Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 12, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Entity File Number | 001-35347 | ||
Entity Registrant Name | Clovis Oncology, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 90-0475355 | ||
Entity Address, Address Line One | 5500 Flatiron Parkway, Suite 100 | ||
Entity Address, City or Town | Boulder | ||
Entity Address, State or Province | CO | ||
Entity Address, Postal Zip Code | 80301 | ||
City Area Code | 303 | ||
Local Phone Number | 625-5000 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | CLVS | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
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 | $ 578,173,019 | ||
Entity Common Stock, Shares Outstanding | 104,529,652 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001466301 | ||
Amendment Flag | false |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||
Product revenue | $ 164,522 | $ 143,006 | $ 95,388 |
Product revenue - extensible list | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Operating expenses: | |||
Research and development | $ 257,707 | $ 283,146 | $ 231,347 |
Selling, general and administrative | 163,894 | 182,769 | 175,781 |
Acquired in-process research and development | 9,440 | ||
Other operating expenses | 3,804 | 9,711 | |
Total expenses | 466,710 | 519,752 | 429,202 |
Operating loss | (302,188) | (376,746) | (333,814) |
Other income (expense): | |||
Interest expense | (30,508) | (19,405) | (13,183) |
Foreign currency loss | (72) | (547) | (346) |
(Loss) gain on extinguishment of debt | (3,277) | 18,480 | |
Loss on convertible senior notes conversion | (35,075) | ||
Legal settlement loss | (26,750) | (27,975) | |
Other income | 1,361 | 6,342 | 7,917 |
Other income (expense), net | (67,571) | (21,880) | (33,587) |
Loss before income taxes | (369,759) | (398,626) | (367,401) |
Income tax benefit (expense) | 547 | (1,798) | (608) |
Net loss | (369,212) | (400,424) | (368,009) |
Other comprehensive income (loss): | |||
Foreign currency translation adjustments, net of tax | 567 | (272) | (2,543) |
Net unrealized (loss) gain on available-for-sale securities, net of tax | (6) | 41 | 82 |
Other comprehensive income (loss): | 561 | (231) | (2,461) |
Comprehensive loss | $ (368,651) | $ (400,655) | $ (370,470) |
Loss per basic and diluted common share: | |||
Basic and diluted net loss per common share | $ (4.38) | $ (7.43) | $ (7.07) |
Basic and diluted weighted average common shares outstanding | 84,307 | 53,873 | 52,066 |
Product | |||
Revenues: | |||
Product revenue | $ 164,500 | $ 143,000 | |
Operating expenses: | |||
Cost of sales | 36,128 | 29,926 | $ 19,444 |
Intangible asset amortization | |||
Operating expenses: | |||
Cost of sales | $ 5,177 | $ 4,760 | $ 2,630 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 240,229 | $ 161,833 |
Accounts receivable, net | 26,511 | 20,562 |
Inventories, net | 30,714 | 26,519 |
Available-for-sale securities | 134,826 | |
Prepaid research and development expenses | 4,245 | 3,881 |
Other current assets | 9,130 | 18,847 |
Total current assets | 310,829 | 366,468 |
Inventories | 104,123 | 98,053 |
Deposit on inventory | 12,350 | |
Property and equipment, net | 12,085 | 15,287 |
Right-of-use assets, net | 30,438 | 28,141 |
Intangible assets, net | 65,743 | 62,920 |
Goodwill | 63,074 | 63,074 |
Other assets | 19,262 | 23,311 |
Total assets | 605,554 | 669,604 |
Current liabilities: | ||
Accounts payable | 26,692 | 32,237 |
Accrued research and development expenses | 43,500 | 53,214 |
Lease liabilities | 5,330 | 5,405 |
Convertible senior notes | 64,198 | |
Other accrued expenses | 45,208 | 42,228 |
Total current liabilities | 184,928 | 133,084 |
Long-term lease liabilities - less current portion | 31,640 | 29,479 |
Convertible senior notes - less current portion | 434,846 | 644,751 |
Borrowings under financing agreement | 110,917 | 34,991 |
Other long-term liabilities | 1,971 | 1,556 |
Total liabilities | 764,302 | 843,861 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2020 and December 31, 2019 | ||
Common stock, $0.001 par value per share, 200,000,000 shares authorized at December 31, 2020 and December 31, 2019, respectively; 103,699,109 and 54,956,341 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 104 | 55 |
Additional paid-in capital | 2,498,179 | 2,114,068 |
Accumulated other comprehensive loss | (44,304) | (44,865) |
Accumulated deficit | (2,612,727) | (2,243,515) |
Total stockholders' deficit | (158,748) | (174,257) |
Total liabilities and stockholders' equity (deficit) | $ 605,554 | $ 669,604 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 103,699,109 | 54,956,341 |
Common stock, shares outstanding | 103,699,109 | 54,956,341 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2017 | $ 51 | $ 1,887,196 | $ (42,173) | $ (1,477,439) | $ 367,635 |
Beginning Balance (in shares) at Dec. 31, 2017 | 50,565,119 | ||||
Issuance of common stock, net of issuance costs | $ 2 | 93,888 | 93,890 | ||
Issuance of common stock, net of issuance costs (in shares) | 1,837,898 | ||||
Issuance of common stock under employee stock purchase plan | 2,097 | 2,097 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 82,820 | ||||
Exercise of stock options | 1,870 | 1,870 | |||
Exercise of stock options (in shares) | 72,886 | ||||
Issuance of common stock from vesting of restricted stock units (in shares) | 238,793 | ||||
Share-based compensation expense | 49,090 | 49,090 | |||
Net unrealized gain (loss) on available-for-sale securities | 82 | 82 | |||
Foreign currency translation adjustments | (2,543) | (2,543) | |||
Adoption of new revenue recognition standard | 2,357 | 2,357 | |||
Net loss | (368,009) | (368,009) | |||
Ending Balance at Dec. 31, 2018 | $ 53 | 2,034,141 | (44,634) | (1,843,091) | 146,469 |
Ending Balance (in shares) at Dec. 31, 2018 | 52,797,516 | ||||
Issuance of common stock under employee stock purchase plan | 1,905 | 1,905 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 175,634 | ||||
Exercise of stock options | 1,361 | 1,361 | |||
Exercise of stock options (in shares) | 188,829 | ||||
Issuance of common stock from vesting of restricted stock units (in shares) | 312,304 | ||||
Share-based compensation expense | 54,304 | 54,304 | |||
Legal settlement | $ 2 | 22,745 | 22,747 | ||
Legal settlement (in shares) | 1,482,058 | ||||
Net unrealized gain (loss) on available-for-sale securities | 41 | 41 | |||
Foreign currency translation adjustments | (272) | (272) | |||
Other financing costs | (388) | (388) | |||
Net loss | (400,424) | (400,424) | |||
Ending Balance at Dec. 31, 2019 | $ 55 | 2,114,068 | (44,865) | (2,243,515) | $ (174,257) |
Ending Balance (in shares) at Dec. 31, 2019 | 54,956,341 | 54,956,341 | |||
Issuance of common stock, net of issuance costs | $ 11 | 83,416 | $ 83,427 | ||
Issuance of common stock, net of issuance costs (in shares) | 11,090,000 | ||||
Issuance of common stock under employee stock purchase plan | $ 1 | 1,419 | 1,420 | ||
Issuance of common stock under employee stock purchase plan (in shares) | 283,588 | ||||
Exercise of stock options | (57) | $ (57) | |||
Exercise of stock options (in shares) | 34,599 | 117,932 | |||
Issuance of common stock from vesting of restricted stock units | $ 1 | (1) | |||
Issuance of common stock from vesting of restricted stock units (in shares) | 1,012,699 | ||||
Share-based compensation expense | 50,794 | $ 50,794 | |||
Net unrealized gain (loss) on available-for-sale securities | (6) | (6) | |||
Foreign currency translation adjustments | 567 | 567 | |||
Convertible senior notes conversion | $ 36 | 248,599 | 248,635 | ||
Convertible senior notes conversion (in shares) | 36,321,882 | ||||
Other financing costs | (59) | (59) | |||
Net loss | (369,212) | (369,212) | |||
Ending Balance at Dec. 31, 2020 | $ 104 | $ 2,498,179 | $ (44,304) | $ (2,612,727) | $ (158,748) |
Ending Balance (in shares) at Dec. 31, 2020 | 103,699,109 | 103,699,109 |
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 loss | $ (369,212) | $ (400,424) | $ (368,009) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Share-based compensation expense | 50,794 | 54,304 | 49,090 |
Depreciation and amortization | 8,198 | 7,768 | 4,601 |
Amortization of premiums and discounts on available-for-sale securities | (174) | (1,521) | 1,345 |
Amortization of debt issuance costs | 2,672 | 2,858 | 2,178 |
Write-off of debt issuance costs related to convertible senior notes transactions | 4,345 | ||
Loss (gain) on extinguishment of debt | 3,277 | (18,480) | |
Loss on convertible senior notes conversion | 35,075 | ||
Legal settlement loss | 22,747 | ||
Acquired in-process research and development | 9,440 | ||
Other | 340 | 804 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | (5,407) | (7,518) | (3,371) |
Inventory | 5,321 | (26,160) | (49,936) |
Prepaid and accrued research and development expenses | (8,313) | 23,233 | 9,145 |
Deposit on inventory | (12,350) | ||
Other operating assets and liabilities | 10,831 | (6,837) | (8,750) |
Accounts payable | (5,852) | 12,289 | 5,770 |
Other accrued expenses | 15,377 | 13,322 | 4,290 |
Net cash used in operating activities | (252,728) | (323,615) | (365,997) |
Investing activities | |||
Purchases of property and equipment | (354) | (3,290) | (9,242) |
Proceeds from sale of property and equipment | 275 | ||
Purchases of available-for-sale securities | (9,962) | (459,835) | (500,000) |
Sales of available-for-sale securities | 144,644 | 621,998 | 300,000 |
Acquired in-process research and development - milestone payment | (8,000) | (15,750) | (55,000) |
Net cash provided by (used in) investing activities | 126,328 | 143,398 | (264,242) |
Financing activities | |||
Proceeds from sale of common stock, net of issuance costs | 246,668 | 93,890 | |
Proceeds from issuance of convertible senior notes, net of issuance costs | 56,619 | 254,879 | 290,887 |
Payment of convertible senior notes | (164,443) | ||
Extinguishment of convertible senior notes | (169,853) | ||
Proceeds from borrowings under ATHENA financing agreement | 65,119 | 32,871 | |
Proceeds from the exercise of stock options and employee stock purchases | 1,362 | 3,266 | 3,967 |
Payments on finance leases | (1,470) | (1,115) | (245) |
Payments on other long-term liabilities | (211) | (160) | (35) |
Net cash provided by financing activities | 203,644 | 119,888 | 388,464 |
Effect of exchange rate changes on cash and cash equivalents | 1,152 | 286 | (547) |
Increase (decrease) in cash and cash equivalents | 78,396 | (60,043) | (242,322) |
Cash and cash equivalents at beginning of period | 161,833 | 221,876 | 464,198 |
Cash and cash equivalents at end of period | 240,229 | 161,833 | 221,876 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 12,075 | 10,515 | 9,188 |
Non-cash investing and financing activities: | |||
Vesting of restricted stock units | $ 7,493 | $ 5,442 | $ 10,808 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2020 | |
Nature of Business | |
Nature of Business | 1. Nature of Business We are a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets. We target our development programs for the treatment of specific subsets of cancer populations, and simultaneously develop, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Our marketed product Rubraca® (rucaparib), an oral small molecule inhibitor of poly ADP-ribose polymerase (“PARP”), is marketed in the United States for two indications specific to recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and also an indication specific to metastatic castration-resistant prostate cancer (“mCRPC”). The initial indication received approval from the FDA in December 2016 and covers the treatment of adult patients with deleterious BRCA In May 2020, the FDA approved Rubraca for the treatment of adult patients with mCRPC associated with a deleterious BRCA mutation (germline and/or somatic) who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this third indication under accelerated approval based on objective response rate and duration of response data from the TRITON2 clinical trial. We launched Rubraca for this indication in the U.S. following receipt of the approval. As an accelerated approval, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for Rubraca’s approval in mCRPC. In August 2020, the FDA approved the use of Foundation Medicine’s blood-based diagnostic test, FoundationOne Liquid CDx, as a companion diagnostic for the detection of deleterious BRCA mutation (germline and/or somatic) to select mCRPC patients for treatment with Rubraca. In Europe, the European Commission granted a conditional marketing authorization in May 2018 for Rubraca as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA BRCA In December 2020, Rubraca met the primary study endpoint of significantly improving PFS versus chemotherapy in the ARIEL4 confirmatory study. Additional ARIEL4 study results are expected to be submitted for presentation at a medical congress meeting in 2021. ARIEL4 is a Phase 3 multicenter, randomized study of Rubraca versus chemotherapy, which enrolled relapsed ovarian cancer patients with BRCA Beyond our labeled indications, we have a clinical development program underway to further evaluate Rubraca in a variety of solid tumor types, either as monotherapy or in combination with other agents, including several studies as part of our ongoing clinical collaboration with Bristol Myers Squibb to evaluate its immunotherapy Opdivo (nivolumab) in combination with Rubraca. We anticipate initial data of Rubraca monotherapy versus placebo from our ATHENA study in the second half of 2021, with the results of Rubraca versus Opdivo in all study populations a year or more later. However, the timing of the ATHENA data readouts is dependent on the timing of data maturity driven by PFS events. We initiated the Phase 2 LODESTAR study in December 2019 to evaluate Rubraca as monotherapy treatment in patients with recurrent solid tumors associated with a deleterious mutation in homologous recombination repair genes. Based on our interactions with the FDA, we believe that this study may be registration-enabling for a targeted gene- and tumor-agnostic label, if data from the trial support the potential for an accelerated approval. Assuming enrollment in this study continues as planned, and subject to the data, we may potentially file an sNDA with the FDA for this indication in the second half of 2021 or the first half of 2022. We hold worldwide rights to Rubraca. Pursuant to our license and collaboration agreement with 3BP, entered into in September 2019, we have initiated development of a peptide-targeted radionuclide therapy (“PTRT”) and imaging agent targeting fibroblast-activating protein (“FAP”). We have completed sufficient preclinical work to support an IND for the lead candidate under our license and collaboration agreement, designated internally as FAP-2286. Accordingly, we submitted two INDs for FAP-2286 for use as imaging and treatment agents in December 2020 to support an initial Phase 1 study to determine the dose and tolerability of FAP-2286 as a therapeutic agent with expansion cohorts planned in multiple tumor types as part of a global development program. The INDs are expected to become effective following receipt and submission, and acceptance by the FDA, of satisfactory chemistry, manufacturing and controls (“CMC”) data for the imaging agent from clinical sites. The FAP-targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 LuMIERE clinical study, which we anticipate initiating in the first half of 2021. We hold U.S. and global rights to FAP-2286, excluding Europe (defined to include Russia, Turkey and Israel), where 3BP retains rights. We are also collaborating with 3BP on a discovery program directed to up to three additional, undisclosed targets for targeted radionuclide therapy, to which we would obtain global rights for any resulting product candidates. Lucitanib, our second product candidate currently in clinical development, is an investigational, oral, potent angiogenesis inhibitor which inhibits vascular endothelial growth factor receptors 1 through 3 (“VEGFR1-3”), platelet-derived growth factor receptors alpha and beta (“PDGFR α/β”) and fibroblast growth factor receptors 1 through 3 (“FGFR1-3”). Lucitanib inhibits the same three pathways as Lenvima® (lenvatinib), which has received an FDA approval for use in endometrial cancer in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. This, together with preclinical data for lucitanib in combination with a PD-1 inhibitor that demonstrated enhanced anti-tumor activity compared to that of single agents, represent a scientific rationale for development of lucitanib in combination with a PD-1 inhibitor, and in February 2019, lucitanib was added to our clinical collaboration with Bristol Myers Squibb. The Clovis-sponsored LIO-1 study of lucitanib in combination with nivolumab in advanced solid tumors and gynecologic cancers is currently enrolling patients in the Phase 2 part of the study. We expect to present interim data from this study at medical meetings in 2021, which are expected to include interim results from the ovarian and endometrial cancer expansion cohorts. We hold the global (excluding China) development and commercialization rights for lucitanib. Liquidity We have incurred significant net losses since inception and have relied on our ability to fund our operations through debt and equity financings. We expect operating losses and negative cash flows to continue for the foreseeable future. As we continue to incur losses, transition to profitability is dependent upon achieving a level of revenue from Rubraca adequate to support our cost structure. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional cash. Based on current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities will allow us to fund our operating plan through at least the next 12 months. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The consolidated financial statements include our accounts and our wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates, including estimates related to revenue deductions, intangible asset impairment, clinical trial accruals and share-based compensation expense. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Revenue Recognition We are currently approved to sell Rubraca in the United States and the Europe markets. We distribute our product principally through a limited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customers subsequently sell our products to patients and health care providers. Separately, we have arrangements with certain payors and other third-parties that provide for government-mandated and privately-negotiated rebates, chargebacks and discounts. See Note 3, Revenue Recognition Cost of Sales – Product Product cost of sales consists primarily of materials, third-party manufacturing costs as well as freight and royalties owed to our licensing partners for Rubraca sales. Cost of Sales – Intangible Asset Amortization Cost of sales for intangible asset amortization consists of the amortization of capitalized milestone payments made to our licensing partners upon FDA approval of Rubraca. Milestone payments are amortized on a straight-line basis over the estimated remaining patent life of Rubraca. Fair Value of Financial Instruments Cash, cash equivalents, available-for-sale securities and contingent purchase consideration are carried at fair value. Financial instruments, including other current assets and accounts payable, are carried at cost, which approximates fair value given their short-term nature (see Note 5, Fair Value Measurements Cash, Cash Equivalents and Available-for-Sale Securities We consider all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations. Marketable securities are considered to be available-for-sale securities and consist of U.S. treasury securities. Available-for-sale securities are reported at fair value on the Consolidated Balance Sheets and unrealized gains and losses are included in accumulated other comprehensive income/loss on the Consolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense) on the Consolidated Statements of Operations and Comprehensive Loss. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on our intent to fund current operations with these securities or to make them available for current operations. We determine whether a decline in the fair value below the amortized cost basis (i.e., impairment) of an available-for-sale debt is security is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in accumulated other comprehensive loss, net of applicable taxes. When evaluating an impairment, entities may not use the length of time a security has been in an unrealized loss position as a factor, either by itself or in combination with other factors, to conclude that a credit loss does not exist. Accounts Receivable We provide an allowance for credit losses based on experience and specifically identified risks. Accounts receivable are charged off against the allowance when we determine that recovery is unlikely and we cease collection efforts. Inventory Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first-out (“FIFO”) basis. Inventories include active pharmaceutical ingredient (“API”), contract manufacturing costs and overhead allocations. We begin capitalizing incurred inventory related costs upon regulatory approval. Prior to regulatory approval, incurred costs for the manufacture of drugs that could potentially be available to support the commercial launch of our products are recognized as research and development expense. We regularly analyze our inventory levels for excess quantities and obsolescence (expiration), considering factors such as historical and anticipated future sales compared to quantities on hand and the remaining shelf-life of Rubraca. Rubraca finished goods have a shelf-life of four years from the date of manufacture. We expect to sell the finished goods prior to expiration. The API currently has a shelf-life of four years from the date of manufacture but can be retested at an immaterial cost with no expected reduction in potency, thereby extending its shelf-life as needed. We expect to consume substantially all of the API over a period of approximately seven years based on our long-range sales projections of Rubraca. We write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and/or inventory in excess of expected sales requirements. Expired inventory would be disposed of and the related costs would be written off as cost of product revenue. Inventories that are not expected to be consumed within 12 months following the balance sheet date are classified as long-term inventories. Long-term inventories primarily consist of API. API is currently produced by Lonza. As the API has undergone significant manufacturing specific to its intended purpose at the point it is purchased by us, we classify the API as work-in-process inventory. In addition, we currently manufacture Rubraca finished goods with a single third-party manufacturer. The disruption or termination of the supply of API or the disruption or termination of the manufacturing of our commercial products could have a material adverse effect on our business, financial position and results of operations. API that is written off due to damage and certain costs related to our dedicated production train at Lonza are included in Other Operating Expenses in the Consolidated Statements of Operations and Comprehensive Loss. Inventory used in clinical trials is expensed as research and development expense when it has been identified for such use. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Equipment purchased for use in manufacturing and clinical trials is evaluated to determine whether the equipment is solely beneficial for a drug candidate in the development stage or whether it has an alternative use. Equipment with an alternative use is capitalized. Leased assets meeting certain finance lease criteria are capitalized and the present value of the related lease payments is recorded as a liability. Assets under finance lease arrangements are depreciated using the straight-line method over the estimated useful lives. Leasehold improvements are amortized over the economic life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The estimated useful lives of our capitalized assets are as follows: Estimated Useful Life Computer hardware and software 3 to 5 years Leasehold improvements 6 years Laboratory, manufacturing and office equipment 5 to 7 years Furniture and fixtures 10 years Long-Lived Assets We review long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected to generate. If the carrying value of the assets exceed their future net undiscounted cash flows, an impairment charge is recognized for the amount by which the carrying value of the assets exceeds the fair value of the assets. Intangible Assets, Net Definite-lived intangible assets related to capitalized milestones under license agreements are amortized on a straight-line basis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the product’s useful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is recorded as a component of cost of sales on the Consolidated Statements of Operations and Comprehensive Loss. Intangible assets are evaluated for impairment at least annually in the fourth quarter or more frequently if impairment indicators exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the decision to discontinue the development of a drug, the receipt of additional clinical or nonclinical data regarding our drug candidate or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales for the drug. In connection with any impairment assessment, the fair value of the intangible assets as of the date of assessment is compared to the carrying value of the intangible asset. Impairment losses are recognized if the carrying value of an intangible asset is both not recoverable and exceeds its fair value. Goodwill Goodwill was recorded as a result of the EOS acquisition in November 2013. Goodwill represents the excess of the purchase price over the fair value of net assets acquired in a business combination accounted for under the acquisition method of accounting and is not amortized, but is subject to impairment testing at least annually in the fourth quarter or when a triggering event is identified that could indicate a potential impairment. We are organized as two reporting units based on our operating segments, U.S. and ex-U.S. We determined that our goodwill was allocated to the U.S. reporting unit and performed impairment testing by assessing qualitative factors to determine whether it is more likely than not (that is, a likelihood of more than 50 percent) that the fair value of a reporting unit is less than its carrying amount. Based on our qualitative assessment, we determined that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount. Therefore, the quantitative goodwill impairment test is not necessary. There is no goodwill impairment as of December 31, 2020. Other Current Assets Other current assets are comprised of the following (in thousands): December 31, December 31, 2020 2019 Prepaid insurance $ 782 $ 505 Prepaid IT 753 698 Prepaid variable considerations 1,191 550 Prepaid expenses - other 2,193 2,821 Value-added tax ("VAT") receivable 2,202 11,920 Receivable - other 1,884 2,176 Other 125 177 Total $ 9,130 $ 18,847 Other Accrued Expenses Other accrued expenses are comprised of the following (in thousands): December 31, December 31, 2020 2019 Accrued personnel costs $ 18,334 $ 16,915 Accrued interest payable for convertible senior notes 2,991 5,903 Income tax payable 907 3,505 Accrued corporate legal fees and professional services 459 310 Accrued royalties 6,617 6,038 Accrued variable considerations 11,701 5,748 Accrued expenses - other 4,199 3,809 Total $ 45,208 $ 42,228 Segment Information As of December 31, 2020, we determined that we have two operating and reportable segments, U.S. and ex-U.S., based on product revenue by geographic areas since our product revenue outside of the United States represented 11% of total product revenue. We designated our reporting segments based on the internal reporting used by the Chief Operating Decision Maker (“CODM”), which is our Chief Executive Officer, for making decisions and assessing performance as the source of our reportable segments. The CODM allocates resources and assesses the performance of each operating segment based on product revenue by geographic areas. Accordingly, we view our business as two reportable operating segments to evaluate performance, allocate resources, set operational targets and forecast our future period financial results. We manage our assets on a company basis, not by segments, as many of our assets are shared or commingled. Our CODM does not regularly review asset information by reportable segment. The majority of long-lived assets for both segments are located in the United States. Research and Development Expense Research and development costs are charged to expense as incurred and include, but are not limited to, salary and benefits, share-based compensation, clinical trial activities, drug development and manufacturing, companion diagnostic development and third-party service fees, including contract research organizations and investigative sites. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred and are reflected on the Consolidated Balance Sheets as prepaid or accrued research and development expenses. Acquired In-Process Research and Development Expense We have acquired and expect to continue to acquire the rights to develop and commercialize new drug candidates. The upfront payments to acquire a new drug compound, as well as subsequent milestone payments, are immediately expensed as acquired in-process research and development provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Once regulatory approval is received, payments to acquire rights, and the related milestone payments, are capitalized and the amortization of such assets recorded to product cost of sales. Share-Based Compensation Expense Share-based compensation is recognized as expense for all share-based awards made to employees and directors and is based on estimated fair values. We determine equity-based compensation at the grant date using the Black-Scholes option pricing model. The value of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. Any changes to the estimated forfeiture rates are accounted for prospectively. Advertising Expense In connection with the FDA approval and commercial launch of Rubraca in 2016, we began to incur advertising costs. Advertising costs are expense when services are performed, or goods are delivered. We incurred $17.0 million, $21.2 million and $15.9 million in expense for the years ended December 31, 2020, 2019 and 2018, respectively. Legal Settlement Loss Following our regulatory announcement in November 2015 of adverse developments in our ongoing clinical trials for rociletinib, we and certain of our current and former executives were named in various securities lawsuits. As a result of these lawsuits, during 2019, we recorded a charge of $26.8 million to settle the Antipodean Complaint. During 2018, we recorded a charge of $8.0 million related to an agreement to resolve a potential litigation claim against us and our officers and we also recorded a charge of $20.0 million related to an agreement reached with the SEC to resolve its investigation. For the remaining actions related to rociletinib, see Note 13, Commitments and Contingencies Concentration of Credit Risk Financial instruments that potentially subject us to concentrations of credit risk are primarily cash, cash equivalents and available-for-sale securities. We maintain our cash and cash equivalent balances in the form of money market accounts with financial institutions that we believe are creditworthy. Available-for-sale securities are invested in accordance with our investment policy. The investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that we believe minimizes the exposure to concentration of credit risk. We have no financial instruments with off-balance sheet risk of accounting loss. Foreign Currency The assets and liabilities of our foreign operations are translated into U.S. dollars at current exchange rates and the results of operations are translated at the average exchange rates for the reported periods. The resulting translation adjustments are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise. Transaction gains and losses are recorded to foreign currency gains (losses) on the Consolidated Statements of Operations and Comprehensive Loss. As of December 31, 2020, and 2019, approximately 3% and 4%, respectively, of our total liabilities were denominated in currencies other than the functional currency. Income Taxes We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Tax benefits are recognized when it is more likely than not that a tax position will be sustained during an audit. Deferred tax assets are reduced by a valuation allowance if current evidence indicates that it is considered more likely than not that these benefits will not be realized. Recently Adopted Accounting Standards In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments”. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. We adopted ASU 2016-13 as of January 1, 2020. Upon the adoption of ASU 2016-13 on January 1, 2020, we are required to determine whether a decline in the fair value below the amortized cost basis (i.e., impairment) of an available-for-sale debt is security is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in accumulated other comprehensive loss, net of applicable taxes. When evaluating an impairment, entities may not use the length of time a security has been in an unrealized loss position as a factor, either by itself or in combination with other factors, to conclude that a credit loss does not exist. We applied this impairment model for available-for-sale debt securities as of January 1, 2020 and no impairment was recognized upon adoption. In addition, no impairment was recognized for the year ended December 31, 2020. We recognized a minimal allowance for credit losses related to our accounts receivable at December 31, 2020. The adoption of ASU 2016-13 did not materially impact our consolidated financial statements and disclosures. In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. We adopted ASU 2018-13 as of January 1, 2020 and there was no material impact on our consolidated financial statements and related disclosures. Recently Issued Accounting Standards From time to time, the FASB or other standards setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification (“ASC”) are communicated through issuance of an ASU. In August 2020, the FASB issued guidance that simplifies an issuer’s accounting for debt and equity instruments. The guidance is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early application is permitted. We plan to adopt this guidance on January 1, 2022. We will evaluate the impact this guidance may have on our consolidated financial statements and related disclosures as the adoption date approaches . |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2020 | |
Revenue Recognition | |
Revenue Recognition | 3. Revenue Recognition We are currently approved to sell Rubraca in the United States and Europe markets. We distribute our product principally through a limited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customers subsequently sell our products to patients and health care providers. We do not believe the loss of one of these customers would significantly impact the ability to distribute our product as we expect that sales volume would be absorbed evenly by the remaining customers. Separately, we have arrangements with certain payors and other third parties that provide for government-mandated and privately-negotiated rebates, chargebacks and discounts. Product Revenue Revenue from product sales are recognized when the performance obligation is satisfied, which is when customers obtain control of our product at a point in time, typically upon delivery. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from price concessions that include rebates, chargebacks, discounts, co-pay assistance, estimated product returns and other allowances that are offered within contracts between us and our customers, health care providers, payors and other indirect customers relating to the sales of our product. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable or a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we adjust these estimates, which would affect product revenue and earnings in the period such variances become known. Government Rebates GPO and Payor Rebates Chargebacks Discounts and Fees Co-pay assistance Returns For the year ended December 31, 2020, and 2019, we recognized $164.5 million and $143.0 million, respectively, of product revenue. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, certain of the costs of Rubraca units recognized as revenue during the year ended December 31, 2017 were expensed prior to the December 19, 2016 FDA approval, and a minimal amount was included in cost of sales during the year ended December 31, 2017. The majority of product sales were of pre-commercialization inventory in 2017. Cost of sales increased in 2018 in relation to product revenue as we depleted these inventories. Product revenue from each of our customers who individually accounted for 10% or more of total revenues, which were all customers in the U.S. segment, consisted of the following: December 31, December 31, 2020 2019 Customer A 21% 25% Customer B 14% 20% Customer C 18% 15% Customer D 11% 12% Customer E 10% 10% |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Property and Equipment | 4. Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2020 2019 Laboratory, manufacturing and office equipment $ 1,267 $ 1,290 Leasehold improvements 17,256 16,946 Furniture and fixtures 2,782 2,805 Computer hardware and software 1,835 1,699 Total property and equipment 23,140 22,740 Less: accumulated depreciation (11,055) (7,453) Total property and equipment, net $ 12,085 $ 15,287 Depreciation expense related to property and equipment was approximately $3.0 million, $3.0 million and $2.0 million for the years ended December 31, 2020, 2019 and 2018, respectively. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 5. Fair Value Measurements Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The three levels of inputs that may be used to measure fair value include: Level 1: Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consist of money market investments. We do not have Level 1 liabilities. Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Our Level 2 assets consist of U.S. treasury securities. We do not have Level 2 liabilities. Level 3: Unobservable inputs that are supported by little or no market activity. We do not have Level 3 assets or liabilities. The following table identifies our assets that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 December 31, 2020 Assets: Money market $ 147,921 $ 147,921 $ — $ — U.S. treasury securities — — — — Total assets at fair value $ 147,921 $ 147,921 $ — $ — December 31, 2019 Assets: Money market $ 61,882 $ 61,882 $ — $ — U.S. treasury securities 189,736 54,910 134,826 — Total assets at fair value $ 251,618 $ 116,792 $ 134,826 $ — There were no liabilities that were measured at fair value on a recurring basis as of December 31, 2020. Financial instruments not recorded at fair value include our convertible senior notes. At December 31, 2020, the carrying amount of the 2021 Notes was $64.2 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $59.8 million. At December 31, 2020, the carrying amount of the 2024 Notes (2019 Issuance) was $83.9 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $75.4 million. At December 31, 2020, the carrying amount of the 2024 Notes (2020 Issuance) was $56.6 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $49.1 million. At December 31, 2020, the carrying amount of the 2025 Notes was $294.3 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $211.1 million. The fair value was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the convertible senior notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system. See Note 10, Debt |
Available-for-Sale Securities
Available-for-Sale Securities | 12 Months Ended |
Dec. 31, 2020 | |
Available-for-Sale Securities | |
Available-for-Sale Securities | 6. Available-for-Sale Securities We did not have available-for-sale securities as of December 31, 2020. As of December 31, 2019, available-for-sale securities consisted of the following (in thousands): Gross Gross Aggregate Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $ 134,826 $ — $ — $ 134,826 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2020 | |
Inventories | |
Inventories | 7. Inventories The following table presents inventories as of December 31, 2020 and December 31, 2019 (in thousands): December 31, December 31, 2020 2019 Work-in-process $ 102,507 $ 104,139 Finished goods, net 32,330 20,433 Total inventories $ 134,837 $ 124,572 At December 31, 2020, we had $30.7 million of current inventory and $104.1 million of long-term inventory. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2020 | |
Intangible Assets | |
Intangible Assets | 8. Intangible Assets At December 31, 2020 and 2019, intangible assets related to capitalized milestones under license agreements consisted of the following (in thousands): December 31, December 31, 2020 2019 Intangible asset - milestones $ 79,850 $ 71,850 Accumulated amortization (14,107) (8,930) Total intangible asset, net $ 65,743 $ 62,920 The increase in our intangible asset – milestones since December 31, 2019 is due to an $8.0 million milestone payment to Pfizer related to the May 2020 FDA approval. See Note 14, License Agreements The estimated useful lives of these intangible assets are based on the estimated remaining patent life of Rubraca and extend through 2031 in Europe and 2035 in the U.S. We recorded amortization expense of $5.2 million and $4.8 million related to capitalized milestone payments during the year ended December 31, 2020 and December 31, 2019, respectively. Amortization expense is included in cost of sales – intangible asset amortization on the Consolidated Statements of Operations and Comprehensive Loss. Estimated future amortization expense for intangible assets as of December 31, 2020 is as follows (in thousands): 2021 $ 5,371 2022 5,371 2023 5,371 2024 5,371 2025 5,371 Thereafter 38,888 $ 65,743 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Leases | 9. Leases At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. We elected not to recognize on the balance sheet leases with terms of one year or less. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, we utilize the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term at an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, maintenance, consumables, etc.) and non-components (e.g. property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values assigned to the lease components and non-lease components. Our facilities operating leases have lease components, non-lease components and non-components, which we have separated because the non-lease components and non-components have variable lease payments and are excluded from the measurement of the lease liabilities. The lease component results in a right-of-use asset being recorded on the balance sheet and amortized as lease expense on a straight-line basis to the statements of operations. We lease all of our office facilities in the U.S. and Europe. Leases with an initial term of 12 months or less are not recorded on the balance sheet; we recognize lease expense for these leases on a straight-line basis over the lease term. Most leases include one or more options to renew. The exercise of lease renewal options is at our sole discretion. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants. We have a finance lease for certain equipment at the dedicated production train at Lonza, our non-exclusive manufacturer of the Rubraca API. The components of lease expense and related cash flows were as follows (in thousands): Year ended December 31, Year ended December 31, 2020 2019 Lease cost Finance lease cost: Amortization of right-of-use assets $ 1,895 $ 1,898 Interest on lease liabilities 816 759 Operating lease cost 4,649 4,003 Short-term lease cost 401 301 Variable lease cost 2,071 2,261 Total lease cost $ 9,832 $ 9,222 Operating cash flows from finance leases $ 816 $ 759 Operating cash flows from operating leases $ 4,649 $ 4,003 Financing cash flows from finance leases $ 1,470 $ 1,115 The weighted-average remaining lease term and weighted-average discount rate were as follows: December 31, 2020 December 31, 2019 Weighted-average remaining lease term (years) Operating leases 6.6 6.9 Finance leases 5.0 6.0 Weighted-average discount rate Operating leases 8% 8% Finance leases 8% 8% Future minimum commitments due under these lease agreements as of December 31, 2020 are as follows (in thousands): Operating Leases Finance Leases Total 2021 5,796 2,287 8,083 2022 5,308 2,287 7,595 2023 4,859 2,287 7,146 2024 4,868 2,287 7,155 2025 5,025 2,287 7,312 Thereafter 9,938 — 9,938 Present value adjustment (8,223) (2,036) (10,259) Present value of lease payments $ 27,571 $ 9,399 $ 36,970 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt | |
Debt | 10 . Debt The following is a summary of our convertible senior notes at December 31, 2020 and 2019 (principal amount in thousands): Principal Amount Principal Amount December 31, 2020 December 31, 2019 Interest Rate Due Date 2021 Notes $ 64,418 $ 97,188 2.50% September 15, 2021 2024 Notes (2019 Issuance) 85,782 263,000 4.50% August 1, 2024 2024 Notes (2020 Issuance) 57,500 — 4.50% August 1, 2024 2025 Notes 300,000 300,000 1.25% May 1, 2025 Total $ 507,700 $ 660,188 2021 Notes In September 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5% convertible senior notes due 2021 (the “2021 Notes”) resulting in net proceeds of $278.3 million after deducting offering expenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation, and the entire principal amount was recorded as a long-term liability on the Consolidated Balance Sheets. The 2021 Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The 2021 Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on March 15 September 15 Holders may convert all or any portion of the 2021 Notes at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 16.1616 shares per $1,000 in principal amount of 2021 Notes, equivalent to a conversion price of approximately $61.88 per share. The conversion rate is subject to adjustment upon the occurrence of certain events described in the indenture. In addition, following certain corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the 2021 Notes in connection with such a corporate event or during the related redemption period in certain circumstances. On or after September 15, 2018, we may redeem the 2021 Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the 2021 Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the 2021 Notes. If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the 2021 Notes, holders may require us to repurchase for cash all or any portion of the 2021 Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2021 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The 2021 Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the 2021 Notes; equal in right of payment to all of our liabilities that are not so subordinated; effectively junior in right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries. In connection with the issuance of the 2021 Notes, we incurred $9.2 million of debt issuance costs, of which $2.0 million of unamortized debt issuance costs were derecognized in connection with the repurchase of the 2021 Notes. The remaining debt issuance costs are presented as a deduction from the convertible senior notes on the Consolidated Balance Sheets and are amortized as interest expense over the expected life of the 2021 Notes using the effective interest method. We determined the expected life of the debt was equal to the seven-year term of the 2021 Notes. In August 2019, we entered into privately negotiated transactions with a limited number of holders to repurchase $190.3 million aggregate principal amount of our outstanding 2021 Notes for an aggregate repurchase price of $171.8 million, including accrued interest. This repurchase resulted in the recognition of $18.5 million gain on extinguishment of debt. In April 2020, we entered into a privately negotiated exchange agreement with a holder (“Holder”) of our 2021 Notes, pursuant to which we issued to such Holder of the 2021 Notes approximately $36.1 million in aggregate principal amount of our currently outstanding 2024 Notes (2019 Issuance) in exchange for approximately $32.8 million in aggregate principal of 2021 Notes held by such Holder (the “Exchange Transaction”), which resulted in a $3.3 million loss on extinguishment of debt. We did not receive any cash proceeds from the Exchange Transaction. 2024 Notes (2019 Issuance) In August 2019, we completed a private placement to qualified institutional buyers of $263.0 million aggregate principal amount of 4.50% convertible senior notes due 2024 (the “2024 Notes (2019 Issuance)”) resulting in net proceeds of $254.9 million, after deducting underwriting discounts and commissions and offering expenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation, and the entire principal amount was recorded as a long-term liability on the Consolidated Balance Sheets. The 2024 Notes (2019 Issuance) are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The 2024 Notes (2019 Issuance) are senior unsecured obligations and bear interest at a rate of 4.50% per year, payable semi-annually in arrears on February 1 August 1 Holders may convert all or any portion of the 2024 Notes (2019 Issuance) at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 137.2213 shares per $1,000 in principal amount of 2024 Notes (2019 Issuance), equivalent to a conversion price of approximately $7.29 per share. The conversion rate is subject to adjustment upon the occurrence of certain events described in the indenture. In addition, following certain corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the 2024 Notes (2019 Issuance) in connection with such a corporate event or during the related redemption period in certain circumstances. We will not have the right to redeem the 2024 Notes (2019 Issuance) prior to their maturity. If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the 2024 Notes (2019 Issuance), holders may require us to repurchase for cash all or any portion of the 2024 Notes (2019 Issuance) at a fundamental change repurchase price equal to 100% of the principal amount of the 2024 Notes (2019 Issuance) to be repurchased plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. No sinking fund is provided for the 2024 Notes (2019 Issuance). The 2024 Notes (2019 Issuance) rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the 2024 Notes (2019 Issuance); equal in right of payment to all of our liabilities that are not so subordinated, including the 2021 Notes and 2025 Notes; effectively junior in right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness, including our borrowing under the Sixth Street financing agreement; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries. In connection with the issuance of the 2024 Notes (2019 Issuance), we incurred $8.0 million of debt issuance costs. The debt issuance costs are presented as a deduction from the convertible senior notes on the Consolidated Balance Sheets and are amortized as interest expense over the expected life of the 2024 Notes (2019 Issuance) using the effective interest method. We determined the expected life of the debt was equal to the five-year term of the 2024 Notes (2019 Issuance). In January 2020, we completed a registered direct offering of an aggregate 17,777,679 shares of our common stock at a price of $9.25 per share to a limited number of holders of our 2024 Notes (2019 Issuance). We used the proceeds of the share offering to repurchase from such holders an aggregate of $123.4 million principal amount of 2024 Notes (2019 Issue) in privately negotiated transactions. In addition, we paid customary fees and expenses in connection with the transactions. As a result, $3.6 million of unamortized debt issuance costs were derecognized and we recognized a $7.8 million loss on the transactions. In April 2020, we completed the Exchange Transaction discussed in the 2021 Notes section above. The additional 2024 Notes (2019 Issuance) issued in the Exchange Transaction were issued as additional notes under that certain Indenture, dated as of August 13, 2019 (the “Indenture”), by and between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and have substantially identical terms to our currently outstanding 2024 Notes (2019 Issuance), except that the additional 2024 Notes (2019 Issuance) will accrue interest from February 1, 2020 and the initial interest payment date on the additional 2024 Notes (2019 Issuance) was August 1, 2020. The Holder paid to the Company accrued interest on the additional 2024 Notes (2019 Issue) from February 1, 2020 to and including April 20, 2020. The additional 2024 Notes (2019 Issuance) will be treated as a single series of securities with the currently outstanding 2024 Notes (2019 Issuance). In April and May 2020, approximately $24.3 million in principal amount of 2024 Notes (2019 Issuance) were converted into 3,331,870 shares of our common stock at the conversion rate of 137.2213 shares per $1,000 in principal amount of 2024 Notes (2019 Issuance). In November 2020, we entered into a privately negotiated exchange and purchase agreement with a holder of our 2024 Notes (2019 Issuance). Pursuant to the agreement, in exchange for approximately $64.8 million aggregate principal amount of 2024 Notes (2019 Issuance) held by the holder, we agreed to issue to the holder a number shares of our common stock (the “Exchanged Shares”) utilizing an exchange ratio that is based in part on the daily volume-weighted average prices (“VWAPs”) per share of our common stock during a seven-day pricing period following execution of the agreement. In addition, pursuant to the agreement, we sold to the holder $57.5 million aggregate principal amount of a new series of 4.50% Convertible Senior Notes due 2024 (the “2024 Notes (2020 Issuance)”) at a purchase price of The number of Exchanged Shares was calculated utilizing an exchange ratio that is based in part on the average VWAPs of our common stock (subject to a floor) during a seven-day pricing period beginning on November 5, 2020 and ending on, and including, November 13, 2020. In November 2020, we issued 2024 Notes (2020 Issuance) The 2024 Notes (2020 Issuance) are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The 2024 Notes (2020 Issuance) are senior unsecured obligations and bear interest at a rate of 4.50% per year, payable semi-annually in arrears on February 1 August 1 Holders may convert all or any portion of the 2024 Notes (2020 Issuance) at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 160.3334 shares per $1,000 in principal amount of 2024 Notes (2020 Issuance), equivalent to a conversion price of approximately $6.24 per share. The initial conversion price represents a premium of approximately 10% to the last reported sale price of $5.67 per share on November 4, 2020. The conversion rate is subject to adjustment upon the occurrence of certain events described in the indenture. In addition, following certain corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the 2024 Notes (2020 Issuance) in connection with such a corporate event or during the related redemption period in certain circumstances. We will not have the right to redeem the 2024 Notes (2020 Issuance) prior to their maturity. If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the 2024 Notes (2020 Issuance), holders may require us to repurchase for cash all or any portion of the 2024 Notes (2020 Issuance) at a fundamental change repurchase price equal to accrued and unpaid interest to, but excluding, the fundamental change repurchase date. No sinking fund is provided for the 2024 Notes (2020 Issuance). The 2024 Notes (2020 Issuance) rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the 2024 Notes (2020 Issuance); equal in right of payment to all of our liabilities that are not so subordinated, including the 2021 Notes, 2024 Notes (2019 Issuance) and 2025 Notes; effectively junior in right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness, including our borrowing under the Sixth Street financing agreement; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries. In connection with the issuance of the 2024 Notes (2020 Issuance), we incurred $0.9 million of debt issuance costs. The debt issuance costs are presented as a deduction from the convertible senior notes on the Consolidated Balance Sheets and are amortized as interest expense over the expected life of the 2024 Notes (2020 Issuance) using the effective interest method. We determined the expected life of the debt was equal to the four-year term of the 2024 Notes (2020 Issuance). 2025 Notes In April 2018, we completed an underwritten public offering of $300.0 million aggregate principal amount of 1.25% convertible senior notes due 2025 (the “2025 Notes”) resulting in net proceeds of $290.9 million, after deducting underwriting discounts and commissions and offering expenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation, and the entire principal amount was recorded as a long-term liability on the Consolidated Balance Sheets. The 2025 Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee, as supplemented by the terms of that certain first supplemental indenture thereto. The 2025 Notes are senior unsecured obligations and bear interest at a rate of 1.25% per year, payable semi-annually in arrears on May 1 November 1 Holders may convert all or any portion of the 2025 Notes at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 13.1278 shares per $1,000 in principal amount of 2025 Notes, equivalent to a conversion price of approximately $76.17 per share. The conversion rate is subject to adjustment upon the occurrence of certain events described in the indenture. In addition, following certain corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the 2025 Notes in connection with such a corporate event or during the related redemption period in certain circumstances. On or after May 2, 2022, we may redeem the 2025 Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the 2025 Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the 2025 Notes. If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the 2025 Notes, holders may require us to repurchase for cash all or any portion of the 2025 Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2025 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The 2025 Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the 2025 Notes; equal in right of payment to all of our liabilities that are not so subordinated, including the 2021 Notes; effectively junior in right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries. In connection with the issuance of the 2025 Notes, we incurred $9.1 million of debt issuance costs. The debt issuance costs are presented as a deduction from the convertible senior notes on the Consolidated Balance Sheets and are amortized as interest expense over the expected life of the 2025 Notes using the effective interest method. We determined the expected life of the debt was equal to the seven-year term of the 2025 Notes. As of December 31, 2020, and 2019, the balance of unamortized debt issuance costs related to the convertible senior notes was $8.7 million and $15.4 million, respectively. Maturities of our convertible notes consisted of the following as of December 31, 2020 (in thousands): 2021 $ 64,418 2022 — 2023 — 2024 143,282 2025 300,000 Thereafter — 507,700 Less debt issuance costs (8,656) Current portion (64,198) Long-term portion $ 434,846 Sixth Street Financing Agreement On May 1, 2019, we entered into a financing agreement (the “Financing Agreement”) with certain affiliates of Sixth Street Partners, LLC (“Sixth Street”) in which we plan to borrow from Sixth Street amounts required to reimburse our actual costs and expenses incurred during each fiscal quarter (limited to agreed budgeted amounts), as such expenses are incurred, related to the ATHENA clinical trial, in an aggregate amount of up to $175 million (the amount actually borrowed, the “Borrowed Amount”). ATHENA is our largest clinical trial, with a planned target enrollment of 1,000 patients across more than 270 sites in at least 25 countries. The Clovis-sponsored phase 3 ATHENA study in advanced ovarian cancer is the first-line maintenance treatment setting evaluating Rubraca plus nivolumab (PD-1 inhibitor), Rubraca, nivolumab and a placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. This study initiated in the second quarter of 2018 and completed enrollment during the second quarter of 2020. We incur borrowings under the Financing Agreement on a quarterly basis, beginning with such expenses incurred during the quarter ended March 31, 2019 and ending generally on the earliest to occur of (i) the termination of the ATHENA Trial, (ii) the date of completion of all activities under the ATHENA Trial Clinical Study Protocol, (iii) the date on which we pay the Discharge Amount (as defined in the Financing Agreement), (iv) the date of the occurrence of a change of control of us (or a sale of all or substantially all of our assets related to Rubraca) or our receipt of notice of certain breaches by us of our obligations under material in-license agreements related to Rubraca and (v) September 30, 2022. We are obligated to repay on a quarterly basis, beginning on the earliest to occur of (i) the termination of the ATHENA Trial, (ii) the approval by the FDA of an update to the label portion of the Rubraca new drug application (“NDA”) to include in such label the treatment of an indication resulting from the ATHENA Trial, (iii) the date on which we determine that the results of the ATHENA Trial are insufficient to achieve such an expansion of the Rubraca label to cover an indication based on the ATHENA Trial and (iv) September 30, 2022 (the “Repayment Start Date”). ● 9.75% (which rate may be increased incrementally up to approximately 10.25% in the event the Borrowed Amount exceeds $166.5 million) of the direct Rubraca net sales recorded by us and our subsidiaries worldwide and our future out-licensees in the United States, if any, during such quarter; ● 19.5% of any royalty payments received by us and our subsidiaries during such quarter based on the sales of Rubraca by our future out-licensees outside the United States, if any; and ● 19.5% of any other amounts received by us and our subsidiaries in connection with any other commercialization arrangement for Rubraca, including any upfront and milestone payments and proceeds of infringement claims (which payments are not subject to the caps described below). Quarterly payments are capped at $8.5 million, unless the label portion of the Rubraca NDA is expanded by the FDA to include such label the treatment of an indication resulting from the ATHENA Trial, in which case the quarterly payment is capped at $13.5 million. In the event the aggregate Borrowed Amount exceeds $166.5 million, such quarterly limits will be incrementally increased to a maximum of approximately $8.94 million and $14.19 million, respectively. The maximum amount required to be repaid under the agreement is two times the aggregate Borrowed Amount, which may be $350 million in the event we borrow the full $175 million under the Financing Agreement. In the event we have not made payments on or before December 30, 2025 equal to at least the Borrowed Amount, we are required to make a lump sum payment in an amount equal to such Borrowed Amount less the aggregate of all prior quarterly payments described above. All other payments are contingent on the performance of Rubraca. There is no final maturity date on the Financing Agreement. Our obligations under the Financing Agreement are secured under a Pledge and Security agreement by a first priority security interest in all of our assets related to Rubraca, including intellectual property rights and a pledge of the equity of our wholly owned subsidiaries, Clovis Oncology UK Limited and Clovis Oncology Ireland Limited. In addition, the obligations are guaranteed by Clovis Oncology UK Limited and Clovis Oncology Ireland Limited, secured by a first priority security interest in all the assets of those subsidiaries. Pursuant to the Financing Agreement, we have agreed to certain limitations on our operations, including limitations on making certain restricted junior payments, including payment of dividends, limitation on liens and certain limitations on the ability of our non-guarantor subsidiaries to own certain assets related to Rubraca and to incur indebtedness. We may terminate the Financing Agreement at any time by paying the lenders an amount (the “Discharge Amount”) equal to the sum of (a) (A) the greater of (x) the Borrowed Amount plus (i) if such date is during calendar year 2019, $35.0 million or (ii) if such date is during calendar year 2020 or thereafter, $50.0 million and (y) (i) if such date is prior to the Repayment Start Date, 1.75 times the Borrowed Amount or (ii) if such date is after the Repayment Start Date, 2.00 times the Borrowed Amount minus (B) the aggregate amount of all quarterly payments previously paid to the lenders plus (b) all other obligations which have accrued but which have not been paid under the loan documents, including expense reimbursement. In the event of (i) a change of control of us, we must pay the Discharge Amount to the lenders and (ii) an event of default under the Financing Agreement (which includes, among other events, breaches or defaults under or terminations of our material in-license agreements related to Rubraca and defaults under our other material indebtedness), the lenders have the right to declare the Discharge Amount to be immediately due and payable. For the year ended December 31, 2020, we recorded $110.9 million as a long-term liability on the Consolidated Balance Sheets and future quarterly draws will be recorded as a long-term liability on the Consolidated Balance Sheets. In connection with the transaction, we incurred $1.8 million of debt issuance costs. The debt issuance costs are presented as a deduction from the Sixth Street financing liability on the Consolidated Balance Sheets and are amortized as interest expense over the expected life of the Financing Agreement using the straight-line method. As of December 31, 2020, the balance of unamortized debt issuance costs was $1.5 million. For the year ended December 31, 2020, we used an effective interest rate of 14.6%. For subsequent periods, we will use the prospective method whereby a new effective interest rate is determined based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. Under this method, the effective interest rate is not constant, and any change in expected cash flows is recognized prospectively as an adjustment to the effective yield. Expected maturities of our Financing Agreement consisted of the following as of December 31, 2020 (in thousands): 2021 $ — 2022 8,934 2023 41,091 2024 45,532 2025 16,820 Thereafter — 112,377 Less debt issuance costs (1,460) Current portion — Long-term portion $ 110,917 The following table sets forth total interest expense recognized during the years ended December 31, 2020, 2019 and 2018 (in thousands): Year ended December 31, 2020 2019 2018 Interest on convertible notes $ 11,934 $ 13,680 $ 9,812 Amortization of debt issuance costs 2,672 2,858 2,178 Debt issuance cost derecognized related to convertible debt transactions 4,345 — — Interest on finance lease 816 759 — Interest on borrowings under ATHENA financing agreement 10,624 1,997 — Accretion of interest on milestone liability — — 977 Interest on capital lease liability — — 216 Other interest 117 111 — Total interest expense $ 30,508 $ 19,405 $ 13,183 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity | |
Stockholders' Equity | 11 . Stockholders’ Equity Common Stock In April 2018, we sold 1,837,898 shares of our common stock in a public offering at $54.41 per share. The net proceeds from the offering were $93.9 million, after deducting underwriting discounts and commissions and offering expenses. In May 2020, we sold 11,090,000 shares of our common stock in a public offering at $8.05 per share. The net proceeds from the offering were $82.8 million, after deducting underwriting discounts and commissions and offering expenses. The holders of common stock are entitled to one vote per share on all matters to be voted upon by our stockholders. Subject to the preferences that may be applicable to any outstanding shares of preferred stock, the holders of common stock are entitled to receive ratably such dividends, if any, as may be declared by our board of directors. Accumulated Other Comprehensive Loss Accumulated other comprehensive loss consists of changes in foreign currency translation adjustments, which includes changes in a subsidiary’s functional currency, and unrealized gains and losses on available-for-sale securities. The changes in accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands): Foreign Currency Unrealized Total Accumulated Translation Adjustments (Losses) Gains Other Comprehensive Loss Balance at December 31, 2018 $ (44,460) $ (174) $ (44,634) Other comprehensive income (loss) (272) 41 (231) Total before tax (44,732) (133) (44,865) Tax effect — — — Balance at December 31, 2019 (44,732) (133) (44,865) Other comprehensive income (loss) 567 (6) 561 Total before tax (44,165) (139) (44,304) Tax effect — — — Balance at December 31, 2020 $ (44,165) $ (139) $ (44,304) The period change in each of the periods was primarily due to the foreign currency translation of the goodwill and deferred income taxes associated with the acquisition of EOS in November 2013. There were no reclassifications out of accumulated other comprehensive loss in the years ended December 31, 2020, 2019 and 2018. Effective October 1, 2018, substantially all assets and activities related to EOS were transferred from our Italian subsidiary to the U.S. This had the impact of changing the functional currency of goodwill from the Euro to USD. Therefore, the balance of goodwill will no longer change due to foreign currency gains and losses. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-Based Compensation | |
