Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2019 | Oct. 29, 2019 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Entity Registrant Name | Karyopharm Therapeutics Inc. | |
Trading Symbol | KPTI | |
Entity Central Index Key | 0001503802 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 62,790,043 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity File Number | 001-36167 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-3931704 | |
Entity Address, Address Line One | 85 Wells Avenue, 2nd Floor | |
Entity Address, City or Town | Newton | |
Entity Address, Postal Zip Code | 02459 | |
City Area Code | 617 | |
Local Phone Number | 658-0600 | |
Document Transition Report | false | |
Document Quarterly Report | true | |
Entity Shell Company | false | |
Entity Address, State or Province | MA | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 168,004 | $ 118,021 |
Short-term investments | 99,525 | 210,178 |
Accounts receivable | 7,928 | |
Inventory | 100 | |
Prepaid expenses and other current assets | 5,310 | 6,413 |
Total current assets | 280,867 | 334,612 |
Property and equipment, net | 3,240 | 3,863 |
Operating lease right-of-use assets | 10,904 | |
Long-term investments | 2,022 | 2,001 |
Restricted cash | 712 | 716 |
Total assets | 297,745 | 341,192 |
Current liabilities: | ||
Accounts payable | 3,068 | 4,332 |
Accrued expenses | 32,421 | 32,493 |
Deferred revenue | 1,053 | 9,362 |
Operating lease liabilities | 1,583 | |
Deferred rent | 390 | |
Other current liabilities | 1,077 | 327 |
Total current liabilities | 39,202 | 46,904 |
Convertible senior notes | 107,962 | 102,664 |
Deferred royalty obligation | 73,589 | |
Operating lease liabilities, net of current portion | 13,643 | |
Deferred revenue, net of current portion | 3,479 | 4,532 |
Deferred rent, net of current portion | 3,922 | |
Total liabilities | 237,875 | 158,022 |
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 62,700,481 shares issued and outstanding at September 30, 2019; 100,000,000 shares authorized; 60,829,308 shares issued and outstanding at December 31, 2018 | 6 | 6 |
Additional paid-in capital | 884,585 | 857,156 |
Accumulated other comprehensive loss | (30) | (244) |
Accumulated deficit | (824,691) | (673,748) |
Total stockholders' equity | 59,870 | 183,170 |
Total liabilities and stockholders' equity | $ 297,745 | $ 341,192 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Common stock, shares issued | 62,705,481 | 60,829,308 |
Common stock, shares outstanding | 62,705,481 | 60,829,308 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Total revenues | $ 13,149 | $ 239 | $ 22,797 | $ 30,130 |
Operating expenses: | ||||
Cost of sales | 1,013 | 1,013 | ||
Research and development | 26,270 | 36,427 | 90,761 | 122,482 |
Selling, general and administrative | 25,267 | 12,966 | 77,032 | 30,076 |
Total operating expenses | 52,550 | 49,393 | 168,806 | 152,558 |
Loss from operations | (39,401) | (49,154) | (146,009) | (122,428) |
Other income (expense): | ||||
Interest income | 1,137 | 1,098 | 4,320 | 2,260 |
Interest expense | (3,093) | (9,180) | ||
Other income (expense) | 10 | (13) | (36) | (20) |
Total other (expense) income, net | (1,946) | 1,085 | (4,896) | 2,240 |
Loss before income taxes | (41,347) | (48,069) | (150,905) | (120,188) |
Income tax provision | (20) | (14) | (38) | (9) |
Net loss | $ (41,367) | $ (48,083) | $ (150,943) | $ (120,197) |
Net loss per share—basic and diluted | $ (0.67) | $ (0.79) | $ (2.46) | $ (2.17) |
Weighted-average number of common shares outstanding used in net loss per share—basic and diluted | 62,092,841 | 60,586,511 | 61,297,249 | 55,465,261 |
Product revenue | ||||
Revenues: | ||||
Total revenues | $ 12,821 | $ 12,821 | ||
License and other revenue | ||||
Revenues: | ||||
Total revenues | $ 328 | $ 239 | $ 9,976 | $ 30,130 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (41,367) | $ (48,083) | $ (150,943) | $ (120,197) |
Comprehensive income (loss) | ||||
Unrealized (loss) gain on investments | (59) | 110 | 250 | 105 |
Foreign currency translation adjustments | (32) | (3) | (36) | (41) |
Comprehensive loss | $ (41,458) | $ (47,976) | $ (150,729) | $ (120,133) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities | ||
Net loss | $ (150,943) | $ (120,197) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 730 | 541 |
Net amortization of premiums and discounts on investments | (1,242) | 280 |
Amortization of debt discount and issuance costs | 5,298 | |
Stock-based compensation expense | 11,742 | 13,378 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (7,928) | |
Inventory | (100) | |
Prepaid expenses and other current assets | 1,108 | (3,039) |
Operating lease right-of-use assets | 807 | |
Accounts payable | (1,215) | (3,425) |
Accrued expenses and other liabilities | 569 | 8,139 |
Operating lease liabilities | (797) | |
Deferred revenue | (9,362) | (8,027) |
Deferred rent | 1,405 | |
Net cash used in operating activities | (151,333) | (110,945) |
Investing activities | ||
Purchases of property and equipment | (156) | (1,270) |
Proceeds from maturities of investments | 202,454 | 94,378 |
Purchases of investments | (90,329) | (97,662) |
Net cash provided by (used in) investing activities | 111,969 | (4,554) |
Financing activities | ||
Proceeds from the issuance of common stock, net of issuance costs | 14,563 | 145,706 |
Proceeds from the exercise of stock options and shares issued under employee stock purchase plan | 1,124 | 2,627 |
Proceeds from deferred royalty obligation, net | 73,682 | |
Net cash provided by financing activities | 89,369 | 148,333 |
Effect of exchange rate on cash, cash equivalents and restricted cash | (26) | (9) |
Net increase in cash, cash equivalents and restricted cash | 49,979 | 32,825 |
Cash, cash equivalents and restricted cash at beginning of period | 118,737 | 69,487 |
Cash, cash equivalents and restricted cash at end of period | 168,716 | 102,312 |
Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets | ||
Cash and cash equivalents | 168,004 | 101,600 |
Long-term restricted cash | 712 | 712 |
Cash, cash equivalents and restricted cash at end of period | 168,716 | $ 102,312 |
Supplemental disclosures: | ||
Deferred financing costs in accrued expenses at period end | 93 | |
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | 11,711 | |
Cash paid for amounts included in the measurement of operating lease liabilities | $ 2,096 |
Condensed Consolidated Statem_4
Condensed Consolidated Statement of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income (loss) [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2017 | $ 129,500 | $ 5 | $ 625,053 | $ (217) | $ (495,341) |
Beginning balance,Shares at Dec. 31, 2017 | 49,533,150 | ||||
Vesting of restricted stock (in shares) | 103,800 | ||||
Exercise of stock options and shares issued under the employee stock purchase plan | 2,627 | 2,627 | |||
Exercise of stock options and shares issued under the employee stock purchase plan, (shares) | 502,483 | ||||
Issuance of common stock | 145,706 | $ 1 | 145,705 | ||
Issuance of common stock (in Shares) | 10,525,424 | ||||
Stock-based compensation expense | 13,378 | 13,378 | |||
Unrealized gain (loss) on investments | 105 | 105 | |||
Foreign currency translation adjustment | (41) | (41) | |||
Net loss | (120,197) | (120,197) | |||
Ending balance at Sep. 30, 2018 | 171,078 | $ 6 | 786,763 | (153) | (615,538) |
Ending balance,Shares at Sep. 30, 2018 | 60,664,857 | ||||
Beginning balance at Jun. 30, 2018 | 213,467 | $ 6 | 781,176 | (260) | (567,455) |
Beginning balance,Shares at Jun. 30, 2018 | 60,501,260 | ||||
Exercise of stock options and shares issued under the employee stock purchase plan | 812 | 812 | |||
Exercise of stock options and shares issued under the employee stock purchase plan, (shares) | 163,597 | ||||
Stock-based compensation expense | 4,775 | 4,775 | |||
Unrealized gain (loss) on investments | 110 | 110 | |||
Foreign currency translation adjustment | (3) | (3) | |||
Net loss | (48,083) | (48,083) | |||
Ending balance at Sep. 30, 2018 | 171,078 | $ 6 | 786,763 | (153) | (615,538) |
Ending balance,Shares at Sep. 30, 2018 | 60,664,857 | ||||
Beginning balance at Dec. 31, 2018 | 183,170 | $ 6 | 857,156 | (244) | (673,748) |
Beginning balance,Shares at Dec. 31, 2018 | 60,829,308 | ||||
Vesting of restricted stock (in shares) | 10,000 | ||||
Exercise of stock options and shares issued under the employee stock purchase plan | 1,124 | 1,124 | |||
Exercise of stock options and shares issued under the employee stock purchase plan, (shares) | 231,722 | ||||
Issuance of common stock | 14,563 | 14,563 | |||
Issuance of common stock (in Shares) | 1,634,451 | ||||
Stock-based compensation expense | 11,742 | 11,742 | |||
Unrealized gain (loss) on investments | 250 | 250 | |||
Foreign currency translation adjustment | (36) | (36) | |||
Net loss | (150,943) | (150,943) | |||
Ending balance at Sep. 30, 2019 | 59,870 | $ 6 | 884,585 | (30) | (824,691) |
Ending balance,Shares at Sep. 30, 2019 | 62,705,481 | ||||
Beginning balance at Jun. 30, 2019 | 82,469 | $ 6 | 865,726 | 61 | (783,324) |
Beginning balance,Shares at Jun. 30, 2019 | 60,965,505 | ||||
Vesting of restricted stock (in shares) | 5,000 | ||||
Exercise of stock options and shares issued under the employee stock purchase plan | 577 | 577 | |||
Exercise of stock options and shares issued under the employee stock purchase plan, (shares) | 100,525 | ||||
Issuance of common stock | 14,563 | 14,563 | |||
Issuance of common stock (in Shares) | 1,634,451 | ||||
Stock-based compensation expense | 3,719 | 3,719 | |||
Unrealized gain (loss) on investments | (59) | (59) | |||
Foreign currency translation adjustment | (32) | (32) | |||
Net loss | (41,367) | (41,367) | |||
Ending balance at Sep. 30, 2019 | $ 59,870 | $ 6 | $ 884,585 | $ (30) | $ (824,691) |
Ending balance,Shares at Sep. 30, 2019 | 62,705,481 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Stockholders' Equity (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | |
Common Stock [Member] | Controlled Equity Offering Sales Agreement [Member] | |||
Issuance of stock, issuance costs | $ 0.3 | $ 0.3 | $ 0.2 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 1. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements of Karyopharm Therapeutics Inc., a Delaware corporation, have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, 10-01. 10-K In July 2019, the U.S. Food and Drug Administration (“FDA”) approved XPOVIO ® Basis of Consolidation The condensed consolidated financial statements at September 30, 2019 include the accounts of Karyopharm Therapeutics Inc. and our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The significant accounting policies used in preparation of these condensed consolidated financial statements on Form 10-Q 10-K r r 10-K Product Revenue Recognition We adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“FASB”) ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In the third quarter of 2019, we began to ship XPOVIO in the United States to specialty pharmacies and specialty distributors, collectively referred to as our customers, under a limited number of distribution arrangements with such third parties. Our specialty pharmacy customers resell XPOVIO directly to patients while our specialty distributor customers resell XPOVIO to healthcare entities, who then resell to patients. In connection with negotiating and executing contracts with our customers, our policy is to expense incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that we would have recognized is one year or less. However, no such costs have been incurred to date. In addition to distribution agreements with our customers, we enter into certain arrangements with group purchasing organizations and/or other payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of our products. In the context of ASC 606, each unit of XPOVIO that is ordered by our customers represents a distinct performance obligation that is completed when control of the product is transferred to the customer. Accordingly, we recognize product revenue when the customer obtains control of our product, which occurs at a point in time, generally upon delivery pursuant to our agreements with our customers. If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are reported. These reserves, as detailed below, 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 customer) or a current liability (if the amount is payable to a party other than a customer). Certain of the amounts noted are known at the time of sale based on contractual terms