Cover Page
Cover Page - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 14, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 0-30739 | ||
Entity Registrant Name | INSMED INC | ||
Entity Incorporation, State or Country Code | VA | ||
Entity Tax Identification Number | 54-1972729 | ||
Entity Address, Address Line One | 700 US Highway 202/206 | ||
Entity Address, City or Town | Bridgewater | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08807 | ||
City Area Code | 908 | ||
Local Phone Number | 977-9900 | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Trading Symbol | INSM | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 3.2 | ||
Entity Common Stock, Shares Outstanding | 118,904,589 | ||
Documents Incorporated by Reference | Portions of the registrant's definitive Proxy Statement for its 2022 Annual Meeting of Shareholders to be filed with the Securities and Exchange Commission no later than May 2, 2022 an | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001104506 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Iselin, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 716,782 | $ 532,756 |
Accounts receivable | 24,351 | 16,562 |
Inventory | 67,009 | 49,592 |
Prepaid expenses and other current assets | 28,898 | 23,982 |
Total current assets | 837,040 | 622,892 |
Marketable securities | 50,043 | 0 |
Fixed assets, net | 52,955 | 53,953 |
Finance lease right-of-use assets | 9,256 | 10,334 |
Operating lease right-of-use assets | 33,305 | 32,946 |
Intangibles, net | 73,809 | 49,261 |
Goodwill | 136,110 | 0 |
Other assets | 50,990 | 26,769 |
Total assets | 1,243,508 | 796,155 |
Current liabilities: | ||
Accounts payable | 35,784 | 42,853 |
Accrued liabilities | 60,665 | 37,807 |
Accrued compensation | 28,581 | 25,591 |
Finance lease liabilities | 609 | 1,081 |
Operating lease liabilities | 9,527 | 11,475 |
Total current liabilities | 135,166 | 118,807 |
Debt, long-term | 566,588 | 356,318 |
Contingent consideration | 75,668 | 0 |
Finance lease liabilities, long-term | 14,103 | 14,713 |
Operating lease liabilities, long-term | 21,441 | 21,255 |
Other long-term liabilities | 20,074 | 9,178 |
Total liabilities | 833,040 | 520,271 |
Shareholders' equity: | ||
Common stock, $0.01 par value; 500,000,000 authorized shares, 118,738,266 and 102,763,060 issued and outstanding shares at December 31, 2021 and December 31, 2020, respectively | 1,187 | 1,028 |
Additional paid-in capital | 2,673,556 | 2,105,252 |
Accumulated deficit | (2,265,243) | (1,830,589) |
Accumulated other comprehensive income | 968 | 193 |
Total shareholders' equity | 410,468 | 275,884 |
Total liabilities and shareholders' equity | $ 1,243,508 | $ 796,155 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Shareholders' equity: | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized shares (in shares) | 500,000,000 | 500,000,000 |
Common stock, issued shares (in shares) | 118,738,266 | 102,763,060 |
Common stock, outstanding shares (in shares) | 118,738,266 | 102,763,060 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Product revenues, net | $ 188,461 | $ 164,413 | $ 136,467 |
Revenue from Contract with Customer, Product and Service [Extensible Enumeration] | Product [Member] | Product [Member] | Product [Member] |
Operating expenses: | |||
Cost of product revenues (excluding amortization of intangible assets) | $ 44,152 | $ 39,872 | $ 24,212 |
Cost, Product and Service [Extensible Enumeration] | Product [Member] | Product [Member] | Product [Member] |
Research and development | $ 272,744 | $ 181,157 | $ 131,711 |
Selling, general and administrative | 234,273 | 203,613 | 210,796 |
Amortization of intangible assets | 5,052 | 5,003 | 4,993 |
Change in fair value of deferred and contingent consideration liabilities | 7,334 | 0 | 0 |
Total operating expenses | 563,555 | 429,645 | 371,712 |
Operating loss | (375,094) | (265,232) | (235,245) |
Investment income | 174 | 1,703 | 9,921 |
Interest expense | (40,473) | (29,564) | (27,705) |
Loss on extinguishment of debt | (17,689) | 0 | 0 |
Other (expense) income, net | (3,330) | 405 | (531) |
Loss before income taxes | (436,412) | (292,688) | (253,560) |
(Benefit) provision for income taxes | (1,758) | 1,402 | 777 |
Net loss | $ (434,654) | $ (294,090) | $ (254,337) |
Net loss per share, Basic (in dollars per share) | $ (3.88) | $ (3.01) | $ (3.01) |
Net loss per share, Diluted (in dollars per share) | $ (3.88) | $ (3.01) | $ (3.01) |
Weighted average basic common shares outstanding (in shares) | 112,111 | 97,605 | 84,560 |
Weighted average diluted common shares outstanding (in shares) | 112,111 | 97,605 | 84,560 |
Net loss | $ (434,654) | $ (294,090) | $ (254,337) |
Other comprehensive income (loss): | |||
Foreign currency translation and other gains (losses) | 775 | 203 | (1) |
Total comprehensive loss | $ (433,879) | $ (293,887) | $ (254,338) |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) |
Balance (in shares) at Dec. 31, 2018 | 77,308,000 | ||||
Balance at Dec. 31, 2018 | $ 208,266 | $ 773 | $ 1,489,664 | $ (1,282,162) | $ (9) |
Comprehensive loss: | |||||
Net loss | (254,337) | (254,337) | |||
Other comprehensive income (loss) | $ (1) | (1) | |||
Exercise of stock options and ESPP shares issuance (in shares) | 1,413,341 | 1,632,000 | |||
Exercise of stock options and ESPP shares issuance | $ 19,700 | $ 16 | 19,684 | ||
Equity component of convertible debt (in shares) | 10,658,000 | ||||
Equity component of convertible debt | 261,074 | $ 107 | 260,967 | ||
Issuance of common stock for vesting of RSUs (in shares) | 84,000 | ||||
Issuance of common stock for vesting of RSUs | 1 | $ 1 | |||
Stock compensation expense | 26,971 | 26,971 | |||
Balance (in shares) at Dec. 31, 2019 | 89,682,000 | ||||
Balance at Dec. 31, 2019 | 261,674 | $ 897 | 1,797,286 | (1,536,499) | (10) |
Comprehensive loss: | |||||
Net loss | (294,090) | (294,090) | |||
Other comprehensive income (loss) | $ 203 | 203 | |||
Exercise of stock options and ESPP shares issuance (in shares) | 1,678,604 | 1,795,000 | |||
Exercise of stock options and ESPP shares issuance | $ 26,072 | $ 18 | 26,054 | ||
Net proceeds from issuance of common stock (in shares) | 11,155,000 | ||||
Net proceeds from issuance of common stock | 245,866 | $ 112 | 245,754 | ||
Issuance of common stock for vesting of RSUs (in shares) | 131,000 | ||||
Issuance of common stock for vesting of RSUs | 1 | $ 1 | |||
Stock compensation expense | 36,158 | 36,158 | |||
Balance (in shares) at Dec. 31, 2020 | 102,763,000 | ||||
Balance at Dec. 31, 2020 | 275,884 | $ 1,028 | 2,105,252 | (1,830,589) | 193 |
Comprehensive loss: | |||||
Net loss | (434,654) | (434,654) | |||
Other comprehensive income (loss) | $ 775 | 775 | |||
Exercise of stock options and ESPP shares issuance (in shares) | 1,235,186 | 1,359,000 | |||
Exercise of stock options and ESPP shares issuance | $ 22,035 | $ 13 | 22,022 | ||
Net proceeds from issuance of common stock (in shares) | 11,500,000 | ||||
Net proceeds from issuance of common stock | 269,886 | $ 115 | 269,771 | ||
Equity component of convertible debt | 196,358 | 196,358 | |||
Equity component of convertible debt redemption | (37,846) | (37,846) | |||
Issuance of common stock for vesting of RSUs (in shares) | 217,000 | ||||
Issuance of common stock for vesting of RSUs | 2 | $ 2 | |||
Issuance of common stock for business acquisition (in shares) | 2,899,000 | ||||
Issuance of common stock for business acquisition | 72,007 | $ 29 | 71,978 | ||
Stock compensation expense | 46,021 | 46,021 | |||
Balance (in shares) at Dec. 31, 2021 | 118,738,000 | ||||
Balance at Dec. 31, 2021 | $ 410,468 | $ 1,187 | $ 2,673,556 | $ (2,265,243) | $ 968 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities | |||
Net loss | $ (434,654) | $ (294,090) | $ (254,337) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 9,130 | 9,147 | 5,188 |
Amortization of intangible assets | 5,052 | 5,003 | 4,993 |
Stock-based compensation expense | 46,021 | 36,158 | 26,971 |
Loss on extinguishment of debt | 17,689 | 0 | 0 |
Amortization of debt issuance costs and accretion of debt discount | 31,039 | 20,378 | 19,382 |
Finance lease amortization expense | 1,078 | 1,078 | 360 |
Noncash operating lease expense | 12,589 | 5,932 | 9,763 |
Change in fair value of deferred and contingent consideration liabilities | 7,334 | 0 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (8,118) | 2,670 | (13,717) |
Inventory | (17,456) | (21,180) | (21,281) |
Prepaid expenses and other current assets | (5,549) | (3,114) | (8,718) |
Other assets | (24,435) | (6,261) | (16,008) |
Accounts payable | (7,575) | 29,825 | (4,966) |
Accrued liabilities, accrued compensation and other | 4,553 | (4,894) | 1,721 |
Net cash used in operating activities | (363,302) | (219,348) | (250,649) |
Investing activities | |||
Purchase of fixed assets | (7,289) | (6,240) | (42,268) |
Purchase of marketable securities | (50,292) | 0 | 0 |
Cash paid for Business Acquisition, net | (6,704) | 0 | 0 |
PARI milestone upon regulatory approvals | 0 | (582) | 0 |
Net cash used in investing activities | (64,285) | (6,822) | (42,268) |
Financing activities | |||
Proceeds from exercise of stock options, ESPP, and RSU vesting | 22,037 | 26,073 | 19,701 |
Proceeds from issuance of common stock, net | 269,886 | 245,866 | 261,074 |
Payment on extinguishment of 1.75% convertible senior notes due 2025 | (12,578) | 0 | 0 |
Payment of principal of 1.75% convertible senior notes due 2025 | (225,000) | 0 | 0 |
Proceeds from issuance of 0.75% convertible senior notes due 2028 | 575,000 | 0 | 0 |
Payment of debt issuance costs | (15,718) | 0 | 0 |
Other financing activities | (1,081) | (936) | 4,503 |
Net cash provided by financing activities | 612,546 | 271,003 | 285,278 |
Effect of exchange rates on cash and cash equivalents | (933) | 494 | (4) |
Net increase (decrease) in cash and cash equivalents | 184,026 | 45,327 | (7,643) |
Cash and cash equivalents at beginning of period | 532,756 | 487,429 | 495,072 |
Cash and cash equivalents at end of period | 716,782 | 532,756 | 487,429 |
Supplemental disclosures of cash flow information: | |||
Cash paid for interest | 10,890 | 9,186 | 7,883 |
Cash paid for income taxes | $ 1,558 | $ 814 | $ 339 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - Convertible Notes Payable | Dec. 31, 2021 |
1.75% convertible senior note due 2025 | |
Interest rate (as a percent) | 1.75% |
0.75% convertible senior notes due 2028 | |
Interest rate (as a percent) | 0.75% |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | Description of Business and Basis of Presentation Description of Business —Insmed is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. The Company's first commercial product, ARIKAYCE, is approved in the US as ARIKAYCE ® (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the EC approved ARIKAYCE for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have C F. In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which the Company refers to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. The Company's clinical-stage pipeline includes brensocatib and TPIP. Brensocatib is a small molecule, oral, reversible inhibitor of DPP1, which the Company is developing for the treatment of patients with bronchiectasis, CF and other neutrophil-mediated diseases. TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PAH and PH-ILD. The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are located in Bridgewater, New Jersey. The Company has legal entities in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan. The Company had $716.8 million in cash and cash equivalents and $50.0 million of marketable securities as of December 31, 2021 and reported a net loss of $434.7 million for the year ended December 31, 2021. Historically, the Company has funded its operations primarily through public offerings of equity securities and debt financings. The Company commenced commercial shipments of ARIKAYCE in October 2018. The Company expects to continue to incur consolidated operating losses, including losses in its US and certain international entities, while funding research and development (R&D) activities for ARIKAYCE, brensocatib, TPIP and its other pipeline programs, and continuing and commencing pre-commercial, commercialization and regulatory activities for ARIKAYCE, and funding other general and administrative activities. The Company expects its future cash requirements to be substantial, and the Company may need to raise additional capital to fund operations, including the continued commercialization of ARIKAYCE and additional clinical trials related to ARIKAYCE, to develop brensocatib and TPIP and to develop, acquire, in-license or co-promote other products or product candidates, including those that address a broad range of rare diseases. The source, timing and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s commercial, regulatory and development activities. Any equity or debt financing will also be contingent upon equity and debt market conditions and interest rates at the time. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict or eliminate all or a portion of its development programs or commercialization efforts. The Company believes it currently has sufficient funds to meet its financial needs for at least the next 12 months. Risks and Uncertainties —There are many uncertainties regarding the COVID-19 pandemic, and the Company is closely monitoring the impact of the pandemic on all aspects of its business, including how the pandemic will impact its patients, employees, suppliers, vendors, business partners and distribution channels. While the pandemic did not materially affect the Company's financial results and business operations for the year ended December 31, 2021, the Company is unable to predict the impact that COVID-19 will have on its financial position and operating results in future periods due to numerous uncertainties. The Company will continue to assess the evolving impact of the COVID-19 pandemic and will make adjustments to its operations as necessary. Basis of Presentation —The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Celtrix Pharmaceuticals, Inc., Insmed Holdings Limited, Insmed Ireland Limited, Insmed France SAS, Insmed Germany GmbH, Insmed Limited, Insmed Netherlands B.V., Insmed Godo Kaisha, Insmed Switzerland GmbH, and Insmed Italy S.R.L.. All intercompany transactions and balances have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates —The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and on various other assumptions. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of revenues and expenses reported for each period presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for revenue allowances, stock-based compensation, income taxes, loss contingencies, acquisition related intangibles including IPR&D and goodwill, fair value of contingent consideration, and accounting for research and development costs. Actual results could differ from those estimates. Cash and Cash Equivalents —The Company considers cash equivalents to be highly liquid investments with maturities of three months or less from the date of purchase. Accounts Receivable —Accounts receivable are recorded net of customer allowances for prompt pay discounts, chargebacks, and any estimated expected credit losses. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. To date, expected credit losses have not been material. Marketable Securities —Marketable securities consists of available-for-sale investments in US Treasury Notes with an original maturity of greater than 90 days. Marketable securities under this classification are recorded at fair value and unrealized gains and losses within accumulated other comprehensive income. The estimated fair value of available-for-sale marketable securities is determined based on quoted market prices. Management does not expect the Company's available-for-sale securities to be sold or redeemed within the next year and therefore has classified the marketable securities as long-term assets in the consolidated balance sheet. Fixed Assets, Net —Fixed assets are recorded at cost and are depreciated on a straight-line basis over the estimated useful lives of the assets. Estimated useful lives of three years to five years are used for computer equipment. Estimated useful lives of seven years are used for laboratory equipment, office equipment, manufacturing equipment and furniture and fixtures. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized for the amount by which the carrying value of the asset exceeds the fair value of the asset. Finite-lived Intangible Assets —Finite-lived intangible assets are measured at their respective fair values on the date they were recorded and, with respect to the acquired ARIKAYCE R&D intangible asset, at the date of subsequent adjustments of fair value. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. Impairment Assessment —The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, the Company measures the amount of the impairment by comparing to the carrying value of the assets to the fair value of the assets. The Company determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed at December 31, 2021. Business Combinations and Asset Acquisitions —The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in ASU 2017-01, Business Combinations, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligations for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, are recognized as a gain or loss and recorded within change in the fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s books. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired). Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets. Indefinite-lived Intangible Assets— Indefinite-lived intangible assets consist of IPR&D. IPR&D acquired directly in a transaction other than a business combination is capitalized if the projects will be further developed or have an alternative future use; otherwise they are expensed. The fair values of IPR&D project assets acquired in business combinations are capitalized. The Company generally utilizes the Multi-Period Excess Earning Method to determine the estimated fair value of the IPR&D assets acquired in a business combination. The projections used in this valuation approach are based on many factors, such as relevant market size, patent protection, and expected pricing and industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of its intangible assets with indefinite lives may not be recoverable, including, but not limited to, expected growth rates, the cost of equity and debt capital, general economic conditions, the Company’s outlook and market performance of the Company’s industry and recent and forecasted financial performance. The Company performed a qualitative annual test for its indefinite-lived intangible assets as of October 1, 2021. During the year ended December 31, 2021, the Company concluded that no impairment exists. Goodwill —Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing at a reporting unit level on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. The Company performed a qualitative annual test for goodwill as of October 1, 2021. During the year ended December 31, 2021, the Company concluded that no impairment exists. The Company reassesses its reporting units as part of its annual segment review. As of December 31, 2021, the Company concluded that it continues to operate as one reporting unit. An entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that the fair value of the reporting unit is less than its carrying amount. Leases —A lease is a contract, or part of a contract, that conveys the right to control the use of explicitly or implicitly identified property, plant or equipment in exchange for consideration. Control of an asset is conveyed to the Company if the Company obtains the right to obtain substantially all of the economic benefits of the asset or the right to direct the use of the asset. The Company recognizes right-of-use (ROU) assets and lease liabilities at the lease commencement date based on the present value of future, fixed lease payments over the term of the arrangement. ROU assets are amortized on a straight-line basis over the term of the lease or are amortized based on consumption, if this approach is more representative of the pattern in which benefit is expected to be derived from the underlying asset. Lease liabilities accrete to yield and are reduced at the time when the lease payment is payable to the vendor. Variable lease payments are recognized at the time when the event giving rise to the payment occurs and are recognized in the consolidated statements of comprehensive loss in the same line item as expenses arising from fixed lease payments. In accordance with Topic 842, leases are measured at present value using the rate implicit in the lease or, if the implicit rate is not determinable, the lessee's implicit borrowing rate. As the implicit rate is not typically available, the Company uses its implicit borrowing rate based on the information available at the lease commencement date to determine the present value of future lease payments. The implicit borrowing rate approximates the rate the Company would pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments. Debt Issuance Costs —Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Debt issuance costs paid to the lender and third parties are reflected as a discount to the debt in the consolidated balance sheets. Unamortized debt issuance costs associated with extinguished debt are expensed in the period of the extinguishment. Fair Value Measurements —The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows: • Level 1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. • Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. • Level 3 — Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. Each major category of financial assets and liabilities measured at fair value on a recurring basis is categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets. The Company's cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions. The following table shows assets and liabilities that are measured at fair value on a recurring basis and their carrying value (in millions): As of December 31, 2021 Fair Value Carrying Value Level 1 Level 2 Level 3 Cash and cash equivalents $ 716.8 $ 716.8 $ — $ — Marketable securities $ 50.0 $ 50.0 $ — $ — Deferred consideration $ 14.9 $ — $ 14.9 $ — Contingent consideration liabilities $ 75.7 $ — $ — $ 75.7 As of December 31, 2020 Fair Value Carrying Value Level 1 Level 2 Level 3 Cash and cash equivalents $ 532.8 $ 532.8 $ — $ — The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. During the year ended December 31, 2021, new Level 1 assets were added in connection with the Companies purchase of available-for-sale securities. Additionally, during the year ended December 31, 2021, new Level 2 and Level 3 liabilities were added in connection with the Business Acquisition. There were no other transfers in or out of Level 1, Level 2 or Level 3 during the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, the Company held $50.0 million of available-for-sale securities, net of an unrealized loss of $0.2 million recorded in accumulated other comprehensive income. As of December 31, 2020, the Company held no securities that were in an unrealized gain or loss position. The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the security was rated below investment grade; (3) how long the security has been in an unrealized loss position; and (4) the Company's ability and intent to retain the investment for a sufficient period of time for it to recover. Deferred Consideration The deferred consideration arose from the Business Acquisition in August 2021 (see Note 15). The Company is obligated to issue to Motus equityholders an aggregate of 184,433 shares of the Company’s common stock on each of the first, second and third anniversaries of the closing date, subject to certain reductions. A valuation of the deferred consideration is performed quarterly with gains and losses included within change in fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss. As the deferred consideration is settled in shares, there is no discount rate applied in the fair value calculation. The deferred consideration has been classified as a Level 2 recurring liability as its valuation utilizes an input, the Insmed share price on the valuation date, which is a directly observable input at the measurement date and for the duration of the liabilities' anticipated lives. Deferred consideration expected to be settled within twelve months or less is classified as a current liability and are included in accrued liabilities. As of December 31, 2021, the fair value of deferred consideration included in accrued liabilities was $4.9 million. Deferred consideration expected to be settled in more than twelve months are classified as a non-current liability and are included in other long-term liabilities. As of December 31, 2021, the fair value of deferred consideration included in other long-term liabilities was $10.0 million. The following observable input was used in the valuation of the deferred consideration as of December 31, 2021: Fair Value as of December 31, 2021 Observable Input Input Value Deferred consideration $14.9 Insmed share price on December 31, 2021 $27.24 Contingent Consideration Liabilities The contingent consideration liabilities arose from the Business Acquisition in August 2021 (see Note 15). The contingent consideration liabilities consist of developmental and regulatory milestones, a priority review voucher milestone and net sales milestones. Upon the achievement of certain development and regulatory milestone events, the Company is obligated to issue to Motus equityholders up to 5,348,572 shares in the aggregate and AlgaeneX equityholders up to 368,867 shares in the aggregate. The fair value of the development and regulatory milestones are estimated utilizing a probability-adjusted approach. At December 31, 2021, the weighted average probability of success was 42%. The development and regulatory milestones will be settled in shares of the Company's common stock. As such, there is no discount rate applied in the fair value calculation. If the Company were to receive a priority review voucher, the Company is obligated to pay to the Motus equityholders a portion of the value of the priority review voucher, subject to certain reductions. The potential payout will be either 50% of the after tax net proceeds received by the Company from a sale of the priority review voucher or 50% of the average of the sales prices for the last three publicly disclosed priority review voucher sales, less certain adjustments. The fair value of the priority review voucher milestone is estimated utilizing a probability-adjusted discounted cash flow approach. This obligation will be settled in cash. The contingent consideration liabilities for net sales milestones were valued using an option pricing model with Monte Carlo simulation. As of December 31, 2021, the fair value of these net sales milestones were deemed immaterial to the overall fair value of the contingent consideration. The contingent consideration liabilities have been classified as a Level 3 recurring liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the inputs to the valuation approach, the estimated fair value could be significantly different than the fair value the Company determined. Contingent consideration liabilities expected to be settled in more than twelve months are classified as a non-current liability. A valuation of the contingent consideration liabilities is performed quarterly with gains and losses included within change in fair value of contingent consideration liabilities in the consolidated statements of comprehensive loss. The following significant unobservable inputs were used in the valuation of the contingent consideration liabilities as of December 31, 2021 (in millions): Contingent Consideration Liabilities Fair Value as of December 31, 2021 Valuation Technique Unobservable Inputs Values Development and regulatory milestones $65.5 Probability-adjusted Probabilities of success 14% - 95% Priority review voucher milestone $5.3 Probability-adjusted discounted cash flow Probability of success 13.5% Discount rate 6.7% The following table is a summary of the changes in the fair value of the Company's valuations for the deferred and contingent consideration liabilities for the period ended December 31, 2021 (in thousands): 2021 January 1, Additions Change in Fair Value Adjustments December 31, Deferred consideration $ — 13,700 1,372 (141) $ 14,931 Contingent consideration $ — 69,706 5,962 — $ 75,668 Convertible Notes The estimated fair value of the of the Company's 0.75% convertible senior notes due 2028 (the 2028 Convertible Notes) (categorized as a Level 2 liability for fair value measurement purposes) as of December 31, 2021 was $633.3 million , determined using current market factors and the ability of the Company to obtain debt on comparable terms to the 2028 Convertible Notes. The $377.8 million carrying value of the 2028 Convertible Notes as of December 31, 2021 excludes the $187.8 million and $9.4 million of the unamortized portion of the debt discount and issuance costs, respectively. The estimated fair value of the of the Company's 1.75% convertible senior notes due 2025 (the 2025 Convertible Notes) (categorized as a Level 2 liability for fair value measurement purposes) as of December 31, 2021 was $228.1 million , determined using current market factors and the ability of the Company to obtain debt on comparable terms to the 2025 Convertible Notes. The $188.8 million carrying value of the 2025 Convertible Notes as of December 31, 2021 excludes the $34.1 million and $2.1 million of the unamortized portion of the debt discount and issuance costs, respectively. Foreign Currency —The Company has operations in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan. The results of its non-US dollar based functional currency operations are translated to US dollars at the average exchange rates during the period. Assets and liabilities are translated at the exchange rate prevailing at the balance sheet date. Equity is translated at the prevailing exchange rate at the date of the equity transaction. Translation adjustments are included in shareholders' equity, as a component of accumulated other comprehensive income. The Company realizes foreign currency transaction gains (losses) in the normal course of business based on movements in the applicable exchange rates. These gains (losses) are included as a component of other (expense) income, net. Concentration of Credit Risk —Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company places its cash equivalents with high credit-quality financial institutions and may invest its short-term investments in US treasury securities, mutual funds and government agency bonds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain safety and liquidity. The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for collectible trade receivables. The following table presents the percentage of gross product revenue represented by the Company's three largest customers as of the year ended December 31, 2021 and 2020. Percentage of Total Gross Product Revenue 2021 2020 Customer A 27% 27 % Customer B 24% 28 % Customer C 24% 23 % The Company relies on third-party manufacturers and suppliers for manufacturing and supply of its products. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturers, or an adverse change in their business, could materially impact future operating results. Revenue Recognition - In accordance with ASC 606, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. For all contracts that fall into the scope of ASC 606, the Company has identified one performance obligation: the sale of ARIKAYCE to its customers. The Company has not incurred or capitalized any incremental costs associated with obtaining contracts with customers. Product revenues, net consist of net sales of ARIKAYCE. The Company's customers in the US include specialty pharmacies and specialty distributors. In December 2020, the Company began recognizing product revenue from commercial sales of ARIKAYCE in Europe. In July 2021, the Company began recognizing product revenue from commercial sales of ARIKAYCE in Japan. G lobally, product revenues are recognized once the Company performs and satisfies all five steps mentioned above. The following table presents a summary of the Company's product revenues, net by geographic location for the years ended December 31, 2021 and 2020 (in thousands). For the Year Ended December 31, 2021 2020 US $ 159,510 $ 157,520 Japan 16,006 — Europe and rest of world 12,945 6,893 Total product revenues, net $ 188,461 $ 164,413 Revenue is recorded at net selling price (transaction price), which includes estimates of variable consideration for which reserves are established for (a) customer credits, such as invoice discounts for prompt pay, (b) estimated government rebates, such as Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (c) estimated chargebacks, and (d) estimated costs of co-payment assistance. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (prompt pay discounts and chargebacks), prepaid expenses (co-payment assistance), or as a current liability (rebates). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company's historical experience, current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Customer credits: The Company's customers are offered various forms of consideration, including prompt payment discounts. The payment terms for sales to specialty pharmacies for prompt payment discounts are based on contractual rates agreed with the respective specialty pharmacies. The Company anticipates that its customers will earn these discounts and, therefore, deducts the full amount of these discounts from total gross product revenues at the time such revenues are recognized. Rebates: The Company contracts with government agencies and managed care organizations, or collectively, third-party payors, so that ARIKAYCE will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company's contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payor mix, and (iv) information obtained from the Company's specialty pharmacies. Chargebacks: Chargebacks are discounts that occur when certain contracted customers, currently public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase directly from the Company's specialty distributor. Contracted customers generally purchase the product at a discounted price and the specialty distributor, in turn, charges back to the Company the difference between the price the specialty distributor initially paid |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The Company's inventory balance consists of the following (in thousands): As of December 31, 2021 2020 Raw materials $ 29,541 $ 21,601 Work-in-process 18,528 18,754 Finished goods 18,940 9,237 $ 67,009 $ 49,592 Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-process and finished goods. The Company began capitalizing inventory costs following FDA approval of ARIKAYCE in September 2018 and has not recorded any significant inventory write-downs since that time. The Company currently uses a limited number of third-party CMOs to produce its inventory. |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Intangibles, Net and Goodwill Intangibles, Net Finite-lived Intangible Assets As of December 31, 2021, the Company's finite-lived intangible assets consisted of acquired ARIKAYCE R&D and the milestones paid to PARI for the license to use PARI's Lamira ® Nebulizer System for the delivery of ARIKAYCE to patients as a result of the FDA and EC approvals of ARIKAYCE in September 2018 and October 2020, respectively. The Company began amortizing its acquired ARIKAYCE R&D and PARI milestones intangible assets in October 2018, over ARIKAYCE's initial regulatory exclusivity period of 12 years. Amortization of these assets during each of the next five years is estimated to be approximately $5.1 million per year. Indefinite-lived Intangible Assets As of December 31, 2021, the Company's indefinite-lived intangible assets consisted of acquired IPR&D from the Business Acquisition (see Note 15). Indefinite-lived intangible assets are not amortized. A rollforward of the Company's intangible assets for the years ended December 31, 2021 and 2020 follows (in thousands): 2021 Intangible Asset January 1, Additions Amortization December 31, Acquired ARIKAYCE R&D $ 47,289 $ — $ (4,850) $ 42,439 Acquired IPR&D — 29,600 — 29,600 PARI milestones 1,972 — (202) 1,770 $ 49,261 $ 29,600 $ (5,052) $ 73,809 2020 Intangible Asset January 1, Additions Amortization December 31, Acquired ARIKAYCE R&D $ 52,139 $ — $ (4,850) $ 47,289 PARI milestone 1,543 582 (153) 1,972 $ 53,682 $ 582 $ (5,003) $ 49,261 Goodwill The Company's goodwill balance of $136.1 million as of December 31, 2021 resulted from the August 2021 Business Acquisition (see Note 15). |
Fixed Assets, net
Fixed Assets, net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets, net | Fixed Assets, Net Fixed assets are stated at cost and depreciated using the straight-line method, based on useful lives as follows (in thousands): Estimated Useful Life (years) As of December 31, Asset Description 2021 2020 Lab equipment 7 $ 11,862 $ 10,352 Furniture and fixtures 7 5,799 5,917 Computer hardware and software 3 - 5 7,264 7,267 Office equipment 7 89 88 Manufacturing equipment 7 1,145 1,567 Leasehold improvements lease term 36,073 35,289 Construction in progress (CIP) — 27,784 21,823 90,016 82,303 Less accumulated depreciation (37,061) (28,350) $ 52,955 $ 53,953 Depreciation expense was $9.1 million, $9.1 million and $5.2 million for the years ended December 31, 2021, 2020 and 2019, respectively. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consist of the following (in thousands): As of December 31, 2021 2020 Accrued clinical trial expenses $ 19,410 $ 6,733 Accrued professional fees 10,678 8,594 Accrued technical operation expenses 6,187 9,164 Accrued royalty payable 6,655 3,423 Accrued interest payable 2,175 3,631 Accrued sales allowances and related costs 8,275 5,051 Deferred consideration from business acquisition 4,883 — Accrued construction costs 551 364 Other accrued liabilities 1,851 847 $ 60,665 $ 37,807 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Leases The Company's lease portfolio consists primarily of office space, manufacturing facilities, research equipment and fleet vehicles. All of the Company's leases are classified as operating leases, except for the Company's corporate headquarters lease, which is classified as a finance lease. The terms of the Company's lease agreements that have commenced range from less than one year to ten years, ten months. In its assessment of the term of each such lease, the Company has not included any options to extend or terminate the lease due to the absence of economic incentives in its lease agreements. Leases that qualify for treatment as a short-term lease are expensed as incurred. These short-term leases are not material to the Company's financial position. Furthermore, the Company does not separate lease and non-lease components for all classes of underlying assets. The Company's leases do not contain residual value guarantees and it does not sublease any of its leased assets. The Company outsources its manufacturing operations to CMOs. Upon review of the agreements with its CMOs, the Company determined that these contracts contain embedded leases for dedicated manufacturing facilities. The Company obtains substantially all of the economic benefits from the use of the manufacturing facilities, has the right to direct how and for what purpose the facility is used throughout the period of use, and the supplier does not have the right to change the operating instructions of the facility. The operating lease right-of-use assets and corresponding lease liabilities associated with the manufacturing facilities is the sum of the minimum guarantees over the life of the production contracts. The table below summarizes the Company's total lease costs included in its consolidated financial statements, as well as other required quantitative disclosures (in thousands). As of December 31, 2021 As of December 31, 2020 Finance lease cost: Amortization of right-of-use assets $ 1,078 $ 1,078 Interest on lease liabilities 1,300 1,301 Total finance lease cost $ 2,378 $ 2,379 Operating lease cost 12,125 8,664 Variable lease cost 7,043 9,950 Total lease cost $ 21,546 $ 20,993 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for finance leases $ 1,300 $ 1,301 Operating cash flows for operating leases $ 14,598 $ 8,813 Financing cash flows for finance leases $ 1,081 $ 936 Right-of-use assets obtained in exchange for new finance lease liabilities $ — $ — Right-of-use assets obtained in exchange for new operating lease liabilities $ 12,948 $ 1,205 Weighted average remaining lease term - finance leases 8.6 years 9.6 years Weighted average remaining lease term - operating leases 3.8 years 4.4 years Weighted average discount rate - finance leases 8.6 % 8.6 % Weighted average discount rate - operating leases 7.0 % 7.4 % In addition to the operating lease costs disclosed above, the Company also records variable consideration for variable lease payments in excess of fixed fees or minimum guarantees. Variable consideration related to the Company's leasing arrangements was $7.0 million and $9.9 million for the years ended December 31, 2021 and 2020, respectively. Variable costs related to CMO manufacturing agreements are direct costs related to the manufacturing of ARIKAYCE and are capitalized within inventory in the Company's consolidated balance sheet, while the variable costs related to other leasing arrangements, not related to the manufacturing of ARIKAYCE, have been classified within operating expenses in the Company's consolidated statements of comprehensive loss. The table below presents the maturity of lease liabilities on an annual basis for the remaining years of the Company's commenced lease agreements (in thousands). Year Ending December 31, Finance Lease Operating Leases 2022 $ 1,819 $ 11,315 2023 1,670 7,927 2024 2,556 7,270 2025 2,615 7,182 2026 2,673 1,218 Thereafter 10,059 311 Total 21,392 35,223 Less: present value discount 6,680 4,255 Present value of lease liabilities $ 14,712 $ 30,968 Balance Sheet Classification at December 31, 2021: Current lease liabilities $ 609 $ 9,527 Long-term lease liabilities 14,103 21,441 Total lease liabilities $ 14,712 $ 30,968 In addition to the Company's lease agreements that have previously commenced and are reflected in the consolidated financial statements, the Company has entered into additional lease agreements that have not yet commenced. The Company entered into certain agreements with Patheon related to increasing its long-term production capacity for ARIKAYCE commercial inventory. The Company has determined that these agreements with Patheon contain an embedded lease for the manufacturing facility and the specialized equipment contained therein. Costs of $32.3 million incurred by the Company under these additional agreements have been classified within |
