Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2021 | Apr. 26, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-33497 | |
Entity Registrant Name | Amicus Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 71-0869350 | |
Entity Address, Address Line One | 3675 Market Street, | |
Entity Address, City or Town | Philadelphia, | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19104 | |
City Area Code | (215) | |
Local Phone Number | 921-7600 | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Trading Symbol | FOLD | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 266,060,455 | |
Entity Central Index Key | 0001178879 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 184,833 | $ 163,240 |
Investments in marketable securities | 232,596 | 320,029 |
Accounts receivable | 44,931 | 46,923 |
Inventories | 18,801 | 19,556 |
Prepaid expenses and other current assets | 21,730 | 29,721 |
Total current assets | 502,891 | 579,469 |
Operating lease right-of-use assets, less accumulated amortization of $7,499 and $7,574 at March 31, 2021 and December 31, 2020, respectively | 22,363 | 23,296 |
Property and equipment, less accumulated depreciation of $15,961 and $14,487 at March 31, 2021 and December 31, 2020, respectively | 43,445 | 43,863 |
In-process research & development | 23,000 | 23,000 |
Goodwill | 197,797 | 197,797 |
Other non-current assets | 20,538 | 19,095 |
Total Assets | 810,034 | 886,520 |
Current liabilities: | ||
Accounts payable | 16,110 | 17,063 |
Accrued expenses and other current liabilities | 57,178 | 96,841 |
Contingent consideration payable | 19,600 | 8,900 |
Operating lease liabilities | 6,764 | 6,872 |
Total current liabilities | 99,652 | 129,676 |
Deferred reimbursements | 7,406 | 7,406 |
Long-term debt | 389,789 | 389,254 |
Contingent consideration payable | 6,696 | 16,925 |
Deferred income taxes | 4,896 | 4,896 |
Operating lease liabilities | 44,431 | 45,604 |
Other non-current liabilities | 6,268 | 6,379 |
Total liabilities | 559,138 | 600,140 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.01 par value, 500,000,000 shares authorized, 266,007,718 and 262,063,461 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 2,680 | 2,650 |
Additional paid-in capital | 2,350,507 | 2,308,578 |
Accumulated other comprehensive income (loss): | ||
Foreign currency translation adjustment | 9,020 | 8,412 |
Unrealized loss on available-for-sale securities | (185) | (185) |
Warrants | 0 | 12,387 |
Accumulated deficit | (2,111,126) | (2,045,462) |
Total stockholders’ equity | 250,896 | 286,380 |
Total Liabilities and Stockholders’ Equity | $ 810,034 | $ 886,520 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation and amortization on finance and operating lease right-of-use leases | $ 7,499 | $ 7,574 |
Accumulated depreciation of property and equipment | $ 15,961 | $ 14,487 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 500,000,000 | 500,000,000 |
Common stock, shares issued (in shares) | 266,007,718 | 262,063,461 |
Common stock, shares outstanding (in shares) | 266,007,718 | 262,063,461 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenue: | ||
Net product sales | $ 66,402 | $ 60,525 |
Cost of goods sold | 6,539 | 6,552 |
Gross profit | 59,863 | 53,973 |
Operating expenses: | ||
Research and development | 64,117 | 89,120 |
Selling, general, and administrative | 46,726 | 40,215 |
Changes in fair value of contingent consideration payable | 471 | 931 |
Depreciation and amortization | 1,604 | 1,764 |
Total operating expenses | 112,918 | 132,030 |
Loss from operations | (53,055) | (78,057) |
Other (expense) income: | ||
Interest income | 165 | 1,515 |
Interest expense | (7,992) | (3,729) |
Other expense | (3,200) | (8,316) |
Loss before income tax | (64,082) | (88,587) |
Income tax expense | (1,582) | (361) |
Net loss attributable to common stockholders | $ (65,664) | $ (88,948) |
Net loss attributable to common stockholders per common share - basic and diluted (in dollars per share) | $ (0.25) | $ (0.35) |
Weighted-average common shares outstanding - basic and diluted (in shares) | 264,369,317 | 256,968,248 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (65,664) | $ (88,948) |
Other comprehensive gain (loss): | ||
Foreign currency translation adjustment gain, net of tax impact of $132 and $1,536, respectively | 608 | 4,196 |
Unrealized loss on available-for-sale securities, net of tax impact of $0 and $(56), respectively | 0 | (209) |
Other comprehensive income | 608 | 3,987 |
Comprehensive loss | $ (65,056) | $ (84,961) |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Foreign currency translation adjustment, tax impact | $ 132 | $ 1,536 |
Available-for-sale securities, tax impact | $ 0 | $ (56) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Warrants | Other Comprehensive Gain (Loss) | Accumulated Deficit |
Balance (in shares) at Dec. 31, 2019 | 255,417,869 | |||||
Balance at Dec. 31, 2019 | $ 476,425 | $ 2,598 | $ 2,227,225 | $ 12,387 | $ 2,825 | $ (1,768,610) |
Increase (Decrease) in Stockholders' Equity | ||||||
Stock issued from exercise of stock options, net (in shares) | 958,947 | |||||
Stock issued from exercise of stock options, net | 6,077 | $ 9 | 6,068 | |||
Restricted stock tax vesting (in shares) | 1,073,139 | |||||
Restricted stock tax vesting | (7,543) | (7,543) | ||||
Stock-based compensation | 12,596 | 12,596 | ||||
Unrealized holding loss on available-for-sale securities | (209) | (209) | ||||
Foreign currency translation adjustment | 4,196 | 4,196 | ||||
Net loss | (88,948) | (88,948) | ||||
Balance (in shares) at Mar. 31, 2020 | 257,449,955 | |||||
Balance at Mar. 31, 2020 | $ 402,594 | $ 2,607 | 2,238,346 | 12,387 | 6,812 | (1,857,558) |
Balance (in shares) at Dec. 31, 2020 | 262,063,461 | 262,063,461 | ||||
Balance at Dec. 31, 2020 | $ 286,380 | $ 2,650 | 2,308,578 | 12,387 | 8,227 | (2,045,462) |
Increase (Decrease) in Stockholders' Equity | ||||||
Stock issued from exercise of stock options, net (in shares) | 488,111 | |||||
Stock issued from exercise of stock options, net | 4,161 | $ 4 | 4,157 | |||
Restricted stock tax vesting (in shares) | 897,063 | |||||
Restricted stock tax vesting | (14,194) | (14,194) | ||||
Stock-based compensation | 20,354 | 20,354 | ||||
Warrants exercised (in shares) | 2,554,999 | |||||
Warrants exercised | 19,230 | $ 26 | 31,591 | (12,387) | ||
Equity component of the convertible notes (in shares) | 4,084 | |||||
Equity component of the convertible notes | 21 | $ 0 | 21 | |||
Unrealized holding loss on available-for-sale securities | 0 | |||||
Foreign currency translation adjustment | 608 | 608 | ||||
Net loss | $ (65,664) | (65,664) | ||||
Balance (in shares) at Mar. 31, 2021 | 266,007,718 | 266,007,718 | ||||
Balance at Mar. 31, 2021 | $ 250,896 | $ 2,680 | $ 2,350,507 | $ 0 | $ 8,835 | $ (2,111,126) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities | ||
Net loss | $ (65,664) | $ (88,948) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization of debt discount and deferred financing | 555 | 231 |
Depreciation and amortization | 1,604 | 1,764 |
Stock-based compensation | 20,354 | 12,596 |
Non-cash changes in the fair value of contingent consideration payable | 471 | 931 |
Foreign currency remeasurement loss | 2,846 | 10,662 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 839 | (8,358) |
Inventories | 741 | (251) |
Prepaid expenses and other current assets | 7,669 | 4,016 |
Accounts payable and accrued expenses | (40,191) | (35,251) |
Other non-current assets and liabilities | (1,578) | (5,334) |
Net cash used in operating activities | (72,354) | (107,942) |
Investing activities | ||
Sale and redemption of marketable securities | 163,680 | 106,140 |
Purchases of marketable securities | (76,247) | (12,088) |
Capital expenditures | (868) | (806) |
Net cash provided by investing activities | 86,565 | 93,246 |
Financing activities | ||
Payment of finance leases | (368) | (21) |
Purchase of vested restricted stock units | (14,194) | (7,543) |
Proceeds from exercise of stock options | 4,161 | 6,077 |
Proceeds from exercise of warrants | 19,230 | 0 |
Net cash provided by (used in) financing activities | 8,829 | (1,487) |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | (1,153) | (4,265) |
Net increase(decrease) in cash, cash equivalents, and restricted cash at the end of the period | 21,887 | (20,448) |
Cash, cash equivalents, and restricted cash at beginning of period | 166,162 | 146,341 |
Cash, cash equivalents, and restricted cash at the end of period | 188,049 | 125,893 |
Supplemental disclosures of cash flow information | ||
Tenant improvements paid through lease incentives | 0 | 254 |
Cash paid during the period for interest | 7,513 | 3,693 |
Capital expenditures unpaid at the end of period | 188 | 589 |
