Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | GWPH | |
Entity Registrant Name | GW PHARMACEUTICALS PLC | |
Entity Central Index Key | 0001351288 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity File Number | 001-35892 | |
City Area Code | +44 | |
Local Phone Number | 1223 266800 | |
Entity Address, Address Line One | Sovereign House | |
Entity Address, Address Line Two | Vision Park | |
Entity Address, Address Line Three | Chivers Way | |
Entity Address, City or Town | Histon | |
Entity Address, State or Province | Cambridge | |
Entity Address, Postal Zip Code | CB24 9BZ | |
Entity Address, Country | United Kingdom | |
Entity Common Stock, Shares Outstanding | 370,628,720 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Assets | ||
Cash and cash equivalents | $ 583,683 | $ 591,497 |
Accounts receivable, net | 32,113 | 4,192 |
Inventory | 60,042 | 33,030 |
Prepaid expenses and other current assets | 21,693 | 17,903 |
Total current assets | 697,531 | 646,622 |
Property, plant, and equipment, net | 107,332 | 90,832 |
Operating lease assets | 18,739 | |
Goodwill | 6,959 | 6,959 |
Deferred tax assets | 8,726 | 8,720 |
Other assets | 3,490 | 2,935 |
Total assets | 842,777 | 756,068 |
Liabilities and stockholders’ equity | ||
Accounts payable | 11,757 | 9,796 |
Accrued liabilities | 66,434 | 52,477 |
Current tax liabilities | 2,384 | |
Other current liabilities | 5,757 | 1,559 |
Total current liabilities | 83,948 | 66,216 |
Long-term liabilities: | ||
Finance lease liabilities | 5,536 | 5,690 |
Operating lease liabilities | 15,139 | |
Other liabilities | 9,262 | 10,082 |
Total long-term liabilities | 29,937 | 15,772 |
Total liabilities | 113,885 | 81,988 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Common stock - Ordinary shares par value £0.001; 370,621,184 shares outstanding as of June 30, 2019; 366,616,688 shares outstanding as of December 31, 2018 | 570 | 564 |
Additional paid-in capital | 1,607,346 | 1,581,144 |
Accumulated deficit | (799,256) | (828,940) |
Accumulated other comprehensive loss | (79,768) | (78,688) |
Total stockholders’ equity | 728,892 | 674,080 |
Total liabilities and stockholders’ equity | $ 842,777 | $ 756,068 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (Parenthetical) - £ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Common stock - Ordinary shares, par value | £ 0.001 | £ 0.001 |
Common stock - Ordinary shares, outstanding | 370,621,184 | 366,616,688 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenues | ||||
Total revenues | $ 72,038 | $ 3,284 | $ 111,285 | $ 6,325 |
Operating expenses | ||||
Cost of product sales | 6,620 | 1,791 | 11,751 | 3,416 |
Research and development | 32,467 | 45,113 | 62,842 | 88,598 |
Selling, general and administrative | 62,273 | 37,786 | 117,351 | 63,959 |
Total operating expenses | 101,360 | 84,690 | 191,944 | 155,973 |
Loss from operations | (29,322) | (81,406) | (80,659) | (149,648) |
Interest income | 2,310 | 999 | 4,397 | 1,758 |
Interest expense | (268) | (313) | (533) | (638) |
Other income | 104,117 | 104,117 | ||
Foreign exchange gain (loss) | 2,026 | (3,660) | 912 | (4,300) |
Income (loss) before income taxes | 78,863 | (84,380) | 28,234 | (152,828) |
Income tax (benefit) expense | (885) | (369) | (1,450) | 644 |
Net income (loss) | $ 79,748 | $ (84,011) | $ 29,684 | $ (153,472) |
Net income (loss) per share: | ||||
Basic | $ 0.21 | $ (0.25) | $ 0.08 | $ (0.45) |
Diluted | $ 0.21 | $ (0.25) | $ 0.08 | $ (0.45) |
Weighted average shares outstanding: | ||||
Basic | 371,712 | 340,457 | 370,776 | 340,355 |
Diluted | 377,435 | 340,457 | 376,674 | 340,355 |
Product Net Sales | ||||
Revenues | ||||
Total revenues | $ 71,489 | $ 3,094 | $ 110,463 | $ 5,906 |
Other Revenue | ||||
Revenues | ||||
Total revenues | $ 549 | $ 190 | $ 822 | $ 419 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 79,748 | $ (84,011) | $ 29,684 | $ (153,472) |
Foreign currency translation adjustments | (4,878) | (5,911) | (1,080) | (1,803) |
Comprehensive income (loss) | $ 74,870 | $ (89,922) | $ 28,604 | $ (155,275) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Beginning balance at Dec. 31, 2017 | $ 623,098 | $ 527 | $ 1,220,206 | $ (523,683) | $ (73,952) |
Beginning balance, Shares at Dec. 31, 2017 | 337,964 | ||||
Issuance of common stock from exercise of stock options | 1 | $ 1 | |||
Issuance of common stock from exercise of stock options, Shares | 549 | ||||
Net income (loss) | (69,461) | (69,461) | |||
Share-based compensation | 6,858 | 6,858 | |||
Other comprehensive income (loss) | 4,108 | 4,108 | |||
Ending balance at Mar. 31, 2018 | 564,604 | $ 528 | 1,227,064 | (593,144) | (69,844) |
Ending balance, Shares at Mar. 31, 2018 | 338,513 | ||||
Beginning balance at Dec. 31, 2017 | 623,098 | $ 527 | 1,220,206 | (523,683) | (73,952) |
Beginning balance, Shares at Dec. 31, 2017 | 337,964 | ||||
Net income (loss) | (153,472) | ||||
Ending balance at Jun. 30, 2018 | 484,251 | $ 529 | 1,236,632 | (677,155) | (75,755) |
Ending balance, Shares at Jun. 30, 2018 | 339,147 | ||||
Beginning balance at Mar. 31, 2018 | 564,604 | $ 528 | 1,227,064 | (593,144) | (69,844) |
Beginning balance, Shares at Mar. 31, 2018 | 338,513 | ||||
Issuance of common stock from exercise of stock options | 1 | $ 1 | |||
Issuance of common stock from exercise of stock options, Shares | 634 | ||||
Net income (loss) | (84,011) | (84,011) | |||
Share-based compensation | 9,568 | 9,568 | |||
Other comprehensive income (loss) | (5,911) | (5,911) | |||
Ending balance at Jun. 30, 2018 | 484,251 | $ 529 | 1,236,632 | (677,155) | (75,755) |
Ending balance, Shares at Jun. 30, 2018 | 339,147 | ||||
Beginning balance at Dec. 31, 2018 | 674,080 | $ 564 | 1,581,144 | (828,940) | (78,688) |
Beginning balance, Shares at Dec. 31, 2018 | 366,617 | ||||
Issuance of common stock from exercise of stock options | 773 | $ 3 | 770 | ||
Issuance of common stock from exercise of stock options, Shares | 1,996 | ||||
Net income (loss) | (50,064) | (50,064) | |||
Share-based compensation | 11,142 | 11,142 | |||
Other comprehensive income (loss) | 3,798 | 3,798 | |||
Ending balance at Mar. 31, 2019 | 639,729 | $ 567 | 1,593,056 | (879,004) | (74,890) |
Ending balance, Shares at Mar. 31, 2019 | 368,613 | ||||
Beginning balance at Dec. 31, 2018 | 674,080 | $ 564 | 1,581,144 | (828,940) | (78,688) |
Beginning balance, Shares at Dec. 31, 2018 | 366,617 | ||||
Net income (loss) | 29,684 | ||||
Ending balance at Jun. 30, 2019 | 728,892 | $ 570 | 1,607,346 | (799,256) | (79,768) |
Ending balance, Shares at Jun. 30, 2019 | 370,621 | ||||
Beginning balance at Mar. 31, 2019 | 639,729 | $ 567 | 1,593,056 | (879,004) | (74,890) |
Beginning balance, Shares at Mar. 31, 2019 | 368,613 | ||||
Issuance of common stock from exercise of stock options | 2,105 | $ 3 | 2,102 | ||
Issuance of common stock from exercise of stock options, Shares | 2,008 | ||||
Net income (loss) | 79,748 | 79,748 | |||
Share-based compensation | 12,188 | 12,188 | |||
Other comprehensive income (loss) | (4,878) | (4,878) | |||
Ending balance at Jun. 30, 2019 | $ 728,892 | $ 570 | $ 1,607,346 | $ (799,256) | $ (79,768) |
Ending balance, Shares at Jun. 30, 2019 | 370,621 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash flows from operating activities | ||
Net income (loss) | $ 29,684 | $ (153,472) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Foreign exchange loss | 882 | 3,930 |
Share-based compensation | 23,330 | 16,426 |
Depreciation and amortization | 4,808 | 4,720 |