Leases | Leases The Company's lease portfolio consists primarily of office space, manufacturing facilities, research equipment and fleet vehicles. All of the Company's leases are classified as operating leases, except for the Company's corporate headquarters lease, which is classified as a finance lease. The terms of the Company's lease agreements that have commenced range from less than one year to ten years, ten months. In its assessment of the term of each such lease, the Company has not included any options to extend or terminate the lease due to the absence of economic incentives in its lease agreements. Leases that qualify for treatment as a short-term lease are expensed as incurred. These short-term leases are not material to the Company's financial position. Furthermore, the Company does not separate lease and non-lease components for all classes of underlying assets. The Company's leases do not contain residual value guarantees and it does not sublease any of its leased assets. The Company outsources its manufacturing operations to CMOs. Upon review of the agreements with its CMOs, the Company determined that these contracts contain embedded leases for dedicated manufacturing facilities. The Company obtains substantially all of the economic benefits from the use of the manufacturing facilities, has the right to direct how and for what purpose the facility is used throughout the period of use, and the supplier does not have the right to change the operating instructions of the facility. The operating lease right-of-use assets and corresponding lease liabilities associated with the manufacturing facilities is the sum of the minimum guarantees over the life of the production contracts. The table below summarizes the Company's total lease costs included in its consolidated financial statements, as well as other required quantitative disclosures (in thousands). As of December 31, 2021 As of December 31, 2020 Finance lease cost: Amortization of right-of-use assets $ 1,078 $ 1,078 Interest on lease liabilities 1,300 1,301 Total finance lease cost $ 2,378 $ 2,379 Operating lease cost 12,125 8,664 Variable lease cost 7,043 9,950 Total lease cost $ 21,546 $ 20,993 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for finance leases $ 1,300 $ 1,301 Operating cash flows for operating leases $ 14,598 $ 8,813 Financing cash flows for finance leases $ 1,081 $ 936 Right-of-use assets obtained in exchange for new finance lease liabilities $ — $ — Right-of-use assets obtained in exchange for new operating lease liabilities $ 12,948 $ 1,205 Weighted average remaining lease term - finance leases 8.6 years 9.6 years Weighted average remaining lease term - operating leases 3.8 years 4.4 years Weighted average discount rate - finance leases 8.6 % 8.6 % Weighted average discount rate - operating leases 7.0 % 7.4 % In addition to the operating lease costs disclosed above, the Company also records variable consideration for variable lease payments in excess of fixed fees or minimum guarantees. Variable consideration related to the Company's leasing arrangements was $7.0 million and $9.9 million for the years ended December 31, 2021 and 2020, respectively. Variable costs related to CMO manufacturing agreements are direct costs related to the manufacturing of ARIKAYCE and are capitalized within inventory in the Company's consolidated balance sheet, while the variable costs related to other leasing arrangements, not related to the manufacturing of ARIKAYCE, have been classified within operating expenses in the Company's consolidated statements of comprehensive loss. The table below presents the maturity of lease liabilities on an annual basis for the remaining years of the Company's commenced lease agreements (in thousands). Year Ending December 31, Finance Lease Operating Leases 2022 $ 1,819 $ 11,315 2023 1,670 7,927 2024 2,556 7,270 2025 2,615 7,182 2026 2,673 1,218 Thereafter 10,059 311 Total 21,392 35,223 Less: present value discount 6,680 4,255 Present value of lease liabilities $ 14,712 $ 30,968 Balance Sheet Classification at December 31, 2021: Current lease liabilities $ 609 $ 9,527 Long-term lease liabilities 14,103 21,441 Total lease liabilities $ 14,712 $ 30,968 In addition to the Company's lease agreements that have previously commenced and are reflected in the consolidated financial statements, the Company has entered into additional lease agreements that have not yet commenced. The Company entered into certain agreements with Patheon related to increasing its long-term production capacity for ARIKAYCE commercial inventory. The Company has determined that these agreements with Patheon contain an embedded lease for the manufacturing facility and the specialized equipment contained therein. Costs of $32.3 million incurred by the Company under these additional agreements have been classified within |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Debt In May 2021, the Company completed an underwritten public offering of the 2028 Convertible Notes, in which the Company sold $575.0 million aggregate principal amount of the 2028 Convertible Notes, including the exercise in full of the underwriters' option to purchase an additional $75.0 million in aggregate principal amount of 2028 Convertible Notes. The Company's net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses of $15.7 million, were approximately $559.3 million. The 2028 Convertible Notes bear interest payable semiannually in arrears on June 1 and December 1 of each year, beginning on December 1, 2021. The 2028 Convertible Notes mature on June 1, 2028, unless earlier converted, redeemed, or repurchased. In January 2018, the Company completed an underwritten public offering of the Convertible Notes, in which the Company sold $450.0 million aggregate principal amount of Convertible Notes, including the exercise in full of the underwriters' option to purchase additional Convertible Notes of $50.0 million. The Company's net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses of $14.2 million, were approximately $435.8 million. The Convertible Notes bear interest payable semiannually in arrears on January 15 and July 15 of each year, beginning on July 15, 2018. The Convertible Notes mature on January 15, 2025, unless earlier converted, redeemed, or repurchased. A portion of the net proceeds from the 2028 Convertible Notes was used to repurchase $225.0 million of the Company's outstanding 2025 Convertible Notes. The Company recorded a loss on early extinguishment of debt of $17.7 million, primarily related to the premium paid on extinguishment of a portion the 2025 Convertible Notes. On or after October 15, 2024, until the close of business on the second scheduled trading day immediately preceding January 15, 2025, holders may convert their 2025 Convertible Notes at any time. The initial conversion rate for the 2025 Convertible Notes is 25.5384 shares of common stock per $1,000 principal amount of 2025 Convertible Notes (equivalent to an initial conversion price of approximately $39.16 per share of common stock). On or after March 1, 2028, until the close of business on the second scheduled trading day immediately preceding June 1, 2028, holders may convert their 2028 Convertible Notes at any time. The initial conversion rate for the 2028 Convertible Notes is 30.7692 shares of common stock per $1,000 principal amount of 2028 Convertible Notes (equivalent to an initial conversion price of approximately $32.50 per share of common stock). Upon conversion of either the 2025 Convertible Notes or the 2028 Convertible Notes, holders may receive cash, shares of the Company's common stock or a combination of cash and shares of the Company's common stock, at the Company's option. The conversion rates will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. Holders may convert their 2025 Convertible Notes prior to October 15, 2024 or their 2028 Convertible Notes prior to March 1, 2028, only under the following circumstances, subject to the conditions set forth in the applicable indenture: (i) during the five business day period immediately after any five consecutive trading day period (the measurement period) in which the trading price per $1,000 principal amount of the applicable series of convertible notes, as determined following a request by a holder of such convertible notes, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the common stock and the conversion rate on such trading day, (ii) the Company elects to distribute to all or substantially all holders of the common stock (a) any rights, options or warrants (other than in connection with a stockholder rights plan for so long as the rights issued under such plan have not detached from the associated shares of common stock) entitling them, for a period of not more than 45 days from the declaration date for such distribution, to subscribe for or purchase shares of common stock at a price per share that is less than the average of the last reported sale prices of the common stock for the 10 consecutive trading day period ending on, and including, the trading day immediately preceding the declaration date for such distribution, or (b) the Company's assets, debt securities or rights to purchase securities of the Company, which distribution has a per share value, as reasonably determined by the board of directors, exceeding 10% of the last reported sale price of the common stock on the trading day immediately preceding the declaration date for such distribution, (iii) if a transaction or event that constitutes a fundamental change or a make-whole fundamental change occurs, or if the Company is a party to (a) a consolidation, merger, combination, statutory or binding share exchange or similar transaction, pursuant to which the common stock would be converted into, or exchanged for, cash, securities or other property or assets, or (b) any sale, conveyance, lease or other transfer or similar transaction in one transaction or a series of transactions of all or substantially all of the consolidated assets of the Company and its subsidiaries, taken as a whole, all or any portion of the applicable series of convertible notes may be surrendered by a holder for conversion at any time from or after the date that is 30 scheduled trading days prior to the anticipated effective date of the transaction, (iv) if during any calendar quarter commencing after the calendar quarter ending on March 31, 2018 or June 30, 2021 for the 2025 Convertible Notes and 2028 Convertible Notes, respectively, (and only during such calendar quarter), the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during the 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, or, (v) if the Company sends a notice of redemption, a holder may surrender all or any portion of its convertible notes, to which the notice of redemption relates, for conversion at any time on or after the date the applicable notice of redemption was sent until the close of business on (a) the second business day immediately preceding the related redemption date or (b) if the Company fails to pay the redemption price on the redemption date as specified in such notice of redemption, such later date on which the redemption price is paid. To date, there have not been any holder initiated redemption requests of either series of convertible notes. Each series of convertible notes can be settled in cash, common stock, or a combination of cash and common stock at the Company's option, and thus, the Company determined the embedded conversion options in both series of convertible notes are not required to be separately accounted for as a derivative. However, since the convertible notes are within the scope of the accounting guidance for cash convertible instruments, the Company is required to separate each series of convertible notes into liability and equity components. The carrying amount of the liability component of each series of convertible notes as of the date of issuance was calculated by measuring the fair value of a similar liability that did not have an associated equity component. The fair value was based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments. The carrying amount of the equity component representing the embedded conversion option for each series of convertible notes was determined by deducting the fair value of the liability component from the gross proceeds of the applicable convertible notes. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense over the expected life of a similar liability that does not have an associated equity component using the effective interest method. The equity component is not remeasured as long as it continues to meet the conditions for equity classification in the accounting guidance for contracts in an entity’s own equity. The fair value of the liability component of the 2025 Convertible Notes on the date of issuance was estimated at $309.1 million using an effective interest rate of 7.6% and, accordingly, the residual equity component on the date of issuance was $140.9 million. The fair value of the liability component of the 2028 Convertible Notes on the date of issuance was estimated at $371.6 million using an effective interest rate of 7.1% and, accordingly, the residual equity component on the date of issuance was $203.4 million. The respective discounts are being amortized to interest expense over the term of the applicable series of convertible notes and have remaining periods of approximately 3.04 years, with respect to the 2025 Convertible Notes, and 6.42 years, with respect to the 2028 Convertible Notes. The following table presents the carrying value of the Company’s debt balance as of December 31, 2021 and 2020 (in thousands): As of December 31, 2021 2020 Face value of outstanding convertible notes $ 800,000 $ 450,000 Debt issuance costs, unamortized (11,539) (5,646) Discount on debt (221,873) (88,036) Long-term debt, net $ 566,588 $ 356,318 As of December 31, 2021, future principal repayments of the debt for each of the fiscal years through maturity were as follows (in thousands): Year Ending December 31: 2022 $ — 2023 — 2024 — 2025 225,000 2026 — 2027 and thereafter 575,000 $ 800,000 The estimated fair value of the debt (categorized as a Level 2 liability for fair value measurement purposes) is determined using current market factors and the ability of the Company to obtain debt at comparable terms to those that are currently in place. As of December 31, 2021 and 2020, the fair value of the Company's debt approximated the carrying amount. Interest Expense Interest expense related to debt and the finance lease for the years ended December 31, 2021, 2020, and 2019, which includes the contractual interest coupon payable semi-annually in cash, the amortization of the issuance costs, and accretion of debt discount is as follows (in thousands): Years Ended December 31, 2021 2020 2019 Contractual interest expense $ 8,134 $ 7,885 $ 7,883 Amortization of debt issuance costs 1,890 1,397 1,397 Accretion of debt discount 29,149 18,981 17,985 Total convertible debt interest expense $ 39,173 $ 28,263 $ 27,265 Finance lease interest expense 1,300 1,301 440 Total interest expense $ 40,473 $ 29,564 $ 27,705 |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' Equity | Shareholders' Equity Common Stock —As of December 31, 2021, the Company had 500,000,000 shares of common stock authorized with a par value of $0.01 and 118,738,266 shares of common stock issued and outstanding. In addition, as of December 31, 2021, the Company had reserved 14,088,960 shares of common stock for issuance upon the exercise of outstanding common stock options and 1,019,714 shares of common stock for issuance upon the vesting of RSUs. The Company has also reserved 23,438,430 shares of common stock for issuance upon conversion of the 2025 Convertible Notes and 2028 Convertible Notes, in the aggregate, subject to adjustment in accordance with the applicable indentures. In connection with the Company’s Business Acquisition, the Company reser ved 9,406,112 s hares of the Company’s common stock, subject to certain closing- related reductions. The shares of the Company’s common stock reserved in connection with the Motus acquisition were partly issued as acquisition consideration at closing, and will also be issued upon the first, second and third anniversaries of the acquisition’s closing date and upon the achievement of certain development and regulatory milestone events, subject to certain reductions. The shares of the Company’s common stock reserved in connection with the AlgaeneX acquisition will be issued upon the achievement of a development milestone event, subject to certain reductions. Of the 9,406,112 shares reserved, subject to certain closing-related reductions, the Company issued 2,889,367 shares of the Company's common stock in connection with its Business Acquisition i n the third quarter of 2021, following certain closing-related deductions. See Note 15 for additional information related to the Business Acquisition . In the second quarter of 2021, the Company completed an underwritten public offering of 11,500,000 shares of the Company's common stock, including 1,500,000 shares issued pursuant to the exercise in full of the underwriters' option to purchase additional shares from the Company, a t a public offering price of $25.00 per share. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expenses of $17.5 million, were $270.1 million. In the first quarter of 2021, the Company entered into a sales agreement with SVB Leerink LLC (SVB Leerink), to sell shares of the Company's common stock, with aggregate gross sales proceeds of up to $250.0 million, from time to time, through an “at the market” equity offering program (the ATM program), under which SVB Leerink acts as sales agent. As of December 31, 2021, the Company had not sold or issued any shares under the ATM program. In the second quarter of 2020, the Company completed an underwritten public offering of 11,155,000 shares of the Company's common stock, including 1,455,000 shares issued pursuant to the exercise in full of the underwriters' option to purchase additional shares from the Company, at a public offering price of $23.25 per share. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and commissions and other offering expenses of $13.5 million, were $245.9 million. In the second quarter of 2019, the Company completed an underwritten public offering of 10,657,692 shares of the Company's common stock, including 1,042,307 shares issued pursuant to the exercise in full of the underwriters' option to purchase additional shares at a public offering price of $26.00. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and commissions and other offering expenses of $16.0 million, were $261.1 million. The offering also included the sale of 400,000 shares from the Company's Chair and Chief Executive Officer, from which the Company received no proceeds. Preferred Stock —As of December 31, 2021 and 2020, the Company had 200,000,000 shares of preferred stock authorized with a par value of $0.01 and no shares of preferred stock were issued and outstanding. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based CompensationThe Company’s current equity compensation plan, the 2019 Incentive Plan, was approved by shareholders at the Company’s Annual Meeting of Shareholders in May 2019. The 2019 Incentive Plan is administered by the Compensation Committee of the Board of Directors of the Company. Under the terms of the 2019 Incentive Plan, the Company is authorized to grant a variety of incentive awards based on its common stock, including stock options (both incentive stock options and non-qualified stock options), RSUs, performance options/shares and other stock awards to eligible employees and non-employee directors. On May 16, 2019, upon the approval of the 2019 Incentive Plan by shareholders, 3,500,000 shares were authorized for issuance thereunder, plus any shares subject to then-outstanding awards under the 2017 Incentive Plan, the 2015 Incentive Plan and the 2013 Incentive Plan that subsequently were canceled, terminated unearned, expired, were forfeited, lapsed for any reason or were settled in cash without the delivery of shares. On May 12, 2020, at the Company's 2020 Annual Meeting of Shareholders, the Company's shareholders approved an amendment of the 2019 Incentive Plan providing for the issuance of an additional 4,500,000 shares under the plan. On May 12, 2021, at the Company's 2021 Annual Meeting of Shareholders, the Company's shareholders approved the second amendment to the 2019 Incentive Plan providing for the issuance of an additional 2,750,000 shares under the plan. As of December 31, 2021, 5,226,409 shares remained for future issuance under the 2019 Incentive Plan. The 2019 Incentive Plan will terminate on May 16, 2029 unless it is extended or terminated earlier pursuant to its terms. In addition, from time to time, the Company makes inducement grants of stock options. These awards are made pursuant to the Nasdaq inducement grant exception as a component of new hires’ employment compensation in connection with the Company’s equity grant program. During the twelve months ended December 31, 2021 and 2020, the Company granted inducement stock options covering 1,117,020 and 996,830 shares, respectively, of the Company's common stock to new employees. Stock Options —The Company calculates the fair value of stock options granted using the Black-Scholes valuation model. The following table summarizes the grant date fair value and assumptions used in determining the fair value of all stock options granted, including grants of inducement options, during the years ended December 31, 2021, 2020 and 2019. 