Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 05, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | HRTX | ||
Entity Registrant Name | HERON THERAPEUTICS, INC. /DE/ | ||
Entity Central Index Key | 0000818033 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Common Stock, Shares Outstanding | 91,396,509 | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity File Number | 001-33221 | ||
Entity Tax Identification Number | 94-2875566 | ||
Entity Address, Address Line One | 4242 CAMPUS POINT COURT | ||
Entity Address, Address Line Two | SUITE 200 | ||
Entity Address, City or Town | SAN DIEGO | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 858 | ||
Local Phone Number | 251-4400 | ||
Entity Interactive Data Current | Yes | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Entity Public Float | $ 1.3 | ||
Document Transition Report | false | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Security Exchange Name | NASDAQ | ||
Documents Incorporated by Reference | Portions of the registrant’s Definitive Proxy Statement related to its 2021 Annual Meeting of Stockholders’ to be held on or about June 17, 2021 are incorporated by reference into Part III of this Annual Report on Form 10-K. Such Definitive Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. Except as expressly incorporated by reference, the registrant’s Definitive Proxy Statement shall not be deemed to be part of this report. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 105,138 | $ 71,898 |
Short-term investments | 103,353 | 319,074 |
Accounts receivable, net | 41,850 | 39,879 |
Inventory | 41,905 | 24,968 |
Prepaid expenses and other current assets | 21,950 | 23,245 |
Total current assets | 314,196 | 479,064 |
Property and equipment, net | 22,737 | 19,618 |
Right-of-use lease assets | 16,277 | 13,754 |
Other assets | 346 | 346 |
Total assets | 353,556 | 512,782 |
Current liabilities: | ||
Accounts payable | 525 | 2,758 |
Accrued clinical and manufacturing liabilities | 49,962 | 34,614 |
Accrued payroll and employee liabilities | 13,597 | 15,248 |
Other accrued liabilities | 28,369 | 36,535 |
Current lease liabilities | 2,997 | 1,926 |
Convertible notes payable to related parties, net of discount | 7,053 | 5,624 |
Total current liabilities | 102,503 | 96,705 |
Non-current lease liabilities | 14,561 | 12,242 |
Total liabilities | 117,064 | 108,947 |
Commitments and contingencies (see Note 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value: 2,500 shares authorized; no shares issued or outstanding at December 31, 2020 and 2019 | ||
Common stock, $0.01 par value: 150,000 shares authorized; 91,310 and 90,304 shares issued and outstanding at December 31, 2020 and 2019, respectively | 913 | 903 |
Additional paid-in capital | 1,628,070 | 1,568,317 |
Accumulated other comprehensive income | 257 | 85 |
Accumulated deficit | (1,392,748) | (1,165,470) |
Total stockholders’ equity | 236,492 | 403,835 |
Total liabilities and stockholders’ equity | $ 353,556 | $ 512,782 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 2,500 | 2,500 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 150,000 | 150,000 |
Common stock, shares issued (in shares) | 91,310 | 90,304 |
Common stock, shares outstanding (in shares) | 91,310 | 90,304 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||
Net product sales | $ 88,638 | $ 145,968 | $ 77,474 |
Operating expenses: | |||
Cost of product sales | 36,189 | 61,619 | 27,512 |
Research and development | 174,533 | 167,382 | 140,032 |
General and administrative | 42,226 | 37,897 | 29,263 |
Sales and marketing | 63,853 | 89,764 | 64,604 |
Total operating expenses | 316,801 | 356,662 | 261,411 |
Loss from operations | (228,163) | (210,694) | (183,937) |
Other income, net: | |||
Interest income | 3,633 | 7,259 | 5,965 |
Interest expense | (1,901) | (1,472) | (2,672) |
Other income (expense) | (847) | 158 | 1,804 |
Total other income, net | 885 | 5,945 | 5,097 |
Net loss | (227,278) | (204,749) | (178,840) |
Other comprehensive income (loss): | |||
Unrealized gains (losses) on short-term investments | 172 | 172 | (77) |
Comprehensive loss | $ (227,106) | $ (204,577) | $ (178,917) |
Basic and diluted net loss per share | $ (2.50) | $ (2.50) | $ (2.44) |
Shares used in computing basic and diluted net loss per share | 90,774 | 81,779 | 73,193 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Cumulative Effect Period of Adoption Adjustment | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit | Accumulated DeficitCumulative Effect Period of Adoption Adjustment |
Balance at Dec. 31, 2017 | $ 131,136 | $ 1,574 | $ 646 | $ 913,955 | $ (10) | $ (783,455) | $ 1,574 |
Balance (in shares) at Dec. 31, 2017 | 64,609 | ||||||
Issuance of common stock in public offerings, net | 363,128 | $ 120 | 363,008 | ||||
Issuance of common stock in public offerings, net (in shares) | 11,963 | ||||||
Conversion benefit included in Convertible Notes issued | 392 | 392 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 1,179 | $ 1 | 1,178 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 72 | ||||||
Issuance of common stock on exercise of stock options | 18,301 | $ 15 | 18,286 | ||||
Issuance of common stock on exercise of stock options (in shares) | 1,530 | ||||||
Stock-based compensation expense | 33,367 | 33,367 | |||||
Net loss | (178,840) | (178,840) | |||||
Net unrealized gain (loss) on short-term investments | (77) | (77) | |||||
Comprehensive loss | (178,917) | ||||||
Balance at Dec. 31, 2018 | 370,160 | $ 782 | 1,330,186 | (87) | (960,721) | ||
Balance (in shares) at Dec. 31, 2018 | 78,174 | ||||||
Issuance of common stock in public offerings, net | 162,151 | $ 99 | 162,052 | ||||
Issuance of common stock in public offerings, net (in shares) | 9,857 | ||||||
Conversion benefit included in Convertible Notes issued | 416 | 416 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 2,109 | $ 1 | 2,108 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 126 | ||||||
Issuance of common stock on exercise of stock options | 22,164 | $ 20 | 22,144 | ||||
Issuance of common stock on exercise of stock options (in shares) | 1,983 | ||||||
Issuance of common stock on exercise of warrants | 1 | $ 1 | |||||
Issuance of common stock on exercise of warrants (in shares) | 132 | ||||||
Issuance of common stock on conversion of convertible notes (in shares) | 32 | ||||||
Stock-based compensation expense | 51,411 | 51,411 | |||||
Net loss | (204,749) | (204,749) | |||||
Net unrealized gain (loss) on short-term investments | 172 | 172 | |||||
Comprehensive loss | (204,577) | ||||||
Balance at Dec. 31, 2019 | 403,835 | $ 903 | 1,568,317 | 85 | (1,165,470) | ||
Balance (in shares) at Dec. 31, 2019 | 90,304 | ||||||
Conversion benefit included in Convertible Notes issued | 440 | 440 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 2,317 | $ 2 | 2,315 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 194 | ||||||
Issuance of common stock on exercise of stock options | 6,759 | $ 5 | 6,754 | ||||
Issuance of common stock on exercise of stock options (in shares) | 545 | ||||||
Issuance of common stock on exercise of warrants | 3 | $ 3 | |||||
Issuance of common stock on exercise of warrants (in shares) | 267 | ||||||
Issuance of common stock on conversion of Convertible Notes | 26 | 26 | |||||
Stock-based compensation expense | 50,218 | 50,218 | |||||
Net loss | (227,278) | (227,278) | |||||
Net unrealized gain (loss) on short-term investments | 172 | 172 | |||||
Comprehensive loss | (227,106) | ||||||
Balance at Dec. 31, 2020 | $ 236,492 | $ 913 | $ 1,628,070 | $ 257 | $ (1,392,748) | ||
Balance (in shares) at Dec. 31, 2020 | 91,310 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities: | |||
Net loss | $ (227,278,000) | $ (204,749,000) | $ (178,840,000) |
Adjustments to reconcile net loss to net cash used for operating activities: | |||
Stock-based compensation expense | 50,218,000 | 51,411,000 | 33,367,000 |
Depreciation and amortization | 2,847,000 | 2,044,000 | 1,513,000 |
Amortization of debt discount | 1,429,000 | 1,050,000 | 890,000 |
Amortization of premium (accretion of discount) on short-term investments | 125,000 | (3,730,000) | (3,412,000) |
Realized gain on available-for-sale investments | 0 | (8,000) | 0 |
Impairment of property and equipment | 847,000 | 107,000 | 72,000 |
Loss on disposal of property and equipment | 62,000 | 29,000 | |
Change in operating assets and liabilities: | |||
Accounts receivable | (1,971,000) | 24,773,000 | (22,778,000) |
Inventory | (16,937,000) | 14,064,000 | (29,122,000) |
Prepaid expenses and other assets | 1,295,000 | (12,052,000) | (7,482,000) |
Accounts payable | (2,233,000) | (14,105,000) | (1,906,000) |
Accrued clinical and manufacturing liabilities | 15,348,000 | 10,144,000 | (3,614,000) |
Accrued payroll and employee liabilities | (1,651,000) | 1,851,000 | 4,537,000 |
Other accrued liabilities | (6,859,000) | 4,558,000 | 14,941,000 |
Net cash used for operating activities | (184,820,000) | (124,580,000) | (191,805,000) |
Investing activities: | |||
Purchases of short-term investments | (134,007,000) | (477,035,000) | (497,104,000) |
Maturities and sales of short-term investments | 349,775,000 | 462,406,000 | 227,700,000 |
Purchases of property and equipment | (6,813,000) | (7,154,000) | (9,171,000) |
Proceeds from the sale of property and equipment | 25,000 | ||
Net cash provided by (used for) investing activities | 208,955,000 | (21,783,000) | (278,550,000) |
Financing activities: | |||
Net proceeds from sale of common stock and/or pre-funded warrants | 162,151,000 | 363,128,000 | |
Proceeds from purchases under the Employee Stock Purchase Plan | 2,317,000 | 2,109,000 | 1,179,000 |
Proceeds from stock option exercises | 6,759,000 | 22,164,000 | 18,301,000 |
Proceeds from conversion of convertible notes payable | 26,000 | ||
Proceeds from warrant exercises | 3,000 | 1,000 | |
Repayment of promissory note payable to related party | (25,000,000) | ||
Net cash provided by financing activities | 9,105,000 | 186,425,000 | 357,608,000 |
Net increase (decrease) in cash and cash equivalents | 33,240,000 | 40,062,000 | (112,747,000) |
Cash and cash equivalents at beginning of year | 71,898,000 | 31,836,000 | 144,583,000 |
Cash and cash equivalents at end of year | $ 105,138,000 | $ 71,898,000 | 31,836,000 |
Supplemental disclosure of cash flow information: | |||
Interest paid | 1,183,000 | ||
Cumulative effect of adoption of new accounting standard | $ 1,574,000 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Business | 1. Organization and Business Heron Therapeutics, Inc. (“Company,” “Heron” or “we”) is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. In August 2016, our first commercial product, SUSTOL ® 3 ® In November 2017, our second commercial product, CINVANTI ® In October 2019, the FDA approved our supplemental New Drug Application (“sNDA”) for CINVANTI to expand the indication and recommended dosage to include the 130 mg single-dose regimen for patients receiving (“MEC”). 1 approved our sNDA for CINVANTI, for IV use, which expanded the administration of CINVANTI beyond the initially approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection. HTX-019 is an investigational agent for the prevention of postoperative nausea and vomiting (“PONV”). HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND ® 1 In September 2020, our third approved product, ZYNRELEF ™ non-opioid, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. As we build large-scale manufacturing capacity to meet the anticipated commercial demand in the U.S. and the rest of the world, we are developing a coordinated global marketing strategy. HTX-011 (ZYNRELEF in Europe) is an investigational agent in the United States and Canada. The FDA granted Breakthrough Therapy designation to HTX-011 and the New Drug Application (“NDA”) received Priority Review designation. A Complete Response Letter (“CRL”) was received from the FDA regarding the NDA for HTX-011 in June 2020. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. At the Type A End-of-Review meeting in September 2020 (the “Type A Meeting”), the FDA agreed with the change to the manufacturing specification proposed by Heron to address the FDA’s concern and agreed with our proposal to bridge the clinical and nonclinical excipient exposure data to address the other 3 deficiencies. HTX-034, our next-generation product candidate for postoperative pain management, is (ZYNRELEF in the Europe) In May 2020, we initiated a Phase 1b/2 clinical study in patients undergoing bunionectomy of HTX-034. As of December 31, 2020, we had $208.5 million in cash, cash equivalents and short-term investments. We have incurred significant operating losses and negative cash flows from operations. Management believes that the Company’s existing cash, cash equivalents and short-term investments will be sufficient to meet the Company’s anticipated cash requirements for at least one year from the date this Annual Report on Form 10-K is filed with the U.S. Securities and Exchange Commission (“SEC”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of Heron Therapeutics, Inc. and its wholly-owned subsidiary, Heron Therapeutics B.V., which was organized in the Netherlands in March 2015. Heron Therapeutics B.V. has no operations and no material assets or liabilities , and there have been no significant transaction s related to Heron Therapeutics B.V. since its inception. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Our significant accounting policies that involve significant judgment and estimates include revenue recognition, investments, inventory and the related reserves, accrued clinical liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates. Cash, Cash Equivalents and Short-term Investments Cash and cash equivalents consist of cash and highly liquid investments with contractual maturities of three months or less from the original purchase date. Short-term investments consist of securities with contractual maturities of greater than three months from the original purchase date. Securities with contractual maturities greater than one year are classified as short-term investments on the consolidated balance sheets, as we have the ability, if necessary, to liquidate these securities to meet our liquidity needs in the next 12 months. We have classified our short-term investments as available-for-sale securities in the accompanying consolidated financial statements. Available-for-sale securities are stated at fair market value, with net changes in unrealized gains and losses reported in other comprehensive loss and realized gains and losses included in other income (expense), net. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. Our bank and investment accounts have been placed under control agreements in accordance with our Senior Secured Convertible Notes (“Convertible Notes”) (see Note 8). Fair Value of Financial Instruments A company may elect to use fair value to measure accounts and loans receivable, available-for-sale and held-to-maturity securities, equity method investments, accounts payable, guarantees and issued debt. Other eligible items include firm commitments for financial instruments that otherwise would not be recognized at inception and non-cash warranty obligations where a warrantor is permitted to pay a third party to provide the warranty goods or services. If the use of fair value is elected, any upfront costs and fees related to the item such as debt issuance costs must be recognized in earnings and cannot be deferred. The fair value election is irrevocable and generally made on an instrument-by-instrument basis, even if a company has similar instruments that it elects not to measure based on fair value. Unrealized gains and losses on existing items for which fair value has been elected are reported as a cumulative adjustment to beginning retained earnings and any changes in fair value are recognized in earnings. We have elected to not apply the fair value option to our financial assets and liabilities. Financial instruments, including cash and cash equivalents, receivables, inventory, prepaid expenses, other current assets, accounts payable and accrued expenses, are carried at cost, which is considered to be representative of their respective fair values because of the short-term maturity of these instruments. Short-term available-for-sale investments are carried at fair value (see Note 3) . Our Convertible Notes outstanding at December 31, 2020 do not have a readily available ascertainable market value, however, the carrying value is considered to approximate its fair value. Concentration of Credit Risk Cash, cash equivalents and short-term investments are financial instruments that potentially subject us to concentrations of credit risk. We deposit our cash in financial institutions. At times, such deposits may be in excess of insured limits. We may also invest our excess cash in money market funds, U.S. government and agencies, corporate debt securities and commercial paper. We have established guidelines relative to our diversification of our cash investments and their maturities in an effort to maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. CINVANTI and SUSTOL are distributed in the U.S. through a limited number of specialty distributors and full line wholesalers (collectively, “Customers”) that resell to healthcare providers and hospitals, the end users of CINVANTI and SUSTOL. The following table includes the percentage of net product sales and accounts receivable balances for our three major Customers, each of which comprised 10% or more of our net product sales: Net Product Sales Accounts Receivable Year Ended December 31, 2020 As of December 31, 2020 Customer A 44.0 % 61.3 % Customer B 33.5 % 29.8 % Customer C 20.8 % 8.5 % Total 98.3 % 99.6 % Accounts Receivable, Net Accounts receivable are recorded at the invoice amount, net of an allowance for doubtful accounts. The allowance for doubtful accounts reflects accounts receivable balances that are believed to be uncollectible. In estimating the allowance for doubtful accounts, we consider: (1) our historical experience with collections and write-offs; (2) the credit quality of our Customers and any recent or anticipated changes thereto; and (3) the outstanding balances and past due amounts from our Customers. We offered extended payment terms to our Customers in connection with our product launches of SUSTOL and CINVANTI in October 2016 and January 2018, respectively, in anticipation of the timing in reimbursement by government and commercial payers. Effective January 2018, we shortened payment terms to certain of our SUSTOL Customers. Effective January 2019, we shortened payment terms to our CINVANTI Customers. As of December 31, 2020, extended payment terms given to our Customers were evaluated in accordance with GAAP and did not impact the collectability of accounts receivables. As of December 31, 2020 and 2019, we determined that an allowance for doubtful accounts was not required. For the years ended December 31, 2020 and 2019, we did not write-off any accounts receivable balances. Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out, or FIFO, basis. We periodically analyze our inventory levels and write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory quantities that are in excess of expected sales requirements as cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as cost of product sales. Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets (generally 5 years). Leasehold improvements are stated at cost and amortized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. Impairment of Long-Lived Assets If indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the asset to the fair value of the asset and record the impairment as a reduction in the carrying value of the related asset with a corresponding charge to operating expenses. Estimating the undiscounted future operating cash flows associated with long-lived assets requires judgment and assumptions that could differ materially from actual results. Leases In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements Codification Improvements to Topic 842, Leases Leases We determine if an agreement is a lease or contains lease components at inception. Operating leases are recorded as lease liabilities with corresponding ROU lease assets on the consolidated balance sheets. ROU lease assets represent our right to use the underlying assets over the lease term, and lease liabilities represent the present value of our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement based on the present value of lease payments over the lease term. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. We use the implicit rate when readily determinable. The ROU lease assets equal the lease liabilities, less unamortized lease incentives, unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease. The lease term includes any option to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. We have lease agreements with both lease and non-lease components, which are generally accounted for separately. Revenue Recognition In May 2014, FASB issued ASU No. 2014-09, Revenue from Contracts with Customers Accrued Clinical Liabilities We accrue clinical costs based on work performed, which relies on estimates of the progress of the trials and the related expenses incurred. Clinical trial related contracts vary significantly in duration, and may be for a fixed amount, based on the achievement of certain contingent events or deliverables, a variable amount based on actual costs incurred, capped at a certain limit or contain a combination of these elements. Revisions are recorded to research and development expense in the period in which the facts that give rise to the revision become known. Historically, revisions have not resulted in material changes to research and development expense; however, a modification in the protocol of a clinical trial or cancellation of a clinical trial could result in a material charge to our results of operations. Research and Development Expense All costs of research and development are expensed in the period incurred. Research and development expense primarily consists of personnel and related costs, stock-based compensation expense, fees paid to outside service providers and consultants, facilities costs and materials used in clinical and preclinical trials and research and development. Patent Costs We incur outside legal fees in connection with filing and maintaining our various patent applications. All patent costs are expensed as incurred and are included in general and administrative expense in the consolidated statements of operations and comprehensive loss. Stock-Based Compensation Expense We estimate the fair value of stock-based payment awards using the Black-Scholes option pricing model. This fair value is then amortized using the straight-line single-option method of attributing the value of stock-based compensation to expense over the requisite service periods of the awards. The Black-Scholes option pricing model requires the input of complex and subjective assumptions, including each option’s expected life and price volatility of the underlying stock. As stock-based compensation expense is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based on historical data. Warrants We have issued warrants to purchase shares of our common stock in conjunction with certain equity financings or in exchange for services. The terms of the warrants were evaluated to determine the appropriate classification as equity or a liability. Income Taxes We recognize the impact of a tax position in our consolidated financial statements if the position is more likely than not to be sustained on examination and on the technical merits of the position. The total amount of unrecognized tax benefits, if recognized, would affect other tax accounts, primarily deferred taxes in future periods, and would not affect our effective tax rate, since we maintain a full valuation allowance against our deferred tax assets (see Note 10). We recognize interest and penalties related to income tax matters in income tax expense. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net changes in unrealized gains and losses on available-for-sale securities are included in other comprehensive income (loss) and represent the difference between our net loss and comprehensive net loss for all periods presented. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, warrants and shares of common stock underlying Convertible Notes are considered to be common stock equivalents and are included in the calculation of diluted net loss per share only when their effect is dilutive. Because we have incurred a net loss for all periods presented in the consolidated statements of operations and comprehensive loss, the following common stock equivalents were not included in the computation of net loss per share because their effect would be anti-dilutive (in thousands): December 31, 2020 2019 2018 Stock options outstanding 18,912 16,665 15,265 Restricted stock units outstanding 603 — — Warrants outstanding 220 508 640 Shares of common stock underlying Convertible Notes outstanding 9,510 8,960 8,473 Recent Accounting Pronouncements Adopted in 2020 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for-sale debt securities. In May 2019, the FASB issued ASU No. 2019-05, Financial Instruments - Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”), which amends ASU 2016-13 by providing entities with an option to irrevocably elect the fair value option to be applied on an instrument-by-instrument basis for eligible financial instruments that are within the scope of Topic 326. The fair value option election does not apply to held-to-maturity debt securities. On January 1, 2020 , we adopted the provisions of ASU 2016-13, which did not have a material impact on our results of operations, financial condition or internal controls . Not Yet Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The FASB ASC Topic 820, Fair Value Measurements & Disclosures , establishes a fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: • Level 1—Observable inputs such as quoted prices in active markets for identical assets or liabilities. • Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. We measure cash, cash equivalents and short-term investments at fair value on a recurring basis. The fair values of these such assets were as follows (in thousands): Fair Value Measurements at Reporting Date Using Balance at December 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash and money market funds $ 49,149 $ 49,149 $ — $ — U.S. treasury bills and government agency obligations 20,276 — 20,276 — U.S. corporate debt securities 11,547 — 11,547 — Foreign corporate debt securities 15,557 — 15,557 — U.S. commercial paper 27,996 — 27,996 — Foreign commercial paper 83,966 — 83,966 — Total $ 208,491 $ 49,149 $ 159,342 $ — Fair Value Measurements at Reporting Date Using Balance at December 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash and money market funds $ 56,931 $ 56,931 $ — $ — U.S. treasury bills and government agency obligations 140,626 140,626 — — U.S. corporate debt securities 80,170 — 80,170 — Foreign corporate debt securities 23,203 — 23,203 — U.S. commercial paper 32,801 — 32,801 — Foreign commercial paper 57,241 — 57,241 — Total $ 390,972 $ 197,557 $ 193,415 $ — We have not transferred any investment securities between the three levels of the fair value hierarchy. As of December 31, 2020, cash equivalents included $55.9 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $103.4 million of available-for-sale securities with contractual maturities of three months to one year. As of December 31, 2019, cash equivalents included $15.0 million of available-for-sale securities with contractual maturities of three months or less. As of December 31, 2019, short-term investments included $279.7 million of available-for-sale securities with contractual maturities of three months to one year and $39.4 million of available-for-sale securities with contractual maturities greater than one year. The money market funds as of December 31, 2020 and 2019 are included in cash and cash equivalents on the consolidated balance sheets. |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Details | 4. Balance Sheet Details Short-Term Investments The following is a summary of our short-term investments (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value U.S. treasury bills and government agency obligations $ 20,110 $ 166 $ — $ 20,276 U.S. corporate debt 11,505 42 — 11,547 Foreign corporate debt 15,508 49 — 15,557 U.S. commercial paper 13,997 — — 13,997 Foreign commercial paper 41,976 — — 41,976 Total $ 103,096 $ 257 $ — $ 103,353 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value U.S. treasury bills and government agency obligations $ 140,567 $ 59 $ — $ 140,626 U.S. corporate debt securities 80,159 11 — 80,170 Foreign corporate debt securities 23,188 15 — 23,203 U.S. commercial paper 32,801 — — 32,801 Foreign commercial paper 42,274 — — 42,274 Total $ 318,989 $ 85 $ — $ 319,074 The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. We regularly monitor and evaluate the realizable value of our marketable securities. We did not recognize any impairment losses for the years ended December 31, 2020 and 2019. Unrealized gains and losses associated with our investments are reported in accumulated other comprehensive loss. For both years ended December 31, 2020 and 2019, we recorded $172,000 in net unrealized gains associated with our short-term investments. For the year ended December 31, 2018, we recorded $77,000 in net unrealized losses associated with our short-term investments. Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We recognized $8,000 in realized gains during the year ended December 31, 2019. We did not recognize any realized gains or losses during the years ended December 31, 2020 and 2018. Inventory Inventory consists of the following (in thousands): December 31, 2020 2019 Raw materials $ 18,994 $ 6,635 Work in process 6,847 12,571 Finished goods 16,064 5,762 Total inventory $ 41,905 $ 24,968 As of December 31, 2020, total inventory included $37.8 million related to CINVANTI and $4.1 million related to SUSTOL. As of December 31, 2019, total inventory included $23.5 million related to CINVANTI and $1.5 million related to SUSTOL. In addition, cost of product sales for the years ended December 31, 2020 and 2019 included charges of $0.1 million and $3.3 million, respectively, resulting from the write-off of short-dated SUSTOL inventory. Property and Equipment Property and equipment, net consists of the following (in thousands): December 31, 2020 2019 Scientific equipment $ 29,135 $ 24,603 Leasehold improvements 878 206 Computer equipment and software 1,461 1,314 Furniture, fixtures and office equipment 2,135 1,520 Property and equipment, gross 33,609 27,643 Less: accumulated depreciation and amortization (10,872 ) (8,025 ) Property and equipment, net $ 22,737 $ 19,618 Depreciation and amortization expense for the years ended December 31, 2020, 2019 and 2018 was $2.8 million, $2.0 million and $1.5 million, respectively. As of December 31, 2020 and 2019, $14.1 million and $13.5 million of property and equipment, respectively, was in process and not depreciated during the respective years. Accrued Payroll and Employee Liabilities and Other Accrued Liabilities Accrued payroll and employee liabilities consist of the following (in thousands): December 31, 2020 2019 Accrued employee salaries and benefits $ 1,691 $ 3,047 Accrued bonuses 8,479 9,545 Accrued vacation 3,427 2,656 Total accrued payroll and employee liabilities $ 13,597 $ 15,248 Other accrued liabilities consist of the following (in thousands): December 31, 2020 2019 Accrued product sales allowances $ 24,571 $ 27,939 Accrued consulting and professional fees 3,450 7,742 Accrued accounts payable 104 310 Other accrued liabilities 244 544 Total other accrued liabilities $ 28,369 $ 36,535 |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue Recognition | 5 . Revenue Recognition Product Sales CINVANTI and SUSTOL are distributed in the U.S. through a limited number of Customers that resell to healthcare providers and hospitals, the end users of CINVANTI and SUSTOL. Adoption of Topic 606 On January 1, 2018, we adopted Topic 606 using the modified retrospective approach applied to those contracts that were not completed as of January 1, 2018. With the adoption of Topic 606, we recognize product sales as revenue when our products are sold to our Customers (sell-in approach). Product sales under Topic 606 are reported net of product sales allowances, which include product returns. Revenue is recognized in an amount that reflects the consideration we expect to receive in exchange for our products. To determine revenue recognition for contracts with customers within the scope of Topic 606, we performed the following 5 steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations of the contract(s); (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract(s); and (v) recognize revenue when (or as) we satisfy the performance obligations. Product Sales Allowances We recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with Customers, historical product returns, rebates or discounts taken, the shelf life of the product and specific known market events, such as competitive pricing and new product introductions. If actual future results vary from our estimates, we may need to adjust these estimates, which could have an effect on product sales and earnings in the period of adjustment. Our product sales allowances include: • Product Returns—We allow our Customers to return product for credit for up to 12 months after its product expiration date. As such, there may be a significant period of time between the time the product is shipped and the time the credit is issued on returned product. • Distributor Fees—We offer contractually determined discounts to our Customers. These discounts are paid no later than two months after the quarter in which product was shipped. • Group Purchasing Organization (“GPO”) Discounts and Rebates—We offer cash discounts to GPO members. These discounts are taken when the GPO members purchase product from our Customers, who then charge back to us the discount amount. Additionally, we offer volume and contract-tier rebates to GPO members. Rebates are based on actual purchase levels during the quarterly rebate purchase period. • GPO Administrative Fees—We pay administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPOs’ members. • Medicaid Rebates—We participate in Medicaid rebate programs, which provide assistance to certain low-income patients based on each individual state’s guidelines regarding eligibility and services. Under the Medicaid rebate programs, we pay a rebate to each participating state, generally within three months after the quarter in which product was sold. We believe our estimated allowance for product returns requires a high degree of judgment and is subject to change based on our experience and certain quantitative and qualitative factors. We believe our estimated allowances for distributor fees, GPO discounts, rebates and administrative fees and Medicaid rebates do not require a high degree of judgment because the amounts are settled within a relatively short period of time. Our product sales allowances and related accruals are evaluated each reporting period and adjusted when trends or significant events indicate that a change in estimate is appropriate. Changes in product sales allowance estimates could materially affect our results of operations and financial position. Net product sales for the year ended December 31, 2020 were $88.6 million, compared to $146.0 million for the same period in 2019. For the year ended December 31, 2020, net products sales of CINVANTI were $87.8 million, compared to $132.2 million for the same period in 2019. For the year ended December 31, 2020, net product sales of SUSTOL were $0.8 million, compared to $13.8 million for the same period in 2019. The following table provides a summary of activity with respect to our product returns, distributor fees and discounts, rebates and administrative fees, which are included in other accrued liabilities on the consolidated balance sheets (in thousands): Discounts, Rebates and Product Distributor Administrative Returns Fees Fees Total Balance at December 31, 2019 $ 2,351 $ 3,999 $ 21,589 $ 27,939 Provision 498 15,964 102,603 119,065 Payments/credits (145 ) (16,033 ) (106,255 ) (122,433 ) Balance at December 31, 2020 $ 2,704 $ 3,930 $ 17,937 $ 24,571 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6 . Commitments and Contingencies Leases As of December 31, 2020, we had an operating lease for 73,328 square feet of laboratory and office space in San Diego, California, with a lease term that expires on December 31, 2025 . We have one 5-year option to renew this lease on expiration. During the year ended December 31, 2020, we paid $3.6 million for our operating lease. We leased 26,067 square feet of laboratory, office and warehouse space in Redwood City, California. The lease for the Redwood City space expired in May 2019. In March 2018, we entered into a sublease agreement for the Redwood City property. The sublease agreement expired in May 2019. We also leased 1,898 square feet of office space in Jersey City, New Jersey. The lease for the Jersey City office space expired in December 2019. Annual future minimum lease payments as of December 31, 2020 are as follows (in thousands): Year ended December 31: 2021 $ 3,942 2022 4,058 2023 4,178 2024 4,274 2025 4,379 Thereafter — Total future minimum lease payments 20,831 Less: discount (3,273 ) Total lease liabilities $ 17,558 Rent expense under all operating leases totaled $3.9 million, $3.1 million and $3.2 million for the years ended December 31, 2020, 2019 and 2018, respectively. Development Agreements We enter into agreements with clinical sites and clinical research organizations for the conduct of our clinical trials and contract manufacturing organizations for the manufacture and supply of preclinical, clinical and commercial materials and drug product. We make payments to these clinical sites and clinical research organizations based in part on the number of eligible patients enrolled and the length of their participation in the clinical trials. In some of our agreements with contract manufacturing organizations, we are required to meet minimum purchase obligations. Under certain of these agreements, we may be subject to penalties in the event that we prematurely terminate these agreements. At this time, due to the variability associated with clinical site agreements, contract research organization agreements and contract manufacturing agreements, we are unable to estimate with certainty the future costs we will incur. We intend to use our current financial resources to fund our obligations under these commitments. |
Reorganization
Reorganization | 12 Months Ended |
Dec. 31, 2020 | |
Reorganizations [Abstract] | |
Reorganization | 7 . Reorganization In October 2020, we implemented changes to our organizational structure. In connection with the reorganization, we provided or will provide employees one-time severance payments upon termination, continued benefits for a specified period of time, outplacement services and certain stock option modifications. The total expense for these activities was $5.6 million, $2.5 million of which is primarily for severance and $3.1 million of which is for non-cash, stock-based compensation expense. For the year ended December 31, 2020, total expenses were $5.6 million, with $1.2 million in research and development expense, $3.7 million in general and administrative expense and $0.7 million in sales and marketing expense. As of December 31, 2020, we had paid $2.4 million of the total cash severance charges. We have accounted for these expenses in accordance with the FASB ASC Topic 420, Exit or Disposal Cost Obligations |
Secured Notes to Related Party
Secured Notes to Related Party | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Secured Notes to Related Party | 8 . Secured Notes to Related Party Convertible Notes In April 2011, we entered into a securities purchase agreement for a private placement of up to $4.5 million in Convertible Notes with certain investors, including Tang Capital Partners, LP (“TCP”). TCP is controlled by Tang Capital Management, LLC (“TCM”). The manager of TCM is Kevin Tang, who served as a director at the time. At the time of issuance, the terms of the Convertible Notes were determined by our independent directors to be no less favorable than terms that would be obtained in an arm’s length financing transaction. We received a total of $4.3 million, net of issuance costs, from the issuance of these Convertible Notes. The Convertible Notes are secured by substantially all of our assets, including placing our bank and investment accounts under a control agreement. The Convertible Notes bear interest at 6% per annum, payable quarterly in cash or in additional principal amount of Convertible Notes, at the election of the purchasers. The Convertible Notes mature on May 2, 2021; however, the holders of the Convertible Notes may require prepayment of the Convertible Notes at any time, at each holder’s option. The Convertible Notes are convertible into shares of our common stock at a rate of 1,250 shares for every $1,000 of outstanding principal due under the Convertible Notes. There is no right to convert the Convertible Notes to the extent that, after giving effect to such conversion, the holder would beneficially own in excess of 9.99% of our outstanding common stock. Each holder of the Convertible Notes can increase or decrease this beneficial ownership conversion limit by written notice to us, which will not be effective until 61 days after delivery of the notice. As of December 31, 2020, we were in compliance with all covenants under the Convertible Notes. On the occurrence of an event of default under the Convertible Notes, the holders of the Convertible Notes have the right to require us to redeem all or a portion of their Convertible Notes. In 2011, we filed a registration statement with the SEC to register for resale 3.5 million shares underlying the Convertible Notes. The registration statement was declared effective on July 29, 2011. The Convertible Note holders have agreed to waive their right to require us to maintain the effectiveness of the registration statement and to register the additional shares underlying the Convertible Notes until they provide notice otherwise. The Convertible Notes contain an embedded conversion feature that was in-the-money on the issuance dates. Based on an effective fixed conversion rate of 1,250 shares for every $1,000 of principal and accrued interest due under the Convertible Notes, the total conversion benefit at issuance exceeded the loan proceeds. Therefore, a debt discount was recorded in an amount equal to the face value of the Convertible Notes on the issuance dates, and we began amortizing the resultant debt discount over the respective 10-year term of the Convertible Notes. During the year ended December 31, 2020, accrued interest of $0.4 million was paid-in-kind and rolled into the Convertible Note principal balance, which resulted in an additional debt discount of $0.4 million. For the years ended December 31, 2020, 2019 and 2018, interest expense relating to the stated rate was $0.4 million for each of the three periods. Interest expense relating to the amortization of the debt discount was $1.4 million, $1.1 million and $0.9 million, respectively. As of December 31, 2020, the carrying value of the Convertible Notes was $7.1 million, which is comprised of the $7.6 million principal amount of the Convertible Notes outstanding, less a debt discount of $0.5 million. As of December 31, 2020, the Convertible Notes were convertible into 9.5 million shares of our common stock. Promissory Note In August 2016, we entered into the Subordinated Secured Promissory Note (“Promissory Note”) with TCP whereby TCP agreed to lend us up to $100.0 million. The Promissory Note had a two-year For the year ended December 31, 2018, interest expense was $1.2 million. In August 2018, we paid the remaining obligation under the Promissory Note, which included $25.0 million of outstanding principal and $0.2 million of accrued interest. As of December 31, 2018, there were no remaining obligations under the Promissory Note. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders’ Equity | 9 . Stockholders’ Equity 2018 Common Stock Offerings In April 2018, we sold 6.9 million shares of our common stock at a public offering price of $26.00 per share. We received total net cash proceeds of $168.7 million (net of $10.7 million in issuance costs) from the sale of the common stock. In June 2018, we sold 5.1 million shares of our common stock at a public offering price of $39.50 per share. We received total net cash proceeds of $194.4 million (net of $5.6 million in issuance costs) from the sale of the common stock. 