and, therefore, are recorded pursuant to the most likely amount method under ASC 606. Other amounts are estimated and take into consideration a range of possible outcomes, which are probability-weighted and recorded in accordance with the expected value method in ASC 606 for relevant factors, such as 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 respective underlying contracts. The amount of variable consideration that 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 under the contracts with our customers will not occur in a future period. The following are the components of variable consideration related to product revenue: Cash discounts and distributor fees: Product returns: Based on the distribution model for XPOVIO, contractual inventory limits with our customers, the price of XPOVIO, and limited contractual return rights, we currently believe there will be minimal XPOVIO returns. However, we will update our estimated return liability each reporting period based on actual shipments of XPOVIO subject to contractual return rights, changes in expectations about the amount of estimated and/or actual returns, and other qualitative considerations. Chargebacks: Government rebates Other incentives: co-payment co-payments co-payment Product revenue reserves and allowances: Accounts Receivable In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns, and chargebacks. Our contracts with customers have standard payment terms that generally require payment within 30 days for specialty pharmacy customers and 65 days for specialty distributor customers. We analyze accounts that are past due for collectability, and periodically evaluate the creditworthiness of our customers. As of September 30, 2019, we determined an allowance for doubtful accounts was not required based upon our review of contractual payment terms and individual customer circumstances. Inventory Prior to regulatory approval, we expensed costs relating to the production of inventory as research and development expense in the period incurred. We capitalize the costs to manufacture our products incurred after regulatory approval when, based on our judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Such costs are generally recorded as costs of sales upon shipment. In connection therewith, we value our inventories at the lower of cost or estimated net realizable value. We determine the cost of our inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out Raw materials and work in process includes all inventory costs prior to packaging and labelling, including raw material, active product ingredient, and drug product. Finished goods include packaged and labelled products. Prior to FDA approval of XPOVIO, all costs related to the manufacturing of XPOVIO that could potentially be available to support the commercial launch of our products were charged to research and development expense in the period incurred, as there was no alternative future use. We analyze our inventory levels for recoverability each reporting period. In the period in which there is an impairment identified, we write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value, and inventory in excess of expected sales requirements as cost of sales. The determination of whether inventory costs will be realizable is based on our estimates. If actual market conditions are less favorable than projected by us, additional write-downs of inventory may be required, which would be recorded as cost of sales. Cost of Sales Cost of sales includes the cost of producing and distributing inventories that are related to product revenue during the respective period, including salary related and stock-based compensation expense for employees involved with production and distribution, freight, and indirect overhead costs, as well as third-party royalties payable on product revenue, net. In addition, shipping and handling costs for product shipments are recorded in cost of sales as incurred. Finally, cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Deferred Royalty Obligation We treat the liability related to net revenues, as discussed further in Note 12, as a deferred royalty obligation, amortized under the effective interest rate method over the estimated life of the revenue streams. We recognize interest expense thereon the Liquidity At September 30, 2019, we had $269.6 million in cash, cash equivalents and investments. We have had recurring losses and incurred a loss of $150.9 million for the nine months ended September 30, 2019. Net cash used in operations for the nine months ended September 30, 2019 was $151.3 million. We expect that our cash, cash equivalents and investments at September 30, 2019, together with the cash we expect to generate from product sales and under our alliances, will be sufficient to fund current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of these financial statements, during which time we plan to continue to commercialize XPOVIO in the United States, which commenced in July 2019. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | 2. Recent Accounting Pronouncements Recently Adopted Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) 2016-02”). 2016-02 Leases Leases right-of-use In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases 2018-10”) 2018-11, Leases (Topic 842) Targeted Improvements 2018-11”). 2018-10 2018-11 2016-02 2016-02, 2018-11 2016-02. ASU 2016-02, 2018-10, 2018-11 2018-11 Pursuant to the guidance under ASU 2016-02, right-of-use non-lease As summarized in the table below, the standard had a material impact on our condensed consolidated balance sheet as of September 30, 2019, specifically through recognition of right-of-use right-of-use right-of-use January 1, 2019 Prior to ASC 842 Adoption ASC 842 as Adjusted Consolidated balance sheet data (in thousands): Operating lease and right-of-use (1) $ — $ 11,711 $ 11,711 Deferred rent (2) $ 390 $ (390 ) $ — Deferred rent non-current (2) $ 3,922 $ (3,922 ) $ — Operating lease liabilities (3) $ — $ 1,175 $ 1,175 Non-current (3) $ — $ 14,848 $ 14,848 (1) Represents capitalization of operating lease right-of-use right-of-use (2) Represents reclassification of deferred rent and tenant incentives to operating lease right-of-use (3) Represents recognition of operating lease liabilities. We implemented internal controls to enable the preparation of financial information upon adoption. In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting 2018-07”). 2018-07 In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements 2018-09”). In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606 2018-18”). 2018-18 2018-18 2018-18 On August 17, 2018, the SEC issued an amendment to Rule 3-04 S-X, year-to-date 10-Q Recently Issued Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments 2016-13”). 2016-13 available-for-sale 2016-13 2016-13 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement—Disclosure Framework-Changes to the Disclosure Requirement for Fair Value Measurement 2018-13”). 2018-13 2018-13 2018-13 In August 2018, the FASB issued ASU No. 2018-15, Intangible-Goodwill and Other Internal-Use Software (Subtopic 350-40) 2018-15”). 2018-15 2018-15 2018-15 |
Product Revenue
Product Revenue | 9 Months Ended |
Sep. 30, 2019 | |
Product Revenue [Member] | |
Product Revenue | 3. Product Revenue To date, our only source of product revenue has been from the U.S. sales of XPOVIO, which we began shipping to our customers in July 2019. For the three months ended September 30, 2019, we recorded a total of $ 2.1 |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | 4. Inventory The following table presents our inventory of XPOVIO at September 30, 2019 and December 31, 2018 (in thousands): September 30, December 31, Raw materials and work in process $ — $ — Finished goods 100 — Total inventory $ 100 $ — At September 30, 2019, all of our inventory was related to XPOVIO, which was approved by the FDA in July 2019, at which time we began to capitalize costs to manufacture XPOVIO. Prior to FDA approval of XPOVIO, all costs related to the manufacturing of XPOVIO and related material were charged to research and development expense in the period incurred. At September 30, 2019, we have determined a reserve related to XPOVIO inventory is not required. |
License and Asset Purchase Agre
License and Asset Purchase Agreements | 9 Months Ended |
Sep. 30, 2019 | |
License and Asset Purchase Agreements [Member] | |
License and Asset Purchase Agreements | 5. License and Asset Purchase Agreements Antengene License Agreement Effective May 23, 2018 (the “Antengene Effective Date”), we entered into a License Agreement (“Antengene License Agreement”) with Antengene Therapeutics Limited, a corporation organized and existing under the laws of Hong Kong (“Antengene”) and a subsidiary of Antengene Corporation Co. Ltd., a corporation organized and existing under the laws of the People’s Republic of China, pursuant to which we granted Antengene exclusive rights to develop and commercialize, at its own cost, KPT-9274, first-in-class non-competitive non-oncology “Non-Oncology KPT-9274 Non-Oncology Pursuant to the terms of the Antengene License Agreement, we received an upfront payment of $11.7 million, and could receive up to $105.0 million in milestone payments if certain development goals are achieved and up to $45.0 million in milestone payments if certain sales milestones are achieved, as well as a high single-digit to low double-digit royalty based on future net sales of the Antengene Licensed Compounds in the Antengene Territory. In addition, upon Antengene’s election and the parties’ full execution of a manufacturing technology transfer plan and satisfaction of other specified conditions (the “Antengene Manufacturing Election”), we will grant to Antengene non-exclusive As part of the Antengene License Agreement, Antengene will also have the right to participate in global clinical studies of the Antengene Licensed Compounds and will bear the cost and expense for patients enrolled in clinical studies in the Antengene Territory. Antengene is responsible for seeking regulatory and marketing approvals for the Antengene Licensed Compounds in the Antengene Territory, as well as any development of the products specifically necessary to obtain such approvals. Antengene is also responsible for the commercialization of the Antengene Licensed Compounds in the Oncology Field and Non-Oncology Until such time as Antengene elects to manufacture its own drug substance, we will furnish clinical supplies of drug substance to Antengene for use in Antengene’s development efforts pursuant to a clinical supply agreement to be entered into by us and Antengene, and Antengene may elect to have us provide commercial supplies of drug product to Antengene pursuant to a commercial supply agreement to be entered into by us and Antengene, in each case the costs of which will be borne by Antengene. The Antengene License Agreement will continue in effect on a product-by-product, country-by-country We assessed the Antengene arrangement in accordance with ASC 606 and concluded that the contract counterparty, Antengene, is a customer. We identified the following material promises under the contract: (i) exclusive licenses for each Antengene Licensed Compound, (ii) initial data transfers for each Antengene Licensed Compound, which consisted of regulatory data compiled by us for the Antengene Licensed Compounds as of the Antengene Effective Date, and (iii) obligations to stand-ready to provide an initial clinical supply for each Antengene Licensed Compound. We also identified immaterial promises under the contract relating to information exchanges and participation on operating committees and other working groups. Separately, we also identified certain customer options that would create an obligation for us if exercised by Antengene, including (i) additional data transfers for each Antengene Licensed Compound, which would consist of the transfer of additional regulatory data compiled by us for each Antengene Licensed Compound after the Antengene Effective Date, (ii) obligations to provide additional clinical supply and related substance supply for each Antengene Licensed Compound upon request by Antengene, (iii) manufacturing technology transfers and licenses for each Antengene Licensed Compound under the Antengene Manufacturing Election, as detailed above, and (iv) options for a backup compound, which represents Antengene’s option to select a replacement compound in the event it elects to discontinue the development of the Antengene