Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 03, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CLVS | |
Entity Registrant Name | Clovis Oncology, Inc. | |
Entity Central Index Key | 0001466301 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 53,004,845 | |
Entity Small Business | false | |
Entity Emerging Growth Company | false |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Product revenue | $ 33,118 | $ 18,523 |
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember |
Operating expenses: | ||
Research and development | $ 62,031 | $ 43,543 |
Selling, general and administrative | 47,761 | 39,274 |
Total expenses | 118,317 | 87,195 |
Operating loss | (85,199) | (68,672) |
Other income (expense): | ||
Interest expense | (3,590) | (2,635) |
Foreign currency loss | (192) | (81) |
Legal settlement loss | (7,975) | |
Other income | 2,400 | 1,409 |
Other expense, net | (1,382) | (9,282) |
Loss before income taxes | (86,581) | (77,954) |
Income tax benefit | 160 | 260 |
Net loss | (86,421) | (77,694) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments, net of tax | (5) | 1,517 |
Net unrealized gain (loss) on available-for-sale securities, net of tax | 75 | (5) |
Other comprehensive (loss) income: | 70 | 1,512 |
Comprehensive loss | $ (86,351) | $ (76,182) |
Loss per basic and diluted common share: | ||
Basic and diluted net loss per common share | $ (1.63) | $ (1.54) |
Basic and diluted weighted average common shares outstanding | 52,891 | 50,602 |
Product | ||
Operating expenses: | ||
Cost of sales | $ 7,405 | $ 4,006 |
Intangible assets amortization | ||
Operating expenses: | ||
Cost of sales | $ 1,120 | $ 372 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 123,308 | $ 221,876 |
Accounts receivable, net | 16,096 | 12,889 |
Inventories, net | 24,986 | 27,072 |
Available-for-sale securities | 283,474 | 298,270 |
Prepaid research and development expenses | 3,761 | 3,579 |
Other current assets | 15,452 | 8,613 |
Total current assets | 467,077 | 572,299 |
Inventories | 114,996 | 113,908 |
Deposit on inventory | 12,350 | 12,350 |
Property and equipment, net | 16,193 | 26,524 |
Right-of-use assets, net | 23,919 | |
Intangible assets, net | 65,810 | 51,930 |
Goodwill | 63,074 | 63,074 |
Other assets | 21,198 | 23,475 |
Total assets | 784,617 | 863,560 |
Current liabilities: | ||
Accounts payable | 43,288 | 28,517 |
Accrued research and development expenses | 33,303 | 29,676 |
Lease liabilities | 4,253 | |
Other accrued expenses | 25,578 | 67,556 |
Total current liabilities | 106,422 | 125,749 |
Long-term lease liabilities - less current portion | 26,047 | |
Convertible senior notes | 576,003 | 575,470 |
Other long-term liabilities | 1,294 | 15,872 |
Total liabilities | 709,766 | 717,091 |
Commitments and contingencies (Note 15) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2019 and December 31, 2018 | ||
Common stock, $0.001 par value per share, 100,000,000 shares authorized at March 31, 2019 and December 31, 2018; 52,994,050 and 52,797,516 shares issued and outstanding at March 31, 2019 and December 31, 2018 respectively | 53 | 53 |
Additional paid-in capital | 2,048,875 | 2,034,142 |
Accumulated other comprehensive loss | (44,564) | (44,634) |
Accumulated deficit | (1,929,513) | (1,843,092) |
Total stockholders' equity | 74,851 | 146,469 |
Total liabilities and stockholders' equity | $ 784,617 | $ 863,560 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
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 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 52,994,050 | 52,797,516 |
Common stock, shares outstanding | 52,994,050 | 52,797,516 |
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 | $ 1,887,197 | $ (42,173) | $ (1,477,440) | $ 367,635 |
Beginning Balance (in shares) at Dec. 31, 2017 | 50,565,119 | ||||
Exercise of stock options | 514 | $ 514 | |||
Exercise of stock options (in shares) | 21,463 | ||||
Issuance of common stock from vesting of restricted stock units, net of shares withheld for taxes (in shares) | 110,889 | ||||
Share-based compensation expense | 11,913 | $ 11,913 | |||
Net unrealized gain on available-for-sale securities | (5) | (5) | |||
Foreign currency translation adjustments | 1,517 | 1,517 | |||
Adoption of new revenue recognition standard | 2,356 | 2,356 | |||
Net loss | (77,694) | (77,694) | |||
Ending Balance at Mar. 31, 2018 | 51 | 1,899,624 | (40,661) | (1,552,778) | $ 306,236 |
Ending Balance (in shares) at Mar. 31, 2018 | 50,697,471 | ||||
Beginning Balance at Dec. 31, 2018 | 53 | 2,034,142 | (44,634) | (1,843,092) | $ 146,469 |
Beginning Balance (in shares) at Dec. 31, 2018 | 52,797,516 | ||||
Exercise of stock options | 1,093 | $ 1,093 | |||
Exercise of stock options (in shares) | 83,132 | ||||
Issuance of common stock from vesting of restricted stock units, net of shares withheld for taxes (in shares) | 113,402 | ||||
Share-based compensation expense | 13,640 | $ 13,640 | |||
Net unrealized gain on available-for-sale securities | 75 | 75 | |||
Foreign currency translation adjustments | (5) | (5) | |||
Net loss | (86,421) | (86,421) | |||
Ending Balance at Mar. 31, 2019 | $ 53 | $ 2,048,875 | $ (44,564) | $ (1,929,513) | $ 74,851 |
Ending Balance (in shares) at Mar. 31, 2019 | 52,994,050 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities | ||
Net loss | $ (86,421) | $ (77,694) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 13,640 | 11,913 |
Depreciation and amortization | 1,722 | 586 |
Amortization of premiums and discounts on available-for-sale securities | (129) | (171) |
Amortization of debt issuance costs | 645 | 326 |
Allowance for obsolete inventories | 174 | |
Lease liabilities | (175) | |
Deferred income taxes | (101) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (3,205) | (3,418) |
Inventory | (24,110) | (41,716) |
Prepaid and accrued research and development expenses | 3,437 | 637 |
Deposit on inventory | 11,157 | |
Other operating assets | (4,726) | (1,890) |
Accounts payable | 5,389 | (1,730) |
Other accrued expenses | (4,692) | 1,466 |
Net cash used in operating activities | (98,451) | (100,635) |
Investing activities | ||
Purchases of property and equipment | (1,231) | (217) |
Purchases of available-for-sale securities | (138,415) | |
Sales of available-for-sale securities | 153,500 | 10,000 |
Acquired in-process research and development - milestone payment | (15,000) | |
Net cash (used in) provided by investing activities | (1,146) | 9,783 |
Financing activities | ||
Proceeds from the exercise of stock options and employee stock purchases | 1,093 | 514 |
Net cash provided by financing activities | 1,093 | 514 |
Effect of exchange rate changes on cash and cash equivalents | (64) | 254 |
Decrease in cash and cash equivalents | (98,568) | (90,084) |
Cash and cash equivalents at beginning of period | 221,876 | 464,198 |
Cash and cash equivalents at end of period | 123,308 | 374,114 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 3,594 | 3,594 |
Non-cash investing and financing activities: | ||
Vesting of restricted stock units | $ 3,277 | $ 6,409 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Nature of Business and Basis of Presentation | |
Nature of Business and Basis of Presentation | 1. Nature of Business and Basis of Presentation Clovis Oncology, Inc. (together with its consolidated subsidiaries, the “Company”, “Clovis”, “we”, “our”, “us”) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, the European Union (“EU”) 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. We have and intend to continue to license or acquire rights to oncology compounds in all stages of clinical development. In exchange for the right to develop and commercialize these compounds, we generally expect to provide the licensor with a combination of upfront payments, milestone payments and royalties on future sales. In addition, we generally expect to assume the responsibility for future drug development and commercialization costs. We currently operate in one segment. Since inception, our operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate activities and since 2016 we have also marketed and sold products. Our 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. The initial indication received approval from the United States Food and Drug Administration (“FDA”) in December 2016 and covers the treatment of adult patients with deleterious BRCA (human genes associated with the repair of damaged DNA) mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. In April 2018, the FDA also approved Rubraca for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The approval in this second, broader and earlier-line indication on a priority review timeline was based on positive data from the phase 3 ARIEL3 clinical trial. Diagnostic testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication. In May 2018, the European Commission granted a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. As this is a conditional approval, it will be necessary to complete certain confirmatory post marketing commitments. In January 2019, the European Commission granted a variation to the marketing authorization to include the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. With this approval, Rubraca is now authorized in the EU for certain patients in the recurrent ovarian cancer maintenance setting regardless of their BRCA mutation status. Rubraca was the first PARP inhibitor licensed for an ovarian cancer treatment indication in the EU and is now the first to be authorized for both treatment and maintenance treatment among eligible patients with ovarian cancer. We completed our launch of Rubraca as maintenance therapy in Germany and the UK in March 2019 and we plan to launch in other EU countries during 2019 and 2020. The initial TRITON2 data presented at ESMO 2018 demonstrated a 44% confirmed objective response rate by investigator assessment in 25 RECIST/PCWG3 response-evaluable patients with a BRCA1/2 alteration. The median duration of response in these patients had not yet been reached at time of presentation. In addition, a 51% confirmed prostate-specific antigen (“PSA”) response rate was observed in 45 PSA response-evaluable patients with a BRCA1/2 alteration. In April 2019, we submitted updated data on 52 patients with BRCA-mutant mCRPC to the FDA, and the response rates in that submission were highly consistent with those shown at ESMO 2018. In the initial TRITON2 data presented at ESMO 2018, the most common treatment-emergent adverse events (“TEAEs”) of any grade (CTCAE Grade 1-4) in all patients regardless of causality included asthenia/fatigue (44.7%, or 38/85), nausea (42.4%, or 36/85), anemia/decreased hemoglobin (28.2%, or 24/85), decreased appetite (28.2%, or 24/85) and constipation (22.4%, or 19/85). Five patients (5.9%) discontinued therapy due to a non-progression TEAE. One patient died due to disease progression. Safety data for Rubraca in men with mCRPC continues to be consistent with those observed in patients with ovarian cancer and other solid tumors. Beyond our initial labeled indication, we have a robust Rubraca 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 Company to evaluate its immunotherapy OPDIVO® (nivolumab) in combination with Rubraca. We hold worldwide rights for Rubraca. In addition to Rubraca, we have one other product candidate. Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of 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). We believe that recent data for a drug similar to lucitanib that inhibits these same pathways – when combined with a PD-1 inhibitor – provide support for development of lucitanib in combination with a PD-1 inhibitor and a Clovis-sponsored study of lucitanib in combination with nivolumab is planned in gynecologic cancers. In addition, we intend to initiate a study of lucitanib in combination with Rubraca in ovarian cancer, based on encouraging data of VEGF and PARP inhibitors in combination. We intend to initiate each of these Phase 1b/2 combination studies in mid-2019. Lucitanib was previously partnered with Les Laboratoires Servier and Institut de Recherches Internationales Servier (collectively, “Servier”) outside the U.S. and Japan (also excluding China); Servier returned its rights to lucitanib in late 2018. We now hold the global development and commercialization rights (except for China) for lucitanib. In early 2019, we provided notice to Celgene Corporation exercising the right to terminate our license to rociletinib, an oral mutant-selective inhibitor of epidermal growth factor receptor (“EGFR”). That termination became effective in the second quarter of 2019. Basis of Presentation All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments that, in the opinion of management, are necessary to fairly state our financial position, results of operations and cash flows for the periods presented herein. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our Annual Report on Form 10-K for the year ended December 31, 2018 (“2018 Form 10-K”) for a broader discussion of our business and the opportunities and risks inherent in such business. 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. 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 revenues from Rubraca adequate to support our cost structure. We may never achieve profitability, and unless or 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 | 3 Months Ended |
Mar. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Recently Adopted Accounting Standards In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”, which requires lessees to recognize assets and liabilities for the rights and obligations created by most leases on their balance sheet. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered after, the date of initial application, with an option to use certain transition relief. We adopted ASU 2016-02 as of January 1, 2019 using the modified retrospective method which leaves the comparative period reporting unchanged. Comparative reporting periods are presented in accordance with Topic 840, while periods subsequent to the effective date are presented in accordance with Topic 842. We have elected to adopt the package practical expedient which allows us: 1) to not reassess whether any expired or existing contracts are or contain leases, 2) to not reassess the lease classification for any expired or existing leases and 3) to not reassess initial direct costs for any existing leases. We also elected not to recognize on the balance sheet leases with terms of 12 months or less. For these short-term leases, we will recognize the lease payments in profit or loss on a straight-line basis over the lease term and the variable lease payments in the period in which the obligation for those payments is incurred. Adoption of the new lease standard resulted in the recording of net right-of-use assets and lease liabilities of approximately $24.9 million and $31.4 million, respectively, as of January 1, 2019. In February 2018, the FASB issued ASU 2018-02, “Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income”, which allow a reclassification from accumulated other comprehensive income (loss) (“AOCI”) to retained earnings for stranded tax effects resulting from the change in the U.S. federal corporate income tax rate on the gross deferred tax amounts at the date of enactment of the Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act”). The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. We adopted the new standard on January 1, 2019 and elected not to reclassify the income tax effects of the Tax Act from AOCI to retained earnings. We continue to release disproportionate income tax effects from AOCI based on the aggregate portfolio approach. The adoption of this standard did not have an impact on our condensed consolidated financial statements. In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, simplifies the accounting for share-based payment granted to nonemployees for goods and services. Under the standard, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. We adopted ASU 2018-07 as of January 1, 2019. There is 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 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. Early adoption is permitted. We will adopt ASU 2018-02 as of January 1, 2020. We are currently evaluating the impact the standard may have on our consolidated financial statements and related disclosures. 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 will adopt ASU 2016-13 as of January 1, 2020. We are currently evaluating the impact the standard may have on our consolidated financial statements and related disclosures. Revenue Recognition We are currently approved to sell Rubraca in the United States and the EU 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. 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 (if the amount is payable to the customers) or a current liability (if the amount is payable to a party other than a customer). 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. Rebates . Rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare coverage gap program. Rebates are amounts owed after the final dispensing of products to a benefit plan participant and are based upon contractual agreements or legal requirements with the public-sector benefit providers. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheet. We estimate our Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. The accrual for rebates is based on the expected utilization from historical data we have accumulated since the Rubraca product launch. Rebates are generally invoiced and paid quarterly in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known or estimated prior quarters’ unpaid rebates. Chargebacks . Chargebacks are discounts that occur when contracted customers, which currently consist primarily of group purchasing organizations, Public Health Service organizations and federal government entities purchasing via the Federal Supply Schedule, purchase directly from our specialty distributors at a discounted price. The specialty distributor, in turn, charges back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the healthcare provider. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. The accrual for specialty distributor chargebacks is estimated based on known chargeback rates and known sales to specialty distributors adjusted for the estimated utilization by healthcare providers. Discounts and Fees . Our payment terms are generally 30 days. Specialty distributors and specialty pharmacies are offered various forms of consideration, including service fees and prompt pay discounts for payment within a specified period. We expect these customers will earn prompt pay discounts and therefore, we deduct the full amount of these discounts and service fees from product sales when revenue is recognized. Co-pay assistance . Patients who have commercial insurance and meet certain eligibility requirements may receive co-pay assistance. The intent of this program is to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are based on actual program participation provided by third-party administrators at month end. Returns . Consistent with industry practice, we generally offer customers a right of return limited only to product that will expire in six months or product that is six months beyond the expiration date. To date, we have had minimal product returns and we currently have a minimal accrual for product returns. We will continue to assess our estimate for product returns as we gain additional historical experience. 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. 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 began capitalizing incurred inventory related costs upon the regulatory approval of Rubraca. Prior to the regulatory approval of Rubraca, we incurred costs for the manufacture of the drug that could potentially be available to support the commercial launch of Rubraca and all such costs were recognized as research and development expense. We regularly analyze our inventory levels for excess quantities and obsolescence (expiration), taking into account 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. 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 eight 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 a single supplier. 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. Inventory used in clinical trials is expensed as research and development expense when it has been identified for such use. Our other significant accounting policies are described in Note 2, Summary of Significant Accounting Policies of the Notes to the Consolidated Financial Statements included in our 2018 Form 10-K. |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
