Cover
Cover - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 17, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Entity Central Index Key | 0001159036 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Current Fiscal Year End Date | --12-31 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Transition Report | false | ||
Entity File Number | 001-32335 | ||
Entity Registrant Name | HALOZYME THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 88-0488686 | ||
Entity Address, Address Line One | 11388 Sorrento Valley Road | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 858 | ||
Local Phone Number | 794-8889 | ||
Title of 12(b) Security | Common Stock, $0.001 Par Value | ||
Trading Symbol | HALO | ||
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 | $ 2.9 | ||
Entity Common Stock, Shares Outstanding | 135,276,380 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | Organization and Business Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme, rHuPH20, is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE ® drug delivery technology with the collaborators’ proprietary compounds. Our approved product and our collaborators’ approved products and product candidates are based on rHuPH20, our patented recombinant human hyaluronidase enzyme. rHuPH20 is the active ingredient in our first commercially approved product, Hylenex® recombinant (“Hylenex”), and it works by breaking down hyaluronan (or “HA”), a naturally occurring carbohydrate that is a major component of the extracellular matrix in tissues throughout the body such as skin and cartilage. This temporarily increases dispersion and absorption allowing for improved subcutaneous delivery of injectable biologics, such as monoclonal antibodies and other large therapeutic molecules, as well as small molecules and fluids. We refer to the application of rHuPH20 to facilitate the delivery of other drugs or fluids as our ENHANZE ® drug delivery technology (“ENHANZE”). We license the ENHANZE technology to form collaborations with biopharmaceutical companies that develop or market drugs requiring or benefiting from injection via the subcutaneous route of administration. In the development of proprietary intravenous (IV) drugs combined with our ENHANZE technology, data have been generated supporting the potential for ENHANZE to reduce treatment burden, as a result of shorter duration of subcutaneous (SC) administration. ENHANZE may enable fixed-dose SC dosing compared to weight-based dosing required for IV administration, and potentially allow for lower rates of infusion related reactions. ENHANZE may enable more flexible treatment options such as home administration by a healthcare professional or potentially the patient. Lastly, certain proprietary drugs co-formulated with ENHANZE have been granted additional exclusivity, extending the patent life of the product beyond the one of the proprietary IV drug. We currently have ENHANZE collaborations with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc. (“Roche”), Baxalta US Inc. and Baxalta GmbH (now members of the Takeda group of companies, following the acquisition of Shire plc by Takeda Pharmaceutical Company Limited in January 2019) (“Baxalta”), Pfizer Inc. (“Pfizer”), Janssen Biotech, Inc. (“Janssen”), AbbVie, Inc. (“AbbVie”), Eli Lilly and Company (“Lilly”), Bristol-Myers Squibb Company (“BMS”), Alexion Pharma Holding (“Alexion”), ARGENX BVBA (“argenx”) and Horizon Therapeutics plc. (Horizon). We receive royalties from three of these collaborations, including royalties from sales of one product from the Baxalta collaboration and three products from the Roche collaboration and one product from Janssen collaboration. Future potential revenues from royalties and fees from ENHANZE collaborations and the sales and/or royalties of our approved products will depend on the ability of Halozyme and our collaborators to develop, manufacture, secure and maintain regulatory approvals for approved products and product candidates and commercialize product candidates. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 147,703 | $ 120,179 |
Marketable securities, available-for-sale | 220,310 | 301,083 |
Accounts receivable, net | 97,730 | 59,442 |
Inventories | 60,747 | 29,359 |
Prepaid expenses and other assets | 28,274 | 33,373 |
Total current assets | 554,764 | 543,436 |
Property and equipment, net | 10,593 | 10,855 |
Prepaid expenses and other assets | 14,067 | 11,083 |
Restricted cash | 500 | 500 |
Total assets | 579,924 | 565,874 |
Current liabilities: | ||
Accounts payable | 1,928 | 6,434 |
Accrued expenses | 20,483 | 55,649 |
Deferred revenue, current portion | 1,746 | 4,012 |
Current portion of long-term debt, net | 397,228 | 19,542 |
Total current liabilities | 421,385 | 85,637 |
Deferred revenue, net of current portion | 4,026 | 1,247 |
Long-term debt, net | 0 | 383,045 |
Other long-term liabilities | 3,466 | 4,180 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity (deficit): | ||
Preferred stock - $0.001 par value; 20,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock - $0.001 par value; 200,000 shares authorized; 142,789 and 129,502 shares issued and outstanding at December 31, 2017 and 2016, respectively | 135 | 137 |
Additional paid-in capital | 625,483 | 695,066 |
Accumulated other comprehensive loss | 22 | 240 |
Accumulated deficit | (474,593) | (603,678) |
Total stockholders' equity (deficit) | 151,047 | 91,765 |
Total liabilities and stockholders' equity (deficit) | $ 579,924 | $ 565,874 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (USD per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (shares) | 20,000,000 | 20,000,000 |
Preferred stock issued (shares) | 0 | 0 |
Preferred stock outstanding (shares) | 0 | 0 |
Common stock, par value (USD per share) | $ 0.001 | $ 0.001 |
Common stock authorized (shares) | 300,000,000 | 300,000,000 |
Common stock issued (shares) | 135,029,987 | 136,712,580 |
Common stock outstanding (shares) | 135,029,987 | 136,712,580 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||
Total revenues | $ 267,594 | $ 195,992 | $ 151,862 |
Operating expenses: | |||
Cost of product sales | 43,367 | 45,546 | 10,136 |
Research and development | 34,236 | 140,804 | 150,252 |
Selling, general and administrative | 45,736 | 77,252 | 60,804 |
Total operating expenses | 123,339 | 263,602 | 221,192 |
Operating income (loss) | 144,255 | (67,610) | (69,330) |
Other income (expense): | |||
Investment and other income, net | 5,425 | 6,986 | 7,578 |
Interest expense | (20,378) | (11,627) | (18,041) |
Net income (loss) before income taxes | 129,302 | (72,251) | (79,793) |
Income tax expense (benefit) | 217 | (11) | 537 |
Net income (loss) | $ 129,085 | $ (72,240) | $ (80,330) |
Net income (loss) per share: | |||
Basic (USD per share) | $ 0.95 | $ (0.50) | $ (0.56) |
Diluted (USD per share) | $ 0.91 | $ (0.50) | $ (0.56) |
Shares used in computing net income (loss) per share: | |||
Basic (shares) | 136,206 | 144,329 | 143,599 |
Diluted (shares) | 141,463 | 144,329 | 143,599 |
Royalties | |||
Revenues: | |||
Total revenues | $ 88,596 | $ 69,899 | $ 78,981 |
Product sales, net | |||
Revenues: | |||
Total revenues | 55,987 | 66,048 | 28,234 |
Revenues under collaborative agreements | |||
Revenues: | |||
Total revenues | $ 123,011 | $ 60,045 | $ 44,647 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | |||
Net income (loss) | $ 129,085 | $ (72,240) | $ (80,330) |
Other comprehensive (loss) income: | |||
Unrealized (loss) gain on marketable securities | (164) | 508 | 182 |
Foreign currency translation adjustment | (32) | 9 | (8) |
Unrealized loss on foreign currency | (22) | 0 | (1) |
Total comprehensive income (loss) | $ 128,867 | $ (71,723) | $ (80,157) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities: | |||
Net income (loss) | $ 129,085 | $ (72,240) | $ (80,330) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | |||
Share-based compensation | 17,204 | 34,776 | 35,696 |
Depreciation and amortization | 3,284 | 4,068 | 2,388 |
Amortization of debt discount | 14,136 | 2,484 | 1,545 |
Amortization of premiums (accretion of discounts) on marketable securities | 839 | (2,469) | (3,090) |
(Gain) loss on disposal of equipment | (772) | 1,431 | 5 |
Deferral of unearned revenue | 4,632 | 0 | 3,000 |
Recognition of deferred revenue | (4,119) | (3,996) | (2,832) |
Deferral of lease payments | (1,033) | (459) | (7) |
Loss on impairment of right-of-use asset | 577 | 1,127 | 0 |
Loss on extinguishment of debt | 0 | 401 | 0 |
Other | (13) | (7) | (9) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (38,288) | (29,437) | 11,613 |
Inventories | (31,388) | (6,734) | (17,480) |
Prepaid expenses and other assets | 2,518 | (19,006) | (5,695) |
Accounts payable and accrued expenses | (41,208) | 4,638 | 5,696 |
Net cash provided (used in) by operating activities | 55,454 | (85,423) | (49,500) |
Investing activities: | |||
Purchases of marketable securities | (226,185) | (389,759) | (311,112) |
Proceeds from maturities of marketable securities | 305,967 | 388,250 | 318,268 |
Purchases of property and equipment | (2,504) | (4,040) | (4,663) |
Proceeds from disposal of property and equipment | 1,076 | 0 | 0 |
Net cash provided by (used in) investing activities | 78,354 | (5,549) | 2,493 |
Financing activities: | |||
Proceeds from issuance of long-term debt, net | 0 | 447,350 | 0 |
Repayment of long-term debt | (19,560) | (108,082) | (77,516) |
Payment of debt issuance cost | 0 | (279) | 0 |
Repurchase of common stock | (150,117) | (199,998) | 0 |
Proceeds from issuance of common stock under equity incentive plans, net of taxes paid related to net share settlement | 63,393 | 14,224 | 13,719 |
Net cash (used in) provided by financing activities | (106,284) | 153,215 | (63,797) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 27,524 | 62,243 | (110,804) |
Cash, cash equivalents and restricted cash at beginning of period | 120,679 | 58,436 | 169,240 |
Cash, cash equivalents and restricted cash at end of period | 148,203 | 120,679 | 58,436 |
Supplemental disclosure of cash flow information: | |||
Interest paid | 6,534 | 9,029 | 16,891 |
Income taxes paid | 180 | 188 | 220 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Amounts accrued for purchases of property and equipment | 117 | 61 | 542 |
Debt issuance cost included in accounts payable | 0 | 68 | 0 |
Right-of-use assets obtained in exchange for lease obligation | 1,746 | 897 | 0 |
Leasehold improvements paid by lessor | $ 0 | $ 0 | $ 1,322 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) Statement - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Adjustment | AdjustmentAccumulated Deficit |
Shares outstanding at Dec. 31, 2017 | 142,789 | ||||||
Total stockholders' equity (deficit) at Dec. 31, 2017 | $ 208,366 | $ 143 | $ 731,044 | $ (450) | $ (522,371) | $ 71,263 | $ 71,263 |
Share-based Compensation | 35,696 | 35,696 | |||||
Issuance of common stock pursuant to exercise of stock options and vesting of restricted stock units and performance restricted stock units, net | 1,932 | ||||||
Value, Stock Options Exercised | 13,719 | $ 2 | 13,717 | ||||
Shares, Restricted Stock Award | 4 | ||||||
Value, Restricted Stock Award | 0 | $ 0 | 0 | ||||
Other Comprehensive Income (Loss) | 173 | 173 | |||||
Net income (loss) | (80,330) | ||||||
Shares outstanding at Dec. 31, 2018 | 144,725 | ||||||
Total stockholders' equity (deficit) at Dec. 31, 2018 | 248,887 | $ 145 | 780,457 | (277) | (531,438) | ||
Share-based Compensation | 34,776 | 34,776 | |||||
Issuance of common stock pursuant to exercise of stock options and vesting of restricted stock units and performance restricted stock units, net | 2,493 | ||||||
Value, Stock Options Exercised | 14,224 | $ 2 | 14,222 | ||||
Shares, Restricted Stock Award | 74 | ||||||
Value, Restricted Stock Award | 0 | $ 0 | 0 | ||||
Stock Repurchased and Retired During Period, Shares | (10,579) | ||||||
Stock Repurchased and Retired During Period, Value | (199,998) | $ (10) | (199,988) | ||||
Adjustments to Additional Paid in Capital, Equity Component of Convertible Debt | 65,599 | 65,599 | |||||
Other Comprehensive Income (Loss) | 517 | 517 | |||||
Net income (loss) | (72,240) | (72,240) | |||||
Shares outstanding at Dec. 31, 2019 | 136,713 | ||||||
Total stockholders' equity (deficit) at Dec. 31, 2019 | 91,765 | $ 137 | 695,066 | 240 | (603,678) | ||
Share-based Compensation | 17,204 | 17,204 | |||||
Issuance of common stock pursuant to exercise of stock options and vesting of restricted stock units and performance restricted stock units, net | 5,278 | ||||||
Value, Stock Options Exercised | 63,393 | $ 5 | 63,388 | ||||
Shares, Restricted Stock Award | 61 | ||||||
Value, Restricted Stock Award | 0 | $ 0 | 0 | ||||
Stock Repurchased and Retired During Period, Shares | (7,022) | ||||||
Stock Repurchased and Retired During Period, Value | (150,117) | $ (7) | (150,110) | ||||
Adjustments to Additional Paid in Capital, Equity Component of Convertible Debt | (65) | (65) | |||||
Other Comprehensive Income (Loss) | (218) | (218) | |||||
Net income (loss) | 129,085 | 129,085 | |||||
Shares outstanding at Dec. 31, 2020 | 135,030 | ||||||
Total stockholders' equity (deficit) at Dec. 31, 2020 | $ 151,047 | $ 135 | $ 625,483 | $ 22 | $ (474,593) |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements include the accounts of Halozyme Therapeutics, Inc. and our wholly owned subsidiary, Halozyme, Inc., and Halozyme, Inc.’s wholly owned subsidiaries, Halozyme Holdings Ltd., Halozyme Switzerland GmbH and Halozyme Switzerland Holdings GmbH. All intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates. Cash Equivalents and Marketable Securities Cash equivalents consist of highly liquid investments, readily convertible to cash, that mature within ninety days or less from the date of purchase. As of December 31, 2020, our cash equivalents consisted of money market funds. Marketable securities are investments with original maturities of more than ninety days from the date of purchase that are specifically identified to fund current operations. Marketable securities are considered available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from the sale of these investments to fund our operations, as necessary. Such available-for-sale investments are carried at fair value with unrealized gains and losses recorded in other comprehensive income (loss) and included as a separate component of stockholders’ equity. The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in investment and other income, net in the consolidated statements of operations. We use the specific identification method for calculating realized gains and losses on marketable securities sold. None of the realized gains and losses and declines in value judged to be as a result of credit loss on marketable securities, if any, are included in investment and other income, net in the consolidated statements of operations. Restricted Cash Under the terms of the leases of our facilities, we are required to maintain letters of credit as security deposits during the terms of such leases. At December 31, 2020 and 2019, restricted cash of $0.5 million was pledged as collateral for the letters of credit. Fair Value of Financial Instruments The authoritative guidance for fair value measurements establishes a three tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Our financial instruments include cash equivalents, available-for-sale marketable securities, accounts receivable, prepaid expenses and other assets, accounts payable, accrued expenses and short-term debt. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment and therefore cannot be determined with precision. The carrying amount of cash equivalents, accounts receivable, prepaid expenses and other assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. Available-for-sale marketable securities consist of asset-backed securities, corporate debt securities, U.S. Treasury securities and commercial paper, and are measured at fair value using Level 1 and Level 2 inputs. Level 2 financial instruments are valued using market prices on less active markets and proprietary pricing valuation models with observable inputs, including interest rates, yield curves, maturity dates, issue dates, settlement dates, reported trades, broker-dealer quotes, issue spreads, benchmark securities or other market related data. We obtain the fair value of Level 2 investments from our investment manager, who obtains these fair values from a third-party pricing source. We validate the fair values of Level 2 financial instruments provided by our investment manager by comparing these fair values to a third-party pricing source. Concentrations of Credit Risk, Sources of Supply and Significant Customers We are subject to credit risk from our portfolio of cash equivalents and marketable securities. These investments were made in accordance with our investment policy which specifies the categories, allocations, and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. We maintain our cash and cash equivalent balances with one major commercial bank and marketable securities with another financial institution. Deposits held with the financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash, cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets. We are also subject to credit risk from our accounts receivable related to our product sales and revenues under our license and collaborative agreements. We have license and collaborative agreements with pharmaceutical companies under which we receive payments for royalties, license fees, milestone payments for specific achievements designated in the collaborative agreements, reimbursements of research and development services and supply of bulk formulation of rHuPH20. In addition, we sell Hylenex ® recombinant in the United States to a limited number of established wholesale distributors in the pharmaceutical industry. Credit is extended based on an evaluation of the customer’s financial condition, and collateral is not required. Management monitors our exposure to accounts receivable by periodically evaluating the collectability of the accounts receivable based on a variety of factors including the length of time the receivables are past due, the financial health of the customer and historical experience. Based upon the review of these factors, we recorded no allowance for doubtful accounts at December 31, 2020 and 2019. Approximately 74% of the accounts receivable balance at December 31, 2020 represents amounts due from Janssen, Roche and Baxalta. Approximately 93% of the accounts receivable balance at December 31, 2019 represents amounts due from Janssen, Roche and Baxalta. The following table indicates the percentage of total revenues in excess of 10% with any single customer: Year Ended December 31, 2020 2019 2018 Partner A 35% 40% 72% Partner B 26% 18% 2% Partner C 11% —% —% Partner D 8% 23% —% We attribute revenues under collaborative agreements, including royalties, to the individual countries where the customer is headquartered. We attribute revenues from product sales to the individual countries to which the product is shipped. Worldwide revenues from external customers are summarized by geographic location in the following table (in thousands): Year Ended December 31, 2020 2019 2018 United States $ 106,918 $ 28,178 $ 26,527 Switzerland 95,949 109,754 109,890 Ireland 30,552 589 5,075 Belgium 20,086 45,060 — Japan 10,644 9,905 8,873 All other foreign 3,445 2,506 1,497 Total revenues $ 267,594 $ 195,992 $ 151,862 We rely on two third-party manufacturers for the supply of bulk rHuPH20 for use in the manufacture of Hylenex recombinant and our other collaboration products and product candidates. Payments due to these suppliers represented 75% and 47% of the accounts payable balance at December 31, 2020 and 2019, respectively. We also rely on a third-party manufacturer for the fill and finish of Hylenex recombinant product under a contract. Payments due to this supplier represented zero and 8% of the accounts payable balance at December 31, 2020 and 2019, respectively. Accounts Receivable, Net Accounts receivable is recorded at the invoiced amount and is non-interest bearing. Accounts receivable is recorded net of allowances for doubtful accounts, cash discounts for prompt payment, distribution fees and chargebacks. We recorded no allowance for doubtful accounts at December 31, 2020 and 2019 as the collectability of accounts receivable was reasonably assured. Inventories Inventories are stated at lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Inventories are reviewed periodically for potential excess, dated or obsolete status. We evaluate the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand. As of December 31, 2020 and 2019, inventories consisted of $1.3 million and $1.4 million, respectively, of Hylenex inventory, net and $59.4 million and $28.0 million, respectively, of bulk rHuPH20, consistent with our plan to build inventory to meet future customer demand. Leases The Company has entered into operating leases primarily for real estate and automobiles. These leases have terms which range from 3 years to 6 years. We determine if an arrangement contains a lease at inception. Right of use (“ROU”) assets and liabilities resulting from operating leases are included in property and equipment, accrued expenses and other long-term liabilities on our consolidated balance sheets. Operating lease ROU assets and liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in determining the discount rate to calculate the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Our leases often include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that we will exercise that option. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. We have lease agreements with lease and non-lease components, which are generally accounted for separately. For certain equipment leases, such as automobiles, we account for the lease and non-lease components as a single lease component. Property and Equipment, Net Property and equipment, including ROU assets are recorded at cost, less accumulated depreciation and amortization. Equipment is depreciated using the straight-line method over its estimated useful life ranging from three years to ten years and leasehold improvements are amortized using the straight-line method over the estimated useful life of the asset or the lease term, whichever is shorter. Impairment of Long-Lived Assets We account for long-lived assets in accordance with authoritative guidance for impairment or disposal of long-lived assets. Long-lived assets are reviewed for events or changes in circumstances, which indicate that their carrying value may not be recoverable. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during the period from transactions and other events and circumstances from non-owner sources. Revenue Recognition We generate revenues from payments received under collaborative agreements and product sales. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations. Revenues under Collaborative Agreements Under these agreements, we grant the collaboration partner a worldwide license to develop and commercialize products using our ENHANZE technology to combine our patented rHuPH20 enzyme with their proprietary biologics directed at up to a specified number of targets. Targets are usually licensed on an exclusive, global basis. Targets selected subsequent to inception of the arrangement require payment of an additional license fee. The collaboration partner is responsible for all development, manufacturing, clinical, regulatory, sales and marketing costs for any products developed under the agreement. We are responsible for supply of bulk rHuPH20 based on the collaboration partner’s purchase orders, and may also be separately engaged to perform research and development services. While these collaboration agreements are similar in that they originate from the same framework, each one is the result of an arms-length negotiation and thus may vary from one to the other. We collect an upfront license payment from collaboration partners, and are also entitled to receive event-based payments subject to collaboration partners’ achievement of specified development, regulatory and sales-based milestones. In several agreements, collaboration partners pay us annual fees to maintain their exclusive license rights if they are unable to advance product development to specified stages. We earn separate fees for bulk rHuPH20 supplies and research and development services. In addition, collaboration partners will pay us royalties at an on average mid-single digit percent rate of their sales if products under the collaboration are commercialized. All amounts owed to us are noncancelable after the underlying triggering event occurs, and nonrefundable once paid. Unless terminated earlier in accordance with its terms, collaborations generally continue in effect until the last to expire royalty payment term, as determined on a product by product and on a country by country basis, with each royalty term starting on the first commercial sale of that product and ending the later of: (i) a specified period or term set forth in the agreement or (ii) expiration of the last to expire of the valid claims of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers a product developed under the collaboration. When there are no valid claims during the applicable royalty term in a given country, the royalty rate is reduced for those sales. Collaboration partners may terminate the agreement prior to expiration for any reason in its entirety or on a target-by-target basis generally upon 90 days prior written notice to us. Upon any such termination, the license granted to collaboration partners (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement (as opposed to a termination), the on-going licenses granted will become perpetual, non-exclusive and fully paid. Although these agreements are in form identified as collaborative agreements, we concluded for accounting purposes they represent contracts with customers, and are not subject to accounting literature on collaborative arrangements. This is because we grant to collaboration partners licenses to our intellectual property, and provide supply of bulk rHuPH20 and research and development services which are all outputs of our ongoing activities, in exchange for consideration. Under these collaborative agreements, we do not develop assets jointly with collaboration partners, and do not share in significant risks of their development or commercialization activities. Accordingly, we concluded our collaborative agreements are appropriately accounted for pursuant to ASC Topic 606, Revenue from Contracts with Customers. Under all of our collaborative agreements, we have identified licenses to use functional intellectual property as the only performance obligation. The intellectual property underlying the license is our proprietary ENHANZE ® technology which represents application of rHuPH20 to facilitate delivery of drugs or fluids. Each of the licenses grants the collaboration partners rights to use our intellectual property as it exists and is identified on the effective date of the license, because there is no ongoing development of the ENHANZE technology required. Therefore, we recognize revenue from licenses at the point when the license becomes effective and the collaboration partner has received access to our intellectual property, usually at the inception of the agreement. When collaboration partners can select additional targets to add to the licenses granted, we consider these rights to be options. We evaluate whether such options contain material rights, i.e. have exercise prices that are discounted compared to what we would charge for a similar license to a new collaboration partner. The exercise price of these options includes a combination of the target selection fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, we conclude the option does not contain a material right, and we consider grants of additional licensing rights upon option exercises to be separate contracts (target selection contracts). We provide customary indemnification and protection of licensed intellectual property for our customers. These provisions are part of assurance that the licenses meet the agreements’ representations and are not obligations to provide goods or services. We also fulfill purchase orders for supply of bulk rHuPH20 and perform research and development services pursuant to projects authorization forms for our collaboration partners, which represent separate contracts. Additionally, we price our supply of bulk rHuPH20 and research and development services at our regular selling prices, called standalone selling price or SSP. Therefore, our collaboration partners do not have material rights to order these items at prices not reflective of SSP. Refer to the discussion below regarding recognition of revenue for these separate contracts. Transaction price for a contract represents the amount to which we are entitled in exchange for providing goods and services to the customer. Transaction price does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of revenue when the uncertainty is resolved. Apart from the upfront license payment (or target selection fees in the target selection contracts), all other fees we may earn under our collaborative agreements are subject to significant uncertainties of product development. Achievement of many of the event-based development and regulatory milestones may not be probable until such milestones are actually achieved. This generally relates to milestones such as obtaining marketing authorization approvals. With respect to other development milestones, e.g. dosing of a first patient in a clinical trial, achievement could be considered probable prior to its actual occurrence, based on the progress towards commencement of the trial. In order to evaluate progress towards commencement of a trial, we assess the status of activities leading up to our collaboration partner’s initiation of a trial such as feedback received from the FDA (if applicable), completion of IND filings, readiness and availability of drug, readiness of study sites and our collaboration partner’s commitment of resources to the program. We do not include any amounts subject to uncertainties into the transaction price until it is probable that the amount will not result in a significant reversal of revenue in the future. At the end of each reporting period, we re- evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. When target exchange rights are held by collaboration partners, and the amounts attributed to these rights are not refundable, they are included in the transaction price. However, they are recorded as deferred revenues because we have a potential performance obligation to provide a new target upon an exchange right being exercised. These amounts are recognized in revenue when the right of exchange expires or is exercised. Because our agreements have one type of performance obligation (licenses) which are typically all transferred at the same time at agreement inception, allocation of transaction price often is not required. However, allocation is required when licenses for some of the individual targets are subject to rights of exchange, because revenue associated with these targets cannot be recognized. We perform an allocation of the upfront amount based on relative SSP of licenses for individual targets. We determine license SSP using income-based valuation approach utilizing risk-adjusted discounted cash flow projections of the estimated return a licensor would receive. When amounts subject to uncertainties, such as milestones and royalties, are included in the transaction price, we attribute them to the specific individual target licenses which generate such milestone or royalty amounts. We also estimate SSP of bulk rHuPH20 and research and development services, to determine that our collaboration partners do not have material rights to order them at discounted prices. For supplies of bulk rHuPH20, because we effectively act as a contract manufacturer to our collaboration partners, we estimate and charge SSP based on the typical contract manufacturer margins consistently with all of our collaborative partners. We determine SSP of research and development services based on a fully-burdened labor rate. Our rates are comparable to those we observe in other collaborative agreements. We also have a history of charging similar rates to all of our collaboration partners. Upfront amounts allocated to licenses to individual targets are recognized as revenue when the license is transferred to the collaboration partner, as discussed above, if the license is not subject to exchange rights, or when the exchange right expires or is exercised. Development milestones and other fees are recognized in revenue when they are included in the transaction price, because by that time we have already transferred the related license to the collaboration partner. Sales-based milestones and royalties cannot be recognized until the underlying sales occur. We do not receive final royalty reports from our collaboration partners until after we complete our financial statements for a prior quarter. Therefore, we recognize revenue based on estimates of the royalty earned, which are based on internal estimates and available preliminary reports provided by our collaboration partners. We will record a true-up in the following quarter if necessary, when final royalty reports are received. To date, we have not recorded any material true-ups. In contracts to provide research and development services, such services represent the only performance obligation. The fees are charged based on hours worked by our employees and the fixed contractual rate per hour, plus third-party pass-through costs, on a monthly basis. We recognize revenues as the related services are performed based on the amounts billed, as the collaboration partner consumes the benefit of research and development work simultaneously as we perform these services, and the amounts billed reflect the value of these services to the customer. Refer to Note 4 Revenue, for further discussion on our collaborative arrangements. Product Sales, Net Hylenex Recombinant We sell Hylenex recombinant in the U.S. to wholesale pharmaceutical distributors, who sell the product to hospitals and other end-user customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual packages of Hylenex recombinant represent performance obligations under each purchase order. We use a contract manufacturer to produce Hylenex recombinant and a third-party logistics (3PL) vendor to process and fulfill orders . We concluded we are the principal in the sales to wholesalers because we control access to services rendered by both vendors and direct their activities. We have no significant obligations to wholesalers to generate pull-through sales. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when wholesalers sell Hylenex recombinant at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. We also pay quarterly distribution fees to certain wholesalers for inventory reporting and chargeback processing, and to GPOs as administrative fees for services and for access to GPO members. We concluded the benefits received in exchange for these fees are not distinct from our sales of Hylenex recombinant, and accordingly we apply these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf life of Hylenex recombinant and our lengthy return period, there may be a significant period of time between when the product is shipped and when we issue credits on returned product. We estimate the transaction price when we receive each purchase order taking into account the expected reductions of the selling price initially billed to the wholesaler arising from all of the above factors. We have compiled historical experience and data to estimate future returns and chargebacks of Hylenex recombinant and the impact of the other discounts and fees we pay. When estimating these adjustments to the transaction price, we reduce it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known. Each purchase order contains only one type of product, and is usually shipped to the wholesaler in a single shipment. Therefore, allocation of the transaction price to individual packages is not required. We recognize revenue from Hylenex recombinant product sales and related cost of sales upon product delivery to the wholesaler location. At that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay us. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights, we do not believe they have a significant incentive to return the product to us. Upon recognition of revenue from product sales of Hylenex recombinant, the estimated amounts of credit for product returns, chargebacks, distribution fees, prompt payment discounts, and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. We monitor actual product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts differ from our estimates, we make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings in the period of adjustment. In connection with the orders placed by wholesalers, we incur costs such as commissions to our sales representatives. However, as revenue from product sales is recognized upon delivery to the wholesaler, which occurs shortly after we receive a purchase order, we do not capitalize these commissions and other costs, based on application of the practical expedient allowed within the applicable guidance. Bulk rHuPH20 We sell bulk rHuPH20 to collaboration partners for use in research and development; subsequent to receiving marketing approval, we sell it for use in collaboration commercial products. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of bulk rHuPH20 represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use contract manufacturers to produce bulk rHuPH20 and have concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of bulk rHuPH20 is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from the sale of bulk rHuPH20 as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. ENHANZE Drug Product We sell ENHANZE drug product to collaboration partners for use in research and development in early phase clinical studies. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of ENHANZE drug product represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use contract manufacturers to produce ENHANZE drug product and we concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of ENHANZE drug product is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from the sale of ENHANZE drug product as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. Revenue Presentation In our statements of operations, we report as revenues under collaborative agreements the upfront payments, event-based development and regulatory milestones and sales milestones. We also include in this category revenues from separate research and development contracts pursuant to project authorization forms. We report royalties received from collaboration partners as a separate line in our statements of operations. Revenues from sales of Hylenex recombinant, bulk rHuPH20 that has alternative future use and ENHANZE drug product are included in product sales, net. In the footnotes to our financial statements, we provide disaggregated revenue information by type of arrangement (product sales, net, collaborative agreements and research and development services), and additionally, by type of payment stream received under collaborative agreements (upfront license fees, event-based development and regulatory milestones and other fees, sales milestones and royalties). Cost of Product Sal |
Fair Value Measurement (Notes)
Fair Value Measurement (Notes) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | Fair Value Measurement Available-for-sale marketable securities consisted of the following (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Asset-backed securities $ 17,013 $ 49 $ — $ 17,062 Corporate debt securities 69,755 42 (8) 69,789 U.S. Treasury securities 45,110 7 — 45,117 Commercial paper 88,342 — — 88,342 $ 220,220 $ 98 $ (8) $ 220,310 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Asset-backed securities $ 30,484 $ 55 $ — $ 30,539 Corporate debt securities 161,308 178 (14) 161,472 U.S. Treasury securities 75,192 40 (5) 75,227 Commercial paper 33,845 — — 33,845 $ 300,829 $ 273 $ (19) $ 301,083 As of December 31, 2020, three available-for-sale marketable securities with a fair market value of $21.2 million were in a gross unrealized loss position of $8 thousand. Based on our review of these marketable securities, we believe none of the unrealized loss is as a result of a credit loss as of December 31, 2020, because we do not intend to sell these securities and it is not more-likely-than-not that we will be required to sell these securities before the recovery of their amortized cost basis. Contractual maturities of available-for-sale debt securities are as follows (in thousands): December 31, 2020 December 31, 2019 Estimated Fair Value Due within one year $ 220,310 $ 274,805 After one but within five years — 26,278 $ 220,310 $ 301,083 The following table summarizes, by major security type, our cash equivalents and available-for-sale marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): December 31, 2020 December 31, 2019 Level 1 Level 2 Total estimated fair value Level 1 Level 2 Total estimated fair value Cash equivalents: Money market funds $ 140,571 $ — $ 140,571 $ 119,949 $ — $ 119,949 Commercial paper — 7,000 7,000 — — — Available-for-sale marketable Asset-backed securities — 17,062 17,062 — 30,539 30,539 Corporate debt securities — 69,789 69,789 — 161,472 161,472 U.S. Treasury securities 45,117 — 45,117 75,227 — 75,227 Commercial paper — 88,342 88,342 — 33,845 33,845 $ 185,688 $ 182,193 $ 367,881 $ 195,176 $ 225,856 $ 421,032 We had no instruments that were classified within Level 3 as of December 31, 2020 and 2019. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue Our disaggregated revenues were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Royalties $ 88,596 $ 69,899 $ 78,981 Product sales, net Sales of bulk rHuPH20 $ 38,237 $ 48,285 $ 12,729 Sales of ENHANZE drug product 719 768 460 Sales of Hylenex 17,031 16,995 15,045 Total product sales, net 55,987 66,048 28,234 Revenues under collaborative agreements: Upfront license and target nomination fees 37,264 53,000 26,336 Event-based development milestones and regulatory milestone and other fees 69,500 5,500 16,000 Sales-based milestones 15,000 — — Research and development services 1,247 1,545 2,311 Total revenues under collaborative agreements 123,011 60,045 44,647 Total revenue $ 267,594 $ 195,992 $ 151,862 During the year ended December 31, 2020 we recognized revenue related to licenses granted to collaboration partners in prior periods in the amount of $173.1 million. This amount represents royalties and sales milestones earned in the current period, as well as $69.5 million of variable consideration in the contracts where uncertainties have been resolved and the development milestones are probable of being achieved or were achieved. We also recognized revenue of $4.1 million during the year ended December 31, 2020 that had been included in deferred revenues at December 31, 2019. We did not recognize any adjustments to reduce sales reserves and allowances liability related to Hylenex recombinant sales in prior periods. Upon the adoption of ASC 606, we recognized an adjustment to increase our accounts receivable by $19.4 million, decrease deferred revenues by $51.8 million, and decrease accumulated deficit by $71.2 million. The impact of applying the provisions of ASC 606 in the year ended December 31, 2018 was to decrease revenues by $4.7 million. Under the previously existing authoritative accounting literature, at December 31, 2018 our accounts receivable, net would have been $19.3 million lower, and our deferred revenue $47.4 million higher, than the amounts reported in our consolidated balance sheet. ASC 606 did not have an aggregate impact on our net cash used in operating activities, but resulted in offsetting changes in net loss and certain assets and liabilities within net cash used in operating activities in the consolidated statement of cash flows. Accounts receivable, net, other contract assets and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands): December 31, 2020 December 31, 2019 Accounts receivable, net $ 90,730 $ 59,442 Other contract assets 7,000 — Deferred revenues 5,772 5,259 As of December 31, 2020, the amounts included in the transaction price of our contracts with customers, including collaboration partners, and allocated to goods and services not yet provided were $55.3 million of which $49.5 million relates to unfulfilled product purchase orders and $5.8 million has been collected and reported as deferred revenues. The unfulfilled product purchase orders are estimated to be delivered in 2021. Of the total deferred revenues of $5.8 million, $1.7 million is expected to be used by our customers within the next 12 months. We recognized contract assets of $7.0 million at December 31, 2020, which relate to development milestones deemed probable of receipt for intellectual property licenses granted to collaboration partners in prior periods. The following table presents amounts under our collaborative agreements included in the transaction price (i.e. cumulative amounts triggered or probable) as of December 31, 2020 (in thousands): Upfront Development Sales Total Collaboration partner and agreement date: Roche (December 2006, September 2017 and October 2018) $ 105,000 $ 47,000 $ 22,000 $ 174,000 Baxalta (September 2007) 10,000 3,000 9,000 22,000 Pfizer (December 2012) 14,500 2,000 — 16,500 Janssen (December 2014) 18,250 42,000 15,000 75,250 AbbVie (June 2015) 23,000 6,000 — 29,000 Lilly (December 2015) 33,000 — — 33,000 BMS (September 2017) 110,000 10,000 — 120,000 Alexion (December 2017) 40,000 6,000 — 46,000 argenx (February 2019) 40,000 25,000 65,000 Horizon (November 2020) 30,000 — $ — 30,000 Royalties 411,881 Total amounts under our collaborative agreements included in the transaction price 1,022,631 (1) Upfront and additional target selection fees (2) Event-based development and regulatory milestone amounts and other fees (3) Sales-based milestone amounts Through December 31, 2020, our collaboration partners have completed development, obtained marketing authorization approvals for certain indications and commenced commercialization of the following products: • Janssen, for DARZALEX FASPRO in US in May 2020 and subsequently in other regions. • Roche, for Herceptin SC in the EU in August 2013 and subsequently in other regions; and MabThera SC in the EU in March 2014 and subsequently in other regions; and Phesgo in the US in June 2020 and subsequently in other regions. • Baxalta, for HYQVIA in the EU and in the US in May 2013. The remaining targets and products are currently in the process of development by the collaboration partners. |