2021 2020 2019 Volatility 70%-71% 66% - 71% 67% - 70% Risk-free interest rate 0.36%-1.20% 0.22% - 1.67% 1.35% - 2.56% Dividend yield 0.0% 0.0% 0.0% Expected option term (in years) 5.84 5.17 5.09 Weighted average fair value of stock options granted $18.50 $13.75 $8.76 For the years ended December 31, 2021, 2020 and 2019, the volatility factor was based on the Company’s historical volatility during the expected option term. The company accounts for forfeitures as they occur. From time to time, the Company has granted performance-conditioned options to certain of its employees. Vesting of these options is subject to the Company achieving certain performance criteria established at the date of grant and the grantees fulfilling a service condition (continued employment). As of December 31, 2021, the Company had performance-conditioned options totaling 114,780 shares outstanding which had not yet met the recognition criteria. The Company had no performance options outstanding as of December 31, 2020 and 2019. The following table summarizes stock option activity for stock options granted for the years ended December 31, 2021, 2020 and 2019 as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value (in '000) Options outstanding at December 31, 2018 9,381,730 $ 16.30 Granted 3,434,270 $ 15.02 Exercised (1,413,341) $ 11.87 Forfeited and expired (909,713) $ 19.02 Options outstanding at December 31, 2019 10,492,946 $ 16.24 Exercisable at December 31, 2019 5,719,818 $ 15.38 Granted 3,990,740 $ 24.12 Exercised (1,678,604) $ 14.04 Forfeited and expired (541,680) $ 23.98 Options outstanding at December 31, 2020 12,263,402 $ 18.84 Exercisable at December 31, 2020 6,028,261 $ 16.15 Granted 4,039,360 $ 30.18 Exercised (1,235,186) $ 15.50 Forfeited and expired (978,616) $ 24.35 Options outstanding at December 31, 2021 14,088,960 $ 22.00 6.91 $ 90,317 Exercisable at December 31, 2021 7,292,851 $ 17.97 5.34 $ 70,204 The total intrinsic value of stock options exercised during the years ended December 31, 2021, 2020 and 2019 was $22.1 million, $24.0 million and $16.5 million, respectively. As of December 31, 2021, there was $83.8 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 1.8 years. Restricted Stock and Restricted Stock Units —The Company may grant Restricted Stock (RS) and Restricted Stock Units (RSUs) to employees and non-employee directors. Each share of RS vests upon and each RSU represents a right to receive one share of the Company's common stock upon the completion of a specific period of continued service. RS and RSU awards granted are valued at the market price of the Company's common stock on the date of grant. The Company recognizes noncash compensation expense for the fair values of these RS and RSUs on a straight-line basis over the requisite service period of these awards. The following table summarizes RSU awards granted during the years ended December 31, 2021, 2020 and 2019: Number of RSUs Weighted Average Grant Price Outstanding at December 31, 2018 227,826 $ 29.14 Granted 407,655 $ 27.89 Released (92,145) $ 28.05 Forfeited (42,514) $ 29.11 Outstanding at December 31, 2019 500,822 $ 28.32 Granted 559,054 $ 23.85 Released (161,774) $ 28.90 Forfeited (53,711) $ 25.43 Outstanding at December 31, 2020 844,391 $ 25.43 Granted 607,578 $ 29.40 Released (291,823) $ 25.93 Forfeited (140,432) $ 27.73 Outstanding at December 31, 2021 1,019,714 $ 27.33 As of December 31, 2021, there was $18.8 million of unrecognized compensation expense related to unvested awards, which is expected to be recognized over a weighted average period of 2.1 years. The following table summarizes the stock-based compensation recorded in the consolidated statements of comprehensive loss related to stock options and RSUs during the years ended December 31, 2021, 2020 and 2019 (in millions): Years Ended December 31, 2021 2020 2019 Research and development expenses $ 17.8 $ 11.8 $ 8.2 Selling, general and administrative expenses 28.2 24.4 18.8 Total stock-based compensation expense $ 46.0 $ 36.2 $ 27.0 Employee Stock Purchase Plan - On May 15, 2018, the Company's shareholders approved the Company’s 2018 Employee Stock Purchase Plan (ESPP). As part of the ESPP, eligible employees may acquire an ownership interest in the Company by purchasing common stock, at a discount, through payroll deductions. The ESPP is compensatory under GAAP and the Company recorded stock compensation expense of $1.3 million, $1.2 million and $1.6 million for the years ended December 31, 2021, 2020 and 2019, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe income tax (benefit) provision was $(1.8) million, $1.4 million and $0.8 million and the effective rates were approximately 0%, 0% and 0% for the years ended December 31, 2021, 2020 and 2019, respectively. As a result of the Tax Cuts and Jobs Act (the Tax Act), the Company recorded a noncurrent receivable to reflect the refund due to the Company in future periods relating to the previously paid alternative minimum tax. The income tax benefit for the year ended December 31, 2021 is primarily due to the partial reversal of a valuation allowance as a result of the Company's recent Business Acquisition (see Note 15), partially offset by current income tax expense. While the Business Acquisition resulted in a deferred tax liability recorded under ASC 805, an adjustment to the valuation allowance is required as this deferred tax liability provides a future reversal of a taxable temporary difference. In addition, the income tax provision for the years ended December 31, 2020 and 2019 reflected current income tax expense recorded as a result of the taxable income in certain of the Company's non-US subsidiaries and certain state income taxes. For the years ended December 31, 2021 and 2020, the Company was also subject to foreign income taxes as a result of legal entities established for activities in Europe and Japan. The Company's loss before income taxes in the US and globally was as follows (in thousands): Years Ended December 31, 2021 2020 2019 US $ (348,845) $ (207,120) $ (201,161) Foreign (87,567) (85,568) (52,399) Total $ (436,412) $ (292,688) $ (253,560) The Company's income tax provision consisted of the following (in thousands): Years Ended December 31, 2021 2020 2019 Current: Federal $ — $ — $ — State 104 268 10 Foreign 1,585 1,134 767 1,689 1,402 777 Deferred: Federal (2,835) — — State (612) — — Foreign — — — (3,447) — — Total $ (1,758) $ 1,402 $ 777 The reconciliation between the federal statutory tax rates and the Company's effective tax rate is as follows: Years Ended December 31, 2021 2020 2019 Statutory federal tax rate 21 % 21 % 21 % Permanent items (1) % — % (1) % State income taxes, net of federal benefit 4 % 4 % 6 % R&D and other tax credits 4 % 2 % 2 % Foreign income taxes (1) % 1 % 1 % Change in valuation allowance (27) % (32) % (32) % Change in Irish trading status — % 4 % 3 % Effective tax rate — % — % — % The trading income tax rate for an Irish company is 12.5% and the non-trading income tax rate is 25%. During 2019, the Company determined that it qualifies as a non-trading company. As such, the Company’s Irish NOLs were revalued to the higher rate. Further, not all expenses incurred will result in a non-trading company loss carryforward. These changes had no impact to income tax expense as a result of the valuation allowance. Deferred tax assets and liabilities are determined based on the difference between financial statement and tax bases using enacted tax rates in effect for the year in which the differences are expected to reverse. The components of the deferred tax assets and liabilities consist of the following: As of December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 471,407 $ 377,093 General business credits 140,121 123,305 Product license 4,963 5,652 Inventory 1,417 3,767 Lease liabilities 10,641 12,421 Stock-based compensation 25,600 21,664 Other 11,520 8,550 Deferred tax assets 665,669 552,452 Valuation allowance (587,408) (509,761) Deferred tax assets, net of valuation allowance $ 78,261 $ 42,691 Deferred tax liabilities: Intangibles $ (15,214) $ (9,163) Right-of-use assets (9,840) (11,054) Convertible debt (54,914) (22,474) Deferred tax liabilities $ (79,968) $ (42,691) Net deferred tax liabilities $ (1,707) $ — The deferred tax assets, net of valuation allowance of $78.3 million and $42.7 million at December 31, 2021 and 2020, respectively, primarily consist of net operating loss and tax credit carryforwards for income tax purposes. Due to the Company's history of operating losses, the Company recorded a valuation allowance on its net deferred tax assets by increasing the valuation allowance by $77.6 million and $96.3 million in 2021 and 2020, respectively, as it was more likely than not that such tax benefits will not be realized. A portion of the valuation allowance increase in 2021 is charged to tax expense and the remainder was charged to equity resulting from equity transactions. As a result of the Business Acquisition (see Note 15) and the convertible debt transactions (see Note 8), there is a net deferred tax liability at December 31, 2021. This is primarily attributable to state net operating loss limitations and the timing of future reversals of taxable temporary differences. At December 31, 2021, the Company had federal net operating loss (NOL) carryforwards for income tax purposes of approximately $1.5 billion and federal tax credit carryforwards of $143.8 million. Due to the limitation on NOLs as more fully discussed below, $1.3 billion of the NOLs are available to offset future taxable income, if any. The NOL carryovers and general business tax credits expire in various years beginning in 2022. For state tax purposes, the Company has approximately $855.0 million of NOLs in various states available to offset against future taxable income. The Company also has California and Virginia NOLs that are entirely limited due to Section 382 (as discussed below). The Company has $332.9 million of non-trading loss carryforwards for Irish tax purposes. The Company has disallowed interest expense carryover of $12.5 million which carryforward indefinitely. The Company completed an Internal Revenue Code Section 382 (Section 382) analysis in order to determine the amount of losses that are currently available for potential offset against future taxable income, if any. It was determined that the utilization of the Company's NOL and general business tax credit carryforwards generated in tax periods up to and including December 2010 were subject to substantial limitations under Section 382 due to ownership changes that occurred at various points from the Company's original organization through December 2010. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of shareholders that own, directly or indirectly, 5% or more of a corporation's stock, in the stock of a corporation by more than 50 percentage points over a testing period (usually 3 years). Since the Company's formation in 1999, it has raised capital through the issuance of common stock on several occasions which, combined with the purchasing shareholders' subsequent disposition of those shares, have resulted in multiple changes in ownership, as defined by Section 382. These ownership changes resulted in substantial limitations on the use of the Company's NOLs and general business tax credit carryforwards up to and including December 2010. The Company continues to track all of its NOLs and tax credit carryforwards but has provided a full valuation allowance to offset those amounts. Law Changes On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted into law in response to the COVID-19 pandemic. The CARES Act contains numerous income tax provisions, such an enhanced interest deductibility, repeal of the 80% limitation with respect to net operating losses arising in taxable years 2018-2020, and additional depreciation deductions related to qualified improvement property. The Company has concluded the analysis of these provisions as of year-end and the CARES Act did not have a material impact on the Company’s income taxes for 2020. The financial statement recognition of the benefit for a tax position is dependent upon the benefit being more likely than not to be sustainable upon audit by the applicable taxing authority. If this threshold is met, the tax benefit is then measured and recognized at the largest amount that is greater than 50% likely of being realized upon ultimate settlement. If such unrecognized tax benefits were realized and not subject to valuation allowances, the Company would recognize a tax benefit of $7.4 million. The following table summarizes the gross amounts of unrecognized tax benefits (in thousands): 2021 2020 Balance as of January 1, $ 5,633 $ 4,836 Additions related to prior period tax positions 112 — Reductions related to prior period tax positions — (32) Additions related to current period tax positions 1,637 829 Balance as of December 31, $ 7,382 $ 5,633 The Company is subject to US federal and state income taxes and the statute of limitations for tax audit is open for the federal tax returns for the years ended 2018 and later, and is generally open for certain states for the years 2017 and later. The Company has incurred net operating losses since inception, except for the year ended December 31, 2009. Such loss carryforwards would be subject to audit in any tax year in which those losses are utilized, notwithstanding the year of origin. The Company's policy is to recognize interest accrued related to unrecognized tax benefits and penalties in income tax expense. The Company has recorded no such expense. As of December 31, 2021 and 2020, the Company has recorded reserves for unrecognized income tax benefits of $7.4 million and $5.6 million, respectively. As any adjustment to the Company’s uncertain tax positions would not result in a cash tax liability, it has not recorded any accrued interest or penalties related to its uncertain tax positions. The Company does not anticipate any material changes in the amount of unrecognized tax positions over the next 12 months. |
License and Other Agreements
License and Other Agreements | 12 Months Ended |
Dec. 31, 2021 | |
License and Other Agreements | |
License and Other Agreements | License and Other Agreements In-License Agreements PARI Pharma GmbH —In April 2008, the Company entered into a licensing agreement with PARI for use of the optimized Lamira Nebulizer System for delivery of ARIKAYCE in treating patients with NTM lung infections, CF and bronchiectasis. Under the licensing agreement, the Company has rights under several US and foreign issued patents and patent applications involving improvements to the optimized Lamira Nebulizer System, to exploit the system with ARIKAYCE for the treatment of such indications, but the Company cannot manufacture the nebulizers except as permitted under the commercialization agreement with PARI, which is described in further detail below. The Lamira Nebulizer System has been approved for use in the US (in combination with ARIKAYCE), the EU and Japan. Under the licensing agreement, the Company paid PARI an upfront license fee and certain milestone payments. Upon FDA acceptance of the Company's New Drug Application and the subsequent FDA and EMA approval of ARIKAYCE, the Company paid PARI additional milestone payments of €1.0 million, €1.5 million and €0.5 million, respectively. In October 2017, the Company exercised an option to buy-down the royalties that will be paid to PARI on ARIKAYCE net sales. As a result, PARI is entitled to receive royalty payments in the mid-single digits on the annual global net sales of ARIKAYCE, pursuant to the licensing agreement, subject to certain specified annual minimum royalties. See below for information related to the commercialization agreement with PARI. Other Agreements PPD Development, L.P. — In April 2020, the Company entered into a master services agreement with PPD pursuant to which it retained PPD to perform clinical development services in connection with certain of its clinical research programs. The master services agreement has an initial term of five years. Either party may terminate (i) any project addendum under the master services agreement for any reason and without cause upon 30 days’ written notice, (ii) any project addendum in the event of the other party’s breach of the master services agreement or such project addendum upon 30 days’ written notice, provided that such breach is not cured within such 30-day period, (iii) the master services agreement or any project addendum immediately upon the occurrence of an insolvency event with respect to the other party or (iv) any project addendum upon 30 days’ written notice if (a) the continuation of the services under such project addendum would post material ethical or safety risks to study participants, (b) any approval from a regulatory authority necessary to perform the applicable study is revoked, suspended or expires without renewal or (c) in the reasonable opinion of such party, continuation of the services provided under such project addendum would be in violation of applicable law. The Company entered into project addenda with PPD to perform clinical development services over several years for, but not limited to, its ARISE, ENCORE ASPEN studies and other brensocatib and TPIP studies. Patheon UK Limited —In October 2017, the Company entered into certain agreements with Patheon related to the increase of its long-term production capacity for ARIKAYCE commercial inventory. The agreements provide for Patheon to manufacture and supply ARIKAYCE for its anticipated commercial needs. Under these agreements, the Company is required to deliver to Patheon the required raw materials, including active pharmaceutical ingredients, and certain fixed assets needed to manufacture ARIKAYCE. Patheon's supply obligations will commence once certain technology transfer and construction services are completed. The Company's manufacturing and supply agreement with Patheon will remain in effect for a fixed initial term, after which it will continue for successive renewal terms unless either party has given written notice of termination. The technology transfer agreement will expire when the parties agree that the technology transfer services have been completed. The agreements may also be terminated under certain other circumstances, including by either party due to a material uncured breach of the other party or the other party’s insolvency. These early termination clauses may reduce the amounts due to the relevant parties. AstraZeneca AB —In October 2016, the Company entered into a license agreement (AZ License Agreement) with AstraZeneca, a Swedish corporation. Pursuant to the terms of the AZ License Agreement, AstraZeneca granted the Company exclusive global rights for the purpose of developing and commercializing AZD7986 (renamed brensocatib). In consideration of the licenses and other rights granted by AstraZeneca, the Company made an upfront payment of $30.0 million, which was included as research and development expense in the fourth quarter of 2016. In December 2020, the Company incurred a $12.5 million milestone payment obligation upon the first dosing in a Phase 3 clinical trial of brensocatib. The Company is also obligated to make a series of additional contingent milestone payments totaling up to an additional $72.5 million upon the achievement of clinical development and regulatory filing milestones. If the Company elects to develop brensocatib for a second indication, the Company will be obligated to make an additional series of contingent milestone payments to AstraZeneca totaling up to $42.5 million, the first of which occurs at the initiation of a Phase 3 trial in the additional indication. The Company is not obligated to make any additional milestone payments for additional indications. In addition, the Company will pay AstraZeneca tiered royalties ranging from a high single-digit to mid-teens on net sales of any approved product based on brensocatib and one additional payment of $35.0 million upon the first achievement of $1.0 billion in annual net sales. The AZ License Agreement provides AstraZeneca with the option to negotiate a future agreement with the Company for commercialization of brensocatib in chronic obstructive pulmonary disease or asthma. Ajinomoto Althea, Inc. —In September 2015, the Company entered into the Fill/Finish Agreement with Althea, for Althea to produce, on a non-exclusive basis, ARIKAYCE in finished dosage form at a 50 kg scale. Under the Fill/Finish Agreement, the Company is obligated to pay a minimum of $2.7 million for the batches of ARIKAYCE produced by Althea each calendar year during the term of the Fill/Finish Agreement. The Fill/Finish Agreement became effective as of January 1, 2015, and following extensions in 2018 and 2021, remains in effect through December 31, 2022. Currently, Althea manufactures placebo for use in our ARIKAYCE clinical trials. PARI Pharma GmbH —In July 2014, the Company entered into the Commercialization Agreement for the manufacture and supply of the Device as optimized for use with ARIKAYCE. Under the Commercialization Agreement, PARI manufactures the Device except in the case of certain defined supply failures, when the Company will have the right to make the Device and have it made by third parties (but not certain third parties deemed under the Commercialization Agreement to compete with PARI). The Commercialization Agreement has an initial term of fifteen years from the first commercial sale of ARIKAYCE in October 2018. The term of the agreement may be extended by the Company for an additional five years by providing written notice to PARI at least one year prior to the expiration of the Initial Term. Notwithstanding the foregoing, the parties have certain rights and obligations under the agreement prior to the commencement of the Initial Term. Resilience Biotechnologies Inc. (successor to Therapure Biopharma Inc.) —In February 2014, the Company entered into a contract manufacturing agreement with Therapure Biopharma Inc., which was assumed by Resilience for the manufacture of ARIKAYCE, on a non-exclusive basis, at a 200 kg scale. Pursuant to the agreement, the Company and Resilience collaborated to construct a production area for the manufacture of ARIKAYCE in Resilience's existing manufacturing facility in Canada. The agreement has an initial term of five years, which began in October 2018, and will renew automatically for successive periods of two years each, unless terminated by either party by providing the required two years prior written notice to the other party. Notwithstanding the foregoing, the parties have rights and obligations under the agreement prior to the commencement of the initial term. Under the agreement, the Company is obligated to pay a minimum of $6 million for commercial ARIKAYCE batches produced and certain manufacturing activities each calendar year. Cystic Fibrosis Foundation Therapeutics, Inc. —In 2004 and 2009, the Company entered into research funding agreements with CFFT whereby it received $1.7 million and $2.2 million in research funding for the development of ARIKAYCE. As a result of the US approval of ARIKAYCE and in accordance with the agreements, as amended, the Company owes milestone payments to CFFT of $13.4 million in the aggregate payable through 2025 , of which $2.5 million has been paid through December 31, 2021 . Furthermore, if certain global sales milestones are met within five years of the commercialization of ARIKAYCE, the Company would owe up to an additional $3.9 million. The Company has determined the likelihood of meeting such global sales milestones and have accrued for these contingent obligations proportionally based on net sales of ARIKAYCE. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments In September 2018, the Company entered into a lease for its new corporate headquarters in Bridgewater, New Jersey. The initial lease term commenced in October 2019 and expires in September 2030. In July 2016, the Company signed an operating lease for laboratory space, also located in Bridgewater, for which the initial lease term was extended in the current year through December 2026. Future minimum rental payments under the Bridgewater leases are $26.3 million. Rent expense charged to operations was $4.9 million, $3.7 million, and $3.2 million for the years ended December 31, 2021, 2020 and 2019, respectively. Rent expense is recorded on a straight-line basis over the term of the applicable leases. In addition to rent, the Company has several firm purchase commitments, primarily related to the manufacturing of ARIKAYCE and annual minimum royalties on global net sales of ARIKAYCE. Future firm purchase commitments under these agreements, the last of which ends in 2034, total $78.2 million. These amounts do not represent the Company's entire anticipated purchases in the future, but instead represent only purchases that are the subject of contractually obligated minimum purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend amounts or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment. Legal Proceedings From time to time, the Company is a party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Retirement Plan | Retirement PlanThe Company has a 401(k) defined contribution plan for the benefit for all US employees and permits voluntary contributions by employees subject to IRS-imposed limitations. The Company matches 100% of eligible employee contributions on the first 4% of employee compensation (up to the IRS maximum). Employer contributions for the year ended December 31, 2021, 2020 and 2019 were $3.0 million, $2.9 million and $2.8 million, respectively. |