Financial Instruments and Fair Value Measurements | |
Financial Instruments and Fair Value Measurements | 3. Financial Instruments and 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 and U.S. treasury securities. 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 that are measured at fair value on a recurring basis. The following table identifies our assets and liabilities that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 March 31, 2019 Assets: Money market $ 44,084 $ 44,084 $ — $ — U.S. treasury securities 303,435 19,961 283,474 — Total assets at fair value $ 347,519 $ 64,045 $ 283,474 $ — December 31, 2018 Assets: Money market $ 81,968 $ 81,968 $ — $ — U.S. treasury securities 308,251 9,981 298,270 — Total assets at fair value $ 390,219 $ 91,949 $ 298,270 $ — There we no liabilities that were measured at fair value on a recurring basis as of March 31, 2019. There were no transfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the three months ended March 31, 2019. Financial instruments not recorded at fair value include our convertible senior notes. At March 31, 2019, the carrying amount of the 2021 Notes was $283.9 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $265.2 million. At March 31, 2019, the carrying amount of the 2025 Notes was $292.1 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $233.9 million. The fair value was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of these notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system. See Note 9, Convertible Senior Notes for discussion of the convertible senior notes. |
Available-for-Sale Securities
Available-for-Sale Securities | 3 Months Ended |
Mar. 31, 2019 | |
Debt Securities, Available-for-sale [Abstract] | |
Available-for-Sale Securities | 4. Available-for-Sale Securities As of March 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 $ 283,434 $ 40 $ — $ 283,474 As of December 31, 2018, 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 $ 298,305 $ — $ (35) $ 298,270 As of March 31, 2019, there were no available-for-sale securities that have been in a continuous unrealized loss position for less than 12 months. As of March 31, 2019, the amortized cost and fair value of available-for-sale securities by contractual maturity were (in thousands): Amortized Fair Cost Value Due in one year or less $ 283,434 $ 283,474 Due in one year to two years — — Total $ 283,434 $ 283,474 |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2019 | |
Inventories | |
Inventories | 5. Inventories The following table presents current and long-term inventories as of March 31, 2019 and December 31, 2018: March 31, December 31, 2019 2018 Work-in-process $ 129,248 $ 126,620 Finished goods 10,888 14,360 Allowance for obsolete inventories (154) — Total inventories $ 139,982 $ 140,980 Some of the costs related to our finished goods on-hand as of December 31, 2018 were expensed as incurred prior to the commercialization of Rubraca on December 19, 2016. At March 31, 2019, we had $25.0 million of current inventory and $115.0 million of long-term inventory. In addition, we had $12.4 million long-term deposit on inventory, which consists of API which we expect to be converted to finished goods and sold beyond the next twelve months. |
Other Current Assets
Other Current Assets | 3 Months Ended |
Mar. 31, 2019 | |
Other Current Assets | |
Other Current Assets | 6. Other Current Assets Other current assets were comprised of the following (in thousands): March 31, December 31, 2019 2018 Prepaid insurance $ 1,720 $ 244 Prepaid advertising 1,620 1,620 Prepaid expenses - other 3,870 3,519 Value-added tax ("VAT") receivable 6,337 — Receivable - other 1,772 2,274 Other 133 956 Total $ 15,452 $ 8,613 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 3 Months Ended |
Mar. 31, 2019 | |
Intangible Assets and Goodwill | |
Intangible Assets and Goodwill | 7. Intangible Assets and Goodwill Intangible assets related to capitalized milestones under license agreements consisted of the following (in thousands): March 31, December 31, 2019 2018 Intangible asset - milestones $ 71,100 $ 56,100 Accumulated amortization (5,290) (4,170) Total intangible asset, net $ 65,810 $ 51,930 The increase in our intangible asset – milestones since December 31, 2018 is due to a $15.0 million milestone payment to Pfizer related to the January 2019 European Commission approval. See Note 13, License Agreements for further discussion of these approvals. 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 $1.1 million and $0.4 million related to capitalized milestone payments during the three months ended March 31, 2019 and March 31, 2018, 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 associated with intangibles is expected to be as follows (in thousands): 2019 $ 3,588 2020 4,784 2021 4,784 2022 4,784 2023 4,784 Thereafter 43,086 $ 65,810 |
Other Accrued Expenses
Other Accrued Expenses | 3 Months Ended |
Mar. 31, 2019 | |
Other Accrued Expenses | |
Other Accrued Expenses | 8. Other Accrued Expenses Other accrued expenses were comprised of the following (in thousands): March 31, December 31, 2019 2018 Accrued personnel costs $ 8,969 $ 15,265 Accrued interest payable 1,862 2,721 Income tax payable 920 847 Accrued corporate legal fees and professional services 965 677 Accrued royalties 5,200 4,854 Accrued variable considerations 3,428 2,183 Current portion of capital lease obligations — 1,031 Purchase of API received not yet invoiced 177 35,472 Accrued expenses - other 4,057 4,506 Total $ 25,578 $ 67,556 |
Lease
Lease | 3 Months Ended |
Mar. 31, 2019 | |
Lease | |
Lease | 9. Lease 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 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): Three months ended March 31, 2019 Lease cost Finance lease cost: Amortization of right-of-use assets $ 356 Interest on lease liabilities 184 Operating lease cost 1,149 Short-term lease cost 49 Variable lease cost 725 Total lease cost $ 2,463 Operating cash flows from finance leases $ 184 Operating cash flows from operating leases $ 1,149 Financing cash flows from finance leases $ 250 The weighted-average remaining lease term and weighted-average discount rate were as follows: March 31, 2019 Weighted-average remaining lease term (years) Operating leases 6.9 Finance leases 6.8 Weighted-average discount rate Operating leases Finance leases Future minimum commitments due under these lease agreements as of March 31, 2019 are as follows (in thousands): Operating Leases Finance Leases Total 2019 (remaining nine months) $ 3,591 $ 1,302 $ 4,893 2020 4,668 1,736 6,404 2021 4,729 1,736 6,465 2022 2,787 1,736 4,523 2023 2,343 1,736 4,079 Thereafter 9,859 3,474 13,333 Present value adjustment (6,710) (2,687) (9,397) Present value of lease payments $ 21,267 $ 9,033 $ 30,300 |
Convertible Senior Notes
Convertible Senior Notes | 3 Months Ended |
Mar. 31, 2019 | |
Convertible Senior Notes | |
Convertible Senior Notes | 10. Convertible Senior Notes 2021 Notes On September 9, 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 and September 15 of each year. The 2021 Notes will mature on September 15, 2021, unless earlier converted, redeemed or repurchased. 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. 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 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. 2025 Notes On April 19, 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 and November 1 of each year. The 2025 Notes will mature on May 1, 2025, unless earlier converted, redeemed or repurchased. 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 March 31, 2019 and December 31, 2018, the balance of unamortized debt issuance costs was $11.5 million and $12.0 million, respectively . The following table sets forth total interest expense recognized during the three months ended March 31, 2019 and 2018 (in thousands): Three months ended March 31, 2019 2018 Contractual interest expense $ 2,734 $ 1,797 Accretion of interest on milestone liability — 512 Amortization of debt issuance costs 645 326 Interest on finance lease 184 — Other interest 27 — Total interest expense $ 3,590 $ 2,635 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders’ Equity | |
Stockholders' Equity | 11. Stockholders’ Equity Common Stock 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 for the three months ended March 31, 2019 and 2018, as follows (in thousands): Foreign Currency Unrealized Total Accumulated Translation Adjustments (Losses) Gains Other Comprehensive Loss 2019 2018 2019 2018 2019 2018 Balance at January 1, $ (44,460) $ (41,917) $ (174) $ (256) $ (44,634) $ (42,173) Other comprehensive income (loss) (5) 1,991 75 (7) 70 1,984 Total before tax (44,465) (39,926) (99) (263) (44,564) (40,189) Tax effect — (474) — 2 — (472) Balance at March 31, $ (44,465) $ (40,400) $ (99) $ (261) $ (44,564) $ (40,661) The period change between December 31, 2018 and March 31, 2019 was primarily due to the deferred income taxes associated with the acquisition of EOS in November 2013. There were no reclassifications out of accumulated other comprehensive loss in each of the three months ended March 31, 2019 and 2018. |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Share-Based Compensation | |