Certain Balance Sheet Items
Certain Balance Sheet Items | 12 Months Ended |
Dec. 31, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Certain Balance Sheet Items | Certain Balance Sheet Items Accounts receivable, net consisted of the following (in thousands): December 31, December 31, Accounts receivable from product sales to collaborators $ 25,198 $ 35,649 Accounts receivable from revenues under collaborative agreements 30,404 3,850 Accounts receivable from royalty payments 32,098 17,149 Accounts receivable from other product sales 4,033 3,591 Other contract assets 7,000 — Subtotal 98,733 60,239 Allowance for distribution fees and discounts (1,003) (797) Total accounts receivable, net $ 97,730 $ 59,442 Inventories consisted of the following (in thousands): December 31, December 31, Raw materials $ 5,813 $ 2,769 Work-in-process 33,738 15,710 Finished goods 21,196 10,880 Total inventories $ 60,747 $ 29,359 Prepaid expenses and other assets consisted of the following (in thousands): December 31, December 31, Prepaid manufacturing expenses $ 35,048 $ 30,156 Prepaid research and development expenses 342 4,964 Other prepaid expenses 2,510 3,655 Other assets 4,441 5,681 Total prepaid expenses and other assets 42,341 44,456 Less long-term portion (14,067) (11,083) Total prepaid expenses and other assets, current $ 28,274 $ 33,373 Prepaid manufacturing expenses include raw materials, slot reservation fees and other amounts paid to contract manufacturing organizations. Such amounts are reclassified to work-in-process inventory as materials are used or the CMO services are complete. Property and equipment, net consisted of the following (in thousands): December 31, December 31, Research equipment $ 7,085 $ 7,403 Manufacturing equipment 5,336 3,858 Computer and office equipment 4,826 4,859 Leasehold improvements 1,628 1,628 Subtotal 18,875 17,748 Accumulated depreciation and amortization (11,582) (10,742) Subtotal $ 7,293 $ 7,006 Right of use of assets $ 3,300 $ 3,849 Property and equipment, net $ 10,593 $ 10,855 Depreciation and amortization expense was approximately $3.3 million, $4.1 million, and $2.4 million for the years ended December 31, 2020, 2019 and 2018, respectively. The depreciation and amortization expense is inclusive of $1.7 million, $1.8 million ROU asset amortization for the years ended December 31, 2020 and 2019, respectively. Accrued expenses consisted of the following (in thousands): December 31, December 31, Accrued outsourced research and development expenses $ 448 $ 8,423 Accrued compensation and payroll taxes 8,078 27,888 Accrued outsourced manufacturing expenses 4,535 9,173 Other accrued expenses 6,020 7,876 Lease liability 4,868 6,469 Total accrued expenses 23,949 59,829 Less long-term portion (3,466) (4,180) Total accrued expenses, current $ 20,483 $ 55,649 Expense associated with the accretion of the lease liabilities was approximately $0.5 million and $0.8 million for the twelve months ended December 31, 2020 and 2019, respectively. Total lease expense for the twelve months ended December 31, 2020 and 2019 $2.2 million and $2.6 million respectively. Cash paid for amounts related to leases for the twelve months ended December 31, 2020 and 2019 was $3.2 million and $3.1 million respectively. Deferred revenue consisted of the following (in thousands): December 31, December 31, Collaborative agreements License fees and event-based payments: — 2,764 Product sales 5,772 2,495 Total deferred revenue 5,772 5,259 Less current portion (1,746) (4,012) Deferred revenue, net of current portion $ 4,026 $ 1,247 |
Debt, Net
Debt, Net | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt, Net | Debt, Net Convertible Notes In November 2019, we completed the sale of $460.0 million in aggregate principal amount of 1.25% Convertible Senior Notes due 2024 (“Convertible Notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (“Securities Act”). The Convertible Notes were issued under an indenture, dated as of November 18, 2019, (“Indenture”) with The Bank of New York Mellon Trust Company, N.A., as trustee. The offer and sale of the Convertible Notes and the shares of common stock issuable upon conversion of the Convertible Notes have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and the Convertible Notes and such shares may not be offered or sold absent registration or an applicable exemption from registration requirements, or in a transaction not subject to, such registration requirements. We received net proceeds from the offering of approximately $447.4 million. We used $200.0 million of the net proceeds from the offering to repurchase shares of common stock, including approximately $143.1 million to repurchase approximately 8.1 million shares of common stock concurrently with the offering in privately negotiated transactions, $6.9 million in open market purchases and $50.0 million to repurchase a total of approximately 2.6 million shares of common stock through an accelerated share repurchase agreement. We used approximately $26.1 million of the net proceeds from the offering to repay all outstanding amounts under its loan agreement with Oxford Finance and Silicon Valley Bank and intend to use the remainder of the net proceeds for general corporate purposes, including additional share repurchases subsequent to the offering and working capital. The Convertible Notes will pay interest semi-annually in arrears on June 1st and December 1st of each year, beginning on June 1, 2020, at an annual rate of 1.25%. As of December 31, 2020, the Convertible Notes were convertible into cash, shares of common stock or a combination of cash and shares of common stock, at our election, based on the applicable conversion rate at such time. The Convertible Notes are general unsecured obligations and will rank senior in right of payment to all indebtedness that is expressly subordinated in right of payment to the Convertible Notes, will rank equally in right of payment with all existing and future liabilities that are not so subordinated, will be effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness and will be structurally subordinated to all indebtedness and other liabilities (including trade payables) of the our current or future subsidiaries. The Convertible Notes have a maturity date of December 1, 2024. Holders may convert their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2020, if the last reported sale price per share of common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period (such five consecutive trading day period, the “measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on Company’s common stock, as described in the offering memorandum; (4) if we call such notes for redemption; and (5) at any time from, and including, June 1, 2024 until the close of business on the scheduled trading day immediately before the maturity date. Upon the occurrence of certain circumstances, holders of the Convertible Notes may require us to purchase all or a portion of their notes for cash, which may require the use of a substantial amount of cash. As of December 31, 2020, the conditional conversion feature was triggered and our notes are classified as a current liability. We believe that it is remote that holders of the notes would choose to convert their notes early because the fair value of the security that a note holder can currently realize in an active market is greater than the conversion value the note holder would realize upon early conversion. For the year ended December 31, 2020, we have positive operating income and positive cash flow from operations and, accordingly, while there can be no assurance, we believe we have the ability to generate sufficient cash flows from operations or to raise additional capital through a variety of financing arrangements to satisfy early conversion of the Convertible Notes. As a result of our plans to early adopt ASU 2020-06, in January 2021 we notified the note holders that we will settle the principal of the Convertible Notes in cash. Therefore, upon conversion, the principal value of the Convertible Notes will be paid in cash and depending on our stock price, any additional amount over principal amount will be settled in shares of common stock. The initial conversion rate for the Convertible Notes will be 41.9208 shares of common stock per $1,000 in principal amount of Convertible Notes, equivalent to a conversion price of approximately $23.85 per share of our common stock. The conversion rate is subject to adjustment as described in the Indenture. In accordance with accounting guidance for debt with conversion and other options, we accounted for the debt and equity components of the Convertible Notes separately. The estimated fair value of the debt component at the date of issuance was $381.8 million, which was computed based on our non-convertible borrowing rate for similar debt of 5.19%, derived from independent valuation analysis. The equity component was allocated a value of $65.6 million and represents the difference between the $447.4 million of net proceeds from the issuance of the Convertible Notes and the $381.8 million estimated fair value of the debt component at the date of issuance. In connection with the Convertible Notes, we paid the initial purchasers of the Convertible Notes a fee of $12.7 million and incurred additional debt issuance costs totaling $0.3 million, which includes expenses that we paid on behalf of the initial purchasers and expenses incurred directly by us. Debt issuance costs, the initial purchasers’ fee and the equity component is presented as a debt discount as of December 31, 2020 in the amount of $62.8 million, and will be amortized over the remaining estimated term of 3.9 using the effective interest method, utilizing an effective interest rate of 5.10%. The net carrying amount of the debt as of December 31, 2020 is $397.2 million. The fair value of the Convertible Notes, which was estimated using trading levels obtained from third-party service provider (Level 2), was $861.7 million at December 31, 2020 and $461.1 million at December 31, 2019. For the year ended December 31, 2020 and 2019, we recognized interest expense of $19.9 million and $2.3 million including contractual coupon interest of $5.8 million and $0.7 million and amortization of the debt discount of $14.1 million and $1.6 million, respectively. As of December 31, 2020, we were in compliance with all covenants under the Indenture and there was no material adverse change in our business, operations or financial condition. Royalty-backed Loan In January 2016, through our wholly-owned subsidiary Halozyme Royalty LLC (“Halozyme Royalty”), we received a $150 million loan (the “Royalty-backed Loan”) pursuant to a credit agreement (the “Credit Agreement”) with BioPharma Credit Investments IV Sub, LP and Athyrium Opportunities II Acquisition LP (the “Royalty-backed Lenders”). Under the terms of the Credit Agreement, Halozyme Therapeutics, Inc. transferred to Halozyme Royalty the right to receive royalty payments from the commercial sales of ENHANZE products owed under the Roche Collaboration and Baxalta Collaboration (“Collaboration Agreements”). The royalty payments from the Collaboration Agreements were used to repay the principal and interest on the loan (the “Royalty Payments”). The Royalty-backed Loan bore interest at a per annum rate of 8.75% plus the three-month LIBOR rate. The three-month LIBOR rate was subject to a floor of 0.7% and a cap of 1.5%. In June 2020, we paid the full remaining balance and final payment of $2.93 million thereby satisfying and discharging all obligations under, and terminating, the Royalty-backed Loan. Oxford and SVB Loan and Security Agreement In June 2016, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”) (collectively, the “Lenders”), providing a senior secured loan facility of up to an aggregate principal amount of $70.0 million, comprising a $55.0 million draw in June 2016 and an additional $15.0 million tranche, which we had the option to draw during the second quarter of 2017 and did not exercise. The initial proceeds were partially used to pay the outstanding principal and final payment of $4.25 million owed on a previous loan agreement with the Lenders. The remaining proceeds were used for working capital and general business requirements. The senior secured loan facility carried a fixed interest rate of 8.25%. The repayment schedule provided for interest only payments for the first 18 months, followed by consecutive equal monthly payments of principal and interest in arrears through the maturity date of January 1, 2021. The Loan Agreement provided for a final payment equal to 5.50% of the initial $55.0 million principal amount, which was due when the Loan Agreement becomes due or upon the prepayment of the facility. We had the option to prepay the outstanding balance of the Loan Agreement in full and exercised this option in November 2019, at which point we paid the full remaining balance and final payment of $26.1 million, thereby satisfying and discharging all obligations under, and terminating, the Loan Agreement. Future maturities and interest payments of long-term debt as of December 31, 2020, are as follows (in thousands): 2021 $ 465,750 2022 — 2023 — 2024 — 2025 — Total minimum payments 465,750 Less amount representing interest (5,750) Gross balance of long-term debt 460,000 Less unamortized debt discount (62,772) Present value of long-term debt 397,228 Less current portion of long-term debt (397,228) Long-term debt, less current portion and unamortized debt discount $ — |
Share-based Compensation (Notes
Share-based Compensation (Notes) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-based Compensation | Share-based Compensation We currently grant stock options, restricted stock awards, performance stock units and restricted stock units under the Amended and Restated 2011 Stock Plan (“2011 Stock Plan”), which was approved by the stockholders on May 6, 2016 an d provides for the grant of up to 44.2 million shares of common stock to selected employees, consultants and non-employee members of our Board of Directors as stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance awards. Awards are subject to terms and conditions established by the Compensation Committee of our Board of Directors. During the year ended December 31, 2020, we granted share-based awards under the 2011 Stock Plan. At December 31, 2020, 6,704,330 shares were subject to outstanding awards and 10,806,631 shares were available for future grants of share-based awards. Total share-based compensation expense related to share-based awards was comprised of the following (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 5,484 $ 15,107 $ 17,220 Selling, general and administrative 11,720 19,669 18,476 Share-based compensation expense $ 17,204 $ 34,776 $ 35,696 Share-based compensation expense by type of share-based award (in thousands): Year Ended December 31, 2020 2019 2018 Stock options $ 8,955 $ 17,624 $ 18,742 RSAs, RSUs and PSUs 8,249 17,152 16,954 $ 17,204 $ 34,776 $ 35,696 Total unrecognized estimated compensation cost by type of award and the weighted-average remaining requisite service period over which such expense is expected to be recognized (in thousands, unless otherwise noted): December 31, 2020 Unrecognized Remaining Stock options $ 18,853 2.60 RSAs $ 460 0.33 RSUs $ 13,241 2.32 PSUs $ 297 1.75 Stock Options. Options granted under the Plans must have an exercise price equal to at least 100% of the fair market value of our common stock on the date of grant. The options generally have a maximum contractual term of ten years and vest at the rate of one-fourth of the shares on the first anniversary of the date of grant and 1/48 of the shares monthly thereafter. Certain option awards provide for accelerated vesting if there is a change in control (as defined in the Plans). A summary of our stock option award activity as of and for the year ended December 31, 2020 is as follows: Shares Weighted Weighted Aggregate Outstanding at December 31, 2019 11,548,229 $14.72 Granted 1,602,087 $20.74 Exercised (4,705,843) $14.08 Canceled/forfeited (2,810,851) $17.02 Outstanding at December 31, 2020 5,633,622 $15.83 6.58 $151.4 million Vested and expected to vest at December 31, 2020 5,633,622 $15.83 6.58 $151.4 million Exercisable at December 31, 2020 3,297,904 $13.36 5.08 $96.8 million The weighted average grant date fair values of options granted during the years ended December 31, 2020, 2019 and 2018 were $20.74 per share, $16.46 per share and $10.33 per share, respectively. The total intrinsic value of options exercised during the years ended December 31, 2020, 2019 and 2018 was approximately $49.7 million, $10.6 million and $11.5 million, respectively. Cash received from stock option exercises for the years ended December 31, 2020, 2019 and 2018 was approximately $66.2 million, $16.5 million and $16.3 million, respectively. The exercise price of stock options granted is equal to the closing price of the common stock on the date of grant. The fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model (“Black-Scholes model”). Expected volatility is based on historical volatility of our common stock. The expected term of options granted is based on analyses of historical employee termination rates and option exercises. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The dividend yield assumption is based on the expectation of no future dividend payments. The assumptions used in the Black-Scholes model were as follows: Year Ended December 31, 2020 2019 2018 Expected volatility 47.57-51.82% 51.56-56.94% 57.18-70.06% Average expected term (in years) 5.1 5.5 5.5 Risk-free interest rate 0.22-1.67% 1.35-2.56% 2.25-2.96% Expected dividend yield — — — Restricted Stock Awards . RSAs are grants that entitle the holder to acquire shares of our common stock at zero cost. The shares covered by a RSA cannot be sold, pledged, or otherwise disposed of until the award vests and any unvested shares may be reacquired by us for the original purchase price following the awardee’s termination of service. The RSAs will generally vest at the rate of one-fourth of the shares on each anniversary of the date of grant. Annual grants of RSAs to the Board of Directors typically vest in approximately one year. The following table summarizes our RSA activity during the year ended December 31, 2020: Number of Weighted Unvested at December 31, 2019 211,123 $11.47 Granted 61,803 $22.66 Vested (210,676) $11.48 Forfeited (447) $8.11 Unvested at December 31, 2020 61,803 $22.66 The estimated fair value of the RSAs was based on the closing market value of our common stock on the date of grant. The total grant date fair value of RSAs vested during the years ended December 31, 2020, 2019 and 2018 was approximately $2.4 million, $3.3 million and $4.5 million, respectively. The fair value of RSAs vested during the years ended December 31, 2020, 2019 and 2018, was approximately $4.3 million, $4.2 million and $7.2 million, respectively. Restricted Stock Units . A RSU is a promise by us to issue a share of our common stock upon vesting of the unit. The RSUs will generally vest at the rate of one-fourth of the shares on each anniversary of the date of grant. The following table summarizes our RSU activity during the year ended December 31, 2020: Number of Weighted Weighted Aggregate Outstanding at December 31, 2019 2,092,439 $15.60 Granted 574,279 $20.25 Vested (714,868) $14.12 Forfeited (921,938) $16.62 Outstanding at December 31, 2020 1,029,912 $18.31 1.23 $44.0 million The estimated fair value of the RSUs was based on the closing market value of our common stock on the date of grant. The total grant date fair value of RSUs vested during the years ended December 31, 2020, 2019 and 2018 was approximately $10.1 million, $19.1 million and $6.7 million, respectively. The fair value of RSUs vested during the years ended December 31, 2020, 2019 and 2018 was approximately $14.0 million, $18.5 million and $11.0 million, respectively. Performance Stock Units . A PSU is a promise by us to issue a share of our common stock upon achievement of a specific performance condition. The following table summarizes our PSU activity during the year ended December 31, 2020: Number of Weighted Outstanding at December 31, 2019 — $0.00 Granted 40,796 $16.32 Vested — $0.00 Forfeited — $0.00 Outstanding at December 31, 2020 40,796 $16.32 The estimated fair value of the PSUs was based on the closing market value of our common stock on the date of grant. The fair value of PSUs vested during the years ended December 31, 2020, 2019 and 2018 was zero. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity During the years ended December 31, 2020, 2019 and 2018, we issued an aggregate of 4,705,843, 1,540,690 and 1,489,138 shares of common stock, respectively, in connection with the exercises of stock options, for net proceeds of approximately $66.2 million, $16.5 million and $16.3 million, respectively. For the years ended December 31, 2020, 2019 and 2018, we issued 571,963, 952,182 and 442,599 shares of common stock, respectively, upon vesting of certain RSUs for which the RSU holders surrendered 142,905, 140,466 and 139,850 RSUs, respectively, to pay for minimum withholding taxes totaling approximately $5.5 million, $7.0 million and $4.2 million, respectively. Stock options and unvested restricted units totaling approximately 6.7 million, 13.6 million and 13.4 million shares of our common stock were outstanding as of December 31, 2020, 2019 and 2018, respectively. Share Repurchases In November 2019, the Board of Directors authorized a capital return program to repurchase up to $550.0 million of outstanding common stock over a three During 2020, we repurchased 6.5 million shares of common stock for $150.0 million at an average price of $23.05. The shares were purchased through open market transactions and through an ASR agreement with Bank of America in December 2020, for which we repurchased $21.7 million of common stock and received 0.5 million shares. We retired the repurchased shares and they resumed the status of authorized and unissued shares. We had the following activity under the approved share repurchase programs (dollars in thousands, except share and per share data) 2020 Total Number of Shares Purchased Weighted Average Price paid Per Share Total Cost (2) First quarter (1) 3,188,795 $16.15 $51,574 Second quarter 88,307 $22.58 $1,996 Third quarter 2,134,716 $27.57 $58,902 Fourth quarter (3) 1,095,366 $34.36 $37,645 6,507,184 $23.05 $150,117 (1) This is in addition to 0.5 million shares delivered in February upon completion of the ASR. (2) Included in the total cost of shares purchased is a commission fee of $0.02 per share. (3) This includes the December 2020 ASR. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases Our administrative offices and research facilities are located in San Diego, California. We lease an aggregate of approximately 50,000 square feet of office and research space in two buildings. The leases commenced in June 2011, November 2013 and June 2018 and continue through January 2023. The leases are subject to approximately 3.0% annual increases throughout the terms of the leases. We also pay a pro rata share of operating costs, insurance costs, utilities and real property taxes. Additionally, we lease certain office equipment under operating leases. Total rent expense was approximately $2.3 million, $2.7 million and $2.5 million for the years ended December 31, 2020, 2019 and 2018, respectively. Approximate annual future minimum operating lease payments as of December 31, 2020 are as follows (in thousands): Year: Operating 2021 $ 2,563 2022 2,564 2023 150 2024 — 2025 — Total minimum lease payments $ 5,277 Less imputed interest (409) Total $ 4,868 The weighted-average remaining lease term of our operating leases is approximately 2.06 years. Other Commitments We have existing supply agreements with contract manufacturing organizations Avid Bioservices, Inc. (“Avid”) and Catalent Indiana LLC (formerly Cook Pharmica LLC) (“Catalent”) to produce supplies of bulk rHuPH20. Under the terms of the agreements, we are committed to certain minimum annual purchases of bulk rHuPH20. At December 31, 2020, we had a $75.9 million minimum purchase obligation in connection with these agreements. In June 2011, we entered into a services agreement with Patheon for the technology transfer and manufacture of Hylenex recombinant. At December 31, 2020, we had a $1.4 million minimum purchase obligation in connection with this agreement. Legal Contingencies From time to time, we may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of our business. Any of these claims could subject us to costly legal expenses and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated results of operations or financial position. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Total income (loss) before income taxes summarized by region were as follows (in thousands): Year Ended December 31, 2020 2019 2018 United States $ 130,427 $ (70,737) $ (45,819) Foreign (1,125) (1,514) (33,974) Net income (loss) before income taxes $ 129,302 $ (72,251) $ (79,793) Significant components of our net deferred tax assets/(liabilities) were as follows (in thousands). December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 84,278 $ 39,401 Deferred revenue 253 1,069 Research and development and orphan drug credits 114,357 114,357 Share-based compensation 4,637 9,972 Alternative minimum tax credit — 1,683 ASC 842 lease liability 1,081 1,454 Interest expense limitation 5,536 2,163 Other, net 3,478 3,037 213,620 173,136 Valuation allowance for deferred tax assets (199,827) (155,100) Deferred tax assets, net of valuation 13,793 18,036 Deferred tax liabilities: Depreciation (1,002) (865) Convertible note (11,776) (14,450) ASC 842 right of use asset (733) (865) Other, net (282) (173) Total deferred tax liabilities (13,793) (16,353) Net deferred tax asset $ — $ 1,683 A valuation allowance of $199.8 million and $155.1 million has been established to offset the net deferred tax assets as of December 31, 2020 and 2019, respectively, as realization of such assets is uncertain. We intend to continue maintaining a full valuation allowance on our DTAs until there is sufficient evidence to support the reversal of all or some portion of these allowances. However, given our current earnings and anticipated future earnings, we believe that there is a reasonable possibility that within the next 12 months, sufficient positive evidence may become available to reach a conclusion that a significant portion of the valuation allowance will no longer be needed. Release of the valuation allowance would result in the recognition of certain DTAs and a decrease to income tax expense for the period the release is recorded. However, the exact timing and amount of the valuation allowance release are subject to change on the basis of the level of profitability that we are able to actually achieve. Income tax expense was comprised of the following components (in thousands): Year Ended December 31, 2020 2019 2018 Current - federal $ (11) $ 114 $ 82 Current - state 228 (40) 519 Deferred - federal — (85) (64) Deferred - state — — — $ 217 $ (11) $ 537 The provision for income taxes on earnings subject to income taxes differs from the statutory federal income tax rate due to the following (in thousands): Year Ended December 31, 2020 2019 2018 Federal income tax expense (benefit) at 21% $ 27,153 $ (15,173) $ (16,754) State income tax benefit, net of federal income tax impact (1,942) (1,509) (4,297) (Decrease) increase in valuation allowance 44,727 8,147 35,731 Worthless stock deduction of international subsidiary (67,322) — — Foreign income subject to tax at other than federal statutory rate 237 318 7,106 Share-based compensation (4,117) 315 (441) Executive compensation limitation 1,434 858 866 Non-deductible expenses and other 47 66 1,599 Research and development credits, net — (1,091) (5,210) Orphan drug credits, net of federal add back — (5,718) (18,063) Convertible note discount in APIC $ — $ 13,776 $ — $ 217 $ (11) $ 537 At December 31, 2020, our unrecognized tax benefit and uncertain tax positions were $19.2 million. Of this, $0.3 million of this amount would affect the effective tax rate and $18.9 million would affect the effective tax rate only in the event the valuation allowance was removed. Of the unrecognized tax benefits, we do not expect any significant changes to occur in the next 12 months. Interest and/or penalties related to uncertain income tax positions are recognized by us as a component of income tax expense. For the years ended December 31, 2020, 2019 and 2018, we recognized an immaterial amount of interest and penalties. The following table summarizes the activity related to our unrecognized tax benefits (in thousands): Year Ended December 31, 2020 2019 2018 Gross unrecognized tax benefits at beginning of period $ 21,483 $ 20,028 $ 14,428 Increases in tax positions for prior years 41 69 3,083 Decreases in tax positions for prior years (2,357) (23) — Increases in tax positions for current year — 1,409 2,517 Gross unrecognized tax benefits at end of period $ 19,167 $ 21,483 $ 20,028 At December 31, 2020, we had federal, California and other state tax net operating loss carryforwards of approximately $310.8 million, $259.8 million and $45.3 million, respectively. The following table shows key expiration dates of the federal and California net operating loss carryforwards (in thousands): Expires in: Net Operating Loss 2020 2021 and beyond 2028 and beyond Federal $ 310,756 $ — $ 310,756 — California $ 259,840 $ — — $ 259,840 At December 31, 2020, we had federal and California research and development tax credit carryforwards of approximately $27.9 million and $19.1 million, respectively. The federal research and development tax credits will begin to expire in 2024 unless previously utilized. The California research and development tax credits will carryforward indefinitely until utilized. Additionally, we had Orphan Drug Credit carryforwards of $88.0 million which will begin to expire in 2034. Pursuant to Internal Revenue Code Section 382, the annual use of the net operating loss carryforwards and research and development tax credits could be limited by any greater than 50% ownership change during any three year testing period. As a result of any such ownership change, portions of our net operating loss carryforwards and research and development tax credits are subject to annual limitations. We completed an updated Section 382 analysis regarding the limitation of the net operating losses and research and development credits as of December 31, 2019. Based upon the analysis, we determined that ownership changes occurred in prior years; however, the annual limitations on net operating loss and research and development tax credit carryforwards will not have a material impact on the future utilization of such carryforwards. We do not provide for U.S. income taxes on the undistributed earnings of our foreign subsidiary as it is our intention to utilize those earnings in the foreign operations for an indefinite period of time. At December 31, 2020 and 2019, there were no undistributed earnings in foreign subsidiaries. We are subject to taxation in the U.S. and in various state and foreign jurisdictions. Our tax years for 2004 and forward are subject to examination by the U.S. and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits. |
Employee Savings Plan (Notes)
Employee Savings Plan (Notes) | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |
Compensation and Employee Benefit Plans [Text Block] | Employee Savings PlanWe have an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code. All employees are eligible to participate, provided they meet the requirements of the plan. We are not required to make matching contributions under the plan. However, we voluntarily contributed to the plan approximately $1.1 million, $2.2 million and $1.3 million for the years ended December 31, 2020, 2019 and 2018, respectively. |
Summary of Unaudited Quarterly
Summary of Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Unaudited Quarterly Financial Information | Summary of Unaudited Quarterly Financial Information The following is a summary of our unaudited quarterly results for the years ended December 31, 2020 and 2019 (in thousands): Quarter Ended 2020 (Unaudited): March 31, June 30, September 30, December 31, Total revenues (1)(2)(3) $ 25,354 $ 55,221 $ 65,316 $ 121,703 Gross profit on product sales $ 2,360 $ 597 $ 3,480 $ 6,183 Total operating expenses $ 28,577 $ 25,666 $ 25,017 $ 44,079 Net (loss) Income $ (6,103) $ 25,817 $ 36,207 $ 73,164 Net (loss) Income per share: Basic $ (0.04) $ 0.19 $ 0.27 $ 0.54 Diluted $ (0.04) $ 0.19 $ 0.25 $ 0.50 Shares used in computing net (loss) income per share: Basic 137,186 135,935 136,578 135,107 Diluted 137,186 138,084 142,081 145,122 Quarter Ended 2019 (Unaudited): March 31, June 30, September 30, December 31, Total revenues (4) $ 56,949 $ 39,148 $ 46,230 $ 53,665 Gross profit on product sales $ 3,741 $ 3,883 $ 6,872 $ 6,006 Total operating expenses (5) $ 53,983 $ 53,125 $ 70,767 $ 85,727 Net Income (loss) $ 1,796 $ (14,624) $ (25,015) $ (34,397) Net Income (loss) per share: Basic $ 0.01 $ (0.10) $ (0.17) $ (0.24) Diluted $ 0.01 $ (0.10) $ (0.17) $ (0.24) Shares used in computing net Income (loss) per share: Basic 144,743 145,411 146,136 141,046 Diluted 147,474 145,411 146,136 141,046 _______________ (1) Revenue for the quarter ended December 31, 2020 included $57.0 million in revenue under a collaborative agreement from Janssen, argenx, Horizon and BMS. (2) Revenue for the quarter ended September 30, 2020 included $32.0 million in revenue under a collaborative arrangement from Roche and argenx. (3) Revenue for the quarter ended June 30, 2020 included $32.3 million in revenue under a collaborative arrangement from Janssen and BMS. (4) Revenue for the quarter ended March 31, 2019 included $30.0 million in revenue under a collaborative arrangement from argenx. (5) Total operating expenses for the quarter ended December 31, 2019 included $28.4 million restructuring charges. |
Schedule II Valuation and Quali
Schedule II Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2020 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II Valuation and Qualifying Accounts | Valuation and Qualifying Accounts (in thousands) Balance at Beginning of Period Additions Deductions Balance at End of Period For the year ended December 31, 2020 Accounts receivable allowances (1) $ 797 $ 13,276 $ (13,070) $ 1,003 For the year ended December 31, 2019 Accounts receivable allowances (1) $ 592 $ 7,327 $ (7,122) $ 797 For the year ended December 31, 2018 Accounts receivable allowances (1) $ 559 $ 5,988 $ (5,955) $ 592 _______________ |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates. |
Cash Equivalents | Cash Equivalents and Marketable Securities Cash equivalents consist of highly liquid investments, readily convertible to cash, that mature within ninety days or less from the date of purchase. As of December 31, 2020, our cash equivalents consisted of money market funds. |
Marketable Securities | Marketable securities are investments with original maturities of more than ninety days from the date of purchase that are specifically identified to fund current operations. Marketable securities are considered available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from the sale of these investments to fund our operations, as necessary. Such available-for-sale investments are carried at fair value with unrealized gains and losses recorded in other comprehensive income (loss) and included as a separate component of stockholders’ equity. The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in investment and other income, net in the consolidated statements of operations. We use the specific identification method for calculating realized gains and losses on marketable securities sold. None of the realized gains and losses and declines in value judged to be as a result of credit loss on marketable securities, if any, are included in investment and other income, net in the consolidated statements of operations. |
Restricted Cash | Restricted Cash Under the terms of the leases of our facilities, we are required to maintain letters of credit as security deposits during the terms of such leases. At December 31, 2020 and 2019, restricted cash of $0.5 million was pledged as collateral for the letters of credit. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The authoritative guidance for fair value measurements establishes a three tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Our financial instruments include cash equivalents, available-for-sale marketable securities, accounts receivable, prepaid expenses and other assets, accounts payable, accrued expenses and short-term debt. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment and therefore cannot be determined with precision. The carrying amount of cash equivalents, accounts receivable, prepaid expenses and other assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. Available-for-sale marketable securities consist of asset-backed securities, corporate debt securities, U.S. Treasury securities and commercial paper, and are measured at fair value using Level 1 and Level 2 inputs. Level 2 financial instruments |
Concentration of Credit Risk, Sources of Supply and Significant Customers | Concentrations of Credit Risk, Sources of Supply and Significant Customers We are subject to credit risk from our portfolio of cash equivalents and marketable securities. These investments were made in accordance with our investment policy which specifies the categories, allocations, and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. We maintain our cash and cash equivalent balances with one major commercial bank and marketable securities with another financial institution. Deposits held with the financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash, cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets. We are also subject to credit risk from our accounts receivable related to our product sales and revenues under our license and collaborative agreements. We have license and collaborative agreements with pharmaceutical companies under which we receive payments for royalties, license fees, milestone payments for specific achievements designated in the collaborative agreements, reimbursements of research and development services and supply of bulk formulation of rHuPH20. In addition, we sell Hylenex ® recombinant in the United States to a limited number of established wholesale distributors in the pharmaceutical industry. Credit is extended based on an evaluation of the customer’s financial condition, and collateral is not required. Management monitors our exposure to accounts receivable by periodically evaluating the collectability of the accounts receivable based on a variety of factors including the length of time the receivables are past due, the financial health of the customer and historical experience. Based upon the review of these factors, we recorded no allowance for doubtful accounts at December 31, 2020 and 2019. Approximately 74% of the accounts receivable balance at December 31, 2020 represents amounts due from Janssen, Roche and Baxalta. Approximately 93% of the accounts receivable balance at December 31, 2019 represents amounts due from Janssen, Roche and Baxalta. The following table indicates the percentage of total revenues in excess of 10% with any single customer: Year Ended December 31, 2020 2019 2018 Partner A 35% 40% 72% Partner B 26% 18% 2% Partner C 11% —% —% Partner D 8% 23% —% We attribute revenues under collaborative agreements, including royalties, to the individual countries where the customer is headquartered. We attribute revenues from product sales to the individual countries to which the product is shipped. Worldwide revenues from external customers are summarized by geographic location in the following table (in thousands): Year Ended December 31, 2020 2019 2018 United States $ 106,918 $ 28,178 $ 26,527 Switzerland 95,949 109,754 109,890 Ireland 30,552 589 5,075 Belgium 20,086 45,060 — Japan 10,644 9,905 8,873 All other foreign 3,445 2,506 1,497 Total revenues $ 267,594 $ 195,992 $ 151,862 We rely on two third-party manufacturers for the supply of bulk rHuPH20 for use in the manufacture of Hylenex recombinant and our other collaboration products and product candidates. Payments due to these suppliers represented 75% and 47% of the accounts payable balance at December 31, 2020 and 2019, respectively. We also rely on a third-party manufacturer for the fill and finish of Hylenex recombinant product under a contract. Payments due to this supplier represented zero and 8% of the accounts payable balance at December 31, 2020 and 2019, respectively. |
Accounts Receivable, Net | Accounts Receivable, Net Accounts receivable is recorded at the invoiced amount and is non-interest bearing. Accounts receivable is recorded net of allowances for doubtful accounts, cash discounts for prompt payment, distribution fees and chargebacks. We recorded no allowance for doubtful accounts at December 31, 2020 and 2019 as the collectability of accounts receivable was reasonably assured. |
Inventories | Inventories Inventories are stated at lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Inventories are reviewed periodically for potential excess, dated or obsolete status. We evaluate the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand. As of December 31, 2020 and 2019, inventories consisted of $1.3 million and $1.4 million, respectively, of Hylenex inventory, net and $59.4 million and $28.0 million, respectively, of bulk rHuPH20, consistent with our plan to build inventory to meet future customer demand. |
Leases | Leases The Company has entered into operating leases primarily for real estate and automobiles. These leases have terms which range from 3 years to 6 years. We determine if an arrangement contains a lease at inception. Right of use (“ROU”) assets and liabilities resulting from operating leases are included in property and equipment, accrued expenses and other long-term liabilities on our consolidated balance sheets. Operating lease ROU assets and liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in determining the discount rate to calculate the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Our leases often include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that we will exercise |
Property and Equipment, Net | Property and Equipment, NetProperty and equipment, including ROU assets are recorded at cost, less accumulated depreciation and amortization. Equipment is depreciated using the straight-line method over its estimated useful life ranging from three years to ten years and leasehold improvements are amortized using the straight-line method over the estimated useful life of the asset or the lease term, whichever is shorter. |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsWe account for long-lived assets in accordance with authoritative guidance for impairment or disposal of long-lived assets. Long-lived assets are reviewed for events or changes in circumstances, which indicate that their carrying value may not be recoverable. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during the period from transactions and other events and circumstances from non-owner sources. |