Business Acquisition
Business Acquisition | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
Business Acquisition | Business AcquisitionOn August 4, 2021, the Company acquired all of the equity interests of Motus and AlgaeneX, each a privately held, preclinical stage company. In connection with the closing of the Company’s acquisition of Motus, the Company issued an aggregate of 2,899,074 shares of the Company’s common stock, following certain closing-related reductions, to Motus’s former stockholders and option holders and certain individuals who are entitled to receive a portion of the acquisition consideration (collectively, Motus equityholders), subject to certain adjustments. The Company is obligated to issue to Motus equityholders an aggregate of 184,433 shares of the Company’s common stock on each of the first, second and third anniversaries of the closing date and up to 5,348,572 shares in the aggregate upon the achievement of certain development and regulatory milestone events, and to pay to the Motus equityholders an aggregate of $35 million upon the achievement of certain net sales-based milestones and a portion of the value of a priority review voucher (to the extent issued to the Company), in each case, subject to certain reductions. At the closing of the Company’s acquisition of AlgaeneX, the Company paid $1.5 million in cash to AlgaeneX’s former stockholders and certain individuals who are entitled to receive a portion of the acquisition consideration (collectively, the AlgaeneX equityholders). The Company is obligated to issue to AlgaeneX’s equityholders an aggregate of 368,867 shares of the Company’s common stock upon the achievement of a development milestone event and pay to AlgaeneX equityholders a mid-single digits licensing fee on certain future payments received by the Company in licensing transactions for AlgaeneX’s manufacturing technology, in each case, subject to certain reductions. The shares of the Company’s common stock issued to the Motus equityholders and the AlgaeneX equityholders were issued, and the shares issuable in the future will be issued, pursuant to Section 4(a)(2) of the Securities Act of 1933, and the numbers of such issued and issuable shares was calculated based on a per share value of $27.11, which is the weighted average price per share of the Company's common stock preceding the closing of the Business Acquisition for the 45 consecutive trading day period beginning on May 24, 2021. The Company will not receive any proceeds from the issuance of common stock to the Motus equityholders or the AlgaeneX equityholders. The Company evaluated the Business Acquisition under ASC 805 and ASU 2017-01, Business Combinations: Clarifying the Definition of a Business. The Company concluded that substantially all of the fair value of the gross assets acquired is not concentrated in a single identifiable asset or a group of similar identifiable assets. The transaction does not pass the screen test and thus management performed a full assessment to determine if the acquired entities met the definition of a business. For the full assessment, management considered whether it has acquired (a) inputs, (b) substantive processes, and (c) outputs. Under ASC 805, to be considered a business, a set of activities and assets is required to have only the first two of the three elements, which together are or will be used in the future to create outputs. Management determined that the acquired entities met the definition of a business since the Company acquired inputs and substantive processes capable of producing outputs. Therefore, the transaction has been accounted for under the acquisition method of accounting. Under the acquisition method, the total purchase price of the acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on the fair values as of the date of the acquisition. The fair value of the consideration totaled approximately $165.5 million, summarized as follows (in thousands): Fair Value of Consideration Cash consideration $ 10,500 Fair value of Insmed common stock issued 71,570 Estimated fair value of contingent consideration liabilities 69,706 Estimated fair value of deferred consideration 13,700 $ 165,476 The Company recorded the assets acquired and liabilities assumed as of the date of the acquisition based on the information available at that date. As of December 31, 2021, the Company finalized the fair values of the assets acquired and liabilities assumed. No purchase price adjustments were recorded during the measurement period, which is the period from the acquisition date through the period ended December 31, 2021. The following table presents the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands). Purchase Price Allocation Cash and cash equivalents $ 3,580 Intangible assets - IPR&D 29,600 Fixed assets 228 Other assets 17 Liabilities assumed (558) Deferred tax liability (3,501) Fair value of net assets acquired 29,366 Goodwill 136,110 $ 165,476 The Company incurred approximately $0.6 million in acquisition-related expenses, which were included in selling, general and administrative expenses in the consolidated statements of comprehensive loss for the periods ended December 31, 2021. The results of Motus's and AlgaeneX's operations have been included in the consolidated statements of comprehensive loss beginning on the acquisition date. The fair value of IPR&D was capitalized as of the acquisition date and accounted for as indefinite-lived intangible assets until completion or disposition of the assets or abandonment of the associated research and development efforts. Upon successful completion of the development efforts, the useful lives of the IPR&D assets will be determined based on the anticipated period of regulatory exclusivity and will be amortized within operating expenses. Until that time, the IPR&D assets will be subject to impairment testing and will not be amortized. The goodwill recorded related to the acquisition is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of acquisition. The goodwill recorded is not deductible for tax purposes. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation —The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Celtrix Pharmaceuticals, Inc., Insmed Holdings Limited, Insmed Ireland Limited, Insmed France SAS, Insmed Germany GmbH, Insmed Limited, Insmed Netherlands B.V., Insmed Godo Kaisha, Insmed Switzerland GmbH, and Insmed Italy S.R.L.. All intercompany transactions and balances have been eliminated in consolidation. |
Use of Estimates | Use of Estimates —The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and on various other assumptions. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of revenues and expenses reported for each period presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for revenue allowances, stock-based compensation, income taxes, loss contingencies, acquisition related intangibles including IPR&D and goodwill, fair value of contingent consideration, and accounting for research and development costs. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents —The Company considers cash equivalents to be highly liquid investments with maturities of three months or less from the date of purchase. |
Accounts Receivable | Accounts Receivable —Accounts receivable are recorded net of customer allowances for prompt pay discounts, chargebacks, and any estimated expected credit losses. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. To date, expected credit losses have not been material. |
Marketable Securities | Marketable Securities—Marketable securities consists of available-for-sale investments in US Treasury Notes with an original maturity of greater than 90 days. Marketable securities under this classification are recorded at fair value and unrealized gains and losses within accumulated other comprehensive income. The estimated fair value of available-for-sale marketable securities is determined based on quoted market prices. Management does not expect the Company's available-for-sale securities to be sold or redeemed within the next year and therefore has classified the marketable securities as long-term assets in the consolidated balance sheet. |
Fixed Assets, Net | Fixed Assets, Net —Fixed assets are recorded at cost and are depreciated on a straight-line basis over the estimated useful lives of the assets. Estimated useful lives of three years to five years are used for computer equipment. Estimated useful lives of seven years are used for laboratory equipment, office equipment, manufacturing equipment and furniture and fixtures. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized for the amount by which the carrying value of the asset exceeds the fair value of the asset. |
Intangible Assets, Net | Finite-lived Intangible Assets —Finite-lived intangible assets are measured at their respective fair values on the date they were recorded and, with respect to the acquired ARIKAYCE R&D intangible asset, at the date of subsequent adjustments of fair value. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. |
Business Combinations and Asset Acquisitions | Business Combinations and Asset Acquisitions —The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in ASU 2017-01, Business Combinations, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligations for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, are recognized as a gain or loss and recorded within change in the fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s books. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired). Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets. |
Indefinite-lived Intangible Assets, Goodwill, and Impairment Assessment | Indefinite-lived Intangible Assets— Indefinite-lived intangible assets consist of IPR&D. IPR&D acquired directly in a transaction other than a business combination is capitalized if the projects will be further developed or have an alternative future use; otherwise they are expensed. The fair values of IPR&D project assets acquired in business combinations are capitalized. The Company generally utilizes the Multi-Period Excess Earning Method to determine the estimated fair value of the IPR&D assets acquired in a business combination. The projections used in this valuation approach are based on many factors, such as relevant market size, patent protection, and expected pricing and industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of its intangible assets with indefinite lives may not be recoverable, including, but not limited to, expected growth rates, the cost of equity and debt capital, general economic conditions, the Company’s outlook and market performance of the Company’s industry and recent and forecasted financial performance. The Company performed a qualitative annual test for its indefinite-lived intangible assets as of October 1, 2021. During the year ended December 31, 2021, the Company concluded that no impairment exists. Goodwill —Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing at a reporting unit level on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. The Company performed a qualitative annual test for goodwill as of October 1, 2021. During the year ended December 31, 2021, the Company concluded that no impairment exists. The Company reassesses its reporting units as part of its annual segment review. As of December 31, 2021, the Company concluded that it continues to operate as one reporting unit. An entity is permitted to first assess qualitative factors to determine if a |
Leases | Leases —A lease is a contract, or part of a contract, that conveys the right to control the use of explicitly or implicitly identified property, plant or equipment in exchange for consideration. Control of an asset is conveyed to the Company if the Company obtains the right to obtain substantially all of the economic benefits of the asset or the right to direct the use of the asset. The Company recognizes right-of-use (ROU) assets and lease liabilities at the lease commencement date based on the present value of future, fixed lease payments over the term of the arrangement. ROU assets are amortized on a straight-line basis over the term of the lease or are amortized based on consumption, if this approach is more representative of the pattern in which benefit is expected to be derived from the underlying asset. Lease liabilities accrete to yield and are reduced at the time when the lease payment is payable to the vendor. Variable lease payments are recognized at the time when the event giving rise to the payment occurs and are recognized in the consolidated statements of comprehensive loss in the same line item as expenses arising from fixed lease payments. In accordance with Topic 842, leases are measured at present value using the rate implicit in the lease or, if the implicit rate is not determinable, the lessee's implicit borrowing rate. As the implicit rate is not typically available, the Company uses its implicit borrowing rate based on the information available at the lease commencement date to determine the present value of future lease payments. The implicit borrowing rate approximates the rate the Company would pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments. |
Debt Issuance Costs | Debt Issuance Costs —Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Debt issuance costs paid to the lender and third parties are reflected as a discount to the debt in the consolidated balance sheets. Unamortized debt issuance costs associated with extinguished debt are expensed in the period of the extinguishment. |
Fair Value Measurements | Fair Value Measurements —The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows: • Level 1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. • Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. • Level 3 — Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. Each major category of financial assets and liabilities measured at fair value on a recurring basis is categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets. The Company's cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions. The following table shows assets and liabilities that are measured at fair value on a recurring basis and their carrying value (in millions): As of December 31, 2021 Fair Value Carrying Value Level 1 Level 2 Level 3 Cash and cash equivalents $ 716.8 $ 716.8 $ — $ — Marketable securities $ 50.0 $ 50.0 $ — $ — Deferred consideration $ 14.9 $ — $ 14.9 $ — Contingent consideration liabilities $ 75.7 $ — $ — $ 75.7 As of December 31, 2020 Fair Value Carrying Value Level 1 Level 2 Level 3 Cash and cash equivalents $ 532.8 $ 532.8 $ — $ — The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. During the year ended December 31, 2021, new Level 1 assets were added in connection with the Companies purchase of available-for-sale securities. Additionally, during the year ended December 31, 2021, new Level 2 and Level 3 liabilities were added in connection with the Business Acquisition. There were no other transfers in or out of Level 1, Level 2 or Level 3 during the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, the Company held $50.0 million of available-for-sale securities, net of an unrealized loss of $0.2 million recorded in accumulated other comprehensive income. As of December 31, 2020, the Company held no securities that were in an unrealized gain or loss position. The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the security was rated below investment grade; (3) how long the security has been in an unrealized loss position; and (4) the Company's ability and intent to retain the investment for a sufficient period of time for it to recover. |
Deferred Consideration and Contingent Consideration Liabilities | Deferred Consideration The deferred consideration arose from the Business Acquisition in August 2021 (see Note 15). The Company is obligated to issue to Motus equityholders an aggregate of 184,433 shares of the Company’s common stock on each of the first, second and third anniversaries of the closing date, subject to certain reductions. A valuation of the deferred consideration is performed quarterly with gains and losses included within change in fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss. As the deferred consideration is settled in shares, there is no discount rate applied in the fair value calculation. Contingent Consideration Liabilities The contingent consideration liabilities arose from the Business Acquisition in August 2021 (see Note 15). The contingent consideration liabilities consist of developmental and regulatory milestones, a priority review voucher milestone and net sales milestones. Upon the achievement of certain development and regulatory milestone events, the Company is obligated to issue to Motus equityholders up to 5,348,572 shares in the aggregate and AlgaeneX equityholders up to 368,867 shares in the aggregate. The fair value of the development and regulatory milestones are estimated utilizing a probability-adjusted approach. At December 31, 2021, the weighted average probability of success was 42%. The development and regulatory milestones will be settled in shares of the Company's common stock. As such, there is no discount rate applied in the fair value calculation. If the Company were to receive a priority review voucher, the Company is obligated to pay to the Motus equityholders a portion of the value of the priority review voucher, subject to certain reductions. The potential payout will be either 50% of the after tax net proceeds received by the Company from a sale of the priority review voucher or 50% of the average of the sales prices for the last three publicly disclosed priority review voucher sales, less certain adjustments. The fair value of the priority review voucher milestone is estimated utilizing a probability-adjusted discounted cash flow approach. This obligation will be settled in cash. The contingent consideration liabilities for net sales milestones were valued using an option pricing model with Monte Carlo simulation. As of December 31, 2021, the fair value of these net sales milestones were deemed immaterial to the overall fair value of the contingent consideration. |
Foreign Currency | Foreign Currency —The Company has operations in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan. The results of its non-US dollar based functional currency operations are translated to US dollars at the average exchange rates during the period. Assets and liabilities are translated at the exchange rate prevailing at the balance sheet date. Equity is translated at the prevailing exchange rate at the date of the equity transaction. Translation adjustments are included in shareholders' equity, as a component of accumulated other comprehensive income. The Company realizes foreign currency transaction gains (losses) in the normal course of business based on movements in the applicable exchange rates. These gains (losses) are included as a component of other (expense) income, net. |
Concentration of Credit Risk | Concentration of Credit Risk —Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company places its cash equivalents with high credit-quality financial institutions and may invest its short-term investments in US treasury securities, mutual funds and government agency bonds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain safety and liquidity. The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for collectible trade receivables. The following table presents the percentage of gross product revenue represented by the Company's three largest customers as of the year ended December 31, 2021 and 2020. Percentage of Total Gross Product Revenue 2021 2020 Customer A 27% 27 % Customer B 24% 28 % Customer C 24% 23 % The Company relies on third-party manufacturers and suppliers for manufacturing and supply of its products. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturers, or an adverse change in their business, could materially impact future operating results. |