Cash paid for taxes | $ 2,472 | $ 1,627 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Amicus Therapeutics, Inc. (the "Company") is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases. The Company has a portfolio of product opportunities led by the first, oral monotherapy for Fabry disease that has achieved widespread global approval, a differentiated biologic for Pompe disease, and an industry leading rare disease gene therapy portfolio. The cornerstone of the Company's portfolio is Galafold ® (also referred to as "migalastat"), the first and only approved oral precision medicine for people living with Fabry disease who have amenable genetic variants. Migalastat is currently approved under the trade name Galafold ® in the United States ("U.S."), European Union ("E.U."), United Kingdom ("U.K."), and Japan, with multiple additional approvals granted and applications pending in several other geographies around the world. The lead biologics program of the Company's pipeline is Amicus Therapeutics GAA ("AT-GAA", also known as ATB200/AT2221, or cipaglucosidase alfa/miglustat), a novel, clinical-stage, potential best-in-class treatment paradigm for Pompe disease. In February 2019, the U.S. Food and Drug Administration ("FDA") granted Breakthrough Therapy designation ("BTD") to AT-GAA for the treatment of late-onset Pompe disease. The Company initiated the rolling Biologic License Application ("BLA") submission to the FDA in the fourth quarter of 2020. The Company has established an industry leading gene therapy portfolio of potential therapies for people living with rare metabolic diseases, through a license with Nationwide Children's Hospital ("Nationwide Children's") and a research collaboration with the University of Pennsylvania ("Penn"). The Company's pipeline includes gene therapy programs in rare, neurologic lysosomal disorders ("LDs"), specifically: CLN6, CLN3, and CLN1 Batten disease, Pompe disease, Fabry disease, CDKL5 deficiency disorder ("CDD"), Mucopolysaccharidosis Type IIIB ("MPS IIIB"), as well as a next generation program in Mucopolysaccharidosis Type IIIA ("MPS IIIA"). This research collaboration with Penn also provides the Company with exclusive disease-specific access and option rights to develop potentially disruptive new gene therapy platform technologies and programs for most LDs and a broader portfolio of more prevalent rare diseases, including Rett Syndrome, Angelman Syndrome, Myotonic Dystrophy, and select other muscular dystrophies. In the first quarter of 2020, the FDA granted Fast Track designation to the CLN3 Batten disease gene therapy, AT-GTX-502, for the treatment of pediatric patients less than 18 years of age. In September 2020 and February 2021, the European Medicines Agency granted Priority Medicines designation and the FDA granted Fast Track Designation, respectively, to the CLN6 Batten disease gene therapy, AT-GTX-501, for the treatment of patients with variant late infantile neuronal ceroid lipofuscinosis 6 ("vLINCL6"). The Company's operations have not been significantly impacted from the novel coronavirus (“COVID-19”) pandemic thus far. However, the Company continued to observe increased lag times between patient identification and Galafold ® initiation due to the resurgence of COVID-19 into 2021. The Company has maintained operations in all geographies, secured its global supply chain for its commercial and clinical products, and maintained the operational integrity of its clinical trials, with minimal disruption. The Company believes its ability to continue to operate without any significant disruptions will depend on the continued health of its employees, the ongoing demand for Galafold ® and the continued operation of its global supply chain. The Company has continued to provide uninterrupted access to medicines for those in need of treatment, while prioritizing the health and safety of its global workforce. However, the Company's results of operations in future periods may be negatively impacted by unknown future impacts from the COVID-19 pandemic. The Company had an accumulated deficit of $2.1 billion as of March 31, 2021 and anticipates incurring losses through the fiscal year ending December 31, 2021 and beyond. The Company has historically funded its operations through stock offerings, debt issuances, Galafold ® revenues, collaborations, and other financing arrangements. Based on current operating models, the Company believes that the current cash position, which includes expected revenues, is sufficient to fund the Company's operations and ongoing research programs to achieve self-sustainability. Potential impacts of the COVID-19 pandemic, business development collaborations, pipeline expansion, and investment in manufacturing capabilities could impact the Company's future capital requirements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying unaudited Consolidated Financial Statements in accordance with the U.S. generally accepted accounting principles ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying unaudited financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company's interim financial information. The accompanying unaudited Consolidated Financial Statements and related notes should be read in conjunction with the Company's financial statements and related notes as contained in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020. For a complete description of the Company's accounting policies, please refer to the Annual Report on Form 10-K for the fiscal year ended December 31, 2020. Consolidation The Consolidated Financial Statements include the accounts of the Company and its subsidiaries. Intercompany accounts and transactions are eliminated in consolidation. Foreign Currency Transactions The functional currency for most of the Company's foreign subsidiaries is their local currency. For non-U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of the Company's foreign operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of stockholders' equity. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. Additionally, the Company assessed the impact COVID-19 pandemic has had on its operations and financial results as of March 31, 2021 and through the issuance of this report. The Company’s analysis was informed by the facts and circumstances as they were known to the Company. This assessment considered the impact COVID-19 may have on financial estimates and assumptions that affect the reported amounts of assets and liabilities and revenue and expenses. Cash, Cash Equivalents, Marketable Securities, and Restricted Cash The Company considers all highly liquid investments purchased with a maturity of three months or less at the date of acquisition to be cash equivalents. Marketable securities consist of fixed income investments with a maturity of greater than three months and other highly liquid investments that can be readily purchased or sold using established markets. These investments are classified as available-for-sale and are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are reported within comprehensive income (loss) in the Statements of Comprehensive Loss. Fair value is based on available market information including quoted market prices, broker or dealer quotations, or other observable inputs. Restricted cash consists primarily of funds held to satisfy the requirements of certain agreements that are restricted in their use and is included in other current assets and other non-current assets on the Company's Consolidated Balance Sheets. Concentration of Credit Risk The Company's financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, and marketable securities. The Company maintains its cash and cash equivalents in bank accounts, which, at times, exceed federally insured limits. The Company invests its marketable securities in high-quality commercial financial instruments. The Company has not recognized any losses from credit risks on such accounts during any of the periods presented. The Company believes it is not exposed to significant credit risk on its cash, cash equivalents, or marketable securities. The Company is subject to credit risk from its accounts receivable related to its product sales of Galafold ® . The Company's accounts receivable at March 31, 2021 have arisen from product sales primarily in Europe and the U.S. The Company will periodically assess the financial strength of its customers to establish allowances for anticipated losses, if any. For accounts receivable that have arisen from named patient sales, the payment terms are predetermined, and the Company evaluates the creditworthiness of each customer on a regular basis. As of March 31, 2021, the Company recorded an allowance for doubtful accounts of $0.1 million. Revenue Recognition The Company's net product sales consist of sales of Galafold ® for the treatment of Fabry disease. The Company has recorded revenue on sales where Galafold ® is available either on a commercial basis or through a reimbursed early access program ("EAP"). Orders for Galafold ® are generally received from distributors and pharmacies with the ultimate payor often a government authority. The Company recognizes