Revenue Recognition | Revenue Recognition We generate revenues from payments received under collaborative agreements and product sales. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations. Revenues under Collaborative Agreements Under these agreements, we grant the collaboration partner a worldwide license to develop and commercialize products using our ENHANZE technology to combine our patented rHuPH20 enzyme with their proprietary biologics directed at up to a specified number of targets. Targets are usually licensed on an exclusive, global basis. Targets selected subsequent to inception of the arrangement require payment of an additional license fee. The collaboration partner is responsible for all development, manufacturing, clinical, regulatory, sales and marketing costs for any products developed under the agreement. We are responsible for supply of bulk rHuPH20 based on the collaboration partner’s purchase orders, and may also be separately engaged to perform research and development services. While these collaboration agreements are similar in that they originate from the same framework, each one is the result of an arms-length negotiation and thus may vary from one to the other. We collect an upfront license payment from collaboration partners, and are also entitled to receive event-based payments subject to collaboration partners’ achievement of specified development, regulatory and sales-based milestones. In several agreements, collaboration partners pay us annual fees to maintain their exclusive license rights if they are unable to advance product development to specified stages. We earn separate fees for bulk rHuPH20 supplies and research and development services. In addition, collaboration partners will pay us royalties at an on average mid-single digit percent rate of their sales if products under the collaboration are commercialized. All amounts owed to us are noncancelable after the underlying triggering event occurs, and nonrefundable once paid. Unless terminated earlier in accordance with its terms, collaborations generally continue in effect until the last to expire royalty payment term, as determined on a product by product and on a country by country basis, with each royalty term starting on the first commercial sale of that product and ending the later of: (i) a specified period or term set forth in the agreement or (ii) expiration of the last to expire of the valid claims of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers a product developed under the collaboration. When there are no valid claims during the applicable royalty term in a given country, the royalty rate is reduced for those sales. Collaboration partners may terminate the agreement prior to expiration for any reason in its entirety or on a target-by-target basis generally upon 90 days prior written notice to us. Upon any such termination, the license granted to collaboration partners (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement (as opposed to a termination), the on-going licenses granted will become perpetual, non-exclusive and fully paid. Although these agreements are in form identified as collaborative agreements, we concluded for accounting purposes they represent contracts with customers, and are not subject to accounting literature on collaborative arrangements. This is because we grant to collaboration partners licenses to our intellectual property, and provide supply of bulk rHuPH20 and research and development services which are all outputs of our ongoing activities, in exchange for consideration. Under these collaborative agreements, we do not develop assets jointly with collaboration partners, and do not share in significant risks of their development or commercialization activities. Accordingly, we concluded our collaborative agreements are appropriately accounted for pursuant to ASC Topic 606, Revenue from Contracts with Customers. Under all of our collaborative agreements, we have identified licenses to use functional intellectual property as the only performance obligation. The intellectual property underlying the license is our proprietary ENHANZE ® technology which represents application of rHuPH20 to facilitate delivery of drugs or fluids. Each of the licenses grants the collaboration partners rights to use our intellectual property as it exists and is identified on the effective date of the license, because there is no ongoing development of the ENHANZE technology required. Therefore, we recognize revenue from licenses at the point when the license becomes effective and the collaboration partner has received access to our intellectual property, usually at the inception of the agreement. When collaboration partners can select additional targets to add to the licenses granted, we consider these rights to be options. We evaluate whether such options contain material rights, i.e. have exercise prices that are discounted compared to what we would charge for a similar license to a new collaboration partner. The exercise price of these options includes a combination of the target selection fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, we conclude the option does not contain a material right, and we consider grants of additional licensing rights upon option exercises to be separate contracts (target selection contracts). We provide customary indemnification and protection of licensed intellectual property for our customers. These provisions are part of assurance that the licenses meet the agreements’ representations and are not obligations to provide goods or services. We also fulfill purchase orders for supply of bulk rHuPH20 and perform research and development services pursuant to projects authorization forms for our collaboration partners, which represent separate contracts. Additionally, we price our supply of bulk rHuPH20 and research and development services at our regular selling prices, called standalone selling price or SSP. Therefore, our collaboration partners do not have material rights to order these items at prices not reflective of SSP. Refer to the discussion below regarding recognition of revenue for these separate contracts. Transaction price for a contract represents the amount to which we are entitled in exchange for providing goods and services to the customer. Transaction price does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of revenue when the uncertainty is resolved. Apart from the upfront license payment (or target selection fees in the target selection contracts), all other fees we may earn under our collaborative agreements are subject to significant uncertainties of product development. Achievement of many of the event-based development and regulatory milestones may not be probable until such milestones are actually achieved. This generally relates to milestones such as obtaining marketing authorization approvals. With respect to other development milestones, e.g. dosing of a first patient in a clinical trial, achievement could be considered probable prior to its actual occurrence, based on the progress towards commencement of the trial. In order to evaluate progress towards commencement of a trial, we assess the status of activities leading up to our collaboration partner’s initiation of a trial such as feedback received from the FDA (if applicable), completion of IND filings, readiness and availability of drug, readiness of study sites and our collaboration partner’s commitment of resources to the program. We do not include any amounts subject to uncertainties into the transaction price until it is probable that the amount will not result in a significant reversal of revenue in the future. At the end of each reporting period, we re- evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. When target exchange rights are held by collaboration partners, and the amounts attributed to these rights are not refundable, they are included in the transaction price. However, they are recorded as deferred revenues because we have a potential performance obligation to provide a new target upon an exchange right being exercised. These amounts are recognized in revenue when the right of exchange expires or is exercised. Because our agreements have one type of performance obligation (licenses) which are typically all transferred at the same time at agreement inception, allocation of transaction price often is not required. However, allocation is required when licenses for some of the individual targets are subject to rights of exchange, because revenue associated with these targets cannot be recognized. We perform an allocation of the upfront amount based on relative SSP of licenses for individual targets. We determine license SSP using income-based valuation approach utilizing risk-adjusted discounted cash flow projections of the estimated return a licensor would receive. When amounts subject to uncertainties, such as milestones and royalties, are included in the transaction price, we attribute them to the specific individual target licenses which generate such milestone or royalty amounts. We also estimate SSP of bulk rHuPH20 and research and development services, to determine that our collaboration partners do not have material rights to order them at discounted prices. For supplies of bulk rHuPH20, because we effectively act as a contract manufacturer to our collaboration partners, we estimate and charge SSP based on the typical contract manufacturer margins consistently with all of our collaborative partners. We determine SSP of research and development services based on a fully-burdened labor rate. Our rates are comparable to those we observe in other collaborative agreements. We also have a history of charging similar rates to all of our collaboration partners. Upfront amounts allocated to licenses to individual targets are recognized as revenue when the license is transferred to the collaboration partner, as discussed above, if the license is not subject to exchange rights, or when the exchange right expires or is exercised. Development milestones and other fees are recognized in revenue when they are included in the transaction price, because by that time we have already transferred the related license to the collaboration partner. Sales-based milestones and royalties cannot be recognized until the underlying sales occur. We do not receive final royalty reports from our collaboration partners until after we complete our financial statements for a prior quarter. Therefore, we recognize revenue based on estimates of the royalty earned, which are based on internal estimates and available preliminary reports provided by our collaboration partners. We will record a true-up in the following quarter if necessary, when final royalty reports are received. To date, we have not recorded any material true-ups. In contracts to provide research and development services, such services represent the only performance obligation. The fees are charged based on hours worked by our employees and the fixed contractual rate per hour, plus third-party pass-through costs, on a monthly basis. We recognize revenues as the related services are performed based on the amounts billed, as the collaboration partner consumes the benefit of research and development work simultaneously as we perform these services, and the amounts billed reflect the value of these services to the customer. Refer to Note 4 Revenue, for further discussion on our collaborative arrangements. Product Sales, Net Hylenex Recombinant We sell Hylenex recombinant in the U.S. to wholesale pharmaceutical distributors, who sell the product to hospitals and other end-user customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual packages of Hylenex recombinant represent performance obligations under each purchase order. We use a contract manufacturer to produce Hylenex recombinant and a third-party logistics (3PL) vendor to process and fulfill orders . We concluded we are the principal in the sales to wholesalers because we control access to services rendered by both vendors and direct their activities. We have no significant obligations to wholesalers to generate pull-through sales. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when wholesalers sell Hylenex recombinant at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. We also pay quarterly distribution fees to certain wholesalers for inventory reporting and chargeback processing, and to GPOs as administrative fees for services and for access to GPO members. We concluded the benefits received in exchange for these fees are not distinct from our sales of Hylenex recombinant, and accordingly we apply these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf life of Hylenex recombinant and our lengthy return period, there may be a significant period of time between when the product is shipped and when we issue credits on returned product. We estimate the transaction price when we receive each purchase order taking into account the expected reductions of the selling price initially billed to the wholesaler arising from all of the above factors. We have compiled historical experience and data to estimate future returns and chargebacks of Hylenex recombinant and the impact of the other discounts and fees we pay. When estimating these adjustments to the transaction price, we reduce it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known. Each purchase order contains only one type of product, and is usually shipped to the wholesaler in a single shipment. Therefore, allocation of the transaction price to individual packages is not required. We recognize revenue from Hylenex recombinant product sales and related cost of sales upon product delivery to the wholesaler location. At that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay us. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights, we do not believe they have a significant incentive to return the product to us. Upon recognition of revenue from product sales of Hylenex recombinant, the estimated amounts of credit for product returns, chargebacks, distribution fees, prompt payment discounts, and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. We monitor actual product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts differ from our estimates, we make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings in the period of adjustment. In connection with the orders placed by wholesalers, we incur costs such as commissions to our sales representatives. However, as revenue from product sales is recognized upon delivery to the wholesaler, which occurs shortly after we receive a purchase order, we do not capitalize these commissions and other costs, based on application of the practical expedient allowed within the applicable guidance. Bulk rHuPH20 We sell bulk rHuPH20 to collaboration partners for use in research and development; subsequent to receiving marketing approval, we sell it for use in collaboration commercial products. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of bulk rHuPH20 represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use contract manufacturers to produce bulk rHuPH20 and have concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of bulk rHuPH20 is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from the sale of bulk rHuPH20 as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. ENHANZE Drug Product We sell ENHANZE drug product to collaboration partners for use in research and development in early phase clinical studies. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of ENHANZE drug product represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use contract manufacturers to produce ENHANZE drug product and we concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of ENHANZE drug product is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from the sale of ENHANZE drug product as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. Revenue Presentation In our statements of operations, we report as revenues under collaborative agreements the upfront payments, event-based development and regulatory milestones and sales milestones. We also include in this category revenues from separate research and development contracts pursuant to project authorization forms. We report royalties received from collaboration partners as a separate line in our statements of operations. Revenues from sales of Hylenex recombinant, bulk rHuPH20 that has alternative future use and ENHANZE drug product are included in product sales, net. In the footnotes to our financial statements, we provide disaggregated revenue information by type of arrangement (product sales, net, collaborative agreements and research and development services), and additionally, by type of payment stream received under collaborative agreements (upfront license fees, event-based development and regulatory milestones and other fees, sales milestones and royalties). |
Cost of Product Sales | Cost of Product SalesCost of product sales consists primarily of raw materials, third-party manufacturing costs, fill and finish costs, freight costs, internal costs and manufacturing overhead associated with the production of Hylenex recombinant and bulk rHuPH20 and ENHANZE drug product. Cost of product sales also consists of the write-down of excess, dated and obsolete inventories and the write-off of inventories that do not meet certain product specifications, if any. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include salaries and benefits, facilities and other overhead expenses, external clinical trial expenses, research related manufacturing services, contract services and other outside expenses. Research and development expenses are charged to operating expenses as incurred when these expenditures relate to our research and development efforts and have no alternative future uses. When bulk rHuPH20 is manufactured for use in research and development by us or our partners and the product cannot be redirected for alternative use due to formulation and manufacturing specifications, the manufacturing costs are recorded as research and development expense. Bulk rHuPH20 that is manufactured for partner use prior to our partner receiving marketing approval from the FDA or comparable regulatory agencies in foreign countries and meet these specifications is recorded as research and development expenses. Bulk rHuPH20 formulations manufactured for general partner and internal use, which can potentially be used by any collaboration partner or by us in Hylenex, is considered to have alternative future use and all manufacturing costs are capitalized as inventory. We are obligated to make upfront payments upon execution of certain research and development agreements. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are recognized as expense as the related goods are delivered or the related services are performed or such time when we do not expect the goods to be delivered or services to be performed. |
Clinical Trial Expenses | Clinical Trial Expenses We make payments in connection with our clinical trials under contracts with contract research organizations that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of our obligation to make payments under these contracts depends on factors such as the successful enrollment or treatment of patients or the completion of other clinical trial milestones. |
Share-Based Compensation | Share-Based Compensation We record compensation expense associated with stock options, restricted stock awards (“RSAs”), restricted stock units (“RSUs”) and performance stock units (“PSUs”) in accordance with the authoritative guidance for stock-based compensation. The cost of employee services received in exchange for an award of an equity instrument is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense on a straight-line basis over the requisite service period of the award. Share-based compensation expense for an award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is reversed. Forfeitures are recognized as a reduction of share-based compensation expense as they occur. |
Income Taxes | Income Taxes We provide for income taxes using the liability method. Under this method, deferred income tax assets and liabilities are determined based on the differences between the financial statement carrying amounts of existing assets and liabilities at each year end and their respective tax bases and are measured using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Significant judgment is required by management to determine our provision for income taxes, our deferred tax assets and liabilities, and the valuation allowance to record against our net deferred tax assets, which are based on complex and evolving tax regulations throughout the world. Deferred tax assets and other tax benefits are recorded when it is more likely than not that the position will be sustained upon audit. While we have begun to utilize certain of our net operating losses, we have not yet established a track record of profitability. Accordingly, valuation allowances have been recorded to reduce our net deferred tax assets to zero until such time as we can demonstrate an ability to realize them. |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income (loss) per common share is computed by dividing net income (loss) for the period by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Outstanding stock options, unvested RSAs, unvested RSUs, unvested PSUs and the Convertible Notes are considered common stock equivalents and are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. For the years ended December 31, 2020, 2019 and 2018, approximately 1.7 million, 33.1 million, and 13.8 million shares, respectively, of outstanding stock options, unvested RSAs, unvested RSUs, unvested PSUs and the Convertible Notes were excluded from the calculation of diluted net income (loss) per common share because their effect was anti-dilutive. The 19.3 million shares underlying the conversion option of the Convertible Notes does not have an impact on our diluted earnings per share when the average market price of our common stock is less than the conversion price of $23.85 per share, as we will settle the principal amount of the Convertible Notes in cash upon conversion. When the average market price of our common stock exceeds the conversion price, we compute the potentially dilutive impact of the shares of common stock related to the Convertible Notes using the treasury stock method. |
Segment Information | Segment InformationWe operate our business in one segment, which includes all activities related to the research, development and commercialization of our proprietary enzymes. This segment also includes revenues and expenses related to (i) research and development and bulk rHuPH20 manufacturing activities conducted under our collaborative agreements with third parties and (ii) product sales of Hylenex recombinant. The chief operating decision-maker reviews the operating results on an aggregate basis and manages the operations as a single operating segment. |