Deferred income taxes | 1,407 | |
Gain from sale of priority review voucher | (104,117) | |
Other | 21 | 148 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (27,924) | (423) |
Inventory | (27,070) | 2,501 |
Prepaid expenses and other current assets | (6,819) | 22,139 |
Other assets | 1,542 | (249) |
Accounts payable | 3,488 | 3,156 |
Current tax liabilities | 619 | (3,458) |
Accrued liabilities | 13,887 | 3,599 |
Other liabilities | (2,192) | 1,265 |
Net cash used in operating activities | (89,861) | (98,311) |
Cash flows from investing activities | ||
Proceeds from sale of priority review voucher | 104,117 | |
Additions to property, plant and equipment | (22,515) | (14,675) |
Additions to capitalized software | (1,017) | (983) |
Net cash provided by (used in) investing activities | 80,585 | (15,658) |
Cash flows from financing activities | ||
Proceeds from exercise of stock options | 2,878 | 2 |
Payments on finance leases | (250) | (143) |
Payments on landlord financing obligation | (273) | (271) |
Net cash provided by (used in) financing activities | 2,355 | (412) |
Effect of exchange rate changes on cash | (893) | (4,906) |
Net decrease in cash and cash equivalents | (7,814) | (119,287) |
Cash and cash equivalents at beginning of period | 591,497 | 559,227 |
Cash and cash equivalents at end of period | 583,683 | 439,940 |
Supplemental disclosure of cash flow information: | ||
Income taxes paid | 3,907 | 3,240 |
Interest paid | (533) | (638) |
Supplemental disclosure of noncash information: | ||
Property and equipment purchases in accounts payable and accrued liabilities | $ 856 | $ 181 |
Business Overview
Business Overview | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business Overview | Note 1: Business Overview GW Pharmaceuticals plc and its subsidiaries (referred to herein as “we,” “us,” “our,” and the “Company”) is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from our proprietary cannabinoid product platform in a broad range of disease areas. The Company is developing a portfolio of cannabinoid medicines, of which the lead product is Epidiolex ® The Company is a public limited company, which has had American Depository Shares (ADSs) registered with the U.S. Securities and Exchange Commission (SEC) and has been listed on Nasdaq since May 1, 2013. The Company’s ADSs each represent twelve ordinary shares of GW Pharmaceuticals plc . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2: Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual financial statements. These accounting principles were applied on a basis consistent with those of the consolidated financial statements contained in the Company’s Annual Report on Form 10-KT for the three-month transition period ended December 31, 2018. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of our financial statements for interim periods. The condensed consolidated balance sheet as of December 31, 2018 was derived from audited annual financial statements but does not include all annual disclosures required by U.S. GAAP. These interim financial statements should be read in conjunction with the audited financial statements for the transition period ended December 31, 2018 included in our Annual Report on Form 10-KT. The results of operations for the three and six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the full year or any other future periods. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates. Fair Value of Financial Instruments The carrying values of the Company’s financial instruments, consisting of cash and cash equivalents, trade receivables, interest and other receivables, and accounts payable and accrued liabilities, approximate fair value due to the relative short-term nature of these instruments. Accounts Receivable Accounts receivable are recorded net of customer allowances for prompt payment discounts, chargebacks, and doubtful accounts. Allowances for prompt payment discounts and chargebacks are based on contractual terms. The Company estimates the allowance for doubtful accounts based on existing contractual payment terms, actual payment patterns of its customers and individual customer circumstances. As of June 30, 2019 and December 31, 2018, the Company determined that an allowance for doubtful accounts was not required and no accounts were written off during the periods presented. Inventory Inventory is stated at the lower of cost or estimated net realizable value. The Company uses a combination of standard and actual costing methodologies to determine the cost basis for its inventories which approximates actual cost. Inventory is valued on a first-in, first-out basis. The Company reduces its inventory to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand, as well as product shelf life. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Prior to approval of Epidiolex by the United States Food and Drug Administration (FDA), all costs related to the manufacturing of Epidiolex were charged to research and development expense in the period incurred. Revenue Recognition The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers Revenue for the Company’s product sales has not been adjusted for the effects of a financing component as the Company expects, at contract inception, that the period between when the Company’s transfers control of the product and when the Company receives payment will be one year or less. Product shipping and handling costs are included in cost of product sales. Epidiolex Product Net Sales Epidiolex was approved by the FDA in June 2018. Subsequent to the approval by the FDA, the United States Drug Enforcement Agency (DEA) took action to change the classification of Epidiolex from a Schedule I controlled substance to a Schedule V controlled substance, thereby allowing Epidiolex to be prescribed and distributed in the United States. On November 1, 2018, the Company launched sales of Epidiolex to specialty pharmacies (SPs) and specialty distributors (SDs). The Company recognizes revenue from product sales upon receipt of product at the SPs and SDs, the date at which the control is transferred, net of the following allowances which are reflected either as a reduction to the related account receivable or as an accrued liability, depending on how the allowance is settled: Distribution Fees : Distribution fees include distribution service fees paid to the SPs and SDs based on a contractually fixed percentage of the wholesale acquisition cost (WAC), and prompt payment discounts. Distribution fees are recorded as an offset to revenue based on contractual terms at the time revenue from the sale is recognized. Rebates : Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare Part D prescription drug benefit , and contractual rebates with commercial payers . Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements with, or statutory requirements pertaining to, Medicaid and Medicare benefit providers. The allowance for rebates is based on statutory discount rates and expected utilization. The Company’s estimates for expected utilization of rebates is based on utilization data received from the SPs since product launch. Rebates are generally invoiced and paid 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 prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust prior period accruals, which would affect revenue in the period of adjustment. Chargebacks : Chargebacks are discounts and fees that relate to contracts with government and other entities purchasing from the SDs at a discounted price. The SDs charge back to the Company the difference between the price initially paid by the SDs and the discounted price paid to the SDs by these entities. The Company also incurs group purchasing organization fees for transactions through certain purchasing organizations. The Company estimates sales with these entities and accrues for anticipated chargebacks and organization fees, based on the applicable contractual terms. If actual future chargebacks vary from these estimates, the Company may need to adjust prior period accruals, which would affect revenue in the period of adjustment. Co-Payment Assistance : The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. Co-payment assistance is accrued for based on actual program participation and estimates of program redemption using data provided by third-party administrators. Product Returns : Consistent with industry practice, the Company offers the SPs and SDs limited product return rights for damages, shipment errors, and expiring product, provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SPs and SDs and has the ability to control the amount of product that is sold to the SPs and SDs, it is able to make a reasonable estimate of future potential product returns based on this on-hand channel inventory data and sell-through data obtained from the SPs and SDs. In arriving at its estimate, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry. The total amount deducted from gross sales for the allowances described above for the three and six months ended June 30, 2019 was $14.5 million and $22.0 million, respectively Sativex Product Net Sales Sales of Sativex, which is currently being commercialized for spasticity due to multiple sclerosis (MS) outside the United States, are made pursuant to license agreements with commercial partners Other Revenue The Company’s other revenue primarily consists of research and development fee revenue for research and development services provided under a collaboration agreement with Otsuka Pharmaceutical Co. Ltd (Otsuka) The research and development fee revenue is recognized at the time the underlying services are performed. The Sativex license agreements contain provisions for the Company to earn variable consideration in the form of regulatory milestone payments, sales-based milestone payments, and royalty payments. The Company has no further performance obligations related to the regulatory milestone payments and these amounts are recognized in accordance with Topic 606 when receipt of these payments becomes probable and there is no significant risk of revenue reversal. Revenue related to the sales-based milestone payments and product royalty payments are subject to the sales-based royalty exception under Topic 606 and will be recognized when the underlying sales are made. Research and Development Expenses Research and development expenses are charged to operations as incurred. Research and development expenses include, among other things, internal and external costs associated with preclinical development, pre-commercialization manufacturing expenses, and clinical trials. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices received from its external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. As actual costs become known, the Company adjusts its accruals accordingly. Research and development expense is presented net of reimbursements from reimbursable tax and expenditure credits from the U.K. government. Reimbursable Concentration Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash, cash equivalents, and accounts receivable. The Company’s cash and cash equivalents balances are primarily in depository accounts at major financial institutions in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. Further, the Company specifies credit quality standards for its customers that are designed to limit the Company’s credit exposure to any single party. Share-based Compensation The Company recognizes share-based compensation expense for grants of stock options under the Company’s Long-Term Incentive Plans to employees and non-employee members of the Company’s board of directors based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period. Expense related to awards with graded vesting is generally recognized over the vesting period using the accelerated attribution method. Income Taxes The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities along with net operating loss and tax credit carryovers. The Company records a valuation allowance against its deferred tax assets to reduce the net carrying value to an amount that it believes is more likely than not to be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. For UK tax purposes, the $104.1 million gain on the sale of the priority review voucher (PRV) is expected to be fully offset by current year operating tax losses generated in the UK. Uncertain tax positions, for which management's assessment is that there is more than a 50% probability of sustaining the position upon challenge by a taxing authority based upon its technical merits, are subjected to certain recognition and measurement criteria. The Company re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. The Company adjusts the level of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions. The Company recognizes interest and penalties related to income tax matters in income tax expense . New Accounting Pronouncements On January 1, 2019, the Company adopted a new accounting standard issued by the Financial Accounting Standards Board (FASB) on accounting for leases using the modified retrospective method. This new accounting standard requires a lessee to recognize an asset and liability for most leases on its balance sheet. The Company elected the optional transition method that allowed for a cumulative-effect adjustment as of January 1, 2019 and did not restate previously reported results in the comparative periods. The Company also elected to adopt certain practical expedients allowed by the new standard, which among other things, allowed the Company to carry forward its historical lease classification. As a result of adoption of the new standard, the Company recorded operating lease assets and liabilities of approximately $20.5 million and $21.1 million, respectively as of January 1, 2019. The operating lease liability was determined based on the present value of the remaining minimum rental payments and the operating lease asset was determined based on the value of the lease liability, adjusted for existing deferred rent balances, which were previously included in other current liabilities and other liabilities. Accounting for the Company’s finance leases remains substantially unchanged. As a result of the adoption of the new leasing accounting standard, the Company’s build-to-suit asset has been reclassified to buildings and the build-to-suit financing obligation has been reclassified to finance lease obligation in the condensed consolidated balance sheets. The adoption of the new standard did not materially impact the Company’s consolidated results of operations or cash flows. In addition, the adoption of this new accounting standard resulted in increased qualitative and quantitative disclosures regarding the amount, timing, and uncertainty of cash flows arising from leases. For further details, see Note 9 Leases |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 3: Fair Value Measurements At June 30, 2019 and December 31, 2018, the Company’s cash equivalents consisted of money market funds, which are classified as Level 1 within the fair value hierarchy defined by authoritative guidance. Investment securities classified as Level 1 are valued using quoted market prices. |
