cash (used in) provided by investing activities | ( | ||||||||||
Cash flows from financing activities: | |||||||||||
Payments to settle convertible notes | ( | ||||||||||
Payments of contingent consideration | ( | ( | |||||||||
Payments for repurchases of common stock | ( | ||||||||||
Proceeds from the exercise of common stock options | |||||||||||
Payments of employee tax withholding related to equity-based compensation | ( | ( | |||||||||
Net cash used in financing activities | ( | ( | |||||||||
Net decrease in cash, cash equivalents, and restricted cash | ( | ( | |||||||||
Cash, cash equivalents, and restricted cash at beginning of the period | |||||||||||
Cash, cash equivalents, and restricted cash at end of the period | $ | $ | |||||||||
Supplemental data for cash flow information: | |||||||||||
Cash (refunded) paid for taxes | $ | ( | $ | ||||||||
Cash paid for interest | $ | $ | |||||||||
Non-cash investing and financing activities: | |||||||||||
Settlement of note receivable in connection with Perosphere acquisition | $ | $ | |||||||||
Right-of-use assets obtained in exchange for lease liabilities | $ | $ |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
McKesson Corporation | % | % | |||||||||
AmerisourceBergen Drug Corporation | % | % | |||||||||
Cardinal Health | % | % |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Product sales, net | |||||||||||
Feraheme | $ | $ | |||||||||
Makena | |||||||||||
Intrarosa | |||||||||||
Other | ( | ||||||||||
Total product sales, net | $ | $ |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Gross product sales | $ | $ | |||||||||
Provision for product sales allowances and accruals: | |||||||||||
Contractual adjustments | |||||||||||
Governmental rebates | |||||||||||
Total | |||||||||||
Product sales, net | $ | $ |
Contractual | Governmental | ||||||||||||||||
Adjustments | Rebates | Total | |||||||||||||||
Balance at December 31, 2019 | $ | $ | $ | ||||||||||||||
Provisions related to current period sales | |||||||||||||||||
Adjustments related to prior period sales | ( | ( | |||||||||||||||
Payments/returns relating to current period sales | ( | ( | |||||||||||||||
Payments/returns relating to prior period sales | ( | ( | ( | ||||||||||||||
Balance at March 31, 2020 | $ | $ | $ |
March 31, 2020 | |||||||||||||||||||||||
Gross | Gross | Estimated | |||||||||||||||||||||
Amortized | Unrealized | Unrealized | Fair | ||||||||||||||||||||
Cost | Gains | Losses | Value | ||||||||||||||||||||
Short-term marketable securities:* | |||||||||||||||||||||||
Corporate debt securities | $ | $ | $ | ( | $ | ||||||||||||||||||
Certificates of deposit | |||||||||||||||||||||||
Commercial paper | |||||||||||||||||||||||
Total short-term marketable securities | $ | $ | $ | ( | $ | ||||||||||||||||||
Long-term marketable securities:** | |||||||||||||||||||||||
Corporate debt securities | $ | $ | $ | ( | $ | ||||||||||||||||||
Certificates of deposit | |||||||||||||||||||||||
Total long-term marketable securities | $ | $ | $ | ( | $ | ||||||||||||||||||
Total marketable securities | $ | $ | $ | ( | $ |
December 31, 2019 | |||||||||||||||||||||||
Gross | Gross | Estimated | |||||||||||||||||||||
Amortized | Unrealized | Unrealized | Fair | ||||||||||||||||||||
Cost | Gains | Losses | Value | ||||||||||||||||||||
Short-term marketable securities:* | |||||||||||||||||||||||
Corporate debt securities | $ | $ | $ | ( | $ | ||||||||||||||||||
U.S. treasury and government agency securities | |||||||||||||||||||||||
Certificates of deposit | |||||||||||||||||||||||
Total short-term marketable securities | $ | $ | $ | ( | $ | ||||||||||||||||||
Long-term marketable securities:** | |||||||||||||||||||||||
Corporate debt securities | $ | $ | $ | $ | |||||||||||||||||||
Total long-term marketable securities | |||||||||||||||||||||||
Total marketable securities | $ | $ | $ | ( | $ |
Fair Value Measurements at March 31, 2020 Using: | |||||||||||||||||||||||
Quoted Prices in | Significant | ||||||||||||||||||||||
Active Markets for | Significant Other | Unobservable | |||||||||||||||||||||
Identical Assets | Observable Inputs | Inputs | |||||||||||||||||||||
Total | (Level 1) | (Level 2) | (Level 3) | ||||||||||||||||||||
Assets: | |||||||||||||||||||||||
Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
Corporate debt securities | |||||||||||||||||||||||
Certificates of deposit | |||||||||||||||||||||||
Commercial paper | |||||||||||||||||||||||
Total assets | $ | $ | $ | $ | |||||||||||||||||||
Fair Value Measurements at December 31, 2019 Using: | |||||||||||||||||||||||
Quoted Prices in | Significant | ||||||||||||||||||||||
Active Markets for | Significant Other | Unobservable | |||||||||||||||||||||
Identical Assets | Observable Inputs | Inputs | |||||||||||||||||||||
Total | (Level 1) | (Level 2) | (Level 3) | ||||||||||||||||||||
Assets: | |||||||||||||||||||||||
Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
Corporate debt securities | |||||||||||||||||||||||
U.S. treasury and government agency securities | |||||||||||||||||||||||
Certificates of deposit | |||||||||||||||||||||||
Total assets | $ | $ | $ | $ | |||||||||||||||||||
Liabilities: | |||||||||||||||||||||||
Contingent consideration - MuGard | $ | $ | $ | $ | |||||||||||||||||||
Total liabilities | $ | $ | $ | $ |
March 31, 2020 | December 31, 2019 | ||||||||||
Raw materials | $ | $ | |||||||||
Work in process | |||||||||||
Finished goods | |||||||||||
Total inventories | $ | $ |
March 31, 2020 | December 31, 2019 | ||||||||||
Computer equipment and software | $ | $ | |||||||||
Furniture and fixtures | |||||||||||
Leasehold improvements | |||||||||||
Laboratory and production equipment | |||||||||||
Construction in progress | |||||||||||
Less: accumulated depreciation | ( | ( | |||||||||
Property and equipment, net | $ | $ |
March 31, 2020 | December 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||
Accumulated | Cumulative | Accumulated | Cumulative | ||||||||||||||||||||||||||||||||||||||||||||
Cost | Amortization | Impairments | Net | Cost | Amortization | Impairments | Net | ||||||||||||||||||||||||||||||||||||||||
Amortizable intangible assets: | |||||||||||||||||||||||||||||||||||||||||||||||
Makena auto-injector developed technology | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
Intrarosa developed technology | |||||||||||||||||||||||||||||||||||||||||||||||
Vyleesi developed technology | |||||||||||||||||||||||||||||||||||||||||||||||
Total intangible assets | $ | $ | $ | $ | $ | $ | $ | $ |
March 31, 2020 | December 31, 2019 | ||||||||||
Commercial rebates, fees and returns | $ | $ | |||||||||
Manufacturing costs | |||||||||||
Salaries, bonuses, and other compensation | |||||||||||
Professional, license, and other fees and expenses | |||||||||||
Research and development expense | |||||||||||
Interest expense | |||||||||||
Restructuring expense | |||||||||||
Total accrued expenses | $ | $ |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Effective tax rate | % | % | |||||||||
Income tax expense (benefit) | $ | $ | ( |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Beginning balance | $ | ( | $ | ( | |||||||