revenue when its performance obligations to its customers have been satisfied, which occurs at a point in time when the pharmacies or distributors obtain control of Galafold ® . The transaction price is determined based on fixed consideration in the Company's customer contracts and is recorded net of estimates for variable consideration, which are third party discounts and rebates. The identified variable consideration is recorded as a reduction of revenue at the time revenue from the sale of Galafold ® is recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes. The following table summarizes the Company's net product sales from Galafold ® disaggregated by geographic area: Three Months Ended March 31, (in thousands) 2021 2020 U.S. $ 20,853 $ 17,772 Ex-U.S. 45,549 42,753 Total net product sales $ 66,402 $ 60,525 Inventories and Cost of Goods Sold Inventories are stated at the lower of cost and net realizable value, determined by the first-in, first-out method. Inventories are reviewed periodically to identify slow-moving or obsolete inventory based on projected sales activity as well as product shelf-life. In evaluating the recoverability of inventories produced, the probability that revenue will be obtained from the future sale of the related inventory is considered and inventory value is written down for inventory quantities in excess of expected requirements. Expired inventory is disposed of and the related costs are recognized as cost of goods sold in the Consolidated Statements of Operations. Cost of goods sold includes the cost of inventory sold, manufacturing and supply chain costs, product shipping and handling costs, provisions for excess and obsolete inventory, as well as royalties payable. Leases The Company primarily enters into lease agreements for office space, equipment, and vehicles. The leases have varying terms, some of which could include options to renew, extend, and early terminate. The Company determines if an arrangement is a lease at contract inception. Operating leases are included in right-of-use ("ROU") assets and lease liabilities on the Consolidated Balance Sheets. ROU assets represent the Company's right to control the use of an explicitly or implicitly identified fixed asset for a period of time and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. Lease payments included in the measurement of the lease liability are comprised of fixed payments. Variable lease payments are excluded from the ROU asset and lease liability and are recognized in the period in which the obligation for those payments is incurred. Variable lease payments are presented in the Consolidated Statements of Operations in the same line item as expenses arising from fixed lease payments for operating leases. The Company has lease agreements that include lease and non-lease components, which the Company accounts for as a single lease component for all underlying asset categories. The lease term for all of the Company's leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Leases with an initial term of 12 months or less are not recorded on the Consolidated Balance Sheets. The Company recognizes lease expense for these leases on a straight-line basis over the lease term. The Company applies this policy to all underlying asset categories. Recent Accounting Developments - Guidance Adopted in 2021 ASU 2019-12 - In December 2019, the Financial Accounting Standard Board issued Accounting Standard Update ("ASU") 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"). This new guidance removes specific exceptions to the general principles in Topic 740. It eliminates the need for an organization to analyze whether the following applies in a given period: (i) exception to the incremental approach for intraperiod tax allocation; (ii) exceptions to accounting for basis differences when there are ownership changes in foreign investments; and (iii) exception in interim period income tax accounting for year-to-date losses that exceed anticipated losses. ASU 2019-12 also improves financial statement preparers’ application of income tax-related guidance and simplifies the following: (i) franchise taxes that are partially based on income; (ii) transactions with a government that result in a step up in the tax basis of goodwill; (iii) separate financial statements of legal entities that are not subject to tax; and (iv) enacted changes in tax laws in interim periods. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted this guidance prospectively on January 1, 2021. The adoption did not have a material impact on the Company's Consolidated Financial Statements or related disclosures. Recent Accounting Developments - Guidance Not Yet Adopted The Company has evaluated recent accounting pronouncements and believes that none of them will have a material effect on the Company's Consolidated Financial Statements or related disclosures. |
Cash, Cash Equivalents, Marketa
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash | 3 Months Ended |
Mar. 31, 2021 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash | Cash, Cash Equivalents, Marketable Securities, and Restricted Cash As of March 31, 2021, the Company held $184.8 million in cash and cash equivalents and $232.6 million of marketable securities which are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are generally reported within accumulated other comprehensive loss in the Statements of Comprehensive Loss. If a decline in the fair value of a marketable security below the Company's cost basis is determined to be other-than-temporary or if an available-for-sale debt security’s fair value is determined to less than the amortized cost and the Company intends or is more than likely to sell the security before recovery and it is not considered a credit loss, such security is written down to its estimated fair value as a new cost basis and the amount of the write-down is included in earnings as an impairment charge. If the unrealized loss of an available-for-sale debt security is determined to be a result of credit loss the Company would recognize an allowance and the corresponding credit loss would be included in earnings. The Company regularly invests excess operating cash in deposits with major financial institutions, money market funds, notes issued by the U.S. government, as well as fixed income investments and U.S. bond funds, both of which can be readily purchased and sold using established markets. The Company believes that the market risk arising from its holdings of these financial instruments is mitigated as many of these securities are either government backed or of the highest credit rating. Investments that have original maturities greater than three months but less than one year are classified as current. Cash, cash equivalents and marketable securities are classified as current unless mentioned otherwise below and consisted of the following: As of March 31, 2021 (in thousands) Cost Gross Gross Fair Cash and cash equivalents $ 184,833 $ — $ — $ 184,833 Corporate debt securities 20,936 — (4) 20,932 Commercial paper 151,300 10 (3) 151,307 Asset-backed securities 13,718 1 (3) 13,716 U.S. government agency bonds 46,228 12 — 46,240 Money market 350 — — 350 Certificates of deposit 51 — — 51 $ 417,416 $ 23 $ (10) $ 417,429 Included in cash and cash equivalents $ 184,833 $ — $ — $ 184,833 Included in marketable securities 232,583 23 (10) 232,596 Total cash, cash equivalents, and marketable securities $ 417,416 $ 23 $ (10) $ 417,429 As of December 31, 2020 (in thousands) Cost Gross Gross Fair Cash and cash equivalents $ 163,240 $ — $ — $ 163,240 Corporate debt securities 39,525 4 (16) 39,513 Commercial paper 217,087 14 (6) 217,095 Asset-backed securities 9,420 18 — 9,438 U.S. government agency bonds 53,583 3 (4) 53,582 Money market 350 — — 350 Certificates of deposit 51 — — 51 $ 483,256 $ 39 $ (26) $ 483,269 Included in cash and cash equivalents $ 163,240 $ — $ — $ 163,240 Included in marketable securities (1) 320,016 39 (26) 320,029 Total cash, cash equivalents, and marketable securities $ 483,256 $ 39 $ (26) $ 483,269 For the three months ended March 31, 2021 there were no realized gains or losses. For the fiscal year ended December 31, 2020, there were nominal realized gains. The cost of securities sold is based on the specific identification method. Unrealized loss positions in the marketable securities as of March 31, 2021 and December 31, 2020 reflect temporary impairments and are not a result of credit loss. Additionally, as these positions have been in a loss position for less than twelve months and the Company does not intend to sell these securities before recovery, the losses are recognized in other comprehensive gain (loss). The fair value of these marketable securities in unrealized loss positions was $114.5 million and $124.9 million as of March 31, 2021 and December 31, 2020, respectively. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Consolidated Statements of Cash Flows. (in thousands) March 31, 2021 March 31, 2020 Cash and cash equivalents $ 184,833 $ 123,231 Restricted cash 3,216 2,662 Cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows $ 188,049 $ 125,893 |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of raw materials, work-in-process, and finished goods related to the manufacture of Galafold ® . The following table summarizes the components of inventories: (in thousands) March 31, 2021 December 31, 2020 Raw materials $ 3,709 $ 5,547 Work-in-process 10,023 7,693 Finished goods 5,069 6,316 Total inventories $ 18,801 $ 19,556 The Company recorded a reserve for inventory of $0.2 million and $0.1 million as of March 31, 2021 and December 31, 2020, respectively. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Debt The Company's debt consists of the following: (in thousands) March 31, 2021 December 31, 2020 Senior Secured Term Loan due 2026: Principal $ 400,000 $ 400,000 Less: debt discount (1) (7,139) (7,434) Less: deferred financing (1) (5,371) (5,592) Net carrying value of the Senior Secured Term Loan $ 387,490 $ 386,974 Convertible Notes (2) : Principal (3) $ 2,800 $ 2,825 Less: debt discount (1) (476) (518) Less: deferred financing (1) (25) (27) Net carrying value of the Convertible Notes $ 2,299 $ 2,280 Net carrying value of Long-term debt $ 389,789 $ 389,254 ______________________________ (1) Included in the Consolidated Balance Sheets within long-term debt and amortized to interest expense over the remaining life of the Convertible Notes and Senior Secured Term Loan using the effective interest rate method. (2) The Convertible Notes are currently convertible as the last reported sale price of the Company's common stock was equal to or more than 130% of the conversion price for at least 20 trading days of the 30 consecutive trading days ending on the last day of the quarter. (3) In the first quarter of 2021, the Company exchanged an aggregate principal amount of $25.0 thousand of Convertible Notes in exchange for an aggregate of approximately 4.1 thousand shares of Company common stock, par value $0.01 per share. Interest Expense The following table sets forth interest expense recognized related to the Company's debt for the three months ended March 31, 2021 and 2020, respectively: Three Months Ended March 31, (in thousands) 2021 2020 Contractual interest expense $ 7,521 $ 3,585 Amortization of debt discount $ 332 $ 206 Amortization of deferred financing $ 223 $ 25 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity In February 2021, 1,050,000 warrants were exercised at $7.06 per share of common stock resulting in gross cash proceeds of $7.4 million. Additionally, in March 2021, 1,294,999 warrants were exercised at $7.98 per share of common stock and 210,000 warrants were exercised at $7.06 per share of common stock resulting in gross cash proceeds of $11.8 million. |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation The Company's Amended and Restated 2007 Equity Incentive Plan (the "Plan") provides for the granting of restricted stock units and options to purchase common stock in the Company to employees, directors, advisors, and consultants at a price to be determined by the Company's Board of Directors. The Plan is intended to encourage ownership of stock by employees and consultants of the Company and to provide additional incentives for them to promote the success of the Company's business. The Board of Directors, or its committee, is responsible for determining the individuals to be granted options, the number of options each individual will receive, the option price per share, and the exercise period of each option. Stock Option Grants The fair value of the stock options granted is estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: Three Months Ended March 31, 2021 2020 Expected stock price volatility 66.7 % 75.2 % Risk free interest rate 0.4 % 1.7 % Expected life of options (years) 5.40 5.67 Expected annual dividend per share $ — $ — A summary of the Company's stock options for the three months ended March 31, 2021 were as follows: Number of Weighted Average Exercise Weighted Average Remaining Aggregate (in thousands) (in millions) Options outstanding, December 31, 2020 14,032 $ 9.54 Granted 1,818 $ 21.46 Exercised (493) $ 8.54 Forfeited (273) $ 12.40 Options outstanding, March 31, 2021 15,084 $ 10.96 6.7 $ 18.5 Vested and unvested expected to vest, March 31, 2021 13,643 $ 10.71 6.4 $ 18.3 Exercisable at March 31, 2021 8,962 $ 9.04 5.2 $ 17.7 During the three months ended March 31, 2021, nominal stock options expired at a weighted average exercise price of $15.36. As of March 31, 2021, the total unrecognized compensation cost related to non-vested stock options granted was $38.7 million and is expected to be recognized over a weighted average period of three years. Restricted Stock Units and Performance-Based Restricted Stock Units (collectively "RSUs") RSUs awarded under the Plan are generally subject to graded vesting and are contingent on an employee's continued service. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. A summary of non-vested RSU activity under the Plan for the three months ended March 31, 2021 is as follows: Number of Weighted Weighted Aggregate (in thousands) (in millions) Non-vested units as of December 31, 2020 7,080 $ 11.35 Granted 2,131 $ 20.22 Vested (1,435) $ 17.38 Forfeited (310) $ 13.36 Non-vested units as of March 31, 2021 7,466 $ 14.14 2.7 $ 73.8 All non-vested units are expected to vest over their normal term. As of March 31, 2021, there was $64.5 million of total unrecognized compensation cost related to unvested RSUs with service-based vesting conditions. These costs are expected to be recognized over a weighted average period of three years. Compensation Expense Related to Equity Awards The following table summarizes information related to compensation expense recognized in the Consolidated Statements of Operations related to the equity awards: Three Months Ended March 31, (in thousands) 2021 2020 Equity compensation expense recognized in: Research and development expense $ 6,305 $ 5,253 Selling, general, and administrative expense 14,049 7,343 Total equity compensation expense $ 20,354 $ 12,596 |
Assets and Liabilities Measured
Assets and Liabilities Measured at Fair Value | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value | Assets and Liabilities Measured at Fair Value The Company's financial assets and liabilities are measured at fair value and classified within the fair value hierarchy, which is defined as follows: Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3 — Inputs that are unobservable for the asset or liability. A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of March 31, 2021 are identified in the following tables: (in thousands) Level 2 Total Assets: Commercial paper $ 151,307 $ 151,307 Asset-backed securities 13,716 13,716 Corporate debt securities 20,932 20,932 U.S. government agency bonds 46,240 46,240 Money market funds 4,296 4,296 $ 236,491 $ 236,491 (in thousands) Level 2 Level 3 Total Liabilities: Contingent consideration payable $ — $ 26,296 $ 26,296 Deferred compensation plan liability 3,946 — 3,946 $ 3,946 $ 26,296 $ 30,242 A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of December 31, 2020 are identified in the following tables: (in thousands) Level 2 Total Assets: Commercial paper $ 217,095 $ 217,095 Asset-backed securities 9,438 9,438 Corporate debt securities 39,513 39,513 U.S. government agency bonds 53,582 53,582 Money market funds 4,427 4,427 $ 324,055 $ 324,055 (in thousands) Level 2 Level 3 Total Liabilities: Contingent consideration payable $ — $ 25,825 $ 25,825 Deferred compensation plan liability 4,078 — 4,078 $ 4,078 $ 25,825 $ 29,903 The Company's Convertible Notes fall into the Level 2 category within the fair value level hierarchy. The fair value was determined using broker quotes in a non-active market for valuation. The fair value of the Convertible Notes at March 31, 2021 was $4.5 million. The Company's Senior Secured Term Loan due 2026 falls into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. The carrying value of the Senior Secured Term Loan due 2026 approximates the fair value. The Company did not have any Level 3 assets as of March 31, 2021 or December 31, 2020. Cash, Money Market Funds, and Marketable Securities The Company classifies its cash within the fair value hierarchy as Level 1 as these assets are valued using quoted prices in an active market for identical assets at the measurement date. The Company considers its investments in marketable securities as available-for-sale and classifies these assets and the money market funds within the fair value hierarchy as Level 2 primarily utilizing broker quotes in a non-active market for valuation of these securities. Contingent Consideration Payable The contingent consideration payable resulted from the acquisition of Callidus Biopharma, Inc. ("Callidus") in November 2013. The most recent valuation