Share-Based Compensation | 12. Share-Based Compensation Stock Options In April 2020, our board of directors approved the 2020 Stock Incentive Plan (the “2020 Plan”), which became effective upon approval. The 2020 Plan provides for the grant of nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other share-based awards to our employees and directors (collectively, “awards”). Common shares authorized for issuance under the 2020 Plan were 6,470,00 three In August 2011, our board of directors approved the 2011 Stock Incentive Plan (the “2011 Plan”), which became effective upon the closing of our initial public offering in November 2011. The 2011 Plan provides for the granting of incentive and nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other share-based awards to our employees and directors. Stock options granted vest ratably over either a one-year period or three-year period for Board of Director grants. Employee stock options generally vest over a four-year period with 25% of the options cliff-vesting after year one and the remaining options vesting ratably over each subsequent month. All stock options expire 10 years from the date of grant. The adoption of the 2020 Plan did not affect the terms and conditions of any outstanding awards granted under the 2011 Plan. Upon the adoption of the 2020 Plan, no future grants will be granted under the 2011 Plan, but the 2011 Plan will remain in effect with respect to outstanding awards granted thereunder. Share-based compensation expense for the years ended December 31, 2020, 2019 and 2018, respectively, was recognized in the accompanying Consolidated Statements of Operations and Comprehensive Loss as follows (in thousands): Year ended December 31, 2020 2019 2018 Research and development $ 25,577 $ 25,838 $ 20,489 Selling, general and administrative 25,217 28,466 28,601 Total share-based compensation expense $ 50,794 $ 54,304 $ 49,090 We did not recognize a tax benefit related to share-based compensation expense during the years ended December 31, 2020, 2019 and 2018 as we maintain net operating loss carryforwards and have established a valuation allowance against the entire net deferred tax asset as of December 31, 2020. The following table summarizes the activity relating to our options to purchase common stock: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Options Price Term (Years) (Thousands) Outstanding at December 31, 2019 6,287,025 $ 42.24 Granted 980,592 7.35 Exercised (117,932) 3.23 Forfeited (649,016) 41.15 Outstanding at December 31, 2020 6,500,669 $ 37.79 5.6 $ 127 Vested and expected to vest at December 31, 2020 6,371,758 $ 38.24 5.5 $ 118 Vested and exercisable at December 31, 2020 5,026,455 $ 43.87 4.7 $ 31 The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price of $4.80 as of December 31, 2020, which would have been received by the option holders had all option holders with in-the-money options exercised their options as of that date. The following table summarizes information about our stock options as of and for the years ended December 31, 2020, 2019 and 2018 (in thousands, except weighted-average grant date fair value per share): Year ended December 31, 2020 2019 2018 Weighted-average grant date fair value per share $ 5.67 $ 13.53 $ 32.09 Intrinsic value of options exercised $ 381 $ 1,525 $ 1,714 Cash received from stock option exercises $ 236 $ 1,361 $ 1,869 As of December 31, 2020, the unrecognized share-based compensation expense related to unvested options, adjusted for expected forfeitures, was $18.1 million and the estimated weighted-average remaining vesting period was 1.5 years. The fair value of each share-based award is estimated on the grant date using the Black-Scholes option pricing model based upon the weighted-average assumptions provided in the following table: Year ended December 31, 2020 2019 2018 Dividend yield — — — Volatility (a) 99 % 93 % 88 % Risk-free interest rate (b) 0.49 % 1.67 % 2.92 % Expected term (years) (c) 6.0 5.9 5.9 (a) Volatility : The expected volatility was estimated using our historical data. (b) Risk-free interest rate: The rate is based on the yield on the grant date of a zero-coupon U.S. Treasury bond whose maturity period approximates the option’s expected term. (c) Expected term: The expected term of the award was estimated using our historical data. The total fair value of stock options vested during the years ended December 31, 2020, 2019 and 2018 was $22.4 million, $32.8 million and $43.3 million, respectively. Restricted Stock Beginning in 2016, we issued restricted stock units (“RSUs”) to certain employees under the 2011 Plan and 2020 Plan. The RSUs vest either (i) over two years, with 50% vesting one year from the date of grant and the remaining 50% vesting two years from the date of grant or (ii) over four years, with 25% vesting one year from the date of grant and the remaining 75% vesting ratably each subsequent quarter over the following three years, as defined in the grant agreement. Vested RSUs are payable in shares of our common stock at the end of the vesting period. RSUs are measured based on the fair value of the underlying stock on the grant date. The minimum statutory tax on the value of common stock shares issued to employees upon vesting are paid by us through the sale of registered shares of our common stock. The following table summarizes the activity related to our unvested RSUs: Weighted Average Number of Grant Date Units Fair Value Unvested at December 31, 2019 2,171,347 $ 28.37 Granted 2,441,804 8.21 Vested (1,012,699) 28.85 Forfeited (636,905) 15.51 Unvested at December 31, 2020 2,963,547 $ 14.36 Expected to vest after December 31, 2020 2,862,148 $ 14.09 As of December 31, 2020, the unrecognized share-based compensation expense related to RSUs, adjusted for expected forfeitures, was $33.6 million and the estimated weighted-average remaining vesting period was 2.2 years. Common Stock Reserved for Issuance As of December 31, 2020, we reserved shares of common stock for future issuance as follows: Available for Grant Total Shares of Common Stock or Future Common Stock Outstanding Issuance Reserved 2009 Equity Incentive Plan 64,522 — 64,522 2011 Stock Incentive Plan 8,878,976 — 8,878,976 2020 Stock Incentive Plan 520,718 5,949,282 6,470,000 2011 Employee Stock Purchase Plan — 361,656 361,656 Total 9,464,216 6,310,938 15,775,154 Employee Stock Purchase Plan In August 2011, our board of directors approved the Clovis Oncology, Inc. 2011 Employee Stock Purchase Plan (the “Purchase Plan”). Each year, on the date of our annual meeting of stockholders and at the discretion of our board of directors, the amount of shares reserved for issuance under the Purchase Plan may be increased by up to the lesser of (1) a number of additional shares of our common stock representing 1% of our then-outstanding shares of common stock, (2) 344,828 shares of our common stock and (3) a lesser number of shares as approved by the Board. The Purchase Plan provides for consecutive six-month offering periods, during which participating employees may elect to have up to 10% of their compensation withheld and applied to the purchase of common stock at the end of each offering period. The purchase price of the common stock is 85% of the lower of the fair value of a share of common stock on the first trading date of each offering period or the fair value of a share of common stock on the last trading day of the offering period. The Purchase Plan will terminate on August 24, 2021, the tenth anniversary of the date of initial adoption of the Purchase Plan. We sold 283,588 and 175,634 shares to employees in 2020 and 2019, respectively. There were 361,656 shares available for sale under the Purchase Plan as of December 31, 2020. The weighted-average estimated grant date fair value of purchase awards under the Purchase Plan during the years ended December 31, 2020 and 2019 was $4.63 and $6.60 per share, respectively. The total share-based compensation expense recorded as a result of the Purchase Plan was approximately $1.1 million, $1.0 million and $0.9 million during the years ended December 31, 2020, 2019 and 2018, respectively. The fair value of purchase awards granted to our employees during the years ended December 31, 2020, 2019 and 2018 was estimated using the Black-Scholes option pricing model based upon the weighted-average assumptions provided in the following table: Year ended December 31, 2020 2019 2018 Dividend yield — — — Volatility (a) 138 % 79 % 51 % Risk-free interest rate (b) 0.90 % 2.20 % 1.90 % Expected term (years) (c) 0.5 0.5 0.5 (a) Volatility : The expected volatility was estimated using our historical data. (b) Risk-free interest rate: The rate is based on the U.S. Treasury yield in effect at the time of grant with terms similar to the contractual term of the purchase right. (c) Expected term: The expected life of the award represents the six-month offering period for the Purchase Plan . |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 13 . Commitments and Contingencies Manufacture and Services Agreement Commitments On October 3, 2016, we entered into a Manufacturing and Services Agreement (the “Agreement”) with a non-exclusive third-party supplier for the production of the active ingredient for Rubraca. Under the terms of the Agreement, we will provide the third-party supplier a rolling forecast for the supply of the active ingredient in Rubraca that will be updated by us on a quarterly basis. We are obligated to order material sufficient to satisfy an initial quantity specified in a forecast. In addition, the third-party supplier has constructed, in its existing facility, a production train that will be exclusively dedicated to the manufacture of the Rubraca active ingredient. We made scheduled capital program fee payments toward capital equipment and other costs associated with the construction of the dedicated production train. Beginning in the fourth quarter of 2018, once the facility was operational, we were obligated to pay a fixed facility fee each quarter for the duration of the Agreement, which expires on December 31, 2025, unless extended by mutual consent of the parties. As of December 31, 2020, $68.1 million of purchase commitments remain under the Agreement. At the time we entered into the Agreement, we evaluated the Agreement as a whole and bifurcated into lease and non-lease components, which consisted of an operating lease of warehouse space, capital lease of equipment, purchase of leasehold improvements and manufacturing costs based upon the relative fair values of each of the deliverables. During October 2018, the production train was placed into service and we recorded the various components of the Agreement. Legal Proceedings We and certain of our officers were named as defendants in several lawsuits, as described below. We cannot reasonably predict the outcome of these legal proceedings, nor can we estimate the amount of loss or range of loss, if any, that may result. An adverse outcome in these proceedings could have a material adverse effect on our results of operations, cash flows or financial condition. Rociletinib-Related Litigation Following Clovis’ regulatory announcement in November 2015 of adverse developments in its ongoing clinical trials for rociletinib, Clovis and certain of its current and former executives were named in various securities lawsuits, the largest of which was a putative class action lawsuit in the District of Colorado (the “Medina Action”) which was settled on October 26, 2017 (the “Medina Settlement”). The remaining actions are discussed below. In March 2017, two putative shareholders of the Company, Macalinao and McKenry (the “Derivative Plaintiffs”), filed shareholder derivative complaints against certain directors and officers of the Company in the Court of Chancery of the State of Delaware. On May 4, 2017, the Macalinao and McKenry actions were consolidated for all purposes in a single proceeding under the caption In re Clovis Oncology, Inc. Derivative Litigation, Case No, 2017-0222 (the “Consolidated Derivative Action”). On May 18, 2017, the Derivative Plaintiffs filed a Consolidated Verified Shareholder Derivative Complaint (the “Consolidated Derivative Complaint”). The Consolidated Derivative Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company by allegedly causing or allowing misrepresentations of the Company’s business operations and prospects, failing to ensure that the TIGER-X clinical trial was being conducted in accordance with applicable rules, regulations and protocols, and engaging in insider trading. The Consolidated Derivative Complaint sought, among other things, an award of money damages. On July 31, 2017, the defendants filed a motion to dismiss the Consolidated Derivative Complaint. Plaintiffs filed an opposition to the motion to dismiss on August 31, 2017, and the defendants filed a reply in further support of the motion to dismiss on September 26, 2017. While the motion to dismiss remained pending, on November 19, 2018, Plaintiffs filed a motion for leave to file a supplemental consolidated complaint, and on November 20, 2018, the Court granted that motion. On November 27, 2018, Plaintiffs filed their supplemental complaint (the “Supplemental Derivative Complaint”), which adds allegations concerning the Company’s, Mr. Mahaffy’s and Mr. Mast’s settlements with the United States Securities and Exchange Commission. Pursuant to a briefing schedule entered by the Court, the defendants filed a supplemental motion to dismiss the Supplemental Derivative Complaint on February 6, 2019; plaintiffs filed an opposition brief on February 22, 2019; and the defendants filed a reply brief on March 5, 2019. The Court held oral arguments on the defendants’ motions to dismiss on June 19, 2019. At the oral arguments, the Court ordered the parties to submit supplemental letter briefs on the motion to dismiss. On October 1, 2019, Vice Chancellor Joseph R. Slights III of the Delaware Chancery Court, issued a Memorandum Opinion granting in part and denying in part defendants’ motions to dismiss. The Supplemental Derivative Complaint was dismissed as to Plaintiffs’ derivative claims for unjust enrichment and insider trading. The Court allowed Plaintiffs’ remaining derivative claim for breach of fiduciary duty to proceed. Defendants filed an answer to the Supplemental Derivative Complaint on December 27, 2019. On December 17, 2019, the parties participated in a mediation, which did not result in a settlement. On December 22, 2019, the Company’s board of directors formed a Special Litigation Committee (the “SLC”) to conduct an investigation of the claims asserted in the Supplemental Derivative Complaint. On February 18, 2020, the SLC moved to stay all proceedings in the Consolidated Derivative Action pending completion of its investigation. Plaintiffs filed their opposition to the motion to stay on March 3, 2020 and the SLC filed its reply on March 13, 2020. On May 12, 2020, after hearing oral argument, Vice Chancellor Slights granted the SLC’s motion to stay proceedings until September 18, 2020 so that the SLC may complete its investigation. On September 11, 2020, Vice Chancellor Slights granted the parties’ request to extend the stay until October 31, 2020, to allow the SLC further time to complete its investigation. On October 26, 2020, Vice Chancellor Slights granted the parties’ request to further extend the stay until November 15, 2020. On November 13, 2020, vice Chancellor Slights granted the parties’ request to further extend the stay until December 15, 2020. On December 16, 2020, the SLC filed a report (the “SLC Report”) containing the findings of its investigation. The SLC Report concludes that the claims asserted in the Consolidated Derivative Action lack merit. Specifically, the SLC Report finds that the defendants did not breach their fiduciary duties in connection with the Company’s TIGER-X clinical trial. Accordingly, on the same date that the SLC Report was filed, the SLC filed a motion to terminate the Consolidated Derivative Action in Delaware Chancery Court. A briefing schedule on the motion to terminate has not yet been set. While the motion to terminate remains pending before Vice Chancellor Slights, the Company does not believe this litigation will have a material impact on its financial position or results of operations. European Patent Opposition Two European patents in the rucaparib camsylate salt/polymorph patent family (European Patent 2534153 and its divisional European Patent 3150610) were opposed. In particular, opposition notices against European Patent 2534153 were filed by two parties on June 20, 2017. During an oral hearing that took place on December 4, 2018, the European Patent Office’s Opposition Division maintained European Patent 2534153 in amended and narrowed form with claims to certain crystalline forms of rucaparib camsylate, including, but not limited to, rucaparib S-camsylate Form A, the crystalline form in Rubraca. Clovis and |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2020 | |
License Agreements | |
License Agreements | 14. License Agreements Rubraca In June 2011, we entered into a license agreement with Pfizer to obtain the exclusive global rights to develop and commercialize Rubraca. The exclusive rights are exclusive even as to Pfizer and include the right to grant sublicenses. Pursuant to the terms of the license agreement, we made a $7.0 million upfront payment to Pfizer and are required to make additional payments to Pfizer for the achievement of certain development and regulatory and sales milestones and royalties on sales as required by the license agreement. Prior to the FDA approval of Rubraca, we made milestone payments of $1.4 million, which were recognized as acquired in-process research and development expense. On August 30, 2016, we entered into a first amendment to the worldwide license agreement with Pfizer, which amends the June 2011 existing worldwide license agreement to permit us to defer payment of the milestone payments payable upon (i) FDA approval of an NDA for 1 st st On December 19, 2016, Rubraca received its initial FDA approval. This approval resulted in a $0.75 million milestone payment to Pfizer as required by the license agreement, which was paid in the first quarter of 2017. This FDA approval also resulted in an obligation to pay a $20.0 million milestone payment, for which we exercised the option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDA approval. We paid the $23.0 million milestone payment in June 2018. In April 2018, Rubraca received a second FDA approval. This approval resulted in an obligation to pay a $15.0 million milestone payment, which we paid in April 2018. In May 2018, Rubraca received its initial European Commission marketing authorization. This approval resulted in an obligation to pay a $20.0 million milestone payment, which we paid in June 2018. In January 2019, Rubraca received a second European Commission approval. This approval resulted in an obligation to pay a $15.0 million milestone payment, which we paid in February 2019. In June 2019, we paid a $0.75 million milestone payment due to the launch of Rubraca as maintenance therapy in Germany in March 2019. In May 2020, Rubraca received a third FDA approval for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 These milestone payments were recognized as intangible assets and are amortized over the estimated remaining useful life of Rubraca. We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize Rubraca and we are responsible for all ongoing development and commercialization costs for Rubraca. We are required to make regulatory milestone payments to Pfizer of up to an additional $8.0 million in aggregate if specified clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, we are obligated to make sales milestone payments to Pfizer if specified annual sales targets for Rubraca are met, which relate to annual sales targets of $250.0 million and above, which, in the aggregate, could amount to total milestone payments of $170.0 million, and tiered royalty payments at a mid-teen percentage rate on net sales, with standard provisions for royalty offsets to the extent we need to obtain any rights from third parties to commercialize Rubraca. The license agreement with Pfizer will remain in effect until the expiration of all of our royalty and sublicense revenue obligations to Pfizer, determined on a product-by-product and country-by-country basis, unless we elect to terminate the license agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specified time periods, Pfizer can terminate the agreement, resulting in a loss of our rights to Rubraca and an obligation to assign or license to Pfizer any intellectual property rights or other rights we may have in Rubraca, including our regulatory filings, regulatory approvals, patents and trademarks for Rubraca. In April 2012, we entered into a license agreement with AstraZeneca to acquire exclusive rights associated with Rubraca under a family of patents and patent applications that claim methods of treating patients with PARP inhibitors in certain indications. The license enables the development and commercialization of Rubraca for the uses claimed by these patents. AstraZeneca also receives royalties on net sales of Rubraca. Lucitanib On November 19, 2013, we acquired all of the issued and outstanding capital stock of EOS pursuant to the terms set forth in that certain Stock Purchase Agreement, dated as of November 19, 2013 (the “Stock Purchase Agreement”), by and among the Company, EOS, its shareholders (the “Sellers”) and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’ representative. Following the acquisition, EOS became a wholly-owned subsidiary of the Company. Under the terms of the Stock Purchase Agreement, in addition to the initial purchase price paid at the time of the closing of the acquisition and other license fees due to Advenchen described below, we will also be obligated to pay to the Sellers a milestone payment of $65.0 million upon obtaining the first NDA approval from the FDA with respect to lucitanib. In October 2008, Ethical Oncology Science, S.p.A. (“EOS”) (now known as Clovis Oncology Italy S.r.l.) entered into an exclusive license agreement with Advenchen Laboratories LLC (“Advenchen”) to develop and commercialize lucitanib on a global basis, excluding China. We are obligated to pay Advenchen tiered royalties at percentage rates in the mid-single digits on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, after giving effect to the first and second amendments to the license agreement, we are required to pay to Advenchen 25% of any consideration, excluding royalties, we receive from sublicensees, in lieu of the milestone obligations set forth in the agreement. We are obligated under the agreement to use commercially reasonable efforts to develop and commercialize at least one product containing lucitanib, and we are also responsible for all remaining development and commercialization costs for lucitanib. The license agreement with Advenchen will remain in effect until the expiration of all of our royalty obligations to Advenchen, determined on a product-by-product and country-by-country basis, unless we elect to terminate the agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specified time periods, Advenchen can terminate the agreement, resulting in a loss of our rights to lucitanib. FAP-2286 and the Radionuclide Therapy Development Program In September 2019, we entered into a global license and collaboration agreement with 3BP to develop and commercialize a PTRT and imaging agent targeting FAP. The lead candidate, designated internally as FAP-2286, is being developed pursuant to a global development plan agreed to by the parties. We are responsible for the costs of all preclinical and clinical development activities described in the plan, including the costs for a limited number of 3BP full-time equivalents and external costs incurred during the preclinical development phase of the collaboration. Upon the signing of the license and collaboration agreement in September 2019, we made a $9.4 million upfront payment to 3BP, which we recognized as acquired in-process research and development expense. Pursuant to the terms of the FAP agreement, we are required to make additional payments to 3BP for annual technology access fees and upon the achievement of certain development and regulatory milestone events (or on certain dates, whichever occur earlier). We are also obligated to pay 3BP single- to low-double-digit royalties on net sales of the FAP-targeted therapeutic product and imaging agent, based on the volume of annual net sales achieved. In addition, 3BP is entitled to receive 34% of any consideration, excluding royalties on the therapeutic product, pursuant to any sublicenses we may grant. We are obligated under the license and collaboration agreement to use diligent efforts to develop FAP-2286 and commercialize a FAP-targeted therapeutic product and imaging agent, and we are responsible for all commercialization costs in our territory. The agreement with 3BP will remain in effect until the expiration of our royalty obligations to 3BP, determined on a product-by-product and country-by-country basis, unless we elect to terminate the agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specified time periods, 3BP can terminate the agreement, resulting in a loss of our rights. 