Holding (losses) gains associated with marketable securities arising during period, net of tax | ( | ||||||||||
Ending balance | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Net loss | $ | ( | $ | ( | |||||||
Weighted average common shares outstanding | |||||||||||
Basic and diluted net loss per share | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Options to purchase shares of common stock | |||||||||||
Shares of common stock issuable upon the vesting of RSUs | |||||||||||
2022 Convertible Notes | |||||||||||
Total |
2019 | 2007 | Lumara Health | Inducement | ||||||||||||||||||||||||||
Plan | Plan | 2013 Plan | Grants | Total | |||||||||||||||||||||||||
Outstanding at December 31, 2019 | |||||||||||||||||||||||||||||
Granted | |||||||||||||||||||||||||||||
Exercised | |||||||||||||||||||||||||||||
Expired or terminated | ( | ( | ( | ( | ( | ||||||||||||||||||||||||
Outstanding at March 31, 2020 |
2019 | 2007 | Lumara Health | Inducement | ||||||||||||||||||||||||||
Plan | Plan | 2013 Plan | Grants | Total | |||||||||||||||||||||||||
Outstanding at December 31, 2019 | |||||||||||||||||||||||||||||
Granted | |||||||||||||||||||||||||||||
Vested | ( | ( | ( | ( | |||||||||||||||||||||||||
Expired or terminated | ( | ( | ( | ( | |||||||||||||||||||||||||
Outstanding at March 31, 2020 |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Cost of product sales | $ | $ | |||||||||
Research and development | |||||||||||
Selling, general and administrative | |||||||||||
Total equity-based compensation expense | |||||||||||
Income tax effect | |||||||||||
After-tax effect of equity-based compensation expense | $ | $ |
Period | Future Minimum Lease Payments | ||||
Remainder of Year Ending December 31, 2020 | $ | ||||
Year Ending December 31, 2021 | |||||
Year Ending December 31, 2022 | |||||
Year Ending December 31, 2023 | |||||
Year Ending December 31, 2024 | |||||
Thereafter | |||||
Total | $ | ||||
Less: Interest | |||||
Operating lease liability | $ |
March 31, 2020 | December 31, 2019 | ||||||||||
2022 Convertible Notes | $ | $ | |||||||||
Total long-term debt | |||||||||||
Less: current maturities | |||||||||||
Long-term debt, net of current maturities | $ | $ |
2022 Convertible Notes | ||||||||
Liability component: | ||||||||
Principal | $ | |||||||
Less: debt discount and issuance costs, net | ||||||||
Net carrying amount | $ | |||||||
Gross equity component | $ | |||||||
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Contractual interest expense | $ | $ | |||||||||
Amortization of debt issuance costs | |||||||||||
Amortization of debt discount | |||||||||||
Total interest expense | $ | $ |
Workforce reduction | Contract termination | Other | Total | ||||||||||||||||||||
Balance accrued at December 31, 2019 | $ | $ | $ | $ | |||||||||||||||||||
Payments | ( | ( | |||||||||||||||||||||
Balance accrued at March 31, 2020 | $ | $ | $ | $ |
Three Months Ended March 31, | 2020 to 2019 | ||||||||||||||||||||||
2020 | 2019 | $ Change | % Change | ||||||||||||||||||||
Product sales, net | |||||||||||||||||||||||
Feraheme | $ | 44,433 | $ | 40,015 | $ | 4,418 | 11 | % | |||||||||||||||
Makena | 21,777 | 31,257 | (9,480) | (30) | % | ||||||||||||||||||
Intrarosa | 3,169 | 4,414 | (1,245) | (28) | % | ||||||||||||||||||
Other | (751) | 43 | (794) | <(100 %) | |||||||||||||||||||
Total product sales, net | $ | 68,628 | $ | 75,729 | $ | (7,101) | (9) | % |
Three Months Ended March 31, | 2020 to 2019 | ||||||||||||||||||||||||||||||||||
2020 | Percent of gross product sales | 2019 | Percent of gross product sales | $ Change | % Change | ||||||||||||||||||||||||||||||
Gross product sales | $ | 232,741 | $ | 211,718 | $ | 21,023 | 10 | % | |||||||||||||||||||||||||||
Provision for product sales allowances and accruals: | |||||||||||||||||||||||||||||||||||
Contractual adjustments | 143,175 | 62 | % | 108,884 | 51 | % | 34,291 | 31 | % | ||||||||||||||||||||||||||
Governmental rebates | 20,938 | 9 | % | 27,105 | 13 | % | (6,167) | (23) | % | ||||||||||||||||||||||||||
Total | 164,113 | 71 | % | 135,989 | 64 | % | 28,124 | 21 | % | ||||||||||||||||||||||||||
Product sales, net | $ | 68,628 | $ | 75,729 | $ | (7,101) | (9) | % |
Three Months Ended March 31, | 2020 to 2019 | ||||||||||||||||||||||
2020 | 2019 | $ Change | % Change | ||||||||||||||||||||
Direct cost of product sales | $ | 14,522 | $ | 14,535 | $ | (13) | — | % | |||||||||||||||
Amortization of intangible assets | 9,837 | 3,942 | 5,895 | >100 % | |||||||||||||||||||
$ | 24,359 | $ | 18,477 | $ | 5,882 | 32 | % | ||||||||||||||||
Direct cost of product sales as a percentage of net product sales | 21 | % | 19 | % |
Three Months Ended March 31, | 2020 to 2019 | ||||||||||||||||||||||
2020 | 2019 | $ Change | % Change | ||||||||||||||||||||
External research and development expenses | $ | 6,052 | $ | 12,499 | $ | (6,447) | (52) | % | |||||||||||||||
Internal research and development expenses | 5,128 | 5,567 | (439) | (8) | % | ||||||||||||||||||
Total research and development expenses | $ | 11,180 | $ | 18,066 | $ | (6,886) | (38) | % |
Three Months Ended March 31, | 2020 to 2019 | ||||||||||||||||||||||
2020 | 2019 | $ Change | % Change | ||||||||||||||||||||
Compensation, payroll taxes and benefits | $ | 29,227 | $ | 30,350 | $ | (1,123) | (4) | % | |||||||||||||||
Professional, consulting and other outside services | 19,958 | 41,013 | (21,055) | (51) | % | ||||||||||||||||||
Fair value of contingent consideration liability | — | (6) | 6 | (100) | % | ||||||||||||||||||
Equity-based compensation expense | 3,512 | 3,325 | 187 | 6 | % | ||||||||||||||||||
Total selling, general and administrative expenses | $ | 52,697 | $ | 74,682 | $ | (21,985) | (29) | % |
Three Months Ended March 31, | |||||||||||
2020 | 2019 | ||||||||||
Effective tax rate | — | % | — | % | |||||||
Income tax expense (benefit) | $ | 100 | $ | (137) |
March 31, 2020 | December 31, 2019 | $ Change | % Change | ||||||||||||||||||||
Cash and cash equivalents | $ | 54,455 | $ | 113,009 | $ | (58,554) | (52) | % | |||||||||||||||
Marketable securities | 70,288 | 58,742 | 11,546 | 20 | % | ||||||||||||||||||
Total | $ | 124,743 | $ | 171,751 | $ | (47,008) | (27) | % | |||||||||||||||
Outstanding principal on 2022 Convertible Notes | $ | 320,000 | $ | 320,000 | $ | — | — | % | |||||||||||||||
Total | $ | 320,000 | $ | 320,000 | $ | — | — | % |
March 31, 2020 | March 31, 2019 | $ Change | ||||||||||||||||||
Net cash used in operating activities | $ | (46,609) | $ | (89,908) | $ | 43,299 | ||||||||||||||
Net cash (used in) provided by investing activities | (10,718) | 11,336 | (22,054) | |||||||||||||||||
Net cash used in financing activities | (1,227) | (36,767) | 35,540 | |||||||||||||||||
Net decrease in cash, cash equivalents, and restricted cash | $ | (58,554) | $ | (115,339) | $ | 56,785 |
Period | Total Number of Shares Purchased (1) | Average Price Paid Per Share | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2) | Maximum Number of Shares (or approximate dollar value) That May Yet Be Purchased Under the Plans or Programs (2) | |||||||||||||||||||