Share-Based Compensation | 12. Share-Based Compensation Share-based compensation expense for all equity-based programs, including stock options, restricted stock units and the employee stock purchase plan, for the three months ended March 31, 2019 and 2018 was recognized in the accompanying Consolidated Statements of Operations as follows (in thousands): Three months ended March 31, 2019 2018 Research and development $ 6,611 $ 5,376 Selling, general and administrative 7,029 6,537 Total share-based compensation expense $ 13,640 $ 11,913 We did not recognize a tax benefit related to share-based compensation expense during the three months ended March 31, 2019 and 2018, respectively, as we maintain net operating loss carryforwards and have established a valuation allowance against the entire net deferred tax asset as of March 31, 2019. Stock Options The following table summarizes the activity relating to our options to purchase common stock for the three months ended March 31, 2019: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Options Price Term (Years) (Thousands) Outstanding at December 31, 2018 6,311,513 $ 46.05 Granted 514,199 25.57 Exercised (83,132) 13.16 Forfeited (111,252) 57.92 Outstanding at March 31, 2019 6,631,328 $ 44.68 6.4 $ 12,945 Vested and expected to vest at March 31, 2019 6,319,568 $ 45.10 6.2 $ 12,713 Vested and exercisable at March 31, 2019 4,554,030 $ 46.90 5.3 $ 11,415 The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price of $24.82 as of March 29, 2019, 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 three months ended March 31, 2019 and 2019 (in thousands, except per share amounts): Three months ended March 31, 2019 2018 Weighted-average grant date fair value per share $ 18.83 $ 43.14 Intrinsic value of options exercised $ 765 $ 762 Cash received from stock option exercises $ 1,094 $ 514 As of March 31, 2019, the unrecognized share-based compensation expense related to unvested options, adjusted for expected forfeitures, was $54.6 million and the estimated weighted-average remaining vesting period was 2.3 years. Restricted Stock The following table summarizes the activity relating to our unvested restricted stock units (“RSUs”) for the three months ended March 31, 2019: Weighted Average Number of Grant Date Units Fair Value Unvested at December 31, 2018 795,684 $ 47.73 Granted 1,977,459 25.67 Vested (113,402) 52.45 Forfeited (51,759) 45.11 Unvested as of March 31, 2019 2,607,982 $ 30.85 Expected to vest after March 31, 2019 2,154,434 $ 31.10 As of March 31, 2019, the unrecognized share-based compensation expense related to unvested RSUs, adjusted for expected forfeitures, was $64.5 million and the estimated weighted-average remaining vesting period was 2.7 years. |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
License Agreements | |
License Agreements | 13. License Agreements Rucaparib In June 2011, we entered into a worldwide license agreement with Pfizer, Inc. to obtain 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 Indication in US and (ii) EMA approval of an MAA for 1 st Indication in EU, to a date that is 18 months after the date of achievement of such milestones. 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 the 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. On April 6, 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 approval. 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 its second European Commission approval. This approval resulted in an obligation to pay a $15.0 million milestone payment, which we paid in February 2019. These milestone payments were recognized as intangible assets and will be 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 rucaparib and we are responsible for all remaining development and commercialization costs for Rubraca. We are required to make regulatory milestone payments to Pfizer of up to an additional $16.75 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 our 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 UK Limited 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 receives royalties on any net sales of rucaparib. Lucitanib In connection with our acquisition of EOS in November 2013, we gained rights to develop and commercialize lucitanib, an oral, selective tyrosine kinase inhibitor. As further described below, EOS licensed the worldwide rights, excluding China, to develop and commercialize lucitanib from Advenchen Laboratories LLC (“Advenchen”). Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by EOS to Servier in exchange for upfront milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development funding commitments. In October 2008, EOS entered into an exclusive license agreement with 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 candidate 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 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. During 2017, we completed the committed on-going development activities related to lucitanib and received full reimbursement of our development costs from Servier. Reimbursements are recorded as a reduction to research and development expense on the Consolidated Statements of Operations. Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; however, data in breast and lung cancer were insufficient to move the program forward. We received notice from Servier of termination of their rights to lucitanib, resulting in the return of global rights (excluding China) for lucitanib to us during October 2018. Pursuant to terms of each of our product license agreements, we will pay royalties to our licensors on sales, if any, of the respective products. Rociletinib In May 2010, we entered into an exclusive worldwide license agreement with Celgene to discover, develop and commercialize a covalent inhibitor of mutant forms of the epidermal growth factor receptor (“EGFR”) gene product. Rociletinib, an oral mutant-selective inhibitor of EGFR, was identified as the lead inhibitor candidate under the license agreement. Following the termination of enrollment in all sponsored clinical studies of rociletinib, we provided notice of termination to Celgene of our license rights to rociletinib, an oral mutant-selective inhibitor of EGFR, and that termination became effective in the second quarter of 2019. |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2019 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 14. 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 2021 Notes and 2025 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): Three and Three months ended March 31, 2019 2018 Common shares under option 5,123 3,908 Convertible senior notes 8,584 4,646 Total potential dilutive shares 13,707 8,554 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies | |
Commitments and Contingencies | 15. Commitments and Contingencies Royalty and License Fee Commitments We have entered into certain license agreements, as identified in Note 13, License Agreements , with third parties that include the payment of development and regulatory milestones, as well as royalty payments, upon the achievement of pre-established development, regulatory and commercial targets. Our payment obligation related to these license agreements is contingent upon the successful development, regulatory approval and commercialization of the licensed products. Due to the nature of these arrangements, the future potential payments are inherently uncertain, and accordingly, we only recognize payment obligations which are probable and estimable as of the balance sheet date. 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 any forecast. In addition, the third-party supplier will construct, in its existing facility, a production train that will be exclusively dedicated to the manufacture of the Rubraca active ingredient. We are obligated to make scheduled capital program fee payments toward capital equipment and other costs associated with the construction of the dedicated production train. Further, once the facility is operational, we are 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 March 31, 2019, $102.5 million of purchase commitments exist 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 open actions currently pending against Clovis are discussed below. On November 10, 2016, Antipodean Domestic Partners (“Antipodean”) filed a complaint (the “Antipodean Complaint”) against Clovis and certain of its officers, directors and underwriters in New York Supreme Court, County of New York. The Antipodean Complaint alleges that the defendants violated certain sections of the Securities Act by making allegedly false statements to Antipodean and in the offering materials for the July 2015 Offering relating to the efficacy of rociletinib, its safety profile, and its prospects for market success. In addition to the Securities Act claims, the Antipodean Complaint also asserts Colorado state law claims and common law claims. Both the state law and common law claims are based on allegedly false and misleading statements regarding rociletinib’s progress toward FDA approval. The Antipodean Complaint seeks compensatory, recessionary, and punitive damages. On December 15, 2016, the Antipodean Plaintiffs filed an amended complaint (the “Antipodean Amended Complaint”) asserting substantially the same claims against the same defendants and purporting to correct certain details in the original Antipodean Complaint. Following a stay that Justice Masley of the New York Supreme Court, County of New York entered in favor of the Medina Action and briefing on defendants’ motions to dismiss, the parties participated in a Preliminary Conference on April 17, 2018, following which the Court entered a preliminary conference order, providing deadlines for document productions, depositions, and other discovery. On May 2, 2018, the Court issued an order denying the defendants’ motion to dismiss. Defendants filed an answer to the Antipodean Amended Complaint on June 6, 2018. Subject to certain specified exceptions, fact discovery was completed on March 1, 2019. The current scheduling order provides for an expert-discovery deadline of June 21, 2019. The Court has scheduled a status conference for June 4, 2019, following which the Court anticipates issuing a revised scheduling order. Clovis and the Antipodean Plaintiffs are scheduled to participate in a mediation on May 20, 2019 in an effort to settle the Antipodean action. There can be no assurance that a settlement will be reached. If a settlement cannot be reached, the Company intends to vigorously defend against the allegations in the Antipodean Amended Complaint. However, there can be no assurance that the defense will be successful. As required under ASC 450, “Contingencies’, the Company accrues for contingencies when it believes that a loss is probable and that it can reasonably estimate the amount of any such loss. The Company has not recorded any accrual for contingent liabilities associated with the Antipodean litigation based on its belief that a potential loss is reasonably possible, but that any possible range of loss in these matters cannot be reasonably estimated at this time. 