was determined using a probability weighted discounted cash flow valuation approach. Gains and losses are included in the Consolidated Statements of Operations. The contingent consideration payable for Callidus has 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 various inputs to the valuation approach, the estimated fair value could be significantly higher or lower than the fair value the Company determined. The following significant unobservable inputs were used in the valuation of the contingent consideration payable of Callidus for the ATB-200 Pompe program: Contingent Consideration Liability Fair Value as of March 31, 2021 Valuation Technique Unobservable Input Range (in thousands) Discount rate 7.5% Clinical and regulatory milestones $ 25,559 Probability weighted discounted cash flow Probability of achievement of milestones 75% - 78% Projected year of payments 2021 - 2022 Contingent consideration liabilities are remeasured to fair value each reporting period using discount rates, probabilities of payment, and projected payment dates. Projected contingent payment amounts related to clinical and regulatory based milestones are discounted back to the current period using a discounted cash flow model. Increases in discount rates and the time to payment may result in lower fair value measurements. Increases or decreases in any of those inputs together, or in isolation, may result in a significantly lower or higher fair value measurement. There is no assurance that any of the conditions for the milestone payments will be met. The following table shows the change in the balance of contingent consideration payable for the three months ended March 31, 2021 and March 31, 2020, respectively: Three Months Ended March 31, (in thousands) 2021 2020 Balance, beginning of the period $ 25,825 $ 22,681 Changes in fair value during the period, included in the Consolidated Statements of Operations 471 931 Balance, end of the period $ 26,296 $ 23,612 |
Basic and Diluted Net Loss per
Basic and Diluted Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss attributable to common stockholders per common share: Three Months Ended March 31, (in thousands, except per share amounts) 2021 2020 Numerator: Net loss attributable to common stockholders $ (65,664) $ (88,948) Denominator: Weighted average common shares outstanding — basic and diluted 264,369,317 256,968,248 Dilutive common stock equivalents would include the dilutive effect of common stock options, convertible debt units, RSUs, and warrants for common stock equivalents. Potentially dilutive common stock equivalents were excluded from the diluted earnings per share denominator for all periods because of their anti-dilutive effect. The table below presents potential shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method: As of March 31, (in thousands) 2021 2020 Options to purchase common stock 15,084 19,086 Convertible notes 458 462 Outstanding warrants, convertible to common stock — 2,554 Unvested restricted stock units 7,466 7,562 Total number of potentially issuable shares 23,008 29,664 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying unaudited Consolidated Financial Statements in accordance with the U.S. generally accepted accounting principles ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying unaudited financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company's interim financial information. |
Consolidation | Consolidation The Consolidated Financial Statements include the accounts of the Company and its subsidiaries. Intercompany accounts and transactions are eliminated in consolidation. |
Foreign Currency Transactions | Foreign Currency Transactions The functional currency for most of the Company's foreign subsidiaries is their local currency. For non-U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of the Company's foreign operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of stockholders' equity. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. Additionally, the Company assessed the impact COVID-19 pandemic has had on its operations and financial results as of March 31, 2021 and through the issuance of this report. The Company’s analysis was informed by the facts and circumstances as they were known to the Company. This assessment considered the impact COVID-19 may have on financial estimates and assumptions that affect the reported amounts of assets and liabilities and revenue and expenses. |
Cash, Cash Equivalents, Marketable Securities and Restricted Cash | Cash, Cash Equivalents, Marketable Securities, and Restricted Cash The Company considers all highly liquid investments purchased with a maturity of three months or less at the date of acquisition to be cash equivalents. Marketable securities consist of fixed income investments with a maturity of greater than three months and other highly liquid investments that can be readily purchased or sold using established markets. These investments are classified as available-for-sale and are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are reported within comprehensive income (loss) in the Statements of Comprehensive Loss. Fair value is based on available market information including quoted market prices, broker or dealer quotations, or other observable inputs. |
Concentration of Credit Risk | Concentration of Credit Risk The Company's financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, and marketable securities. The Company maintains its cash and cash equivalents in bank accounts, which, at times, exceed federally insured limits. The Company invests its marketable securities in high-quality commercial financial instruments. The Company has not recognized any losses from credit risks on such accounts during any of the periods presented. The Company believes it is not exposed to significant credit risk on its cash, cash equivalents, or marketable securities. The Company is subject to credit risk from its accounts receivable related to its product sales of Galafold ® |
Revenue Recognition | Revenue Recognition The Company's net product sales consist of sales of Galafold ® for the treatment of Fabry disease. The Company has recorded revenue on sales where Galafold ® is available either on a commercial basis or through a reimbursed early access program ("EAP"). Orders for Galafold ® are generally received from distributors and pharmacies with the ultimate payor often a government authority. The Company recognizes revenue when its performance obligations to its customers have been satisfied, which occurs at a point in time when the pharmacies or distributors obtain control of Galafold ® . The transaction price is determined based on fixed consideration in the Company's customer contracts and is recorded net of estimates for variable consideration, which are third party discounts and rebates. The identified variable consideration is recorded as a reduction of revenue at the time revenue from the sale of Galafold ® is recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes. |
Inventories and Cost of Goods Sold | Inventories and Cost of Goods Sold Inventories are stated at the lower of cost and net realizable value, determined by the first-in, first-out method. Inventories are reviewed periodically to identify slow-moving or obsolete inventory based on projected sales activity as well as product shelf-life. In evaluating the recoverability of inventories produced, the probability that revenue will be obtained from the future sale of the related inventory is considered and inventory value is written down for inventory quantities in excess of expected requirements. Expired inventory is disposed of and the related costs are recognized as cost of goods sold in the Consolidated Statements of Operations. |
Leases | Leases The Company primarily enters into lease agreements for office space, equipment, and vehicles. The leases have varying terms, some of which could include options to renew, extend, and early terminate. The Company determines if an arrangement is a lease at contract inception. Operating leases are included in right-of-use ("ROU") assets and lease liabilities on the Consolidated Balance Sheets. ROU assets represent the Company's right to control the use of an explicitly or implicitly identified fixed asset for a period of time and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. Lease payments included in the measurement of the lease liability are comprised of fixed payments. Variable lease payments are excluded from the ROU asset and lease liability and are recognized in the period in which the obligation for those payments is incurred. Variable lease payments are presented in the Consolidated Statements of Operations in the same line item as expenses arising from fixed lease payments for operating leases. The Company has lease agreements that include lease and non-lease components, which the Company accounts for as a single lease component for all underlying asset categories. The lease term for all of the Company's leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. |