January 1, 2020 through January 31, 2020 | 2,754 | $ | 12.33 | — | 3,019,737 | ||||||||||||||||||
February 1, 2020 through February 29, 2020 | 99,032 | 9.03 | — | 3,452,241 | |||||||||||||||||||
March 1, 2020 through March 31, 2020 | 36,399 | 7.74 | — | 4,329,267 | |||||||||||||||||||
Total | 138,185 | $ | 8.76 | — |
Exhibit Number | Description | |||||||
10.1 | ||||||||
10.2 | ||||||||
10.3+ | ||||||||
10.4+ | ||||||||
10.5+ | ||||||||
31.1+ | ||||||||
31.2+ | ||||||||
32.1++ | ||||||||
32.2++ | ||||||||
101.SCH+ | Inline XBRL Taxonomy Extension Schema Document | |||||||
101.CAL+ | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||
101.LAB+ | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||
101.PRE+ | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||
101.DEF+ | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||
104+ | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*) |
+ | Exhibits marked with a plus sign (“+”) are filed herewith. | ||||
++ | Exhibits marked with a double plus sign (“++”) are furnished herewith. |
AMAG PHARMACEUTICALS, INC. | |||||||||||
By: | /s/ Scott D. Myers | ||||||||||
Scott D. Myers | |||||||||||
President and Chief Executive Officer (Principal Executive Officer) | |||||||||||
Date: | May 11, 2020 | ||||||||||
AMAG PHARMACEUTICALS, INC. | |||||||||||
By: | /s/ Edward Myles | ||||||||||
Edward Myles | |||||||||||
Executive Vice President of Finance, Chief Financial Officer, Chief Operating Officer and Treasurer (Principal Financial and Accounting Officer) | |||||||||||
Date: | May 11, 2020 |
Incremental Number ofOption Shares Exercisable | Exercisability Date | ||||
_____________ (___%) | ____________ | ||||
_____________ (___%) | ____________ | ||||
_____________ (___%) | ____________ | ||||
_____________ (___%) | ____________ |
AMAG PHARMACEUTICALS, INC. | ||||||||||||||
By: | ||||||||||||||
Name: | Scott D. Myers | |||||||||||||
Title: | President and Chief Executive Officer | |||||||||||||
Dated: | |||||||||||||||||
Optionee's Signature | |||||||||||||||||
Optionee's name and address: | |||||||||||||||||
Incremental Number ofRestricted Stock Units Vested | Vesting Date | ||||
_____________ (___%) | _______________ | ||||
_____________ (___%) | _______________ | ||||
_____________ (___%) | _______________ | ||||
AMAG PHARMACEUTICALS, INC. | ||||||||||||||
By: | ||||||||||||||
Name: | Scott D. Myers | |||||||||||||
Title: | President and Chief Executive Officer | |||||||||||||
Dated: | |||||||||||||||||
Grantee's Signature | |||||||||||||||||
Grantee's name and address: | |||||||||||||||||
Date: | May 11, 2020 | |||||||
/s/ Scott D. Myers | ||||||||
Scott D. Myers | ||||||||
President and Chief Executive Officer (Principal Executive Officer) |
Date: | May 11, 2020 | |||||||
/s/ Edward Myles | ||||||||
Edward Myles | ||||||||
Executive Vice President of Finance, Chief Financial Officer and Treasurer (Principal Financial Officer) |
/s/ Scott D. Myers | |||||
Scott D. Myers | |||||
President and Chief Executive Officer | |||||
(Principal Executive Officer) | |||||
May 11, 2020 |
/s/ Edward Myles | |||||
Edward Myles | |||||
Executive Vice President of Finance, Chief Financial Officer and Treasurer | |||||
(Principal Financial Officer) | |||||
May 11, 2020 |
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CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2020 |
Mar. 31, 2019 |
|
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (24,491) | $ (122,084) |
Other comprehensive loss: | ||
Holding (losses) gains associated with marketable securities arising during period, net of tax | (548) | 609 |
Total comprehensive loss | $ (25,039) | $ (121,475) |
Basis of Presentation and Summary of Significant Accounting Policies |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of Presentation and Summary of Significant Accounting Policies | BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of our financial position and results of operations for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). In accordance with GAAP for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2019 (our “Annual Report”). Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report. Principles of Consolidation The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates and Assumptions The preparation of our condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including product sales revenue; product sales allowances and accruals; allowance for expected credit losses; marketable securities; inventory; fair value estimates used to assess impairment of long-lived assets, including goodwill and other intangible assets; debt obligations; certain accrued liabilities, including clinical trial accruals; equity-based compensation expense; and income taxes, inclusive of valuation allowances, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to contain or treat its impact, as well as the economic impact on local, regional and national customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results could differ materially from these estimates. Restricted Cash We classified $0.5 million of our cash as restricted cash, a non-current asset on the balance sheet, as of March 31, 2020 and December 31, 2019. This amount represented the security deposit delivered to the landlord of our Waltham, Massachusetts headquarters. Concentrations and Significant Customer Information Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. We currently hold our excess cash primarily in institutional money market funds, corporate debt securities, U.S. treasury and government agency securities and certificates of deposit. As of March 31, 2020, we did not have a material concentration in any single investment. Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. The following table sets forth customers who represented 10% or more of our total revenues for the three months ended March 31, 2020 and 2019:
Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors and specialty pharmacies. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for expected credit losses. At March 31, 2020 and December 31, 2019, three customers accounted for 10% or more of our accounts receivable balances, representing approximately 87% and 85% in the aggregate of our total accounts receivable, respectively. We are currently dependent on a single supplier for certain of our manufacturing processes, including for Feraheme drug substance (produced in two separate facilities) and a single supplier for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason. Credit Losses In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). We adopted Topic 326 effective January 1, 2020 using a modified retrospective approach. The adoption of Topic 326 did not have a material impact on our condensed consolidated financial statements and accordingly, no transition adjustment was recorded at the adoption date. Under Topic 326, we estimate expected credit losses for our trade receivables held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We also evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at the reporting date.