2019 Common Stock Offerings In October 2019, we sold 9.9 million shares of our common stock at a public offering price of $17.50 per share. We received total net cash proceeds of $162.2 million (net of $10.3 million in issuance costs) from the sale of the common stock. Public Offering Warrants In June 2014, as a component of our public offering, we sold 600,000 pre-funded warrants to purchase shares of our common stock. The pre-funded warrants have an exercise price of $0.01 per share and expire on June 30, 2021. During the year ended December 31, 2017, warrant holders exercised 4,426 warrants under the cashless exercise provision in each such holder’s warrant, which resulted in the net issuance of 4,423 shares of common stock and no net cash proceeds to us. During the year ended December 31, 2019, warrant holders exercised 132,130 warrants, which resulted in the issuance of 132,130 shares for net cash proceeds of $1,321. During the year ended December 31, 2020, warrant holders exercised 267,870 warrants, which resulted in the issuance of 267,870 shares for net cash proceeds of $2,679. As of December 31, 2020, 195,574 warrants from the June 2014 public offering remain outstanding. Common Stock Reserved for Future Issuance Shares of our common stock reserved for future issuance as of December 31, 2020 were as follows: Number of Shares Stock options outstanding 18,912,529 Restricted stock units outstanding 602,741 Stock options available for grant 1,575,955 Employee Stock Purchase Plan 176,250 Warrants outstanding 220,164 Shares of common stock underlying Convertible Notes outstanding (see Note 8) 9,510,208 Total shares reserved for future issuance 30,997,847 Employee Stock Purchase Plan In 1997, our stockholders approved our Employee Stock Purchase Plan (“ESPP”) at which time a maximum of 10,000 shares of common stock were available for issuance. In December 2007, May 2009, June 2011, May 2014, May 2015, June 2016, June 2017 and June 2019, our stockholders authorized increases in the number of shares reserved for issuance under the ESPP by 5,000, 10,000, 25,000, 25,000, 100,000, 100,000, 200,000 and 300,000 shares, respectively, for a total of 775,000 shares reserved at December 31, 2020. Under the terms of the ESPP, employees can elect to have up to a maximum of 10% of their base earnings withheld to purchase shares of our common stock. The purchase price of the stock is 85% of the lower of the closing prices for our common stock on either: (i) the first trading day in the enrollment period, as defined in the ESPP, in which the purchase is made, or (ii) the purchase date. The length of the enrollment period is 6 months. Enrollment dates are the first business day of May and November. Under the ESPP, we issued 193,841, 125,727, and 71,499 shares in 2020, 2019 and 2018, respectively. The weighted-average exercise price per share of the purchase rights exercised during 2020, 2019 and 2018 was $11.95, $16.77 and $16.48, respectively. As of December 31, 2020, 598,750 shares of common stock have been issued under the ESPP and 176,250 shares of common stock are available for future issuance. Stock Option Plans We currently have one stock option plan from which we can grant options and restricted stock awards to employees, officers, directors and consultants. In December 2007, the stockholders approved our 2007 Amended and Restated Equity Incentive Plan (“2007 Plan”) at which time a maximum of 150,000 shares of common stock were available for grant. In May 2010, June 2011, May 2014, May 2015, June 2016, June 2017 and June 2019, our stockholders approved amendments to our 2007 Plan to increase the maximum number of shares of common stock available for grant by 100,000, 4,500,000, 1,750,000, 4,300,000, 3,000,000, 5,000,000 and 7,000,000 shares of common stock, respectively, resulting in an aggregate of 25,800,000 shares of common stock authorized for issuance as of December 31, 2020. At December 31, 2020, there were 1,575,955 shares available for future grant under the 2007 Plan. Any shares that are issuable on exercise of options granted that expire, are cancelled or that we receive pursuant to a net exercise of options are available for future grant and issuance. In 2014, 2013 and 2012, we granted options to certain employees outside of our stockholder approved stock option plans. All options to purchase our common stock were granted with an exercise price that equals fair market value of the underlying common stock on the grant dates and expire no later than 10 years from the date of grant. The options are exercisable in accordance with vesting schedules that generally provide for them to be fully vested and exercisable 4 years after the date of grant, provided, however, that we have also issued stock options awards that are subject to performance vesting requirements. All stock option grants issued outside of our stockholder approved plans have been registered on Form S-8 with the SEC. In 2020, we began granting restricted stock units (“RSUs”) to employees and non-employee directors pursuant to the 2007 Plan. We satisfy such grants through the issuance of new shares upon vesting. The following table summarizes the stock option plan activity (including RSUs): Outstanding Options Weighted- Average Number of Exercise Shares Price Balance at December 31, 2017 13,462,964 $ 15.03 Granted 4,052,011 $ 26.83 Exercised (1,529,509 ) $ 11.97 Cancelled (720,859 ) $ 17.98 Balance at December 31, 2018 15,264,607 $ 18.33 Granted 4,933,480 $ 24.21 Exercised (1,983,221 ) $ 11.18 Cancelled (1,550,226 ) $ 23.26 Balance at December 31, 2019 16,664,640 $ 20.47 Granted 4,659,942 $ 13.95 Exercised (544,441 ) $ 12.41 Cancelled (1,264,871 ) $ 22.84 Balance at December 31, 2020 19,515,270 $ 18.98 For the year ended December 31, 2020, equity awards cancelled (included in the above table) consisted of 922,578 options and RSUs forfeited with a weighted-average exercise price of $22.76 and 342,293 options expired with a weighted-average exercise price of $23.04. As of December 31, 2020, options exercisable have a weighted-average remaining contractual term of 5.7 years. The total intrinsic value of stock option exercises, which is the difference between the exercise price and closing price of our common stock on the date of exercise, during the years ended December 31, 2020 and 2019 was $3.2 million and $25.0 million, respectively. As of December 31, 2020 and 2019, the total intrinsic value of options outstanding and exercisable was $69.1 million and $56.3 million, respectively. Years Ended December 31, 2020 2019 2018 Weighted- Weighted- Weighted- Average Average Average Exercise Exercise Exercise Options Price Options Price Options Price Exercisable at end of year 10,237,202 $ 18.74 7,436,379 $ 17.02 6,523,093 $ 14.83 Options vested or expected to vest 18,179,553 $ 19.58 15,962,432 $ 20.31 14,449,017 $ 18.11 Exercise prices and weighted-average remaining contractual lives for the options outstanding as of December 31, 2020 were: Weighted- Weighted- Average Average Weighted- Exercise Remaining Average Price of Options Range of Contractual Exercise Options Options Outstanding Exercise Prices Life (in years) Price Exercisable Exercisable 2,700,473 $5.20–$13.00 3.97 $ 10.14 2,691,327 $ 10.14 800,371 $13.05–$15.55 6.13 14.31 655,173 14.22 3,582,407 $15.72 9.75 15.72 149,197 15.72 2,838,033 $15.78–$17.89 6.10 16.87 2,348,090 16.84 3,688,255 $18.00–$24.97 7.15 22.97 2,036,430 23.10 3,498,912 $25.02 8.63 25.02 1,010,859 25.02 1,804,078 $25.06–$39.00 6.64 30.58 1,346,126 30.43 18,912,529 7.21 19.59 10,237,202 18.74 On December 31, 2020, we had reserved 19,515,270 shares of common stock for future issuance on exercise of outstanding options and vesting of outstanding restricted stock units granted under the 2007 Plan, as well as the non-plan grants. Valuation and Expense Information The following table summarizes stock-based compensation expense related to stock-based payment awards pursuant to our equity compensation arrangements (in thousands): December 31, 2020 2019 2018 Research and development $ 20,731 $ 19,202 $ 13,689 General and administrative 15,601 13,564 9,630 Sales and marketing 13,886 18,645 10,048 Total stock-based compensation expense $ 50,218 $ 51,411 $ 33,367 As of December 31, 2020, there was $116.1 million of total unrecognized compensation cost related to non-vested, stock-based payment awards granted under all of our equity compensation plans and all non-plan option grants. Total unrecognized compensation cost will be adjusted for future changes in estimated forfeitures. We expect to recognize this compensation cost over a weighted-average period of 2.8 years. The fair value of RSUs is estimated based on the closing market price of our common stock on the date of the grant. RSUs generally vest quarterly over a four-year We estimated the fair value of each option grant and ESPP purchase right on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: Options: December 31, 2020 2019 2018 Risk-free interest rate 0.5 % 1.8 % 2.8 % Dividend yield — % — % — % Volatility 69.4 % 66.5 % 70.4 % Expected life (years) 6 6 6 ESPP: December 31, 2020 2019 2018 Risk-free interest rate 0.1 % 1.9 % 2.4 % Dividend yield — % — % — % Volatility 67.7 % 52.1 % 59.7 % Expected life (months) 6 6 6 The weighted-average fair value of options granted was $9.76, $14.70 and $17.24 for the years ended December 31, 2020, 2019 and 2018, respectively. The weighted-average fair value of shares purchased through the ESPP was $5.18, $5.94 and $9.95 for the years ended December 31, 2020, 2019 and 2018, respectively. The risk-free interest rate assumption is based on observed interest rates on U.S. Treasury debt securities with maturities close to the expected term of our employee and director stock options and ESPP purchases. The dividend yield assumption is based on our history and expectation of dividend payouts. We have never paid dividends on our common stock, and we do not anticipate paying dividends in the foreseeable future. We used our historical stock price to estimate volatility. The expected life of employee and director stock options represents the average of the contractual term of the options and the weighted-average vesting period, as permitted under the simplified method. We have elected to use the simplified method, as we do not have enough historical exercise experience to provide a reasonable basis on which to estimate the expected term. The expected life for the ESPP purchase rights is 6 months, which represents the length of each purchase period. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10 . Income Taxes For the years ended December 31, 2020, 2019 and 2018, we did not record a provision for income taxes due to a full valuation allowance against our deferred tax assets. The difference between the provision for income taxes and income taxes computed using the effective U.S. federal statutory rate is as follows (in thousands): December 31, 2020 2019 2018 Tax at statutory federal rate $ (47,728 ) $ (42,997 ) $ (37,557 ) State tax, net of federal benefit (8,218 ) (9,823 ) (6,527 ) Research and development credits (4,327 ) (4,855 ) (4,775 ) Stock-based compensation expense 4,675 2,906 (2,059 ) Non-deductible compensation 1,455 4,720 901 Change in valuation allowance 53,621 49,479 50,834 Other 522 570 (817 ) Provision for income taxes $ — $ — $ — Deferred income tax assets and liabilities arising from differences between accounting for financial statement purposes and tax purposes, less valuation allowance at year-end are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforward $ 251,971 $ 210,301 Research and development credits 49,683 42,490 Stock-based compensation 20,211 15,628 Lease liabilities 4,330 3,487 Other 3,777 3,818 Total gross deferred tax assets 329,972 275,724 Deferred tax liabilities: Right-of-use lease assets (4,014 ) (3,385 ) Total gross deferred tax liabilities (4,014 ) (3,385 ) Valuation allowance (325,958 ) (272,339 ) Net deferred tax assets $ — $ — We have established a valuation allowance to offset net deferred tax assets as of December 31, 2020 and 2019 due to the uncertainty of realizing future tax benefits from such assets. As of December 31, 2020, we had federal, California and other state net operating loss (“NOL”) carryforwards of $1.0 billion, $111.9 million and $515.5 million, respectively. The federal NOL carryforwards consist of $549.7 million generated before January 1, 2018, which will begin to expire in 2021, and $492.0 million that can be carried forward indefinitely, but are subject to the 80% taxable income limitation. The state NOL carryforwards will begin to expire in 2028. As of December 31, 2020, we had federal and state research and development credit carryforwards of $39.4 million and $18.1 million, respectively. The federal research and development credit carryforwards will begin to expire in 2022. The state research and development credit carryforwards will begin to expire in 2023. Internal Revenue Code (“IRC”) Sections 382 and 383 place a limitation on the amount of taxable income that can be offset by NOL and credit carryforwards after a change in control (generally greater than 50% change in ownership within a three-year period) of a loss corporation. Generally, after a change in control, a loss corporation cannot deduct NOL and credit carryforwards in excess of the IRC Sections 382 and 383 limitation. State jurisdictions have similar rules. We have previously performed an analysis of IRC Sections 382 and 383 through 2018 and determined there were ownership changes in 2007, 2011 and 2013. We are currently in the process of updating our IRC Sections 382 and 383 analysis through 2020. The limitation in the federal and state NOL and research and development credit carryforwards that expire unused would reduce the deferred tax assets, which are fully offset by a valuation allowance. We file U.S. and state income tax returns with varying statutes of limitations. The tax years from 2002 to 2020 remain open to examination due to the carryover of unused NOL carryforwards and tax credits. A reconciliation of our unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Balance at beginning of year $ 4,784 $ 2,385 $ 120 Additions for tax positions of prior years 341 147 — Additions based on tax positions related to current year 2,281 2,252 2,265 Balance at end of year $ 7,406 $ 4,784 $ 2,385 Due to our valuation allowance, the $7.4 million of unrecognized tax benefits would not affect the effective tax rate, if recognized. It is the Company’s practice to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2020, we had no accrued interest and penalties related to uncertain tax positions. We do not expect any material changes to the estimated amount of liability associated with our uncertain tax positions within the next 12 months. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was enacted and signed into law in response to the COVID-19 pandemic. GAAP requires recognition of the tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act includes changes to the tax provisions that benefits business entities and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act. The tax relief measures for businesses include a five-year On June 29, 2020, California Assembly Bill 85 was signed into law. The legislation suspends the California net operating loss deductions for 2020, 2021, and 2022 for certain taxpayers and imposes a limitation of certain California tax credits for 2020, 2021, and 2022. The legislation disallows the use of California net operating loss deductions if the taxpayer recognizes business income and its adjusted gross income is greater than $1,000,000. The carryover periods for net operating loss deductions disallowed by this provision will be extended. Additionally, any business credit will only offset a maximum of $5,000,000 of California tax. Given our loss position in the current year, the new legislation did not impact the current year provision or our financial statements for the year ended December 31, 2020. We will continue to monitor possible California net operating loss and credit limitations in future periods. On December 27, 2020, the “Consolidated Appropriations Act, 2021” was enacted and signed into law to further COVID-19 economic relief and extend certain expiring tax provisions. The relief package includes a tax provision clarifying that businesses with forgiven PPP loans can deduct regular business expenses that are paid for with the loan proceeds. Additional pandemic relief tax measures include an expansion of the employee retention credit, enhanced charitable contribution deductions, and a temporary full deduction for business expenses for food and beverages provided by a restaurant. The provisions did not have a material impact on our financial statements for the year ended December 31, 2020. |