Revenue Recognition | Revenue Recognition - In accordance with ASC 606, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. For all contracts that fall into the scope of ASC 606, the Company has identified one performance obligation: the sale of ARIKAYCE to its customers. The Company has not incurred or capitalized any incremental costs associated with obtaining contracts with customers. Product revenues, net consist of net sales of ARIKAYCE. The Company's customers in the US include specialty pharmacies and specialty distributors. In December 2020, the Company began recognizing product revenue from commercial sales of ARIKAYCE in Europe. In July 2021, the Company began recognizing product revenue from commercial sales of ARIKAYCE in Japan. G lobally, product revenues are recognized once the Company performs and satisfies all five steps mentioned above. The following table presents a summary of the Company's product revenues, net by geographic location for the years ended December 31, 2021 and 2020 (in thousands). For the Year Ended December 31, 2021 2020 US $ 159,510 $ 157,520 Japan 16,006 — Europe and rest of world 12,945 6,893 Total product revenues, net $ 188,461 $ 164,413 Revenue is recorded at net selling price (transaction price), which includes estimates of variable consideration for which reserves are established for (a) customer credits, such as invoice discounts for prompt pay, (b) estimated government rebates, such as Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (c) estimated chargebacks, and (d) estimated costs of co-payment assistance. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (prompt pay discounts and chargebacks), prepaid expenses (co-payment assistance), or as a current liability (rebates). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company's historical experience, current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Customer credits: The Company's customers are offered various forms of consideration, including prompt payment discounts. The payment terms for sales to specialty pharmacies for prompt payment discounts are based on contractual rates agreed with the respective specialty pharmacies. The Company anticipates that its customers will earn these discounts and, therefore, deducts the full amount of these discounts from total gross product revenues at the time such revenues are recognized. Rebates: The Company contracts with government agencies and managed care organizations, or collectively, third-party payors, so that ARIKAYCE will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company's contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payor mix, and (iv) information obtained from the Company's specialty pharmacies. Chargebacks: Chargebacks are discounts that occur when certain contracted customers, currently public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase directly from the Company's specialty distributor. Contracted customers generally purchase the product at a discounted price and the specialty distributor, in turn, charges back to the Company the difference between the price the specialty distributor initially paid and the discounted price paid by the contracted customers. The Company estimates chargebacks provided to the specialty distributor and deducts these estimated amounts from gross product revenues, and from accounts receivable, at the time revenues are recognized. Co-payment assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish accruals for co-payment assistance. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue. The Company adjusts its accruals for co-pay assistance based on actual redemption activity and estimates of future redemptions related to sales in the current period. If any, or all, of the Company's actual experience varies from its estimates, the Company may need to adjust prior period accruals, affecting revenue in the period of adjustment. The following table provides a summary roll-forward of the Company's sales allowances and related accruals for the years ended December 31, 2021 and 2020, which have been deducted in arriving at product revenues, net (in thousands). Customer Credits, Fees and Discounts Rebates, Chargebacks and Co-pay Assistance Total Balance as of December 31, 2020 $ 453 $ 4,518 $ 4,971 Allowances for current period sales 6,788 21,347 28,135 Allowances for prior period sales — (476) (476) Payments and credits (4,119) (20,113) (24,232) Balance as of December 31, 2021 $ 3,122 $ 5,276 $ 8,398 Balance as of December 31, 2019 $ 464 $ 5,171 $ 5,635 Allowances for current period sales 3,731 18,244 21,975 Allowances for prior period sales — (288) (288) Payments and credits (3,742) (18,609) (22,351) Balance as of December 31, 2020 $ 453 $ 4,518 $ 4,971 The Company also recognizes revenue related to various EAPs in Europe, predominately in France. EAPs are intended to make products available on a named patient basis before they are commercially available in accordance with local regulations. |
Inventory and cost of product revenues (excluding amortization of intangible assets) | Inventory and Cost of Product Revenues (excluding amortization of intangible assets) —Inventory is stated at the lower of cost and net realizable value. The Company began capitalizing inventory costs following FDA approval of ARIKAYCE in September 2018. Inventory is sold on a first-in, first-out (FIFO) basis. The Company periodically reviews inventory for expiry and obsolescence and, if necessary, writes down accordingly. If quality specifications are not met during the manufacturing process, such inventory is written off to cost of product revenues (excluding amortization of intangible assets) in the period identified. Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of ARIKAYCE sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses and revenue-based milestone payments. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. Prior to FDA approval of ARIKAYCE, the Company expensed all inventory-related costs in the period incurred. Inventory used for clinical development purposes is expensed to R&D expense when consumed. |
Research and Development | Research and Development —R&D expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in the Company's research and development functions, including medical affairs. R&D expense also includes other internal operating expenses, the cost of manufacturing a product candidate, including the medical devices for drug delivery, for clinical study, the cost of conducting clinical studies, and the cost of conducting |
Stock-Based Compensation | Stock-based Compensation —The Company recognizes stock-based compensation expense for awards of equity instruments to employees and directors based on the grant-date fair value of those awards. The grant-date fair value of the award is recognized as compensation expense ratably over the requisite service period, which generally equals the vesting period of the award. The Company may also grant performance-based stock options to employees from time-to-time. The grant-date fair value of performance-based stock options is recognized as compensation expense over the implicit service period using the accelerated attribution method once it is probable that the performance condition will be achieved. Stock-based compensation expense is included in both R&D and SG&A expenses in the consolidated statements of comprehensive loss. |
Investment Income and Interest Expense | Investment Income and Interest Expense —Investment income consists of interest income earned on the Company's cash and cash equivalents and marketable securities. Interest expense consists primarily of interest costs related to the Company's debt. |
Income Taxes | Income Taxes —The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to reduce the deferred tax assets to the amount that is expected to be realized. In evaluating the need for a valuation allowance, the Company takes into account various factors, including the expected level of future taxable income and available tax planning strategies. If actual results differ from the assumptions made in the evaluation of a valuation allowance, the Company records a change in valuation allowance through income tax expense in the period such determination is made. The Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based solely on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that is more likely than not to be sustained upon ultimate settlement. As any adjustment to the Company’s uncertain tax positions would not result in a cash tax liability, it has not recorded any accrued interest or penalties related to its uncertain tax positions. The Company's policy for interest and penalties related to income tax exposures is to recognize interest and penalties as a component of the income tax provision in the consolidated statements of comprehensive loss. |
Net Loss Per Share | Net Loss Per Share —Basic net loss per share is computed by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options and restricted stock units would be anti-dilutive as the Company incurred a net loss in all periods presented. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options would be determined based on the treasury stock method. |
Segment Information | Segment Information —The Company currently operates in one business segment, which is the development and commercialization of therapies for patients with rare diseases. The Company has a single management team that reports to the Chief Executive Officer, the chief operating decision maker, who comprehensively manages the entire business. The Company does not operate separate lines of business with respect to its products or product candidates. Accordingly, the Company has one reportable segment. |
Recently Adopted Accounting Pronouncements and Recent Accounting Pronouncements (Not Yet Adopted) | Recently Adopted Accounting Pronouncements —In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending the existing guidance. For public business entities, the guidance was effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2020. The Company adopted this guidance January 1, 2021. The adoption of the guidance did not have a material impact on the consolidated financial statements and accompanying notes. Recent Accounting Pronouncements (Not Yet Adopted) —In August 2020, the FASB issued ASU 2020-06, Debt — Accounting for Convertible Instruments, to reduce the complexity associated with applying US generally accepted accounting principles (GAAP) to certain financial instruments with characteristics of liabilities and equity. For convertible instruments, the number of accounting models for convertible debt instruments is reduced, which results in fewer embedded conversion features being separately recognized from the host contract as compared with current GAAP. Only convertible instruments that meet the definition of a derivative or are issued with substantial premiums will continue to be subject to the separation models. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2021. A modified retrospective and a fully retrospective transition method are both permitted. The Company anticipates transitioning using the modified retrospective method and anticipates the impact of adopting ASU 2020-06 to result in a January 1, 2022 opening balance sheet adjustment increasing debt |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Carrying Value and Fair Value of Assets and Liabilities | The following table shows assets and liabilities that are measured at fair value on a recurring basis and their carrying value (in millions): As of December 31, 2021 Fair Value Carrying Value Level 1 Level 2 Level 3 Cash and cash equivalents $ 716.8 $ 716.8 $ — $ — Marketable securities $ 50.0 $ 50.0 $ — $ — Deferred consideration $ 14.9 $ — $ 14.9 $ — Contingent consideration liabilities $ 75.7 $ — $ — $ 75.7 As of December 31, 2020 Fair Value Carrying Value Level 1 Level 2 Level 3 Cash and cash equivalents $ 532.8 $ 532.8 $ — $ — |
Summary of Observable Inputs in Valuation of Deferred Consideration | The following observable input was used in the valuation of the deferred consideration as of December 31, 2021: Fair Value as of December 31, 2021 Observable Input Input Value Deferred consideration $14.9 Insmed share price on December 31, 2021 $27.24 |
Summary of Significant Unobservable Inputs Used in the Valuation of the Contingent Consideration Payables | The following significant unobservable inputs were used in the valuation of the contingent consideration liabilities as of December 31, 2021 (in millions): Contingent Consideration Liabilities Fair Value as of December 31, 2021 Valuation Technique Unobservable Inputs Values Development and regulatory milestones $65.5 Probability-adjusted Probabilities of success 14% - 95% Priority review voucher milestone $5.3 Probability-adjusted discounted cash flow Probability of success 13.5% Discount rate 6.7% The following table is a summary of the changes in the fair value of the Company's valuations for the deferred and contingent consideration liabilities for the period ended December 31, 2021 (in thousands): 2021 January 1, Additions Change in Fair Value Adjustments December 31, Deferred consideration $ — 13,700 1,372 (141) $ 14,931 Contingent consideration $ — 69,706 5,962 — $ 75,668 |
Schedules of Concentration of Risk, by Risk Factor | The following table presents the percentage of gross product revenue represented by the Company's three largest customers as of the year ended December 31, 2021 and 2020. Percentage of Total Gross Product Revenue 2021 2020 Customer A 27% 27 % Customer B 24% 28 % Customer C 24% 23 % |
Summary of Product Revenues by Geographic Location | The following table presents a summary of the Company's product revenues, net by geographic location for the years ended December 31, 2021 and 2020 (in thousands). For the Year Ended December 31, 2021 2020 US $ 159,510 $ 157,520 Japan 16,006 — Europe and rest of world 12,945 6,893 Total product revenues, net $ 188,461 $ 164,413 |
Contract with Customer, Asset, Allowance for Credit Loss | The following table provides a summary roll-forward of the Company's sales allowances and related accruals for the years ended December 31, 2021 and 2020, which have been deducted in arriving at product revenues, net (in thousands). Customer Credits, Fees and Discounts Rebates, Chargebacks and Co-pay Assistance Total Balance as of December 31, 2020 $ 453 $ 4,518 $ 4,971 Allowances for current period sales 6,788 21,347 28,135 Allowances for prior period sales — (476) (476) Payments and credits (4,119) (20,113) (24,232) Balance as of December 31, 2021 $ 3,122 $ 5,276 $ 8,398 Balance as of December 31, 2019 $ 464 $ 5,171 $ 5,635 Allowances for current period sales 3,731 18,244 21,975 Allowances for prior period sales — (288) (288) Payments and credits (3,742) (18,609) (22,351) Balance as of December 31, 2020 $ 453 $ 4,518 $ 4,971 |
Reconciliation of the Weighted Average Number of Shares Used to Compute Basic and Diluted Net Loss per Share | The following table sets forth the reconciliation of the weighted average number of shares used to compute basic and diluted net loss per share for the years ended December 31, 2021, 2020 and 2019. Years Ended December 31, 2021 2020 2019 (in thousands, except per share amounts) Numerator: Net loss $ (434,654) $ (294,090) $ (254,337) Denominator: Weighted average common shares used in calculation of basic net loss per share: 112,111 97,605 84,560 Effect of dilutive securities: Common stock options — — — Unvested restricted stock and restricted stock units — — — Convertible debt securities — — — Weighted average common shares outstanding used in calculation of diluted net loss per share 112,111 97,605 84,560 Net loss per share: Basic and diluted $ (3.88) $ (3.01) $ (3.01) |
Potentially Dilutive Securities Excluded from Computations of Diluted Weighted Average Common Shares Outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of December 31, 2021, 2020 and 2019 as their effect would have been anti-dilutive (in thousands). As of December 31, 2021 2020 2019 Common stock options 14,089 12,263 10,493 Unvested restricted stock and restricted stock units 1,020 844 501 Convertible debt securities 23,438 11,492 11,492 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | The Company's inventory balance consists of the following (in thousands): As of December 31, 2021 2020 Raw materials $ 29,541 $ 21,601 Work-in-process 18,528 18,754 Finished goods 18,940 9,237 $ 67,009 $ 49,592 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule Intangible Assets | A rollforward of the Company's intangible assets for the years ended December 31, 2021 and 2020 follows (in thousands): 2021 Intangible Asset January 1, Additions Amortization December 31, Acquired ARIKAYCE R&D $ 47,289 $ — $ (4,850) $ 42,439 Acquired IPR&D — 29,600 — 29,600 PARI milestones 1,972 — (202) 1,770 $ 49,261 $ 29,600 $ (5,052) $ 73,809 2020 Intangible Asset January 1, Additions Amortization December 31, Acquired ARIKAYCE R&D $ 52,139 $ — $ (4,850) $ 47,289 PARI milestone 1,543 582 (153) 1,972 $ 53,682 $ 582 $ (5,003) $ 49,261 |
Fixed Assets, net (Tables)
Fixed Assets, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Fixed Assets | Fixed assets are stated at cost and depreciated using the straight-line method, based on useful lives as follows (in thousands): Estimated Useful Life (years) As of December 31, Asset Description 2021 2020 Lab equipment 7 $ 11,862 $ 10,352 Furniture and fixtures 7 5,799 5,917 Computer hardware and software 3 - 5 7,264 7,267 Office equipment 7 89 88 Manufacturing equipment 7 1,145 1,567 Leasehold improvements lease term 36,073 35,289 Construction in progress (CIP) — 27,784 21,823 90,016 82,303 Less accumulated depreciation (37,061) (28,350) $ 52,955 $ 53,953 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued liabilities consist of the following (in thousands): As of December 31, 2021 2020 Accrued clinical trial expenses $ 19,410 $ 6,733 Accrued professional fees 10,678 8,594 Accrued technical operation expenses 6,187 9,164 Accrued royalty payable 6,655 3,423 Accrued interest payable 2,175 3,631 Accrued sales allowances and related costs 8,275 5,051 Deferred consideration from business acquisition 4,883 — Accrued construction costs 551 364 Other accrued liabilities 1,851 847 $ 60,665 $ 37,807 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Lease, Cost | The table below summarizes the Company's total lease costs included in its consolidated financial statements, as well as other required quantitative disclosures (in thousands). As of December 31, 2021 As of December 31, 2020 Finance lease cost: Amortization of right-of-use assets $ 1,078 $ 1,078 Interest on lease liabilities 1,300 1,301 Total finance lease cost $ 2,378 $ 2,379 Operating lease cost 12,125 8,664 Variable lease cost 7,043 9,950 Total lease cost $ 21,546 $ 20,993 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for finance leases $ 1,300 $ 1,301 Operating cash flows for operating leases $ 14,598 $ 8,813 Financing cash flows for finance leases $ 1,081 $ 936 Right-of-use assets obtained in exchange for new finance lease liabilities $ — $ — Right-of-use assets obtained in exchange for new operating lease liabilities $ 12,948 $ 1,205 Weighted average remaining lease term - finance leases 8.6 years 9.6 years Weighted average remaining lease term - operating leases 3.8 years 4.4 years Weighted average discount rate - finance leases 8.6 % 8.6 % Weighted average discount rate - operating leases 7.0 % 7.4 % |
Maturity of Operating Lease Liabilities | The table below presents the maturity of lease liabilities on an annual basis for the remaining years of the Company's commenced lease agreements (in thousands). Year Ending December 31, Finance Lease Operating Leases 2022 $ 1,819 $ 11,315 2023 1,670 7,927 2024 2,556 7,270 2025 2,615 7,182 2026 2,673 1,218 Thereafter 10,059 311 Total 21,392 35,223 Less: present value discount 6,680 4,255 Present value of lease liabilities $ 14,712 $ 30,968 Balance Sheet Classification at December 31, 2021: Current lease liabilities $ 609 $ 9,527 Long-term lease liabilities 14,103 21,441 Total lease liabilities $ 14,712 $ 30,968 |
Maturity of Finance Lease Liabilities | The table below presents the maturity of lease liabilities on an annual basis for the remaining years of the Company's commenced lease agreements (in thousands). Year Ending December 31, Finance Lease Operating Leases 2022 $ 1,819 $ 11,315 2023 1,670 7,927 2024 2,556 7,270 2025 2,615 7,182 2026 2,673 1,218 Thereafter 10,059 311 Total 21,392 35,223 Less: present value discount 6,680 4,255 Present value of lease liabilities $ 14,712 $ 30,968 Balance Sheet Classification at December 31, 2021: Current lease liabilities $ 609 $ 9,527 Long-term lease liabilities 14,103 21,441 Total lease liabilities $ 14,712 $ 30,968 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Components of Debt Balance | The following table presents the carrying value of the Company’s debt balance as of December 31, 2021 and 2020 (in thousands): As of December 31, 2021 2020 Face value of outstanding convertible notes $ 800,000 $ 450,000 Debt issuance costs, unamortized (11,539) (5,646) Discount on debt (221,873) (88,036) Long-term debt, net $ 566,588 $ 356,318 |
Schedule of Future Principal Repayments of Debt | As of December 31, 2021, future principal repayments of the debt for each of the fiscal years through maturity were as follows (in thousands): Year Ending December 31: 2022 $ — 2023 — 2024 — 2025 225,000 2026 — 2027 and thereafter 575,000 $ 800,000 |
Summary of Interest Expense | Interest expense related to debt and the finance lease for the years ended December 31, 2021, 2020, and 2019, which includes the contractual interest coupon payable semi-annually in cash, the amortization of the issuance costs, and accretion of debt discount is as follows (in thousands): Years Ended December 31, 2021 2020 2019 Contractual interest expense $ 8,134 $ 7,885 $ 7,883 Amortization of debt issuance costs 1,890 1,397 1,397 Accretion of debt discount 29,149 18,981 17,985 Total convertible debt interest expense $ 39,173 $ 28,263 $ 27,265 Finance lease interest expense 1,300 1,301 440 Total interest expense $ 40,473 $ 29,564 $ 27,705 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Fair Value Assumptions for Stock Options | The following table summarizes the grant date fair value and assumptions used in determining the fair value of all stock options granted, including grants of inducement options, during the years ended December 31, 2021, 2020 and 2019. 2021 2020 2019 Volatility 70%-71% 66% - 71% 67% - 70% Risk-free interest rate 0.36%-1.20% 0.22% - 1.67% 1.35% - 2.56% Dividend yield 0.0% 0.0% 0.0% Expected option term (in years) 5.84 5.17 5.09 Weighted average fair value of stock options granted $18.50 $13.75 $8.76 |
Summary of Stock Option Activity | The following table summarizes stock option activity for stock options granted for the years ended December 31, 2021, 2020 and 2019 as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value (in '000) Options outstanding at December 31, 2018 9,381,730 $ 16.30 Granted 3,434,270 $ 15.02 Exercised (1,413,341) $ 11.87 Forfeited and expired (909,713) $ 19.02 Options outstanding at December 31, 2019 10,492,946 $ 16.24 Exercisable at December 31, 2019 5,719,818 $ 15.38 Granted 3,990,740 $ 24.12 Exercised (1,678,604) $ 14.04 Forfeited and expired (541,680) $ 23.98 Options outstanding at December 31, 2020 12,263,402 $ 18.84 Exercisable at December 31, 2020 6,028,261 $ 16.15 Granted 4,039,360 $ 30.18 Exercised (1,235,186) $ 15.50 Forfeited and expired (978,616) $ 24.35 Options outstanding at December 31, 2021 14,088,960 $ 22.00 6.91 $ 90,317 Exercisable at December 31, 2021 7,292,851 $ 17.97 5.34 $ 70,204 |
Summary of RSU Activity | The following table summarizes RSU awards granted during the years ended December 31, 2021, 2020 and 2019: Number of RSUs Weighted Average Grant Price Outstanding at December 31, 2018 227,826 $ 29.14 Granted 407,655 $ 27.89 Released (92,145) $ 28.05 Forfeited (42,514) $ 29.11 Outstanding at December 31, 2019 500,822 $ 28.32 Granted 559,054 $ 23.85 Released (161,774) $ 28.90 Forfeited (53,711) $ 25.43 Outstanding at December 31, 2020 844,391 $ 25.43 Granted 607,578 $ 29.40 Released (291,823) $ 25.93 Forfeited (140,432) $ 27.73 Outstanding at December 31, 2021 1,019,714 $ 27.33 |
Summary of Allocation of Employee Stock-Based Compensation | The following table summarizes the stock-based compensation recorded in the consolidated statements of comprehensive loss related to stock options and RSUs during the years ended December 31, 2021, 2020 and 2019 (in millions): Years Ended December 31, 2021 2020 2019 Research and development expenses $ 17.8 $ 11.8 $ 8.2 Selling, general and administrative expenses 28.2 24.4 18.8 Total stock-based compensation expense $ 46.0 $ 36.2 $ 27.0 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes in the US and Globally | The Company's loss before income taxes in the US and globally was as follows (in thousands): Years Ended December 31, 2021 2020 2019 US $ (348,845) $ (207,120) $ (201,161) Foreign (87,567) (85,568) (52,399) Total $ (436,412) $ (292,688) $ (253,560) |