Composition of Certain Balance
Composition of Certain Balance Sheet Captions | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Composition of Certain Balance Sheet Captions | Note 4: Composition of Certain Balance Sheet Captions: Inventory consisted of the following: June 30, December 31, 2019 2018 (in thousands) Raw materials $ 1,375 $ 676 Work in process 52,567 28,709 Finished goods 6,100 3,645 $ 60,042 $ 33,030 Property, plant and equipment, net, consisted of the following: June 30, December 31, 2019 2018 (in thousands) Buildings $ 4,567 $ 4,573 Machinery and equipment 34,402 32,598 Leasehold improvements 36,560 36,004 Office and IT equipment 2,769 2,481 Construction-in-process 62,067 44,546 140,365 120,202 Accumulated depreciation (33,033 ) (29,370 ) $ 107,332 $ 90,832 Depreciation of property and equipment was $2.1 million and $2.2 million for the three months ended June 30, 2019 and 2018, respectively. Depreciation of property and equipment was $4.2 million and $4.4 million for the six months ended June 30, 2019 and 2018, respectively. The Company did not have any significant property, plant, or equipment write-offs in the three or six months ended June 30, 2019 and 2018. Accrued liabilities consisted of the following: June 30, December 31, 2019 2018 (in thousands) Accrued compensation and benefits $ 15,992 $ 18,482 Accrued vendor fees 17,591 11,452 Clinical trial accruals 10,051 10,059 Accrued growing fees 3,038 2,717 Accrued sales rebates and discounts 11,091 628 Other 8,671 9,139 $ 66,434 $ 52,477 Other current liabilities consisted of the following: June 30, December 31, 2019 2018 (in thousands) Finance lease liabilities $ 287 $ 400 Operating lease liabilities 4,594 — Landlord financing 556 539 Other 320 620 $ 5,757 $ 1,559 Other liabilities consisted of the following: June 30, December 31, 2019 2018 (in thousands) Landlord financing obligation $ 9,136 $ 9,434 Other 126 648 $ 9,262 $ 10,082 |
Earnings per share
Earnings per share | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Earnings per share | Note 5: Earnings per share The computation of basic earnings per share (EPS) is based on the weighted-average number of our ordinary shares outstanding. For the purpose of this calculation, vested nominal strike-price options are considered ordinary shares outstanding. The computation of diluted EPS is based on the weighted-average number of ordinary shares outstanding and potentially dilutive common stock equivalents outstanding for the period, primarily shares that may be issued under the Company’s stock option plans, determined using the treasury stock method. The Company incurred net losses for the three and six months ended June 30, 2018 and therefore did not include potentially dilutive common stock equivalents in the computation of diluted net loss per share. For the three and six months ended June 30, 2018, options totaling approximately 12.7 million ordinary shares were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive. The computation for basic and diluted EPS were as follows (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 (in thousands, except per share amounts) Net income (loss) for basic and diluted EPS $ 79,748 $ (84,011 ) $ 29,684 $ (153,472 ) Weighted-average shares for basic EPS 371,712 340,457 370,776 340,355 Effect of dilutive securities 5,723 — 5,898 — Weighted-average shares for diluted EPS 377,435 340,457 376,674 340,355 Net income (loss) per share: Basic EPS $ 0.21 $ (0.25 ) $ 0.08 $ (0.45 ) Diluted EPS $ 0.21 $ (0.25 ) $ 0.08 $ (0.45 ) |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Note 6: Stockholders’ Equity In October 2018, the Company completed a public offering of 2,185,000 ADSs listed on the Nasdaq Global Market, representing 26,220,000 ordinary shares of the Company, at a price of $158.00 per ADS. The net proceeds from this transaction after underwriting discounts and commissions were approximately $324.6 million. |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | Note 7: Share-Based Compensation Compensation expense for share-based awards is recognized over the requisite service period using the accelerated attribution method. An estimated forfeiture rate has been applied to unvested awards for the purpose of calculating The fair value of stock option awards is estimated using the Black-Scholes option-pricing model. The determination of fair value using the Black-Scholes model is affected by the Company’s ADS price as well as assumptions regarding a number of complex and subjective variables, including expected ADS price volatility, risk-free interest rate, expected dividends and projected employee stock option exercise behaviors. The Company estimates its stock price volatility using a combination of historical stock price volatility and the average implied volatility of options traded in the open market. The risk-free interest rate assumption is based on observed interest rates for the appropriate term of the Company’s stock options. The Company has never declared or paid dividends and has no plans to do so in the foreseeable future. The expected option life assumption is estimated using the simplified method prescribed by ASC Topic 718, Compensation – Stock Compensation, The table below summarizes the total share-based compensation expense included in the Company’s statements of operations for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 (in thousands) (in thousands) Research and development $ 2,443 $ 2,131 $ 4,841 $ 3,418 Sales, general and administrative 9,074 6,890 17,187 12,048 $ 11,517 $ 9,021 $ 22,028 $ 15,466 For the three months ended June 30, 2019 and 2018, $0.7 million and $0.5 million of share-based compensation related to manufacturing operations was capitalized into inventory, respectively. For the six months ended June 30, 2019 and 2018, $1.3 million and $1.0 million of share-based compensation related to manufacturing operations was capitalized into inventory, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8: Commitments and Contingencies As of June 30, 2019, the Company was not a party to any material legal proceedings. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Leases | Note 9: Leases The Company leases buildings, land, equipment, and automobiles. Additionally, the Company has growing and cultivation contracts that contain embedded facility leases. The Company determines if an arrangement is a lease or contains a lease at contract inception. For contracts that are or contain leases, the Company records right-of-use (ROU) lease assets and lease liabilities at lease commencement based on the present value of lease payments over the lease term. The lease term includes renewal option periods when those options are reasonably certain to be exercised. The present value of lease payments is calculated using the Company’s incremental collateralized borrowing rate unless an implicit rate is readily determinable. ROU lease assets include any upfront payments and exclude lease incentives. Leases are classified at lease commencement as either operating leases or finance leases. Operating lease assets are included in non-current assets and operating lease liabilities are included in other current liabilities and operating lease liabilities in our condensed consolidated balance sheets. Operating lease cost is recognized on a straight-line basis over the lease term. Finance lease assets are included in property, plant and equipment, net, and finance lease liabilities are included in other current liabilities and finance lease liabilities in our condensed consolidated balance sheets. Finance lease cost is recognized as depreciation expense of fixed assets and interest expense on finance lease liabilities. Leases with an initial term of 12 months or less are not recorded in the consolidated balance sheets and expense for these leases is recognized on a straight-line basis over the lease term. As of June 30, 2019, the Company has a lease agreement for office space that has not yet commenced with fixed lease payments totaling $3.2 million. The lease is expected to commence in the third quarter of 2019. No operating or finance lease assets were exchanged for lease liabilities in the three or six months ended June 30, 2019. The Company’s lease costs consist of the following: Three Months Ended June 30, Six Months Ended June 30, 2019 2019 (in thousands) (in thousands) Lease cost Operating lease cost (1) $ 1,827 $ 3,250 Finance lease cost Amortization of leased assets 96 194 Interest on lease liabilities 108 192 Total lease cost $ 2,031 $ 3,636 (1) For the three and six months ended June 30, 2019, approximately $0.8 million and $1.2 million of operating and finance lease cost related to manufacturing operations was capitalized into inventory, respectively. The following table summarizes cash flow information related to the Company’s lease obligations: Six Months Ended June 30, 2019 (in thousands) Operating cash used for operating leases $ 2,877 Operating cash used for finance leases $ 192 Financing cash used for finance leases $ 250 The following table summarizes the Company’s lease assets and liabilities: As of June 30, 2019 (in thousands) Lease assets Operating lease assets $ 18,739 Finance lease assets 5,117 Total lease assets $ 23,856 Lease liabilities Current Operating lease liabilities 4,594 Finance lease liabilities 287 Non-current Operating lease liabilities 15,139 Finance lease liabilities 5,536 Total lease liabilities $ 25,556 The following table summarizes other supplemental information related to the Company’s lease obligations: As of June 30, 2019 Weighted average remaining lease term (years) Operating leases 7.5 Finance leases 14.7 Weighted average discount rate Operating leases 5.8 % Finance leases 7.6 % The Company’s future minimum annual lease payments under operating and finance leases as of June 30, 2019 are as follows: Operating Leases Finance Leases (in thousands) 2019 (remaining 6 months) $ 2,346 $ 371 2020 4,583 704 2021 3,703 704 2022 2,677 697 2023 1,953 694 2024 1,784 694 Thereafter 7,777 5,966 Total lease payments $ 24,823 $ 9,830 Less amounts representing interest 5,090 4,007 Total lease obligations $ 19,733 $ 5,823 Prior to January 1, 2019, the Company accounted for leases under the previous U.S. GAAP lease guidance, Accounting Standards Codification Topic 840, Leases |
Sale of Priority Review Voucher
Sale of Priority Review Voucher | 6 Months Ended |
Jun. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Sale of Priority Review Voucher | Note 10: Sale of Priority Review Voucher In April 2019, the Company sold the rare pediatric disease priority review voucher (PRV) it received from the FDA in connection with the United States approval of Epidiolex to Biohaven Pharmaceutical Holding Ltd. for consideration of $105.0 million. The net proceeds of $104.1 million from the sale of the PRV was recognized as a gain on the sale of an intangible asset within other income on the consolidated statements of operations, as the PRV did not have a carrying value on the Company’s consolidated balance sheet at the time of sale. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual financial statements. These accounting principles were applied on a basis consistent with those of the consolidated financial statements contained in the Company’s Annual Report on Form 10-KT for the three-month transition period ended December 31, 2018. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of our financial statements for interim periods. The condensed consolidated balance sheet as of December 31, 2018 was derived from audited annual financial statements but does not include all annual disclosures required by U.S. GAAP. These interim financial statements should be read in conjunction with the audited financial statements for the transition period ended December 31, 2018 included in our Annual Report on Form 10-KT. The results of operations for the three and six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the full year or any other future periods. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying values of the Company’s financial instruments, consisting of cash and cash equivalents, trade receivables, interest and other receivables, and accounts payable and accrued liabilities, approximate fair value due to the relative short-term nature of these instruments. |
Accounts Receivable | Accounts Receivable Accounts receivable are recorded net of customer allowances for prompt payment discounts, chargebacks, and doubtful accounts. Allowances for prompt payment discounts and chargebacks are based on contractual terms. The Company estimates the allowance for doubtful accounts based on existing contractual payment terms, actual payment patterns of its customers and individual customer circumstances. As of June 30, 2019 and December 31, 2018, the Company determined that an allowance for doubtful accounts was not required and no accounts were written off during the periods presented. |
Inventory | Inventory Inventory is stated at the lower of cost or estimated net realizable value. The Company uses a combination of standard and actual costing methodologies to determine the cost basis for its inventories which approximates actual cost. Inventory is valued on a first-in, first-out basis. The Company reduces its inventory to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand, as well as product shelf life. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Prior to approval of Epidiolex by the United States Food and Drug Administration (FDA), all costs related to the manufacturing of Epidiolex were charged to research and development expense in the period incurred. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers Revenue for the Company’s product sales has not been adjusted for the effects of a financing component as the Company expects, at contract inception, that the period between when the Company’s transfers control of the product and when the Company receives payment will be one year or less. Product shipping and handling costs are included in cost of product sales. |