Licensed Compounds (the “Antengene Transfer Options”). The Antengene Transfer Options individually represent material rights, as they were offered at a significant and incremental discount. Therefore, they were further assessed as performance obligations under the Antengene License Agreement. Finally, we also identified certain other customer options that would create a manufacturing obligation for us if exercised by Antengene, including for commercial supply. These options do not represent a material right, as they are not offered at a significant and incremental discount. In further evaluating the promises detailed above, we determined that the exclusive licenses, initial data transfers, and stand-ready obligation to provide initial clinical supply for each Antengene Licensed Compound were not distinct from one another, and must be combined as four separate performance obligations (the “Antengene Combined License Obligation for selinexor”, “Antengene Combined License Obligation for eltanexor”, “Antengene Combined License Obligation for KPT-9274” KPT-9274, We further determined that the up-front KPT-9274 KPT-9274, Upon execution of the Antengene License Agreement, the only fixed component of the transaction price included the $11.7 million up-front re-evaluate Through the nine months ended September 30, 2019, we recognized $9.4 million in revenue under the Antengene License Agreement, as the Antengene Combined License Obligation for selinexor was satisfied when the initial clinical supply of selinexor was delivered during the second quarter of 2019. Revenue will be recognized for the Antengene Combined License Obligation for eltanexor, the Antengene Combined License Obligation for KPT-9274, KPT-9274 non-current Biogen Asset Purchase Agreement On January 24, 2018, we entered into an Asset Purchase Agreement (the “APA”) and Letter Agreement with Biogen MA Inc., a Massachusetts corporation and subsidiary of Biogen, Inc. (“Biogen”). Under the terms of the APA and Letter Agreement, we sold to Biogen exclusive worldwide rights to develop and commercialize our oral SINE compound KPT-350 m KPT-350 know-how KPT-350 KPT-350 KPT-350 KPT-350 country-by-country We and Biogen have made customary representations and warranties and agreed to customary covenants in the APA, including covenants requiring Biogen to use commercially reasonable efforts to develop KPT-350 We assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Biogen, is a customer. We identified the following material promises in the arrangement: the Transfer of IP and the Manufacturing License. We also identified immaterial promises under the contract that were not deemed performance obligations. We further determined that other promises for Additional Supply and Transition Assistance represented customer options, which would create an obligation for us if exercised by Biogen. Since no additional or material consideration is owed to us by Biogen upon exercise of the customer options for Additional Supply and Transition Assistance, we determined that both are offered at significant and incremental discounts. Accordingly, they were assessed as material rights and, therefore, separate performance obligations in the arrangement. We then determined that the Transfer of IP and the Manufacturing License were not distinct from one another and must be combined as a performance obligation (the “Combined Performance Obligation”). This is because Biogen requires the Manufacturing License to derive benefit from the Transfer of IP. Based on these determinations, as well as the considerations noted above with respect to the material rights for Additional Supply and Transition Assistance, we identified three distinct performance obligations at the inception of the contract: (i) the Combined Performance Obligation, (ii) the material right for Additional Supply, and (iii) the material right for Transition Assistance. We further determined that the up-front Upon execution of the APA, the transaction price included only the $10.0 million up-front re-evaluate Ono License Agreement Effective October 11, 2017 (the “Ono Effective Date”), we entered into a license agreement (the “Ono License Agreement”) with Ono Pharmaceutical Co., Ltd., a corporation organized and existing under the laws of Japan (“Ono”), pursuant to which we granted Ono exclusive rights to develop and commercialize, at its own cost, selinexor and eltanexor, for the diagnosis, treatment and/or prevention of all human oncology indications (the “Ono Field”) in Japan, Republic of Korea, Republic of China (Taiwan) and Hong Kong, as well as in the ten Southeast Asian countries currently comprising the Association of Southeast Asian Nations (the “Ono Territory”) (the “Ono Exclusive License”). Pursuant to the terms of the Ono License Agreement, we received an upfront payment of ¥2.5 billion (US$21.9 million on the date received), and could receive up to ¥10.15 billion (approximately US$90.5 million at the exchange rate as of the Ono Effective Date) in milestone payments if certain development goals are achieved and up to ¥9.0 billion (approximately US$80.2 million at the exchange rate as of the Ono Effective Date) in milestone payments if certain sales milestones are achieved, as well as a low double-digit royalty based on future net sales of selinexor and eltanexor in the Ono Territory. In addition, upon Ono’s election and the parties’ full execution of a manufacturing technology transfer plan and satisfaction of other specified conditions (the “Ono Manufacturing Election”), we will grant to Ono non-exclusive As part of the Ono License Agreement, Ono will also have the right to participate in global clinical studies of selinexor and eltanexor and will bear the cost and expense for patients enrolled in clinical studies in the Ono Territory. Ono is responsible for seeking regulatory and marketing approvals for selinexor and eltanexor in the Ono Territory, as well as any development of the products specifically necessary to obtain such approvals. Ono is also responsible for the commercialization of products containing selinexor or eltanexor in the Ono Field in the Ono Territory at its own cost and expense. Subject to the Ono Manufacturing Election, we will furnish clinical supplies of drug substance to Ono for use in Ono’s development efforts pursuant to a clinical supply agreement to be entered into by us and Ono, and Ono may elect to have us provide commercial supplies of drug product to Ono pursuant to a commercial supply agreement to be entered into by us and Ono, in each case the costs of which will be borne by Ono. The Ono License Agreement will continue in effect on a product-by-product, country-by-country W In further evaluating the promises detailed above, we determined that the (i) Ono Exclusive License, initial data transfer, and initial clinical supply for selinexor and (ii) Ono Exclusive License, initial data transfer, and obligation to stand-ready to provide initial clinical supply of eltanexor were not distinct from one another, and must be combined as two separate performance obligations (the “Ono Combined License Obligation for selinexor” and the “Ono Combined License Obligation for eltanexor”). This is because, for both selinexor and eltanexor, Ono requires the initial data transfer and clinical supply to derive benefit from the Ono Exclusive License since we did not grant manufacturing licenses for selinexor and eltanexor at contract inception. We also determined that each of the Ono Transfer Options represents a distinct performance obligation. Based on these determinations, we identified six distinct performance obligations at the inception of the Ono License Agreement, including (i) the Ono Combined License Obligation for selinexor, (ii) the Ono Combined License Obligation for eltanexor, and the four components of the Ono Transfer Options, including (iii) the material right for additional data transfer, (iv) the material right for additional clinical supply and related substance supply, (iv) the material right for manufacturing technology transfer and license, and (vi) the material right for the option for a backup compound. We further determined that the up-front Upon execution of the Ono License Agreement, the transaction price included only the ¥2.5 billion (US$21.9 million on the date received) up-front re-evaluate As the initial clinical supply of selinexor was delivered in April 2018, the Ono Combined License Obligation for selinexor was determined to be fulfilled and revenue of $19.7 million was recognized during the quarter ended June non-current Anivive License Agreement On April 28, 2017 (the “Anivive Effective Date”), we entered into a license agreement (the “Anivive Agreement”) with Anivive Lifesciences, Inc. (“Anivive”), a biopharmaceutical company engaged in the research, development and commercialization of animal health medicines, pursuant to which we have granted Anivive an exclusive, worldwide license to develop and commercialize verdinexor (KPT-335) We assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Anivive, is a customer. We identified the following material promises under the contract, the Anivive Exclusive License and the technology transfer, which consisted of regulatory data compiled by us for the licensed compound and product as of the Anivive Effective Date. We also identified immaterial promises under the contract that were not deemed performance obligations, including participating on a product advisory committee and sharing regulatory matter information. We further determined that other promises for (i) transfer of additional technology in the future, if developed by us, and (ii) facilitating manufacturing and supply relationships with our third-party contract manufacturers represented customer options, would create an obligation for us if exercised by Anivive. Since no additional or immaterial consideration is owed to us by Anivive upon exercise of the customer options noted, we determined that both are offered at significant and incremental discounts. Accordingly, they were assessed as material rights and, therefore, separate performance obligations in the arrangement. In further evaluating the promises detailed above, we determined that the Anivive Exclusive License and the technology transfer were not distinct from one another and must be combined as a performance obligation (the “Anivive Combined License Obligation”). This is because Anivive requires the technology transfer to derive benefit from the Anivive Exclusive License. Based on these determinations, we identified three distinct performance obligations at the inception of the contract: (i) the Anivive Combined License Obligation, (ii) the material right for transfer of additional technology in the future, if developed by us, and (iii) the material right for facilitating manufacturing and supply relationships with our third-party contract manufacturers. We further determined that the up-front As referenced above, the up-front re-evaluate To date, we have recognized $1.3 million of revenue associated with the Anivive Agreement. Revenue for the upfront payment and technology transfer milestone was recognized upon completion of the technology transfer in October 2017, as all promises under the Anivive Combined License Obligation had been fulfilled. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 6. Fair Value of Financial Instruments Financial instruments, including cash, restricted cash, prepaid expenses and other current assets, accounts payable and accrued expenses are presented at amounts that approximate fair value at September 30, 2019 and December 31, 2018. We are required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 inputs Quoted prices in active markets for identical assets or liabilities Level 2 inputs Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly Level 3 inputs Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability Items classified as Level 2 within the valuation hierarchy consist of commercial paper, corporate debt securities, U.S. government agency securities and certificates of deposit. We estimate the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar securities, issuer credit spreads, benchmark yields, and other observable inputs. We validate the prices provided by our third-party pricing sources by understanding the models used, obtaining market values from other pricing sources and analyzing pricing data in certain instances. In certain cases where there is limited activity or less transparency around inputs to valuation, the related assets or liabilities are classified as Level 3. The embedded derivative liability associated with our deferred royalty obligation, as discussed further in Note 12, is measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of deferred royalty obligation. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of interest and other income (expense), net. The assumptions used in the option pricing Monte Carlo simulation model include: (1) our estimates of the probability and timing of related events; (2) the probability-weighted net sales of XPOVIO and any of our other future products, including worldwide net product sales and upfront payments, milestones and royalties; (3) our risk-adjusted discount rate that includes a company specific risk premium; (4) our cost of debt; (5) volatility; and (6) the probability of a change in control occurring during the term of the instrument. Our embedded derivative liability is described in Note 12, “Long-Term Obligations.” The following table presents information about our financial assets that have been measured at fair value at September 30, 2019 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 78,063 $ 78,063 $ — $ — Investments: Short-term: Corporate debt securities 49,708 — 49,708 — Commercial paper 36,440 — 36,440 — U.S. government and agency securities 13,377 13,377 Long-term: Corporate debt securities 2,022 2,022 Total financial assets $ 179,610 $ 78,063 $ 101,547 $ — The following table presents information about our financial assets that have been measured at fair value at December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 62,320 $ 62,320 $ — $ — Corporate debt securities 6,823 — 6,823 — Commercial paper 7,738 — 7,738 — Investments: Short-term: Corporate debt securities 143,079 — 143,079 — Commercial paper 43,978 — 43,978 — U.S. government and agency securities 19,124 — 19,124 — Certificate of deposit 3,997 — 3,997 — Long-term: Corporate debt securities (one to two year maturity) 2,001 — 2,001 — $ 289,060 $ 62,320 $ 226,740 $ — |
Investments
Investments | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 7. Investments The following table summarizes our investments in debt securities, classified as available-for-sale, Amortized Cost Gross Unrealized Gains Gross Unrealized Loss Fair Value Short-term: Corporate debt securities $ 49,692 $ 19 $ (3) $ 49,708 Commercial paper 36,431 12 (3) 36,440 U.S. government and agency securities 13,367 10 13,377 Long-term: Corporate debt securities 2,021 1 2,022 $ 101,511 $ 42 $ (6 ) $ 101,547 The following table summarizes our investments in debt securities, classified as available-for-sale Amortized Cost Gross Unrealized Gains Gross Unrealized Loss Fair Value Short-term: Corporate debt securities $ 143,254 $ 3 $ (178) $ 143,079 Commercial paper 44,001 — (23) 43,978 U.S. government and agency securities 19,131 10 (17) 19,124 Certificate of deposit 4,000 — (3) 3,997 Long-term: Corporate debt securities (one to two year maturity) 2,007 — (6) 2,001 $ 212,393 $ 13 $ (227 ) $ 212,179 At September 30, 2019 and December 31, 2018, we held 11 and 79 debt securities, respectively, that were in an unrealized loss position. The aggregate fair value of debt securities in an unrealized loss position at September 30, 2019 and December 31, 2018 was $23.1 million and $180.6 million, respectively. As of September 30, 2019, 1 corporate debt security with a fair value of $1.0 million has been in a continuous unrealized loss position for more than 12 months. The unrealized loss related to this corporate debt security is included in accumulated other comprehensive loss as of September 30, 2019. At September 30, 2019, we did not intend to sell the security with an unrealized loss position in accumulated other comprehensive income, and it is not likely that we will be required to sell this security before recovery of its We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the condensed consolidated statements of operations if we have experienced a credit loss and have the intent to sell the investment or if it is more likely than not that we will be required to sell the investment before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with our investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. The unrealized losses at September 30, 2019 and December 31, 2018 are attributable to changes in interest rates and we do not believe any unrealized losses represent other-than-temporary impairments. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 8. Net Loss Per Share Basic and diluted net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Our potentially dilutive shares, which include outstanding stock options and unvested restricted stock and restricted stock units, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three and Nine Months Ended September 30, 2019 2018 Outstanding stock options 10,210,890 8,962,643 Unvested restricted stock units 834,600 25,000 We have the option to settle the conversion obligation for our 3.00% convertible senior notes issued October 2018, and due 2025 |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation | 9. Stock-based Compensation Stock Options A summary of our stock option activity and related information follows: Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2018 8,917,084 $ 13.78 7.4 $ 8,197 Granted 2,996,650 8.08 Exercised (131,143 ) 5.55 Canceled (1,571,701 ) 13.77 Outstanding at September 30, 2019 10,210,890 12.22 7.0 $ 12,443 Exercisable at September 30, 2019 5,426,297 $ 14.64 5.5 $ 7,869 Total stock-based compensation expense related to stock options for the nine months ended September 30, 2019 and 2018 was $9.8 million and $12.8 million, respectively. As of September 30, 2019, there was $28.7 million of total unrecognized stock-based compensation expense related to stock options. The expense is expected to be recognized over a weighted-average period of 2.77 years. Restricted Stock Units A restricted stock unit (“RSU”) represents the right to receive one share of our common stock upon vesting of the RSU. The fair value of each RSU is based on the closing price of our common stock on the date of grant. We grant RSUs with service conditions that vest in two or four equal annual installments provided that the employee remains employed with us (“Time-Based RSUs”). During the nine months ended September 30, 2019, we granted Time-Based RSUs under the 2013 Stock Incentive Plan (the “2013 Plan”) that vest in four equal annual installments. The following is a summary of RSU activity for the 2013 Plan for the nine months ended September 30, 2019: Number of Shares Underlying RSUs Weighted- Average Grant Date Fair Value Unvested at December 31, 2018 25,000 $ 9.87 Granted 1,049,900 9.16 Forfeited (230,300 ) 9.24 Vested (10,000 ) 8.13 Unvested at September 30, 2019 834,600 $ 9.18 The total stock-based compensation expense related to RSUs for the nine months ended September 30, 2019 and 2018 was $1.2 million and $0.3 million, respectively. As of September 30, 2019, there was $6.4 million of unrecognized compensation costs related to unvested Time-Based RSUs, which are expected to be recognized over a weighted-average period of 3.34 years. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | 10. Leases Operating Leases We are party to an operating lease of 98,502 square feet of office and research space in Newton, Massachusetts with a term through September 30, 2025 (the “Newton, MA Lease”). Pursuant to the Newton, MA Lease, we have provided a security deposit in the form of a cash-collateralized letter of credit in the amount of $0.6 million. The amount is classified within restricted cash. Upon the adoption of ASU 2016-02, right-of-use right-of-use 2016-02 The Newton, MA Lease provides for increases in future minimum annual rental payments, as defined in the lease agreement. The Newton, MA Lease also includes real estate taxes and common area maintenance (“CAM”) charges in the annual rental payments. As these charges were included in minimum annual rental payments as part of our accounting for the Newton, MA Lease under ASC 840 through December 31, 2018, we have included such amounts in the calculation of the operating lease liability, consistent with ASC 842 and our accounting policy elections thereunder, as specified in Note 2, “Recent Accounting Pronouncements.” The operating lease cost for the Newton, MA Lease for the nine months ended September 30, 2019 was $2.1 million, of which approximately $0.7 million was charges for CAM. In addition, we are party to short-term leases having a term of twelve months or less at the commencement date. We recognize short-term lease expense on a straight-line basis and do not record a related right-of Lease Commitments As of September 30, 2019, future minimum lease payments under non-cancellable right-of-use Years end ing Future Minimum Payments 2019 $ 793 2020 3,200 2021 3,277 2022 3,447 2023 and thereafter 10,453 Total minimum lease payments $ 21,170 Less: present value adjustment (5,944 ) Present value of minimum lease payments $ 15,226 As of September 30, 2019, the remaining lease term on the Newton, MA Lease was 5.9 years. The lease has a renewal option for an additional five years, although there is no economic penalty for failure to exercise the option. However, because we did not elect the use of hindsight in estimating the lease term for leases subject to transition to the new standard, and the renewal option was not previously considered in our assessment of the lease term for the Newton, MA Lease before adoption of ASC 842, the renewal option was not considered as part of the lease term in calculating the operating lease right-of-use As a discount rate was not directly observable for our Newton, MA Lease, the discount rate used to calculate the net present value of future payments was our incremental borrowing rate calculated at transition based on the remaining lease term. Upon adoption and through September 30, 2019, the discount rate used to calculate the operating lease liability was 11.0%. The incremental borrowing rate is the rate of interest that the we would expect to pay to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. In determining the incremental borrowing rate, we considered (i) our estimated public credit rating, (ii) our observable debt yields, as well as other bonds in the market issued by other companies with similar credit ratings as us, and (iii) adjustments necessary for collateral, lease term, and inflation or foreign currency. |
Equity
Equity | 9 Months Ended |
Sep. 30, 2019 | |
Federal Home Loan Banks [Abstract] | |
Equity | 11. Equity Underwritten Offerings On May 7, 2018, we completed a follow-on S-3 333-222726) Open Market Sale Agreement On August 17, 2018, we entered into an Open Market Sale Agreement (the “Open Market Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”), pursuant to which we may issue and sell shares of our common stock having an aggregate offering price of up to $75.0 million (the “Open Market Shares”) from time to time through Jefferies (the “Open Market Offering”). Under the Open Market Sale Agreement, Jefferies may sell the Open Market Shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. We may sell the Open Market Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the Open Market Sale Agreement, but we have no obligation to sell any of the Open Market Shares in the Open Market Offering. We or Jefferies may suspend or terminate the offering of Open Market Shares upon notice to the other party and subject to other conditions. We have agreed to pay Jefferies commissions for its services in acting as agent in the sale of the Open Market Shares in the amount of up to 3.0% of gross proceeds from the sale of the Open Market Shares pursuant to the Open Market Sale Agreement. We have also agreed to provide Jefferies with customary indemnification and contribution rights. For the three and nine months ended September 30, 2019, we have sold an aggregate of 1,634,451 Open Market Shares under the Open Market Sale Agreement, for net proceeds of approximately $14.6 million. |
Long-Term Obligations
Long-Term Obligations | 9 Months Ended |
Sep. 30, 2019 | |
3% Convertible Senior Notes Due 2025 [Member] | |