|
Subsequent Events (Details) - USD ($) $ in Thousands |
2 Months Ended | 3 Months Ended | |
---|---|---|---|
Jun. 30, 2020 |
Mar. 31, 2020 |
Mar. 31, 2019 |
|
Subsequent Event [Line Items] | |||
Restructuring expenses | $ 0 | $ 7,420 | |
Subsequent Event | Forecast | |||
Subsequent Event [Line Items] | |||
Percentage of expected employees displaced from company restructuring | 30.00% | ||
Restructuring expenses | $ 8,000 |
Current Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2020 |
Dec. 31, 2019 |
---|---|---|
Payables and Accruals [Abstract] | ||
Commercial rebates, fees and returns | $ 117,854 | $ 118,427 |
Manufacturing costs | 17,014 | 21,364 |
Salaries, bonuses, and other compensation | 16,356 | 18,693 |
Professional, license, and other fees and expenses | 10,232 | 13,392 |
Research and development expense | 2,270 | 3,539 |
Interest expense | 3,467 | 867 |
Restructuring expense | 468 | 797 |
Total accrued expenses | $ 167,661 | $ 177,079 |
Inventories (Details) - USD ($) $ in Thousands |
Mar. 31, 2020 |
Dec. 31, 2019 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 8,438 | $ 5,211 |
Work in process | 5,131 | 6,248 |
Finished goods | 20,107 | 20,094 |
Total inventories | $ 33,676 | $ 31,553 |
Inventories (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of major classes of inventories | Our major classes of inventories were as follows as of March 31, 2020 and December 31, 2019 (in thousands):
|
Basis of Presentation and Summary of Significant Accounting Policies (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of customers representing greater than 10% of revenue balances | The following table sets forth customers who represented 10% or more of our total revenues for the three months ended March 31, 2020 and 2019:
|
Income Taxes (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of effective income tax rate and income tax expense (benefit) | The following table summarizes our effective tax rate and income tax expense (benefit) for the three months ended March 31, 2020 and 2019 (in thousands except for percentages):
|
Inventories |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | INVENTORIES Our major classes of inventories were as follows as of March 31, 2020 and December 31, 2019 (in thousands):
|
Income Taxes |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | INCOME TAXES The following table summarizes our effective tax rate and income tax expense (benefit) for the three months ended March 31, 2020 and 2019 (in thousands except for percentages):
For the three months ended March 31, 2020, we recognized an immaterial income tax expense, representing an effective tax rate of 0%. The difference between the statutory federal tax rate of 21% and the effective tax rate of 0% for the three months ended March 31, 2020, was primarily attributable to the valuation allowance established against our current period losses generated. We have established a valuation allowance on our deferred tax assets to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. The income tax expense for the three months ended March 31, 2020 primarily related to state income taxes. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act was signed into law making several changes to the Internal Revenue Code. The changes include, but are not limited to, temporarily increasing the limitation on the amount of deductible interest expense, allowing taxpayers with alternative minimum tax credits to claim a refund for the entire amount of the credit instead of recovering the credit through refunds over a period of years, as required by the 2017 Tax Cuts and Jobs Act, allowing companies to carryback certain net operating losses, and temporarily increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income. The tax law changes in the CARES Act did not have a material impact on our income tax provision. For the three months ended March 31, 2019, we recognized an immaterial income tax benefit, representing an effective tax rate of 0%. The income tax benefit for the three months ended March 31, 2019 primarily related to state taxes and the offset of the recognition of the income tax expense recorded in other comprehensive loss associated with the increase in the fair value of the available-for-sale debt securities that we carried at fair market value during the period. The difference between the statutory federal tax rate of 21% and the effective tax rate of 0% for the three months ended March 31, 2019 was primarily attributable to the valuation allowance established against our current period losses generated and the non-deductible IPR&D expense related to the Perosphere acquisition.
|
Basis of Presentation and Summary of Significant Accounting Policies (Policies) |
3 Months Ended |
---|---|
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of our financial position and results of operations for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). In accordance with GAAP for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2019 (our “Annual Report”). Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report.
|
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
|
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of our condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including product sales revenue; product sales allowances and accruals; allowance for expected credit losses; marketable securities; inventory; fair value estimates used to assess impairment of long-lived assets, including goodwill and other intangible assets; debt obligations; certain accrued liabilities, including clinical trial accruals; equity-based compensation expense; and income taxes, inclusive of valuation allowances, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to contain or treat its impact, as well as the economic impact on local, regional and national customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results could differ materially from these estimates.
|
Concentrations and Significant Customer Information | Concentrations and Significant Customer InformationFinancial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. We currently hold our excess cash primarily in institutional money market funds, corporate debt securities, U.S. treasury and government agency securities and certificates of deposit.Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors and specialty pharmacies. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for expected credit losses.We are currently dependent on a single supplier for certain of our manufacturing processes, including for Feraheme drug substance (produced in two separate facilities) and a single supplier for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason. |
Recently Issued, Proposed and Adopted Accounting Pronouncements | Credit Losses In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). We adopted Topic 326 effective January 1, 2020 using a modified retrospective approach. The adoption of Topic 326 did not have a material impact on our condensed consolidated financial statements and accordingly, no transition adjustment was recorded at the adoption date. Under Topic 326, we estimate expected credit losses for our trade receivables held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We also evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at the reporting date. RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that are adopted by us as of the specified effective date. There were no applicable accounting pronouncements issued but not adopted as of March 31, 2020.RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We adopted ASU 2016-13 effective January 1, 2020. The adoption of ASU 2016-13 did not have a material impact on our condensed consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”) as part of its Simplification Initiative to reduce the cost and complexity in accounting for income taxes. ASU 2019-12 removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of GAAP. The guidance is effective for interim and annual periods beginning after December 15, 2020, with early adoption permitted. We adopted ASU 2019-12 effective January 1, 2020. The adoption of ASU 2019-12 did not have a material impact on our condensed consolidated financial statements.
|
Stockholders' Equity |
3 Months Ended |
---|---|
Mar. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY As of January 1, 2020, we had $26.8 million available under the share repurchase program initially approved by our Board of Directors in January 2016, which was updated in March 2019 to permit the repurchase of up to an aggregate of $80.0 million in shares of our common stock. During the three months ended March 31, 2020, we did not repurchase shares of common stock under this program. As of March 31, 2020, $26.8 million remains available for future repurchases under this program. |
Restructuring Expenses |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring Expenses | RESTRUCTURING EXPENSES In February 2019, we completed a restructuring to combine our women’s health and maternal health sales forces into one integrated sales team, which promotes Intrarosa, the Makena auto-injector and Vyleesi. Approximately 110 employees were displaced through this workforce reduction. We recorded one-time restructuring charges of $7.4 million primarily related to severance and related benefits on our condensed consolidated statement of operations during the first quarter of 2019. The remaining accrued restructuring charges incurred under this program will be paid in cash by the end of the first quarter of 2021. The following table displays a rollforward of the changes to the accrued balances as of March 31, 2020 (in thousands):
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Commitments and Contingencies - Narrative (Details) $ in Thousands |
3 Months Ended | ||||
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Nov. 06, 2019
defendant
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Sep. 25, 2019
USD ($)
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Mar. 31, 2020
USD ($)
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Mar. 31, 2019
USD ($)
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Dec. 31, 2019
USD ($)
|
|
Loss Contingencies [Line Items] | |||||
Operating lease, liability | $ 23,498 | ||||
Operating lease, right-of-use asset | $ 22,835 | $ 23,286 | |||
Weighted average remaining operating lease term | 7 years 8 months 12 days | ||||
Weighted average operating lease discount rate | 5.10% | ||||
Lease cost | $ 1,300 | $ 1,100 | |||
Operating cash outflows from operating leases | 1,200 | $ 1,200 | |||
Minimum purchase commitments | $ 99,200 | ||||
Amount of damages sought after by plaintiff | $ 50,000 | ||||
Civil Case In Saginaw Chippewa Indian Tribe V. Purdue Pharma Et Al | Pending Litigation | |||||
Loss Contingencies [Line Items] | |||||
Number of other pharmaceutical companies named as defendants | defendant | 40 | ||||
Minimum | |||||
Loss Contingencies [Line Items] | |||||
Remaining operating lease term | 1 year | ||||
Maximum | |||||
Loss Contingencies [Line Items] | |||||
Remaining operating lease term | 8 years |
Restructuring Expenses (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of components of restructuring expenses | The following table displays a rollforward of the changes to the accrued balances as of March 31, 2020 (in thousands):
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Earnings Per Share (Tables) |
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Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of components of basic and diluted earnings per share | The components of basic and diluted earnings per share for the three months ended March 31, 2020 and 2019 were as follows (in thousands, except per share data):
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Schedule of anti-dilutive securities from computation of diluted net income (loss) per share | The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of restricted stock units (“RSUs”), and the conversion of the 2022 Convertible Notes, which were excluded from our computation of diluted net loss per share because their inclusion would have been anti-dilutive (in thousands):
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Revenue Recognition - Disaggregated Revenue By Products (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2020 |
Mar. 31, 2019 |
|
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 68,661 | $ 75,804 |
Feraheme | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 44,433 | 40,015 |
Makena | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 21,777 | 31,257 |
Intrarosa | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 3,169 | 4,414 |
Other | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ (751) | $ 43 |
Equity-Based Compensation |
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Share-based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity-Based Compensation | EQUITY-BASED COMPENSATION We currently maintain three equity compensation plans; our 2019 Equity Incentive Plan (the “2019 Plan”), which was approved by our stockholders at our 2019 annual meeting and replaced our Fourth Amended and Restated 2007 Equity Incentive Plan (the “2007 Plan”), the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (the “Lumara Health 2013 Plan”) and our 2015 Employee Stock Purchase Plan (“2015 ESPP”). All outstanding stock options granted under each of our equity compensation plans other than our 2015 ESPP have an exercise price equal to the closing price of a share of our common stock on the grant date. Stock Options The following table summarizes stock option activity for the three months ended March 31, 2020:
Restricted Stock Units The following table summarizes RSU activity for the three months ended March 31, 2020:
Equity-Based Compensation Expense Equity-based compensation expense for the three months ended March 31, 2020 and 2019 consisted of the following (in thousands):
In addition to the equity-based compensation expense presented in the table above, we incurred $0.7 million of equity-based compensation expense related to the restructuring activities during the first quarter of 2019, (as discussed further in Note R, below), which is classified within restructuring expense on our condensed consolidated statement of operations for the three months ended March 31, 2019.