3BP also has the right to terminate the agreement under certain circumstances in connection with our change of control in which the acquiring party retains a product competitive with the FAP-targeted therapeutic product or, in the event marketing authorization has not yet been obtained, does not agree to the then-current global development plan. In February 2020, we finalized the terms of a drug discovery collaboration agreement with 3BP to identify up to three additional, undisclosed targets for peptide-targeted radionuclide therapy, to which we will obtain global rights for any resulting product candidates. We are responsible for the costs of all preclinical and clinical development activities conducted under the discovery program, including the costs for a limited number of 3BP full-time equivalents and external costs incurred during the discovery and preclinical development phase for each collaboration target. The discovery collaboration agreement was effective December 31, 2019, for which we incurred a $2.1 million technology access fee, which we accrued and recognized as a research and development expense. Pursuant to the terms of the discovery collaboration agreement, we are required to make additional payments to 3BP for annual technology access fees and upon the achievement of certain development and regulatory milestone events (or on certain dates, whichever occur earlier). We are also obligated to pay 3BP a 6% royalty on net sales of License Products (as defined in the agreement), based on the volume of quarterly net sales achieved. We are obligated under the discovery collaboration agreement to use diligent efforts to develop and commercialize the product candidates, if any, that result from the discovery program, and we are responsible for all clinical development and commercialization costs. The agreement with 3BP will remain in effect until the expiration of our royalty obligations to 3BP, determined on a product-by-product and country-by-country basis, unless we elect to terminate the agreement earlier. If we fail to meet our obligations under the agreement and are unable to cure such failure within specified time periods, 3BP can terminate the agreement, resulting in a loss of our rights. |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2020 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 15. Net Loss Per Common Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding using the treasury-stock method for the stock options and RSUs and the if-converted method for the convertible senior notes. As a result of our net losses for the periods presented, all potentially dilutive common share equivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share. The shares outstanding at the end of the respective periods presented in the table below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in thousands): Year ended December 31, 2020 2019 2018 Common shares under stock incentive plans 3,095 2,480 1,319 Convertible senior notes 25,969 41,598 8,584 Total potential dilutive shares 29,064 44,078 9,903 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Income Taxes | 16. Income Taxes We are subject to U.S. federal, state and foreign income tax. Year ended December 31, 2020 2019 2018 Domestic $ (370,839) $ (399,497) $ (368,402) Foreign 1,080 871 1,001 Total loss before income taxes $ (369,759) $ (398,626) $ (367,401) The income tax provision consists of the following current and deferred tax expense (benefit) amounts (in thousands): Year ended December 31, 2020 2019 2018 Current tax: U.S. Federal & State $ 50 $ 3 $ 15 Foreign (597) 1,795 593 Total current expense (benefit) (547) 1,798 608 Deferred tax: U.S. Federal & State — — — Foreign — — — Total deferred (benefit) — — — Total income tax expense (benefit) $ (547) $ 1,798 $ 608 A reconciliation of the U.S. federal statutory income tax rate to our effective tax rate is provided below: Year ended December 31, 2020 2019 2018 Federal income tax benefit at statutory rate (21.0) % (21.0) % (21.0) % State income tax benefit, net of federal benefit (1.6) (2.9) (3.1) Tax credits (1.5) (1.1) (1.3) Change in uncertain tax positions 0.1 (4.3) 0.1 SEC settlement costs — — 1.1 Convertible debt transactions 2.2 — — Prior year true ups 0.9 0.1 (0.8) Share based compensation 2.6 2.3 0.8 Tax rate changes 1.4 0.1 0.3 Change in valuation allowance 16.1 26.5 23.2 Other 0.6 0.8 0.9 Effective income tax rate (0.2) % 0.5 % 0.2 % The significant components of our deferred tax assets and liabilities are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforward $ 414,932 $ 396,100 Tax credit carryforwards 247,064 243,901 Interest expense limitation carryforward 5,371 4,449 Intangible assets 94,558 61,459 Share-based compensation expense 33,169 34,006 Product acquisition costs 4,992 6,288 Lease liabilities 6,122 5,317 Accrued liabilities and other 7,488 5,817 Total deferred tax assets 813,696 757,337 Valuation allowance (806,622) (750,508) Deferred tax assets, net of valuation allowance 7,074 6,829 Deferred tax liabilities: Right-of-use assets (6,799) (6,337) Prepaid expenses and fixed assets (275) (492) Total deferred tax liabilities (7,074) (6,829) Net deferred tax liability $ — $ — The Tax Cuts and Jobs Act (the “Act”), enacted in the U.S. on December 22, 2017, subjects a U.S. shareholder to tax on the Global Intangible Low-Taxed Income (“GILTI”) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, “Accounting for Global Intangible Low-Taxed Income”, states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. We have elected to account for GILTI in the year the tax is incurred. The realization of deferred tax assets is dependent upon a number of factors including future earnings, the timing and amount of which is uncertain. A valuation allowance was established for the net deferred tax asset balance due to management’s belief that the realization of these assets is not likely to occur in the foreseeable future. We recorded a net increase to the valuation allowance of $56.1 million and $102.6 million for the years ended December 31, 2020 and 2019, respectively, primarily due to the growth in net operating losses and amortizable research and development expenses incurred during the year. In addition, the Company recognizes tax benefits if it is more likely than not to be sustained under audit by the relevant taxing authority based on technical merits. An uncertain tax position will not be recognized if it has less than a 50% likelihood of being sustained during audit. If the threshold is met, the tax benefit is measured and recognized at the largest amount above the greater than 50% likelihood threshold at time of settlement. The balance of unrecognized tax benefits at December 31, 2020 of $8.0 million, if recognized, would not impact the Company’s effective tax rate as long as we remain subject to a full valuation allowance. The following table summarizes the gross amounts of unrecognized tax benefits (in thousands): Year ended December 31, 2020 2019 Balance at beginning of year $ 7,525 $ 24,775 Changes related to prior period tax positions 64 (35) Additions related to current period tax positions 415 398 Settlements with tax authorities — (17,613) Expiration of statute of limitations — — Balance at end of year $ 8,004 $ 7,525 As of December 31, 2020, we had approximately $1.7 billion, $1.6 billion and $2.0 million of U.S., federal, state and foreign net operating loss carryforwards, respectively. The U.S. federal net operating losses, generated prior to the enactment of the Act, totaling $1.1 billion, will expire from 2029 to 2037 if not utilized and the U.S. federal net operating losses generated after the enactment of the Act, totaling $0.6 billion, do not expire and are carried forward indefinitely. U.S. state net operating losses will expire from 2024 to 2040 if not utilized. We have research and development and orphan drug tax credit carryforwards of We believe that a change in ownership as defined under Section 382 of the U.S. Internal Revenue Code occurred as a result of our public offering of common stock completed in April 2012. Future utilization of the federal net operating losses (“NOL”) and tax credit carryforwards accumulated from inception to the change in ownership date will be subject to annual limitations to offset future taxable income. It is possible that a change in ownership will occur in the future, which will limit the NOL amounts generated since the last estimated change of ownership. As of December 31, 2019, our audit by the Internal Revenue Service was finalized for the year ended December 31, 2015. The amount of orphan drug tax credit for years 2009 and 2010 was adjusted, but no additional taxes are due as a result of our net operating losses; this also resulted in a release of the uncertain tax position (“UTP”) of $17.6 million and a decrease to the U.S. federal net operating loss carryforward due to the release of the UTP recorded against the credit. Our federal and state income taxes for the period from January 1, 2009 to December 31, 2014, other than the orphan drug tax credit, and January 1, 2016 through December 31, 2020 remain open to an audit. Our foreign subsidiaries are also subject to tax audits by tax authorities in the jurisdictions where they operate for the periods from December 31, 2016 to December 31, 2020. We may be assessed interest and penalties related to the settlement of tax positions and such amounts will be recognized within income tax expense when assessed. To date, no interest and penalties have been recognized. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2020 | |
Employee Benefit Plans | |
Employee Benefit Plans | 17. Employee Benefit Plans We maintain a retirement plan, which is qualified under section 401(k) of the Internal Revenue Code for our U.S. employees. The plan allows eligible employees to defer, at the employee’s discretion, pretax compensation up to the IRS annual limits. We matched contributions up to 4% of the eligible employee’s compensation or the maximum amount permitted by law. Total expense for contributions made to U.S. employees was approximately $2.1 million, $2.2 million and $2.0 million for the years ended December 31, 2020, 2019 and 2018, respectively. Our international employees participate in retirement plans or postretirement life insurance plans governed by the local laws in effect for the country in which they reside. We made contributions to the retirement plans or postretirement life insurance plans of international employees of approximately $1.5 million, $1.1 million and $0.9 million for the years ended December 31, 2020, 2019 and 2018, respectively. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2020 | |
Segment Information | |
Segment Information | 18. Segment Information The following table presents information about our reportable segments for the year months ended December 31, 2020, 2019 and 2018 (in thousands): Year ended December 31, 2020 2019 2018 U.S. Ex-U.S. Total U.S. Ex-U.S. Total U.S. Ex-U.S. Total Product revenue $ 146,259 $ 18,263 $ 164,522 $ 137,187 $ 5,819 $ 143,006 $ 95,388 $ — $ 95,388 Operating expenses: Cost of sales - product 29,526 6,602 36,128 28,179 1,747 29,926 19,444 — 19,444 Cost of sales - intangible asset amortization 2,287 2,890 5,177 1,956 2,804 4,760 1,954 676 2,630 Research and development 249,444 8,263 257,707 275,518 7,628 283,146 226,925 4,422 231,347 Selling, general and administrative 139,455 24,439 163,894 161,132 21,637 182,769 161,743 14,038 175,781 Acquired in-process research and development — — — 9,440 — 9,440 — — — Other operating expenses 3,804 — 3,804 9,711 — 9,711 — — — Total expenses 424,516 42,194 466,710 485,936 33,816 519,752 410,066 19,136 429,202 Operating loss (278,257) (23,931) (302,188) (348,749) (27,997) (376,746) (314,678) (19,136) (333,814) |
Quarterly Information (Unaudite
Quarterly Information (Unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Information (Unaudited) | |
Quarterly Information (Unaudited) | 19. Quarterly Information (Unaudited) The results of operations on a quarterly basis for the years ended December 31, 2020 and 2019 were as follows (in thousands): March 31, June 30, September 30, December 31, March 31, June 30, September 30, December 31, 2020 2020 2020 2020 2019 2019 2019 2019 Revenues: ` Product revenue $ 42,564 $ 39,887 $ 38,772 $ 43,299 $ 33,118 $ 32,978 $ 37,603 $ 39,307 Operating expenses: Cost of sales - product 9,096 9,120 8,438 9,474 7,405 6,445 8,134 7,942 Cost of sales - intangible asset amortization 1,212 1,280 1,343 1,342 1,120 1,217 1,212 1,211 Research and development 68,221 69,878 62,902 56,706 62,031 70,746 77,896 72,473 Selling, general and administrative 42,598 41,902 38,636 40,758 47,761 48,029 41,811 45,168 Acquired in-process research and development — — — — — — 9,440 — Other operating expenses 3,449 355 — — — — 5,539 4,172 Total expenses 124,576 122,535 111,319 108,280 118,317 126,437 144,032 130,966 Operating loss (82,012) (82,648) (72,547) (64,981) (85,199) (93,459) (106,429) (91,659) Other income (expense): Interest expense (9,561) (6,739) (6,859) (7,349) (3,590) (3,817) (5,278) (6,720) Foreign currency (loss) gain (877) 142 633 30 (192) (226) (229) 100 (Loss) gain on extinguishment of debt — (3,277) — — — — 18,480 — Loss on convertible senior notes conversion (7,791) — — (27,284) — — — — Legal settlement loss — — — — — (25,000) (1,750) — Other income 841 239 79 202 2,400 1,899 781 1,262 Other income (expense), net (17,388) (9,635) (6,147) (34,401) (1,382) (27,144) 12,004 (5,358) Loss before income taxes (99,400) (92,283) (78,694) (99,382) (86,581) (120,603) (94,425) (97,017) Income tax benefit (expense) 68 36 18 425 160 176 350 (2,484) Net loss $ (99,332) $ (92,247) $ (78,676) $ (98,957) $ (86,421) $ (120,427) $ (94,075) $ (99,501) Basic and diluted net loss per common share $ (1.39) $ (1.15) $ (0.89) $ (1.02) $ (1.63) $ (2.27) $ (1.72) $ (1.81) Basic and diluted weighted average common shares outstanding 71,662 80,453 88,255 96,681 52,891 53,028 54,707 54,834 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The consolidated financial statements include our accounts and our wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates, including estimates related to revenue deductions, intangible asset impairment, clinical trial accruals and share-based compensation expense. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Revenue Recognition | Revenue Recognition We are currently approved to sell Rubraca in the United States and the Europe markets. We distribute our product principally through a limited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customers subsequently sell our products to patients and health care providers. Separately, we have arrangements with certain payors and other third-parties that provide for government-mandated and privately-negotiated rebates, chargebacks and discounts. See Note 3, Revenue Recognition |
Cost of Sales | Cost of Sales – Product Product cost of sales consists primarily of materials, third-party manufacturing costs as well as freight and royalties owed to our licensing partners for Rubraca sales. Cost of Sales – Intangible Asset Amortization Cost of sales for intangible asset amortization consists of the amortization of capitalized milestone payments made to our licensing partners upon FDA approval of Rubraca. Milestone payments are amortized on a straight-line basis over the estimated remaining patent life of Rubraca. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Cash, cash equivalents, available-for-sale securities and contingent purchase consideration are carried at fair value. Financial instruments, including other current assets and accounts payable, are carried at cost, which approximates fair value given their short-term nature (see Note 5, Fair Value Measurements |
Cash, Cash Equivalents and Available-for-Sale Securities | Cash, Cash Equivalents and Available-for-Sale Securities We consider all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations. Marketable securities are considered to be available-for-sale securities and consist of U.S. treasury securities. Available-for-sale securities are reported at fair value on the Consolidated Balance Sheets and unrealized gains and losses are included in accumulated other comprehensive income/loss on the Consolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense) on the Consolidated Statements of Operations and Comprehensive Loss. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on our intent to fund current operations with these securities or to make them available for current operations. We determine whether a decline in the fair value below the amortized cost basis (i.e., impairment) of an available-for-sale debt is security is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in accumulated other comprehensive loss, net of applicable taxes. When evaluating an impairment, entities may not use the length of time a security has been in an unrealized loss position as a factor, either by itself or in combination with other factors, to conclude that a credit loss does not exist. |
Accounts Receivable | Accounts Receivable We provide an allowance for credit losses based on experience and specifically identified risks. Accounts receivable are charged off against the allowance when we determine that recovery is unlikely and we cease collection efforts. |
Inventory | Inventory Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first-out (“FIFO”) basis. Inventories include active pharmaceutical ingredient (“API”), contract manufacturing costs and overhead allocations. We begin capitalizing incurred inventory related costs upon regulatory approval. Prior to regulatory approval, incurred costs for the manufacture of drugs that could potentially be available to support the commercial launch of our products are recognized as research and development expense. We regularly analyze our inventory levels for excess quantities and obsolescence (expiration), considering factors such as historical and anticipated future sales compared to quantities on hand and the remaining shelf-life of Rubraca. Rubraca finished goods have a shelf-life of four years from the date of manufacture. We expect to sell the finished goods prior to expiration. The API currently has a shelf-life of four years from the date of manufacture but can be retested at an immaterial cost with no expected reduction in potency, thereby extending its shelf-life as needed. We expect to consume substantially all of the API over a period of approximately seven years based on our long-range sales projections of Rubraca. We write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and/or inventory in excess of expected sales requirements. Expired inventory would be disposed of and the related costs would be written off as cost of product revenue. Inventories that are not expected to be consumed within 12 months following the balance sheet date are classified as long-term inventories. Long-term inventories primarily consist of API. API is currently produced by Lonza. As the API has undergone significant manufacturing specific to its intended purpose at the point it is purchased by us, we classify the API as work-in-process inventory. In addition, we currently manufacture Rubraca finished goods with a single third-party manufacturer. The disruption or termination of the supply of API or the disruption or termination of the manufacturing of our commercial products could have a material adverse effect on our business, financial position and results of operations. API that is written off due to damage and certain costs related to our dedicated production train at Lonza are included in Other Operating Expenses in the Consolidated Statements of Operations and Comprehensive Loss. Inventory used in clinical trials is expensed as research and development expense when it has been identified for such use. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Equipment purchased for use in manufacturing and clinical trials is evaluated to determine whether the equipment is solely beneficial for a drug candidate in the development stage or whether it has an alternative use. Equipment with an alternative use is capitalized. Leased assets meeting certain finance lease criteria are capitalized and the present value of the related lease payments is recorded as a liability. Assets under finance lease arrangements are depreciated using the straight-line method over the estimated useful lives. Leasehold improvements are amortized over the economic life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The estimated useful lives of our capitalized assets are as follows: Estimated Useful Life Computer hardware and software 3 to 5 years Leasehold improvements 6 years Laboratory, manufacturing and office equipment 5 to 7 years Furniture and fixtures 10 years |
Long-Lived Assets | Long-Lived Assets We review long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected to generate. If the carrying value of the assets exceed their future net undiscounted cash flows, an impairment charge is recognized for the amount by which the carrying value of the assets exceeds the fair value of the assets. |
Intangible Assets, Net | Intangible Assets, Net Definite-lived intangible assets related to capitalized milestones under license agreements are amortized on a straight-line basis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the product’s useful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is recorded as a component of cost of sales on the Consolidated Statements of Operations and Comprehensive Loss. Intangible assets are evaluated for impairment at least annually in the fourth quarter or more frequently if impairment indicators exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the decision to discontinue the development of a drug, the receipt of additional clinical or nonclinical data regarding our drug candidate or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales for the drug. In connection with any impairment assessment, the fair value of the intangible assets as of the date of assessment is compared to the carrying value of the intangible asset. Impairment losses are recognized if the carrying value of an intangible asset is both not recoverable and exceeds its fair value. |
Goodwill | Goodwill Goodwill was recorded as a result of the EOS acquisition in November 2013. Goodwill represents the excess of the purchase price over the fair value of net assets acquired in a business combination accounted for under the acquisition method of accounting and is not amortized, but is subject to impairment testing at least annually in the fourth quarter or when a triggering event is identified that could indicate a potential impairment. We are organized as two reporting units based on our operating segments, U.S. and ex-U.S. We determined that our goodwill was allocated to the U.S. reporting unit and performed impairment testing by assessing qualitative factors to determine whether it is more likely than not (that is, a likelihood of more than 50 percent) that the fair value of a reporting unit is less than its carrying amount. Based on our qualitative assessment, we determined that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount. Therefore, the quantitative goodwill impairment test is not necessary. There is no goodwill impairment as of December 31, 2020. |
Other Current Assets | Other Current Assets Other current assets are comprised of the following (in thousands): December 31, December 31, 2020 2019 Prepaid insurance $ 782 $ 505 Prepaid IT 753 698 Prepaid variable considerations 1,191 550 Prepaid expenses - other 2,193 2,821 Value-added tax ("VAT") receivable 2,202 11,920 Receivable - other 1,884 2,176 Other 125 177 Total $ 9,130 $ 18,847 |
Other Accrued Expenses | Other Accrued Expenses Other accrued expenses are comprised of the following (in thousands): December 31, December 31, 2020 2019 Accrued personnel costs $ 18,334 $ 16,915 Accrued interest payable for convertible senior notes 2,991 5,903 Income tax payable 907 3,505 Accrued corporate legal fees and professional services 459 310 Accrued royalties 6,617 6,038 Accrued variable considerations 11,701 5,748 Accrued expenses - other 4,199 3,809 Total $ 45,208 $ 42,228 |
Segment Information | Segment Information As of December 31, 2020, we determined that we have two operating and reportable segments, U.S. and ex-U.S., based on product revenue by geographic areas since our product revenue outside of the United States represented 11% of total product revenue. We designated our reporting segments based on the internal reporting used by the Chief Operating Decision Maker (“CODM”), which is our Chief Executive Officer, for making decisions and assessing performance as the source of our reportable segments. The CODM allocates resources and assesses the performance of each operating segment based on product revenue by geographic areas. Accordingly, we view our business as two reportable operating segments to evaluate performance, allocate resources, set operational targets and forecast our future period financial results. We manage our assets on a company basis, not by segments, as many of our assets are shared or commingled. Our CODM does not regularly review asset information by reportable segment. The majority of long-lived assets for both segments are located in the United States. |
Research and Development Expense | Research and Development Expense Research and development costs are charged to expense as incurred and include, but are not limited to, salary and benefits, share-based compensation, clinical trial activities, drug development and manufacturing, companion diagnostic development and third-party service fees, including contract research organizations and investigative sites. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred and are reflected on the Consolidated Balance Sheets as prepaid or accrued research and development expenses. |
Acquired In-Process Research and Development Expense | Acquired In-Process Research and Development Expense We have acquired and expect to continue to acquire the rights to develop and commercialize new drug candidates. The upfront payments to acquire a new drug compound, as well as subsequent milestone payments, are immediately expensed as acquired in-process research and development provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Once regulatory approval is received, payments to acquire rights, and the related milestone payments, are capitalized and the amortization of such assets recorded to product cost of sales. |