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 purported to rely on documents produced by the Company in response to prior demands for inspection of the Company’s books and records served on the Company by each of Macalinao and McKenry under 8 Del. C. § 220. 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. Oral argument on the defendants’ motions to dismiss has been rescheduled for June 19, 2019. The Company intends to vigorously defend against the allegations in the Supplemental Derivative Complaint, but there can be no assurance that the defense will be successful. On March 20, 2017, a purported shareholder of the Company, filed a shareholder derivative complaint (the “Guo Complaint”) against certain officers and directors of the Company in the United States District Court for the District of Colorado. The Guo Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company by either recklessly or with gross negligence approving or permitting misrepresentations of the Company’s business operations and prospects. The Guo Complaint also alleged claims for waste of corporate assets and unjust enrichment. Finally, the Guo Complaint alleged that certain of the individual defendants violated Section 14(a) of the Securities Exchange Act, by allegedly negligently issuing, causing to be issued, and participating in the issuance of materially misleading statements to stockholders in the Company’s Proxy Statement on Schedule DEF 14A in connection with the 2015 Annual Meeting of Stockholders, held on June 11, 2015. The Guo Complaint sought, among other things, an award of money damages. On June 19, 2017, the parties filed a joint motion to stay the Guo action pending resolution of the motion to dismiss the Consolidated Derivative Complaint. On June 20, 2017, the court granted the motion to stay. The Company intends to vigorously defend against the allegations in the Guo Complaint, but there can be no assurance that the defense will be successful. European Patent Opposition Two oppositions were filed in the granted European counterpart of the rucaparib camsylate salt/polymorph patent on June 20, 2017. The European Patent Office’s Opposition Division held an oral hearing on December 4, 2018, during which it upheld claims, narrowed from the originally granted patent, to certain crystalline forms of rucaparib camsylate, including, but not limited to, rucaparib S-camsylate Form A, the crystalline form in Rubraca. On February 4, 2019, the Opposition Division issued a written decision confirming its decision at the oral hearing. Clovis and/or either opponent have an opportunity to appeal the written decision of the European Opposition Division. Notices of appeal were filed before April 14, 2019 by Clovis and one of the opponents, Hexal, and appeal briefs are due June 14, 2019. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events On May 1, 2019, we entered into a financing agreement with certain affiliates of TPG Sixth Street Partners, LLC (“TPG”) in which we plan to borrow from TPG 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. 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 is currently enrolling patients. We expect to incur borrowings under the financing agreement on a quarterly basis, beginning with an initial draw of $8.6 million upon the execution of the financing agreement with respect to 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 the loan 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. Payments are based on a certain percentage of the revenues generated from the sales and any future out-licensing of Rubraca with quarterly payment caps depending on trial outcome. 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. Our obligations under the financing agreement will be 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 will initially be guaranteed by Clovis Oncology UK Limited and Clovis Oncology Ireland Limited, secured by a first priority security interest in all the assets of those subsidiary guarantors. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments that, in the opinion of management, are necessary to fairly state our financial position, results of operations and cash flows for the periods presented herein. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our Annual Report on Form 10-K for the year ended December 31, 2018 (“2018 Form 10-K”) for a broader discussion of our business and the opportunities and risks inherent in such business. |
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. |
Liquidity | 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 revenues from Rubraca adequate to support our cost structure. We may never achieve profitability, and unless or 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. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”, which requires lessees to recognize assets and liabilities for the rights and obligations created by most leases on their balance sheet. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered after, the date of initial application, with an option to use certain transition relief. We adopted ASU 2016-02 as of January 1, 2019 using the modified retrospective method which leaves the comparative period reporting unchanged. Comparative reporting periods are presented in accordance with Topic 840, while periods subsequent to the effective date are presented in accordance with Topic 842. We have elected to adopt the package practical expedient which allows us: 1) to not reassess whether any expired or existing contracts are or contain leases, 2) to not reassess the lease classification for any expired or existing leases and 3) to not reassess initial direct costs for any existing leases. We also elected not to recognize on the balance sheet leases with terms of 12 months or less. For these short-term leases, we will recognize the lease payments in profit or loss on a straight-line basis over the lease term and the variable lease payments in the period in which the obligation for those payments is incurred. Adoption of the new lease standard resulted in the recording of net right-of-use assets and lease liabilities of approximately $24.9 million and $31.4 million, respectively, as of January 1, 2019. In February 2018, the FASB issued ASU 2018-02, “Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income”, which allow a reclassification from accumulated other comprehensive income (loss) (“AOCI”) to retained earnings for stranded tax effects resulting from the change in the U.S. federal corporate income tax rate on the gross deferred tax amounts at the date of enactment of the Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act”). The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. We adopted the new standard on January 1, 2019 and elected not to reclassify the income tax effects of the Tax Act from AOCI to retained earnings. We continue to release disproportionate income tax effects from AOCI based on the aggregate portfolio approach. The adoption of this standard did not have an impact on our condensed consolidated financial statements. In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, simplifies the accounting for share-based payment granted to nonemployees for goods and services. Under the standard, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. We adopted ASU 2018-07 as of January 1, 2019. There is no material impact on our consolidated financial statements and related disclosures. |
Recently Issued Accounting Standards | 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 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. Early adoption is permitted. We will adopt ASU 2018-02 as of January 1, 2020. We are currently evaluating the impact the standard may have on our consolidated financial statements and related disclosures. 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 will adopt ASU 2016-13 as of January 1, 2020. We are currently evaluating the impact the standard may have on our consolidated financial statements and related disclosures. |