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Debt |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt | DEBT Our outstanding debt obligations as of March 31, 2020 and December 31, 2019 consisted of the following (in thousands):
Convertible Notes The outstanding balance of our 2022 Convertible Notes as of March 31, 2020 consisted of the following (in thousands):
In accordance with accounting guidance for debt with conversion and other options, we separately account for the liability and equity components of our 2022 Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option (the “Equity Component”) due to our ability to settle the 2022 Convertible Notes in cash, common stock or a combination of cash and common stock, at our option. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The Equity Component of the 2022 Convertible Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the 2022 Convertible Notes and the fair value of the liability of the 2022 Convertible Notes on the date of issuance. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense using the effective interest method over five years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. 2022 Convertible Notes In the second quarter of 2017, we issued $320.0 million aggregate principal amount of convertible senior notes due in 2022 (the “2022 Convertible Notes”) and received net proceeds of $310.4 million from the sale of the 2022 Convertible Notes, after deducting fees and expenses of $9.6 million. The approximate $9.6 million of debt issuance costs primarily consisted of underwriting, legal and other professional fees, and we allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $9.6 million of debt issuance costs, $2.2 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $7.4 million was allocated to the liability component and is now recorded as a reduction of the 2022 Convertible Notes on our condensed consolidated balance sheets. The portion allocated to the liability component is amortized to interest expense using the effective interest method over five years. The 2022 Convertible Notes are governed by the terms of an indenture between us, as issuer, and Wilmington Trust, National Association, as the trustee. The 2022 Convertible Notes are senior unsecured obligations and bear interest at a rate of 3.25% per year, payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2017. The 2022 Convertible Notes will mature on June 1, 2022, unless earlier repurchased or converted. Upon conversion of the 2022 Convertible Notes, such 2022 Convertible Notes will be convertible into, at our election, cash, shares of our common stock, or a combination thereof, at a conversion rate of 36.5464 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which corresponds to an initial conversion price of approximately $27.36 per share of our common stock. The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends. At any time prior to the close of business on the business day immediately preceding March 1, 2022, holders may convert their 2022 Convertible Notes at their option only under the following circumstances: 1)during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; 2)during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of the 2022 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; or 3)upon the occurrence of specified corporate events. On or after March 1, 2022, until the close of business on the business day immediately preceding the maturity date, holders may convert all or any portion of their 2022 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances. The 2022 Convertible Notes were not convertible as of March 31, 2020. We determined the expected life of the debt was equal to the -year term on the 2022 Convertible Notes. The effective interest rate on the liability component was 9.49% for the period from the date of issuance through March 31, 2020. As of March 31, 2020, the “if-converted value” did not exceed the remaining principal amount of the 2022 Convertible Notes. 2019 Convertible Notes In February 2014, we issued $200.0 million aggregate principal amount of the 2019 Convertible Notes. During 2017, we entered into privately negotiated transactions with certain investors to repurchase approximately $178.5 million aggregate principal amount of the 2019 Convertible Notes for an aggregate repurchase price of approximately $192.7 million, including accrued interest. The remaining $21.4 million of 2019 Convertible Notes matured on February 15, 2019 and were settled with cash. Convertible Notes Interest Expense The following table sets forth total interest expense recognized related to the Convertible Notes during the three months ended March 31, 2020 and 2019 (in thousands):
Future Payments Future annual principal payments on our long-term debt as of March 31, 2020 include $320.0 million due during the year ending December 31, 2022.
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Subsequent Events |
3 Months Ended |
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Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS In May 2020, we announced a restructuring to reduce the size of our organization in conjunction with the divestiture of Intrarosa and Vyleesi and expected declines in our revenue due to the COVID-19 pandemic. Approximately 30 percent of the workforce is being displaced through this workforce reduction. We expect to record a one-time restructuring charge of approximately $8.0 million primarily related to severance and related benefits in the second quarter of 2020 and expect the workforce reduction to be substantially completed by the end of the second quarter of 2020. |
Accumulated Other Comprehensive Loss (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2020 |
Mar. 31, 2019 |
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AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||
Beginning balance | $ 286,119 | $ 746,655 |
Holding (losses) gains associated with marketable securities arising during period, net of tax | (548) | 609 |
Ending balance | 263,738 | 614,719 |
Accumulated Other Comprehensive Loss | ||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||
Beginning balance | (3,239) | (3,985) |
Ending balance | $ (3,787) | $ (3,376) |
Stockholders' Equity (Details) - USD ($) |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2020 |
Jan. 01, 2020 |
Mar. 31, 2019 |
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Equity [Abstract] | |||
Share repurchase program, remaining authorized amount | $ 26,800,000 | $ 26,800,000 | |
Share repurchase program, authorized amount | $ 80,000,000.0 | ||
Common stock repurchased and retired (in shares) | 0 |
Revenue Recognition - Total Gross Product (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2020 |
Mar. 31, 2019 |
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Provision for product sales allowances and accruals: | ||
Revenues | $ 68,661 | $ 75,804 |
Product Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Gross product sales | 232,741 | 211,718 |
Provision for product sales allowances and accruals: | ||
Contractual adjustments | 143,175 | 108,884 |
Governmental rebates | 20,938 | 27,105 |
Total | 164,113 | 135,989 |
Revenues | $ 68,628 | $ 75,729 |
Description of Business (Details) |
3 Months Ended |
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Mar. 31, 2020
productCandidate
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of product candidates | 2 |
Equity-Based Compensation (Tables) |
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Share-based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of details regarding stock option activity | The following table summarizes stock option activity for the three months ended March 31, 2020:
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Summary of details regarding restricted stock activity | The following table summarizes RSU activity for the three months ended March 31, 2020:
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Schedule of equity-based compensation expense | Equity-based compensation expense for the three months ended March 31, 2020 and 2019 consisted of the following (in thousands):
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Description of Business |
3 Months Ended |
---|---|
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products and product candidates across a range of therapeutic areas. Our currently marketed products support the health of patients in the areas of hematology and maternal and women’s health, including Feraheme® (ferumoxytol injection) for intravenous use, Makena® (hydroxyprogesterone caproate injection) auto-injector, Intrarosa® (prasterone) vaginal inserts and Vyleesi® (bremelanotide injection). In addition to our approved products, our portfolio includes two product candidates, AMAG-423 (digoxin immune fab (ovine)), which is being studied for the treatment of severe preeclampsia, and ciraparantag, which is being studied as an anticoagulant reversal agent. In December 2019, we completed a review of our product portfolio and strategy. This strategic review resulted in our intention to divest Intrarosa® (prasterone) and Vyleesi® (bremelanotide injection), as announced in January 2020. We determined that these anticipated actions did not result in the related assets meeting the criteria to be recorded as held for sale at March 31, 2020. Throughout this Quarterly Report on Form 10-Q, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “AMAG,” “we,” “us,” or “our.” COVID-19 The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption on a global scale, including in the United States, where we market our products, where our operations and employees reside and where we conduct clinical trials, as well as in Europe and other countries where we are conducting our AMAG-423 Phase 2b/3a study. The COVID-19 pandemic did not significantly impact our financial results during the three months ended March 31, 2020, but will likely impact our financial results in future periods in 2020. The extent to which the COVID-19 pandemic impacts our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict. While there have been no material impairments to date, any prolonged material disruptions to our sales, supply, research and development efforts and/or operations could negatively impact the Company’s business, operations and/or financial results.