Share-Based Compensation Expense | Share-Based Compensation Expense Share-based compensation is recognized as expense for all share-based awards made to employees and directors and is based on estimated fair values. We determine equity-based compensation at the grant date using the Black-Scholes option pricing model. The value of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. Any changes to the estimated forfeiture rates are accounted for prospectively. |
Advertising Expense | Advertising Expense In connection with the FDA approval and commercial launch of Rubraca in 2016, we began to incur advertising costs. Advertising costs are expense when services are performed, or goods are delivered. We incurred $17.0 million, $21.2 million and $15.9 million in expense for the years ended December 31, 2020, 2019 and 2018, respectively. |
Legal Settlement Loss | Legal Settlement Loss Following our regulatory announcement in November 2015 of adverse developments in our ongoing clinical trials for rociletinib, we and certain of our current and former executives were named in various securities lawsuits. As a result of these lawsuits, during 2019, we recorded a charge of $26.8 million to settle the Antipodean Complaint. During 2018, we recorded a charge of $8.0 million related to an agreement to resolve a potential litigation claim against us and our officers and we also recorded a charge of $20.0 million related to an agreement reached with the SEC to resolve its investigation. For the remaining actions related to rociletinib, see Note 13, Commitments and Contingencies |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject us to concentrations of credit risk are primarily cash, cash equivalents and available-for-sale securities. We maintain our cash and cash equivalent balances in the form of money market accounts with financial institutions that we believe are creditworthy. Available-for-sale securities are invested in accordance with our investment policy. The investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that we believe minimizes the exposure to concentration of credit risk. We have no financial instruments with off-balance sheet risk of accounting loss. |
Foreign Currency | Foreign Currency The assets and liabilities of our foreign operations are translated into U.S. dollars at current exchange rates and the results of operations are translated at the average exchange rates for the reported periods. The resulting translation adjustments are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise. Transaction gains and losses are recorded to foreign currency gains (losses) on the Consolidated Statements of Operations and Comprehensive Loss. As of December 31, 2020, and 2019, approximately 3% and 4%, respectively, of our total liabilities were denominated in currencies other than the functional currency. |
Income Taxes | Income Taxes We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Tax benefits are recognized when it is more likely than not that a tax position will be sustained during an audit. Deferred tax assets are reduced by a valuation allowance if current evidence indicates that it is considered more likely than not that these benefits will not be realized. |
Recently Adopted and Issued Accounting Standards | Recently Adopted Accounting Standards In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments”. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. We adopted ASU 2016-13 as of January 1, 2020. Upon the adoption of ASU 2016-13 on January 1, 2020, we are required to determine whether a decline in the fair value below the amortized cost basis (i.e., impairment) of an available-for-sale debt is security is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in accumulated other comprehensive loss, net of applicable taxes. When evaluating an impairment, entities may not use the length of time a security has been in an unrealized loss position as a factor, either by itself or in combination with other factors, to conclude that a credit loss does not exist. We applied this impairment model for available-for-sale debt securities as of January 1, 2020 and no impairment was recognized upon adoption. In addition, no impairment was recognized for the year ended December 31, 2020. We recognized a minimal allowance for credit losses related to our accounts receivable at December 31, 2020. The adoption of ASU 2016-13 did not materially impact our consolidated financial statements and disclosures. In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. We adopted ASU 2018-13 as of January 1, 2020 and there was no material impact on our consolidated financial statements and related disclosures. Recently Issued Accounting Standards From time to time, the FASB or other standards setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification (“ASC”) are communicated through issuance of an ASU. In August 2020, the FASB issued guidance that simplifies an issuer’s accounting for debt and equity instruments. The guidance is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early application is permitted. We plan to adopt this guidance on January 1, 2022. We will evaluate the impact this guidance may have on our consolidated financial statements and related disclosures as the adoption date approaches . |
Convertible Senior Notes | The remaining debt issuance costs are presented as a deduction from the convertible senior notes on the Consolidated Balance Sheets and are amortized as interest expense over the expected life of the 2021 Notes using the effective interest method. We determined the expected life of the debt was equal to the seven-year term of the 2021 Notes. |
Net Loss Per Common Share | Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding using the treasury-stock method for the stock options and RSUs and the if-converted method for the convertible senior notes. As a result of our net losses for the periods presented, all potentially dilutive common share equivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share. |
Fair Value Measurements | Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The three levels of inputs that may be used to measure fair value include: Level 1: Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consist of money market investments. We do not have Level 1 liabilities. Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Our Level 2 assets consist of U.S. treasury securities. We do not have Level 2 liabilities. Level 3: Unobservable inputs that are supported by little or no market activity. We do not have Level 3 assets or liabilities. |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss Accumulated other comprehensive loss consists of changes in foreign currency translation adjustments, which includes changes in a subsidiary’s functional currency, and unrealized gains and losses on available-for-sale securities. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Estimated Useful Lives of Capitalized Assets | Estimated Useful Life Computer hardware and software 3 to 5 years Leasehold improvements 6 years Laboratory, manufacturing and office equipment 5 to 7 years Furniture and fixtures 10 years |
Other Current Assets | Other current assets are comprised of the following (in thousands): December 31, December 31, 2020 2019 Prepaid insurance $ 782 $ 505 Prepaid IT 753 698 Prepaid variable considerations 1,191 550 Prepaid expenses - other 2,193 2,821 Value-added tax ("VAT") receivable 2,202 11,920 Receivable - other 1,884 2,176 Other 125 177 Total $ 9,130 $ 18,847 |
Other Accrued Expenses | Other accrued expenses are comprised of the following (in thousands): December 31, December 31, 2020 2019 Accrued personnel costs $ 18,334 $ 16,915 Accrued interest payable for convertible senior notes 2,991 5,903 Income tax payable 907 3,505 Accrued corporate legal fees and professional services 459 310 Accrued royalties 6,617 6,038 Accrued variable considerations 11,701 5,748 Accrued expenses - other 4,199 3,809 Total $ 45,208 $ 42,228 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue Recognition | |
Product Revenue Percentage from Customers Over 10% | December 31, December 31, 2020 2019 Customer A 21% 25% Customer B 14% 20% Customer C 18% 15% Customer D 11% 12% Customer E 10% 10% |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Property and Equipment | Property and equipment consisted of the following (in thousands): December 31, 2020 2019 Laboratory, manufacturing and office equipment $ 1,267 $ 1,290 Leasehold improvements 17,256 16,946 Furniture and fixtures 2,782 2,805 Computer hardware and software 1,835 1,699 Total property and equipment 23,140 22,740 Less: accumulated depreciation (11,055) (7,453) Total property and equipment, net $ 12,085 $ 15,287 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Measurements | |
Assets Measured at Fair Value on Recurring Basis | The following table identifies our assets that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 December 31, 2020 Assets: Money market $ 147,921 $ 147,921 $ — $ — U.S. treasury securities — — — — Total assets at fair value $ 147,921 $ 147,921 $ — $ — December 31, 2019 Assets: Money market $ 61,882 $ 61,882 $ — $ — U.S. treasury securities 189,736 54,910 134,826 — Total assets at fair value $ 251,618 $ 116,792 $ 134,826 $ — |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Available-for-Sale Securities | |
Summary of Available-for-Sale Securities | As of December 31, 2019, available-for-sale securities consisted of the following (in thousands): Gross Gross Aggregate Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $ 134,826 $ — $ — $ 134,826 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventories | |
Schedule of Inventories | The following table presents inventories as of December 31, 2020 and December 31, 2019 (in thousands): December 31, December 31, 2020 2019 Work-in-process $ 102,507 $ 104,139 Finished goods, net 32,330 20,433 Total inventories $ 134,837 $ 124,572 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Intangible Assets | |
Intangible assets related to capitalized milestones under license agreements | At December 31, 2020 and 2019, intangible assets related to capitalized milestones under license agreements consisted of the following (in thousands): December 31, December 31, 2020 2019 Intangible asset - milestones $ 79,850 $ 71,850 Accumulated amortization (14,107) (8,930) Total intangible asset, net $ 65,743 $ 62,920 |
Estimated future amortization expense for intangible assets | Estimated future amortization expense for intangible assets as of December 31, 2020 is as follows (in thousands): 2021 $ 5,371 2022 5,371 2023 5,371 2024 5,371 2025 5,371 Thereafter 38,888 $ 65,743 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Schedule of components of lease expense and related cash flows | The components of lease expense and related cash flows were as follows (in thousands): Year ended December 31, Year ended December 31, 2020 2019 Lease cost Finance lease cost: Amortization of right-of-use assets $ 1,895 $ 1,898 Interest on lease liabilities 816 759 Operating lease cost 4,649 4,003 Short-term lease cost 401 301 Variable lease cost 2,071 2,261 Total lease cost $ 9,832 $ 9,222 Operating cash flows from finance leases $ 816 $ 759 Operating cash flows from operating leases $ 4,649 $ 4,003 Financing cash flows from finance leases $ 1,470 $ 1,115 |
Schedule of weighted-average remaining lease term and weighted-average discount rate | The weighted-average remaining lease term and weighted-average discount rate were as follows: December 31, 2020 December 31, 2019 Weighted-average remaining lease term (years) Operating leases 6.6 6.9 Finance leases 5.0 6.0 Weighted-average discount rate Operating leases 8% 8% Finance leases 8% 8% |
Schedule of future minimum commitments due under lease agreements | Future minimum commitments due under these lease agreements as of December 31, 2020 are as follows (in thousands): Operating Leases Finance Leases Total 2021 5,796 2,287 8,083 2022 5,308 2,287 7,595 2023 4,859 2,287 7,146 2024 4,868 2,287 7,155 2025 5,025 2,287 7,312 Thereafter 9,938 — 9,938 Present value adjustment (8,223) (2,036) (10,259) Present value of lease payments $ 27,571 $ 9,399 $ 36,970 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt | |
Schedule of Future Annual Principal Payments on Convertible Senior Notes | The following is a summary of our convertible senior notes at December 31, 2020 and 2019 (principal amount in thousands): Principal Amount Principal Amount December 31, 2020 December 31, 2019 Interest Rate Due Date 2021 Notes $ 64,418 $ 97,188 2.50% September 15, 2021 2024 Notes (2019 Issuance) 85,782 263,000 4.50% August 1, 2024 2024 Notes (2020 Issuance) 57,500 — 4.50% August 1, 2024 2025 Notes 300,000 300,000 1.25% May 1, 2025 Total $ 507,700 $ 660,188 |
Schedule of aggregate convertible | Maturities of our convertible notes consisted of the following as of December 31, 2020 (in thousands): 2021 $ 64,418 2022 — 2023 — 2024 143,282 2025 300,000 Thereafter — 507,700 Less debt issuance costs (8,656) Current portion (64,198) Long-term portion $ 434,846 |
Schedule of expected maturities of Finance Agreement | Expected maturities of our Financing Agreement consisted of the following as of December 31, 2020 (in thousands): 2021 $ — 2022 8,934 2023 41,091 2024 45,532 2025 16,820 Thereafter — 112,377 Less debt issuance costs (1,460) Current portion — Long-term portion $ 110,917 |
Schedule of Total Interest Expense Recognized Related to Notes | The following table sets forth total interest expense recognized during the years ended December 31, 2020, 2019 and 2018 (in thousands): Year ended December 31, 2020 2019 2018 Interest on convertible notes $ 11,934 $ 13,680 $ 9,812 Amortization of debt issuance costs 2,672 2,858 2,178 Debt issuance cost derecognized related to convertible debt transactions 4,345 — — Interest on finance lease 816 759 — Interest on borrowings under ATHENA financing agreement 10,624 1,997 — Accretion of interest on milestone liability — — 977 Interest on capital lease liability — — 216 Other interest 117 111 — Total interest expense $ 30,508 $ 19,405 $ 13,183 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity | |
Component of Other Comprehensive Income (Loss) | The changes in accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands): Foreign Currency Unrealized Total Accumulated Translation Adjustments (Losses) Gains Other Comprehensive Loss Balance at December 31, 2018 $ (44,460) $ (174) $ (44,634) Other comprehensive income (loss) (272) 41 (231) Total before tax (44,732) (133) (44,865) Tax effect — — — Balance at December 31, 2019 (44,732) (133) (44,865) Other comprehensive income (loss) 567 (6) 561 Total before tax (44,165) (139) (44,304) Tax effect — — — Balance at December 31, 2020 $ (44,165) $ (139) $ (44,304) |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-Based Compensation | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | Share-based compensation expense for the years ended December 31, 2020, 2019 and 2018, respectively, was recognized in the accompanying Consolidated Statements of Operations and Comprehensive Loss as follows (in thousands): Year ended December 31, 2020 2019 2018 Research and development $ 25,577 $ 25,838 $ 20,489 Selling, general and administrative 25,217 28,466 28,601 Total share-based compensation expense $ 50,794 $ 54,304 $ 49,090 |
Summary of Stock Options Activity | Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Options Price Term (Years) (Thousands) Outstanding at December 31, 2019 6,287,025 $ 42.24 Granted 980,592 7.35 Exercised (117,932) 3.23 Forfeited (649,016) 41.15 Outstanding at December 31, 2020 6,500,669 $ 37.79 5.6 $ 127 Vested and expected to vest at December 31, 2020 6,371,758 $ 38.24 5.5 $ 118 Vested and exercisable at December 31, 2020 5,026,455 $ 43.87 4.7 $ 31 |
Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award | The following table summarizes information about our stock options as of and for the years ended December 31, 2020, 2019 and 2018 (in thousands, except weighted-average grant date fair value per share): Year ended December 31, 2020 2019 2018 Weighted-average grant date fair value per share $ 5.67 $ 13.53 $ 32.09 Intrinsic value of options exercised $ 381 $ 1,525 $ 1,714 Cash received from stock option exercises $ 236 $ 1,361 $ 1,869 |
Weighted-Average Assumptions | Year ended December 31, 2020 2019 2018 Dividend yield — — — Volatility (a) 99 % 93 % 88 % Risk-free interest rate (b) 0.49 % 1.67 % 2.92 % Expected term (years) (c) 6.0 5.9 5.9 (a) Volatility : The expected volatility was estimated using our historical data. (b) Risk-free interest rate: The rate is based on the yield on the grant date of a zero-coupon U.S. Treasury bond whose maturity period approximates the option’s expected term. (c) Expected term: The expected term of the award was estimated using our historical data. |
Summary of activity related to our unvested RSUs | Weighted Average Number of Grant Date Units Fair Value Unvested at December 31, 2019 2,171,347 $ 28.37 Granted 2,441,804 8.21 Vested (1,012,699) 28.85 Forfeited (636,905) 15.51 Unvested at December 31, 2020 2,963,547 $ 14.36 Expected to vest after December 31, 2020 2,862,148 $ 14.09 |
Reserved Shares of Common Stock for Future Issuance | Available for Grant Total Shares of Common Stock or Future Common Stock Outstanding Issuance Reserved 2009 Equity Incentive Plan 64,522 — 64,522 2011 Stock Incentive Plan 8,878,976 — 8,878,976 2020 Stock Incentive Plan 520,718 5,949,282 6,470,000 2011 Employee Stock Purchase Plan — 361,656 361,656 Total 9,464,216 6,310,938 15,775,154 |
Weighted-Average Assumptions Used to Estimate Fair Value of Purchase Awards Granted | Year ended December 31, 2020 2019 2018 Dividend yield — — — Volatility (a) 138 % 79 % 51 % Risk-free interest rate (b) 0.90 % 2.20 % 1.90 % Expected term (years) (c) 0.5 0.5 0.5 (a) Volatility : The expected volatility was estimated using our historical data. (b) Risk-free interest rate: The rate is based on the U.S. Treasury yield in effect at the time of grant with terms similar to the contractual term of the purchase right. (c) Expected term: The expected life of the award represents the six-month offering period for the Purchase Plan . |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Net Loss Per Common Share | |
Shares Outstanding Excluded from Calculation of Diluted Net Loss Per Share | The shares outstanding at the end of the respective periods presented in the table below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in thousands): Year ended December 31, 2020 2019 2018 Common shares under stock incentive plans 3,095 2,480 1,319 Convertible senior notes 25,969 41,598 8,584 Total potential dilutive shares 29,064 44,078 9,903 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Loss Before Income Taxes | The geographical components of loss before income taxes consisted of the following (in thousands): Year ended December 31, 2020 2019 2018 Domestic $ (370,839) $ (399,497) $ (368,402) Foreign 1,080 871 1,001 Total loss before income taxes $ (369,759) $ (398,626) $ (367,401) |
Current and Deferred Tax Expenses (Benefit) | The income tax provision consists of the following current and deferred tax expense (benefit) amounts (in thousands): Year ended December 31, 2020 2019 2018 Current tax: U.S. Federal & State $ 50 $ 3 $ 15 Foreign (597) 1,795 593 Total current expense (benefit) (547) 1,798 608 Deferred tax: U.S. Federal & State — — — Foreign — — — Total deferred (benefit) — — — Total income tax expense (benefit) $ (547) $ 1,798 $ 608 |
Reconciliation of Federal Statutory Income Tax Rate to Effective Income Tax Rate | Year ended December 31, 2020 2019 2018 Federal income tax benefit at statutory rate (21.0) % (21.0) % (21.0) % State income tax benefit, net of federal benefit (1.6) (2.9) (3.1) Tax credits (1.5) (1.1) (1.3) Change in uncertain tax positions 0.1 (4.3) 0.1 SEC settlement costs — — 1.1 Convertible debt transactions 2.2 — — Prior year true ups 0.9 0.1 (0.8) Share based compensation 2.6 2.3 0.8 Tax rate changes 1.4 0.1 0.3 Change in valuation allowance 16.1 26.5 23.2 Other 0.6 0.8 0.9 Effective income tax rate (0.2) % 0.5 % 0.2 % |
Components of Deferred Tax Assets and Liabilities | The significant components of our deferred tax assets and liabilities are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforward $ 414,932 $ 396,100 Tax credit carryforwards 247,064 243,901 Interest expense limitation carryforward 5,371 4,449 Intangible assets 94,558 61,459 Share-based compensation expense 33,169 34,006 Product acquisition costs 4,992 6,288 Lease liabilities 6,122 5,317 Accrued liabilities and other 7,488 5,817 Total deferred tax assets 813,696 757,337 Valuation allowance (806,622) (750,508) Deferred tax assets, net of valuation allowance 7,074 6,829 Deferred tax liabilities: Right-of-use assets (6,799) (6,337) Prepaid expenses and fixed assets (275) (492) Total deferred tax liabilities (7,074) (6,829) Net deferred tax liability $ — $ — |
Schedule of Unrecognized tax benefits | The following table summarizes the gross amounts of unrecognized tax benefits (in thousands): Year ended December 31, 2020 2019 Balance at beginning of year $ 7,525 $ 24,775 Changes related to prior period tax positions 64 (35) Additions related to current period tax positions 415 398 Settlements with tax authorities — (17,613) Expiration of statute of limitations — — Balance at end of year $ 8,004 $ 7,525 |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Segment Information | |
Schedule of information about reportable segments | The following table presents information about our reportable segments for the year months ended December 31, 2020, 2019 and 2018 (in thousands): Year ended December 31, 2020 2019 2018 U.S. Ex-U.S. Total U.S. Ex-U.S. Total U.S. Ex-U.S. Total Product revenue $ 146,259 $ 18,263 $ 164,522 $ 137,187 $ 5,819 $ 143,006 $ 95,388 $ — $ 95,388 Operating expenses: Cost of sales - product 29,526 6,602 36,128 28,179 1,747 29,926 19,444 — 19,444 Cost of sales - intangible asset amortization 2,287 2,890 5,177 1,956 2,804 4,760 1,954 676 2,630 Research and development 249,444 8,263 257,707 275,518 7,628 283,146 226,925 4,422 231,347 Selling, general and administrative 139,455 24,439 163,894 161,132 21,637 182,769 161,743 14,038 175,781 Acquired in-process research and development — — — 9,440 — 9,440 — — — Other operating expenses 3,804 — 3,804 9,711 — 9,711 — — — Total expenses 424,516 42,194 466,710 485,936 33,816 519,752 410,066 19,136 429,202 Operating loss (278,257) (23,931) (302,188) (348,749) (27,997) (376,746) (314,678) (19,136) (333,814) |
Quarterly Information (Unaudi_2
Quarterly Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Information (Unaudited) | |
Results of Operations on Quarterly Basis | The results of operations on a quarterly basis for the years ended December 31, 2020 and 2019 were as follows (in thousands): March 31, June 30, September 30, December 31, March 31, June 30, September 30, December 31, 2020 2020 2020 2020 2019 2019 2019 2019 Revenues: ` Product revenue $ 42,564 $ 39,887 $ 38,772 $ 43,299 $ 33,118 $ 32,978 $ 37,603 $ 39,307 Operating expenses: Cost of sales - product 9,096 9,120 8,438 9,474 7,405 6,445 8,134 7,942 Cost of sales - intangible asset amortization 1,212 1,280 1,343 1,342 1,120 1,217 1,212 1,211 Research and development 68,221 69,878 62,902 56,706 62,031 70,746 77,896 72,473 Selling, general and administrative 42,598 41,902 38,636 40,758 47,761 48,029 41,811 45,168 Acquired in-process research and development — — — — — — 9,440 — Other operating expenses 3,449 355 — — — — 5,539 4,172 Total expenses 124,576 122,535 111,319 108,280 118,317 126,437 144,032 130,966 Operating loss (82,012) (82,648) (72,547) (64,981) (85,199) (93,459) (106,429) (91,659) Other income (expense): Interest expense (9,561) (6,739) (6,859) (7,349) (3,590) (3,817) (5,278) (6,720) Foreign currency (loss) gain (877) 142 633 30 (192) (226) (229) 100 (Loss) gain on extinguishment of debt — (3,277) — — — — 18,480 — Loss on convertible senior notes conversion (7,791) — — (27,284) — — — — Legal settlement loss — — — — — (25,000) (1,750) — Other income 841 239 79 202 2,400 1,899 781 1,262 Other income (expense), net (17,388) (9,635) (6,147) (34,401) (1,382) (27,144) 12,004 (5,358) Loss before income taxes (99,400) (92,283) (78,694) (99,382) (86,581) (120,603) (94,425) (97,017) Income tax benefit (expense) 68 36 18 425 160 176 350 (2,484) Net loss $ (99,332) $ (92,247) $ (78,676) $ (98,957) $ (86,421) $ (120,427) $ (94,075) $ (99,501) Basic and diluted net loss per common share $ (1.39) $ (1.15) $ (0.89) $ (1.02) $ (1.63) $ (2.27) $ (1.72) $ (1.81) Basic and diluted weighted average common shares outstanding 71,662 80,453 88,255 96,681 52,891 53,028 54,707 54,834 |