Other Income (Expense), Net
Other Income (Expense), Net | 12 Months Ended |
Dec. 31, 2020 | |
Other Income And Expenses [Abstract] | |
Other Income (Expense), Net | 1 1 . Other Income (Expense), Net In 2018, we recorded $1.9 million in income to other income (expense), net resulting from the disgorgement of short-swing profits arising from the sales of our common stock by a beneficial owner pursuant to Section 16(b) of the Securities and Exchange Act of 1934. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2020 | |
Compensation And Retirement Disclosure [Abstract] | |
Employee Benefit Plan | 1 2 . Employee Benefit Plan We have a defined contribution 401(k) plan (“Plan”) covering substantially all of our employees. In the past three calendar years, we made matching cash contributions equal to 50% of each participant’s contribution during the Plan year up to a maximum amount equal to the lesser of 3% of each participant’s annual compensation or $8,550, $8,400 and $8,250 for the years ended December 31, 2020, 2019 and 2018, respectively. Such amounts were recorded as expense in the corresponding years. We may also contribute additional discretionary amounts to the Plan as we determine. For the years ended December 31, 2020, 2019 and 2018, we contributed $1.1 million, $1.0 million and $0.7 million, respectively, to the Plan. No discretionary contributions have been made to the Plan since its inception. |
Summary of Quarterly Consolidat
Summary of Quarterly Consolidated Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Quarterly Consolidated Financial Data (Unaudited) | 1 3 . Summary of Quarterly Consolidated Financial Data (Unaudited) The following is a summary of the unaudited quarterly results of operations for the years ended December 31, 2020 and 2019: 2020 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 25,400 $ 22,668 $ 19,965 $ 20,605 Cost of product sales (10,622 ) (9,005 ) (7,170 ) (9,392 ) Gross Profit 14,778 13,663 12,795 11,213 Operating expenses: Research and development 36,894 44,004 49,182 44,453 General and administrative 10,422 9,819 9,482 12,503 Sales and marketing 20,196 15,589 12,515 15,553 Loss from operations (52,734 ) (55,749 ) (58,384 ) (61,296 ) Other income (expense), net 1,155 559 156 (985 ) Net loss $ (51,579 ) $ (55,190 ) $ (58,228 ) $ (62,281 ) Basic and diluted net loss per share $ (0.57 ) $ (0.61 ) $ (0.64 ) $ (0.68 ) 2019 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 31,602 $ 36,659 $ 42,624 $ 35,083 Cost of product sales (14,962 ) (13,588 ) (17,195 ) (15,874 ) Gross Profit 16,640 23,071 25,429 19,209 Operating expenses: Research and development 42,972 41,425 34,708 48,277 General and administrative 9,648 9,778 8,597 9,874 Sales and marketing 28,720 23,647 16,977 20,420 Loss from operations (64,700 ) (51,779 ) (34,853 ) (59,362 ) Other income, net 1,688 1,557 1,258 1,442 Net loss $ (63,012 ) $ (50,222 ) $ (33,595 ) $ (57,920 ) Basic and diluted net loss per share $ (0.80 ) $ (0.63 ) $ (0.42 ) $ (0.65 ) |
Summary of Significant Account
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of Heron Therapeutics, Inc. and its wholly-owned subsidiary, Heron Therapeutics B.V., which was organized in the Netherlands in March 2015. Heron Therapeutics B.V. has no operations and no material assets or liabilities , and there have been no significant transaction s related to Heron Therapeutics B.V. since its inception. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Our significant accounting policies that involve significant judgment and estimates include revenue recognition, investments, inventory and the related reserves, accrued clinical liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates. |
Cash, Cash Equivalents and Short-term Investments | Cash, Cash Equivalents and Short-term Investments Cash and cash equivalents consist of cash and highly liquid investments with contractual maturities of three months or less from the original purchase date. Short-term investments consist of securities with contractual maturities of greater than three months from the original purchase date. Securities with contractual maturities greater than one year are classified as short-term investments on the consolidated balance sheets, as we have the ability, if necessary, to liquidate these securities to meet our liquidity needs in the next 12 months. We have classified our short-term investments as available-for-sale securities in the accompanying consolidated financial statements. Available-for-sale securities are stated at fair market value, with net changes in unrealized gains and losses reported in other comprehensive loss and realized gains and losses included in other income (expense), net. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. Our bank and investment accounts have been placed under control agreements in accordance with our Senior Secured Convertible Notes (“Convertible Notes”) (see Note 8). |
Fair Value of Financial Instruments | Fair Value of Financial Instruments A company may elect to use fair value to measure accounts and loans receivable, available-for-sale and held-to-maturity securities, equity method investments, accounts payable, guarantees and issued debt. Other eligible items include firm commitments for financial instruments that otherwise would not be recognized at inception and non-cash warranty obligations where a warrantor is permitted to pay a third party to provide the warranty goods or services. If the use of fair value is elected, any upfront costs and fees related to the item such as debt issuance costs must be recognized in earnings and cannot be deferred. The fair value election is irrevocable and generally made on an instrument-by-instrument basis, even if a company has similar instruments that it elects not to measure based on fair value. Unrealized gains and losses on existing items for which fair value has been elected are reported as a cumulative adjustment to beginning retained earnings and any changes in fair value are recognized in earnings. We have elected to not apply the fair value option to our financial assets and liabilities. Financial instruments, including cash and cash equivalents, receivables, inventory, prepaid expenses, other current assets, accounts payable and accrued expenses, are carried at cost, which is considered to be representative of their respective fair values because of the short-term maturity of these instruments. Short-term available-for-sale investments are carried at fair value (see Note 3) . Our Convertible Notes outstanding at December 31, 2020 do not have a readily available ascertainable market value, however, the carrying value is considered to approximate its fair value. |
Concentration of Credit Risk | Concentration of Credit Risk Cash, cash equivalents and short-term investments are financial instruments that potentially subject us to concentrations of credit risk. We deposit our cash in financial institutions. At times, such deposits may be in excess of insured limits. We may also invest our excess cash in money market funds, U.S. government and agencies, corporate debt securities and commercial paper. We have established guidelines relative to our diversification of our cash investments and their maturities in an effort to maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. CINVANTI and SUSTOL are distributed in the U.S. through a limited number of specialty distributors and full line wholesalers (collectively, “Customers”) that resell to healthcare providers and hospitals, the end users of CINVANTI and SUSTOL. The following table includes the percentage of net product sales and accounts receivable balances for our three major Customers, each of which comprised 10% or more of our net product sales: Net Product Sales Accounts Receivable Year Ended December 31, 2020 As of December 31, 2020 Customer A 44.0 % 61.3 % Customer B 33.5 % 29.8 % Customer C 20.8 % 8.5 % Total 98.3 % 99.6 % |
Accounts Receivable, Net | Accounts Receivable, Net Accounts receivable are recorded at the invoice amount, net of an allowance for doubtful accounts. The allowance for doubtful accounts reflects accounts receivable balances that are believed to be uncollectible. In estimating the allowance for doubtful accounts, we consider: (1) our historical experience with collections and write-offs; (2) the credit quality of our Customers and any recent or anticipated changes thereto; and (3) the outstanding balances and past due amounts from our Customers. We offered extended payment terms to our Customers in connection with our product launches of SUSTOL and CINVANTI in October 2016 and January 2018, respectively, in anticipation of the timing in reimbursement by government and commercial payers. Effective January 2018, we shortened payment terms to certain of our SUSTOL Customers. Effective January 2019, we shortened payment terms to our CINVANTI Customers. As of December 31, 2020, extended payment terms given to our Customers were evaluated in accordance with GAAP and did not impact the collectability of accounts receivables. As of December 31, 2020 and 2019, we determined that an allowance for doubtful accounts was not required. For the years ended December 31, 2020 and 2019, we did not write-off any accounts receivable balances. |
Inventory | Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out, or FIFO, basis. We periodically analyze our inventory levels and write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory quantities that are in excess of expected sales requirements as cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as cost of product sales. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets (generally 5 years). Leasehold improvements are stated at cost and amortized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets If indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the asset to the fair value of the asset and record the impairment as a reduction in the carrying value of the related asset with a corresponding charge to operating expenses. Estimating the undiscounted future operating cash flows associated with long-lived assets requires judgment and assumptions that could differ materially from actual results. |
Leases | Leases In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements Codification Improvements to Topic 842, Leases Leases We determine if an agreement is a lease or contains lease components at inception. Operating leases are recorded as lease liabilities with corresponding ROU lease assets on the consolidated balance sheets. ROU lease assets represent our right to use the underlying assets over the lease term, and lease liabilities represent the present value of our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement based on the present value of lease payments over the lease term. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. We use the implicit rate when readily determinable. The ROU lease assets equal the lease liabilities, less unamortized lease incentives, unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease. The lease term includes any option to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. We have lease agreements with both lease and non-lease components, which are generally accounted for separately. |
Revenue Recognition | Revenue Recognition In May 2014, FASB issued ASU No. 2014-09, Revenue from Contracts with Customers |
Accrued Clinical Liabilities | Accrued Clinical Liabilities We accrue clinical costs based on work performed, which relies on estimates of the progress of the trials and the related expenses incurred. Clinical trial related contracts vary significantly in duration, and may be for a fixed amount, based on the achievement of certain contingent events or deliverables, a variable amount based on actual costs incurred, capped at a certain limit or contain a combination of these elements. Revisions are recorded to research and development expense in the period in which the facts that give rise to the revision become known. Historically, revisions have not resulted in material changes to research and development expense; however, a modification in the protocol of a clinical trial or cancellation of a clinical trial could result in a material charge to our results of operations. |
Research and Development Expense | Research and Development Expense All costs of research and development are expensed in the period incurred. Research and development expense primarily consists of personnel and related costs, stock-based compensation expense, fees paid to outside service providers and consultants, facilities costs and materials used in clinical and preclinical trials and research and development. |
Patent Costs | Patent Costs We incur outside legal fees in connection with filing and maintaining our various patent applications. All patent costs are expensed as incurred and are included in general and administrative expense in the consolidated statements of operations and comprehensive loss. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense We estimate the fair value of stock-based payment awards using the Black-Scholes option pricing model. This fair value is then amortized using the straight-line single-option method of attributing the value of stock-based compensation to expense over the requisite service periods of the awards. The Black-Scholes option pricing model requires the input of complex and subjective assumptions, including each option’s expected life and price volatility of the underlying stock. As stock-based compensation expense is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based on historical data. |
Warrants | Warrants We have issued warrants to purchase shares of our common stock in conjunction with certain equity financings or in exchange for services. The terms of the warrants were evaluated to determine the appropriate classification as equity or a liability. |
Income Taxes | Income Taxes We recognize the impact of a tax position in our consolidated financial statements if the position is more likely than not to be sustained on examination and on the technical merits of the position. The total amount of unrecognized tax benefits, if recognized, would affect other tax accounts, primarily deferred taxes in future periods, and would not affect our effective tax rate, since we maintain a full valuation allowance against our deferred tax assets (see Note 10). We recognize interest and penalties related to income tax matters in income tax expense. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net changes in unrealized gains and losses on available-for-sale securities are included in other comprehensive income (loss) and represent the difference between our net loss and comprehensive net loss for all periods presented. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, warrants and shares of common stock underlying Convertible Notes are considered to be common stock equivalents and are included in the calculation of diluted net loss per share only when their effect is dilutive. Because we have incurred a net loss for all periods presented in the consolidated statements of operations and comprehensive loss, the following common stock equivalents were not included in the computation of net loss per share because their effect would be anti-dilutive (in thousands): December 31, 2020 2019 2018 Stock options outstanding 18,912 16,665 15,265 Restricted stock units outstanding 603 — — Warrants outstanding 220 508 640 Shares of common stock underlying Convertible Notes outstanding 9,510 8,960 8,473 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Adopted in 2020 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for-sale debt securities. In May 2019, the FASB issued ASU No. 2019-05, Financial Instruments - Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”), which amends ASU 2016-13 by providing entities with an option to irrevocably elect the fair value option to be applied on an instrument-by-instrument basis for eligible financial instruments that are within the scope of Topic 326. The fair value option election does not apply to held-to-maturity debt securities. On January 1, 2020 , we adopted the provisions of ASU 2016-13, which did not have a material impact on our results of operations, financial condition or internal controls . Not Yet Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) |