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Debt - Total Interest Expense Recognized Related to the Convertible Notes (Details) - Convertible Debt - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2020 |
Mar. 31, 2019 |
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Debt Instrument [Line Items] | ||
Contractual interest expense | $ 2,600 | $ 2,667 |
Amortization of debt issuance costs | 370 | 354 |
Amortization of debt discount | 3,634 | 3,429 |
Total interest expense | $ 6,604 | $ 6,450 |
Fair Value Measurements - Debt (Details) $ in Millions |
Mar. 31, 2020
USD ($)
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Senior Convertible Notes Due 2022 | Significant Other Observable Inputs (Level 2) | |
Debt | |
Fair value of debt | $ 247.7 |
Goodwill and Intangible Assets, Net - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | |
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Mar. 31, 2020 |
Mar. 31, 2019 |
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Goodwill and Intangible Assets Disclosure [Abstract] | ||
Weighted average remaining amortization period for finite-lived intangible assets | 1 year | |
Amortization of finite-lived intangible assets | $ 9.8 | $ 3.9 |
Accumulated Other Comprehensive Loss (Tables) |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of changes in accumulated other comprehensive loss | The following table summarizes the changes in the accumulated balances of other comprehensive loss during the three months ended March 31, 2020 and 2019 (in thousands):
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Property and Equipment, Net (Tables) |
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Schedule of property and equipment, net | Property and equipment, net consisted of the following as of March 31, 2020 and December 31, 2019 (in thousands):
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Revenue Recognition (Tables) |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disaggregated revenue | The following table provides information about disaggregated revenue by products for the three months ended March 31, 2020 and 2019 (in thousands):
Total gross product sales were offset by product sales allowances and accruals for the three months ended March 31, 2020 and 2019 as follows (in thousands):
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Product revenue allowance and accrual activity | The following table summarizes the product revenue allowance and accrual activity for the three months ended March 31, 2020 (in thousands):
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Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | FAIR VALUE MEASUREMENTS The following tables present information about our assets and liabilities that we measure at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques utilized to determine such fair value as of March 31, 2020 and December 31, 2019 (in thousands):
Cash Equivalents Our cash equivalents are classified as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets and do not have any restrictions on redemption. As of March 31, 2020 and December 31, 2019, cash equivalents were primarily comprised of funds in money market accounts. Marketable Securities Our marketable securities are classified as Level 2 assets under the fair value hierarchy as the values of these assets are primarily determined from independent pricing services, which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based upon other significant observable market transactions. At the end of each reporting period, we perform quantitative and qualitative analysis of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analysis, we did not adjust or override any fair value measurements provided by our pricing services as of March 31, 2020. In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during the three months ended March 31, 2020. Debt We estimate the fair value of our debt obligations using quoted market prices obtained from third-party pricing services, which are classified as Level 2 inputs. As of March 31, 2020, the estimated fair value of our 2022 Convertible Notes (as defined below) was $247.7 million, which differed from its carrying value. See Note Q, “Debt” for additional information on our debt obligations.
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Current Liabilities |
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Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Current Liabilities | CURRENT LIABILITIES Accrued expenses consisted of the following as of March 31, 2020 and December 31, 2019 (in thousands):
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Commitments and Contingencies |
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Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Commitments Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. These include commitments related to our facility and vehicle leases, purchases of inventory, debt obligations, and other purchase obligations. Operating Lease Obligations As of March 31, 2020, we had operating lease liabilities of $23.5 million and related right-of-use assets of $22.8 million related to operating leases for real estate, including our corporate headquarters, vehicles and office equipment. As of March 31, 2020, our leases have remaining terms of to eight years. The weighted average remaining lease term and discount rate for our operating leases was 7.7 years and 5.1% at March 31, 2020, respectively. Lease costs for our operating leases were $1.3 million and $1.1 million for the three months ended March 31, 2020 and 2019, respectively. Operating cash outflows for operating leases were $1.2 million for each of the three months ended March 31, 2020 and 2019, respectively. Future minimum payments under our non-cancelable operating leases as of March 31, 2020 are as follows (in thousands):
Purchase Obligations Purchase obligations primarily represent minimum purchase commitments for inventory. As of March 31, 2020, our minimum purchase commitments totaled $99.2 million. Contingent Regulatory and Commercial Milestone Payments We are required to make payments contingent on the achievement of certain regulatory and/or commercial milestones under the terms of our collaboration, license and other strategic agreements. Please refer to Note P, “Acquisitions, Collaboration, License and Other Strategic Agreements” for additional details regarding these contingent payments. Contingencies Legal Proceedings We accrue a liability for legal contingencies when we believe that it is both probable that a liability has been incurred and that we can reasonably estimate the amount of the loss. We review these accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made. For certain matters referenced below, the liability is not probable or the amount cannot be reasonably estimated and, therefore, accruals have not been made. In addition, in accordance with the relevant authoritative guidance, for any matters in which the likelihood of material loss is at least reasonably possible, we will provide disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, we will provide disclosure to that effect. We expense legal costs as they are incurred. On November 6, 2019, we were served with a summons in a case filed in the U.S. District Court, Northern District of Ohio, captioned Civil Case in Saginaw Chippewa Indian Tribe v. Purdue Pharma et al (Case No. 1-19-op-45841). The complaint names K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), certain of its successor entities, subsidiaries and affiliate entities as defendants, along with over forty other pharmaceutical companies. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it and its then-existing subsidiaries became our wholly-owned subsidiaries. The plaintiff in this action alleges that KV’s subsidiary, Ethex Corporation (as well as the other pharmaceutical companies named in the complaint), manufactured, promoted, sold, and distributed opioids, including a generic version of morphine. Defendants KV and Ethex Corporation were dismissed without prejudice from this Chippewa case pursuant to an order dated March 26, 2020. KV and Ethex were also named but not served in several other similar cases and were dismissed without prejudice from these other cases by orders dated March 26, 2020. On November 1, 2019, we were named as a defendant in a class action lawsuit filed in the United States District Court for the Western District of Missouri, captioned Barnes v. AMAG Pharmaceuticals, Inc., Case No. 3:19-cv-05088-RK (W.D. Mo.). Subsequently, other plaintiffs represented by the same law firm filed similar class action lawsuits in other jurisdictions, and the lawsuits have been consolidated in the United States District Court for the District of New Jersey, Zamfirova et al. v. AMAG Pharmaceuticals, Inc., Case No. 20-00152-JMV-SCM (April 2, 2020). The plaintiffs in this action, on behalf of themselves and purported state-wide classes of similarly situated consumers in California, Kansas, Missouri, New Jersey, New York, and Wisconsin, assert claims for violation of state consumer protection laws and unjust enrichment based on allegations that we and/or our predecessor companies made misrepresentations and omissions regarding the effectiveness of Makena in connection with the sale and marketing of that product from 