Nature of Business (Details)
Nature of Business (Details) | 12 Months Ended |
Dec. 31, 2020itemproduct | |
Number of other product candidates | product | 2 |
Minimum estimated number of months operating plan funded | 12 months |
Minimum | |
Number of chemotherapies received by an adult patient | 2 |
Number of prior lines of platinum based chemotherapy received by patient | 2 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) $ in Thousands | Jan. 01, 2020USD ($) | Dec. 31, 2020USD ($)segment | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Summary of Significant Accounting Policies | ||||
Shelf-life of API | 4 years | |||
Consumption period of API | 7 years | |||
Number of operating and reportable segments | segment | 2 | |||
Impairment of goodwill | $ 0 | |||
Advertising expense | $ 17,000 | $ 21,200 | $ 15,900 | |
Legal settlement charge recognized during the period | $ 26,800 | 20,000 | ||
Total liabilities denominated in currencies other than functional currency | 3.00% | 4.00% | ||
Product revenue | Non-U.S | ex U.S. | ||||
Summary of Significant Accounting Policies | ||||
Percentage of revenues | 11.00% | |||
Board of Directors | ||||
Summary of Significant Accounting Policies | ||||
Legal settlement charge recognized during the period | $ 8,000 | |||
ASU 16-13 | ||||
Cash, Cash Equivalents and Available-for-Sale Securities | ||||
Impairment for available for debt securities | $ 0 | $ 0 | ||
Rucaparib | ||||
Summary of Significant Accounting Policies | ||||
Shelf life of inventory | 4 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Computer hardware and software | Minimum | |
Property and Equipment | |
Property and equipment, estimated useful lives | 3 years |
Computer hardware and software | Maximum | |
Property and Equipment | |
Property and equipment, estimated useful lives | 5 years |
Leasehold improvements | |
Property and Equipment | |
Property and equipment, estimated useful lives | 6 years |
Laboratory, manufacturing, and office equipment | Minimum | |
Property and Equipment | |
Property and equipment, estimated useful lives | 5 years |
Laboratory, manufacturing, and office equipment | Maximum | |
Property and Equipment | |
Property and equipment, estimated useful lives | 7 years |
Furniture and fixtures | |
Property and Equipment | |
Property and equipment, estimated useful lives | 10 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies | ||
Prepaid insurance | $ 782 | $ 505 |
Prepaid IT | 753 | 698 |
Prepaid variable considerations | 1,191 | 550 |
Prepaid expenses - other | 2,193 | 2,821 |
Value-added tax ("VAT") receivable | 2,202 | 11,920 |
Receivable - other | 1,884 | 2,176 |
Other | 125 | 177 |
Total | $ 9,130 | $ 18,847 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Other Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies | ||
Accrued personnel costs | $ 18,334 | $ 16,915 |
Accrued interest payable for convertible senior notes | 2,991 | 5,903 |
Income tax payable | 907 | 3,505 |
Accrued corporate legal fees and professional services | 459 | 310 |
Accrued royalties | 6,617 | 6,038 |
Accrued variable considerations | 11,701 | 5,748 |
Accrued expenses - other | 4,199 | 3,809 |
Total | $ 45,208 | $ 42,228 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Advertising Expenses (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule Of Significant Accounting Policies [Line Items] | |||
Advertising Expense | $ 17 | $ 21.2 | $ 15.9 |
Revenue Recognition (Details)
Revenue Recognition (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 | |
Revenue Recognition | |||||||||||
Payment terms number of days | 30 days | ||||||||||
Amortization period of the asset | true | ||||||||||
Revenue | $ 43,299 | $ 38,772 | $ 39,887 | $ 42,564 | $ 39,307 | $ 37,603 | $ 32,978 | $ 33,118 | $ 164,522 | $ 143,006 | $ 95,388 |
Product | |||||||||||
Revenue Recognition | |||||||||||
Revenue | $ 164,500 | $ 143,000 | |||||||||
Customer A | |||||||||||
Revenue Recognition | |||||||||||
Percentage of revenues | 21.00% | 25.00% | |||||||||
Customer B | |||||||||||
Revenue Recognition | |||||||||||
Percentage of revenues | 14.00% | 20.00% | |||||||||
Customer C | |||||||||||
Revenue Recognition | |||||||||||
Percentage of revenues | 18.00% | 15.00% | |||||||||
Customer D | |||||||||||
Revenue Recognition | |||||||||||
Percentage of revenues | 11.00% | 12.00% | |||||||||
Customer E | |||||||||||
Revenue Recognition | |||||||||||
Percentage of revenues | 10.00% | 10.00% |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property and Equipment | ||
Property and equipment, gross | $ 23,140 | $ 22,740 |
Less: accumulated depreciation | (11,055) | (7,453) |
Total property and equipment, net | 12,085 | 15,287 |
Laboratory, manufacturing, and office equipment | ||
Property and Equipment | ||
Property and equipment, gross | 1,267 | 1,290 |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment, gross | 17,256 | 16,946 |
Furniture and fixtures | ||
Property and Equipment | ||
Property and equipment, gross | 2,782 | 2,805 |
Computer hardware and software | ||
Property and Equipment | ||
Property and equipment, gross | $ 1,835 | $ 1,699 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property and Equipment | |||
Depreciation expense on property and equipment | $ 3 | $ 3 | $ 2 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Measurements | ||
Assets at fair value | $ 147,921 | $ 251,618 |
Liabilities at fair value | 0 | |
Money market | ||
Fair Value Measurements | ||
Assets at fair value | 147,921 | 61,882 |
U.S. treasury securities | ||
Fair Value Measurements | ||
Assets at fair value | 0 | 189,736 |
Fair Value, Inputs, Level 1 | ||
Fair Value Measurements | ||
Assets at fair value | 147,921 | 116,792 |
Fair Value, Inputs, Level 1 | Money market | ||
Fair Value Measurements | ||
Assets at fair value | 147,921 | 61,882 |
Fair Value, Inputs, Level 1 | U.S. treasury securities | ||
Fair Value Measurements | ||
Assets at fair value | 0 | 54,910 |
Fair Value, Inputs, Level 2 | ||
Fair Value Measurements | ||
Assets at fair value | 0 | 134,826 |
Fair Value, Inputs, Level 2 | Money market | ||
Fair Value Measurements | ||
Assets at fair value | 0 | 0 |
Fair Value, Inputs, Level 2 | U.S. treasury securities | ||
Fair Value Measurements | ||
Assets at fair value | 0 | 134,826 |
Fair Value, Inputs, Level 3 | ||
Fair Value Measurements | ||
Assets at fair value | 0 | 0 |
Fair Value, Inputs, Level 3 | Money market | ||
Fair Value Measurements | ||
Assets at fair value | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. treasury securities | ||
Fair Value Measurements | ||
Assets at fair value | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Measurements | ||
Convertible senior notes - less current portion | $ 434,846 | $ 644,751 |
Convertible Senior Unsecured Notes 2021 Notes | ||
Fair Value Measurements | ||
Convertible senior notes - less current portion | 64,200 | |
Convertible Senior Unsecured Notes 2021 Notes | Fair Value, Inputs, Level 2 | ||
Fair Value Measurements | ||
Convertible senior notes, fair value | 59,800 | |
Convertible Senior Unsecured Notes 2024 Notes | ||
Fair Value Measurements | ||
Convertible senior notes, fair value | 75,400 | |
Principal amount outstanding | 83,900 | |
2024 Notes (2020 Issuance) | ||
Fair Value Measurements | ||
Convertible senior notes - less current portion | 56,600 | |
Convertible senior notes, fair value | 49,100 | |
Convertible Senior Unsecured Notes 2025 Notes | ||
Fair Value Measurements | ||
Convertible senior notes, fair value | 211,100 | |
Principal amount outstanding | $ 294,300 |
Available-for-Sale Securities_2
Available-for-Sale Securities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Available-for-Sale Securities | |
Available-for-sale securities | $ 134,826 |
U.S. treasury securities | |
Available-for-Sale Securities | |
Amortized Cost | 134,826 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | 0 |
Aggregate Fair Value | $ 134,826 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventories | ||
Work-in-process | $ 102,507 | $ 104,139 |
Finished goods, net | 32,330 | 20,433 |
Total inventories | 134,837 | 124,572 |
Current inventory | 30,714 | 26,519 |
Long-term inventory | $ 104,123 | $ 98,053 |
Intangible Assets (Details)
Intangible Assets (Details) - Licensing Agreements - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Finite Lived Intangible Assets [Line Items] | ||
Intangible asset - milestones | $ 79,850 | $ 71,850 |
Accumulated amortization | (14,107) | (8,930) |
Total intangible asset, net | $ 65,743 | $ 62,920 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - Licensing Agreements - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
May 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Finite Lived Intangible Assets | |||
Milestone payment related to FDA approval | $ 8 | ||
Amortization of Intangible Assets | $ 5.2 | $ 4.8 |
Intangible Assets - Estimated F
Intangible Assets - Estimated Future Amortization (Details) - Licensing Agreements - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Finite Lived Intangible Assets | ||
2021 | $ 5,371 | |
2022 | 5,371 | |
2023 | 5,371 | |
2024 | 5,371 | |
2025 | 5,371 | |
Thereafter | 38,888 | |
Total intangible asset, net | $ 65,743 | $ 62,920 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Lessee Disclosure [Abstract] | ||
Amortization of right-of-use assets | $ 1,895 | $ 1,898 |
Interest on lease liabilities | 816 | 759 |
Operating lease cost | 4,649 | 4,003 |
Short-term lease cost | 401 | 301 |
Variable lease cost | 2,071 | 2,261 |
Total lease cost | 9,832 | 9,222 |
Cash flows from leases | ||
Operating cash flows from finance leases | 816 | 759 |
Operating cash flows from operating leases | 4,649 | 4,003 |
Financing cash flows from finance leases | $ 1,470 | $ 1,115 |
Leases - Weighted Average (Deta
Leases - Weighted Average (Details) | Dec. 31, 2020 | Dec. 31, 2019 |
Weighted-average remaining lease term (years) | ||
Operating leases | 6 years 7 months 6 days | 6 years 10 months 24 days |
Finance leases | 5 years | 6 years |
Weighted-average discount rate | ||
Operating leases | 8.00% | 8.00% |
Finance leases | 8.00% | 8.00% |
Leases - Future minimum commitm
Leases - Future minimum commitments (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Operating Leases | |
2021 | $ 5,796 |
2022 | 5,308 |
2023 | 4,859 |
2024 | 4,868 |
2025 | 5,025 |
Thereafter | 9,938 |
Present value adjustment | (8,223) |
Present value of lease payments | $ 27,571 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent us-gaap:OtherLiabilitiesNoncurrent |
Finance Leases | |
2021 | $ 2,287 |
2022 | 2,287 |
2023 | 2,287 |
2024 | 2,287 |
2025 | 2,287 |
Present value of adjustment | (2,036) |
Present value of lease payments | 9,399 |
Total | |
2021 | 8,083 |
2022 | 7,595 |
2023 | 7,146 |
2024 | 7,155 |
2025 | 7,312 |
Thereafter | 9,938 |
Present value adjustment | (10,259) |
Present value of lease payments | $ 36,970 |
Debt (Details)
Debt (Details) $ / shares in Units, $ in Thousands | Nov. 06, 2020USD ($)shares | Nov. 04, 2020$ / shares | Aug. 13, 2019USD ($)$ / shares | May 01, 2019USD ($)countryitemsite | Sep. 09, 2014 | Nov. 30, 2020USD ($) | Apr. 30, 2020USD ($) | Aug. 31, 2019USD ($) | Apr. 30, 2018USD ($)D$ / shares | Sep. 30, 2014USD ($)itemD$ / shares | May 31, 2020USD ($)shares | Dec. 31, 2020USD ($)$ / shares | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($) |
Debt Instrument | |||||||||||||||||||||
Aggregate principal amount | $ 507,700 | $ 660,188 | $ 507,700 | $ 660,188 | |||||||||||||||||
Debt issuance costs | 8,656 | 8,656 | |||||||||||||||||||
Gain (loss) on extinguishment of debt | 0 | $ 0 | $ (3,277) | $ 0 | 0 | $ 18,480 | $ 0 | $ 0 | (3,277) | 18,480 | |||||||||||
Debt issuance cost | 1,460 | 1,460 | |||||||||||||||||||
Borrowings under financing agreement | 110,917 | 34,991 | 110,917 | 34,991 | |||||||||||||||||
2019 | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Repayments of debt | 35,000 | ||||||||||||||||||||
2020 | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Repayments of debt | $ 50,000 | ||||||||||||||||||||
Date is prior to Repayment Start Date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Debt instrument ratio of borrowed amount | 1.75% | ||||||||||||||||||||
Date is after Repayment Start Date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Debt instrument ratio of borrowed amount | 2.00% | ||||||||||||||||||||
Sixth Street Partners, LLC | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Principal amount outstanding | 110,900 | $ 110,900 | |||||||||||||||||||
Debt issuance cost | 1,800 | 1,800 | |||||||||||||||||||
Unamortized debt issuance costs | $ 1,500 | $ 1,500 | |||||||||||||||||||
Number of patients | item | 1,000 | ||||||||||||||||||||
Number of countries | country | 25 | ||||||||||||||||||||
Interest rate based on amount borrowed | 9.75% | 10.25% | 10.25% | ||||||||||||||||||
Percentage of royalty payment received | 19.50% | ||||||||||||||||||||
Percentage of other amounts received | 19.50% | ||||||||||||||||||||
Quarterly payments based on a certain percentage of revenues | $ 8,500 | ||||||||||||||||||||
Quarterly payments with label portion expanded by FDA | $ 13,500 | ||||||||||||||||||||
Ratio of repayment amount | 2 | ||||||||||||||||||||
Aggregate borrowed amount | $ 166,500 | ||||||||||||||||||||
Effective interest rate | 14.60% | 14.60% | |||||||||||||||||||
Sixth Street Partners, LLC | Minimum | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Number of sites | site | 270 | ||||||||||||||||||||
Sixth Street Partners, LLC | Maximum | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Aggregate principal amount | $ 175,000 | ||||||||||||||||||||
Aggregate borrowed amount | $ 350,000 | ||||||||||||||||||||
Convertible Senior Unsecured Notes | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Aggregate principal amount | $ 263,000 | $ 300,000 | $ 287,500 | ||||||||||||||||||
Convertible senior notes, interest rate | 4.50% | 4.50% | 1.25% | 2.50% | |||||||||||||||||
Convertible senior notes, maturity date | Sep. 15, 2021 | ||||||||||||||||||||
Net proceeds from convertible senior notes | $ 254,900 | $ 290,900 | $ 278,300 | ||||||||||||||||||
Common stock initial conversion rate per $1,000 in principal amount | 137.2213 | 13.1278 | 16.1616 | ||||||||||||||||||
Convertible senior notes, initial conversion price per share | $ / shares | $ 7.29 | $ 76.17 | $ 61.88 | ||||||||||||||||||
Debt instrument, redemption period start date | Sep. 15, 2018 | ||||||||||||||||||||
Last reported sale price of common stock as a percent of conversion price | 150.00% | 150.00% | |||||||||||||||||||
Debt instrument, conversion in effect for number of trading days | 20 | 20 | |||||||||||||||||||
Debt instrument conversion, consecutive trading day period | D | 30 | 30 | |||||||||||||||||||
Debt instrument, trading days preceding redemption notice, maximum | 2 | 2 | |||||||||||||||||||
Debt instrument redemption price percentage to principal amount | 100.00% | 100.00% | |||||||||||||||||||
Debt instrument repurchase percentage | 100.00% | 100.00% | 100.00% | ||||||||||||||||||
Debt issuance costs | $ 9,100 | $ 9,200 | |||||||||||||||||||
Unamortized debt issuance costs derecognized | $ 2,000 | ||||||||||||||||||||
Debt instrument term | 5 years | 7 years | 7 years | ||||||||||||||||||
Unamortized debt issuance costs | $ 8,700 | 15,400 | $ 8,700 | 15,400 | |||||||||||||||||
Convertible Senior Unsecured Notes | Semi Annual Payment, First payment date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Interest payment date on senior notes | --05-01 | --03-15 | |||||||||||||||||||
Convertible Senior Unsecured Notes | Semi Annual Payment, Second payment date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Interest payment date on senior notes | --11-01 | --09-15 | |||||||||||||||||||
2021 Notes | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Aggregate principal amount | $ 32,800 | $ 64,418 | 97,188 | $ 64,418 | 97,188 | ||||||||||||||||
Convertible senior notes, interest rate | 2.50% | 2.50% | |||||||||||||||||||
Convertible senior notes, maturity date | Sep. 15, 2021 | ||||||||||||||||||||
Principal amount outstanding | $ 190,300 | ||||||||||||||||||||
Aggregate repurchase price including accrued interest | 171,800 | ||||||||||||||||||||
Gain (loss) on extinguishment of debt | 3,300 | $ 18,500 | |||||||||||||||||||
2024 Notes (2019 Issuance) | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Aggregate principal amount | $ 36,100 | $ 24,300 | $ 85,782 | 263,000 | $ 85,782 | 263,000 | |||||||||||||||
Convertible senior notes, interest rate | 4.50% | 4.50% | |||||||||||||||||||
Convertible senior notes, maturity date | Aug. 1, 2024 | ||||||||||||||||||||
Common stock initial conversion rate per $1,000 in principal amount | 137.2213 | ||||||||||||||||||||
Debt issuance costs | $ 8,000 | ||||||||||||||||||||
Debt instrument term | 4 years | ||||||||||||||||||||
Debt conversion to number of shares of common stock | shares | 3,331,870 | ||||||||||||||||||||
Principal amount of debt converted | $ 64,800 | ||||||||||||||||||||
2024 Notes (2019 Issuance) | Semi Annual Payment, First payment date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Interest payment date on senior notes | --02-01 | ||||||||||||||||||||
2024 Notes (2019 Issuance) | Semi Annual Payment, Second payment date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Interest payment date on senior notes | --08-01 | ||||||||||||||||||||
2024 Notes (2020 Issuance) | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Aggregate principal amount | $ 57,500 | $ 57,500 | $ 57,500 | ||||||||||||||||||
Convertible senior notes, interest rate | 4.50% | 4.50% | 4.50% | ||||||||||||||||||
Convertible senior notes, maturity date | Aug. 1, 2024 | ||||||||||||||||||||
Common stock initial conversion rate per $1,000 in principal amount | 160.3334 | ||||||||||||||||||||
Convertible senior notes, initial conversion price per share | $ / shares | $ 5.67 | $ 6.24 | $ 6.24 | ||||||||||||||||||
Last reported sale price of common stock as a percent of conversion price | 10.00% | ||||||||||||||||||||
Debt instrument repurchase percentage | 100.00% | ||||||||||||||||||||
Debt issuance costs | $ 900 | ||||||||||||||||||||
Unamortized debt issuance costs derecognized | $ 1,400 | ||||||||||||||||||||
Gain (loss) on extinguishment of debt | $ (27,300) | ||||||||||||||||||||
Debt conversion to number of shares of common stock | shares | 15,112,848 | ||||||||||||||||||||
Purchase of price of debt per $1000 principal amount | $ 1 | ||||||||||||||||||||
2024 Notes (2020 Issuance) | Semi Annual Payment, First payment date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Interest payment date on senior notes | --02-01 | ||||||||||||||||||||
2024 Notes (2020 Issuance) | Semi Annual Payment, Second payment date | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Interest payment date on senior notes | --08-01 | ||||||||||||||||||||
2025 Notes | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Aggregate principal amount | $ 300,000 | $ 300,000 | $ 300,000 | $ 300,000 | |||||||||||||||||
Convertible senior notes, interest rate | 1.25% | 1.25% | |||||||||||||||||||
Convertible senior notes, maturity date | May 1, 2025 | ||||||||||||||||||||
Borrowing Exceeds $166.5 million | Sixth Street Partners, LLC | Minimum | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Quarterly payments based on a certain percentage of revenues | $ 8,940 | ||||||||||||||||||||
Borrowing Exceeds $166.5 million | Sixth Street Partners, LLC | Maximum | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Quarterly payments with label portion expanded by FDA | 14,190 | ||||||||||||||||||||
Scenario | Sixth Street Partners, LLC | Minimum | |||||||||||||||||||||
Debt Instrument | |||||||||||||||||||||
Borrowings under financing agreement | $ 166,500 | $ 166,500 |
Debt - Convertible senior notes
Debt - Convertible senior notes (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
May 31, 2020 | Jan. 31, 2020 | Apr. 30, 2018 | 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 | |
Debt Instrument [Line Items] | |||||||||||||
Common shares issued in a public offering | 11,090,000 | 1,837,898 | |||||||||||
Sale of stock, price per share | $ 8.05 | $ 54.41 | |||||||||||
Loss on extinguishment of debt | $ 0 | $ 0 | $ 3,277 | $ 0 | $ 0 | $ (18,480) | $ 0 | $ 0 | $ 3,277 | $ (18,480) | |||
Convertible Senior Unsecured Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Unamortized debt issuance costs | $ 8,700 | $ 15,400 | $ 8,700 | $ 15,400 | |||||||||
2024 Notes (2019 Issuance) | Direct registered offering | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Common shares issued in a public offering | 17,777,679 | ||||||||||||
Sale of stock, price per share | $ 9.25 | ||||||||||||
Principal amount of debt repurchase | $ 123,400 | ||||||||||||
Unamortized debt issuance costs | 3,600 | ||||||||||||
Loss on extinguishment of debt | $ 7,800 |
Debt - Amounts outstanding conv
Debt - Amounts outstanding convertible senior notes (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Convertible notes including debt issuance costs | $ 507,700 | |
Less debt issuance costs | (8,656) | |
Current portion | (64,198) | |
Long-term portion | 434,846 | $ 644,751 |
2021 Notes | ||
Debt Instrument [Line Items] | ||
Convertible notes including debt issuance costs | 64,418 | |
2024 Notes (both 2019 and 2020 Issuance) | ||
Debt Instrument [Line Items] | ||
Convertible notes including debt issuance costs | 143,282 | |
2025 Notes | ||
Debt Instrument [Line Items] | ||
Convertible notes including debt issuance costs | $ 300,000 |
Debt - Expected maturities of F
Debt - Expected maturities of Financing Agreement (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
2022 | $ 8,934 | |
2023 | 41,091 | |
2024 | 45,532 | |
2025 | 16,820 | |
Expected maturities of financing agreement including debt issuance costs | 112,377 | |
Less debt issuance costs | (1,460) | |
Long-term portion | 110,917 | $ 34,991 |
Sixth Street Partners, LLC | ||
Debt Instrument [Line Items] | ||
Less debt issuance costs | $ (1,800) |
Debt - Interest expense recogni
Debt - Interest expense recognized (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 | |
Debt | |||||||||||
Interest on convertible notes | $ 11,934 | $ 13,680 | $ 9,812 | ||||||||
Amortization of debt issuance costs | 2,672 | 2,858 | 2,178 | ||||||||
Debt issuance cost derecognized related to convertible debt transactions | 4,345 | ||||||||||
Interest on finance lease | 816 | 759 | |||||||||
Interest on borrowings under ATHENA financing agreement | 10,624 | 1,997 | |||||||||
Accretion of interest on milestone liability | 977 | ||||||||||
Interest on capital lease liability | 216 | ||||||||||
Other interest | 117 | 111 | |||||||||
Total interest expense | $ 7,349 | $ 6,859 | $ 6,739 | $ 9,561 | $ 6,720 | $ 5,278 | $ 3,817 | $ 3,590 | $ 30,508 | $ 19,405 | $ 13,183 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 31, 2020USD ($)$ / sharesshares | Apr. 30, 2018USD ($)$ / sharesshares | Dec. 31, 2020USD ($)Vote | Dec. 31, 2018USD ($) | |
Stockholders' Equity | ||||
Common shares issued in a public offering | shares | 11,090,000 | 1,837,898 | ||
Price per share in a public offering | $ / shares | $ 8.05 | $ 54.41 | ||
Proceeds from offering | $ | $ 82,800 | $ 93,900 | $ 246,668 | $ 93,890 |
Number of votes per common share | Vote | 1 |
Stockholders' Equity - Accumula
Stockholders' Equity - Accumulated Other Comprehensive Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accumulated Other Comprehensive Loss | |||
Beginning balance | $ (44,865) | $ (44,634) | |
Other comprehensive income (loss) | 561 | (231) | |
Total before tax | (44,304) | (44,865) | |
Tax effect | 0 | 0 | |
Ending balance | (44,304) | (44,865) | $ (44,634) |
Reclassifications out of accumulated other comprehensive loss | 0 | 0 | 0 |
Foreign Currency Translation Adjustments | |||
Accumulated Other Comprehensive Loss | |||
Beginning balance | (44,732) | (44,460) | |
Other comprehensive income (loss) | 567 | (272) | |
Total before tax | (44,165) | (44,732) | |
Tax effect | 0 | 0 | |
Ending balance | (44,165) | (44,732) | (44,460) |
Unrealized (Losses) Gains | |||
Accumulated Other Comprehensive Loss | |||
Beginning balance | (133) | (174) | |
Other comprehensive income (loss) | (6) | 41 | |
Total before tax | (139) | (133) | |