Summary of Significant Accou_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Percentage of Net Product Sales and Accounts Receivable Balance | The following table includes the percentage of net product sales and accounts receivable balances for our three major Customers, each of which comprised 10% or more of our net product sales: Net Product Sales Accounts Receivable Year Ended December 31, 2020 As of December 31, 2020 Customer A 44.0 % 61.3 % Customer B 33.5 % 29.8 % Customer C 20.8 % 8.5 % Total 98.3 % 99.6 % |
Common Stock Equivalents Excluded From Computation of Net Loss Per Share | Because we have incurred a net loss for all periods presented in the consolidated statements of operations and comprehensive loss, the following common stock equivalents were not included in the computation of net loss per share because their effect would be anti-dilutive (in thousands): December 31, 2020 2019 2018 Stock options outstanding 18,912 16,665 15,265 Restricted stock units outstanding 603 — — Warrants outstanding 220 508 640 Shares of common stock underlying Convertible Notes outstanding 9,510 8,960 8,473 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | We measure cash, cash equivalents and short-term investments at fair value on a recurring basis. The fair values of these such assets were as follows (in thousands): Fair Value Measurements at Reporting Date Using Balance at December 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash and money market funds $ 49,149 $ 49,149 $ — $ — U.S. treasury bills and government agency obligations 20,276 — 20,276 — U.S. corporate debt securities 11,547 — 11,547 — Foreign corporate debt securities 15,557 — 15,557 — U.S. commercial paper 27,996 — 27,996 — Foreign commercial paper 83,966 — 83,966 — Total $ 208,491 $ 49,149 $ 159,342 $ — Fair Value Measurements at Reporting Date Using Balance at December 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash and money market funds $ 56,931 $ 56,931 $ — $ — U.S. treasury bills and government agency obligations 140,626 140,626 — — U.S. corporate debt securities 80,170 — 80,170 — Foreign corporate debt securities 23,203 — 23,203 — U.S. commercial paper 32,801 — 32,801 — Foreign commercial paper 57,241 — 57,241 — Total $ 390,972 $ 197,557 $ 193,415 $ — |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Short-Term Investments | The following is a summary of our short-term investments (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value U.S. treasury bills and government agency obligations $ 20,110 $ 166 $ — $ 20,276 U.S. corporate debt 11,505 42 — 11,547 Foreign corporate debt 15,508 49 — 15,557 U.S. commercial paper 13,997 — — 13,997 Foreign commercial paper 41,976 — — 41,976 Total $ 103,096 $ 257 $ — $ 103,353 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value U.S. treasury bills and government agency obligations $ 140,567 $ 59 $ — $ 140,626 U.S. corporate debt securities 80,159 11 — 80,170 Foreign corporate debt securities 23,188 15 — 23,203 U.S. commercial paper 32,801 — — 32,801 Foreign commercial paper 42,274 — — 42,274 Total $ 318,989 $ 85 $ — $ 319,074 |
Schedule of Inventory | Inventory consists of the following (in thousands): December 31, 2020 2019 Raw materials $ 18,994 $ 6,635 Work in process 6,847 12,571 Finished goods 16,064 5,762 Total inventory $ 41,905 $ 24,968 |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following (in thousands): December 31, 2020 2019 Scientific equipment $ 29,135 $ 24,603 Leasehold improvements 878 206 Computer equipment and software 1,461 1,314 Furniture, fixtures and office equipment 2,135 1,520 Property and equipment, gross 33,609 27,643 Less: accumulated depreciation and amortization (10,872 ) (8,025 ) Property and equipment, net $ 22,737 $ 19,618 |
Schedule of Accrued Liabilities | Accrued payroll and employee liabilities consist of the following (in thousands): December 31, 2020 2019 Accrued employee salaries and benefits $ 1,691 $ 3,047 Accrued bonuses 8,479 9,545 Accrued vacation 3,427 2,656 Total accrued payroll and employee liabilities $ 13,597 $ 15,248 Other accrued liabilities consist of the following (in thousands): December 31, 2020 2019 Accrued product sales allowances $ 24,571 $ 27,939 Accrued consulting and professional fees 3,450 7,742 Accrued accounts payable 104 310 Other accrued liabilities 244 544 Total other accrued liabilities $ 28,369 $ 36,535 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Summary of Activity to Product Returns, Distributor Fees and Discounts, Rebates and Administrative Fees | The following table provides a summary of activity with respect to our product returns, distributor fees and discounts, rebates and administrative fees, which are included in other accrued liabilities on the consolidated balance sheets (in thousands): Discounts, Rebates and Product Distributor Administrative Returns Fees Fees Total Balance at December 31, 2019 $ 2,351 $ 3,999 $ 21,589 $ 27,939 Provision 498 15,964 102,603 119,065 Payments/credits (145 ) (16,033 ) (106,255 ) (122,433 ) Balance at December 31, 2020 $ 2,704 $ 3,930 $ 17,937 $ 24,571 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Future Minimum Lease Payments | Annual future minimum lease payments as of December 31, 2020 are as follows (in thousands): Year ended December 31: 2021 $ 3,942 2022 4,058 2023 4,178 2024 4,274 2025 4,379 Thereafter — Total future minimum lease payments 20,831 Less: discount (3,273 ) Total lease liabilities $ 17,558 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Future Issuance | Shares of our common stock reserved for future issuance as of December 31, 2020 were as follows: Number of Shares Stock options outstanding 18,912,529 Restricted stock units outstanding 602,741 Stock options available for grant 1,575,955 Employee Stock Purchase Plan 176,250 Warrants outstanding 220,164 Shares of common stock underlying Convertible Notes outstanding (see Note 8) 9,510,208 Total shares reserved for future issuance 30,997,847 |
Summary of Stock Option Plan Activity (Including Restricted Stock Units) | The following table summarizes the stock option plan activity (including RSUs): Outstanding Options Weighted- Average Number of Exercise Shares Price Balance at December 31, 2017 13,462,964 $ 15.03 Granted 4,052,011 $ 26.83 Exercised (1,529,509 ) $ 11.97 Cancelled (720,859 ) $ 17.98 Balance at December 31, 2018 15,264,607 $ 18.33 Granted 4,933,480 $ 24.21 Exercised (1,983,221 ) $ 11.18 Cancelled (1,550,226 ) $ 23.26 Balance at December 31, 2019 16,664,640 $ 20.47 Granted 4,659,942 $ 13.95 Exercised (544,441 ) $ 12.41 Cancelled (1,264,871 ) $ 22.84 Balance at December 31, 2020 19,515,270 $ 18.98 |
Schedule of Options Exercisable, Vested or Expected to Vest | Years Ended December 31, 2020 2019 2018 Weighted- Weighted- Weighted- Average Average Average Exercise Exercise Exercise Options Price Options Price Options Price Exercisable at end of year 10,237,202 $ 18.74 7,436,379 $ 17.02 6,523,093 $ 14.83 Options vested or expected to vest 18,179,553 $ 19.58 15,962,432 $ 20.31 14,449,017 $ 18.11 |
Schedule of Exercise Prices And Weighted-average Remaining Contractual Lives For Options Outstanding | Exercise prices and weighted-average remaining contractual lives for the options outstanding as of December 31, 2020 were: Weighted- Weighted- Average Average Weighted- Exercise Remaining Average Price of Options Range of Contractual Exercise Options Options Outstanding Exercise Prices Life (in years) Price Exercisable Exercisable 2,700,473 $5.20–$13.00 3.97 $ 10.14 2,691,327 $ 10.14 800,371 $13.05–$15.55 6.13 14.31 655,173 14.22 3,582,407 $15.72 9.75 15.72 149,197 15.72 2,838,033 $15.78–$17.89 6.10 16.87 2,348,090 16.84 3,688,255 $18.00–$24.97 7.15 22.97 2,036,430 23.10 3,498,912 $25.02 8.63 25.02 1,010,859 25.02 1,804,078 $25.06–$39.00 6.64 30.58 1,346,126 30.43 18,912,529 7.21 19.59 10,237,202 18.74 |
Summary of Stock-Based Compensation Expense related to Stock-Based Payment Awards | The following table summarizes stock-based compensation expense related to stock-based payment awards pursuant to our equity compensation arrangements (in thousands): December 31, 2020 2019 2018 Research and development $ 20,731 $ 19,202 $ 13,689 General and administrative 15,601 13,564 9,630 Sales and marketing 13,886 18,645 10,048 Total stock-based compensation expense $ 50,218 $ 51,411 $ 33,367 |
Summary of Fair Value of Option Grant and ESPP Purchase Right on Grant Date Using Black-Scholes Option Pricing Model | We estimated the fair value of each option grant and ESPP purchase right on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: Options: December 31, 2020 2019 2018 Risk-free interest rate 0.5 % 1.8 % 2.8 % Dividend yield — % — % — % Volatility 69.4 % 66.5 % 70.4 % Expected life (years) 6 6 6 ESPP: December 31, 2020 2019 2018 Risk-free interest rate 0.1 % 1.9 % 2.4 % Dividend yield — % — % — % Volatility 67.7 % 52.1 % 59.7 % Expected life (months) 6 6 6 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The difference between the provision for income taxes and income taxes computed using the effective U.S. federal statutory rate is as follows (in thousands): December 31, 2020 2019 2018 Tax at statutory federal rate $ (47,728 ) $ (42,997 ) $ (37,557 ) State tax, net of federal benefit (8,218 ) (9,823 ) (6,527 ) Research and development credits (4,327 ) (4,855 ) (4,775 ) Stock-based compensation expense 4,675 2,906 (2,059 ) Non-deductible compensation 1,455 4,720 901 Change in valuation allowance 53,621 49,479 50,834 Other 522 570 (817 ) Provision for income taxes $ — $ — $ — |
Schedule of Deferred Tax Assets and Liabilities | Deferred income tax assets and liabilities arising from differences between accounting for financial statement purposes and tax purposes, less valuation allowance at year-end are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforward $ 251,971 $ 210,301 Research and development credits 49,683 42,490 Stock-based compensation 20,211 15,628 Lease liabilities 4,330 3,487 Other 3,777 3,818 Total gross deferred tax assets 329,972 275,724 Deferred tax liabilities: Right-of-use lease assets (4,014 ) (3,385 ) Total gross deferred tax liabilities (4,014 ) (3,385 ) Valuation allowance (325,958 ) (272,339 ) Net deferred tax assets $ — $ — |
Summary of Unrecognized Tax Benefits | A reconciliation of our unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Balance at beginning of year $ 4,784 $ 2,385 $ 120 Additions for tax positions of prior years 341 147 — Additions based on tax positions related to current year 2,281 2,252 2,265 Balance at end of year $ 7,406 $ 4,784 $ 2,385 |
Summary of Quarterly Consolid_2
Summary of Quarterly Consolidated Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Unaudited Quarterly Results of Operations | The following is a summary of the unaudited quarterly results of operations for the years ended December 31, 2020 and 2019: 2020 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 25,400 $ 22,668 $ 19,965 $ 20,605 Cost of product sales (10,622 ) (9,005 ) (7,170 ) (9,392 ) Gross Profit 14,778 13,663 12,795 11,213 Operating expenses: Research and development 36,894 44,004 49,182 44,453 General and administrative 10,422 9,819 9,482 12,503 Sales and marketing 20,196 15,589 12,515 15,553 Loss from operations (52,734 ) (55,749 ) (58,384 ) (61,296 ) Other income (expense), net 1,155 559 156 (985 ) Net loss $ (51,579 ) $ (55,190 ) $ (58,228 ) $ (62,281 ) Basic and diluted net loss per share $ (0.57 ) $ (0.61 ) $ (0.64 ) $ (0.68 ) 2019 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 31,602 $ 36,659 $ 42,624 $ 35,083 Cost of product sales (14,962 ) (13,588 ) (17,195 ) (15,874 ) Gross Profit 16,640 23,071 25,429 19,209 Operating expenses: Research and development 42,972 41,425 34,708 48,277 General and administrative 9,648 9,778 8,597 9,874 Sales and marketing 28,720 23,647 16,977 20,420 Loss from operations (64,700 ) (51,779 ) (34,853 ) (59,362 ) Other income, net 1,688 1,557 1,258 1,442 Net loss $ (63,012 ) $ (50,222 ) $ (33,595 ) $ (57,920 ) Basic and diluted net loss per share $ (0.80 ) $ (0.63 ) $ (0.42 ) $ (0.65 ) |
Organization and Business - Add
Organization and Business - Additional Information (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Business [Line Items] | |
Cash, cash equivalents and short-term investments | $ 208.5 |
HTX-034 | |
Business [Line Items] | |
Percentage of patients remained opioid free | 45.50% |
Percentage of reduction in pain intensity | 71.00% |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - Percentage of Net Product Sales and Accounts Receivable Balance (Details) - Customer Concentration Risk | 12 Months Ended |
Dec. 31, 2020 | |
Revenue Benchmark | |
Product Information [Line Items] | |
Concentration risk percentage | 98.30% |
Revenue Benchmark | Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 44.00% |
Revenue Benchmark | Second Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 33.50% |
Revenue Benchmark | Third Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 20.80% |
Accounts Receivable | |
Product Information [Line Items] | |
Concentration risk percentage | 99.60% |
Accounts Receivable | Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 61.30% |
Accounts Receivable | Second Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 29.80% |
Accounts Receivable | Third Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 8.50% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | Jan. 01, 2018 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Product Information [Line Items] | ||||||||||||
Cumulative adjustment to accumulated deficit | $ (1,392,748) | $ (1,165,470) | $ (1,392,748) | $ (1,165,470) | ||||||||
Product sales allowances | 24,571 | 27,939 | 24,571 | 27,939 | ||||||||
Cost of product sales | $ 9,392 | $ 7,170 | $ 9,005 | $ 10,622 | $ 15,874 | $ 17,195 | $ 13,588 | $ 14,962 | $ 36,189 | $ 61,619 | $ 27,512 | |
Accounting Standards Update 2014-09 | ||||||||||||
Product Information [Line Items] | ||||||||||||
Gross product sales | $ 2,900 | |||||||||||
Cost of product sales | 200 | |||||||||||
Accounting Standards Update 2014-09 | Product Sales Allowance | ||||||||||||
Product Information [Line Items] | ||||||||||||
Product sales allowances | 1,100 | |||||||||||