Revenue Recognition | Revenue Recognition We are currently approved to sell Rubraca in the United States and the EU 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. 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 (if the amount is payable to the customers) or a current liability (if the amount is payable to a party other than a customer). 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. Rebates . Rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare coverage gap program. Rebates are amounts owed after the final dispensing of products to a benefit plan participant and are based upon contractual agreements or legal requirements with the public-sector benefit providers. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheet. We estimate our Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. The accrual for rebates is based on the expected utilization from historical data we have accumulated since the Rubraca product launch. Rebates are generally invoiced and paid quarterly in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known or estimated prior quarters’ unpaid rebates. Chargebacks . Chargebacks are discounts that occur when contracted customers, which currently consist primarily of group purchasing organizations, Public Health Service organizations and federal government entities purchasing via the Federal Supply Schedule, purchase directly from our specialty distributors at a discounted price. The specialty distributor, in turn, charges back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the healthcare provider. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. The accrual for specialty distributor chargebacks is estimated based on known chargeback rates and known sales to specialty distributors adjusted for the estimated utilization by healthcare providers. Discounts and Fees . Our payment terms are generally 30 days. Specialty distributors and specialty pharmacies are offered various forms of consideration, including service fees and prompt pay discounts for payment within a specified period. We expect these customers will earn prompt pay discounts and therefore, we deduct the full amount of these discounts and service fees from product sales when revenue is recognized. Co-pay assistance . Patients who have commercial insurance and meet certain eligibility requirements may receive co-pay assistance. The intent of this program is to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are based on actual program participation provided by third-party administrators at month end. Returns . Consistent with industry practice, we generally offer customers a right of return limited only to product that will expire in six months or product that is six months beyond the expiration date. To date, we have had minimal product returns and we currently have a minimal accrual for product returns. We will continue to assess our estimate for product returns as we gain additional historical experience. |
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. |
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 began capitalizing incurred inventory related costs upon the regulatory approval of Rubraca. Prior to the regulatory approval of Rubraca, we incurred costs for the manufacture of the drug that could potentially be available to support the commercial launch of Rubraca and all such costs were recognized as research and development expense. We regularly analyze our inventory levels for excess quantities and obsolescence (expiration), taking into account 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. 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 eight 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 a single supplier. 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. Inventory used in clinical trials is expensed as research and development expense when it has been identified for such use. Our other significant accounting policies are described in Note 2, Summary of Significant Accounting Policies of the Notes to the Consolidated Financial Statements included in our 2018 Form 10-K. |
Convertible Senior Notes | 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 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. |
Lucitanib | Reimbursements are recorded as a reduction to research and development expense on the Consolidated Statements of Operations. Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; however, data in breast and lung cancer were insufficient to move the program forward. We received notice from Servier of termination of their rights to lucitanib, resulting in the return of global rights (excluding China) for lucitanib to us during October 2018. |
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 2021 Notes and 2025 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. |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Financial Instruments and Fair Value Measurements | |
Assets Measured at Fair Value on Recurring Basis | The following table identifies our assets and liabilities that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 March 31, 2019 Assets: Money market $ 44,084 $ 44,084 $ — $ — U.S. treasury securities 303,435 19,961 283,474 — Total assets at fair value $ 347,519 $ 64,045 $ 283,474 $ — December 31, 2018 Assets: Money market $ 81,968 $ 81,968 $ — $ — U.S. treasury securities 308,251 9,981 298,270 — Total assets at fair value $ 390,219 $ 91,949 $ 298,270 $ — |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Securities, Available-for-sale [Abstract] | |
Summary of Available-for-Sale Securities | As of March 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 $ 283,434 $ 40 $ — $ 283,474 As of December 31, 2018, 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 $ 298,305 $ — $ (35) $ 298,270 |
Schedule of Amortized Cost and Fair Value of Available-for-Sale Securities by Contractual Maturity | As of March 31, 2019, the amortized cost and fair value of available-for-sale securities by contractual maturity were (in thousands): Amortized Fair Cost Value Due in one year or less $ 283,434 $ 283,474 Due in one year to two years — — Total $ 283,434 $ 283,474 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventories | |
Schedule of Inventories | March 31, December 31, 2019 2018 Work-in-process $ 129,248 $ 126,620 Finished goods 10,888 14,360 Allowance for obsolete inventories (154) — Total inventories $ 139,982 $ 140,980 |
Other Current Assets (Tables)
Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Other Current Assets | |
Schedule Of other current assets | Other current assets were comprised of the following (in thousands): March 31, December 31, 2019 2018 Prepaid insurance $ 1,720 $ 244 Prepaid advertising 1,620 1,620 Prepaid expenses - other 3,870 3,519 Value-added tax ("VAT") receivable 6,337 — Receivable - other 1,772 2,274 Other 133 956 Total $ 15,452 $ 8,613 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Intangible Assets and Goodwill | |
Intangible assets related to capitalized milestones under license agreements | Intangible assets related to capitalized milestones under license agreements consisted of the following (in thousands): March 31, December 31, 2019 2018 Intangible asset - milestones $ 71,100 $ 56,100 Accumulated amortization (5,290) (4,170) Total intangible asset, net $ 65,810 $ 51,930 |
Estimated future amortization expense for intangible assets | Estimated future amortization expense associated with intangibles is expected to be as follows (in thousands): 2019 $ 3,588 2020 4,784 2021 4,784 2022 4,784 2023 4,784 Thereafter 43,086 $ 65,810 |
Other Accrued Expenses (Tables)
Other Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Other Accrued Expenses | |
Schedule of other accrued expenses | Other accrued expenses were comprised of the following (in thousands): March 31, December 31, 2019 2018 Accrued personnel costs $ 8,969 $ 15,265 Accrued interest payable 1,862 2,721 Income tax payable 920 847 Accrued corporate legal fees and professional services 965 677 Accrued royalties 5,200 4,854 Accrued variable considerations 3,428 2,183 Current portion of capital lease obligations — 1,031 Purchase of API received not yet invoiced 177 35,472 Accrued expenses - other 4,057 4,506 Total $ 25,578 $ 67,556 |
Lease (Tables)
Lease (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Lease | |
Schedule of components of lease expense and related cash flows | The components of lease expense and related cash flows were as follows (in thousands): Three months ended March 31, 2019 Lease cost Finance lease cost: Amortization of right-of-use assets $ 356 Interest on lease liabilities 184 Operating lease cost 1,149 Short-term lease cost 49 Variable lease cost 725 Total lease cost $ 2,463 Operating cash flows from finance leases $ 184 Operating cash flows from operating leases $ 1,149 Financing cash flows from finance leases $ 250 |
Schedule of weighted-average remaining lease term and weighted-average discount rate | March 31, 2019 Weighted-average remaining lease term (years) Operating leases 6.9 Finance leases 6.8 Weighted-average discount rate Operating leases Finance leases |
Schedule of future minimum commitments due under lease agreements | Operating Leases Finance Leases Total 2019 (remaining nine months) $ 3,591 $ 1,302 $ 4,893 2020 4,668 1,736 6,404 2021 4,729 1,736 6,465 2022 2,787 1,736 4,523 2023 2,343 1,736 4,079 Thereafter 9,859 3,474 13,333 Present value adjustment (6,710) (2,687) (9,397) Present value of lease payments $ 21,267 $ 9,033 $ 30,300 |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Convertible Senior Notes | |
Schedule of Total Interest Expense Recognized Related to Notes | Three months ended March 31, 2019 2018 Contractual interest expense $ 2,734 $ 1,797 Accretion of interest on milestone liability — 512 Amortization of debt issuance costs 645 326 Interest on finance lease 184 — Other interest 27 — Total interest expense $ 3,590 $ 2,635 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders’ Equity | |
Component of Other Comprehensive Income (Loss) | The changes in accumulated balances related to each component of other comprehensive income (loss) are summarized for the three months ended March 31, 2019 and 2018, as follows (in thousands): Foreign Currency Unrealized Total Accumulated Translation Adjustments (Losses) Gains Other Comprehensive Loss 2019 2018 2019 2018 2019 2018 Balance at January 1, $ (44,460) $ (41,917) $ (174) $ (256) $ (44,634) $ (42,173) Other comprehensive income (loss) (5) 1,991 75 (7) 70 1,984 Total before tax (44,465) (39,926) (99) (263) (44,564) (40,189) Tax effect — (474) — 2 — (472) Balance at March 31, $ (44,465) $ (40,400) $ (99) $ (261) $ (44,564) $ (40,661) |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Share-Based Compensation | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | Share-based compensation expense for all equity-based programs, including stock options, restricted stock units and the employee stock purchase plan, for the three months ended March 31, 2019 and 2018 was recognized in the accompanying Consolidated Statements of Operations as follows (in thousands): Three months ended March 31, 2019 2018 Research and development $ 6,611 $ 5,376 Selling, general and administrative 7,029 6,537 Total share-based compensation expense $ 13,640 $ 11,913 |
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, 2018 6,311,513 $ 46.05 Granted 514,199 25.57 Exercised (83,132) 13.16 Forfeited (111,252) 57.92 Outstanding at March 31, 2019 6,631,328 $ 44.68 6.4 $ 12,945 Vested and expected to vest at March 31, 2019 6,319,568 $ 45.10 6.2 $ 12,713 Vested and exercisable at March 31, 2019 4,554,030 $ 46.90 5.3 $ 11,415 |