Tax effect | 0 | 0 | |
Ending balance | $ (139) | $ (133) | $ (174) |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Aug. 31, 2011 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Share-based compensation expense, tax benefit recognized | $ 0 | $ 0 | $ 0 | ||
Closing stock price | $ 4.80 | ||||
Stock options vested | $ 22,400 | 32,800 | 43,300 | ||
Stock-based compensation expense | 50,794 | $ 54,304 | 49,090 | ||
Common shares under stock incentive plans | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Unrecognized stock-based compensation expense related to unvested stock options | $ 18,100 | ||||
Unrecognized stock-based compensation expense related to non-vested options and/or RSUs, weighted-average remaining vesting period | 1 year 6 months | ||||
Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Unrecognized stock-based compensation expense related to unvested stock options | $ 33,600 | ||||
Unrecognized stock-based compensation expense related to non-vested options and/or RSUs, weighted-average remaining vesting period | 2 years 2 months 12 days | ||||
Weighted-average estimated grant date fair value of purchase awards under Purchase Plan | $ 28.85 | ||||
2011 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock options expiration period | 10 years | ||||
2011 Stock Incentive Plan | Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 4 years | ||||
2011 Stock Incentive Plan | Vesting after year one | Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 1 year | ||||
Percentage of grant vest contingent on approval | 50.00% | ||||
2011 Stock Incentive Plan | Vesting after year two | Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 2 years | ||||
Percentage of grant vest contingent on approval | 50.00% | ||||
2011 Stock Incentive Plan | One year from date of grant | Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 1 year | ||||
Percentage of grant vest contingent on approval | 25.00% | ||||
2011 Stock Incentive Plan | End of the vesting period | Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 3 years | ||||
Percentage of grant vest contingent on approval | 75.00% | ||||
2011 Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Increase in amount of shares reserved for issuance as percentage of outstanding shares of common stock | 1.00% | ||||
Increase in amount of shares reserved for issuance | 344,828 | ||||
Employee stock purchase plan offering period | 6 months | ||||
Purchase plan participating employees compensation withheld and applied to purchase of common stock | 10.00% | ||||
Share based compensation arrangement by share based payment award purchase price of common stock percent | 85.00% | ||||
Purchase plan termination date | Aug. 24, 2021 | ||||
Common stock shares sold to employees | 283,588 | 175,634 | |||
Shares of common stock remaining for future grant | 361,656 | ||||
Weighted-average estimated grant date fair value of purchase awards under Purchase Plan | $ 4.63 | $ 6.60 | |||
Stock-based compensation expense | $ 1,100 | $ 1,000 | $ 900 | ||
2020 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Common stock shares authorized | 647,000 | ||||
Stock options expiration period | 10 years | ||||
Minimum | Board of Directors | 2011 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 1 year | ||||
Minimum | Board of Directors | 2020 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 1 year | ||||
Maximum | Board of Directors | 2011 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 3 years | ||||
Maximum | Board of Directors | 2020 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 3 years | ||||
Employee Stock | 2011 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 4 years | ||||
Employee Stock | 2011 Stock Incentive Plan | Vesting after year one | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Percentage of grant vest contingent on approval | 25.00% | ||||
Employee Stock | Minimum | 2020 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 3 years | ||||
Employee Stock | Maximum | 2020 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Stock vesting period | 4 years | ||||
Employee Stock three year vest | 2020 Stock Incentive Plan | Vesting after year one | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Percentage of grant vest contingent on approval | 33.00% | ||||
Employee Stock four year vest | 2020 Stock Incentive Plan | Vesting after year one | |||||
Share Based Compensation Arrangement By Share Based Payment Award | |||||
Percentage of grant vest contingent on approval | 25.00% |
Share-Based Compensation - Shar
Share-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |||
Total Share-based compensation expense | $ 50,794 | $ 54,304 | $ 49,090 |
Research and development | |||
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |||
Total Share-based compensation expense | 25,577 | 25,838 | 20,489 |
Selling, general and administrative | |||
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |||
Total Share-based compensation expense | $ 25,217 | $ 28,466 | $ 28,601 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Stock Options Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Share-Based Compensation | |
Beginning Balance, Number of Options Outstanding | shares | 6,287,025 |
Granted, Number of Options | shares | 980,592 |
Exercised, Number of Options | shares | (117,932) |
Forfeited, Number of Options | shares | (649,016) |
Ending Balance, Number of Options Outstanding | shares | 6,500,669 |
Vested and expected to vest, Number of Options Outstanding | shares | 6,371,758 |
Vested and exercisable, Number of Options Outstanding | shares | 5,026,455 |
Beginning Balance, Weighted Average Exercise Price | $ / shares | $ 42.24 |
Granted, Weighted Average Exercise Price | $ / shares | 7.35 |
Exercised, Weighted Average Exercise Price | $ / shares | 3.23 |
Forfeited, Weighted Average Exercise Price | $ / shares | 41.15 |
Ending Balance, Weighted Average Exercise Price | $ / shares | 37.79 |
Vested and expected to vest, Weighted Average Exercise Price | $ / shares | 38.24 |
Vested and exercisable, Weighted Average Exercise Price | $ / shares | $ 43.87 |
Outstanding, Weighted Average Remaining Contractual Term (Years) | 5 years 7 months 6 days |
Vested and expected to vest, Weighted Average Remaining Contractual Term (Years) | 5 years 6 months |
Vested and exercisable, Weighted Average Remaining Contractual Term (Years) | 4 years 8 months 12 days |
Outstanding, Aggregate Intrinsic Value | $ | $ 127 |
Vested and expected to vest, Aggregate Intrinsic Value | $ | 118 |
Vested and exercisable, Aggregate Intrinsic Value | $ | $ 31 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-Based Compensation | |||
Weighted-average grant date fair value per share | $ 5.67 | $ 13.53 | $ 32.09 |
Intrinsic value of options exercised | $ 381 | $ 1,525 | $ 1,714 |
Cash received from stock option exercises | $ 236 | $ 1,361 | $ 1,869 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted-Average Assumptions Used to Estimate Fair Value of Purchase Awards Granted (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Volatility | 99.00% | 93.00% | 88.00% |
Risk-free interest rate | 0.49% | 1.67% | 2.92% |
Expected term (years) | 6 years | 5 years 10 months 24 days | 5 years 10 months 24 days |
Employee Stock Purchase Plans | |||
Share Based Compensation Arrangement By Share Based Payment Award | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Volatility | 138.00% | 79.00% | 51.00% |
Risk-free interest rate | 0.90% | 2.20% | 1.90% |
Expected term (years) | 6 months | 6 months | 6 months |
Share-Based Compensation - RSUs
Share-Based Compensation - RSUs Activity (Details) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award | |
Number of Units, Unvested as of Beginning Balance | shares | 2,171,347 |
Number of Units, Granted | shares | 2,441,804 |
Number of Units, Vested | shares | (1,012,699) |
Number of Units, Forfeited | shares | (636,905) |
Number of Units, Unvested as of Ending Balance | shares | 2,963,547 |
Expected to vest after December 31, 2020 | shares | 2,862,148 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 28.37 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 8.21 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 28.85 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 15.51 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | 14.36 |
Weighted Average Grant Date Fair Value, Expected to vest after December 31, 2020 | $ / shares | $ 14.09 |
Share-Based Compensation - Rese
Share-Based Compensation - Reserved Shares of Common Stock for Future Issuance (Details) | Dec. 31, 2020shares |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |
Common Stock Outstanding | 9,464,216 |
Available for Grant or Future Issuance | 6,310,938 |
Total Shares of Common Stock Reserved | 15,775,154 |
2009 Equity Incentive Plan | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |
Common Stock Outstanding | 64,522 |
Available for Grant or Future Issuance | 0 |
Total Shares of Common Stock Reserved | 64,522 |
2011 Stock Incentive Plan | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |
Common Stock Outstanding | 8,878,976 |
Available for Grant or Future Issuance | 0 |
Total Shares of Common Stock Reserved | 8,878,976 |
2020 Stock Incentive Plan | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |
Common Stock Outstanding | 520,718 |
Available for Grant or Future Issuance | 5,949,282 |
Total Shares of Common Stock Reserved | 6,470,000 |
2011 Employee Stock Purchase Plan | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | |
Common Stock Outstanding | 0 |
Available for Grant or Future Issuance | 361,656 |
Total Shares of Common Stock Reserved | 361,656 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Nov. 10, 2019plaintiff | Jun. 20, 2017patent | Mar. 31, 2017shareholder | Dec. 31, 2020USD ($) |
Commitments and Contingencies | ||||
Purchase commitments | $ | $ 68.1 | |||
Number of putative shareholders | shareholder | 2 | |||
Number of patents in salt and polymorph patent family | patent | 2 | |||
Number of opponents | plaintiff | 1 |
License Agreements (Details)
License Agreements (Details) $ in Thousands | Dec. 19, 2016USD ($) | Aug. 30, 2016 | Nov. 19, 2013USD ($) | Jun. 30, 2020USD ($) | Feb. 29, 2020item | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Feb. 28, 2019USD ($) | Jun. 30, 2018USD ($) | Apr. 30, 2018USD ($) | Jun. 30, 2011USD ($) | Oct. 31, 2008 | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2020USD ($) |
License Agreements | ||||||||||||||||||||||
Acquired in-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 9,440 | $ 0 | $ 0 | ||||||||||||||
Rucaparib | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Milestone payments | $ 750 | |||||||||||||||||||||
Rucaparib | EMA [Member] | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Milestone payment obligation | $ 15,000 | $ 20,000 | ||||||||||||||||||||
Rucaparib | First approval of NDA by FDA | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Milestone payment obligation | $ 15,000 | |||||||||||||||||||||
Rucaparib | Third approval of Rubraca as monotherapy treatment | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Milestone payments | $ 8,000 | |||||||||||||||||||||
3B Pharmaceuticals | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Percentage of Non-Royalty Consideration Payable on Sublicense Agreements | 34.00% | |||||||||||||||||||||
License Agreements Licensor Pfizer | Rucaparib | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Milestone payments | $ 23,000 | $ 750 | ||||||||||||||||||||
Milestone payment incurred as a result of government approval | $ 20,000 | |||||||||||||||||||||
Deferred milestone payment | $ 23,000 | |||||||||||||||||||||
Maximum number of months after FDA approval | 18 months | 18 months | ||||||||||||||||||||
License Agreements Licensor Pfizer | Rucaparib | Minimum | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Annual sales target for sales milestone payments | $ 250,000 | |||||||||||||||||||||
License Agreements Licensor Pfizer | Rucaparib | Maximum | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Maximum potential future development, regulatory milestone payments | 8,000 | |||||||||||||||||||||
Additional maximum payments payable on attaining the sales target | $ 170,000 | 170,000 | ||||||||||||||||||||
License Agreement Terms | 3B Pharmaceuticals | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Acquired in-process research and development | $ 9,400 | |||||||||||||||||||||
Number of additional undisclosed targets | item | 3 | |||||||||||||||||||||
Research and development expense | $ 2,100 | |||||||||||||||||||||
Percentage Of Royalty On Net Sales | 6.00% | |||||||||||||||||||||
License Agreement Terms | License Agreements Licensor Pfizer | Rucaparib | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Upfront payment | $ 7,000 | |||||||||||||||||||||
Milestones paid to Pfizer prior to FDA approval | $ 1,400 | |||||||||||||||||||||
License Agreement Terms | Advenchen Laboratories LLC | License Agreements Lucitanib | ||||||||||||||||||||||
License Agreements | ||||||||||||||||||||||
Milestone payment obligation | $ 65,000 | |||||||||||||||||||||
Percentage of Non-Royalty Consideration Payable on Sublicense Agreements | 25.00% |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share | |||
Total potential dilutive shares | 29,064 | 44,078 | 9,903 |
Common shares under stock incentive plans | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share | |||
Total potential dilutive shares | 3,095 | 2,480 | 1,319 |
Convertible senior notes | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share | |||
Total potential dilutive shares | 25,969 | 41,598 | 8,584 |
Income Taxes - Loss Before Inco
Income Taxes - Loss Before Income Taxes (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 | |
Income Taxes | |||||||||||
Domestic | $ (370,839) | $ (399,497) | $ (368,402) | ||||||||
Foreign | 1,080 | 871 | 1,001 | ||||||||
Loss before income taxes | $ (99,382) | $ (78,694) | $ (92,283) | $ (99,400) | $ (97,017) | $ (94,425) | $ (120,603) | $ (86,581) | $ (369,759) | $ (398,626) | $ (367,401) |
Income Taxes - Current and Defe
Income Taxes - Current and Deferred Tax Expenses (Benefit) (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 | |
Current tax: | |||||||||||
U.S. Federal & State | $ 50 | $ 3 | $ 15 | ||||||||
Foreign | (597) | 1,795 | 593 | ||||||||
Total current expense (benefit) | (547) | 1,798 | 608 | ||||||||
Deferred tax: | |||||||||||
U.S. Federal & State | 0 | 0 | 0 | ||||||||
Foreign | 0 | 0 | 0 | ||||||||
Total deferred (benefit) | 0 | 0 | 0 | ||||||||
Total income tax expense (benefit) | $ (425) | $ (18) | $ (36) | $ (68) | $ 2,484 | $ (350) | $ (176) | $ (160) | $ (547) | $ 1,798 | $ 608 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate to Effective Income Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes | |||
Federal income tax benefit at statutory rate | (21.00%) | (21.00%) | (21.00%) |
State income tax benefit, net of federal benefit | (1.60%) | (2.90%) | (3.10%) |
Tax credits | (1.50%) | (1.10%) | (1.30%) |
Change in uncertain tax positions | 0.10% | (4.30%) | 0.10% |
SEC settlement costs | 0.00% | 0.00% | 1.10% |
Convertible debt transactions | 2.20% | 0.00% | 0.00% |
Prior year true ups | 0.90% | 0.10% | (0.80%) |
Share based compensation | 2.60% | 2.30% | 0.80% |
Tax rate changes | 1.40% | 0.10% | 0.30% |
Change in valuation allowance | 16.10% | 26.50% | 23.20% |
Other | 0.60% | 0.80% | 0.90% |
Effective income tax rate | (0.20%) | 0.50% | 0.20% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforward | $ 414,932 | $ 396,100 |
Tax credit carryforwards | 247,064 | 243,901 |
Interest expense limitation carryforward | 5,371 | 4,449 |
Intangible assets | 94,558 | 61,459 |
Share-based compensation expense | 33,169 | 34,006 |
Product acquisition costs | 4,992 | 6,288 |
Lease liabilities | 6,122 | 5,317 |
Accrued liabilities and other | 7,488 | 5,817 |
Total deferred tax assets | 813,696 | 757,337 |
Valuation allowance | (806,622) | (750,508) |
Deferred tax assets, net of valuation allowance | 7,074 | 6,829 |
Deferred tax liabilities: | ||
Right -of -use assets | (6,799) | (6,337) |
Prepaid expenses and other | (275) | (492) |
Total deferred tax liabilities | (7,074) | (6,829) |
Net deferred tax liability | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes | |||
Increase to valuation allowance | $ 56,100 | $ 102,600 | |
Unrecognized tax benefits | 8,004 | $ 7,525 | $ 24,775 |
Net Operating loss carryforwards, subject to expiration | 1,100 | ||
Net Operating loss carryforwards, not subject to expiration | 600 | ||
Research and development and orphan drug tax credit carryforwards | 254,500 | ||
Orphan drug tax credit | 17,600 | ||
U.S. federal | |||
Income Taxes | |||
Net operating loss carryforwards | 1,700,000 | ||
State | |||
Income Taxes | |||
Net operating loss carryforwards | 1,600,000 | ||
Foreign Country | |||
Income Taxes | |||
Net operating loss carryforwards | $ 2,000,000 | ||
Minimum | U.S. federal | |||
Income Taxes | |||
Net operating loss carryforwards expiration year | 2029 | ||
Minimum | State | |||
Income Taxes | |||
Net operating loss carryforwards expiration year | 2024 | ||
Maximum | U.S. federal | |||
Income Taxes | |||
Net operating loss carryforwards expiration year | 2037 | ||
Maximum | State | |||
Income Taxes | |||
Net operating loss carryforwards expiration year | 2040 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns | ||
Balance at beginning of year | $ 7,525 | $ 24,775 |
Changes related to prior period tax positions | 64 | 35 |
Additions related to current period tax positions | 415 | 398 |
Settlements with tax authorities | 17,613 | |
Expiration of statute of limitations | 0 | |
Balance at end of year | $ 8,004 | $ 7,525 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Employee Benefit Plans | |||
Defined contribution plan, employer's contribution percentage | 4.00% | ||
United States | |||
Employee Benefit Plans | |||
Matching contributions to employees | $ 2.1 | $ 2.2 | $ 2 |
Foreign Defined Contribution Plan | |||
Employee Benefit Plans | |||
Matching contributions to employees | $ 1.5 | $ 1.1 | $ 0.9 |
Segment Information - Reportabl
Segment Information - Reportable segments (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 | |
Segment Reporting Information [Line Items] | |||||||||||
Product revenue | $ 43,299 | $ 38,772 | $ 39,887 | $ 42,564 | $ 39,307 | $ 37,603 | $ 32,978 | $ 33,118 | $ 164,522 | $ 143,006 | $ 95,388 |
Product revenue - extensible list | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Operating expenses: | |||||||||||
Research and development | $ 56,706 | $ 62,902 | $ 69,878 | $ 68,221 | $ 72,473 | $ 77,896 | $ 70,746 | $ 62,031 | $ 257,707 | $ 283,146 | $ 231,347 |
Selling, general and administrative | 40,758 | 38,636 | 41,902 | 42,598 | 45,168 | 41,811 | 48,029 | 47,761 | 163,894 | 182,769 | 175,781 |
Acquired in-process research and development | 9,440 | ||||||||||
Other operating expenses | 0 | 0 | 355 | 3,449 | 4,172 | 5,539 | 0 | 0 | 3,804 | 9,711 | |
Total expenses | 108,280 | 111,319 | 122,535 | 124,576 | 130,966 | 144,032 | 126,437 | 118,317 | 466,710 | 519,752 | 429,202 |
Operating loss | (64,981) | (72,547) | (82,648) | (82,012) | (91,659) | (106,429) | (93,459) | (85,199) | (302,188) | (376,746) | (333,814) |
Product | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product revenue | 164,500 | 143,000 | |||||||||
Operating expenses: | |||||||||||
Cost of sales - product | 9,474 | 8,438 | 9,120 | 9,096 | 7,942 | 8,134 | 6,445 | 7,405 | 36,128 | 29,926 | 19,444 |
Intangible asset amortization | |||||||||||
Operating expenses: | |||||||||||
Cost of sales - product | $ 1,342 | $ 1,343 | $ 1,280 | $ 1,212 | $ 1,211 | $ 1,212 | $ 1,217 | $ 1,120 | 5,177 | 4,760 | 2,630 |
U.S. | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product revenue | $ 146,259 | $ 137,187 | $ 95,388 | ||||||||
Product revenue - extensible list | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | ||||||||
Operating expenses: | |||||||||||
Research and development | $ 249,444 | $ 275,518 | $ 226,925 | ||||||||
Selling, general and administrative | 139,455 | 161,132 | 161,743 | ||||||||
Acquired in-process research and development | 9,440 | ||||||||||
Other operating expenses | 3,804 | 9,711 | |||||||||
Total expenses | 424,516 | 485,936 | 410,066 | ||||||||
Operating loss | (278,257) | (348,749) | (314,678) | ||||||||
U.S. | Product | |||||||||||
Operating expenses: | |||||||||||
Cost of sales - product | 29,526 | 28,179 | 19,444 | ||||||||
U.S. | Intangible asset amortization | |||||||||||
Operating expenses: | |||||||||||
Cost of sales - product | 2,287 | 1,956 | $ 1,954 | ||||||||
ex U.S. | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product revenue | $ 18,263 | $ 5,819 | |||||||||
Product revenue - extensible list | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | ||||||||
Operating expenses: | |||||||||||
Research and development | $ 8,263 | $ 7,628 | $ 4,422 | ||||||||
Selling, general and administrative | 24,439 | 21,637 | 14,038 | ||||||||
Total expenses | 42,194 | 33,816 | 19,136 | ||||||||
Operating loss | (23,931) | (27,997) | (19,136) | ||||||||
ex U.S. | Product | |||||||||||
Operating expenses: | |||||||||||
Cost of sales - product | 6,602 | 1,747 | |||||||||
ex U.S. | Intangible asset amortization | |||||||||||
Operating expenses: | |||||||||||
Cost of sales - product | $ 2,890 | $ 2,804 | $ 676 |
Quarterly Information (Unaudi_3
Quarterly Information (Unaudited) (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 | |
Revenues: | |||||||||||
Product revenue | $ 43,299 | $ 38,772 | $ 39,887 | $ 42,564 | $ 39,307 | $ 37,603 | $ 32,978 | $ 33,118 | $ 164,522 | $ 143,006 | $ 95,388 |
Product revenue - extensible list | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Operating expenses: | |||||||||||
Research and development | $ 56,706 | $ 62,902 | $ 69,878 | $ 68,221 | $ 72,473 | $ 77,896 | $ 70,746 | $ 62,031 | $ 257,707 | $ 283,146 | $ 231,347 |
Selling, general and administrative | 40,758 | 38,636 | 41,902 | 42,598 | 45,168 | 41,811 | 48,029 | 47,761 | 163,894 | 182,769 | 175,781 |
Acquired in-process research and development | 0 | 0 | 0 | 0 | 0 | 9,440 | 0 | 0 | |||
Other operating expenses | 0 | 0 | 355 | 3,449 | 4,172 | 5,539 | 0 | 0 | 3,804 | 9,711 | |
Total expenses | 108,280 | 111,319 | 122,535 | 124,576 | 130,966 | 144,032 | 126,437 | 118,317 | 466,710 | 519,752 | 429,202 |
Operating loss | (64,981) | (72,547) | (82,648) | (82,012) | (91,659) | (106,429) | (93,459) | (85,199) | (302,188) | (376,746) | (333,814) |
Other income (expense): | |||||||||||
Interest expense | (7,349) | (6,859) | (6,739) | (9,561) | (6,720) | (5,278) | (3,817) | (3,590) | (30,508) | (19,405) | (13,183) |
Foreign currency (loss) gain | 30 | 633 | 142 | (877) | 100 | (229) | (226) | (192) | (72) | (547) | (346) |
(Loss) gain on extinguishment of debt | 0 | 0 | (3,277) | 0 | 0 | 18,480 | 0 | 0 | (3,277) | 18,480 | |
Loss on convertible senior notes conversion | (27,284) | 0 | 0 | (7,791) | 0 | 0 | 0 | 0 | (35,075) | ||
Legal settlement loss | 0 | 0 | 0 | 0 | 0 | (1,750) | (25,000) | 0 | (26,750) | (27,975) | |
Other income | 202 | 79 | 239 | 841 | 1,262 | 781 | 1,899 | 2,400 | 1,361 | 6,342 | 7,917 |
Other income (expense), net | (34,401) | (6,147) | (9,635) | (17,388) | (5,358) | 12,004 | (27,144) | (1,382) | (67,571) | (21,880) | (33,587) |
Loss before income taxes | (99,382) | (78,694) | (92,283) | (99,400) | (97,017) | (94,425) | (120,603) | (86,581) | (369,759) | (398,626) | (367,401) |
Income tax benefit (expense) | 425 | 18 | 36 | 68 | (2,484) | 350 | 176 | 160 | 547 | (1,798) | (608) |
Net loss | $ (98,957) | $ (78,676) | $ (92,247) | $ (99,332) | $ (99,501) | $ (94,075) | $ (120,427) | $ (86,421) | $ (369,212) | $ (400,424) | $ (368,009) |
Basic and diluted net loss per common share | $ (1.02) | $ (0.89) | $ (1.15) | $ (1.39) | $ (1.81) | $ (1.72) | $ (2.27) | $ (1.63) | $ (4.38) | $ (7.43) | $ (7.07) |
Basic and diluted weighted average common shares outstanding | 96,681 | 88,255 | 80,453 | 71,662 | 54,834 | 54,707 | 53,028 | 52,891 | 84,307 | 53,873 | 52,066 |
Product | |||||||||||
Revenues: | |||||||||||
Product revenue | $ 164,500 | $ 143,000 | |||||||||
Operating expenses: | |||||||||||
Cost of sales | $ 9,474 | $ 8,438 | $ 9,120 | $ 9,096 | $ 7,942 | $ 8,134 | $ 6,445 | $ 7,405 | 36,128 | 29,926 | $ 19,444 |
Intangible asset amortization | |||||||||||
Operating expenses: | |||||||||||
Cost of sales | $ 1,342 | $ 1,343 | $ 1,280 | $ 1,212 | $ 1,211 | $ 1,212 | $ 1,217 | $ 1,120 | $ 5,177 | $ 4,760 | $ 2,630 |