2011 through the present. Because this case is at the earliest stage, we are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any. On August 29, 2019, Lunar Representative, LLC (“Plaintiff”), on behalf of the former equity holders of Lumara Health Inc. (“Lumara”), filed a complaint against us in the Delaware Court of Chancery, captioned Lunar Representative, LLC v. AMAG Pharmaceuticals, Inc. (No. 2019-0688-JTL). On September 25, 2019, we filed a motion to dismiss the complaint. On January 9, 2020, Plaintiff filed an amended complaint. Plaintiff alleges that we did not exercise commercially reasonable efforts to market and sell the drug product Makena, and failed to achieve sales milestones for Makena, in breach of certain provisions of the September 28, 2014 Agreement and Plan of Merger between, among other parties, us and Lumara. Plaintiff filed an amended complaint on January 9, 2020. On January 24, 2020, we filed a motion to dismiss the amended complaint and filed our opening brief in support of such motion to dismiss the amended complaint on April 14, 2020. Plaintiff is seeking damages of $50.0 million, together with pre- and post-judgment interest, as well as attorneys’ fees and costs. At this time, based on available information, we are unable to reasonably assess the ultimate outcome of this case or determine an estimate, or a range of estimates, of potential losses. We believe this lawsuit is without merit and intend to vigorously defend against the allegations. On or about April 6, 2016, we received Notice of a Lawsuit and Request to Waive Service of a Summons in a case entitled Plumbers’ Local Union No. 690 Health Plan v. Actavis Group et. al. (“Plumbers’ Union”), which was filed in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania and, after removal to federal court, is now pending in the United States District Court for the Eastern District of Pennsylvania (Civ. Action No. 16-65-AB). Thereafter, we were also made aware of a related complaint entitled Delaware Valley Health Care Coalition v. Actavis Group et. al. (“Delaware Valley”), which was filed with the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania District Court of Pennsylvania (Case ID: 160200806). The complaints name K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), certain of its successor entities, subsidiaries and affiliate entities (the “Subsidiaries”), along with a number of other pharmaceutical companies. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. We have not been served with process or waived service of summons in either case. The actions are being brought alleging unfair and deceptive trade practices with regard to certain pricing practices that allegedly resulted in certain payers overpaying for certain of KV’s generic products. On July 21, 2016, the Plaintiff in the Plumbers’ Union case dismissed KV with prejudice to refiling and on October 6, 2016, all claims against the Subsidiaries were dismissed without prejudice. We are in discussions with Plaintiff’s counsel to similarly dismiss all claims in the Delaware Valley case. Because we have not been served with process in the Delaware Valley case, we are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any. On July 20, 2015, the Federal Trade Commission (the “FTC”) notified us that it is conducting an investigation into whether Lumara Health or its predecessor engaged in unfair methods of competition with respect to Makena or any hydroxyprogesterone caproate product. As previously disclosed, we provided the FTC with a response in August 2015. We believe we have fully cooperated with the FTC and we have had no further interactions with the FTC on this matter since we provided our response to the FTC in August 2015. For further information on this matter, see Note P, “Commitments and Contingencies” to our Annual Report. We may periodically become subject to other legal proceedings and claims arising in connection with ongoing business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the above actions, we are not aware of any material claims against us as of March 31, 2020.
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Recently Issued and Proposed Accounting Pronouncements |
3 Months Ended |
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Mar. 31, 2020 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Issued and Proposed Accounting Pronouncements | RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that are adopted by us as of the specified effective date. There were no applicable accounting pronouncements issued but not adopted as of March 31, 2020. |
Debt (Tables) |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of outstanding debt obligations | Our outstanding debt obligations as of March 31, 2020 and December 31, 2019 consisted of the following (in thousands):
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Schedule of outstanding convertible debt | The outstanding balance of our 2022 Convertible Notes as of March 31, 2020 consisted of the following (in thousands):
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Schedule of total interest expense recognized related to the convertible debt | The following table sets forth total interest expense recognized related to the Convertible Notes during the three months ended March 31, 2020 and 2019 (in thousands):
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Commitments and Contingencies - Operating Leases Maturity (Details) $ in Thousands |
Mar. 31, 2020
USD ($)
|
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Commitments and Contingencies Disclosure [Abstract] | |
Remainder of Year Ending December 31, 2020 | $ 3,076 |
Year Ending December 31, 2021 | 3,357 |
Year Ending December 31, 2022 | 3,898 |
Year Ending December 31, 2023 | 3,261 |
Year Ending December 31, 2024 | 3,246 |
Thereafter | 12,192 |
Total | 29,030 |
Less: Interest | 5,532 |
Operating lease liability | $ 23,498 |
Income Taxes - Schedule of Effective Income Tax Rate and Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands |
3 Months Ended | |
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Mar. 31, 2020 |
Mar. 31, 2019 |
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Income Tax Disclosure [Abstract] | ||
Effective tax rate | 0.00% | 0.00% |
Income tax expense (benefit) | $ 100 | $ (137) |
Marketable Securities - Narrative (Details) - USD ($) |
3 Months Ended | |
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Mar. 31, 2020 |
Mar. 31, 2019 |
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Investments, Debt and Equity Securities [Abstract] | ||
Allowance for credit losses on marketable securities recognized within consolidated statements of operations | $ 0 | |
Marketable securities, losses in an unrealized loss position for more than one year | $ 0 | $ 0 |
Other-than-temporary impairment losses recognized within consolidated statements of operations | $ 0 |
Property and Equipment, Net (Details) - USD ($) $ in Thousands |
Mar. 31, 2020 |
Dec. 31, 2019 |
---|---|---|
Property, plant and equipment, net | ||
Property and equipment, gross | $ 14,781 | $ 15,492 |
Less: accumulated depreciation | (11,469) | (11,376) |
Property and equipment, net | 3,312 | 4,116 |
Computer equipment and software | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 1,568 | 1,568 |
Furniture and fixtures | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 1,714 | 1,714 |
Leasehold improvements | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 4,985 | 4,984 |
Laboratory and production equipment | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 6,278 | 6,570 |
Construction in progress | ||
Property, plant and equipment, net | ||
Property and equipment, gross | $ 236 | $ 656 |
Restructuring Expenses - Components of Restructuring Expenses (Details) $ in Thousands |
3 Months Ended |
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Mar. 31, 2020
USD ($)
| |
Restructuring Reserve [Roll Forward] | |
Accrued restructuring, beginning of period | $ 797 |
Payments | (329) |
Accrued restructuring, end of period | 468 |
Workforce reduction | |
Restructuring Reserve [Roll Forward] | |
Accrued restructuring, beginning of period | 797 |
Payments | (329) |
Accrued restructuring, end of period | 468 |
Contract termination | |
Restructuring Reserve [Roll Forward] | |
Accrued restructuring, beginning of period | 0 |
Payments | 0 |
Accrued restructuring, end of period | 0 |
Other | |
Restructuring Reserve [Roll Forward] | |
Accrued restructuring, beginning of period | 0 |
Payments | 0 |
Accrued restructuring, end of period | $ 0 |
Debt - Outstanding Convertible Note Balances (Details) - USD ($) $ in Thousands |
Mar. 31, 2020 |
Dec. 31, 2019 |
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Liability component: | ||
Total long-term debt | $ 281,038 | $ 277,034 |
Convertible Debt | 2022 Convertible Notes | ||
Liability component: | ||
Principal | 320,000 | |
Less: debt discount and issuance costs, net | 38,962 | |
Total long-term debt | 281,038 | $ 277,034 |
Gross equity component | $ 72,576 |
Accumulated Other Comprehensive Loss |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accumulated Other Comprehensive Loss | ACCUMULATED OTHER COMPREHENSIVE LOSS The following table summarizes the changes in the accumulated balances of other comprehensive loss during the three months ended March 31, 2020 and 2019 (in thousands):