Long-Term Obligations | 12. Long-Term Obligations 3.00% Convertible Senior Notes due 2025 On October 16, 2018, we completed an offering of $150.0 million aggregate principal amount of our 3.00% convertible senior notes due 2025 (the “Notes”). In addition, on October 26, 2018, we issued an additional $22.5 million aggregate principal amount of the Notes pursuant to the full exercise of the option to purchase additional Notes granted to the initial purchasers in the offering. The Notes were sold in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act. In accordance with accounting guidance for debt with conversion and other options, we separately accounted for the liability component (“Liability Component”) and the embedded conversion option (“Equity Component”) of the Notes by allocating the proceeds between the Liability Component and the Equity Component, due to our ability to settle the Notes in cash, shares of our common stock or a combination of cash and shares of our common stock, at our option. In connection with the issuance of the Notes, we incurred approximately $5.6 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs between the Liability Component and the Equity Component based on the allocation of the proceeds. Of the total debt issuance costs, $2.2 million was allocated to the Equity Component and recorded as a reduction to additional paid-in The Notes are our senior unsecured obligations and bear interest at a rate of 3.00% per year payable semiannually in arrears on April 15 and October 15 of each year, beginning on April 15, 2019. Upon conversion, the Notes will be convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election. October 15, 2025 Holders of the Notes may convert all or any portion of their Notes, in multiples of $1 principal amount, at their option at any time prior to the close of business on the business day immediately preceding June 15, 2025 (1) during any calendar quarter commencing after the calendar quarter ending on December 31, 2018 (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 (2) during the five business day period immediately after any five consecutive trading day period (the “Measurement Period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the Measurement Period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; (3) if we call the Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or (4) upon the occurrence of specified corporate events as described within the indenture governing the Notes. As of September 30, 2019, none of the above circumstances had occurred and as such, the Notes could not have been converted. We may not redeem the Notes prior to October 15, 2022. On or after October 15, 2022, we may redeem for cash all or part of the Notes at our option if the last reported sale price of our common stock equals or exceeds 130% of the conversion price then in effect for at least 20 days prior to the date on which we send any notice of redemption. The redemption price will be 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any. In addition, calling any convertible note for redemption will constitute a make-whole fundamental change with respect to that convertible note, in which case the conversion rate applicable to the conversion of that convertible note, if it is converted in connection with the redemption, will be increased in certain circumstances. The initial carrying amount of the Liability Component of $101.2 million was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible The outstanding balances of the Notes as of September 30, 2019 consisted of the following (in thousands): Liability component: Principal $ 172,500 Less: debt discount and issuance costs, net (64,538 ) Net carrying amount $ 107,962 Equity component: $ 65,641 We determined the expected life of the Notes was equal to its seven-year term. The effective interest rate on the Liability Component of the Notes was 11.85%. As of September 30, 2019, the “if-converted The following table sets forth total interest expense recognized related to the Notes during the nine months ended September 30, 2019 (in thousands): Nine Months Ended September 30, 2019 Contractual interest expense $ 3,882 Amortization of debt discount 5,045 Amortization of debt issuance costs 253 Total interest expense $ 9,180 Future minimum payments on the Notes as of September 30, 2019 were as follows (in thousands): Years ended December 31, Future Minimum Payments 2019 $ 2,588 2020 5,175 2021 5,175 2022 5,175 2023 and thereafter 188,025 Total minimum payments $ 206,138 Less: interest (33,638 ) Less: unamortized discount (64,538 ) Less: current portion — Convertible senior notes $ 107,962 Deferred Royalty Obligation In September 2019, we entered into a Revenue Interest Financing Agreement (the “Revenue Interest Agreement”) with HealthCare Royalty Partners III, L.P. and HealthCare Royalty Partners IV, L.P. (“HCR”) whereby HCR will receive payments from us at ti ered In exchange for the First Investment Amount, HCR will receive a tiered royalty in the mid-single and of our , including worldwi de du c s are If HCR has not received 65% of the Investment Amount by December 31, 2022 or 100% of the Investment Amount by December 31, 2024, we must make a cash payment sufficient to gross HCR up to such minimum amounts. As the repayment of the funded amount is contingent upon worldwide net product sales and upfront payments, milestones, and royalties, the repayment term may be shortened or extended depending on actual worldwide net product sales and upfront payments, milestones, and royalties. The repayment period commenced on October 1, 2019 and expires on the earlier of (i) the date in which HCR has received cash payments totaling an aggregate of 185% of the Investment Amount or (ii) the legal maturity date of October 1, 2031. If HCR has not received payments equal to 185% of the Investment Amount by the twelve-year anniversary of the initial closing date, we shall pay an amount equal to the Investment Amount plus a specific annual rate of return less payments previously received. We have evaluated the terms of the Revenue Interest Agreement and concluded that the features of the Investment Amount are similar to those of a debt instrument. Accordingly, we have accounted for the transaction as long-term debt. We have evaluated the terms of the debt and determined that the repayment of 185% of the Investment Amount, less any payments made to date, upon a change of control is an embedded derivative that requires bifurcation from the debt instrument and fair value recognition. We determined the fair value of the derivative using an option pricing Monte Carlo simulation model taking into account the probability of change of control occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 6. The aggregate fair value of the embedded derivative at issuance date is included in deferred royalty obligation. We will remeasure the embedded derivative to fair value each reporting period until the time the features lapse and/or termination of the Revenue Interest Agreement. The effective interest rate as of September 30, 2019 was 17.3%. In connection with the Revenue Interest Agreement, we incurred debt issuance costs totaling $1.4 million. Debt issuance costs have been netted against the debt as of September 30, 2019 and are being amortized over the estimated term of the debt using the effective interest method , adjusted on a prospective basis for changes in the underlying assumptions and inputs. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs requires that we make estimates that could impact the short and long-term classification of these costs, as well as the period over which these costs will be amortized. The carrying value of the deferred royalty obligation at September 30, 2019 was $72.3 million based on $75.0 million of proceeds, net of fair value of the bifurcated embedded derivative liability and debt issuance costs incurred. The carrying value of the deferred royalty obligation approximates fair value at September 30, 2019 and was measured using Level 3 inputs. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements of Karyopharm Therapeutics Inc., a Delaware corporation, have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, 10-01. 10-K In July 2019, the U.S. Food and Drug Administration (“FDA”) approved XPOVIO ® |
Basis of Consolidation | Basis of Consolidation The condensed consolidated financial statements at September 30, 2019 include the accounts of Karyopharm Therapeutics Inc. and our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The significant accounting policies used in preparation of these condensed consolidated financial statements on Form 10-Q 10-K r r 10-K |
Product Revenue Recognition | Product Revenue Recognition We adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“FASB”) ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In the third quarter of 2019, we began to ship XPOVIO in the United States to specialty pharmacies and specialty distributors, collectively referred to as our customers, under a limited number of distribution arrangements with such third parties. Our specialty pharmacy customers resell XPOVIO directly to patients while our specialty distributor customers resell XPOVIO to healthcare entities, who then resell to patients. In connection with negotiating and executing contracts with our customers, our policy is to expense incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that we would have recognized is one year or less. However, no such costs have been incurred to date. In addition to distribution agreements with our customers, we enter into certain arrangements with group purchasing organizations and/or other payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of our products. In the context of ASC 606, each unit of XPOVIO that is ordered by our customers represents a distinct performance obligation that is completed when control of the product is transferred to the customer. Accordingly, we recognize product revenue when the customer obtains control of our product, which occurs at a point in time, generally upon delivery pursuant to our agreements with our customers. If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are reported. These reserves, as detailed below, 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 customer) or a current liability (if the amount is payable to a party other than a customer). Certain of the amounts noted are known at the time of sale based on contractual terms and, therefore, are recorded pursuant to the most likely amount method under ASC 606. Other amounts are estimated and take into consideration a range of possible outcomes, which are probability-weighted and recorded in accordance with the expected value method in ASC 606 for relevant factors, such as 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 respective underlying contracts. The amount of variable consideration that 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 under the contracts with our customers will not occur in a future period. The following are the components of variable consideration related to product revenue: Cash discounts and distributor fees: Product returns: Based on the distribution model for XPOVIO, contractual inventory limits with our customers, the price of XPOVIO, and limited contractual return rights, we currently believe there will be minimal XPOVIO returns. However, we will update our estimated return liability each reporting period based on actual shipments of XPOVIO subject to contractual return rights, changes in expectations about the amount of estimated and/or actual returns, and other qualitative considerations. Chargebacks: Government rebates Other incentives: co-payment co-payments co-payment Product revenue reserves and allowances: |
Accounts Receivable | Accounts Receivable In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns, and chargebacks. Our contracts with customers have standard payment terms that generally require payment within 30 days for specialty pharmacy customers and 65 days for specialty distributor customers. We analyze accounts that are past due for collectability, and periodically evaluate the creditworthiness of our customers. As of September 30, 2019, we determined an allowance for doubtful accounts was not required based upon our review of contractual payment terms and individual customer circumstances. |