Adoption and Pending Adoption of Recent Accounting Pronouncements | Adoption and Pending Adoption of Recent Accounting Pronouncements The following table provides a brief description of recently issued accounting standards, those adopted in the current period and those not yet adopted: Standard Description Effective Date Effect on the Financial In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) The new guidance eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, the new guidance requires that the if-converted method is used in computing diluted EPS for all convertible instruments January 1, 2022 (Early adoption permitted effective January 1, 2021) We plan to early adopt ASU 2020-06 as of January 1, 2021 on a modified retrospective basis, which is expected to result in an approximate $65.6 million decrease in additional paid in capital from the derecognition of the bifurcated equity component, $52.6 million increase in debt from the derecognition of the discount associated with the bifurcated equity component and $13.0 million decrease to the opening balance of accumulated deficit, representing the cumulative non-cash interest expense recognized related to the amortization of the bifurcated conversion option. We expect to write-off the related deferred tax liabilities of $11.8 million with a corresponding adjustment to the valuation allowance, resulting in no net impact to the cumulative adjustment to retained earnings. As we intended and have the ability to settle the principal amount of the convertible notes in cash upon conversion, in January 2021 we notified the note holders that we will settle the principal of the convertible notes in cash, removing our option to settle the principal of the notes in shares. Therefore, shares used for diluted EPS will continue to be limited to the excess conversion value over the principal amount of the convertible note. Diluted earnings per share will be impacted due to the elimination of non-cash interest expense associated with the amortization of the equity component. In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and other Internal-Use Software (Subtopic 350-40) The new guidance aligns the requirement for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirement for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). January 1, 2020 We adopted the new guidance on January 1, 2020. The adoption did not have a material impact on our condensed consolidated financial position or results of operations. Standard Description Effective Date Effect on the Financial In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820). The new guidance removes, modifies and adds to certain disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. January 1, 2020 We adopted the new guidance on January 1, 2020. The adoption did not have a material impact on our condensed consolidated financial position or results of operations. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. January 1, 2020 We adopted the new guidance on January 1, 2020. The adoption did not have a material impact on our condensed consolidated financial position or results of operations. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedules of Concentration of Risk, by Risk Factor | The following table indicates the percentage of total revenues in excess of 10% with any single customer: Year Ended December 31, 2020 2019 2018 Partner A 35% 40% 72% Partner B 26% 18% 2% Partner C 11% —% —% Partner D 8% 23% —% We attribute revenues under collaborative agreements, including royalties, to the individual countries where the customer is headquartered. We attribute revenues from product sales to the individual countries to which the product is shipped. Worldwide revenues from external customers are summarized by geographic location in the following table (in thousands): Year Ended December 31, 2020 2019 2018 United States $ 106,918 $ 28,178 $ 26,527 Switzerland 95,949 109,754 109,890 Ireland 30,552 589 5,075 Belgium 20,086 45,060 — Japan 10,644 9,905 8,873 All other foreign 3,445 2,506 1,497 Total revenues $ 267,594 $ 195,992 $ 151,862 |
Schedule of Earnings Per Share, Basic and Diluted | A reconciliation of the numerators and the denominators of the basic and diluted net income (loss) per common share computations is as follows (in thousands, except per share amounts): Year Ended December 31, 2020 2019 2018 Numerator: Net income (loss) $ 129,085 $ (72,240) $ (80,330) Denominator: Weighted average common shares outstanding for basic 136,206 144,329 143,599 Net effect of dilutive common stock equivalents 5,257 — — Weighted average common shares outstanding for diluted 141,463 144,329 143,599 Net income (loss) per share: Basic $ 0.95 $ (0.50) $ (0.56) Diluted $ 0.91 $ (0.50) $ (0.56) |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Available-for-sale marketable securities | Available-for-sale marketable securities consisted of the following (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Asset-backed securities $ 17,013 $ 49 $ — $ 17,062 Corporate debt securities 69,755 42 (8) 69,789 U.S. Treasury securities 45,110 7 — 45,117 Commercial paper 88,342 — — 88,342 $ 220,220 $ 98 $ (8) $ 220,310 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Asset-backed securities $ 30,484 $ 55 $ — $ 30,539 Corporate debt securities 161,308 178 (14) 161,472 U.S. Treasury securities 75,192 40 (5) 75,227 Commercial paper 33,845 — — 33,845 $ 300,829 $ 273 $ (19) $ 301,083 |
Investments Classified by Contractual Maturity Date [Table Text Block] | Contractual maturities of available-for-sale debt securities are as follows (in thousands): December 31, 2020 December 31, 2019 Estimated Fair Value Due within one year $ 220,310 $ 274,805 After one but within five years — 26,278 $ 220,310 $ 301,083 |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | The following table summarizes, by major security type, our cash equivalents and available-for-sale marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): December 31, 2020 December 31, 2019 Level 1 Level 2 Total estimated fair value Level 1 Level 2 Total estimated fair value Cash equivalents: Money market funds $ 140,571 $ — $ 140,571 $ 119,949 $ — $ 119,949 Commercial paper — 7,000 7,000 — — — Available-for-sale marketable Asset-backed securities — 17,062 17,062 — 30,539 30,539 Corporate debt securities — 69,789 69,789 — 161,472 161,472 U.S. Treasury securities 45,117 — 45,117 75,227 — 75,227 Commercial paper — 88,342 88,342 — 33,845 33,845 $ 185,688 $ 182,193 $ 367,881 $ 195,176 $ 225,856 $ 421,032 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | Our disaggregated revenues were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Royalties $ 88,596 $ 69,899 $ 78,981 Product sales, net Sales of bulk rHuPH20 $ 38,237 $ 48,285 $ 12,729 Sales of ENHANZE drug product 719 768 460 Sales of Hylenex 17,031 16,995 15,045 Total product sales, net 55,987 66,048 28,234 Revenues under collaborative agreements: Upfront license and target nomination fees 37,264 53,000 26,336 Event-based development milestones and regulatory milestone and other fees 69,500 5,500 16,000 Sales-based milestones 15,000 — — Research and development services 1,247 1,545 2,311 Total revenues under collaborative agreements 123,011 60,045 44,647 Total revenue $ 267,594 $ 195,992 $ 151,862 |
Contract with Customer, Asset and Liability | Accounts receivable, net, other contract assets and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands): December 31, 2020 December 31, 2019 Accounts receivable, net $ 90,730 $ 59,442 Other contract assets 7,000 — Deferred revenues 5,772 5,259 |
Schedule of Collaborative Agreements | The following table presents amounts under our collaborative agreements included in the transaction price (i.e. cumulative amounts triggered or probable) as of December 31, 2020 (in thousands): Upfront Development Sales Total Collaboration partner and agreement date: Roche (December 2006, September 2017 and October 2018) $ 105,000 $ 47,000 $ 22,000 $ 174,000 Baxalta (September 2007) 10,000 3,000 9,000 22,000 Pfizer (December 2012) 14,500 2,000 — 16,500 Janssen (December 2014) 18,250 42,000 15,000 75,250 AbbVie (June 2015) 23,000 6,000 — 29,000 Lilly (December 2015) 33,000 — — 33,000 BMS (September 2017) 110,000 10,000 — 120,000 Alexion (December 2017) 40,000 6,000 — 46,000 argenx (February 2019) 40,000 25,000 65,000 Horizon (November 2020) 30,000 — $ — 30,000 Royalties 411,881 Total amounts under our collaborative agreements included in the transaction price 1,022,631 (1) Upfront and additional target selection fees (2) Event-based development and regulatory milestone amounts and other fees (3) Sales-based milestone amounts |
Certain Balance Sheet Items (Ta
Certain Balance Sheet Items (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Accounts Receivable | Accounts receivable, net consisted of the following (in thousands): December 31, December 31, Accounts receivable from product sales to collaborators $ 25,198 $ 35,649 Accounts receivable from revenues under collaborative agreements 30,404 3,850 Accounts receivable from royalty payments 32,098 17,149 Accounts receivable from other product sales 4,033 3,591 Other contract assets 7,000 — Subtotal 98,733 60,239 Allowance for distribution fees and discounts (1,003) (797) Total accounts receivable, net $ 97,730 $ 59,442 |
Summary of Inventories | Inventories consisted of the following (in thousands): December 31, December 31, Raw materials $ 5,813 $ 2,769 Work-in-process 33,738 15,710 Finished goods 21,196 10,880 Total inventories $ 60,747 $ 29,359 |
Summary of Prepaid Expenses and Other Assets | Prepaid expenses and other assets consisted of the following (in thousands): December 31, December 31, Prepaid manufacturing expenses $ 35,048 $ 30,156 Prepaid research and development expenses 342 4,964 Other prepaid expenses 2,510 3,655 Other assets 4,441 5,681 Total prepaid expenses and other assets 42,341 44,456 Less long-term portion (14,067) (11,083) Total prepaid expenses and other assets, current $ 28,274 $ 33,373 |
Summary of Property and Equipment | Property and equipment, net consisted of the following (in thousands): December 31, December 31, Research equipment $ 7,085 $ 7,403 Manufacturing equipment 5,336 3,858 Computer and office equipment 4,826 4,859 Leasehold improvements 1,628 1,628 Subtotal 18,875 17,748 Accumulated depreciation and amortization (11,582) (10,742) Subtotal $ 7,293 $ 7,006 Right of use of assets $ 3,300 $ 3,849 Property and equipment, net $ 10,593 $ 10,855 |
Summary of Accrued Expenses | Accrued expenses consisted of the following (in thousands): December 31, December 31, Accrued outsourced research and development expenses $ 448 $ 8,423 Accrued compensation and payroll taxes 8,078 27,888 Accrued outsourced manufacturing expenses 4,535 9,173 Other accrued expenses 6,020 7,876 Lease liability 4,868 6,469 Total accrued expenses 23,949 59,829 Less long-term portion (3,466) (4,180) Total accrued expenses, current $ 20,483 $ 55,649 |
Summary of Deferred Revenue | Deferred revenue consisted of the following (in thousands): December 31, December 31, Collaborative agreements License fees and event-based payments: — 2,764 Product sales 5,772 2,495 Total deferred revenue 5,772 5,259 Less current portion (1,746) (4,012) Deferred revenue, net of current portion $ 4,026 $ 1,247 |
Debt, Net (Tables)
Debt, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Maturities of Long-term Debt | Future maturities and interest payments of long-term debt as of December 31, 2020, are as follows (in thousands): 2021 $ 465,750 2022 — 2023 — 2024 — 2025 — Total minimum payments 465,750 Less amount representing interest (5,750) Gross balance of long-term debt 460,000 Less unamortized debt discount (62,772) Present value of long-term debt 397,228 Less current portion of long-term debt (397,228) Long-term debt, less current portion and unamortized debt discount $ — |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Total share-based compensation expense related to share-based awards was comprised of the following (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 5,484 $ 15,107 $ 17,220 Selling, general and administrative 11,720 19,669 18,476 Share-based compensation expense $ 17,204 $ 34,776 $ 35,696 |
Share-based Payment Arrangement, Cost by Plan [Table Text Block] | Share-based compensation expense by type of share-based award (in thousands): Year Ended December 31, 2020 2019 2018 Stock options $ 8,955 $ 17,624 $ 18,742 RSAs, RSUs and PSUs 8,249 17,152 16,954 $ 17,204 $ 34,776 $ 35,696 |
Share-based Payment Arrangement, Nonvested Award, Cost [Table Text Block] | Total unrecognized estimated compensation cost by type of award and the weighted-average remaining requisite service period over which such expense is expected to be recognized (in thousands, unless otherwise noted): December 31, 2020 Unrecognized Remaining Stock options $ 18,853 2.60 RSAs $ 460 0.33 RSUs $ 13,241 2.32 PSUs $ 297 1.75 |
Share-based Payment Arrangement, Option, Activity [Table Text Block] | A summary of our stock option award activity as of and for the year ended December 31, 2020 is as follows: Shares Weighted Weighted Aggregate Outstanding at December 31, 2019 11,548,229 $14.72 Granted 1,602,087 $20.74 Exercised (4,705,843) $14.08 Canceled/forfeited (2,810,851) $17.02 Outstanding at December 31, 2020 5,633,622 $15.83 6.58 $151.4 million Vested and expected to vest at December 31, 2020 5,633,622 $15.83 6.58 $151.4 million Exercisable at December 31, 2020 3,297,904 $13.36 5.08 $96.8 million |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | The assumptions used in the Black-Scholes model were as follows: Year Ended December 31, 2020 2019 2018 Expected volatility 47.57-51.82% 51.56-56.94% 57.18-70.06% Average expected term (in years) 5.1 5.5 5.5 Risk-free interest rate 0.22-1.67% 1.35-2.56% 2.25-2.96% Expected dividend yield — — — |
Share-based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity [Table Text Block] | The following table summarizes our RSA activity during the year ended December 31, 2020: Number of Weighted Unvested at December 31, 2019 211,123 $11.47 Granted 61,803 $22.66 Vested (210,676) $11.48 Forfeited (447) $8.11 Unvested at December 31, 2020 61,803 $22.66 |
Share-based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block] | The following table summarizes our RSU activity during the year ended December 31, 2020: Number of Weighted Weighted Aggregate Outstanding at December 31, 2019 2,092,439 $15.60 Granted 574,279 $20.25 Vested (714,868) $14.12 Forfeited (921,938) $16.62 Outstanding at December 31, 2020 1,029,912 $18.31 1.23 $44.0 million |
Schedule of Nonvested Performance-based Units Activity | The following table summarizes our PSU activity during the year ended December 31, 2020: Number of Weighted Outstanding at December 31, 2019 — $0.00 Granted 40,796 $16.32 Vested — $0.00 Forfeited — $0.00 Outstanding at December 31, 2020 40,796 $16.32 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Schedule of Activity under Approved Share Repurchase Programs | We had the following activity under the approved share repurchase programs (dollars in thousands, except share and per share data) 2020 Total Number of Shares Purchased Weighted Average Price paid Per Share Total Cost (2) First quarter (1) 3,188,795 $16.15 $51,574 Second quarter 88,307 $22.58 $1,996 Third quarter 2,134,716 $27.57 $58,902 Fourth quarter (3) 1,095,366 $34.36 $37,645 6,507,184 $23.05 $150,117 (1) This is in addition to 0.5 million shares delivered in February upon completion of the ASR. (2) Included in the total cost of shares purchased is a commission fee of $0.02 per share. (3) This includes the December 2020 ASR. |
Commitments and Contingencies C
Commitments and Contingencies Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Approximate annual future minimum operating lease payments as of December 31, 2020 are as follows (in thousands): Year: Operating 2021 $ 2,563 2022 2,564 2023 150 2024 — 2025 — Total minimum lease payments $ 5,277 Less imputed interest (409) Total $ 4,868 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign [Table Text Block] | Total income (loss) before income taxes summarized by region were as follows (in thousands): Year Ended December 31, 2020 2019 2018 United States $ 130,427 $ (70,737) $ (45,819) Foreign (1,125) (1,514) (33,974) Net income (loss) before income taxes $ 129,302 $ (72,251) $ (79,793) |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Significant components of our net deferred tax assets/(liabilities) were as follows (in thousands). December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 84,278 $ 39,401 Deferred revenue 253 1,069 Research and development and orphan drug credits 114,357 114,357 Share-based compensation 4,637 9,972 Alternative minimum tax credit — 1,683 ASC 842 lease liability 1,081 1,454 Interest expense limitation 5,536 2,163 Other, net 3,478 3,037 213,620 173,136 Valuation allowance for deferred tax assets (199,827) (155,100) Deferred tax assets, net of valuation 13,793 18,036 Deferred tax liabilities: Depreciation (1,002) (865) Convertible note (11,776) (14,450) ASC 842 right of use asset (733) (865) Other, net (282) (173) Total deferred tax liabilities (13,793) (16,353) Net deferred tax asset $ — $ 1,683 |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | Income tax expense was comprised of the following components (in thousands): Year Ended December 31, 2020 2019 2018 Current - federal $ (11) $ 114 $ 82 Current - state 228 (40) 519 Deferred - federal — (85) (64) Deferred - state — — — $ 217 $ (11) $ 537 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | The provision for income taxes on earnings subject to income taxes differs from the statutory federal income tax rate due to the following (in thousands): Year Ended December 31, 2020 2019 2018 Federal income tax expense (benefit) at 21% $ 27,153 $ (15,173) $ (16,754) State income tax benefit, net of federal income tax impact (1,942) (1,509) (4,297) (Decrease) increase in valuation allowance 44,727 8,147 35,731 Worthless stock deduction of international subsidiary (67,322) — — Foreign income subject to tax at other than federal statutory rate 237 318 7,106 Share-based compensation (4,117) 315 (441) Executive compensation limitation 1,434 858 866 Non-deductible expenses and other 47 66 1,599 Research and development credits, net — (1,091) (5,210) Orphan drug credits, net of federal add back — (5,718) (18,063) Convertible note discount in APIC $ — $ 13,776 $ — $ 217 $ (11) $ 537 |
Summary of Positions for which Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Table Text Block] | The following table summarizes the activity related to our unrecognized tax benefits (in thousands): Year Ended December 31, 2020 2019 2018 Gross unrecognized tax benefits at beginning of period $ 21,483 $ 20,028 $ 14,428 Increases in tax positions for prior years 41 69 3,083 Decreases in tax positions for prior years (2,357) (23) — Increases in tax positions for current year — 1,409 2,517 Gross unrecognized tax benefits at end of period $ 19,167 $ 21,483 $ 20,028 |
Summary of Operating Loss Carryforwards [Table Text Block] | The following table shows key expiration dates of the federal and California net operating loss carryforwards (in thousands): Expires in: Net Operating Loss 2020 2021 and beyond 2028 and beyond Federal $ 310,756 $ — $ 310,756 — California $ 259,840 $ — — $ 259,840 |
Summary of Unaudited Quarterl_2
Summary of Unaudited Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information [Table Text Block] | The following is a summary of our unaudited quarterly results for the years ended December 31, 2020 and 2019 (in thousands): Quarter Ended 2020 (Unaudited): March 31, June 30, September 30, December 31, Total revenues (1)(2)(3) $ 25,354 $ 55,221 $ 65,316 $ 121,703 Gross profit on product sales $ 2,360 $ 597 $ 3,480 $ 6,183 Total operating expenses $ 28,577 $ 25,666 $ 25,017 $ 44,079 Net (loss) Income $ (6,103) $ 25,817 $ 36,207 $ 73,164 Net (loss) Income per share: Basic $ (0.04) $ 0.19 $ 0.27 $ 0.54 Diluted $ (0.04) $ 0.19 $ 0.25 $ 0.50 Shares used in computing net (loss) income per share: Basic 137,186 135,935 136,578 135,107 Diluted 137,186 138,084 142,081 145,122 Quarter Ended 2019 (Unaudited): March 31, June 30, September 30, December 31, Total revenues (4) $ 56,949 $ 39,148 $ 46,230 $ 53,665 Gross profit on product sales $ 3,741 $ 3,883 $ 6,872 $ 6,006 Total operating expenses (5) $ 53,983 $ 53,125 $ 70,767 $ 85,727 Net Income (loss) $ 1,796 $ (14,624) $ (25,015) $ (34,397) Net Income (loss) per share: Basic $ 0.01 $ (0.10) $ (0.17) $ (0.24) Diluted $ 0.01 $ (0.10) $ (0.17) $ (0.24) Shares used in computing net Income (loss) per share: Basic 144,743 145,411 146,136 141,046 Diluted 147,474 145,411 146,136 141,046 _______________ (1) Revenue for the quarter ended December 31, 2020 included $57.0 million in revenue under a collaborative agreement from Janssen, argenx, Horizon and BMS. (2) Revenue for the quarter ended September 30, 2020 included $32.0 million in revenue under a collaborative arrangement from Roche and argenx. (3) Revenue for the quarter ended June 30, 2020 included $32.3 million in revenue under a collaborative arrangement from Janssen and BMS. (4) Revenue for the quarter ended March 31, 2019 included $30.0 million in revenue under a collaborative arrangement from argenx. (5) Total operating expenses for the quarter ended December 31, 2019 included $28.4 million restructuring charges. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Restricted Cash and Investments, Current [Abstract] | ||
Restricted cash | $ 500 | $ 500 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies Concentrations of Credit Risk (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Concentration Risk [Line Items] | |||
Accounts Receivable, Allowance for Credit Loss, Current | $ 0 | $ 0 | |
Total revenues | 267,594,000 | 195,992,000 | $ 151,862,000 |
Geographic Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Total revenues | $ 267,594,000 | 195,992,000 | 151,862,000 |
Sales [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 10.00% | ||
United States | Geographic Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Total revenues | $ 106,918,000 | 28,178,000 | 26,527,000 |
Switzerland | Geographic Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Total revenues | 95,949,000 | 109,754,000 | 109,890,000 |
Ireland | Geographic Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Total revenues | 30,552,000 | 589,000 | 5,075,000 |
Belgium | Geographic Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Total revenues | 20,086,000 | 45,060,000 | 0 |
Japan | Geographic Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Total revenues | 10,644,000 | 9,905,000 | 8,873,000 |
All other foreign | Geographic Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Total revenues | $ 3,445,000 | $ 2,506,000 | $ 1,497,000 |
Roche and Baxalta [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage (instant date) | 74.00% | 93.00% | |
Partner A | Sales [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 35.00% | 40.00% | 72.00% |
Partner B | Sales [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 26.00% | 18.00% | 2.00% |
Partner C | Sales [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 11.00% | 0.00% | 0.00% |
Partner D | Sales [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 8.00% | 23.00% | 0.00% |
Bulk formulation [Member] | Accounts Payable [Member] | Supplier Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Number of manufacturers | 2 | ||
Concentration Risk, Percentage (instant date) | 75.00% | 47.00% | |