Schedule of Components Income Tax (Benefit) Provision | The Company's income tax provision consisted of the following (in thousands): Years Ended December 31, 2021 2020 2019 Current: Federal $ — $ — $ — State 104 268 10 Foreign 1,585 1,134 767 1,689 1,402 777 Deferred: Federal (2,835) — — State (612) — — Foreign — — — (3,447) — — Total $ (1,758) $ 1,402 $ 777 |
Reconciliation Between Federal Statutory Tax Rate and Effective Tax Rate | The reconciliation between the federal statutory tax rates and the Company's effective tax rate is as follows: Years Ended December 31, 2021 2020 2019 Statutory federal tax rate 21 % 21 % 21 % Permanent items (1) % — % (1) % State income taxes, net of federal benefit 4 % 4 % 6 % R&D and other tax credits 4 % 2 % 2 % Foreign income taxes (1) % 1 % 1 % Change in valuation allowance (27) % (32) % (32) % Change in Irish trading status — % 4 % 3 % Effective tax rate — % — % — % |
Schedule of Components of Deferred Tax Assets and Liabilities | The components of the deferred tax assets and liabilities consist of the following: As of December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 471,407 $ 377,093 General business credits 140,121 123,305 Product license 4,963 5,652 Inventory 1,417 3,767 Lease liabilities 10,641 12,421 Stock-based compensation 25,600 21,664 Other 11,520 8,550 Deferred tax assets 665,669 552,452 Valuation allowance (587,408) (509,761) Deferred tax assets, net of valuation allowance $ 78,261 $ 42,691 Deferred tax liabilities: Intangibles $ (15,214) $ (9,163) Right-of-use assets (9,840) (11,054) Convertible debt (54,914) (22,474) Deferred tax liabilities $ (79,968) $ (42,691) Net deferred tax liabilities $ (1,707) $ — |
Schedule of Unrecognized Tax Benefits | The following table summarizes the gross amounts of unrecognized tax benefits (in thousands): 2021 2020 Balance as of January 1, $ 5,633 $ 4,836 Additions related to prior period tax positions 112 — Reductions related to prior period tax positions — (32) Additions related to current period tax positions 1,637 829 Balance as of December 31, $ 7,382 $ 5,633 |
Business Acquisition (Tables)
Business Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
Schedule of Business Acquisitions, by Acquisition | The fair value of the consideration totaled approximately $165.5 million, summarized as follows (in thousands): Fair Value of Consideration Cash consideration $ 10,500 Fair value of Insmed common stock issued 71,570 Estimated fair value of contingent consideration liabilities 69,706 Estimated fair value of deferred consideration 13,700 $ 165,476 |
Schedule of Recognized Identified Assets Acquired and Liabilities Assumed | The following table presents the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands). Purchase Price Allocation Cash and cash equivalents $ 3,580 Intangible assets - IPR&D 29,600 Fixed assets 228 Other assets 17 Liabilities assumed (558) Deferred tax liability (3,501) Fair value of net assets acquired 29,366 Goodwill 136,110 $ 165,476 |
Description of Business and B_2
Description of Business and Basis of Presentation - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Cash and cash equivalents | $ 716,782 | $ 532,756 | |
Net loss | (434,654) | (294,090) | $ (254,337) |
Marketable securities | $ 50,043 | $ 0 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | Jan. 01, 2022USD ($) | Aug. 04, 2021shares | Aug. 31, 2021sale | Sep. 30, 2021shares | Dec. 31, 2021USD ($)reportingUnitsegment | Dec. 31, 2020USD ($)security | Dec. 31, 2019USD ($) | May 31, 2021USD ($) | Jan. 31, 2018USD ($) |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Number of Reporting Units | reportingUnit | 1 | ||||||||
Fair value transfers in or out of Level 1, Level 2 or Level 3 | $ 0 | $ 0 | |||||||
Available-for-sale securities | 50,043,000 | $ 0 | |||||||
Available-for-sale, unrealized loss | 200,000 | ||||||||
Available-for-sale Securities, Gross Unrealized Gain (Loss), Number of Securities | security | 0 | ||||||||
Unamortized portion of debt discount | 221,873,000 | $ 88,036,000 | |||||||
Debt issuance costs, unamortized | $ 11,539,000 | 5,646,000 | |||||||
Number of operating segments | segment | 1 | ||||||||
Number of reportable segments | segment | 1 | ||||||||
Debt, long-term | $ 566,588,000 | 356,318,000 | |||||||
Deferred tax liabilities | (79,968,000) | (42,691,000) | |||||||
Retained earnings | (2,265,243,000) | (1,830,589,000) | |||||||
Additional paid-in capital | (2,673,556,000) | (2,105,252,000) | |||||||
Amortization of debt issuance costs and accretion of debt discount | $ 1,890,000 | $ 1,397,000 | $ 1,397,000 | ||||||
Cumulative Effect, Period of Adoption, Adjustment | Subsequent Event | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Debt issuance costs, unamortized | $ 6,000,000 | ||||||||
Debt, long-term | 222,000,000 | ||||||||
Deferred tax liabilities | 1,000,000 | ||||||||
Retained earnings | 79,000,000 | ||||||||
Additional paid-in capital | 294,000,000 | ||||||||
Convertible Debt | Cumulative Effect, Period of Adoption, Adjustment | Subsequent Event | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Amortization of debt issuance costs and accretion of debt discount | $ 3,300,000 | ||||||||
0.75% convertible senior notes due 2028 | Convertible Notes Payable | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Interest rate (as a percent) | 0.75% | ||||||||
Convertible senior notes | $ 371,600,000 | ||||||||
Unamortized portion of debt discount | $ 187,800,000 | ||||||||
Debt issuance costs, unamortized | $ 9,400,000 | 15,700,000 | |||||||
1.75% convertible senior note due 2025 | Convertible Notes Payable | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Interest rate (as a percent) | 1.75% | ||||||||
Convertible senior notes | $ 203,400,000 | $ 309,100,000 | |||||||
Unamortized portion of debt discount | $ 34,100,000 | ||||||||
Debt issuance costs, unamortized | $ 2,100,000 | $ 14,200,000 | |||||||
Development and regulatory milestones | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Weighted-average probability of reaching milestone, percentage | 42.00% | ||||||||
Accrued Liabilities, Current | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Deferred consideration | $ 4,900,000 | ||||||||
Other Noncurrent Liabilities | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Deferred consideration | 10,000,000 | ||||||||
Motus Biosciences, Inc. | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Shares issued in acquisition (in shares) | shares | 2,899,074 | 2,889,367 | |||||||
Shares issued upon milestone achievements (in shares) | shares | 5,348,572 | ||||||||
Motus Biosciences, Inc. | Level 2 | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Deferred consideration | 14,900,000 | ||||||||
Motus Biosciences, Inc. | Development and regulatory milestones | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Proceeds of sale of priority review voucher obligated to pay to equity holders, percentage | 50.00% | ||||||||
Potential payout, average sales prices for publicly disclosed sales, percentage | 50.00% | ||||||||
Number of publicly disclosed sales used to determine average sales price owed to equity holders | sale | 3 | ||||||||
Motus Biosciences, Inc. | First anniversary of closing date | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Shares issued in acquisition (in shares) | shares | 184,433 | ||||||||
Motus Biosciences, Inc. | Second anniversary of closing date | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Shares issued in acquisition (in shares) | shares | 184,433 | ||||||||
Motus Biosciences, Inc. | Third anniversary of closing date | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Shares issued in acquisition (in shares) | shares | 184,433 | ||||||||
AlgaeneX, Inc. | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Shares issued upon milestone achievements (in shares) | shares | 368,867 | ||||||||
Carrying Value | Recurring basis | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Available-for-sale securities | 50,000,000 | ||||||||
Deferred consideration | 14,900,000 | ||||||||
Carrying Value | Recurring basis | 0.75% convertible senior notes due 2028 | Level 2 | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Convertible senior notes | 377,800,000 | ||||||||
Carrying Value | Recurring basis | 1.75% convertible senior note due 2025 | Level 2 | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Convertible senior notes | 188,800,000 | ||||||||
Fair Value | Recurring basis | Level 2 | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Available-for-sale securities | 0 | ||||||||
Deferred consideration | 14,900,000 | ||||||||
Fair Value | Recurring basis | 0.75% convertible senior notes due 2028 | Level 2 | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Convertible senior notes | 633,300,000 | ||||||||
Fair Value | Recurring basis | 1.75% convertible senior note due 2025 | Level 2 | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Convertible senior notes | $ 228,100,000 | ||||||||
Computer hardware and software | Minimum | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Estimated Useful Life (years) | 3 years | ||||||||
Computer hardware and software | Maximum | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Estimated Useful Life (years) | 5 years | ||||||||
Laboratory equipment, office equipment, manufacturing equipment and furniture and fixtures | |||||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||||||
Estimated Useful Life (years) | 7 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 50,043 | $ 0 |
Recurring basis | Carrying Value | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 716,800 | 532,800 |
Marketable securities | 50,000 | |
Deferred consideration | 14,900 | |
Contingent consideration liabilities | 75,700 | |
Recurring basis | Fair Value | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 716,800 | 532,800 |
Marketable securities | 50,000 | |
Deferred consideration | 0 | |
Contingent consideration liabilities | 0 | |
Recurring basis | Fair Value | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Marketable securities | 0 | |
Deferred consideration | 14,900 | |
Contingent consideration liabilities | 0 | |
Recurring basis | Fair Value | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | $ 0 |
Deferred consideration | 0 | |
Contingent consideration liabilities | $ 75,700 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Significant Observable Inputs of Deferred Business Acquisition Liabilities (Details) - Motus Biosciences, Inc. - USD ($) $ / shares in Units, $ in Millions | Dec. 31, 2021 | Aug. 04, 2021 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Share price used to calculate issuable shares (in dollars per share) | $ 27.11 | |
Insmed share price on December 31, 2021 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Share price used to calculate issuable shares (in dollars per share) | $ 27.24 | |
Level 2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Deferred consideration | $ 14.9 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Significant Unobservable Inputs of Contingent Consideration Liability (Details) $ in Millions | Dec. 31, 2021USD ($) |
Development and regulatory milestones | Probabilities of success | Minimum | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0.14 |
Development and regulatory milestones | Probabilities of success | Maximum | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0.95 |
Development and regulatory milestones | Level 3 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Contingent consideration liabilities | $ 65.5 |
Priority review voucher milestone | Probabilities of success | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0.135 |
Priority review voucher milestone | Discount rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0.067 |
Priority review voucher milestone | Level 3 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Contingent consideration liabilities | $ 5.3 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Changes in the Fair Value of Deferred and Contingent Consideration Liabilities (Details) - Level 3 - Recurring basis $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Deferred consideration | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning balance | $ 0 |
Additions | 13,700 |
Change in Fair Value | 1,372 |
Adjustments | (141) |
Ending balance | 14,931 |
Contingent consideration | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning balance | 0 |
Additions | 69,706 |
Change in Fair Value | 5,962 |
Adjustments | 0 |
Ending balance | $ 75,668 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Concentration Risk (Details) - Sales Revenue, Product Line - Customer Concentration Risk | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Customer A | ||
Concentration Risk [Line Items] | ||
Percentage of Total Gross Product Revenue | 27.00% | 27.00% |
Customer B | ||
Concentration Risk [Line Items] | ||
Percentage of Total Gross Product Revenue | 24.00% | 28.00% |
Customer C | ||
Concentration Risk [Line Items] | ||
Percentage of Total Gross Product Revenue | 24.00% | 23.00% |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Revenue by Geographic Location (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||
Product revenues, net | $ 188,461 | $ 164,413 | $ 136,467 |
US | |||
Disaggregation of Revenue [Line Items] | |||
Product revenues, net | 159,510 | 157,520 | |
Japan | |||
Disaggregation of Revenue [Line Items] | |||
Product revenues, net | 16,006 | 0 | |
Europe and rest of world | |||
Disaggregation of Revenue [Line Items] | |||
Product revenues, net | $ 12,945 | $ 6,893 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Allowance for Credit Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Contract with Customer, Asset, Allowance for Credit Loss [Roll Forward] | ||
Balance at beginning | $ 4,971 | $ 5,635 |
Allowances for current period sales | 28,135 | 21,975 |
Allowances for prior period sales | (476) | (288) |
Payments and credits | (24,232) | (22,351) |
Ending balance | 8,398 | 4,971 |
Customer Credits, Fees and Discounts | ||
Contract with Customer, Asset, Allowance for Credit Loss [Roll Forward] | ||
Balance at beginning | 453 | 464 |
Allowances for current period sales | 6,788 | 3,731 |
Allowances for prior period sales | 0 | 0 |
Payments and credits | (4,119) | (3,742) |
Ending balance | 3,122 | 453 |
Rebates, Chargebacks and Co-pay Assistance | ||
Contract with Customer, Asset, Allowance for Credit Loss [Roll Forward] | ||
Balance at beginning | 4,518 | 5,171 |
Allowances for current period sales | 21,347 | 18,244 |
Allowances for prior period sales | (476) | (288) |
Payments and credits | (20,113) | (18,609) |
Ending balance | $ 5,276 | $ 4,518 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | |||
Net loss | $ (434,654) | $ (294,090) | $ (254,337) |
Denominator: | |||
Weighted average common shares used in calculation of basic net loss per share (in shares) | 112,111 | 97,605 | 84,560 |
Effect of dilutive securities: | |||
Dilutive securities, convertible debt (in shares) | 0 | 0 | 0 |
Weighted average common shares outstanding used in calculation of diluted net loss per share (in shares) | 112,111 | 97,605 | 84,560 |
Net loss per share: | |||
Basic (in dollars per share) | $ (3.88) | $ (3.01) | $ (3.01) |
Diluted (in dollars per share) | $ (3.88) | $ (3.01) | $ (3.01) |
Common stock options | |||
Effect of dilutive securities: | |||
Dilutive securities, share-based payment (in shares) | 0 | 0 | 0 |
Unvested restricted stock and restricted stock units | |||
Effect of dilutive securities: | |||
Dilutive securities, share-based payment (in shares) | 0 | 0 | 0 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Anti-dilutive Securities (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Common stock options | |||
Anti-dilutive securities excluded from computations of diluted weighted-average common shares outstanding | |||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding (in shares) | 14,089 | 12,263 | 10,493 |
Unvested restricted stock and restricted stock units | |||
Anti-dilutive securities excluded from computations of diluted weighted-average common shares outstanding | |||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding (in shares) | 1,020 | 844 | 501 |
Convertible debt securities | |||
Anti-dilutive securities excluded from computations of diluted weighted-average common shares outstanding | |||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding (in shares) | 23,438 | 11,492 | 11,492 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 29,541 | $ 21,601 |
Work-in-process | 18,528 | 18,754 |
Finished goods | 18,940 | 9,237 |
Inventory, Net | $ 67,009 | $ 49,592 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Intangible assets estimated useful life | 12 years | |
Amortization of intangible assets, 2022 | $ 5,100 | |
Amortization of intangible assets, 2023 | 5,100 | |
Amortization of intangible assets, 2024 | 5,100 | |
Amortization of intangible assets, 2025 | 5,100 | |
Amortization of intangible assets, 2026 | 5,100 | |
Goodwill | $ 136,110 | $ 0 |
Intangible Assets, Net (Details
Intangible Assets, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Finite-lived Intangible Assets [Roll Forward] | |||
Intangibles, gross | $ 49,261 | $ 53,682 | |
Additions | $ 29,600 | 582 | |
Amortization | (5,052) | (5,003) | (4,993) |
Intangibles, net | 73,809 | 49,261 | |
Acquired ARIKAYCE R&D | |||
Finite-lived Intangible Assets [Roll Forward] | |||
Intangibles, gross | 47,289 | 52,139 | |
Additions | 0 | 0 | |
Amortization | (4,850) | (4,850) | |
Intangibles, net | 42,439 | 47,289 | |
Acquired IPR&D | |||
Finite-lived Intangible Assets [Roll Forward] | |||
Intangibles, gross | 0 | ||
Additions | 29,600 | ||
Amortization | 0 | ||
Intangibles, net | 29,600 | ||
PARI milestones | |||
Finite-lived Intangible Assets [Roll Forward] | |||
Intangibles, gross | 1,972 | $ 1,543 | |
Additions | 0 | 582 | |
Amortization | (202) | (153) | |
Intangibles, net | $ 1,770 | $ 1,972 |
Fixed Assets, net (Details)
Fixed Assets, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment | |||
Fixed assets, gross | $ 90,016 | $ 82,303 | |
Less accumulated depreciation | (37,061) | (28,350) | |
Fixed assets, net | 52,955 | 53,953 | |
Depreciation expense | $ 9,100 | 9,100 | $ 5,200 |
Lab equipment | |||
Property, Plant and Equipment | |||
Estimated Useful Life (years) | 7 years | ||
Fixed assets, gross | $ 11,862 | 10,352 | |
Furniture and fixtures | |||
Property, Plant and Equipment | |||
Estimated Useful Life (years) | 7 years | ||
Fixed assets, gross | $ 5,799 | 5,917 | |
Computer hardware and software | |||
Property, Plant and Equipment | |||
Fixed assets, gross | $ 7,264 | 7,267 | |
Computer hardware and software | Minimum | |||
Property, Plant and Equipment | |||
Estimated Useful Life (years) | 3 years | ||
Computer hardware and software | Maximum | |||
Property, Plant and Equipment | |||
Estimated Useful Life (years) | 5 years | ||
Office equipment | |||
Property, Plant and Equipment | |||
Estimated Useful Life (years) | 7 years | ||
Fixed assets, gross | $ 89 | 88 | |
Manufacturing equipment | |||
Property, Plant and Equipment | |||
Estimated Useful Life (years) | 7 years | ||
Fixed assets, gross | $ 1,145 | 1,567 | |
Leasehold improvements | |||
Property, Plant and Equipment | |||
Fixed assets, gross | 36,073 | 35,289 | |
Construction in progress (CIP) | |||
Property, Plant and Equipment | |||
Fixed assets, gross | $ 27,784 | $ 21,823 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued clinical trial expenses | $ 19,410 | $ 6,733 |
Accrued professional fees | 10,678 | 8,594 |
Accrued technical operation expenses | 6,187 | 9,164 |
Accrued royalty payable | 6,655 | 3,423 |
Accrued interest payable | 2,175 | 3,631 |
Accrued sales allowances and related costs | 8,275 | 5,051 |
Deferred consideration from business acquisition | 4,883 | 0 |
Accrued construction costs | 551 | 364 |
Other accrued liabilities | 1,851 | 847 |
Total accrued expenses | $ 60,665 | $ 37,807 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | ||
Variable lease payments | $ 7 | $ 9.9 |
Lease cost, future right-of-use asset | $ 32.3 | |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Remaining lease term | 1 year | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Remaining lease term | 10 years 10 months |
Leases - Lease, Cost (Details)
Leases - Lease, Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Lease, Cost [Abstract] | |||
Amortization of right-of-use assets | $ 1,078 | $ 1,078 | $ 360 |
Finance lease interest expense | 1,300 | 1,301 | $ 440 |
Total finance lease cost | 2,378 | 2,379 | |
Operating lease cost | 12,125 | 8,664 | |
Variable lease cost | 7,043 | 9,950 | |
Total lease cost | 21,546 | 20,993 | |
Cash Flow, Lessee [Abstract] | |||
Operating cash flows for finance leases | 1,300 | 1,301 | |
Operating cash flows for operating leases | 14,598 | 8,813 | |
Financing cash flows for finance leases | 1,081 | 936 | |
Right-of-use assets obtained in exchange for new finance lease liabilities | 0 | 0 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 12,948 | $ 1,205 | |
Weighted average remaining lease term - finance leases | 8 years 7 months 6 days | 9 years 7 months 6 days | |
Weighted average remaining lease term - operating leases | 3 years 9 months 18 days | 4 years 4 months 24 days | |
Weighted average discount rate - finance leases | 8.60% | 8.60% | |
Weighted average discount rate - operating leases | 7.00% | 7.40% |
Leases - Maturity of Lease Liab
Leases - Maturity of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Finance Lease | ||
2022 | $ 1,819 | |
2023 | 1,670 | |
2024 | 2,556 | |
2025 | 2,615 | |
2026 | 2,673 | |
Thereafter | 10,059 | |
Total | 21,392 | |
Less: present value discount | 6,680 | |
Present value of lease liabilities | 14,712 | |
Finance lease liabilities | 609 | $ 1,081 |
Finance lease liabilities, long-term | 14,103 | 14,713 |
Total lease liabilities | 14,712 | |
Operating Leases | ||
2022 | 11,315 | |
2023 | 7,927 | |
2024 | 7,270 | |
2025 | 7,182 | |
2026 | 1,218 | |
Thereafter | 311 | |
Total | 35,223 | |
Less: present value discount | 4,255 | |
Present value of lease liabilities | 30,968 | |
Operating lease liabilities | 9,527 | 11,475 |
Long-term lease liabilities | 21,441 | $ 21,255 |
Total lease liabilities | $ 30,968 |
Debt - Narrative (Details)
Debt - Narrative (Details) | 1 Months Ended | 12 Months Ended | |||