Inventory | Inventory Prior to regulatory approval, we expensed costs relating to the production of inventory as research and development expense in the period incurred. We capitalize the costs to manufacture our products incurred after regulatory approval when, based on our judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Such costs are generally recorded as costs of sales upon shipment. In connection therewith, we value our inventories at the lower of cost or estimated net realizable value. We determine the cost of our inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out Raw materials and work in process includes all inventory costs prior to packaging and labelling, including raw material, active product ingredient, and drug product. Finished goods include packaged and labelled products. Prior to FDA approval of XPOVIO, all costs related to the manufacturing of XPOVIO that could potentially be available to support the commercial launch of our products were charged to research and development expense in the period incurred, as there was no alternative future use. We analyze our inventory levels for recoverability each reporting period. In the period in which there is an impairment identified, we write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value, and inventory in excess of expected sales requirements as cost of sales. The determination of whether inventory costs will be realizable is based on our estimates. If actual market conditions are less favorable than projected by us, additional write-downs of inventory may be required, which would be recorded as cost of sales. |
Cost of Sales | Cost of Sales Cost of sales includes the cost of producing and distributing inventories that are related to product revenue during the respective period, including salary related and stock-based compensation expense for employees involved with production and distribution, freight, and indirect overhead costs, as well as third-party royalties payable on product revenue, net. In addition, shipping and handling costs for product shipments are recorded in cost of sales as incurred. Finally, cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. |
Deferred Royalty Obligation | Deferred Royalty Obligation We treat the liability related to net revenues, as discussed further in Note 12, as a deferred royalty obligation, amortized under the effective interest rate method over the estimated life of the revenue streams. We recognize interest expense thereon the |
Liquidity | Liquidity At September 30, 2019, we had $269.6 million in cash, cash equivalents and investments. We have had recurring losses and incurred a loss of $150.9 million for the nine months ended September 30, 2019. Net cash used in operations for the nine months ended September 30, 2019 was $151.3 million. We expect that our cash, cash equivalents and investments at September 30, 2019, together with the cash we expect to generate from product sales and under our alliances, will be sufficient to fund current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of these financial statements, during which time we plan to continue to commercialize XPOVIO in the United States, which commenced in July 2019. |
Recent Accounting Pronouncements | 2. Recent Accounting Pronouncements Recently Adopted Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) 2016-02”). 2016-02 Leases Leases right-of-use In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases 2018-10”) 2018-11, Leases (Topic 842) Targeted Improvements 2018-11”). 2018-10 2018-11 2016-02 2016-02, 2018-11 2016-02. ASU 2016-02, 2018-10, 2018-11 2018-11 Pursuant to the guidance under ASU 2016-02, right-of-use non-lease As summarized in the table below, the standard had a material impact on our condensed consolidated balance sheet as of September 30, 2019, specifically through recognition of right-of-use right-of-use right-of-use January 1, 2019 Prior to ASC 842 Adoption ASC 842 as Adjusted Consolidated balance sheet data (in thousands): Operating lease and right-of-use (1) $ — $ 11,711 $ 11,711 Deferred rent (2) $ 390 $ (390 ) $ — Deferred rent non-current (2) $ 3,922 $ (3,922 ) $ — Operating lease liabilities (3) $ — $ 1,175 $ 1,175 Non-current (3) $ — $ 14,848 $ 14,848 (1) Represents capitalization of operating lease right-of-use right-of-use (2) Represents reclassification of deferred rent and tenant incentives to operating lease right-of-use (3) Represents recognition of operating lease liabilities. We implemented internal controls to enable the preparation of financial information upon adoption. In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting 2018-07”). 2018-07 In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements 2018-09”). In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606 2018-18”). 2018-18 2018-18 2018-18 On August 17, 2018, the SEC issued an amendment to Rule 3-04 S-X, year-to-date 10-Q |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Changes and Error Corrections [Abstract] | |
Schedule of Adjustments in Balance Sheet due to Adoption of ASC 842 | January 1, 2019 Prior to ASC 842 Adoption ASC 842 as Adjusted Consolidated balance sheet data (in thousands): Operating lease and right-of-use (1) $ — $ 11,711 $ 11,711 Deferred rent (2) $ 390 $ (390 ) $ — Deferred rent non-current (2) $ 3,922 $ (3,922 ) $ — Operating lease liabilities (3) $ — $ 1,175 $ 1,175 Non-current (3) $ — $ 14,848 $ 14,848 (1) Represents capitalization of operating lease right-of-use right-of-use (2) Represents reclassification of deferred rent and tenant incentives to operating lease right-of-use (3) Represents recognition of operating lease liabilities. |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | The following table presents our inventory of XPOVIO at September 30, 2019 and December 31, 2018 (in thousands): September 30, December 31, Raw materials and work in process $ — $ — Finished goods 100 — Total inventory $ 100 $ — |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets That Have Been Measured at Fair Value | The following table presents information about our financial assets that have been measured at fair value at September 30, 2019 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 78,063 $ 78,063 $ — $ — Investments: Short-term: Corporate debt securities 49,708 — 49,708 — Commercial paper 36,440 — 36,440 — U.S. government and agency securities 13,377 13,377 Long-term: Corporate debt securities 2,022 2,022 Total financial assets $ 179,610 $ 78,063 $ 101,547 $ — The following table presents information about our financial assets that have been measured at fair value at December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 62,320 $ 62,320 $ — $ — Corporate debt securities 6,823 — 6,823 — Commercial paper 7,738 — 7,738 — Investments: Short-term: Corporate debt securities 143,079 — 143,079 — Commercial paper 43,978 — 43,978 — U.S. government and agency securities 19,124 — 19,124 — Certificate of deposit 3,997 — 3,997 — Long-term: Corporate debt securities (one to two year maturity) 2,001 — 2,001 — $ 289,060 $ 62,320 $ 226,740 $ — |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Investments, Classified as Available-for-Sale | The following table summarizes our investments in debt securities, classified as available-for-sale, Amortized Cost Gross Unrealized Gains Gross Unrealized Loss Fair Value Short-term: Corporate debt securities $ 49,692 $ 19 $ (3) $ 49,708 Commercial paper 36,431 12 (3) 36,440 U.S. government and agency securities 13,367 10 13,377 Long-term: Corporate debt securities 2,021 1 2,022 $ 101,511 $ 42 $ (6 ) $ 101,547 The following table summarizes our investments in debt securities, classified as available-for-sale Amortized Cost Gross Unrealized Gains Gross Unrealized Loss Fair Value Short-term: Corporate debt securities $ 143,254 $ 3 $ (178) $ 143,079 Commercial paper 44,001 — (23) 43,978 U.S. government and agency securities 19,131 10 (17) 19,124 Certificate of deposit 4,000 — (3) 3,997 Long-term: Corporate debt securities (one to two year maturity) 2,007 — (6) 2,001 $ 212,393 $ 13 $ (227 ) $ 212,179 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Were Excluded From The Calculation of Diluted Net Loss Per Share Due to Their Anti-Dilutive Effect | The following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three and Nine Months Ended September 30, 2019 2018 Outstanding stock options 10,210,890 8,962,643 Unvested restricted stock units 834,600 25,000 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity for Employees and Nonemployees | A summary of our stock option activity and related information follows: Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2018 8,917,084 $ 13.78 7.4 $ 8,197 Granted 2,996,650 8.08 Exercised (131,143 ) 5.55 Canceled (1,571,701 ) 13.77 Outstanding at September 30, 2019 10,210,890 12.22 7.0 $ 12,443 Exercisable at September 30, 2019 5,426,297 $ 14.64 5.5 $ 7,869 |
Summary of RSU Activity | During the nine months ended September 30, 2019, we granted Time-Based RSUs under the 2013 Stock Incentive Plan (the “2013 Plan”) that vest in four equal annual installments. The following is a summary of RSU activity for the 2013 Plan for the nine months ended September 30, 2019: Number of Shares Underlying RSUs Weighted- Average Grant Date Fair Value Unvested at December 31, 2018 25,000 $ 9.87 Granted 1,049,900 9.16 Forfeited (230,300 ) 9.24 Vested (10,000 ) 8.13 Unvested at September 30, 2019 834,600 $ 9.18 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Schedule of Minimum Future Rent Payments Under Lease Agreement | As of September 30, 2019, future minimum lease payments under non-cancellable right-of-use Years end ing Future Minimum Payments 2019 $ 793 2020 3,200 2021 3,277 2022 3,447 2023 and thereafter 10,453 Total minimum lease payments $ 21,170 Less: present value adjustment (5,944 ) Present value of minimum lease payments $ 15,226 |
Long-Term Obligations (Tables)
Long-Term Obligations (Tables) - 3% Convertible Senior Notes Due 2025 [Member] | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Outstanding Balances of Convertible Notes | The outstanding balances of the Notes as of September 30, 2019 consisted of the following (in thousands): Liability component: Principal $ 172,500 Less: debt discount and issuance costs, net (64,538 ) Net carrying amount $ 107,962 Equity component: $ 65,641 |
Schedule of Interest Expense Recognized Related to Convertible Notes | The following table sets forth total interest expense recognized related to the Notes during the nine months ended September 30, 2019 (in thousands): Nine Months Ended September 30, 2019 Contractual interest expense $ 3,882 Amortization of debt discount 5,045 Amortization of debt issuance costs 253 Total interest expense $ 9,180 |
Summary of Future Minimum Payments on Convertible Notes | Future minimum payments on the Notes as of September 30, 2019 were as follows (in thousands): Years ended December 31, Future Minimum Payments 2019 $ 2,588 2020 5,175 2021 5,175 2022 5,175 2023 and thereafter 188,025 Total minimum payments $ 206,138 Less: interest (33,638 ) Less: unamortized discount (64,538 ) Less: current portion — Convertible senior notes $ 107,962 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Regulatory Assets [Abstract] | ||||
Cash, cash equivalents and short and long-term investments | $ 269,600 | $ 269,600 | ||
Net loss | $ 41,367 | $ 48,083 | 150,943 | $ 120,197 |
Net cash used in operations | $ 151,333 | $ 110,945 |
Recent Accounting Pronounceme_3
Recent Accounting Pronouncements - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Jan. 01, 2019 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease, right-of-use asset | $ 10,904 | $ 11,711 | [1] |
Lease liability | 15,226 | $ 1,175 | [2] |
Accounting Standards Update 2016-02 [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease, right-of-use asset | 11,700 | ||
Lease liability | $ 16,000 | ||
[1] | Represents capitalization of operating lease right-of-use assets, offset by reclassification of deferred rent and tenant incentives to operating lease right-of-use assets. | ||
[2] | Represents recognition of operating lease liabilities. |
Recent Accounting Pronoucements
Recent Accounting Pronoucements - Schedule of Adjustments in Balance Sheet due to Adoption of ASC 842 (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | ||
Adjustments For Change In Accounting Principle [Line Items] | |||||
Operating lease and right-of-use assets | $ 10,904 | $ 11,711 | [1] | ||
Deferred rent | $ 390 | ||||
Deferred rent non-current | $ 3,922 | ||||
Operating lease liabilities | 15,226 | 1,175 | [2] | ||
Non-current operating lease liabilities | $ 13,643 | 14,848 | [2] | ||
Previously Reported [Member] | |||||
Adjustments For Change In Accounting Principle [Line Items] | |||||
Deferred rent | [3] | 390 | |||
Deferred rent non-current | [3] | 3,922 | |||
Restatement Adjustment [Member] | |||||
Adjustments For Change In Accounting Principle [Line Items] | |||||
Operating lease and right-of-use assets | [1] | 11,711 | |||
Deferred rent | [3] | (390) | |||