Accounting Standards Update 2018-13 | ||||||||||||
Product Information [Line Items] | ||||||||||||
Change in accounting principle, accounting standards update, adopted | true | true | ||||||||||
Change in accounting principle, accounting standards update, immaterial effect | true | true | ||||||||||
Accounting Standards Update 2016-13 | ||||||||||||
Product Information [Line Items] | ||||||||||||
Change in accounting principle, accounting standards update, adopted | true | true | ||||||||||
Change in accounting principle, accounting standards update, immaterial effect | true | true | ||||||||||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | Jan. 1, 2020 | ||||||||||
Cumulative Effect Period of Adoption Adjustment | Accounting Standards Update 2014-09 | ||||||||||||
Product Information [Line Items] | ||||||||||||
Cumulative adjustment to accumulated deficit | $ (1,600) | |||||||||||
Leasehold Improvements | ||||||||||||
Product Information [Line Items] | ||||||||||||
Estimated useful lives | 5 years |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded From Computation of Net Loss Per Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Option | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Shares excluded (in shares) | 18,912 | 16,665 | 15,265 |
Restricted Stock Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Shares excluded (in shares) | 603 | ||
Warrant | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Shares excluded (in shares) | 220 | 508 | 640 |
Convertible Debt Securities | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Shares excluded (in shares) | 9,510 | 8,960 | 8,473 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 103,353 | $ 319,074 |
U.S. Treasury Bills and Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 20,276 | 140,626 |
U.S. Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 11,547 | 80,170 |
Foreign Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 15,557 | 23,203 |
U.S. Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 13,997 | 32,801 |
Fair Value, Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 208,491 | 390,972 |
Fair Value, Recurring | Foreign Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 83,966 | 57,241 |
Fair Value, Recurring | U.S. Treasury Bills and Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 20,276 | 140,626 |
Fair Value, Recurring | U.S. Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 11,547 | 80,170 |
Fair Value, Recurring | Foreign Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 15,557 | 23,203 |
Fair Value, Recurring | U.S. Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 27,996 | 32,801 |
Fair Value, Recurring | Cash and Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and money market funds | 49,149 | 56,931 |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 49,149 | 197,557 |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. Treasury Bills and Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 140,626 | |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Cash and Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and money market funds | 49,149 | 56,931 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 159,342 | 193,415 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Foreign Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 83,966 | 57,241 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | U.S. Treasury Bills and Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 20,276 | |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | U.S. Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 11,547 | 80,170 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Foreign Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 15,557 | 23,203 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | U.S. Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 27,996 | $ 32,801 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | ||
Financial instruments transferred among fair value hierarchy levels | $ 0 | |
Cash equivalents included of available-for-sale securities | 55,900,000 | $ 15,000,000 |
Available for sale securities with contractual maturities of three months to one year. | $ 103,400,000 | 279,700,000 |
Available for sale securities with contractual maturities greater than one year | $ 39,400,000 |
Balance Sheet Details - Summary
Balance Sheet Details - Summary of Short -Term Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | $ 103,096 | $ 318,989 |
Available-for-sale securities, gross unrealized gains | 257 | 85 |
Available-for-sale securities | 103,353 | 319,074 |
U.S. Treasury Bills and Government Agency Obligations | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 20,110 | 140,567 |
Available-for-sale securities, gross unrealized gains | 166 | 59 |
Available-for-sale securities | 20,276 | 140,626 |
U.S. Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 11,505 | 80,159 |
Available-for-sale securities, gross unrealized gains | 42 | 11 |
Available-for-sale securities | 11,547 | 80,170 |
Foreign Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 15,508 | 23,188 |
Available-for-sale securities, gross unrealized gains | 49 | 15 |
Available-for-sale securities | 15,557 | 23,203 |
U.S. Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 13,997 | 32,801 |
Available-for-sale securities | 13,997 | 32,801 |
Foreign Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 41,976 | 42,274 |
Available-for-sale securities | $ 41,976 | $ 42,274 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Debt securities, impairment losses | $ 0 | $ 0 | |
Debt securities, available-for-sale, unrealized gain (loss) | 172,000 | 172,000 | $ (77,000) |
Debt securities, available-for-sale, realized gain (loss) | 0 | 8,000 | 0 |
Inventory | 41,905,000 | 24,968,000 | |
Depreciation and amortization | 2,847,000 | 2,044,000 | $ 1,513,000 |
Construction in Progress, Gross | 14,100,000 | 13,500,000 | |
SUSTOL | |||
Inventory | 4,100,000 | 1,500,000 | |
Cost of product sales, charges | 100,000 | 3,300,000 | |
CINVANTI | |||
Inventory | $ 37,800,000 | $ 23,500,000 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 18,994 | $ 6,635 |
Work in process | 6,847 | 12,571 |
Finished goods | 16,064 | 5,762 |
Total inventory | $ 41,905 | $ 24,968 |
Balance Sheet Details - Sched_2
Balance Sheet Details - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 33,609 | $ 27,643 |
Less: accumulated depreciation and amortization | (10,872) | (8,025) |
Property and equipment, net | 22,737 | 19,618 |
Scientific Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 29,135 | 24,603 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 878 | 206 |
Computer Equipment and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,461 | 1,314 |
Furniture, Fixtures and Office Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,135 | $ 1,520 |
Balance Sheet Details - Sched_3
Balance Sheet Details - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued payroll and employee liabilities | ||
Accrued employee salaries and benefits | $ 1,691 | $ 3,047 |
Accrued bonuses | 8,479 | 9,545 |
Accrued vacation | 3,427 | 2,656 |
Total accrued payroll and employee liabilities | 13,597 | 15,248 |
Other accrued liabilities | ||
Accrued product sales allowances | 24,571 | 27,939 |
Accrued consulting and professional fees | 3,450 | 7,742 |
Accrued accounts payable | 104 | 310 |
Other accrued liabilities | 244 | 544 |
Total other accrued liabilities | $ 28,369 | $ 36,535 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | |||||||||||
Net product sales | $ 20,605 | $ 19,965 | $ 22,668 | $ 25,400 | $ 35,083 | $ 42,624 | $ 36,659 | $ 31,602 | $ 88,638 | $ 145,968 | $ 77,474 |
CINVANTI | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Net product sales | 87,800 | 132,200 | |||||||||
SUSTOL | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Net product sales | $ 800 | $ 13,800 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Activity to Product Returns, Distributor Fees and Discounts, Rebates and Administrative Fees (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Product Information [Line Items] | |
Balance | $ 27,939 |
Provision | 119,065 |
Payments/credits | (122,433) |
Balance | 24,571 |
Product Returns | |
Product Information [Line Items] | |
Balance | 2,351 |
Provision | 498 |
Payments/credits | (145) |
Balance | 2,704 |
Distributor Fees | |
Product Information [Line Items] | |
Balance | 3,999 |
Provision | 15,964 |
Payments/credits | (16,033) |
Balance | 3,930 |
Discounts, Rebates and Administrative Fees | |
Product Information [Line Items] | |
Balance | 21,589 |
Provision | 102,603 |
Payments/credits | (106,255) |
Balance | $ 17,937 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020USD ($)ft² | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Lessee Lease Description [Line Items] | |||
Operating lease, rent expense | $ | $ 3.9 | $ 3.1 | $ 3.2 |
San Diego, California | |||
Lessee Lease Description [Line Items] | |||
Area of real estate property | 73,328 | ||
Lease expiration date | Dec. 31, 2025 | ||
Lessee, operating lease, renewal term | 5 years | ||
Lessee, operating lease, existence of option to extend | true | ||
Operating lease cash payments | $ | $ 3.6 | ||
Redwood City, California | |||
Lessee Lease Description [Line Items] | |||
Area of real estate property | 26,067 | ||
Lease expiration date | 2019-05 | ||
Sublease expiration date | 2019-05 | ||
Jersey City, New Jersey | |||
Lessee Lease Description [Line Items] | |||
Area of real estate property | 1,898 | ||
Lease expiration date | 2019-12 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2021 | $ 3,942 |
2022 | 4,058 |
2023 | 4,178 |
2024 | 4,274 |
2025 | 4,379 |
Total future minimum lease payments | 20,831 |
Less: discount | (3,273) |
Total lease liabilities | $ 17,558 |
Reorganization - Additional Inf
Reorganization - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Oct. 31, 2020 | Dec. 31, 2020 | |
Restructuring charges, total | $ 5.6 | $ 5.6 |
Research And Development Expense | ||
Restructuring charges, total | 1.2 | |
General and Administrative Expense | ||
Restructuring charges, total | 3.7 | |
Sales And Marketing Expense | ||
Restructuring charges, total | 0.7 | |
Employee Severance | ||
Restructuring charges, total | 2.5 | |
Payments for restructuring charges | $ 2.4 | |
Accelerated Non-Cash Stock Option Expense | ||
Restructuring charges, total | $ 3.1 |
Secured Notes to Related Party
Secured Notes to Related Party - Additional Information (Details) | Aug. 05, 2016USD ($) | Aug. 02, 2016USD ($)shares | Jul. 29, 2011shares | Aug. 31, 2018USD ($) | Aug. 31, 2016USD ($) | Apr. 30, 2011USD ($)Dayshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Debt Instrument [Line Items] | |||||||||
Proceeds from convertible debt | $ 4,300,000 | ||||||||
Amortization of debt discount | $ 1,429,000 | $ 1,050,000 | $ 890,000 | ||||||
Debt instrument, convertible, number shares of equity instruments | shares | 9,500,000 | ||||||||
Convertible Notes | |||||||||
Debt Instrument [Line Items] | |||||||||
Convertible debt issuable in connection with private placement | $ 4,500,000 | ||||||||
Debt instrument, interest rate | 6.00% | ||||||||
Debt instrument, maturity date | May 2, 2021 | ||||||||
Debt instrument conversion ratio multiple of principal | $ 1,000 | ||||||||
Beneficial ownership after conversion | 9.99% | ||||||||
Notice period associated with beneficial ownership percentage limitation convertible notes | Day | 61 | ||||||||
Common shares registered for resale in connection with convertible notes | shares | 3,500,000 | ||||||||
Debt instrument, term | 10 years | ||||||||
Paid-in-kind interest | $ 400,000 | ||||||||
Debt instrument, additional debt discount | 400,000 | ||||||||
Interest expense, debt, excluding amortization | 400,000 | 400,000 | 400,000 | ||||||
Amortization of debt discount | 1,400,000 | $ 1,100,000 | 900,000 | ||||||
Carrying value of debt | 7,100,000 | ||||||||
Debt instrument, face amount | 7,600,000 | ||||||||
Debt instrument, unamortized discount, total | $ 500,000 | ||||||||
Convertible Notes | Common Stock | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, number of shares issued for convertible notes | shares | 1,250 | ||||||||
Term Loan | Tang Capital | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, interest rate | 8.00% | ||||||||
Debt instrument, term | 2 years | ||||||||
Carrying value of debt | 0 | ||||||||
Debt agreement, maximum borrowing capacity | $ 100,000,000 | ||||||||
Proceeds from issuance of long-term debt, total | $ 50,000,000 | ||||||||
Proceeds from issuance of long-term debt, subject to achievement of corporate milestone | $ 50,000,000 | ||||||||
Debt instrument, fee amount | $ 0 | ||||||||
Debt instrument, number of warrants | shares | 0 | ||||||||
Debt instrument, convertible, beneficial conversion feature | $ 0 | ||||||||
Interest expense | $ 1,200,000 | ||||||||
Debt outstanding principal paid | $ 25,000,000 | ||||||||
Debt accrued interest paid | $ 200,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||||||||||
Oct. 31, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Apr. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2016 | May 31, 2015 | Jun. 30, 2014 | May 31, 2014 | Jun. 30, 2011 | May 31, 2010 | May 31, 2009 | Dec. 31, 2007 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 1997 | |
Class Of Stock [Line Items] | ||||||||||||||||||
Proceeds from issuance of common stock | $ 162,200,000 | $ 194,400,000 | $ 168,700,000 | $ 162,151,000 | $ 363,128,000 | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 220,164 | |||||||||||||||||
Common stock, shares, issued, total | 91,310,000 | 90,304,000 | ||||||||||||||||
Common stock, capital shares reserved for future issuance | 30,997,847 | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 1,575,955 | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, exercisable, weighted average remaining contractual term | 5 years 8 months 12 days | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, exercises in period, intrinsic value | $ 3,200 | $ 25,000 | ||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, outstanding, intrinsic value | $ 69,100 | $ 56,300 | ||||||||||||||||
Common stock future issuance on exercise of outstanding options and vesting of outstanding restricted stock units granted | 19,515,270 | |||||||||||||||||
Total unrecognized compensation cost related to non-vested, stock-based payment awards | $ 116,100,000 | |||||||||||||||||
Total unrecognized compensation cost, expect to recognize over weighted average period | 2 years 9 months 18 days | |||||||||||||||||
Stock Option and RSUs | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Share-based compensation arrangements by share-based payment award, options, exercises in period, weighted average exercise price | $ 12.41 | $ 11.18 | $ 11.97 | |||||||||||||||
Share-based compensation arrangement by share-based payment award, options, forfeitures in period | 922,578 | |||||||||||||||||
Share-based compensation arrangements by share-based payment award, options, forfeitures in period, weighted average exercise price | $ 22.76 | |||||||||||||||||
Share-based Payment Arrangement, Option | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, expirations in period | 342,293 | |||||||||||||||||
Share-based compensation arrangements by share-based payment award, options, expirations in period, weighted average exercise price | $ 23.04 | |||||||||||||||||
Expected life | 6 years | 6 years | 6 years | |||||||||||||||