Product Net Sales | Epidiolex Product Net Sales Epidiolex was approved by the FDA in June 2018. Subsequent to the approval by the FDA, the United States Drug Enforcement Agency (DEA) took action to change the classification of Epidiolex from a Schedule I controlled substance to a Schedule V controlled substance, thereby allowing Epidiolex to be prescribed and distributed in the United States. On November 1, 2018, the Company launched sales of Epidiolex to specialty pharmacies (SPs) and specialty distributors (SDs). The Company recognizes revenue from product sales upon receipt of product at the SPs and SDs, the date at which the control is transferred, net of the following allowances which are reflected either as a reduction to the related account receivable or as an accrued liability, depending on how the allowance is settled: Distribution Fees : Distribution fees include distribution service fees paid to the SPs and SDs based on a contractually fixed percentage of the wholesale acquisition cost (WAC), and prompt payment discounts. Distribution fees are recorded as an offset to revenue based on contractual terms at the time revenue from the sale is recognized. Rebates : Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare Part D prescription drug benefit , and contractual rebates with commercial payers . Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements with, or statutory requirements pertaining to, Medicaid and Medicare benefit providers. The allowance for rebates is based on statutory discount rates and expected utilization. The Company’s estimates for expected utilization of rebates is based on utilization data received from the SPs since product launch. Rebates are generally invoiced and paid 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 prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust prior period accruals, which would affect revenue in the period of adjustment. Chargebacks : Chargebacks are discounts and fees that relate to contracts with government and other entities purchasing from the SDs at a discounted price. The SDs charge back to the Company the difference between the price initially paid by the SDs and the discounted price paid to the SDs by these entities. The Company also incurs group purchasing organization fees for transactions through certain purchasing organizations. The Company estimates sales with these entities and accrues for anticipated chargebacks and organization fees, based on the applicable contractual terms. If actual future chargebacks vary from these estimates, the Company may need to adjust prior period accruals, which would affect revenue in the period of adjustment. Co-Payment Assistance : The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. Co-payment assistance is accrued for based on actual program participation and estimates of program redemption using data provided by third-party administrators. Product Returns : Consistent with industry practice, the Company offers the SPs and SDs limited product return rights for damages, shipment errors, and expiring product, provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SPs and SDs and has the ability to control the amount of product that is sold to the SPs and SDs, it is able to make a reasonable estimate of future potential product returns based on this on-hand channel inventory data and sell-through data obtained from the SPs and SDs. In arriving at its estimate, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry. The total amount deducted from gross sales for the allowances described above for the three and six months ended June 30, 2019 was $14.5 million and $22.0 million, respectively Sativex Product Net Sales Sales of Sativex, which is currently being commercialized for spasticity due to multiple sclerosis (MS) outside the United States, are made pursuant to license agreements with commercial partners |
Other Revenue | Other Revenue The Company’s other revenue primarily consists of research and development fee revenue for research and development services provided under a collaboration agreement with Otsuka Pharmaceutical Co. Ltd (Otsuka) The research and development fee revenue is recognized at the time the underlying services are performed. The Sativex license agreements contain provisions for the Company to earn variable consideration in the form of regulatory milestone payments, sales-based milestone payments, and royalty payments. The Company has no further performance obligations related to the regulatory milestone payments and these amounts are recognized in accordance with Topic 606 when receipt of these payments becomes probable and there is no significant risk of revenue reversal. Revenue related to the sales-based milestone payments and product royalty payments are subject to the sales-based royalty exception under Topic 606 and will be recognized when the underlying sales are made. |
Research and Development Expenses | Research and Development Expenses Research and development expenses are charged to operations as incurred. Research and development expenses include, among other things, internal and external costs associated with preclinical development, pre-commercialization manufacturing expenses, and clinical trials. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices received from its external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. As actual costs become known, the Company adjusts its accruals accordingly. Research and development expense is presented net of reimbursements from reimbursable tax and expenditure credits from the U.K. government. Reimbursable |
Concentration Risk | Concentration Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash, cash equivalents, and accounts receivable. The Company’s cash and cash equivalents balances are primarily in depository accounts at major financial institutions in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. Further, the Company specifies credit quality standards for its customers that are designed to limit the Company’s credit exposure to any single party. |
Share-based Compensation | Share-based Compensation The Company recognizes share-based compensation expense for grants of stock options under the Company’s Long-Term Incentive Plans to employees and non-employee members of the Company’s board of directors based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period. Expense related to awards with graded vesting is generally recognized over the vesting period using the accelerated attribution method. |
Income Taxes | Income Taxes The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities along with net operating loss and tax credit carryovers. The Company records a valuation allowance against its deferred tax assets to reduce the net carrying value to an amount that it believes is more likely than not to be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. For UK tax purposes, the $104.1 million gain on the sale of the priority review voucher (PRV) is expected to be fully offset by current year operating tax losses generated in the UK. Uncertain tax positions, for which management's assessment is that there is more than a 50% probability of sustaining the position upon challenge by a taxing authority based upon its technical merits, are subjected to certain recognition and measurement criteria. The Company re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. The Company adjusts the level of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions. The Company recognizes interest and penalties related to income tax matters in income tax expense . |