Deferred rent non-current | [3] | (3,922) | |||
Operating lease liabilities | [2] | 1,175 | |||
Non-current operating lease liabilities | [2] | $ 14,848 | |||
[1] | Represents capitalization of operating lease right-of-use assets, offset by reclassification of deferred rent and tenant incentives to operating lease right-of-use assets. | ||||
[2] | Represents recognition of operating lease liabilities. | ||||
[3] | Represents reclassification of deferred rent and tenant incentives to operating lease right-of-use assets. |
Product Revenue - Additional In
Product Revenue - Additional Information (Detail) $ in Millions | 3 Months Ended |
Sep. 30, 2019USD ($) | |
Revenue from Contract with Customer [Abstract] | |
Reduction Of Revenue | $ (2.1) |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory Current (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials and work in process | ||
Finished goods | 100 | |
Total inventory | $ 100 |
License and Asset Purchase Ag_2
License and Asset Purchase Agreements - Additional Information - Antengene License Agreement (Detail) - Antengene Therapeutics Limited [Member] - USD ($) $ in Millions | May 23, 2018 | Sep. 30, 2019 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Revenues | $ 9.4 | |
Deferred Revenue, current | 1.1 | |
Deferred Revenue, non-current | $ 1.2 | |
Government Research Grant Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
License agreement termination prior notice period | 180 days | |
License agreement termination description | License Agreement may be terminated earlier by (i) either party for breach of the Antengene License Agreement by the other party or in the event of the insolvency or bankruptcy of the other party, (ii) Antengene on a product-by-product basis for certain safety reasons or on a product-by-product, country-by-country basis for any reason with 180 days’ prior notice or (iii) us in the event Antengene challenges or assists with a challenge to certain of our patent rights. | |
Government Research Grant Agreement [Member] | Development Milestone [Member] | Maximum [Member] | Scenario, Plan [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | $ 105 | |
Government Research Grant Agreement [Member] | Sales Milestone Events [Member] | Maximum [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | 45 | |
Commercial milestone payments receivable | 45 | |
Government Research Grant Agreement [Member] | Development Goals [Member] | Maximum [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | 105 | |
Selinexor [Member] | Government Research Grant Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Performance obligations | $ 9.4 | |
Eltanexor [Member] | Government Research Grant Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Performance obligations | 1 | |
KPT-9274 [Member] | Government Research Grant Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Performance obligations | 1.1 | |
Verdinexor [Member] | Government Research Grant Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Performance obligations | 0.2 | |
Up-front Payment Arrangement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Upfront payments | $ 2.3 | |
Up-front Payment Arrangement [Member] | Government Research Grant Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Upfront payments | $ 11.7 |
License and Asset Purchase Ag_3
License and Asset Purchase Agreements - Additional Information - Biogen Asset Purchase Agreement (Detail) - USD ($) $ in Millions | Jan. 24, 2018 | Apr. 28, 2017 | Mar. 31, 2018 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Revenues | $ 5.8 | ||
Biogen MA Inc [Member] | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Revenues | $ 10 | ||
Biogen MA Inc [Member] | Asset Purchase Agreement [Member] | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Upfront payment received | $ 10 | ||
Commercial milestone payments receivable | 65 | ||
Performance obligations | 10 | ||
Biogen MA Inc [Member] | Asset Purchase Agreement [Member] | Scenario, Plan [Member] | Maximum [Member] | Sales Milestone [Member] | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Milestone payments receivable | $ 142 |
License and Asset Purchase Ag_4
License and Asset Purchase Agreements - Additional Information - Ono License Agreement (Detail) - Ono Pharmaceutical Co Ltd [Member] | Oct. 11, 2017JPY (¥) | Oct. 11, 2017USD ($) | Jun. 30, 2019USD ($) | Sep. 30, 2019JPY (¥) | Sep. 30, 2019USD ($) | Oct. 11, 2017USD ($) |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Revenues | $ 19,700,000 | |||||
Deferred Revenue, non-current | $ 2,200,000 | |||||
Government Research Grant Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
License agreement termination prior notice period | 180 days | |||||
License agreement termination description | the Ono License Agreement may be terminated earlier by (i) either party for breach of the Ono License Agreement by the other party or in the event of the insolvency or bankruptcy of the other party, (ii) Ono on a product-by-product basis for certain safety reasons or on a product-by-product, country-by-country basis for any reason with 180 days’ prior notice or (iii) us in the event Ono challenges or assists with a challenge to certain of our patent rights. | |||||
Commercial milestone payments receivable | ¥ 9,000,000,000 | 80,200,000 | ||||
Government Research Grant Agreement [Member] | Development Goals [Member] | Maximum [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestone payments receivable | ¥ 10,150,000,000 | $ 90,500,000 | ||||
Government Research Grant Agreement [Member] | Sales Milestone Events [Member] | Maximum [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestone payments receivable | 9,000,000,000 | $ 80,200,000 | ||||
Government Research Grant Agreement [Member] | Scenario, Plan [Member] | Clinical Development and Regulatory Milestone [Member] | Maximum [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestone payments receivable | ¥ 10,150,000,000 | 90,500,000 | ||||
Selinexor [Member] | Government Research Grant Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Performance obligations | 19,700,000 | |||||
Eltanexor [Member] | Government Research Grant Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Performance obligations | $ 2,200,000 | |||||
Up-front Payment Arrangement [Member] | Government Research Grant Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Upfront payments | ¥ 2,500,000,000 | $ 21,900,000 |
License and Asset Purchase Ag_5
License and Asset Purchase Agreements - Additional Information - Anivive License Agreement (Detail) - USD ($) | Apr. 28, 2017 | Sep. 30, 2019 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | $ 5,800,000 | |
Government Research Grant Agreement [Member] | Anivive Lifesciences, Inc. [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Performance obligations | $ 1,300,000 | |
Revenues | 1,300,000 | |
Government Research Grant Agreement [Member] | Anivive Lifesciences, Inc. [Member] | Maximum [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | 43,300,000 | |
Government Research Grant Agreement [Member] | Anivive Lifesciences, Inc. [Member] | Technology Transfer [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | 300,000 | 300,000 |
Government Research Grant Agreement [Member] | Anivive Lifesciences, Inc. [Member] | Clinical Development and Regulatory Milestone [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | 5,800,000 | |
Government Research Grant Agreement [Member] | Anivive Lifesciences, Inc. [Member] | Sales Milestone Events [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payments receivable | 37,500,000 | |
Up-front Payment Arrangement [Member] | Government Research Grant Agreement [Member] | Anivive Lifesciences, Inc. [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Upfront payments | $ 1,000,000 | $ 1,000,000 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Schedule of Financial Assets That Have Been Measured at Fair Value (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Financial assets | ||
Investments | $ 179,610 | $ 289,060 |
Corporate Debt Securities [Member] | ||
Financial assets | ||
Cash equivalents | 6,823 | |
Commercial Paper [Member] | ||
Financial assets | ||
Cash equivalents | 7,738 | |
Short-term [Member] | Corporate Debt Securities [Member] | ||
Financial assets | ||
Investments | 49,708 | 143,079 |
Short-term [Member] | Commercial Paper [Member] | ||
Financial assets | ||
Investments | 36,440 | 43,978 |
Short-term [Member] | US Government and Agency Securities [Member] | ||
Financial assets | ||
Investments | 13,377 | 19,124 |
Long-term [Member] | Corporate Debt Securities [Member] | ||
Financial assets | ||
Investments | 2,022 | 2,001 |
Money Market Funds [Member] | ||
Financial assets | ||
Cash equivalents | 78,063 | 62,320 |
Certificates of Deposit [Member] | Short-term [Member] | ||
Financial assets | ||
Investments | 3,997 | |
Level 1 [Member] | ||
Financial assets | ||
Investments | 78,063 | 62,320 |
Level 1 [Member] | Money Market Funds [Member] | ||
Financial assets | ||
Cash equivalents | 78,063 | 62,320 |
Level 2 [Member] | ||
Financial assets | ||
Investments | 101,547 | 226,740 |
Level 2 [Member] | Corporate Debt Securities [Member] | ||
Financial assets | ||
Cash equivalents | 6,823 | |
Level 2 [Member] | Commercial Paper [Member] | ||
Financial assets | ||
Cash equivalents | 7,738 | |
Level 2 [Member] | Short-term [Member] | Corporate Debt Securities [Member] | ||
Financial assets | ||
Investments | 49,708 | 143,079 |
Level 2 [Member] | Short-term [Member] | Commercial Paper [Member] | ||
Financial assets | ||
Investments | 36,440 | 43,978 |
Level 2 [Member] | Short-term [Member] | US Government and Agency Securities [Member] | ||
Financial assets | ||
Investments | 13,377 | 19,124 |
Level 2 [Member] | Long-term [Member] | Corporate Debt Securities [Member] | ||
Financial assets | ||
Investments | $ 2,022 | 2,001 |
Level 2 [Member] | Certificates of Deposit [Member] | Short-term [Member] | ||
Financial assets | ||
Investments | $ 3,997 |
Investments - Summary of Invest
Investments - Summary of Investments, Classified as Available-for-Sale (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 101,511 | $ 212,393 |
Gross Unrealized Gains | 42 | 13 |
Gross Unrealized Loss | (6) | (227) |
Fair Value | 101,547 | 212,179 |
Short-term [Member] | Certificates of Deposit [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 4,000 | |
Gross Unrealized Loss | (3) | |
Fair Value | 3,997 | |
Short-term [Member] | Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 49,692 | 143,254 |
Gross Unrealized Gains | 19 | 3 |
Gross Unrealized Loss | (3) | (178) |
Fair Value | 49,708 | 143,079 |
Short-term [Member] | Commercial Paper [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 36,431 | 44,001 |
Gross Unrealized Gains | 12 | |
Gross Unrealized Loss | (3) | (23) |
Fair Value | 36,440 | 43,978 |
Short-term [Member] | US Government and Agency Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 13,367 | 19,131 |
Gross Unrealized Gains | 10 | 10 |
Gross Unrealized Loss | (17) | |
Fair Value | 13,377 | 19,124 |
Long-term [Member] | Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 2,021 | 2,007 |
Gross Unrealized Gains | 1 | |
Gross Unrealized Loss | (6) | |
Fair Value | $ 2,022 | $ 2,001 |
Investments - Additional Inform
Investments - Additional Information (Detail) | Sep. 30, 2019USD ($)Securities | Dec. 31, 2018USD ($)Securities |
Debt Securities, Available-for-sale [Line Items] | ||
Number of debt securities with unrealized loss position for less than one year | Securities | 11 | 79 |
Aggregate fair value of debt securities with unrealized loss position for less than one year | $ 23,100,000 | $ 180,600,000 |
Unrealized losses, other-than-temporary impairments | $ 0 | $ 0 |
Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Number of corporate debt securities with continuous unrealized loss position for more than 12 months | Securities | 1 | |
Aggregate fair value of corporate debt securities with continuous unrealized loss position for more than 12 months | $ 1,000,000 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potentially Dilutive Securities Were Excluded From The Calculation of Diluted Net Loss Per Share Due to Their Anti-Dilutive Effect (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Outstanding Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Dilutive securities excluded from the calculation of diluted net loss per share due to anti-dilutive effect (in shares) | 10,210,890 | 8,962,643 | 10,210,890 | 8,962,643 |