Sales of Hylenex | Accounts Payable [Member] | Supplier Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage (instant date) | 0.00% | 8.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies Accounts Receivable (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Accounts Receivable, Allowance for Credit Loss, Current | $ 0 | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory [Line Items] | ||
Inventory, Net | $ 60,747 | $ 29,359 |
Sales of Hylenex | ||
Inventory [Line Items] | ||
Inventory, Net | 1,300 | 1,400 |
bulk rHuPH20 | ||
Inventory [Line Items] | ||
Inventory, Net | $ 59,400 | $ 28,000 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies Leases (Details) | Dec. 31, 2020 |
Minimum | |
Lessee, Operating Lease, Term of Contract | 3 years |
Maximum | |
Lessee, Operating Lease, Term of Contract | 6 years |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
Summary of Significant Accou_10
Summary of Significant Accounting Policies Revenue recognition (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Collaborative agreements termination notification | |||
Cost of Goods and Services Sold | $ 43,367 | $ 45,546 | $ 10,136 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies Research and development (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
In-license technologies [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Research and Development, in-line technologies | $ 0 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies Income tax (Details) | Dec. 31, 2020USD ($) |
Income Tax Disclosure [Abstract] | |
Deferred tax asset excluding amount for AMT | $ 0 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2019 | |
Loss Per Share Disclosure [Line Items] | ||||||||||||
Net income (loss) | $ 73,164 | $ 36,207 | $ 25,817 | $ (6,103) | $ (34,397) | $ (25,015) | $ (14,624) | $ 1,796 | $ 129,085 | $ (72,240) | $ (80,330) | |
Weighted average stock outstanding - basic (USD per share) | 135,107 | 136,578 | 135,935 | 137,186 | 141,046 | 146,136 | 145,411 | 144,743 | 136,206 | 144,329 | 143,599 | |
Shares excluded from calculation of diluted net loss, amount | 5,257 | 0 | 0 | |||||||||
Weighted average stock outstanding - diluted (USD per share) | 145,122 | 142,081 | 138,084 | 137,186 | 141,046 | 146,136 | 145,411 | 147,474 | 141,463 | 144,329 | 143,599 | |
Earnings per share - basic (USD per share) | $ 0.54 | $ 0.27 | $ 0.19 | $ (0.04) | $ (0.24) | $ (0.17) | $ (0.10) | $ 0.01 | $ 0.95 | $ (0.50) | $ (0.56) | |
Earnings per share - diluted (USD per share) | $ 0.50 | $ 0.25 | $ 0.19 | $ (0.04) | $ (0.24) | $ (0.17) | $ (0.10) | $ 0.01 | $ 0.91 | $ (0.50) | $ (0.56) | |
Net loss per share (Textuals) [Abstract] | ||||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,700 | 33,100 | 13,800 | |||||||||
1.25% Convertible Senior Notes due 2024 [Member] | ||||||||||||
Net loss per share (Textuals) [Abstract] | ||||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 19,300 | |||||||||||
Convertible Debt [Member] | 1.25% Convertible Senior Notes due 2024 [Member] | ||||||||||||
Net loss per share (Textuals) [Abstract] | ||||||||||||
Debt Instrument, Convertible, Conversion Price | $ 23.85 |
Summary of Significant Accou_14
Summary of Significant Accounting Policies Segment information (Details) | 12 Months Ended |
Dec. 31, 2020segment | |
Segment Reporting [Abstract] | |
Number of Operating Segments | 1 |
Fair Value Measurement - Summar
Fair Value Measurement - Summary (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of Available-for-sale Securities | ||
Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value | $ 21,200 | |
Amortized cost | 220,220 | $ 300,829 |
Gross Unrealized Gains | 98 | 273 |
Gross Unrealized Losses | (8) | (19) |
Estimated fair value | 220,310 | 301,083 |
Asset-backed Securities [Member] | ||
Schedule of Available-for-sale Securities | ||
Debt Securities, Available-for-sale, Amortized Cost | 17,013 | 30,484 |
Gross Unrealized Gains | 49 | 55 |
Gross Unrealized Losses | 0 | 0 |
Debt Securities, Available-for-sale | 17,062 | 30,539 |
Corporate Debt Securities [Member] | ||
Schedule of Available-for-sale Securities | ||
Debt Securities, Available-for-sale, Amortized Cost | 69,755 | 161,308 |
Gross Unrealized Gains | 42 | 178 |
Gross Unrealized Losses | (8) | (14) |
Estimated fair value | 69,789 | 161,472 |
US Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities | ||
Debt Securities, Available-for-sale, Amortized Cost | 45,110 | 75,192 |
Gross Unrealized Gains | 7 | 40 |
Gross Unrealized Losses | 0 | (5) |
Estimated fair value | 45,117 | 75,227 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities | ||
Debt Securities, Available-for-sale, Amortized Cost | 88,342 | 33,845 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated fair value | $ 88,342 | $ 33,845 |
Fair Value Measurement Textuals
Fair Value Measurement Textuals (Details) $ in Thousands | Dec. 31, 2020USD ($)security |
Fair Value Disclosures [Abstract] | |
Available-for-sale, Securities in Unrealized Loss Positions, Qualitative Disclosure, Number of Positions | security | 3 |
Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value | $ 21,200 |
Available-for-sale Securities, Continuous Unrealized Loss Position, Accumulated Loss | $ (8) |
Fair Value Measurement Maturiti
Fair Value Measurement Maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Disclosures [Abstract] | ||
Due within one year | $ 220,310 | $ 274,805 |
After one but within five years | 0 | 26,278 |
Available-for-sale Securities | $ 220,310 | $ 301,083 |
Fair Value Measurement Fair Val
Fair Value Measurement Fair Value Measures (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | $ 220,310,000 | $ 301,083,000 |
Fair Value Disclosure | 367,881,000 | 421,032,000 |
Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash Equivalents | 140,571,000 | 119,949,000 |
Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 88,342,000 | 33,845,000 |
Corporate Debt Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 69,789,000 | 161,472,000 |
US Treasury Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 45,117,000 | 75,227,000 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Fair Value Disclosure | 185,688,000 | 195,176,000 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Fair Value Disclosure | 182,193,000 | 225,856,000 |
Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 88,342,000 | |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments, Level 3 | 0 | 0 |
Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 88,342,000 | 33,845,000 |
Available-for-sale Securities | 88,342,000 | 33,845,000 |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 0 | 0 |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 33,845,000 | |
Asset-backed Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 17,013,000 | 30,484,000 |
Debt Securities, Available-for-sale | 17,062,000 | 30,539,000 |
Asset-backed Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 0 | 0 |
Asset-backed Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 17,062,000 | 30,539,000 |
US Treasury Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 45,110,000 | 75,192,000 |
Available-for-sale Securities | 45,117,000 | 75,227,000 |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 45,117,000 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 75,227,000 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 0 | 0 |
Corporate Debt Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 69,755,000 | 161,308,000 |
Available-for-sale Securities | 69,789,000 | 161,472,000 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 0 | 0 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 69,789,000 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Debt Securities, Available-for-sale | 161,472,000 | |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash Equivalents | 140,571,000 | |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash Equivalents | 119,949,000 | |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash Equivalents | $ 0 | $ 0 |
Revenue - Disaggregation of Rev
Revenue - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 267,594 | $ 195,992 | $ 151,862 |
Royalties | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 88,596 | 69,899 | 78,981 |
Product sales, net | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 55,987 | 66,048 | 28,234 |
Sales of bulk rHuPH20 | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 38,237 | 48,285 | 12,729 |
Sales of ENHANZE drug product | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 719 | 768 | 460 |
Sales of Hylenex | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 17,031 | 16,995 | 15,045 |
Revenues under collaborative agreements | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 123,011 | 60,045 | 44,647 |
Upfront license and target nomination fees | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 37,264 | 53,000 | 26,336 |
Event-based development milestones and regulatory milestone and other fees | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 69,500 | 5,500 | 16,000 |
Sales-based milestones | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 15,000 | 0 | 0 |
Research and development services | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 1,247 | $ 1,545 | $ 2,311 |
Revenue - Textuals (Details)
Revenue - Textuals (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenue related to licenses granted to collaboration partners | $ 173,100 | ||||||||||
Recognition of deferred revenue | (4,119) | $ (3,996) | $ (2,832) | ||||||||
Deferred revenues | $ 5,772 | $ 5,259 | 5,772 | 5,259 | |||||||
Accumulated deficit | (474,593) | (603,678) | (474,593) | (603,678) | |||||||
Revenues | 121,703 | $ 65,316 | $ 55,221 | $ 25,354 | 53,665 | $ 46,230 | $ 39,148 | $ 56,949 | |||
Accounts receivable, net | 97,730 | 59,442 | 97,730 | 59,442 | |||||||
Deferred revenues | 5,772 | 5,259 | 5,772 | 5,259 | |||||||
Deferred Credits and Other Liabilities | 5,800 | 5,800 | |||||||||
2017 Roche | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Development milestones | 69,500 | ||||||||||
OtherCollaborators | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenues | 55,300 | 55,300 | |||||||||
Difference between Revenue Guidance in Effect before and after Topic 606 | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Accounts receivable | 19,400 | ||||||||||
Deferred revenues | 51,800 | ||||||||||
Accounting Standards Update 2014-09 | Difference between Revenue Guidance in Effect before and after Topic 606 | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 4,700 | ||||||||||
Accounts receivable, net | 19,300 | ||||||||||
Deferred revenues | (47,400) | ||||||||||
Product sales, net | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenues | 5,772 | 2,495 | 5,772 | 2,495 | |||||||
Deferred Credits and Other Liabilities, Current | 49,500 | 49,500 | |||||||||
License fees and event-based payments | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Recognition of deferred revenue | 4,100 | ||||||||||
Deferred revenues | $ 0 | $ 2,764 | $ 0 | $ 2,764 | |||||||
Revision of Prior Period, Accounting Standards Update, Adjustment | Difference between Revenue Guidance in Effect before and after Topic 606 | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Accumulated deficit | $ 71,200 |
Revenue - Contract with Custome
Revenue - Contract with Customer, Asset and Liability (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred Credits and Other Liabilities | $ 5,800 | |
Accounts receivable, net | 97,730 | $ 59,442 |
Deferred revenues | 5,772 | 5,259 |
Other contract assets | 7,000 | $ 0 |
Accounts Receivable, after Allowance for Credit Loss, Current, excluding Other Contract Assets | $ 90,730 |
Revenue - Revenue Recognition,
Revenue - Revenue Recognition, Multiple-deliverable Arrangements (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | $ 267,594 | $ 195,992 | $ 151,862 |
Contract with Customer, Asset, Allowance for Credit Loss | 1,022,631 | ||
Roche | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 174,000 | ||
Baxalta | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 22,000 | ||
Pfizer | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 16,500 | ||
Janssen | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 75,250 | ||
AbbVie | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 29,000 | ||
Lilly | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 33,000 | ||
BMS | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 120,000 | ||
Alexion | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 46,000 | ||
argenx [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 65,000 | ||
Upfront | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 37,264 | 53,000 | 26,336 |
Upfront | Roche | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 105,000 | ||
Upfront | Baxalta | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 10,000 | ||
Upfront | Pfizer | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 14,500 | ||
Upfront | Janssen | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 18,250 | ||
Upfront | AbbVie | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 23,000 | ||
Upfront | Lilly | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 33,000 | ||
Upfront | BMS | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 110,000 | ||
Upfront | Alexion | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 40,000 | ||
Upfront | argenx [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 40,000 | ||
Upfront | Horizon | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 30,000 | ||
Development | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 69,500 | 5,500 | 16,000 |
Development | Roche | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 47,000 | ||
Development | Baxalta | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 3,000 | ||
Development | Pfizer | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 2,000 | ||
Development | Janssen | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 42,000 | ||
Development | AbbVie | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 6,000 | ||
Development | BMS | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 10,000 | ||
Development | Alexion | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 6,000 | ||
Development | argenx [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 25,000 | ||
Sales | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 15,000 | 0 | 0 |
Sales | Roche | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 22,000 | ||
Sales | Baxalta | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 9,000 | ||
Sales | Janssen | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with Customer, Asset, Allowance for Credit Loss | 15,000 | ||
Royalties | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenues | 88,596 | $ 69,899 | $ 78,981 |
Contract with Customer, Asset, Allowance for Credit Loss | $ 411,881 |
Revenue - Revenue, Remaining Pe
Revenue - Revenue, Remaining Performance Obligation (Details) - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2021-01-01 $ in Millions | Dec. 31, 2020USD ($) |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Revenue, Remaining Performance Obligation, Amount | $ 1.7 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 12 months |
Certain Balance Sheet Items - A
Certain Balance Sheet Items - Accounts receivable (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accounts Receivable, after Allowance for Credit Loss, Current [Abstract] | ||
Accounts receivable from product sales to collaborators | $ 25,198 | $ 35,649 |
Accounts receivable from revenues under collaborative agreements | 30,404 | 3,850 |
Accounts receivable from royalty payments | 32,098 | 17,149 |
Accounts receivable from other product sales | 4,033 | 3,591 |
Other contract assets | 7,000 | 0 |
Subtotal | 98,733 | 60,239 |
Allowance for distribution fees and discounts | (1,003) | (797) |
Total accounts receivable, net | $ 97,730 | $ 59,442 |
Certain Balance Sheet Items - I
Certain Balance Sheet Items - Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Inventory, Raw Materials | $ 5,813 | $ 2,769 |
Inventory, Work in Process | 33,738 | 15,710 |
Inventory, Finished Goods | 21,196 | 10,880 |
Summary of Inventories | ||
Total inventories | $ 60,747 | $ 29,359 |
Certain Balance Sheet Items - P
Certain Balance Sheet Items - Prepaid expenses and other assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid manufacturing expenses | $ 35,048 | $ 30,156 |
Prepaid research and development expenses | 342 | 4,964 |
Other prepaid expenses | 2,510 | 3,655 |
Other assets | 4,441 | 5,681 |
Total prepaid expense and other assets | 42,341 | 44,456 |
Less long-term portion | (14,067) | (11,083) |
Total prepaid expense and other assets, current | $ 28,274 | $ 33,373 |
Certain Balance Sheet Items -_2
Certain Balance Sheet Items - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property and equipment, gross | $ 18,875 | $ 17,748 |
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment, Excluding Capital Leased Assets | (11,582) | (10,742) |
Property, Plant and Equipment, Net, Excluding Capital Leased Assets | 7,293 | 7,006 |
Operating Lease, Right-of-Use Asset | 3,300 | 3,849 |
Property and equipment, net | 10,593 | 10,855 |
Research equipment | ||
Property, Plant and Equipment, Gross, Excluding Capital Leased Assets | 7,085 | 7,403 |
Manufacturing equipment | ||
Property, Plant and Equipment, Gross, Excluding Capital Leased Assets | 5,336 | 3,858 |
Computer and office equipment | ||
Property, Plant and Equipment, Gross, Excluding Capital Leased Assets | 4,826 | 4,859 |
Leasehold improvements | ||
Property, Plant and Equipment, Gross, Excluding Capital Leased Assets | $ 1,628 | $ 1,628 |
Certain Balance Sheet Items -_3
Certain Balance Sheet Items - Property and Equipment, Net (Textuals) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Nov. 30, 2019 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||||||||
Loss on impairment of right-of-use asset | $ 577 | $ 1,127 | $ 0 | |||||
(Gain) loss on disposal of equipment | (772) | 1,431 | 5 | |||||
Depreciation and amortization | ||||||||
Depreciation and amortization | 3,284 | 4,068 | $ 2,388 | |||||
Finance Lease, Right-of-Use Asset, Amortization | 1,700 | 1,800 | ||||||
Treasury Stock, Value, Acquired, Cost Method | $ 6,900 | $ 37,645 | $ 58,902 | $ 1,996 | $ 51,574 | $ 150,117 | $ 200,000 |
Certain Balance Sheet Items -_4
Certain Balance Sheet Items - Accrued Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Payables and Accruals [Abstract] | ||
Operating Lease, Accretion Of Liability | $ 500 | $ 800 |
Summary of Accrued Expenses | ||
Accrued outsourced research and development expenses | 448 | 8,423 |
Accrued compensation and payroll taxes | 8,078 | 27,888 |
Accrued outsourced manufacturing expenses | 4,535 | 9,173 |
Other accrued expenses | 6,020 | 7,876 |
Lease liability | 4,868 | 6,469 |
Total accrued expenses | 23,949 | 59,829 |
Less long-term portion | (3,466) | (4,180) |
Total accrued expenses, current | $ 20,483 | $ 55,649 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent | us-gaap:AccruedLiabilitiesCurrent |
Operating Lease, Cost | $ 2,200 | $ 2,600 |
Operating Lease, Payments | $ 3,200 | $ 3,100 |
Certain Balance Sheet Items - D
Certain Balance Sheet Items - Deferred Revenue (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred revenue | ||
Total deferred revenue | $ 5,772 | $ 5,259 |
Less current portion | (1,746) | (4,012) |
Deferred revenue, net of current portion | 4,026 | 1,247 |
License fees and event-based payments | ||
Deferred revenue | ||
Total deferred revenue | 0 | 2,764 |
Product sales | ||
Deferred revenue | ||
Total deferred revenue | $ 5,772 | $ 2,495 |
Debt, Net - Long-Term Debt Text
Debt, Net - Long-Term Debt Textuals (Details) $ / shares in Units, shares in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Feb. 29, 2020shares | Nov. 30, 2019USD ($)trading_day$ / sharesshares | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($) | |
Debt Instrument [Line Items] | |||||||||
Long-term Debt, Fair Value | $ 397,228,000 | $ 397,228,000 | |||||||
Payments of Debt Issuance Costs | 0 | $ 279,000 | $ 0 | ||||||
Long-term Debt | 0 | 0 | 383,045,000 | ||||||
Non-Convertible Borrowing Rate for Similar Debt, Percent | 5.19% | ||||||||
Debt Instrument, Convertible, Carrying Amount of Equity Component | $ 65,600,000 | ||||||||
Proceeds from Convertible Debt | 447,400,000 | ||||||||
Payments for Repurchase of Common Stock | 200,000,000 | 150,117,000 | 199,998,000 | 0 | |||||
Interest Expense, debt | 19,900,000 | 2,300,000 | |||||||
Debt Instrument, Periodic Payment, Interest | 5,800,000 | 700,000 | |||||||
Amortization of debt discount | 14,136,000 | 2,484,000 | $ 1,545,000 | ||||||
Debt Instrument, Unamortized Discount | 62,772,000 | 62,772,000 | |||||||
Treasury Stock, Value, Acquired, Cost Method | $ 6,900,000 | 37,645,000 | $ 58,902,000 | $ 1,996,000 | $ 51,574,000 | $ 150,117,000 | $ 200,000,000 | ||
Treasury Stock, Shares, Acquired | shares | 0.5 | 8.1 | 6.5 | 11.1 | |||||
Repayments of Debt | $ 26,100,000 | ||||||||
Current portion of long-term debt, net | 397,228,000 | $ 397,228,000 | $ 19,542,000 | ||||||
Debt Instrument, Fair Value Disclosure | $ 861,700,000 | $ 861,700,000 | 461,100,000 | ||||||
1.25% Convertible Senior Notes due 2024 | |||||||||
Debt Instrument [Line Items] | |||||||||
Amortization of debt discount | $ 1,600,000 | ||||||||
Convertible Senior Notes | 1.25% Convertible Senior Notes due 2024 | |||||||||
Debt Instrument [Line Items] | |||||||||
Face amount of debt instrument | $ 460,000,000 | ||||||||
Stated interest rate (as a percent) | 1.25% | ||||||||
Conversion rate (shares) | 41.9208 | ||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 23.85 | ||||||||
Long-term Debt, Fair Value | $ 381,800,000 | ||||||||
Payments of Debt Issuance Costs | 300,000 | ||||||||
Lender Fee | 12,700,000 | ||||||||
Debt Instrument, Convertible, Remaining Discount Amortization Period | 3 years 10 months 24 days | ||||||||
Debt Instrument, Interest Rate, Effective Percentage | 5.10% | 5.10% | |||||||
Royalty-backed Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Face amount of debt instrument | $ 150,000,000 | $ 150,000,000 | |||||||
Debt Instrument, Description of Variable Rate Basis | 8.75% plus the three-month LIBOR rate | ||||||||
Royalty-backed Loan | Minimum | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.70% | ||||||||
Royalty-backed Loan | Maximum | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 1.50% | ||||||||
Secured Debt | |||||||||
Debt Instrument [Line Items] | |||||||||
Final payment | 4,250,000 | $ 4,250,000 | |||||||
Senior Loans [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Face amount of debt instrument | $ 70,000,000 | $ 70,000,000 | |||||||
Stated interest rate (as a percent) | 8.25% | 8.25% | |||||||
Secured debt original draw | $ 55,000,000 | $ 55,000,000 | |||||||
Final payment as percent of original principal | 5.50% | ||||||||
Debt Instrument, Unused Borrowing Capacity, Amount | $ 15,000,000 | $ 15,000,000 | |||||||
Debt Instrument, interest only period | interest only payments for the first 18 months | ||||||||