May 31, 2021USD ($)day$ / shares | Jan. 31, 2018USD ($)day$ / shares | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Debt Instrument [Line Items] | |||||
Unamortized debt issuance costs | $ 11,539,000 | $ 5,646,000 | |||
Net proceeds | 575,000,000 | 0 | $ 0 | ||
Loss on extinguishment of debt | 17,689,000 | $ 0 | $ 0 | ||
0.75% convertible senior notes due 2028 | |||||
Debt Instrument [Line Items] | |||||
Initial conversion rate | 0.0307692 | ||||
1.75% convertible senior note due 2025 | |||||
Debt Instrument [Line Items] | |||||
Initial conversion rate | 0.0255384 | ||||
Convertible Notes Payable | 0.75% convertible senior notes due 2028 | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | $ 575,000,000 | ||||
Option to purchase additional debt | 75,000,000 | ||||
Unamortized debt issuance costs | 15,700,000 | $ 9,400,000 | |||
Net proceeds | $ 559,300,000 | ||||
Initial conversion price (in dollars per share) | $ / shares | $ 32.50 | ||||
Convertible senior notes | $ 371,600,000 | ||||
Effective interest rate | 7.10% | ||||
Remaining discount amortization period | 6 years 5 months 1 day | ||||
Convertible Notes Payable | 0.75% convertible senior notes due 2028 | Conversion Term (i) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days | day | 5 | ||||
Threshold consecutive trading days | day | 5 | ||||
Threshold percentage of stock price trigger | 98.00% | ||||
Convertible Notes Payable | 0.75% convertible senior notes due 2028 | Conversion Term (ii) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days | day | 45 | ||||
Threshold consecutive trading days | day | 10 | ||||
Threshold percentage of stock price trigger | 10.00% | ||||
Convertible Notes Payable | 0.75% convertible senior notes due 2028 | Conversion Term (iii) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days following fundamental change | day | 30 | ||||
Convertible Notes Payable | 0.75% convertible senior notes due 2028 | Conversion Term (iv) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days | day | 20 | ||||
Threshold consecutive trading days | day | 30 | ||||
Threshold percentage of stock price trigger | 130.00% | ||||
Convertible Notes Payable | 1.75% convertible senior note due 2025 | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | $ 450,000,000 | ||||
Option to purchase additional debt | 50,000,000 | ||||
Unamortized debt issuance costs | 14,200,000 | $ 2,100,000 | |||
Net proceeds | $ 435,800,000 | ||||
Debt Instrument, Repurchase Amount | $ 225,000,000 | ||||
Loss on extinguishment of debt | 17,700,000 | ||||
Initial conversion price (in dollars per share) | $ / shares | $ 39.16 | ||||
Convertible senior notes | $ 203,400,000 | $ 309,100,000 | |||
Equity component of convertible debt | $ 140,900,000 | ||||
Effective interest rate | 7.60% | ||||
Remaining discount amortization period | 3 years 14 days | ||||
Convertible Notes Payable | 1.75% convertible senior note due 2025 | Conversion Term (i) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days | day | 5 | ||||
Threshold consecutive trading days | day | 5 | ||||
Threshold percentage of stock price trigger | 98.00% | ||||
Convertible Notes Payable | 1.75% convertible senior note due 2025 | Conversion Term (ii) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days | day | 45 | ||||
Threshold consecutive trading days | day | 10 | ||||
Threshold percentage of stock price trigger | 10.00% | ||||
Convertible Notes Payable | 1.75% convertible senior note due 2025 | Conversion Term (iii) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days following fundamental change | day | 30 | ||||
Convertible Notes Payable | 1.75% convertible senior note due 2025 | Conversion Term (iv) | |||||
Debt Instrument [Line Items] | |||||
Threshold trading days | day | 20 | ||||
Threshold consecutive trading days | day | 30 | ||||
Threshold percentage of stock price trigger | 130.00% |
Debt - Components of Debt (Deta
Debt - Components of Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Debt issuance costs, unamortized | $ (11,539) | $ (5,646) |
Discount on debt | (221,873) | (88,036) |
Long-term debt, net | 566,588 | 356,318 |
Convertible Notes Payable | ||
Debt Instrument [Line Items] | ||
Face value of outstanding convertible notes | $ 800,000 | $ 450,000 |
Debt - Future Principal Repayme
Debt - Future Principal Repayments of Debt (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 0 |
2023 | 0 |
2024 | 0 |
2025 | 225,000 |
2026 | 0 |
2027 and thereafter | 575,000 |
Long-term debt | $ 800,000 |
Debt - Interest Expense (Detail
Debt - Interest Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |||
Contractual interest expense | $ 8,134 | $ 7,885 | $ 7,883 |
Amortization of debt issuance costs and accretion of debt discount | 1,890 | 1,397 | 1,397 |
Accretion of debt discount | 29,149 | 18,981 | 17,985 |
Total convertible debt interest expense | 39,173 | 28,263 | 27,265 |
Finance lease interest expense | 1,300 | 1,301 | 440 |
Total interest expense | $ 40,473 | $ 29,564 | $ 27,705 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | Aug. 04, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||||||||
Common stock, authorized shares (in shares) | 500,000,000 | 500,000,000 | ||||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||||||
Common stock, issued shares (in shares) | 118,738,266 | 102,763,060 | ||||||
Common stock, outstanding shares (in shares) | 118,738,266 | 102,763,060 | ||||||
Offering price per share (in dollars per share) | $ 25 | $ 23.25 | $ 26 | |||||
Payments of stock issuance costs | $ 17.5 | $ 13.5 | $ 16 | |||||
Preferred stock, authorized (in shares) | 200,000,000 | 200,000,000 | ||||||
Preferred stock, par value (in shares) | $ 0.01 | $ 0.01 | ||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||
Public Stock Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Shares sold in offering (in shares) | 11,500,000 | 11,155,000 | 10,657,692 | |||||
Aggregate net proceeds from stock offering | $ 270.1 | $ 245.9 | $ 261.1 | |||||
Over-Allotment Option | ||||||||
Class of Stock [Line Items] | ||||||||
Shares sold in offering (in shares) | 1,500,000 | 1,455,000 | 1,042,307 | |||||
ATM Program | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock authorized, aggregate gross sales proceeds (up to) | $ 250 | |||||||
Public Stock Offering - Shares From Company's Chairman and Chief Executive Officer | ||||||||
Class of Stock [Line Items] | ||||||||
Shares sold in offering (in shares) | 400,000 | |||||||
Aggregate net proceeds from stock offering | $ 0 | |||||||
Motus Biosciences, Inc. | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares reserved for issuance (in shares) | 9,406,112 | |||||||
Shares issued in acquisition (in shares) | 2,899,074 | 2,889,367 | ||||||
Convertible Notes Payable | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares reserved for issuance (in shares) | 23,438,430 | |||||||
Common stock options | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares reserved for issuance (in shares) | 14,088,960 | |||||||
RSUs | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares reserved for issuance (in shares) | 1,019,714 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Millions | May 12, 2021 | May 12, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | May 16, 2019 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares available for grant (in shares) | 5,226,409 | ||||||
Inducement stock option granted to new employees (in shares) | 1,117,020 | 996,830 | |||||
Options outstanding (in shares) | 14,088,960 | 12,263,402 | 10,492,946 | 9,381,730 | |||
Performance-condition options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options outstanding (in shares) | 114,780 | 0 | 0 | ||||
Common stock options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Total intrinsic value of stock options exercised during the period | $ 22.1 | $ 24 | $ 16.5 | ||||
Unrecognized compensation expense related to unvested stock options | $ 83.8 | ||||||
Expected weighted average period for recognizing unrecognized compensation expense | 1 year 9 months 18 days | ||||||
Restricted Stock and Restricted Stock Units | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of common shares each award holder is entitled to receive (in shares) | 1 | ||||||
RSUs | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expected weighted average period for recognizing unrecognized compensation expense | 2 years 1 month 6 days | ||||||
Unrecognized compensation expense related to unvested awards | $ 18.8 | ||||||
Employee Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expense | $ 1.3 | $ 1.2 | $ 1.6 | ||||
2019 Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock, maximum authorized for issuance (in shares) | 3,500,000 | ||||||
Number of additional shares authorized (in shares) | 2,750,000 | 4,500,000 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value Assumptions, Stock Options (Details) - Common stock options - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Fair value and assumptions used in determining fair value of stock options | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected option term (in years) | 5 years 10 months 2 days | 5 years 2 months 1 day | 5 years 1 month 2 days |
Weighted average fair value of stock options granted (in dollars per share) | $ 18.50 | $ 13.75 | $ 8.76 |
Minimum | |||
Fair value and assumptions used in determining fair value of stock options | |||
Volatility | 70.00% | 66.00% | 67.00% |
Risk-free interest rate | 0.36% | 0.22% | 1.35% |
Maximum | |||
Fair value and assumptions used in determining fair value of stock options | |||
Volatility | 71.00% | 71.00% | 70.00% |
Risk-free interest rate | 1.20% | 1.67% | 2.56% |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | |||
Options outstanding beginning of the year (in shares) | 12,263,402 | 10,492,946 | 9,381,730 |
Granted (in shares) | 4,039,360 | 3,990,740 | 3,434,270 |
Exercised (in shares) | (1,235,186) | (1,678,604) | (1,413,341) |
Forfeited and expired (in shares) | (978,616) | (541,680) | (909,713) |
Options outstanding end of the year (in shares) | 14,088,960 | 12,263,402 | 10,492,946 |
Exercisable (in shares) | 7,292,851 | 6,028,261 | 5,719,818 |
Weighted Average Exercise Price | |||
Options outstanding beginning of the year (in dollars per share) | $ 18.84 | $ 16.24 | $ 16.30 |
Granted (in dollars per share) | 30.18 | 24.12 | 15.02 |
Exercised (in dollars per share) | 15.50 | 14.04 | 11.87 |
Forfeited and expired (in dollars per share) | 24.35 | 23.98 | 19.02 |
Options outstanding end of the year (in dollars per share) | 22 | 18.84 | 16.24 |
Exercisable (in dollars per share) | $ 17.97 | $ 16.15 | $ 15.38 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Weighted Average Remaining Contractual Life in Years, Options outstanding | 6 years 10 months 28 days | ||
Weighted Average Remaining Contractual Life in Years, Exercisable | 5 years 4 months 2 days | ||
Aggregate Intrinsic Value, Options outstanding | $ 90,317 | ||
Aggregate Intrinsic Value, Exercisable | $ 70,204 |
Stock-Based Compensation - RSU
Stock-Based Compensation - RSU Activity (Details) - RSUs - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of RSUs | |||
Outstanding, beginning balance (in shares) | 844,391 | 500,822 | 227,826 |
Granted (in shares) | 607,578 | 559,054 | 407,655 |
Released (in shares) | (291,823) | (161,774) | (92,145) |
Forfeited (in shares) | (140,432) | (53,711) | (42,514) |
Outstanding, ending balance (in shares) | 1,019,714 | 844,391 | 500,822 |
Weighted Average Exercise Price | |||
Outstanding Weighted Average Grant Price (in dollars per share) | $ 25.43 | $ 28.32 | $ 29.14 |
Granted (in dollars per share) | 29.40 | 23.85 | 27.89 |
Released (in dollars per share) | 25.93 | 28.90 | 28.05 |
Forfeited (in dollars per share) | 27.73 | 25.43 | 29.11 |
Outstanding Weighted Average Grant Price (in dollars per share) | $ 27.33 | $ 25.43 | $ 28.32 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock-based Compensation Expense, Stock Options and RSUs (Details) - Stock options and RSUs - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 46 | $ 36.2 | $ 27 |
Research and development expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 17.8 | 11.8 | 8.2 |
Selling, general and administrative expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 28.2 | $ 24.4 | $ 18.8 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
NOL carryforwards | |||
Income tax provision (benefit) | $ (1,758,000) | $ 1,402,000 | $ 777,000 |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Deferred tax assets, net of valuation allowance | $ 78,261,000 | $ 42,691,000 | |
Increase (decrease) in valuation allowance | 77,600,000 | 96,300,000 | |
Disallowed interest expense | 12,500,000 | ||
Tax benefit | 7,382,000 | 5,633,000 | $ 4,836,000 |
Unrecognized tax benefits, interest and penalties accrued | 0 | $ 0 | |
Federal | |||
NOL carryforwards | |||
Net operating loss carryforwards for income tax purposes | 1,500,000,000 | ||
Tax credit carryforwards | 143,800,000 | ||
Operating loss carryforwards | $ 1,300,000,000 | ||
Ireland | |||
NOL carryforwards | |||
Effective tax rate, trading income of Irish company | 12.50% | ||
Effective tax rate, non-trading income of Irish company | 25.00% | ||
Operating loss carryforwards, non-trading loss | $ 332,900,000 | ||
Various states | |||
NOL carryforwards | |||
Operating loss carryforwards | $ 855,000,000 |
Income Taxes - Loss Before Inco
Income Taxes - Loss Before Income Taxes in the US and Globally (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
US | $ (348,845) | $ (207,120) | $ (201,161) |
Foreign | (87,567) | (85,568) | (52,399) |
Loss before income taxes | $ (436,412) | $ (292,688) | $ (253,560) |
Income Taxes - Income Tax (Bene
Income Taxes - Income Tax (Benefit) Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 104 | 268 | 10 |
Foreign | 1,585 | 1,134 | 767 |
Current income tax provision (benefit) | 1,689 | 1,402 | 777 |
Deferred: | |||
Federal | (2,835) | 0 | 0 |
State | (612) | 0 | 0 |
Foreign | 0 | 0 | 0 |
Deferred income tax provision (benefit) | (3,447) | 0 | 0 |
Total | $ (1,758) | $ 1,402 | $ 777 |
Income Taxes - Reconciliation B
Income Taxes - Reconciliation Between Federal Statutory Tax Rate and Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Statutory federal tax rate | 21.00% | 21.00% | 21.00% |
Permanent items | (1.00%) | 0.00% | (1.00%) |
State income taxes, net of federal benefit | 4.00% | 4.00% | 6.00% |
R&D and other tax credits | 4.00% | 2.00% | 2.00% |
Foreign income taxes | (1.00%) | 1.00% | 1.00% |
Change in valuation allowance | (27.00%) | (32.00%) | (32.00%) |
Change in Irish trading status | 0.00% | 4.00% | 3.00% |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 471,407 | $ 377,093 |
General business credits | 140,121 | 123,305 |
Product license | 4,963 | 5,652 |
Inventory | 1,417 | 3,767 |
Lease liabilities | 10,641 | 12,421 |
Stock-based compensation | 25,600 | 21,664 |
Other | 11,520 | 8,550 |
Deferred tax assets | 665,669 | 552,452 |
Valuation allowance | (587,408) | (509,761) |
Deferred tax assets, net of valuation allowance | 78,261 | 42,691 |
Deferred tax liabilities: | ||
Intangibles | (15,214) | (9,163) |
Right-of-use assets | (9,840) | (11,054) |
Convertible debt | (54,914) | (22,474) |
Deferred tax liabilities | (79,968) | (42,691) |
Net deferred tax liabilities | $ (1,707) | $ 0 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Net deferred tax assets as of January 1 | $ 5,633 | $ 4,836 |
Additions related to prior period tax positions | 112 | 0 |
Reductions related to prior period tax positions | 0 | (32) |
Additions related to current period tax positions | 1,637 | 829 |
Net deferred tax assets as of December 31 | $ 7,382 | $ 5,633 |
License and Other Agreements (D
License and Other Agreements (Details) € in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | 216 Months Ended | ||||||||
Dec. 31, 2020USD ($) | Apr. 30, 2020 | Oct. 31, 2016USD ($) | Jul. 31, 2014 | Feb. 28, 2014USD ($) | Apr. 30, 2008EUR (€) | Dec. 31, 2016USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2009USD ($) | Dec. 31, 2004USD ($) | Dec. 31, 2021USD ($) | Sep. 30, 2015USD ($) | |
PARI Agreement | ||||||||||||
Collaboration Agreements | ||||||||||||
Initial term of contract manufacturing agreement | 15 years | |||||||||||
Additional term of contract manufacturing agreement | 5 years | |||||||||||
PARI Agreement | Minimum | ||||||||||||
Collaboration Agreements | ||||||||||||
Written notice period required for termination of contract manufacturing agreement | 1 year | |||||||||||
PARI Agreement | Milestone, New Drug Application | ||||||||||||
Collaboration Agreements | ||||||||||||
PARI milestone upon FDA approval | € | € 1 | |||||||||||
PARI Agreement | Milestone, FDA Approval | ||||||||||||
Collaboration Agreements | ||||||||||||
PARI milestone upon FDA approval | € | 1.5 | |||||||||||
PARI Agreement | Milestone, EMA Approval | ||||||||||||
Collaboration Agreements | ||||||||||||
PARI milestone upon FDA approval | € | € 0.5 | |||||||||||
PPD Development, L.P. Agreement | ||||||||||||
Collaboration Agreements | ||||||||||||
Initial term of clinical development services agreement | 5 years | |||||||||||
Written notice termination term of clinical development services agreement | 30 days | |||||||||||
License Agreement with AstraZeneca | ||||||||||||
Collaboration Agreements | ||||||||||||
Royalty payment | $ 35 | |||||||||||
License Agreement with AstraZeneca | Maximum | ||||||||||||
Collaboration Agreements | ||||||||||||
Aggregate payment upon the achievement of certain clinical milestones | 72.5 | |||||||||||
Additional contingent payments upon second indication to develop INS1007 | 42.5 | |||||||||||
License Agreement with AstraZeneca | License and Service | ||||||||||||
Collaboration Agreements | ||||||||||||
Annual net sales | $ 1,000 | |||||||||||
License Agreement with AstraZeneca | Research and development expenses | ||||||||||||
Collaboration Agreements | ||||||||||||
Upfront payment | $ 30 | |||||||||||
Phase 3 study payment | $ 12.5 | |||||||||||
CFFT | ||||||||||||
Collaboration Agreements | ||||||||||||
Compensation earned under research funding agreements with CFFT | $ 2.2 | $ 1.7 | ||||||||||
Royalty payable on approval of ARIKAYCE as commercialized drug | $ 13.4 | $ 13.4 | ||||||||||
Royalty expense paid for ARIKAYCE approval | 2.5 | |||||||||||
Period for meeting sales milestones for additional royalty payments | 5 years | |||||||||||
Royalty payable on meeting certain sales milestones | $ 3.9 | $ 3.9 | ||||||||||
Fill/Finish Agreement | ||||||||||||
Collaboration Agreements | ||||||||||||
Minimum obligation | $ 2.7 | |||||||||||
Resilience Biotechnologies | ||||||||||||
Collaboration Agreements | ||||||||||||
Minimum obligation | $ 6 | |||||||||||
Initial term of contract manufacturing agreement | 5 years | |||||||||||
Written notice period required for termination of contract manufacturing agreement | 2 years | |||||||||||
Period of each automatic renewal of contract manufacturing agreement | 2 years |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments | |||
Future minimum rental payments under Bridgewater | $ 35,223 | ||
Rent expense charged to operations | 4,900 | $ 3,700 | $ 3,200 |
Future minimum commitments due for firm purchase | 78,200 | ||
Bridgewater, NJ Facility | |||
Commitments | |||
Future minimum rental payments under Bridgewater | $ 26,300 |
Retirement Plan (Details)
Retirement Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |||
Employer matching contribution, percent of match | 100.00% | ||
Employer matching contribution, percent of employees' gross pay | 4.00% | ||
Employer contributions | $ 3 | $ 2.9 | $ 2.8 |
Business Acquisition - Narrativ
Business Acquisition - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 04, 2021 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Business Acquisition [Line Items] | |||||
Cash paid in acquisition | $ 6,704 | $ 0 | $ 0 | ||
Motus Biosciences, Inc. and AlgaeneX, Inc. | |||||
Business Acquisition [Line Items] | |||||
Cash paid in acquisition | $ 10,500 | ||||
Fair value of total consideration | $ 165,476 | ||||
Acquisition related expenses | $ 600 | ||||
Motus Biosciences, Inc. | |||||
Business Acquisition [Line Items] | |||||
Shares issued in acquisition (in shares) | 2,899,074 | 2,889,367 | |||
Shares issued upon milestone achievements (in shares) | 5,348,572 | ||||
Cash to be paid upon achievement of milestones | $ 35,000 | ||||
Share price used to calculate issuable shares (in dollars per share) | $ 27.11 | ||||
Motus Biosciences, Inc. | First anniversary of closing date | |||||
Business Acquisition [Line Items] | |||||
Shares issued in acquisition (in shares) | 184,433 | ||||
Motus Biosciences, Inc. | Second anniversary of closing date | |||||
Business Acquisition [Line Items] | |||||
Shares issued in acquisition (in shares) | 184,433 | ||||
Motus Biosciences, Inc. | Third anniversary of closing date | |||||
Business Acquisition [Line Items] | |||||
Shares issued in acquisition (in shares) | 184,433 | ||||
AlgaeneX, Inc. | |||||
Business Acquisition [Line Items] | |||||
Shares issued upon milestone achievements (in shares) | 368,867 | ||||
Cash paid in acquisition | $ 1,500 | ||||
Share price used to calculate issuable shares (in dollars per share) | $ 27.11 |
Business Acquisition - Summary
Business Acquisition - Summary of Consideration Transferred (Details) - USD ($) $ in Thousands | Aug. 04, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Business Acquisition [Line Items] | ||||
Cash consideration | $ 6,704 | $ 0 | $ 0 | |
Motus Biosciences, Inc. and AlgaeneX, Inc. | ||||
Business Acquisition [Line Items] | ||||
Cash consideration | $ 10,500 | |||
Fair value of Insmed common stock issued | 71,570 | |||
Estimated fair value of contingent consideration liabilities | 69,706 | |||
Estimated fair value of deferred consideration | 13,700 | |||
Business combination, consideration transferred, Total | $ 165,476 |
Business Acquisition - Summar_2
Business Acquisition - Summary of Recognized Identifiable Assets Acquired and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Aug. 04, 2021 | Dec. 31, 2020 |
Business Acquisition [Line Items] | |||
Goodwill | $ 136,110 | $ 0 | |
Motus Biosciences, Inc. and AlgaeneX, Inc. | |||
Business Acquisition [Line Items] | |||
Cash and cash equivalents | $ 3,580 | ||
Intangible assets - IPR&D | 29,600 | ||
Fixed assets | 228 | ||
Other assets | 17 | ||
Liabilities assumed | (558) | ||
Deferred tax liability | (3,501) | ||
Fair value of net assets acquired | 29,366 | ||
Goodwill | 136,110 | ||
Business Combination, Recognized Identifiable Assets Acquired, Goodwill, and Liabilities Assumed, Net | $ 165,476 |