New Accounting Pronouncements | New Accounting Pronouncements On January 1, 2019, the Company adopted a new accounting standard issued by the Financial Accounting Standards Board (FASB) on accounting for leases using the modified retrospective method. This new accounting standard requires a lessee to recognize an asset and liability for most leases on its balance sheet. The Company elected the optional transition method that allowed for a cumulative-effect adjustment as of January 1, 2019 and did not restate previously reported results in the comparative periods. The Company also elected to adopt certain practical expedients allowed by the new standard, which among other things, allowed the Company to carry forward its historical lease classification. As a result of adoption of the new standard, the Company recorded operating lease assets and liabilities of approximately $20.5 million and $21.1 million, respectively as of January 1, 2019. The operating lease liability was determined based on the present value of the remaining minimum rental payments and the operating lease asset was determined based on the value of the lease liability, adjusted for existing deferred rent balances, which were previously included in other current liabilities and other liabilities. Accounting for the Company’s finance leases remains substantially unchanged. As a result of the adoption of the new leasing accounting standard, the Company’s build-to-suit asset has been reclassified to buildings and the build-to-suit financing obligation has been reclassified to finance lease obligation in the condensed consolidated balance sheets. The adoption of the new standard did not materially impact the Company’s consolidated results of operations or cash flows. In addition, the adoption of this new accounting standard resulted in increased qualitative and quantitative disclosures regarding the amount, timing, and uncertainty of cash flows arising from leases. For further details, see Note 9 Leases |
Composition of Certain Balanc_2
Composition of Certain Balance Sheet Captions (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: June 30, December 31, 2019 2018 (in thousands) Raw materials $ 1,375 $ 676 Work in process 52,567 28,709 Finished goods 6,100 3,645 $ 60,042 $ 33,030 |
Schedule of Property, Plant and Equipment, Net | Property, plant and equipment, net, consisted of the following: June 30, December 31, 2019 2018 (in thousands) Buildings $ 4,567 $ 4,573 Machinery and equipment 34,402 32,598 Leasehold improvements 36,560 36,004 Office and IT equipment 2,769 2,481 Construction-in-process 62,067 44,546 140,365 120,202 Accumulated depreciation (33,033 ) (29,370 ) $ 107,332 $ 90,832 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following: June 30, December 31, 2019 2018 (in thousands) Accrued compensation and benefits $ 15,992 $ 18,482 Accrued vendor fees 17,591 11,452 Clinical trial accruals 10,051 10,059 Accrued growing fees 3,038 2,717 Accrued sales rebates and discounts 11,091 628 Other 8,671 9,139 $ 66,434 $ 52,477 |
Schedule of Other Current Liabilities | Other current liabilities consisted of the following: June 30, December 31, 2019 2018 (in thousands) Finance lease liabilities $ 287 $ 400 Operating lease liabilities 4,594 — Landlord financing 556 539 Other 320 620 $ 5,757 $ 1,559 |
Schedule of Other Liabilities | Other liabilities consisted of the following: June 30, December 31, 2019 2018 (in thousands) Landlord financing obligation $ 9,136 $ 9,434 Other 126 648 $ 9,262 $ 10,082 |
Earnings per share (Tables)
Earnings per share (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Computation for Basic and Diluted EPS | The computation for basic and diluted EPS were as follows (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 (in thousands, except per share amounts) Net income (loss) for basic and diluted EPS $ 79,748 $ (84,011 ) $ 29,684 $ (153,472 ) Weighted-average shares for basic EPS 371,712 340,457 370,776 340,355 Effect of dilutive securities 5,723 — 5,898 — Weighted-average shares for diluted EPS 377,435 340,457 376,674 340,355 Net income (loss) per share: Basic EPS $ 0.21 $ (0.25 ) $ 0.08 $ (0.45 ) Diluted EPS $ 0.21 $ (0.25 ) $ 0.08 $ (0.45 ) |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Share-based Compensation Expense Included in Statements of Operations | The table below summarizes the total share-based compensation expense included in the Company’s statements of operations for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 (in thousands) (in thousands) Research and development $ 2,443 $ 2,131 $ 4,841 $ 3,418 Sales, general and administrative 9,074 6,890 17,187 12,048 $ 11,517 $ 9,021 $ 22,028 $ 15,466 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Summary of Lease Costs | The Company’s lease costs consist of the following: Three Months Ended June 30, Six Months Ended June 30, 2019 2019 (in thousands) (in thousands) Lease cost Operating lease cost (1) $ 1,827 $ 3,250 Finance lease cost Amortization of leased assets 96 194 Interest on lease liabilities 108 192 Total lease cost $ 2,031 $ 3,636 (1) |
Summary of Cash Flow Information Related to Lease Obligations | The following table summarizes cash flow information related to the Company’s lease obligations: Six Months Ended June 30, 2019 (in thousands) Operating cash used for operating leases $ 2,877 Operating cash used for finance leases $ 192 Financing cash used for finance leases $ 250 |
Summary of Lease Assets and Liabilities | The following table summarizes the Company’s lease assets and liabilities: As of June 30, 2019 (in thousands) Lease assets Operating lease assets $ 18,739 Finance lease assets 5,117 Total lease assets $ 23,856 Lease liabilities Current Operating lease liabilities 4,594 Finance lease liabilities 287 Non-current Operating lease liabilities 15,139 Finance lease liabilities 5,536 Total lease liabilities $ 25,556 |
Summary of Other Supplemental Information Related to Lease Obligations | The following table summarizes other supplemental information related to the Company’s lease obligations: As of June 30, 2019 Weighted average remaining lease term (years) Operating leases 7.5 Finance leases 14.7 Weighted average discount rate Operating leases 5.8 % Finance leases 7.6 % |
Summary of Future Minimum Annual Lease Payments Under Operating and Finance Leases | The Company’s future minimum annual lease payments under operating and finance leases as of June 30, 2019 are as follows: Operating Leases Finance Leases (in thousands) 2019 (remaining 6 months) $ 2,346 $ 371 2020 4,583 704 2021 3,703 704 2022 2,677 697 2023 1,953 694 2024 1,784 694 Thereafter 7,777 5,966 Total lease payments $ 24,823 $ 9,830 Less amounts representing interest 5,090 4,007 Total lease obligations $ 19,733 $ 5,823 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Jan. 01, 2019 | |
Summary Of Significant Accounting Policies [Line Items] | ||||||
Accounts receivable written off | $ 0 | $ 0 | ||||
Amount deducted from gross sales for allowances | $ 14,500,000 | 22,000,000 | ||||
Reimbursable research and development tax and expenditure credits | 700,000 | $ 500,000 | 1,500,000 | $ 1,600,000 | ||
Gain on sale of priority review voucher | 104,117,000 | |||||
Operating lease assets | 18,739,000 | 18,739,000 | $ 20,500,000 | |||
Lease liabilities | 25,556,000 | 25,556,000 | $ 21,100,000 | |||
Topic 606 | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Performance obligations related to regulatory milestone payments | $ 0 | $ 0 |
Composition of Certain Balanc_3
Composition of Certain Balance Sheet Captions - Schedule of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,375 | $ 676 |
Work in process | 52,567 | 28,709 |
Finished goods | 6,100 | 3,645 |
Inventory | $ 60,042 | $ 33,030 |
Composition of Certain Balanc_4
Composition of Certain Balance Sheet Captions - Schedule of Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 140,365 | $ 120,202 |