Recent Accounting Developments | Recent Accounting Developments - Guidance Adopted in 2021 ASU 2019-12 - In December 2019, the Financial Accounting Standard Board issued Accounting Standard Update ("ASU") 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"). This new guidance removes specific exceptions to the general principles in Topic 740. It eliminates the need for an organization to analyze whether the following applies in a given period: (i) exception to the incremental approach for intraperiod tax allocation; (ii) exceptions to accounting for basis differences when there are ownership changes in foreign investments; and (iii) exception in interim period income tax accounting for year-to-date losses that exceed anticipated losses. ASU 2019-12 also improves financial statement preparers’ application of income tax-related guidance and simplifies the following: (i) franchise taxes that are partially based on income; (ii) transactions with a government that result in a step up in the tax basis of goodwill; (iii) separate financial statements of legal entities that are not subject to tax; and (iv) enacted changes in tax laws in interim periods. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted this guidance prospectively on January 1, 2021. The adoption did not have a material impact on the Company's Consolidated Financial Statements or related disclosures. Recent Accounting Developments - Guidance Not Yet Adopted The Company has evaluated recent accounting pronouncements and believes that none of them will have a material effect on the Company's Consolidated Financial Statements or related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Disaggregation of Revenue | The following table summarizes the Company's net product sales from Galafold ® disaggregated by geographic area: Three Months Ended March 31, (in thousands) 2021 2020 U.S. $ 20,853 $ 17,772 Ex-U.S. 45,549 42,753 Total net product sales $ 66,402 $ 60,525 |
Cash, Cash Equivalents, Marke_2
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Schedule of cash, cash equivalents and marketable securities | Cash, cash equivalents and marketable securities are classified as current unless mentioned otherwise below and consisted of the following: As of March 31, 2021 (in thousands) Cost Gross Gross Fair Cash and cash equivalents $ 184,833 $ — $ — $ 184,833 Corporate debt securities 20,936 — (4) 20,932 Commercial paper 151,300 10 (3) 151,307 Asset-backed securities 13,718 1 (3) 13,716 U.S. government agency bonds 46,228 12 — 46,240 Money market 350 — — 350 Certificates of deposit 51 — — 51 $ 417,416 $ 23 $ (10) $ 417,429 Included in cash and cash equivalents $ 184,833 $ — $ — $ 184,833 Included in marketable securities 232,583 23 (10) 232,596 Total cash, cash equivalents, and marketable securities $ 417,416 $ 23 $ (10) $ 417,429 As of December 31, 2020 (in thousands) Cost Gross Gross Fair Cash and cash equivalents $ 163,240 $ — $ — $ 163,240 Corporate debt securities 39,525 4 (16) 39,513 Commercial paper 217,087 14 (6) 217,095 Asset-backed securities 9,420 18 — 9,438 U.S. government agency bonds 53,583 3 (4) 53,582 Money market 350 — — 350 Certificates of deposit 51 — — 51 $ 483,256 $ 39 $ (26) $ 483,269 Included in cash and cash equivalents $ 163,240 $ — $ — $ 163,240 Included in marketable securities (1) 320,016 39 (26) 320,029 Total cash, cash equivalents, and marketable securities $ 483,256 $ 39 $ (26) $ 483,269 |
Schedule of cash, cash equivalents, and restricted cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Consolidated Statements of Cash Flows. (in thousands) March 31, 2021 March 31, 2020 Cash and cash equivalents $ 184,833 $ 123,231 Restricted cash 3,216 2,662 Cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows $ 188,049 $ 125,893 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories for the period | The following table summarizes the components of inventories: (in thousands) March 31, 2021 December 31, 2020 Raw materials $ 3,709 $ 5,547 Work-in-process 10,023 7,693 Finished goods 5,069 6,316 Total inventories $ 18,801 $ 19,556 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of liability components of long term debt | The Company's debt consists of the following: (in thousands) March 31, 2021 December 31, 2020 Senior Secured Term Loan due 2026: Principal $ 400,000 $ 400,000 Less: debt discount (1) (7,139) (7,434) Less: deferred financing (1) (5,371) (5,592) Net carrying value of the Senior Secured Term Loan $ 387,490 $ 386,974 Convertible Notes (2) : Principal (3) $ 2,800 $ 2,825 Less: debt discount (1) (476) (518) Less: deferred financing (1) (25) (27) Net carrying value of the Convertible Notes $ 2,299 $ 2,280 Net carrying value of Long-term debt $ 389,789 $ 389,254 ______________________________ (1) Included in the Consolidated Balance Sheets within long-term debt and amortized to interest expense over the remaining life of the Convertible Notes and Senior Secured Term Loan using the effective interest rate method. (2) The Convertible Notes are currently convertible as the last reported sale price of the Company's common stock was equal to or more than 130% of the conversion price for at least 20 trading days of the 30 consecutive trading days ending on the last day of the quarter. (3) In the first quarter of 2021, the Company exchanged an aggregate principal amount of $25.0 thousand of Convertible Notes in exchange for an aggregate of approximately 4.1 thousand shares of Company common stock, par value $0.01 per share. |
Components of total interest expense | The following table sets forth interest expense recognized related to the Company's debt for the three months ended March 31, 2021 and 2020, respectively: Three Months Ended March 31, (in thousands) 2021 2020 Contractual interest expense $ 7,521 $ 3,585 Amortization of debt discount $ 332 $ 206 Amortization of deferred financing $ 223 $ 25 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Fair Value of Options | The fair value of the stock options granted is estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: Three Months Ended March 31, 2021 2020 Expected stock price volatility 66.7 % 75.2 % Risk free interest rate 0.4 % 1.7 % Expected life of options (years) 5.40 5.67 Expected annual dividend per share $ — $ — |
Schedule of Stock Options Activity | A summary of the Company's stock options for the three months ended March 31, 2021 were as follows: Number of Weighted Average Exercise Weighted Average Remaining Aggregate (in thousands) (in millions) Options outstanding, December 31, 2020 14,032 $ 9.54 Granted 1,818 $ 21.46 Exercised (493) $ 8.54 Forfeited (273) $ 12.40 Options outstanding, March 31, 2021 15,084 $ 10.96 6.7 $ 18.5 Vested and unvested expected to vest, March 31, 2021 13,643 $ 10.71 6.4 $ 18.3 Exercisable at March 31, 2021 8,962 $ 9.04 5.2 $ 17.7 |
Schedule of Non-Vested RSU Activity under the Plan | A summary of non-vested RSU activity under the Plan for the three months ended March 31, 2021 is as follows: Number of Weighted Weighted Aggregate (in thousands) (in millions) Non-vested units as of December 31, 2020 7,080 $ 11.35 Granted 2,131 $ 20.22 Vested (1,435) $ 17.38 Forfeited (310) $ 13.36 Non-vested units as of March 31, 2021 7,466 $ 14.14 2.7 $ 73.8 |
Schedule of Equity Compensation Expenses | The following table summarizes information related to compensation expense recognized in the Consolidated Statements of Operations related to the equity awards: Three Months Ended March 31, (in thousands) 2021 2020 Equity compensation expense recognized in: Research and development expense $ 6,305 $ 5,253 Selling, general, and administrative expense 14,049 7,343 Total equity compensation expense $ 20,354 $ 12,596 |
Assets and Liabilities Measur_2
Assets and Liabilities Measured at Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of assets and liabilities subject to fair value measurements | A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of March 31, 2021 are identified in the following tables: (in thousands) Level 2 Total Assets: Commercial paper $ 151,307 $ 151,307 Asset-backed securities 13,716 13,716 Corporate debt securities 20,932 20,932 U.S. government agency bonds 46,240 46,240 Money market funds 4,296 4,296 $ 236,491 $ 236,491 (in thousands) Level 2 Level 3 Total Liabilities: Contingent consideration payable $ — $ 26,296 $ 26,296 Deferred compensation plan liability 3,946 — 3,946 $ 3,946 $ 26,296 $ 30,242 A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of December 31, 2020 are identified in the following tables: (in thousands) Level 2 Total Assets: Commercial paper $ 217,095 $ 217,095 Asset-backed securities 9,438 9,438 Corporate debt securities 39,513 39,513 U.S. government agency bonds 53,582 53,582 Money market funds 4,427 4,427 $ 324,055 $ 324,055 (in thousands) Level 2 Level 3 Total Liabilities: Contingent consideration payable $ — $ 25,825 $ 25,825 Deferred compensation plan liability 4,078 — 4,078 $ 4,078 $ 25,825 $ 29,903 |