Restricted Stock Units | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | |||||||||||||||||
Employee Stock Purchase Plan | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 10,000 | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of additional shares authorized | 300,000 | 200,000 | 100,000 | 100,000 | 25,000 | 25,000 | 10,000 | 5,000 | 775,000 | |||||||||
Share-based compensation arrangement by share-based payment award maximum employee earnings with held to purchase common stock percent | 10.00% | |||||||||||||||||
Share-based compensation arrangement by share-based payment award discount on stock price | 85.00% | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, shares issued in period | 193,841 | 125,727 | 71,499 | |||||||||||||||
Share-based compensation arrangements by share-based payment award, options, exercises in period, weighted average exercise price | $ 11.95 | $ 16.77 | $ 16.48 | |||||||||||||||
Common stock, shares, issued, total | 598,750 | |||||||||||||||||
Common stock, capital shares reserved for future issuance | 176,250 | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value | $ 9.76 | 14.70 | 17.24 | |||||||||||||||
Share-based compensation arrangement by share-based payment award, per share weighted-average fair value price of shares purchased | $ 5.18 | $ 5.94 | $ 9.95 | |||||||||||||||
Expected life | 6 months | |||||||||||||||||
Equity Incentive Plan 2007 | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 150,000 | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of additional shares authorized | 7,000,000 | 5,000,000 | 3,000,000 | 4,300,000 | 1,750,000 | 4,500,000 | 100,000 | 25,800,000 | ||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 1,575,955 | |||||||||||||||||
Pre-funded Warrants | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 600,000 | |||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | |||||||||||||||||
Class of warrant or right, expiration date | Jun. 30, 2021 | |||||||||||||||||
Class of warrant or right, exercised during period | 267,870 | 132,130 | 4,426 | |||||||||||||||
Proceeds from issuance of warrants | $ 2,679,000 | $ 1,321,000 | $ 0 | |||||||||||||||
Class of warrant or right, outstanding | 195,574 | |||||||||||||||||
Common Stock | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Number of shares issued | 9,900,000 | 5,100,000 | 6,900,000 | 9,857,000 | 11,963,000 | |||||||||||||
Share price | $ 17.50 | $ 39.50 | $ 26 | |||||||||||||||
Payments of stock issuance costs | $ 10,300,000 | $ 5,600,000 | $ 10,700,000 | |||||||||||||||
Issuance of common stock on exercise of warrants (in shares) | 267,000 | 132,000 | ||||||||||||||||
Common Stock | Pre-funded Warrants | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Issuance of common stock on exercise of warrants (in shares) | 267,870 | 132,130 | 4,423 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Details) | Dec. 31, 2020shares |
Stockholders Equity Note [Abstract] | |
Stock options outstanding | 18,912,529 |
Restricted stock units outstanding | 602,741 |
Stock options available for grant | 1,575,955 |
Employee Stock Purchase Plan | 176,250 |
Warrants outstanding | 220,164 |
Shares of common stock underlying Convertible Notes outstanding (see Note 8) | 9,510,208 |
Total shares reserved for future issuance | 30,997,847 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Plan Activity (Including Restricted Stock Units) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of shares outstanding | 18,912,529 | ||
Stock Option and RSUs | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of shares outstanding | 16,664,640 | 15,264,607 | 13,462,964 |
Number of shares granted | 4,659,942 | 4,933,480 | 4,052,011 |
Number of shares exercised | (544,441) | (1,983,221) | (1,529,509) |
Number of shares cancelled | (1,264,871) | (1,550,226) | (720,859) |
Number of shares outstanding | 19,515,270 | 16,664,640 | 15,264,607 |
Number of shares outstanding, weighted average exercise price | $ 20.47 | $ 18.33 | $ 15.03 |
Number of shares granted, weighted average exercise price | 13.95 | 24.21 | 26.83 |
Number of shares exercised, weighted average exercise price | 12.41 | 11.18 | 11.97 |
Number of shares cancelled, weighted average exercise price | 22.84 | 23.26 | 17.98 |
Number of shares outstanding, weighted average exercise price | $ 18.98 | $ 20.47 | $ 18.33 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Options Exercisable, Vested or Expected to Vest (Details) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Equity [Abstract] | |||
Options exercisable at end of year | 10,237,202 | 7,436,379 | 6,523,093 |
Options vested or expected to vest | 18,179,553 | 15,962,432 | 14,449,017 |
Options exercisable at end of year, weighted average exercise price | $ 18.74 | $ 17.02 | $ 14.83 |
Options vested or expected to vest, weighted average exercise price | $ 19.58 | $ 20.31 | $ 18.11 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Exercise Prices And Weighted-average Remaining Contractual Lives For Options Outstanding (Details) | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Options Outstanding (in shares) | shares | 18,912,529 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 2 months 15 days |
Weighted- Average Exercise Price (in dollars per share) | $ 19.59 |
Options Exercisable (in shares) | shares | 10,237,202 |
Weighted- Average Exercise Price of Options Exercisable | $ 18.74 |
Exercise Price Range 1 | |
Options Outstanding (in shares) | shares | 2,700,473 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 5.20 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 13 |
Weighted- Average Remaining Contractual Life (Year) | 3 years 11 months 19 days |
Weighted- Average Exercise Price (in dollars per share) | $ 10.14 |
Options Exercisable (in shares) | shares | 2,691,327 |
Weighted- Average Exercise Price of Options Exercisable | $ 10.14 |
Exercise Price Range 2 | |
Options Outstanding (in shares) | shares | 800,371 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 13.05 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 15.55 |
Weighted- Average Remaining Contractual Life (Year) | 6 years 1 month 17 days |
Weighted- Average Exercise Price (in dollars per share) | $ 14.31 |
Options Exercisable (in shares) | shares | 655,173 |
Weighted- Average Exercise Price of Options Exercisable | $ 14.22 |
Exercise Price Range 3 | |
Options Outstanding (in shares) | shares | 3,582,407 |
Exercise Prices | $ 15.72 |
Weighted- Average Remaining Contractual Life (Year) | 9 years 9 months |
Weighted- Average Exercise Price (in dollars per share) | $ 15.72 |
Options Exercisable (in shares) | shares | 149,197 |
Weighted- Average Exercise Price of Options Exercisable | $ 15.72 |
Exercise Price Range 4 | |
Options Outstanding (in shares) | shares | 2,838,033 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 15.78 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 17.89 |
Weighted- Average Remaining Contractual Life (Year) | 6 years 1 month 6 days |
Weighted- Average Exercise Price (in dollars per share) | $ 16.87 |
Options Exercisable (in shares) | shares | 2,348,090 |
Weighted- Average Exercise Price of Options Exercisable | $ 16.84 |
Exercise Price Range 5 | |
Options Outstanding (in shares) | shares | 3,688,255 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 18 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 24.97 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 1 month 24 days |
Weighted- Average Exercise Price (in dollars per share) | $ 22.97 |
Options Exercisable (in shares) | shares | 2,036,430 |
Weighted- Average Exercise Price of Options Exercisable | $ 23.10 |
Exercise Price Range 6 | |
Options Outstanding (in shares) | shares | 3,498,912 |
Exercise Prices | $ 25.02 |
Weighted- Average Remaining Contractual Life (Year) | 8 years 7 months 17 days |
Weighted- Average Exercise Price (in dollars per share) | $ 25.02 |
Options Exercisable (in shares) | shares | 1,010,859 |
Weighted- Average Exercise Price of Options Exercisable | $ 25.02 |
Exercise Price Range 7 | |
Options Outstanding (in shares) | shares | 1,804,078 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 25.06 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 39 |
Weighted- Average Remaining Contractual Life (Year) | 6 years 7 months 20 days |
Weighted- Average Exercise Price (in dollars per share) | $ 30.58 |
Options Exercisable (in shares) | shares | 1,346,126 |
Weighted- Average Exercise Price of Options Exercisable | $ 30.43 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Stock-Based Compensation Expense related to Stock-Based Payment Awards (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 50,218 | $ 51,411 | $ 33,367 |
Research and Development Expense | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense | 20,731 | 19,202 | 13,689 |
General and Administrative Expense | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense | 15,601 | 13,564 | 9,630 |
Sales and Marketing Expense | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 13,886 | $ 18,645 | $ 10,048 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Fair Value of Option Grant and ESPP Purchase Right on Grant Date Using Black-Scholes Option Pricing Model (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Risk-free interest rate | 0.50% | 1.80% | 2.80% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Volatility | 69.40% | 66.50% | 70.40% |
Expected life | 6 years | 6 years | 6 years |
Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Risk-free interest rate | 0.10% | 1.90% | 2.40% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Volatility | 67.70% | 52.10% | 59.70% |
Expected life | 6 months | 6 months | 6 months |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Tax at statutory federal rate | $ (47,728) | $ (42,997) | $ (37,557) |
State tax, net of federal benefit | (8,218) | (9,823) | (6,527) |
Research and development credits | (4,327) | (4,855) | (4,775) |
Stock-based compensation expense | 4,675 | 2,906 | (2,059) |
Non-deductible compensation | 1,455 | 4,720 | 901 |
Change in valuation allowance | 53,621 | 49,479 | 50,834 |
Other | 522 | 570 | (817) |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforward | $ 251,971 | $ 210,301 |
Research and development credits | 49,683 | 42,490 |
Stock-based compensation | 20,211 | 15,628 |
Lease liabilities | 4,330 | 3,487 |
Other | 3,777 | 3,818 |
Total gross deferred tax assets | 329,972 | 275,724 |
Deferred tax liabilities: | ||
Right-of-use lease assets | (4,014) | (3,385) |
Total gross deferred tax liabilities | (4,014) | (3,385) |
Valuation allowance | $ (325,958) | $ (272,339) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | Jun. 29, 2020 | Mar. 27, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Operating Loss Carryforwards [Line Items] | ||||||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 49,683,000 | $ 42,490,000 | ||||
Unrecognized Tax Benefits, Ending Balance | 7,406,000 | $ 4,784,000 | $ 2,385,000 | $ 120,000 | ||
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | 0 | |||||
Net operating loss carryback period | 5 years | |||||
Suspension of taxable income limitation percentage for operating loss carryforward | 80.00% | |||||
California Franchise Tax Board | Minimum | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Adjusted gross income for disallowance of net operating loss deductions | $ 1,000,000 | |||||
California Franchise Tax Board | Maximum | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Business credit offset amount | $ 5,000,000 | |||||
Domestic Tax Authority | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Operating Loss Carryforwards, Total | 1,000,000,000 | |||||
Expiring Operating Loss Carryforwards | $ 549,700,000 | |||||
Net operating loss carryforwards expiration year | 2021 | |||||
Indefinite Operating Loss Carryforwards | $ 492,000,000 | |||||
Taxable income limitation percentage for operating loss carryforward | 80.00% | |||||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 39,400,000 | |||||
Research and development credit carryforwards expiration year | 2022 | |||||
State and Local Jurisdiction | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Net operating loss carryforwards expiration year | 2028 | |||||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 18,100,000 | |||||
Research and development credit carryforwards expiration year | 2023 | |||||
State and Local Jurisdiction | California Franchise Tax Board | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Operating Loss Carryforwards, Total | $ 111,900,000 | |||||
State and Local Jurisdiction | Other State Jurisdiction | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Operating Loss Carryforwards, Total | $ 515,500,000 |
Income Taxes - Summary of Unrec
Income Taxes - Summary of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Balance at beginning of year | $ 4,784 | $ 2,385 | $ 120 |
Additions for tax positions of prior years | 341 | 147 | |
Additions based on tax positions related to current year | 2,281 | 2,252 | 2,265 |
Balance at end of year | $ 7,406 | $ 4,784 | $ 2,385 |
Other Income (Expense), Net - A
Other Income (Expense), Net - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Other income (expense) | $ (847) | $ 158 | $ 1,804 |
Disgorgement of Short-Swing Profits from the Sale of Common Stock | |||
Other income (expense) | $ 1,900 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Defined contribution plan, employer matching contribution, percent of match | 50.00% | 50.00% | 50.00% |
Defined contribution plan, maximum annual contributions by employer per employee, amount | $ 8,550 | $ 8,400 | $ 8,250 |
Defined contribution plan, cost | $ 1,100,000 | $ 1,000,000 | $ 700,000 |
Maximum | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Defined contribution plan, employer matching contribution, percent of employees' gross pay | 3.00% | 3.00% | 3.00% |
Summary of Quarterly Consolid_3
Summary of Quarterly Consolidated Financial Data (Unaudited) - Summary of Unaudited Quarterly Results of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||||||||||
Net product sales | $ 20,605 | $ 19,965 | $ 22,668 | $ 25,400 | $ 35,083 | $ 42,624 | $ 36,659 | $ 31,602 | $ 88,638 | $ 145,968 | $ 77,474 |
Cost of product sales | (9,392) | (7,170) | (9,005) | (10,622) | (15,874) | (17,195) | (13,588) | (14,962) | (36,189) | (61,619) | (27,512) |
Gross Profit | 11,213 | 12,795 | 13,663 | 14,778 | 19,209 | 25,429 | 23,071 | 16,640 | |||
Operating expenses: | |||||||||||
Research and development | 44,453 | 49,182 | 44,004 | 36,894 | 48,277 | 34,708 | 41,425 | 42,972 | 174,533 | 167,382 | 140,032 |
General and administrative | 12,503 | 9,482 | 9,819 | 10,422 | 9,874 | 8,597 | 9,778 | 9,648 | 42,226 | 37,897 | 29,263 |
Sales and marketing | 15,553 | 12,515 | 15,589 | 20,196 | 20,420 | 16,977 | 23,647 | 28,720 | 63,853 | 89,764 | 64,604 |
Loss from operations | (61,296) | (58,384) | (55,749) | (52,734) | (59,362) | (34,853) | (51,779) | (64,700) | (228,163) | (210,694) | (183,937) |
Other income (expense), net | (985) | 156 | 559 | 1,155 | 1,442 | 1,258 | 1,557 | 1,688 | 885 | 5,945 | 5,097 |
Net loss | $ (62,281) | $ (58,228) | $ (55,190) | $ (51,579) | $ (57,920) | $ (33,595) | $ (50,222) | $ (63,012) | $ (227,278) | $ (204,749) | $ (178,840) |
Basic and diluted net loss per share | $ (0.68) | $ (0.64) | $ (0.61) | $ (0.57) | $ (0.65) | $ (0.42) | $ (0.63) | $ (0.80) | $ (2.50) | $ (2.50) | $ (2.44) |