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 three months ended March 31, 2019 and 2019 (in thousands, except per share amounts): Three months ended March 31, 2019 2018 Weighted-average grant date fair value per share $ 18.83 $ 43.14 Intrinsic value of options exercised $ 765 $ 762 Cash received from stock option exercises $ 1,094 $ 514 |
Summary of activity related to our unvested RSUs | Weighted Average Number of Grant Date Units Fair Value Unvested at December 31, 2018 795,684 $ 47.73 Granted 1,977,459 25.67 Vested (113,402) 52.45 Forfeited (51,759) 45.11 Unvested as of March 31, 2019 2,607,982 $ 30.85 Expected to vest after March 31, 2019 2,154,434 $ 31.10 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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): Three and Three months ended March 31, 2019 2018 Common shares under option 5,123 3,908 Convertible senior notes 8,584 4,646 Total potential dilutive shares 13,707 8,554 |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Details) | 1 Months Ended | 3 Months Ended |
Apr. 30, 2019item | Mar. 31, 2019segmentproductitem | |
Number of operating segments | segment | 1 | |
Confirmed objective response rate by investigator assessment (as a percent) | 44.00% | |
Number of RECIST/PCWG3 response-evaluable patients with a BRCA1/2 alteration | 25 | |
Confirmed prostate-specific antigen (“PSA”) response rate observed (as a percent) | 51.00% | |
Number of PSA response-evaluable patients with a BRCA1/2 alteration | 45 | |
Number of patients with BRCA-mutant mCRPC to the FDA | 52 | |
Common treatment-emergent adverse events in all patients regardless of causality, asthenia/fatigue (as a percent) | 44.70% | |
Common treatment-emergent adverse events in all patients regardless of causality, nausea (as a percent) | 42.40% | |
Common treatment-emergent adverse events in all patients regardless of causality, anemia/decreased hemoglobin (as a percent) | 28.20% | |
Common treatment-emergent adverse events in all patients regardless of causality, decreased appetite (as a percent) | 28.20% | |
Common treatment-emergent adverse events in all patients regardless of causality, constipation (as a percent) | 22.40% | |
Number of patients discontinued therapy due to a non-progression TEAE | 5 | |
Percentage of patients discontinued therapy due to a non-progression TEAE | 5.90% | |
Number of patient died due to disease progression | 1 | |
Number of other product candidates | product | 1 | |
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 | |
Common treatment-emergent adverse events in all patients regardless of causality, asthenia/fatigue (as a percent) | 38.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, nausea (as a percent) | 36.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, anemia/decreased hemoglobin (as a percent) | 24.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, decreased appetite (as a percent) | 24.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, constipation (as a percent) | 19.00% | |
Maximum | ||
Common treatment-emergent adverse events in all patients regardless of causality, asthenia/fatigue (as a percent) | 85.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, nausea (as a percent) | 85.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, anemia/decreased hemoglobin (as a percent) | 85.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, decreased appetite (as a percent) | 85.00% | |
Common treatment-emergent adverse events in all patients regardless of causality, constipation (as a percent) | 85.00% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Jan. 01, 2019 | |
Product Revenue | ||
Amortization period of the asset | true | |
Summary of Significant Accounting Policies | ||
Right-of-use assets, net | $ 23,919 | $ 24,900 |
Lease liabilities | $ 30,300 | $ 31,400 |
Payment terms number of days | 30 days | |
Shelf-life of API | 4 years | |
Consumption period of API | 8 years | |
Rucaparib | ||
Summary of Significant Accounting Policies | ||
Shelf life of inventory | 4 years |
Financial Instruments and Fai_3
Financial Instruments and Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value Measurements | ||
Assets at fair value | $ 347,519 | $ 390,219 |
Money market | ||
Fair Value Measurements | ||
Assets at fair value | 44,084 | 81,968 |
U.S. treasury securities | ||
Fair Value Measurements | ||
Assets at fair value | 303,435 | 308,251 |
Fair Value, Inputs, Level 1 | ||
Fair Value Measurements | ||
Assets at fair value | 64,045 | 91,949 |
Fair Value, Inputs, Level 1 | Money market | ||
Fair Value Measurements | ||
Assets at fair value | 44,084 | 81,968 |
Fair Value, Inputs, Level 1 | U.S. treasury securities | ||
Fair Value Measurements | ||
Assets at fair value | 19,961 | 9,981 |
Fair Value, Inputs, Level 2 | ||
Fair Value Measurements | ||
Assets at fair value | 283,474 | 298,270 |
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 | 283,474 | 298,270 |
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 |
Financial Instruments and Fai_4
Financial Instruments and Fair Value Measurements - More Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Fair Value Measurements | ||
Liabilities at fair value | $ 0 | |
Transfers between level 1 and level 2, assets | 0 | |
Transfers between level 2 and level 1, assets | 0 | |
Transfers between level 1 and level 2, liabilities | 0 | |
Transfers between level 2 and level 1, liabilities | 0 | |
Transfer of assets into level 3 | 0 | |
Transfer of assets out of level 3 | 0 | |
Transfer of liabilities into level 3 | 0 | |
Transfer of liabilities out of level 3 | 0 | |
Convertible senior notes | 576,003 | $ 575,470 |
Convertible Senior Unsecured Notes 2021 Notes | ||
Fair Value Measurements | ||
Convertible senior notes | 283,900 | |
Convertible Senior Unsecured Notes 2021 Notes | Fair Value, Inputs, Level 2 | ||
Fair Value Measurements | ||
Convertible senior notes, fair value | 265,200 | |
Convertible Senior Unsecured Notes 2025 Notes | ||
Fair Value Measurements | ||
Convertible senior notes | 292,100 | |
Convertible senior notes, fair value | $ 233,900 |
Available-for-Sale Securities_2
Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Available-for-Sale Securities | ||
Amortized Cost | $ 283,434 | |
Aggregate Fair Value | 283,474 | |
Available for sale continuous unrealized loss position less than12 months | 0 | |
U.S. treasury securities | ||
Available-for-Sale Securities | ||
Amortized Cost | 283,434 | $ 298,305 |
Gross Unrealized Gains | 40 | 0 |
Gross Unrealized Losses | (35) | |
Aggregate Fair Value | $ 283,474 | $ 298,270 |
Available-for-Sale Securities -
Available-for-Sale Securities - Additional Information (Details) $ in Thousands | Mar. 31, 2019USD ($) |
Debt Securities, Available-for-sale [Abstract] | |
Amortized Cost, Due in one year or less | $ 283,434 |
Amortized Cost, Due in one year to two years | 0 |
Amortized Cost | 283,434 |
Fair Value, Due in one year or less | 283,474 |
Fair Value, Due in one year to two years | 0 |
Aggregate Fair Value | $ 283,474 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventories | ||
Work-in-process | $ 129,248 | $ 126,620 |
Finished goods | 10,888 | 14,360 |
Allowance for obsolete inventories | (154) | |
Total inventories | 139,982 | 140,980 |
Current inventory | 24,986 | 27,072 |
Long-term inventory | 114,996 | $ 113,908 |
Cash deposit on non-current inventory made to a manufacturer | $ 12,400 |
Other Current Assets (Details)
Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Other Current Assets | ||
Prepaid insurance | $ 1,720 | $ 244 |
Prepaid advertising | 1,620 | 1,620 |
Prepaid expenses - other | 3,870 | 3,519 |
Value-added tax ("VAT") receivable | 6,337 | |
Receivable - other | 1,772 | 2,274 |
Other | 133 | 956 |
Total | $ 15,452 | $ 8,613 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Details) - Licensing Agreements - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Finite Lived Intangible Assets [Line Items] | ||
Intangible asset - milestones | $ 71,100 | $ 56,100 |
Accumulated amortization | (5,290) | (4,170) |
Total intangible asset, net | $ 65,810 | $ 51,930 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |||
Feb. 28, 2019 | Jun. 30, 2018 | Apr. 30, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Licensing Agreements | |||||
Finite Lived Intangible Assets | |||||
Amortization of Intangible Assets | $ 1.1 | $ 0.4 | |||
Rucaparib | EMA [Member] | |||||
Finite Lived Intangible Assets | |||||
Milestone payments | $ 15 | $ 20 | |||
Rucaparib | First approval of NDA by FDA | |||||
Finite Lived Intangible Assets | |||||
Milestone payments | $ 15 |
Intangible Assets and Goodwil_4
Intangible Assets and Goodwill - Estimated Future Amortization (Details) - Licensing Agreements - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Finite Lived Intangible Assets | ||
2019 | $ 3,588 | |
2020 | 4,784 | |
2021 | 4,784 | |
2022 | 4,784 | |
2023 | 4,784 | |
Thereafter | 43,086 | |
Total intangible asset, net | $ 65,810 | $ 51,930 |
Other Accrued Expenses (Details
Other Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Other Accrued Expenses | ||
Accrued personnel costs | $ 8,969 | $ 15,265 |
Accrued interest payable | 1,862 | 2,721 |
Income tax payable | 920 | 847 |
Accrued corporate legal fees and professional services | 965 | 677 |
Accrued royalties | 5,200 | 4,854 |
Accrued variable considerations | 3,428 | 2,183 |
Current portion of capital lease obligations | 1,031 | |
Purchase of API received not yet invoiced | 177 | 35,472 |
Accrued expenses - other | 4,057 | 4,506 |
Total | $ 25,578 | $ 67,556 |
Lease (Details)
Lease (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Cash flows from leases | |
Operating cash flows from finance leases | $ 184 |
Operating cash flows from operating leases | 1,149 |
Financing cash flows from finance leases | 250 |
Amortization of right-of-use assets | 356 |
Interest on lease liabilities | 184 |
Operating lease cost | 1,149 |
Short-term lease cost | 49 |