Schedule of significant unobservable inputs used in the valuation of the contingent consideration payable | The following significant unobservable inputs were used in the valuation of the contingent consideration payable of Callidus for the ATB-200 Pompe program: Contingent Consideration Liability Fair Value as of March 31, 2021 Valuation Technique Unobservable Input Range (in thousands) Discount rate 7.5% Clinical and regulatory milestones $ 25,559 Probability weighted discounted cash flow Probability of achievement of milestones 75% - 78% Projected year of payments 2021 - 2022 |
Schedule of changes in contingent consideration payable | The following table shows the change in the balance of contingent consideration payable for the three months ended March 31, 2021 and March 31, 2020, respectively: Three Months Ended March 31, (in thousands) 2021 2020 Balance, beginning of the period $ 25,825 $ 22,681 Changes in fair value during the period, included in the Consolidated Statements of Operations 471 931 Balance, end of the period $ 26,296 $ 23,612 |
Basic and Diluted Net Loss pe_2
Basic and Diluted Net Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of reconciliation of the numerator and denominator used in computing basic and diluted net loss per common share | The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss attributable to common stockholders per common share: Three Months Ended March 31, (in thousands, except per share amounts) 2021 2020 Numerator: Net loss attributable to common stockholders $ (65,664) $ (88,948) Denominator: Weighted average common shares outstanding — basic and diluted 264,369,317 256,968,248 |
Schedule of potential shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method | The table below presents potential shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method: As of March 31, (in thousands) 2021 2020 Options to purchase common stock 15,084 19,086 Convertible notes 458 462 Outstanding warrants, convertible to common stock — 2,554 Unvested restricted stock units 7,466 7,562 Total number of potentially issuable shares 23,008 29,664 |
Description of Business (Detail
Description of Business (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 2,111,126 | $ 2,045,462 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Accounting Policies [Abstract] | ||
Allowance for doubtful accounts receivable | $ 100 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Net product sales | 66,402 | $ 60,525 |
U.S. | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Net product sales | 20,853 | 17,772 |
Ex-U.S. | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Net product sales | $ 45,549 | $ 42,753 |
Cash, Cash Equivalents, Marke_3
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |||
Cash and cash equivalents | $ 184,833,000 | $ 163,240,000 | $ 123,231,000 |
Available-for-sale debt securities | 232,596,000 | 320,029,000 | |
Realized gain (loss) on debt securities | 0 | 0 | |
Fair value of available-for-sale debt securities in unrealized loss positions | $ 114,500,000 | $ 124,900,000 |
Cash, Cash Equivalents, Marke_4
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash - Components (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 |
Cash, Money Market Funds, and Marketable Securities | |||
Cash and cash equivalents | $ 184,833 | $ 163,240 | $ 123,231 |
Fair Value, Cash balances | 184,833 | 163,240 | |
Cost, available-for-sale securities | 232,583 | 320,016 | |
Gross unrealized gain, available-for-sale securities | 23 | 39 | |
Gross unrealized loss, available-for-sale securities | (10) | (26) | |
Fair value, available-for-sale debt securities | 232,596 | 320,029 | |
Cost, Cash balances and available-for-sale securities | 417,416 | 483,256 | |
Gross unrealized gain, Cash balances and available-for-sale securities | 23 | 39 | |
Gross unrealized loss, Cash balances and available-for-sale securities | (10) | (26) | |
Fair value, Cash balances and available-for-sale securities | 417,429 | 483,269 | |
Corporate debt securities | |||
Cash, Money Market Funds, and Marketable Securities | |||
Corporate debt securities, Cost | 20,936 | 39,525 | |
Corporate debt securities, Gross Unrealized Gain | 0 | 4 | |
Corporate debt securities, Gross Unrealized Loss | (4) | (16) | |
Corporate debt securities, Fair Value | 20,932 | 39,513 | |
Commercial paper | |||
Cash, Money Market Funds, and Marketable Securities | |||
Cost, available-for-sale securities | 151,300 | 217,087 | |
Gross unrealized gain, available-for-sale securities | 10 | 14 | |
Gross unrealized loss, available-for-sale securities | (3) | (6) | |
Fair value, available-for-sale debt securities | 151,307 | 217,095 | |
Asset-backed securities | |||
Cash, Money Market Funds, and Marketable Securities | |||
Corporate debt securities, Cost | 13,718 | 9,420 | |
Corporate debt securities, Gross Unrealized Gain | 1 | 18 | |
Corporate debt securities, Gross Unrealized Loss | (3) | 0 | |
Corporate debt securities, Fair Value | 13,716 | 9,438 | |
U.S. government agency bonds | |||
Cash, Money Market Funds, and Marketable Securities | |||
Corporate debt securities, Cost | 46,228 | 53,583 | |
Corporate debt securities, Gross Unrealized Gain | 12 | 3 | |
Corporate debt securities, Gross Unrealized Loss | 0 | (4) | |
Corporate debt securities, Fair Value | 46,240 | 53,582 | |
Money market | |||
Cash, Money Market Funds, and Marketable Securities | |||
Cost, available-for-sale securities | 350 | 350 | |
Gross unrealized gain, available-for-sale securities | 0 | 0 | |
Gross unrealized loss, available-for-sale securities | 0 | 0 | |
Fair value, available-for-sale debt securities | 350 | 350 | |
Certificates of deposit | |||
Cash, Money Market Funds, and Marketable Securities | |||
Cost, available-for-sale securities | 51 | 51 | |
Gross unrealized gain, available-for-sale securities | 0 | 0 | |
Gross unrealized loss, available-for-sale securities | 0 | 0 | |
Fair value, available-for-sale debt securities | $ 51 | $ 51 |
Cash, Cash Equivalents, Marke_5
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash - Cash, Cash Equivalents, And Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | ||||
Cash and cash equivalents | $ 184,833 | $ 163,240 | $ 123,231 | |
Restricted cash | 3,216 | 2,662 | ||
Cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows | $ 188,049 | $ 166,162 | $ 125,893 | $ 146,341 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 3,709 | $ 5,547 |
Work-in-process | 10,023 | 7,693 |
Finished goods | 5,069 | 6,316 |
Total inventories | 18,801 | 19,556 |
Reserve for inventory | $ 200 | $ 100 |
Debt - Summary of Long Term Deb
Debt - Summary of Long Term Debt (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021USD ($)day$ / sharesshares | Dec. 31, 2020USD ($)$ / shares | |
Debt Instrument [Line Items] | ||
Net carrying value | $ 389,789 | $ 389,254 |
Debt conversion, converted instrument, shares issued | shares | 4,100 | |
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 |
Senior Loans | Senior Secured Term Loan due 2026 | ||
Debt Instrument [Line Items] | ||
Long-term debt | $ 400,000 | $ 400,000 |
Less: debt discount | (7,139) | (7,434) |
Less: deferred financing | (5,371) | (5,592) |
Net carrying value | 387,490 | 386,974 |
Convertible Notes | Convertible Senior Notes 2016, Due 2023 | ||
Debt Instrument [Line Items] | ||
Long-term debt | 2,800 | 2,825 |
Less: debt discount | (476) | (518) |
Less: deferred financing | (25) | (27) |
Net carrying value | $ 2,299 | $ 2,280 |
Threshold percentage | 130.00% | |
Threshold trading days | 20 days | |
Threshold consecutive trading days | day | 30 | |
Debt conversion, converted instrument, amount | $ 25 |
Debt - Interest Expense (Detail
Debt - Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Debt Disclosure [Abstract] | ||
Contractual interest expense | $ 7,521 | $ 3,585 |
Amortization of debt discount | 332 | 206 |
Amortization of deferred financing | $ 223 | $ 25 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock and Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2021 | Feb. 28, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | |
Collaborative Agreements | ||||
Proceeds from exercise of warrants | $ 19,230 | $ 0 | ||
Outstanding warrants, convertible to common stock | ||||
Collaborative Agreements | ||||
Stock issued from equity financing (in shares) | 1,050,000 | |||
Proceeds from exercise of warrants | $ 11,800 | $ 7,400 | ||
Outstanding warrants, convertible to common stock | Stock Exercises at $7.98 | ||||
Collaborative Agreements | ||||
Stock issued from equity financing (in shares) | 1,294,999 | |||
Outstanding warrants, convertible to common stock | Stock Exercises at $7.06 | ||||
Collaborative Agreements | ||||
Stock issued from equity financing (in shares) | 210,000 | |||
Outstanding warrants, convertible to common stock | Common Stock | ||||
Collaborative Agreements | ||||