Accumulated depreciation | (33,033) | (29,370) |
Property, plant and equipment, net | 107,332 | 90,832 |
Buildings | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 4,567 | 4,573 |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 34,402 | 32,598 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 36,560 | 36,004 |
Office and IT Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 2,769 | 2,481 |
Construction-in-Process | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 62,067 | $ 44,546 |
Composition of Certain Balanc_5
Composition of Certain Balance Sheet Captions - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||||
Depreciation of property and equipment | $ 2,100,000 | $ 2,200,000 | $ 4,200,000 | $ 4,400,000 |
Property, plant or equipment write-offs | $ 0 | $ 0 | $ 0 | $ 0 |
Composition of Certain Balanc_6
Composition of Certain Balance Sheet Captions - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued compensation and benefits | $ 15,992 | $ 18,482 |
Accrued vendor fees | 17,591 | 11,452 |
Clinical trial accruals | 10,051 | 10,059 |
Accrued growing fees | 3,038 | 2,717 |
Accrued sales rebates and discounts | 11,091 | 628 |
Other | 8,671 | 9,139 |
Accrued liabilities | $ 66,434 | $ 52,477 |
Composition of Certain Balanc_7
Composition of Certain Balance Sheet Captions - Schedule of Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Other Liabilities Current [Abstract] | ||
Finance lease liabilities | $ 287 | $ 400 |
Operating lease liabilities | 4,594 | |
Landlord financing | 556 | 539 |
Other | 320 | 620 |
Other current liabilities | $ 5,757 | $ 1,559 |
Composition of Certain Balanc_8
Composition of Certain Balance Sheet Captions - Schedule of Other Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Other Liabilities Disclosure [Abstract] | ||
Landlord financing obligation | $ 9,136 | $ 9,434 |
Other | 126 | 648 |
Other liabilities | $ 9,262 | $ 10,082 |
Earnings per share - Additional
Earnings per share - Additional Information (Details) - shares shares in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | |
Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from calculation of diluted net loss per share | 12.7 | 12.7 |
Earnings per share - Computatio
Earnings per share - Computation for Basic and Diluted EPS (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Earnings Per Share [Abstract] | ||||||
Net income (loss) for basic and diluted EPS | $ 79,748 | $ (50,064) | $ (84,011) | $ (69,461) | $ 29,684 | $ (153,472) |
Weighted-average shares for basic EPS | 371,712 | 340,457 | 370,776 | 340,355 | ||
Effect of dilutive securities | 5,723 | 5,898 | ||||
Weighted-average shares for diluted EPS | 377,435 | 340,457 | 376,674 | 340,355 | ||
Net income (loss) per share: | ||||||
Basic EPS | $ 0.21 | $ (0.25) | $ 0.08 | $ (0.45) | ||
Diluted EPS | $ 0.21 | $ (0.25) | $ 0.08 | $ (0.45) |
Stockholder's Equity - Addition
Stockholder's Equity - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended |
Oct. 31, 2018USD ($)$ / sharesshares | |
Class Of Stock [Line Items] | |
ADS price per share | $ / shares | $ 158 |
Proceeds from issuance of shares | $ | $ 324.6 |
American Depositary Shares ("ADSs") | |
Class Of Stock [Line Items] | |
Shares issued | 2,185,000 |
Common Stock | |
Class Of Stock [Line Items] | |
Shares issued | 26,220,000 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Share-based Compensation Expense Included in Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 11,517 | $ 9,021 | $ 22,028 | $ 15,466 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 2,443 | 2,131 | 4,841 | 3,418 |
Sales, General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 9,074 | $ 6,890 | $ 17,187 | $ 12,048 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock based compensation expense | $ 11,517 | $ 9,021 | $ 22,028 | $ 15,466 |
Inventory | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock based compensation expense | $ 700 | $ 500 | $ 1,300 | $ 1,000 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Leases [Abstract] | |||||
Fixed lease payments not yet commenced | $ 3,200,000 | $ 3,200,000 | |||
Operating lease assets were exchanged for lease liabilities | 0 | 0 | |||
Finance lease assets were exchanged for lease liabilities | 0 | 0 | |||
Operating and finance lease cost related to manufacturing operations capitalized into inventory | $ 800,000 | $ 1,200,000 | |||
Rent expense for operating leases | $ 1,100,000 | $ 2,100,000 | |||
Leases payments, 2019 | $ 6,400,000 | ||||
Leases payments, 2020 | 6,900,000 | ||||
Leases payments, 2021 | 5,700,000 | ||||
Leases payments, 2022 | 4,200,000 | ||||
Leases payments, 2023 | 2,800,000 | ||||
Leases payments, thereafter | $ 11,800,000 |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Lease cost | ||
Operating lease cost | $ 1,827 | $ 3,250 |
Finance lease cost | ||
Amortization of leased assets | 96 | 194 |
Interest on lease liabilities | 108 | 192 |
Total lease cost | $ 2,031 | $ 3,636 |
Leases - Summary of Cash Flow I
Leases - Summary of Cash Flow Information Related to Lease Obligations (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Leases [Abstract] | ||
Operating cash used for operating leases | $ 2,877 | |
Operating cash used for finance leases | 192 | |
Financing cash used for finance leases | $ 250 | $ 143 |
Leases - Summary of Lease Asset
Leases - Summary of Lease Assets and Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Lease assets | |||
Operating lease assets | $ 18,739 | $ 20,500 | |
Finance lease assets | 5,117 | ||
Total lease assets | 23,856 | ||
Current | |||
Operating lease liabilities | 4,594 | ||
Finance lease liabilities | 287 | $ 400 | |
Non-current | |||
Operating lease liabilities | 15,139 | ||
Finance lease liabilities | 5,536 | $ 5,690 | |
Total lease liabilities | $ 25,556 | $ 21,100 |
Leases - Summary of Other Suppl
Leases - Summary of Other Supplemental Information Related to Lease Obligations (Details) | Jun. 30, 2019 |
Weighted average remaining lease term (years) | |
Operating leases | 7 years 6 months |
Finance leases | 14 years 8 months 12 days |
Weighted average discount rate | |
Operating leases | 5.80% |
Finance leases | 7.60% |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Annual Lease Payments Under Operating and Finance Leases (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Leases [Abstract] | |
Operating Leases, 2019 (remaining 6 months) | $ 2,346 |
Operating Leases, 2020 | 4,583 |
Operating Leases, 2021 | 3,703 |
Operating Leases, 2022 | 2,677 |
Operating Leases, 2023 | 1,953 |
Operating Leases, 2024 | 1,784 |
Operating Leases, Thereafter | 7,777 |
Operating Leases, Total lease payments | 24,823 |
Operating Leases, Less amounts representing interest | 5,090 |
Operating Leases, Total lease obligations | 19,733 |
Finance Lease, 2019 (remaining 6 months) | 371 |
Finance Leases, 2020 | 704 |
Finance Leases, 2021 | 704 |
Finance Leases, 2022 | 697 |
Finance Leases, 2023 | 694 |
Finance Leases, 2024 | 694 |
Finance Leases, Thereafter | 5,966 |
Finance Leases, Total lease payments | 9,830 |
Finance Leases, Less amounts representings interest | 4,007 |
Finance Leases, Total lease obligations | $ 5,823 |
Sale of Priority Review Vouch_2
Sale of Priority Review Voucher - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended |
Apr. 30, 2019 | Jun. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Consideration for sale of priority review voucher | $ 105,000 | |
Proceeds from sale of priority review voucher | $ 104,100 | $ 104,117 |