Shares acquired in privately negotiated transaction | |||||||||
Debt Instrument [Line Items] | |||||||||
Treasury Stock, Value, Acquired, Cost Method | 143,100,000 | ||||||||
Accelerated Share Repurchase Program | |||||||||
Debt Instrument [Line Items] | |||||||||
Treasury Stock, Value, Acquired, Cost Method | $ 50,000,000 | ||||||||
Treasury Stock, Shares, Acquired | shares | 2.6 | ||||||||
Debt Instrument, Redemption, Period One | Convertible Senior Notes | 1.25% Convertible Senior Notes due 2024 | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Convertible, Threshold Percentage of Stock Price Trigger | 130.00% | ||||||||
Debt Instrument, Convertible, Threshold Trading Days | trading_day | 20 | ||||||||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | trading_day | 30 | ||||||||
Debt Instrument, Redemption, Period Two | Convertible Senior Notes | 1.25% Convertible Senior Notes due 2024 | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Convertible, Threshold Percentage of Stock Price Trigger | 98.00% | ||||||||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | trading_day | 5 |
Debt, Net - Debt Table (Details
Debt, Net - Debt Table (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Disclosure [Abstract] | ||
2018 | $ 465,750 | |
2019 | 0 | |
2020 | 0 | |
2021 | 0 | |
2022 | 0 | |
Total minimum payments | 465,750 | |
Less amount representing interest | (5,750) | |
Gross balance of long-term debt | 460,000 | |
Less unamortized debt discount | (62,772) | |
Present value of long-term debt | 397,228 | |
Less current portion of long-term debt | (397,228) | $ (19,542) |
Long-term debt, less current portion and unamortized debt discount | $ 0 |
Share-based Compensation Textua
Share-based Compensation Textuals (Details) | 12 Months Ended |
Dec. 31, 2020shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common Stock, Capital Shares Reserved for Future Issuance | 10,806,631 |
Options, Exercise Price, Percent of Share Price | 100.00% |
Options, Outstanding, Initial Contractual Term | 10 years |
Cliff Vesting, First Anniversary [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Award Vesting Rights, Percentage | 25.00% |
Monthly Vesting, after One Year [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Award Vesting Rights, Percentage | 2.08% |
RSUs | Percentage Vesting [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Award Vesting Rights, Percentage | 25.00% |
Outstanding awards [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares Subject To Outstanding Awards | 6,704,330 |
RSAs | Percentage Vesting [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Award Vesting Rights, Percentage | 25.00% |
Amended and Restated 2011 Stock Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares Authorized | 44,200,000 |
Share-based Compensation Expens
Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Payment Arrangement, Expense | $ 17,204 | $ 34,776 | $ 35,696 |
Stock options | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Payment Arrangement, Expense | 8,955 | 17,624 | 18,742 |
RSU, RSA, and PRSU awards [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Payment Arrangement, Expense | 8,249 | 17,152 | 16,954 |
Research and Development Expense [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Payment Arrangement, Expense | 5,484 | 15,107 | 17,220 |
Selling, General and Administrative Expenses [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Payment Arrangement, Expense | $ 11,720 | $ 19,669 | $ 18,476 |
Share-based Compensation Unreco
Share-based Compensation Unrecognized Expense (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Stock options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 18,853 |
Compensation Cost Not yet Recognized, Period for Recognition | 2 years 7 months 6 days |
RSAs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 460 |
Compensation Cost Not yet Recognized, Period for Recognition | 3 months 29 days |
RSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 13,241 |
Compensation Cost Not yet Recognized, Period for Recognition | 2 years 3 months 25 days |
Performance Shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 297 |
Compensation Cost Not yet Recognized, Period for Recognition | 1 year 9 months |
Share-based Compensation Option
Share-based Compensation Options (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Options, Outstanding, Number, period start | 11,548,229 | ||
Options, Outstanding, Weighted Average Exercise Price, period start | $ 14.72 | ||
Options, Grants in Period, Gross | 1,602,087 | ||
Options, Grants in Period, Weighted Average Exercise Price | $ 20.74 | ||
Options, Exercises in Period | (4,705,843) | ||
Options, Exercises in Period, Weighted Average Exercise Price | $ 14.08 | ||
Options, Forfeitures and Expirations in Period | (2,810,851) | ||
Options, Forfeitures and Expirations in Period, Weighted Average Exercise Price | $ 17.02 | ||
Options, Outstanding, Number, period end | 5,633,622 | 11,548,229 | |
Options, Outstanding, Weighted Average Exercise Price, period end | $ 15.83 | $ 14.72 | |
Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 6 months 29 days | ||
Options, Outstanding, Intrinsic Value | $ 151.4 | ||
Options, Vested and Expected to Vest, Outstanding, Number | 5,633,622 | ||
Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ 15.83 | ||
Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 6 years 6 months 29 days | ||
Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value | $ 151.4 | ||
Options, Vested and Expected to Vest, Exercisable, Number | 3,297,904 | ||
Options, Vested and Expected to Vest, Exercisable, Weighted Average Exercise Price | $ 13.36 | ||
Options, Vested and Expected to Vest, Exercisable, Weighted Average Remaining Contractual Term | 5 years 29 days | ||
Options, Vested and Expected to Vest, Exercisable, Aggregate Intrinsic Value | $ 96.8 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 20.74 | $ 16.46 | $ 10.33 |
Options, Exercises in Period, Intrinsic Value | $ 49.7 | $ 10.6 | $ 11.5 |
Proceeds from Stock Options Exercised | $ 66.2 | $ 16.5 | $ 16.3 |
Share-based Compensation Valuat
Share-based Compensation Valuation (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items] | |||
Fair Value Assumptions, Weighted Average Expected Term | 5 years 1 month 6 days | 5 years 6 months | 5 years 6 months |
Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% | 0.00% |
Fair Value Assumptions, Risk Free Interest Rate, Minimum | 0.22% | 1.35% | 2.25% |
Fair Value Assumptions, Risk Free Interest Rate, Maximum | 1.67% | 2.56% | 2.96% |
Minimum | |||
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items] | |||
Fair Value Assumptions, Weighted Average Volatility Rate | 47.57% | 51.56% | 57.18% |
Maximum | |||
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items] | |||
Fair Value Assumptions, Weighted Average Volatility Rate | 51.82% | 56.94% | 70.06% |
Share-based Compensation Restri
Share-based Compensation Restricted Stock Awards (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Additional Disclosures [Abstract] | |||
Restricted stock award holder exercise price | $ 0 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 1 year | ||
RSAs | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Nonvested, Number, period start | 211,123 | ||
Nonvested, Weighted Average Grant Date Fair Value, period start | $ 11.47 | ||
Grants in Period | 61,803 | ||
Grants in Period, Weighted Average Grant Date Fair Value | $ 22.66 | ||
Vested in Period | (210,676) | ||
Vested in Period, Weighted Average Grant Date Fair Value | $ 11.48 | ||
Forfeited in Period | (447) | ||
Forfeitures, Weighted Average Grant Date Fair Value | $ 8.11 | ||
Nonvested, Number, period end | 61,803 | 211,123 | |
Nonvested, Weighted Average Grant Date Fair Value, period end | $ 22.66 | $ 11.47 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Additional Disclosures [Abstract] | |||
Vested in Period, Fair Value | $ 2.4 | $ 3.3 | $ 4.5 |
Aggregate Intrinsic Value, Vested | $ 4.3 | $ 4.2 | $ 7.2 |
Share-based Compensation Rest_2
Share-based Compensation Restricted Stock Units (Details) - RSUs - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Nonvested, Number, period start | 2,092,439 | ||
Nonvested, Weighted Average Grant Date Fair Value, period start | $ 15.60 | ||
Grants in Period | 574,279 | ||
Grants in Period, Weighted Average Grant Date Fair Value | $ 20.25 | ||
Vested in Period | (714,868) | ||
Vested in Period, Weighted Average Grant Date Fair Value | $ 14.12 | ||
Forfeited in Period | (921,938) | ||
Forfeitures, Weighted Average Grant Date Fair Value | $ 16.62 | ||
Nonvested, Number, period end | 1,029,912 | 2,092,439 | |
Nonvested, Weighted Average Grant Date Fair Value, period end | $ 18.31 | $ 15.60 | |
Outstanding, Weighted Average Remaining Contractual Terms | 1 year 2 months 23 days | ||
Aggregate Intrinsic Value, Nonvested | $ 44 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Additional Disclosures [Abstract] | |||
Vested in Period, Fair Value | 10.1 | $ 19.1 | $ 6.7 |
Aggregate Intrinsic Value, Vested | $ 14 | $ 18.5 | $ 11 |
Share-based Compensation - Perf
Share-based Compensation - Performance Stock Units (Details) - Performance Shares - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Nonvested, Number, period start | 0 | |
Grants in Period | 40,796 | |
Vested in Period | 0 | |
Forfeited in Period | 0 | |
Nonvested, Number, period end | 40,796 | 0 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Nonvested, Weighted Average Grant Date Fair Value, period start | $ 0 | |
Grants in Period, Weighted Average Grant Date Fair Value | 16.32 | |
Vested in Period, Weighted Average Grant Date Fair Value | 0 | |
Forfeitures, Weighted Average Grant Date Fair Value | 0 | |
Nonvested, Weighted Average Grant Date Fair Value, period end | $ 16.32 | $ 0 |
Aggregate Intrinsic Value, Vested | $ 0 |
Share-based Compensation (Detai
Share-based Compensation (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
RSUs | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Aggregate Intrinsic Value, Vested | $ 14 | $ 18.5 | $ 11 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stockholders' equity (deficit) (textual) | |||
Number of shares of common stock issued as a result of stock option exercises | 4,705,843 | ||
Net proceeds from stock options exercised | $ 66.2 | $ 16.5 | $ 16.3 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 5,633,622 | 11,548,229 | |
Stock options | |||
Stockholders' equity (deficit) (textual) | |||
Number of shares of common stock issued as a result of stock option exercises | 4,705,843 | 1,540,690 | 1,489,138 |
Net proceeds from stock options exercised | $ 66.2 | $ 16.5 | $ 16.3 |
RSUs | |||
Stockholders' equity (deficit) (textual) | |||
Shares, Restricted Stock Award | 571,963 | 952,182 | 442,599 |
Number of RSUs surrendered to pay for minimum withholding taxes | 142,905 | 140,466 | 139,850 |
Payments for tax withholding for restricted stock units vested, net | $ 5.5 | $ 7 | $ 4.2 |
Stock Options And Restricted Stock Units [Member] | |||
Stockholders' equity (deficit) (textual) | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 6,700,000 | 13,600,000 | 13,400,000 |
Stockholders' Equity - Share Re
Stockholders' Equity - Share Repurchases (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2020 | Feb. 29, 2020 | Nov. 30, 2019 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Equity, Class of Treasury Stock [Line Items] | |||||||||
Stock Repurchase Program, Period in Force | 3 years | ||||||||
Authorized repurchase amount | $ 550,000,000 | ||||||||
Stock repurchased (shares) | 500,000 | 8,100,000 | 6,500,000 | 11,100,000 | |||||
Value of stock repurchased | $ 6,900,000 | $ 37,645,000 | $ 58,902,000 | $ 1,996,000 | $ 51,574,000 | $ 150,117,000 | $ 200,000,000 | ||
Stock Repurchased During Period, Shares | 1,095,366 | 2,134,716 | 88,307 | 3,188,795 | 6,507,184 | ||||
Treasury Stock Acquired, Average Cost Per Share | $ 18.03 | $ 34.36 | $ 27.57 | $ 22.58 | $ 16.15 | $ 23.05 | |||
Treasury Stock Acquired, Fee Cost Per Share | $ 0.02 | ||||||||
Accelerated Share Repurchases, Date [Domain] | |||||||||
Equity, Class of Treasury Stock [Line Items] | |||||||||
Value of stock repurchased | $ 21,700,000 | ||||||||
2020 Share Repurchase Program - Bank of America | |||||||||
Equity, Class of Treasury Stock [Line Items] | |||||||||
Stock repurchased (shares) | 500,000 |
Commitments and Contingencies O
Commitments and Contingencies Operating Lease textual (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020USD ($)ft² | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Lessee, Lease, Description [Line Items] | |||
Operating Lease, Weighted Average Remaining Lease Term | 2 years 21 days | ||
Loss on impairment of right-of-use asset | $ 577 | $ 1,127 | $ 0 |
Operating Leases, Rent Expense, Net | $ 2,300 | $ 2,700 | $ 2,500 |
Office and Research Facility [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Operating Leases, Area Leased | ft² | 50,000 | ||
Operating Leases, Base Rent, Periodic Increase, Percent | 3.00% | ||
Number of buildings | 2 |
Commitments and Contingencies_2
Commitments and Contingencies Commitments and Contingencies (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Loss on impairment of right-of-use asset | $ 577 | $ 1,127 | $ 0 |
Operating Leases, Rent Expense, Net | 2,300 | 2,700 | $ 2,500 |
2021 | 2,563 | ||
2022 | 2,564 | ||
2023 | 150 | ||
2024 | 0 | ||
2025 | 0 | ||
Total minimum lease payments | 5,277 | ||
Less imputed interest | (409) | ||
Total | $ 4,868 | $ 6,469 |
Commitments and Contingencies_3
Commitments and Contingencies Other Commitments (Details) $ in Millions | Dec. 31, 2020USD ($) |
Avid Commercial Supply Agreement [Member] | |
Long-term Purchase Commitment [Line Items] | |
Purchase Obligation | $ 75.9 |
Patheon [Member] | |
Long-term Purchase Commitment [Line Items] | |
Purchase Obligation | $ 1.4 |
Income Taxes Net Income (Loss)
Income Taxes Net Income (Loss) By Region (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
United States | $ 130,427 | $ (70,737) | $ (45,819) |
Foreign | (1,125) | (1,514) | (33,974) |
Income (loss) before income taxes | $ 129,302 | $ (72,251) | $ (79,793) |
Income Taxes Components Deferre
Income Taxes Components Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
Deferred Tax Assets, Operating Loss Carryforwards | $ 84,278 | $ 39,401 |
Deferred Tax Assets, Deferred Income | 253 | 1,069 |
Deferred Tax Assets, Tax Credit Carryforwards, Research | 114,357 | 114,357 |
Deferred Tax Assets, Tax Deferred Expense, Compensation and Benefits, Share-based Compensation Cost | 4,637 | 9,972 |
Deferred Tax Assets, Tax Credit Carryforwards, Alternative Minimum Tax | 0 | 1,683 |
Deferred Tax Assets, Lease Liabilities | 1,081 | 1,454 |
Deferred Tax Assets, Interest Expense Limitation | 5,536 | 2,163 |
Deferred Tax Assets, Other | 3,478 | 3,037 |
Deferred Tax Assets, Gross | 213,620 | 173,136 |
Deferred Tax Assets, Valuation Allowance | (199,827) | (155,100) |
Deferred Tax Assets, Net of Valuation Allowance | 13,793 | 18,036 |
Deferred Tax Liabilities, Property, Plant and Equipment | (1,002) | (865) |
Deferred Tax Liabilities, Convertible Note | (11,776) | (14,450) |
Deferred Tax Liabilities, Right-of-Use Asset | (733) | (865) |
Deferred Tax Liabilities, Other | (282) | (173) |
Deferred Tax Liabilities, Net, Noncurrent | (13,793) | (16,353) |
Deferred Tax Assets, Net | $ 0 | $ 1,683 |
Income Taxes Income Tax Expense
Income Taxes Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Current Federal Tax Expense (Benefit) | $ (11) | $ 114 | $ 82 |
Current State Tax Expense | 228 | (40) | 519 |
Deferred Federal Income Tax Benefit | 0 | (85) | (64) |
Deferred State Income Tax Expense | 0 | 0 | 0 |
Income tax expense (benefit) | $ 217 | $ (11) | $ 537 |
Income Taxes Schedule of Income
Income Taxes Schedule of Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Federal income tax expense (benefit) at 21% | $ 27,153 | $ (15,173) | $ (16,754) |
State income tax benefit, net of federal income tax impact | (1,942) | (1,509) | (4,297) |
(Decrease) increase in valuation allowance | 44,727 | 8,147 | 35,731 |
Worthless stock deduction of international subsidiary | (67,322) | 0 | 0 |
Foreign income subject to tax at other than federal statutory rate | 237 | 318 | 7,106 |
Share-based compensation | (4,117) | 315 | (441) |
Executive compensation limitation | 1,434 | 858 | 866 |
Non-deductible expenses and other | 47 | 66 | 1,599 |
Research and development credits, net | 0 | (1,091) | (5,210) |
Orphan drug credits, net of federal add back | 0 | (5,718) | (18,063) |
Convertible note discount in APIC | 0 | 13,776 | 0 |
Income Tax Expense (Benefit), Continuing Operations, Discontinued Operations | $ 217 | $ (11) | $ 537 |
Income Taxes Unrecognized Tax B
Income Taxes Unrecognized Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | $ 300 | ||
Unrecognized Tax Benefits, beginning of period | 21,483 | $ 20,028 | $ 14,428 |
Increase Resulting from Prior Period Tax Positions | 41 | 69 | 3,083 |
Decrease Resulting from Prior Period Tax Positions | (2,357) | (23) | 0 |
Increase Resulting from Current Period Tax Positions | 0 | 1,409 | 2,517 |
Unrecognized Tax Benefits, end of period | 19,167 | $ 21,483 | $ 20,028 |
Unrecognized Tax Benefits that Would Impact Effective Tax Rate, no valuation allowance | $ 18,900 |
Income Taxes Operating Loss Car
Income Taxes Operating Loss Carryforward Expiration (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Internal Revenue Service (IRS) [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | $ 310,756 |
Internal Revenue Service (IRS) [Member] | 2018 expiration [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | 0 |
Internal Revenue Service (IRS) [Member] | 2021 and beyond expiration [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | 310,756 |
Internal Revenue Service (IRS) [Member] | 2028 and beyond expiration [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | 0 |
State and Local Jurisdiction [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | 259,840 |
State and Local Jurisdiction [Member] | 2018 expiration [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | 0 |
State and Local Jurisdiction [Member] | 2021 and beyond expiration [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | 0 |
State and Local Jurisdiction [Member] | 2028 and beyond expiration [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | $ 259,840 |
Income Taxes Tax textuals (Deta
Income Taxes Tax textuals (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Tax Credit Carryforward [Line Items] | ||||
Deferred Tax Assets, Valuation Allowance | $ 199,827,000 | $ 155,100,000 | ||
Unrecognized Tax Benefits | 19,167,000 | 21,483,000 | $ 20,028,000 | $ 14,428,000 |
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | 300,000 | |||
Unrecognized Tax Benefits that Would Impact Effective Tax Rate, no valuation allowance | 18,900,000 | |||
Undistributed Earnings of Foreign Subsidiaries | 0 | $ 0 | ||
Internal Revenue Service (IRS) [Member] | ||||
Tax Credit Carryforward [Line Items] | ||||
Operating Loss Carryforwards | 310,756,000 | |||
Internal Revenue Service (IRS) [Member] | Research Tax Credit Carryforward [Member] | ||||
Tax Credit Carryforward [Line Items] | ||||
Tax Credit Carryforward, Amount | 27,900,000 | |||
Internal Revenue Service (IRS) [Member] | General Business Tax Credit Carryforward [Member] | ||||
Tax Credit Carryforward [Line Items] | ||||
Tax Credit Carryforward, Amount | 88,000,000 | |||
State and Local Jurisdiction [Member] | ||||
Tax Credit Carryforward [Line Items] | ||||
Operating Loss Carryforwards | 259,840,000 | |||
State and Local Jurisdiction [Member] | California | ||||
Tax Credit Carryforward [Line Items] | ||||
Operating Loss Carryforwards | 259,800,000 | |||
State and Local Jurisdiction [Member] | Other States | ||||
Tax Credit Carryforward [Line Items] | ||||
Operating Loss Carryforwards | 45,300,000 | |||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||||
Tax Credit Carryforward [Line Items] | ||||
Tax Credit Carryforward, Amount | $ 19,100,000 |
Employee Savings Plan (Details)
Employee Savings Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |||
Employer Discretionary Contribution Amount | $ 1.1 | $ 2.2 | $ 1.3 |
Summary of Unaudited Quarterl_3
Summary of Unaudited Quarterly Financial Information - Quarterly Financial Information (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 121,703 | $ 65,316 | $ 55,221 | $ 25,354 | $ 53,665 | $ 46,230 | $ 39,148 | $ 56,949 | |||
Gross Profit | 6,183 | 3,480 | 597 | 2,360 | 6,006 | 6,872 | 3,883 | 3,741 | |||
Operating Expenses | 44,079 | 25,017 | 25,666 | 28,577 | 85,727 | 70,767 | 53,125 | 53,983 | |||
Net income (loss) | $ 73,164 | $ 36,207 | $ 25,817 | $ (6,103) | $ (34,397) | $ (25,015) | $ (14,624) | $ 1,796 | $ 129,085 | $ (72,240) | $ (80,330) |
Earnings per share - basic (USD per share) | $ 0.54 | $ 0.27 | $ 0.19 | $ (0.04) | $ (0.24) | $ (0.17) | $ (0.10) | $ 0.01 | $ 0.95 | $ (0.50) | $ (0.56) |
Earnings per share - diluted (USD per share) | $ 0.50 | $ 0.25 | $ 0.19 | $ (0.04) | $ (0.24) | $ (0.17) | $ (0.10) | $ 0.01 | $ 0.91 | $ (0.50) | $ (0.56) |
Weighted average stock outstanding - basic (USD per share) | 135,107 | 136,578 | 135,935 | 137,186 | 141,046 | 146,136 | 145,411 | 144,743 | 136,206 | 144,329 | 143,599 |
Weighted average stock outstanding - diluted (USD per share) | 145,122 | 142,081 | 138,084 | 137,186 | 141,046 | 146,136 | 145,411 | 147,474 | 141,463 | 144,329 | 143,599 |
Summary of Unaudited Quarterl_4
Summary of Unaudited Quarterly Financial Information - Textuals (Details) - USD ($) $ in Millions | 3 Months Ended | ||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||||
Restructuring Charges | $ 28.4 | ||||
Roche | |||||
Disaggregation of Revenue [Line Items] | |||||
Proceeds from Collaborator | $ 30 | ||||
Effect of Fourth Quarter Events [Line Items] | |||||
Proceeds from Collaborator | $ 30 | ||||
Janssen and BMS [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Proceeds from Collaborator | $ 32.3 | ||||
Effect of Fourth Quarter Events [Line Items] | |||||
Proceeds from Collaborator | $ 32.3 | ||||
Roche and argenx [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Proceeds from Collaborator | $ 32 | ||||
Effect of Fourth Quarter Events [Line Items] | |||||
Proceeds from Collaborator | $ 32 | ||||
Janssen, argenx, Horizon and BMS [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Proceeds from Collaborator | $ 57 | ||||
Effect of Fourth Quarter Events [Line Items] | |||||
Proceeds from Collaborator | $ 57 |
Schedule II Valuation and Qua_2
Schedule II Valuation and Qualifying Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |||
Accounts receivable allowance, beginning balance | $ 797 | $ 592 | $ 559 |
Additions | 13,276 | 7,327 | 5,988 |
Deductions | (13,070) | (7,122) | (5,955) |
Accounts receivable allowance, ending balance | $ 1,003 | $ 797 | $ 592 |