Warrants exercise price (in dollars per share) | $ 7.06 | |||
Outstanding warrants, convertible to common stock | Common Stock | Stock Exercises at $7.98 | ||||
Collaborative Agreements | ||||
Warrants exercise price (in dollars per share) | $ 7.98 | $ 7.98 | ||
Outstanding warrants, convertible to common stock | Common Stock | Stock Exercises at $7.06 | ||||
Collaborative Agreements | ||||
Warrants exercise price (in dollars per share) | $ 7.06 | $ 7.06 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted-average Assumptions (Details) - Options to purchase common stock - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected stock price volatility | 66.70% | 75.20% |
Risk free interest rate | 0.40% | 1.70% |
Expected life of options (years) | 5 years 4 months 24 days | 5 years 8 months 1 day |
Expected annual dividend per share (in dollars per share) | $ 0 | $ 0 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Details) - Options to purchase common stock $ / shares in Units, shares in Thousands, $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Number of Shares | |
Options outstanding (in shares) | shares | 14,032 |
Options, Granted (in shares) | shares | 1,818 |
Options, Exercised (in shares) | shares | (493) |
Options, Forfeited (in shares) | shares | (273) |
Options outstanding (in shares) | shares | 15,084 |
Options, Vested and unvested expected to vest (in shares) | shares | 13,643 |
Options, Exercisable (in shares) | shares | 8,962 |
Weighted Average Exercise Price | |
Options outstanding (in dollars per share) | $ / shares | $ 9.54 |
Options, Granted (in dollars per share) | $ / shares | 21.46 |
Options, Exercised (in dollars per share) | $ / shares | 8.54 |
Options, Forfeited (in dollars per share) | $ / shares | 12.40 |
Options outstanding (in dollars per share) | $ / shares | 10.96 |
Options, Vested and unvested expected to vest (in dollars per share) | $ / shares | 10.71 |
Options, Exercisable (in dollars per share) | $ / shares | $ 9.04 |
Additional Disclosures | |
Weighted average remaining contractual life, options outstanding | 6 years 8 months 12 days |
Weighted average remaining contractual life, options vested and unvested expected to vest | 6 years 4 months 24 days |
Weighted average remaining contractual life, options exercisable | 5 years 2 months 12 days |
Aggregate intrinsic value, options outstanding | $ | $ 18.5 |
Aggregate intrinsic value, vested and unvested expected to vest | $ | 18.3 |
Aggregate intrinsic value, exercisable | $ | $ 17.7 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) $ / shares in Units, $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($)$ / shares | |
Options to purchase common stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options, expired (in dollars per share) | $ / shares | $ 15.36 |
Total unrecognized compensation costs | $ 38.7 |
Unrecognized compensation costs, period for recognition (in years) | 3 years |
Unvested restricted stock units | Stock Option Plan Amended Restated 2007 Equity Incentive Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Total unrecognized compensation costs | $ 64.5 |
Unrecognized compensation costs, period for recognition (in years) | 3 years |
Share-Based Compensation - RSUs
Share-Based Compensation - RSUs and PBRSUs Summary (Details) - Unvested restricted stock units - Stock Option Plan Amended Restated 2007 Equity Incentive Plan $ / shares in Units, shares in Thousands, $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Number of Shares | |
Non-vested units (in shares) | shares | 7,080 |
Granted (in shares) | shares | 2,131 |
Vested (in shares) | shares | (1,435) |
Forfeited (in shares) | shares | (310) |
Non-vested units (in shares) | shares | 7,466 |
Weighted Average Grant Date Fair Value | |
Non-vested units (in dollars per share) | $ / shares | $ 11.35 |
Granted (in dollars per share) | $ / shares | 20.22 |
Vested (in dollars per share) | $ / shares | 17.38 |
Forfeited (in dollars per share) | $ / shares | 13.36 |
Non-vested units (in dollars per share) | $ / shares | $ 14.14 |
Additional Disclosures | |
Non-vested units, weighted average remaining years | 2 years 8 months 12 days |
Non-vested units, aggregate intrinsic value | $ | $ 73.8 |
Share-Based Compensation - Expe
Share-Based Compensation - Expense Summary (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total equity compensation expense | $ 20,354 | $ 12,596 |
Research and development expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total equity compensation expense | 6,305 | 5,253 |
Selling, general, and administrative expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total equity compensation expense | $ 14,049 | $ 7,343 |
Assets and Liabilities Measur_3
Assets and Liabilities Measured at Fair Value - Components by Hierarchy Level (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Fair value of assets | $ 236,491 | $ 324,055 |
Liabilities: | ||
Contingent consideration payable | 26,296 | 25,825 |
Deferred compensation plan liability | 3,946 | 4,078 |
Fair value of liabilities | 30,242 | 29,903 |
Commercial paper | ||
Assets: | ||
Fair value of assets | 151,307 | 217,095 |
Asset-backed securities | ||
Assets: | ||
Fair value of assets | 13,716 | 9,438 |
Corporate debt securities | ||
Assets: | ||
Fair value of assets | 20,932 | 39,513 |
U.S. government agency bonds | ||
Assets: | ||
Fair value of assets | 46,240 | 53,582 |
Money market funds | ||
Assets: | ||
Fair value of assets | 4,296 | 4,427 |
Level 2 | ||
Assets: | ||
Fair value of assets | 236,491 | 324,055 |
Liabilities: | ||
Contingent consideration payable | 0 | 0 |
Deferred compensation plan liability | 3,946 | 4,078 |
Fair value of liabilities | 3,946 | 4,078 |
Fair value of the Convertible Notes | 4,500 | |
Level 2 | Commercial paper | ||
Assets: | ||
Fair value of assets | 151,307 | 217,095 |
Level 2 | Asset-backed securities | ||
Assets: | ||
Fair value of assets | 13,716 | 9,438 |
Level 2 | Corporate debt securities | ||
Assets: | ||
Fair value of assets | 20,932 | 39,513 |
Level 2 | U.S. government agency bonds | ||
Assets: | ||
Fair value of assets | 46,240 | 53,582 |
Level 2 | Money market funds | ||
Assets: | ||
Fair value of assets | 4,296 | 4,427 |
Level 3 | ||
Liabilities: | ||
Contingent consideration payable | 26,296 | 25,825 |
Deferred compensation plan liability | 0 | 0 |
Fair value of liabilities | $ 26,296 | $ 25,825 |
Assets and Liabilities Measur_4
Assets and Liabilities Measured at Fair Value - Significant Unobservable Inputs (Details) $ in Thousands | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration payable | $ 26,296 | $ 25,825 |
Level 3 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration payable | 26,296 | $ 25,825 |
Callidus Biopharma Inc | Clinical and regulatory milestones | ATB200 Pompe Program | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration payable | $ 25,559 | |
Callidus Biopharma Inc | Clinical and regulatory milestones | Probability of achievement of milestones | ATB200 Pompe Program | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.75 | |
Callidus Biopharma Inc | Clinical and regulatory milestones | Probability of achievement of milestones | ATB200 Pompe Program | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.78 | |
Callidus Biopharma Inc | Clinical and regulatory milestones | Level 3 | Discount rate | ATB200 Pompe Program | Probability weighted discounted cash flow | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.075 |
Assets and Liabilities Measur_5
Assets and Liabilities Measured at Fair Value - Contingent Consideration Roll Forward (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of the period | $ 25,825 | $ 22,681 |
Changes in fair value during the period, included in the Consolidated Statements of Operations | 471 | 931 |
Balance, end of the period | $ 26,296 | $ 23,612 |
Basic and Diluted Net Loss pe_3
Basic and Diluted Net Loss per Common Share (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Numerator: | ||
Net loss attributable to common stockholders | $ (65,664) | $ (88,948) |
Denominator: | ||
Weighted-average common shares outstanding - basic and diluted (in shares) | 264,369,317 | 256,968,248 |
Antidilutive securities excluded from computation of diluted earnings per share (in shares) | 23,008,000 | 29,664,000 |
Options to purchase common stock | ||
Denominator: | ||
Antidilutive securities excluded from computation of diluted earnings per share (in shares) | 15,084,000 | 19,086,000 |
Convertible notes | ||
Denominator: | ||
Antidilutive securities excluded from computation of diluted earnings per share (in shares) | 458,000 | 462,000 |
Outstanding warrants, convertible to common stock | ||
Denominator: | ||
Antidilutive securities excluded from computation of diluted earnings per share (in shares) | 0 | 2,554,000 |
Unvested restricted stock units | ||
Denominator: | ||
Antidilutive securities excluded from computation of diluted earnings per share (in shares) | 7,466,000 | 7,562,000 |