Unvested Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Dilutive securities excluded from the calculation of diluted net loss per share due to anti-dilutive effect (in shares) | 834,600 | 25,000 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) | Oct. 16, 2018 | Sep. 30, 2019 |
Notes, maturity date | Oct. 15, 2025 | |
3% Convertible Senior Notes Due 2025 [Member] | ||
Notes, interest rate | 3.00% | 11.85% |
Notes, maturity date | Oct. 15, 2025 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Option Activity for Employees and Nonemployees (Detail) - Employee and Nonemployee Stock Option [Member] - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares, Outstanding, Beginning balance | 8,917,084 | |
Shares, Granted | 2,996,650 | |
Shares, Exercised | (131,143) | |
Shares, Forfeited | (1,571,701) | |
Shares, Outstanding, Ending balance | 10,210,890 | 8,917,084 |
Shares, Exercisable | 5,426,297 | |
Weighted-Average Exercise Price Per Share, Outstanding, Beginning balance | $ 13.78 | |
Weighted-Average Exercise Price Per Share, Granted | 8.08 | |
Weighted-Average Exercise Price Per Share, Exercised | 5.55 | |
Weighted-Average Exercise Price Per Share, Forfeited | 13.77 | |
Weighted-Average Exercise Price Per Share, Outstanding, Ending balance | 12.22 | $ 13.78 |
Weighted-Average Exercise Price Per Share, Exercisable | $ 14.64 | |
Weighted-Average Remaining Contractual Term (years), Outstanding | 7 years | 7 years 4 months 24 days |
Weighted-Average Remaining Contractual Term (years), Exercisable | 5 years 6 months | |
Aggregate Intrinsic Value, Outstanding | $ 12,443 | $ 8,197 |
Aggregate Intrinsic Value, Exercisable | $ 7,869 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Detail) $ in Millions | 9 Months Ended | |
Sep. 30, 2019USD ($)Installmentshares | Sep. 30, 2018USD ($) | |
Equity Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 9.8 | $ 12.8 |
Total unrecognized stock-based compensation expense | $ 28.7 | |
Period for recognition of unrecognized expense | 2 years 9 months 7 days | |
Unvested Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1.2 | 0.3 |
Period for recognition of unrecognized expense | 3 years 4 months 2 days | |
Total unrecognized stock-based compensation expense | $ 6.4 | |
Minimum [Member] | Unvested Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Service condition that vest in equal annual installment | Installment | 2 | |
Maximum [Member] | Unvested Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Service condition that vest in equal annual installment | Installment | 4 | |
2013 Plan [Member] | Unvested Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Service condition that vest in equal annual installment | Installment | 4 | |
ESPP [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 0.7 | $ 0.3 |
Total unrecognized stock-based compensation expense | $ 0.1 | |
Offering period | 6 months | |
Purchase price of common stock | 85.00% | |
Number of shares of common stock authorized | shares | 242,424 | |
Common stock shares available for issuance under ESPP | shares | 720,676 | |
Percentage of shares of common stock available for issuance | 1.00% | |
Employee stock purchase plan, description | In 2013, our stockholders approved the reservation of 242,424 shares of our common stock for issuance under the ESPP, plus an annual increase to be added on the first day of each fiscal year, commencing on January 1, 2015 and ending on December 31, 2023, equal to the lesser of 484,848 shares of our common stock, 1% of the number of outstanding shares on such date, or an amount determined by the board of directors. | |
ESPP [Member] | Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock shares available for issuance under ESPP | shares | 484,848 |
Stock-based Compensation - Su_2
Stock-based Compensation - Summary of RSU Activity (Detail) - Unvested Restricted Stock Units [Member] | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares Underlying RSUs, Unvested beginning balance | shares | 25,000 |
Number of Shares Underlying RSUs, Granted | shares | 1,049,900 |
Number of Shares Underlying RSUs, Forfeited | shares | (230,300) |
Number of Shares Underlying RSUs, Vested | shares | (10,000) |
Number of Shares Underlying RSUs, Unvested ending balance | shares | 834,600 |
Weighted-Average Grant Date Fair Value, Unvested beginning balance | $ / shares | $ 9.87 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 9.16 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 9.24 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 8.13 |
Weighted-Average Grant Date Fair Value, Unvested ending balance | $ / shares | $ 9.18 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2019USD ($)ft² | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | ||
Leases [Line Items] | ||||
Operating lease right-of-use asset | $ 10,904 | $ 11,711 | [1] | |
Operating lease liability | 15,226 | $ 1,175 | [2] | |
Deferred rent | $ 3,922 | |||
Operating lease cost | $ 2,100 | |||
Lease term | 5 years 10 months 24 days | |||
Operating lease discount rate | 11.00% | |||
Common Area Maintenance [Member] | ||||
Leases [Line Items] | ||||
Operating lease cost | $ 700 | |||
Accounting Standards Update 2016-02 [Member] | ||||
Leases [Line Items] | ||||
Operating lease right-of-use asset | 11,700 | |||
Operating lease liability | $ 16,000 | |||
Allowance for improvements | 1,700 | |||
Deferred rent | $ 2,600 | |||
Office and Research Space Lease [Member] | ||||
Leases [Line Items] | ||||
Office and laboratory space leased | ft² | 98,502 | |||
Security deposit in the form of a letter of credit | $ 600 | |||
[1] | Represents capitalization of operating lease right-of-use assets, offset by reclassification of deferred rent and tenant incentives to operating lease right-of-use assets. | |||
[2] | Represents recognition of operating lease liabilities. |
Leases - Schedule of Minimum Fu
Leases - Schedule of Minimum Future Rent Payments Under Lease Agreement (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Jan. 01, 2019 | [1] |
Commitments and Contingencies Disclosure [Abstract] | |||
2019 | $ 793 | ||
2020 | 3,200 | ||
2021 | 3,277 | ||
2022 | 3,447 | ||
2023 and thereafter | 10,453 | ||
Total minimum lease payments | 21,170 | ||
Less: present value adjustment | (5,944) | ||
Present value of minimum lease payments | $ 15,226 | $ 1,175 | |
[1] | Represents recognition of operating lease liabilities. |
Equity - Controlled Equity Offe
Equity - Controlled Equity Offering Sales Agreement - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Aug. 17, 2018 | May 07, 2018 | Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 |
Common Stock [Member] | |||||
Equity Offering [Line Items] | |||||
Number of shares of common stock sold in public offering | 10,525,424 | 1,634,451 | 1,634,451 | 10,525,424 | |
Public offering price of common shares | $ 14.75 | ||||
Net proceeds after deducting underwriting discounts, commissions and offering expenses | $ 145.7 | ||||
Open Market Sale Agreement [Member] | |||||
Equity Offering [Line Items] | |||||
Number of shares of common stock sold in public offering | 0 | 1,634,451 | 1,634,451 | ||
Net proceeds from sale of common stock | $ 14.6 | $ 14.6 | |||
Maximum [Member] | Jefferies LLC [Member] | Open Market Sale Agreement [Member] | |||||
Equity Offering [Line Items] | |||||
Aggregate offering price | $ 75 | ||||
Percentage of commission of gross proceeds from the sale of Shares | 3.00% |
Long-Term Obligations - Additio
Long-Term Obligations - Additional Information (Detail) | Oct. 15, 2022d | Oct. 16, 2018USD ($)$ / sharesshares | Sep. 30, 2019USD ($)d | Oct. 26, 2018USD ($) |
Subsequent Event [Line Items] | ||||
Notes, maturity date | Oct. 15, 2025 | |||
Debt instrument convertible threshold consecutive trading days | d | 5 | |||
Description of debt instrument convertible period | during the five business day period immediately after any five consecutive trading day | |||
Principal amount of notes used in conversion rate | $ 1,000 | |||
Debt instrument convertible threshold maximum percentage of product of last reported sale price of common stock | 98.00% | |||
Equity component of convertible notes recognized as debt discount | $ 67,900,000 | |||
Proceeds from issuance of convertible notes | 172,500,000 | |||
Fair value of liability of convertible notes | 104,700,000 | |||
Estimated fair value of convertible notes | $ 156,300,000 | |||
Expected life of convertible notes | 7 years | |||
Debt instrument, convertible, if-converted value in excess of principal | $ 0 | |||
Deferred Royalty Obligation [Member] | Level 3 [Member] | ||||
Subsequent Event [Line Items] | ||||
Deferred royalty obligation at fair value | 72,300,000 | |||
Revenue Interest Financing Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Debt issuance costs | 1,400,000 | |||
First investment amount | 75,000,000 | |||
Second investment amount | $ 75,000,000 | |||
Debt Instrument Interest Rate | 17.30% | |||
Revenue Interest Financing Agreement [Member] | HealthCare Royalty Partners IV LP [Member] | ||||
Subsequent Event [Line Items] | ||||
Aggregate Royalties Percentage | 185.00% | |||
Revenue Interest Financing Agreement [Member] | HealthCare Royalty Partners IV LP [Member] | Royalty Due On December 31, 2022 [Member] | ||||
Subsequent Event [Line Items] | ||||
Royalty Payable Percentage | 65.00% | |||
Revenue Interest Financing Agreement [Member] | HealthCare Royalty Partners IV LP [Member] | Royalty Due On December 31, 2024 [Member] | ||||
Subsequent Event [Line Items] | ||||
Royalty Payable Percentage | 100.00% | |||
Convertible Note Offering [Member] | ||||
Subsequent Event [Line Items] | ||||
Notes converted in to common stock, amount | shares | 63.0731 | |||
Notes converted in to common stock, shares | $ 1,000,000 | |||
Notes, conversion price per share | $ / shares | $ 15.85 | |||
3% Convertible Senior Notes Due 2025 [Member] | ||||
Subsequent Event [Line Items] | ||||
Aggregate principal amount | $ 150,000,000 | $ 22,500,000 | ||
Debt issuance costs | $ 5,600,000 | |||
Debt issuance costs allocated to equity component and recorded as a reduction to additional paid-in capital | 2,200,000 | |||
Debt issuance costs allocated to liability component and recorded as a reduction of convertible notes | $ 3,400,000 | |||
Debt discount and issuance costs amortized to interest expense, amortization period | 7 years | |||
Notes, interest rate | 3.00% | 11.85% | ||
Notes, maturity date | Oct. 15, 2025 | |||
Principal amount of notes used in conversion rate | $ 1 | |||
Debt instrument, convertible latest date | Jun. 15, 2025 | |||
Notes conversion price, percentage | 130.00% | |||
Notes instrument, trading days | d | 20 | |||
Debt instrument convertible threshold consecutive trading days | d | 30 | |||
Initial amount of liability component | $ 101,200,000 | |||
Equity component of convertible notes recognized as debt discount | $ 65,641,000 | |||
3% Convertible Senior Notes Due 2025 [Member] | Scenario, Forecast [Member] | ||||
Subsequent Event [Line Items] | ||||
Notes conversion price, percentage | 130.00% | |||
Notes instrument, trading days | d | 20 | |||
Debt instrument convertible threshold consecutive trading days | d | 30 | |||
Notes, repurchase price | 100.00% |
Long-Term Obligations - Summary
Long-Term Obligations - Summary of Outstanding Balances of Convertible Notes (Detail) $ in Thousands | Sep. 30, 2019USD ($) |
Liability component: | |
Equity component | $ 67,900 |
3% Convertible Senior Notes Due 2025 [Member] | |
Liability component: | |
Principal | 172,500 |
Less: debt discount and issuance costs, net | (64,538) |
Net carrying amount | 107,962 |
Equity component | $ 65,641 |
Long-Term Obligations - Schedul
Long-Term Obligations - Schedule of Interest Expense Recognized Related to Convertible Notes (Detail) - 3% Convertible Senior Notes Due 2025 [Member] $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Debt Instrument [Line Items] | |
Contractual interest expense | $ 3,882 |
Amortization of debt discount | 5,045 |
Amortization of debt issuance costs | 253 |
Total interest expense | $ 9,180 |
Long-Term Obligations - Summa_2
Long-Term Obligations - Summary of Future Minimum Payments on Convertible Notes (Detail) - 3% Convertible Senior Notes Due 2025 [Member] $ in Thousands | Sep. 30, 2019USD ($) |
Debt Instrument [Line Items] | |
2019 | $ 2,588 |
2020 | 5,175 |
2021 | 5,175 |
2022 | 5,175 |
2023 and thereafter | 188,025 |
Total minimum payments | 206,138 |
Less: interest | (33,638) |
Less: unamortized discount | (64,538) |
Less: current portion | 0 |
Convertible senior notes | $ 107,962 |