Variable lease cost | 725 |
Total lease cost | $ 2,463 |
Lease - Weighted Average (Detai
Lease - Weighted Average (Details) | Mar. 31, 2019 |
Weighted-average remaining lease term (years) | |
Operating leases | 6 years 10 months 24 days |
Finance leases | 6 years 9 months 18 days |
Weighted-average discount rate | |
Operating leases | 8.00% |
Finance leases | 8.00% |
Lease - Future minimum commitme
Lease - Future minimum commitments (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 |
Operating Leases | ||
2019 | $ 3,591 | |
2020 | 4,668 | |
2021 | 4,729 | |
2022 | 2,787 | |
2023 | 2,343 | |
Thereafter | 9,859 | |
Present value adjustment | (6,710) | |
Present value of lease payments | 21,267 | |
Finance Leases | ||
2019 | 1,302 | |
2020 | 1,736 | |
2021 | 1,736 | |
2022 | 1,736 | |
2023 | 1,736 | |
Thereafter | 3,474 | |
Present value of adjustment | (2,687) | |
Present value of lease payments | 9,033 | |
Total | ||
2019 | 4,893 | |
2020 | 6,404 | |
2021 | 6,465 | |
2022 | 4,523 | |
2023 | 4,079 | |
Thereafter | 13,333 | |
Present value adjustment | (9,397) | |
Present value of lease payments | $ 30,300 | $ 31,400 |
Convertible Senior Notes (Detai
Convertible Senior Notes (Details) - Convertible Senior Unsecured Notes $ / shares in Units, $ in Millions | Apr. 19, 2018USD ($)D$ / shares | Sep. 09, 2014USD ($)Ditem$ / shares | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Debt Instrument | ||||
Aggregate principal amount of public offering | $ 300 | $ 287.5 | ||
Convertible senior notes, interest rate | 1.25% | 2.50% | ||
Net proceeds from convertible senior notes | $ 290.9 | $ 278.3 | ||
Convertible senior notes, maturity date | Sep. 15, 2021 | |||
Common stock initial conversion rate per $1,000 in principal amount | 13.1278 | 16.1616 | ||
Convertible senior notes, initial conversion price per share | $ / shares | $ 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 | D | 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% | ||
Debt issuance costs | $ 9.1 | $ 9.2 | ||
Debt instrument term | 7 years | 7 years | ||
Unamortized debt issuance costs | $ 11.5 | $ 12 | ||
Semi Annual Payment, First payment date | ||||
Debt Instrument | ||||
Interest payment date on senior notes | --05-01 | --03-15 | ||
Semi Annual Payment, Second payment date | ||||
Debt Instrument | ||||
Interest payment date on senior notes | --11-01 | --09-15 |
Convertible Senior Notes - Addi
Convertible Senior Notes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Convertible Senior Notes | ||
Contractual interest expense | $ 2,734 | $ 1,797 |
Accretion of interest on milestone liability | 512 | |
Amortization of debt issuance costs | 645 | 326 |
Interest on finance lease | 184 | |
Other interest | 27 | |
Total interest expense | $ 3,590 | $ 2,635 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 3 Months Ended |
Mar. 31, 2019Vote | |
Stockholders’ Equity | |
Number Of Vote Per Common Stock | 1 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Accumulated Other Comprehensive Loss | ||
Beginning balance | $ (44,634) | $ (42,173) |
Other comprehensive income (loss) | 70 | 1,984 |
Total before tax | (44,564) | (40,189) |
Tax effect | 0 | (472) |
Ending balance | (44,564) | (40,661) |
Reclassifications out of accumulated other comprehensive loss | 0 | 0 |
Foreign Currency Translation Adjustments | ||
Accumulated Other Comprehensive Loss | ||
Beginning balance | (44,460) | (41,917) |
Other comprehensive income (loss) | (5) | 1,991 |
Total before tax | (44,465) | (39,926) |
Tax effect | 0 | (474) |
Ending balance | (44,465) | (40,400) |
Unrealized (Losses) Gains | ||
Accumulated Other Comprehensive Loss | ||
Beginning balance | (174) | (256) |
Other comprehensive income (loss) | 75 | (7) |
Total before tax | (99) | (263) |
Tax effect | 0 | 2 |
Ending balance | $ (99) | $ (261) |
Share-Based Compensation (Detai
Share-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 29, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award | |||
Total Share-based compensation expense | $ 13,640 | $ 11,913 | |
Employee Service Share Based Compensation Tax Benefit From Compensation Expense | 0 | 0 | |
Closing Stock Price | $ 24.82 | ||
Research and development | |||
Share Based Compensation Arrangement By Share Based Payment Award | |||
Total Share-based compensation expense | 6,611 | 5,376 | |
Selling, general and administrative | |||
Share Based Compensation Arrangement By Share Based Payment Award | |||
Total Share-based compensation expense | 7,029 | $ 6,537 | |
Common shares under option | |||
Share Based Compensation Arrangement By Share Based Payment Award | |||
Unrecognized stock-based compensation expense related to unvested stock options | $ 54,600 | ||
Unrecognized stock-based compensation expense related to non-vested options and/or RSUs, weighted-average remaining vesting period | 2 years 3 months 18 days | ||
Restricted Stock Units (RSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award | |||
Unrecognized stock-based compensation expense related to unvested RSUs | $ 64,500 | ||
Unrecognized stock-based compensation expense related to non-vested options and/or RSUs, weighted-average remaining vesting period | 2 years 8 months 12 days |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Stock Options Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Compensation | ||
Beginning Balance, Number of Options Outstanding | 6,311,513 | |
Number of Options, Granted | 514,199 | |
Number of Options, Exercised | (83,132) | (21,463) |
Number of Options, Forfeited | (111,252) | |
Ending Balance, Number of Options Outstanding | 6,631,328 | |
Number of Options, Vested and expected to vest at June 30,2018 | 6,319,568 | |
Number of Options, Vested and exercisable at June 30,2018 | 4,554,030 | |
Beginning Balance, Weighted Average Exercise Price | $ 46.05 | |
Granted, Weighted Average Exercise Price | 25.57 | |
Exercised, Weighted Average Exercise Price | 13.16 | |
Forfeited, Weighted Average Exercise Price | 57.92 | |
Ending Balance, Weighted Average Exercise Price | 44.68 | |
Vested and expected to vest, Weighted Average Exercise Price | 45.10 | |
Vested and exercisable, Weighted Average Exercise Price | $ 46.90 | |
Outstanding, Weighted Average Remaining Contractual Term (Years) | 6 years 4 months 24 days | |
Vested and expected to vest, Weighted Average Remaining Contractual Term (Years) | 6 years 2 months 12 days | |
Exercisable, Weighted Average Remaining Contractual Term (Years) | 5 years 3 months 18 days | |
Outstanding at June 30, 2018, Aggregate Intrinsic Value | $ 12,945 | |
Vested and expected to vest at June 30, 2018, Aggregate Intrinsic Value | 12,713 | |
Vested and exercisable at June 30, 2018, Aggregate Intrinsic Value | $ 11,415 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Compensation | ||
Weighted-average grant date fair value per share | $ 18.83 | $ 43.14 |
Intrinsic value of options exercised | $ 765 | $ 762 |
Cash received from stock option exercises | $ 1,094 | $ 514 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award | |
Unvested as of Beginning Balance | shares | 795,684 |
Number of Units, Granted | shares | 1,977,459 |
Number of Units, Vested | shares | (113,402) |
Number of Units, Forfeited | shares | (51,759) |
Unvested as of Ending Balance | shares | 2,607,982 |
Number of Units, Expected to vest after March 31, 2018 | shares | 2,154,434 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 47.73 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 25.67 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 52.45 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 45.11 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | 30.85 |
Weighted Average Grant Date Fair Value, Expected to vest after March 31, 2018 | $ / shares | $ 31.10 |
License Agreements (Details)
License Agreements (Details) $ in Thousands | Dec. 19, 2016USD ($) | Feb. 28, 2019USD ($) | Jun. 30, 2018USD ($) | Apr. 30, 2018USD ($) | Jun. 30, 2011USD ($) | Oct. 31, 2008 | Mar. 31, 2019USD ($)item | Mar. 31, 2017USD ($) |
Minimum | ||||||||
License Agreements | ||||||||
Number Of Prior Lines Of Platinum Based Chemotherapy | item | 2 | |||||||
Rucaparib | EMA [Member] | ||||||||
License Agreements | ||||||||
Milestone payments | $ 15,000 | $ 20,000 | ||||||
Rucaparib | First approval of NDA by FDA | ||||||||
License Agreements | ||||||||
Milestone payments | $ 15,000 | |||||||
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 | |||||||
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 | 16,750 | |||||||
Additional maximum payments payable on attaining the sales target | $ 170,000 | |||||||
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 | ||||||||
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 | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share | ||
Total potential dilutive shares | 13,707 | 8,554 |
Common shares under option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share | ||
Total potential dilutive shares | 5,123 | 3,908 |
Convertible senior notes | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share | ||
Total potential dilutive shares | 8,584 | 4,646 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Jun. 20, 2017item | Mar. 31, 2017shareholder | Mar. 31, 2019USD ($) |
Commitments and Contingencies | |||
Purchase commitments | $ | $ 102.5 | ||
Number of putative shareholders | shareholder | 2 | ||
Number of oppositions filed regarding salt and polymorph patents | item | 2 |
Subsequent Events (Details)
Subsequent Events (Details) - TPG Sixth Street Partners, LLC - Financing Agreement $ in Millions | May 01, 2019USD ($)sitecountryitem | Mar. 31, 2019USD ($) |
Subsequent Event [Line Items] | ||
Initial draw amount | $ 8.6 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Number of patients | item | 1,000 | |
Number of countries | country | 25 | |
Number of times required to be repaid | item | 2 | |
Aggregate borrowed amount | $ 350 | |
Subsequent Event | Minimum | ||
Subsequent Event [Line Items] | ||
Number of sites | site | 270 | |
Subsequent Event | Maximum | ||
Subsequent Event [Line Items] | ||
Reimbursement of cost and expenses | $ 175 |