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Revenue Recognition |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition | REVENUE RECOGNITION Product Revenue and Allowances and Accruals The following table provides information about disaggregated revenue by products for the three months ended March 31, 2020 and 2019 (in thousands):
Total gross product sales were offset by product sales allowances and accruals for the three months ended March 31, 2020 and 2019 as follows (in thousands):
The following table summarizes the product revenue allowance and accrual activity for the three months ended March 31, 2020 (in thousands):
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Property and Equipment, Net |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net | PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following as of March 31, 2020 and December 31, 2019 (in thousands):
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Current Liabilities (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of accrued expenses | Accrued expenses consisted of the following as of March 31, 2020 and December 31, 2019 (in thousands):
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Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of assets and liabilities measured at fair value on a recurring basis | The following tables present information about our assets and liabilities that we measure at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques utilized to determine such fair value as of March 31, 2020 and December 31, 2019 (in thousands):
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Goodwill and Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2020 |
Dec. 31, 2019 |
---|---|---|
Amortizable intangible assets: | ||
Cost | $ 216,755 | $ 216,755 |
Accumulated amortization | 51,681 | 41,844 |
Cumulative impairments | 151,291 | 151,291 |
Net | 13,783 | 23,620 |
Makena auto-injector developed technology | Developed Technology Rights | ||
Amortizable intangible assets: | ||
Cost | 79,100 | 79,100 |
Accumulated amortization | 17,755 | 15,782 |
Cumulative impairments | 55,426 | 55,426 |
Net | 5,919 | 7,892 |
Intrarosa developed technology | Developed Technology Rights | ||
Amortizable intangible assets: | ||
Cost | 77,655 | 77,655 |
Accumulated amortization | 18,786 | 16,798 |
Cumulative impairments | 56,881 | 56,881 |
Net | 1,988 | 3,976 |
Vyleesi developed technology | Developed Technology Rights | ||
Amortizable intangible assets: | ||
Cost | 60,000 | 60,000 |
Accumulated amortization | 15,140 | 9,264 |
Cumulative impairments | 38,984 | 38,984 |
Net | $ 5,876 | $ 11,752 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Mar. 31, 2020 |
Dec. 31, 2019 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 2,000,000 | 2,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 117,500,000 | 117,500,000 |
Common stock, shares issued (in shares) | 34,266,256 | 33,999,081 |
Common stock, shares outstanding (in shares) | 34,266,256 | 33,999,081 |
Restructuring Expenses - Narrative (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | |
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Feb. 28, 2019
employee
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Mar. 31, 2020
USD ($)
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Mar. 31, 2019
USD ($)
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Restructuring and Related Activities [Abstract] | |||
Number of employees displaced through workforce reduction | employee | 110 | ||
Restructuring charges | $ | $ 0 | $ 7,420 |
Debt - Schedule of Outstanding Debt Obligations (Details) - USD ($) $ in Thousands |
Mar. 31, 2020 |
Dec. 31, 2019 |
---|---|---|
Debt Instrument [Line Items] | ||
Total long-term debt | $ 281,038 | $ 277,034 |
Less: current maturities | 0 | 0 |
Long-term debt, net of current maturities | 281,038 | 277,034 |
Convertible Debt | 2022 Convertible Notes | ||
Debt Instrument [Line Items] | ||
Total long-term debt | $ 281,038 | $ 277,034 |
Marketable Securities |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable Securities | MARKETABLE SECURITIESAs of March 31, 2020 and December 31, 2019, our marketable securities consisted of securities classified as available-for-sale in accordance with accounting standards which provide guidance related to accounting and classification of certain investments in marketable securities. The following is a summary of our marketable securities as of March 31, 2020 and December 31, 2019 (in thousands):
* Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets.
* Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets. Impairments and Unrealized Gains and Losses on Marketable Securities We adopted Topic 326 effective January 1, 2020. Under Topic 326, we evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at March 31, 2020. We did not recognize any allowance for credit losses on our condensed consolidated statements of operations related to our marketable securities during the three months ended March 31, 2020. As of March 31, 2020, we had no losses in an unrealized loss position for more than one year. Based on the contractual terms and credit ratings of these investments, we expect to recover the entire amortized cost basis of each security. We do not intend to sell the investments and it is not more likely than not that we will be required to sell the investments before recovery of their amortized cost bases. We considered various factors, including the length of time that each security was in an unrealized loss position and our ability and intent to hold these securities until the recovery of their amortized cost basis occurs. Future events may occur, or additional information may become available, which may cause us to identify credit losses where we do not expect to receive cash flows sufficient to recover the entire amortized cost basis of a security and may necessitate the recording of future realized losses on securities in our portfolio. Significant losses in the estimated fair values of our marketable securities could have a material adverse effect on our earnings in future periods. As of March 31, 2019, we had no material losses in an unrealized loss position for more than one year and did not recognize any other-than-temporary impairment losses in our condensed consolidated statements of operations related to our marketable securities during the three months ended March 31, 2019.
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets, Net | GOODWILL AND INTANGIBLE ASSETS, NET Goodwill During the first quarter, as a result of a number of business factors, including our market capitalization being below our carrying value and the potential impact of the COVID-19 pandemic, we performed a qualitative interim impairment assessment of our goodwill balance as of March 31, 2020. We determined that it was not more likely than not that the fair value of our reporting unit was less than its carrying value and therefore, did not perform a quantitative interim impairment test as of March 31, 2020. Our qualitative assessment was based on management’s estimates and assumptions, a number of which are dependent on external factors, including the severity and duration of the COVID-19 pandemic. To the extent actual results differ materially from these estimates and we experience further negative developments in subsequent periods, interim impairment assessments could be required, which could result in an impairment of goodwill. Intangible Assets As of March 31, 2020 and December 31, 2019, our intangible assets consisted of the following (in thousands):
As of March 31, 2020, the weighted average remaining amortization period for our finite-lived intangible assets was less than one year. Total amortization expense for the three months ended March 31, 2020 and 2019 was $9.8 million and $3.9 million, respectively. Amortization expense is recorded in cost of product sales on our condensed consolidated statements of operations. We expect our finite-lived intangible assets to be fully amortized in 2020.
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Earnings Per Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share | EARNINGS PER SHARE The components of basic and diluted earnings per share for the three months ended March 31, 2020 and 2019 were as follows (in thousands, except per share data):
The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of restricted stock units (“RSUs”), and the conversion of the 2022 Convertible Notes, which were excluded from our computation of diluted net loss per share because their inclusion would have been anti-dilutive (in thousands):
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Goodwill and Intangible Assets, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of finite-lived intangible assets | As of March 31, 2020 and December 31, 2019, our intangible assets consisted of the following (in thousands):
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Marketable Securities (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of marketable securities | The following is a summary of our marketable securities as of March 31, 2020 and December 31, 2019 (in thousands):
* Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets.
* Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets.
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