Document And Entity Information
Document And Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 01, 2019 | Jun. 30, 2018 | |
Document Information [Line Items] | |||
Entity Registrant Name | HERON THERAPEUTICS, INC. /DE/ | ||
Entity Central Index Key | 818,033 | ||
Trading Symbol | hrtx | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Common Stock, Shares Outstanding (in shares) | 78,181,651 | ||
Entity Public Float | $ 2.8 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Shell Company | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 31,836 | $ 144,583 |
Short-term investments | 300,535 | 27,796 |
Accounts receivable, net | 64,652 | 41,874 |
Inventory | 39,032 | 10,108 |
Prepaid expenses and other current assets | 11,193 | 3,702 |
Total current assets | 447,248 | 228,063 |
Property and equipment, net | 14,677 | 5,981 |
Other assets | 254 | 263 |
Total assets | 462,179 | 234,307 |
Current liabilities: | ||
Accounts payable | 16,863 | 18,769 |
Accrued clinical and manufacturing liabilities | 24,470 | 26,920 |
Accrued payroll and employee liabilities | 13,397 | 8,860 |
Other accrued liabilities | 32,715 | 17,175 |
Deferred revenue | 2,763 | |
Promissory note payable to related party | 25,000 | |
Convertible notes payable to related parties, net of discount | 4,574 | 3,684 |
Total current liabilities | 92,019 | 103,171 |
Commitments and contingencies (see Note 6) | ||
Stockholders’ equity (deficit): | ||
Preferred stock, $0.01 par value: 2,500 shares authorized; no shares issued or outstanding at December 31, 2018 and 2017 | ||
Common stock, $0.01 par value: 150,000 shares authorized; 78,174 and 64,609 shares issued and outstanding at December 31, 2018 and 2017, respectively | 782 | 646 |
Additional paid-in capital | 1,330,186 | 913,955 |
Accumulated other comprehensive loss | (87) | (10) |
Accumulated deficit | (960,721) | (783,455) |
Total stockholders’ equity | 370,160 | 131,136 |
Total liabilities and stockholders’ equity | $ 462,179 | $ 234,307 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares shares in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
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) | 78,174 | 64,609 |
Common stock, shares outstanding (in shares) | 78,174 | 64,609 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
Net product sales | $ 77,474 | $ 30,767 | $ 1,279 |
Operating expenses: | |||
Cost of product sales | 27,512 | 4,588 | 35 |
Research and development | 140,032 | 138,582 | 103,125 |
General and administrative | 29,263 | 25,554 | 21,366 |
Sales and marketing | 64,604 | 56,601 | 47,668 |
Total operating expenses | 261,411 | 225,325 | 172,194 |
Loss from operations | (183,937) | (194,558) | (170,915) |
Other income (expense), net: | |||
Interest income | 5,965 | 1,049 | 445 |
Interest expense | (2,672) | (3,937) | (2,664) |
Other (expense) income | 1,804 | (38) | (9) |
Total other income (expense), net | 5,097 | (2,926) | (2,228) |
Net loss | (178,840) | (197,484) | (173,143) |
Other comprehensive loss: | |||
Net unrealized gain on short-term investments | (77) | 7 | 23 |
Comprehensive loss | $ (178,917) | $ (197,477) | $ (173,120) |
Basic and diluted net loss per share (in dollars per share) | $ (2.44) | $ (3.65) | $ (4.56) |
Shares used in computing basic and diluted net loss per share (in shares) | 73,193 | 54,040 | 37,925 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2015 | 36,106,000 | ||||
Balance at Dec. 31, 2015 | $ 361 | $ 530,617 | $ (40) | $ (412,828) | $ 118,110 |
Conversion benefit included in Convertible Notes issued | 348 | 348 | |||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 55,000 | ||||
Issuance of common stock under Employee Stock Purchase Plan | $ 1 | 770 | $ 771 | ||
Issuance of common stock on exercise of stock options (in shares) | 798,000 | 798,363 | |||
Issuance of common stock on exercise of stock options | $ 8 | 6,676 | $ 6,684 | ||
Issuance of common stock on exercise of warrants (in shares) | 2,396,000 | ||||
Issuance of common stock on exercise of warrants | $ 24 | (24) | |||
Stock-based compensation expense | 25,956 | 25,956 | |||
Net loss | (173,143) | (173,143) | |||
Net unrealized gain on short-term investments | 23 | 23 | |||
Comprehensive loss | (173,120) | ||||
Balance (in shares) at Dec. 31, 2016 | 39,355,000 | ||||
Balance at Dec. 31, 2016 | $ 394 | 564,343 | (17) | (585,971) | (21,251) |
Conversion benefit included in Convertible Notes issued | 369 | 369 | |||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 77,000 | ||||
Issuance of common stock under Employee Stock Purchase Plan | $ 1 | 988 | $ 989 | ||
Issuance of common stock on exercise of stock options (in shares) | 1,351,000 | 1,350,605 | |||
Issuance of common stock on exercise of stock options | $ 13 | 11,450 | $ 11,463 | ||
Issuance of common stock on exercise of warrants (in shares) | 4,000 | ||||
Issuance of common stock on exercise of warrants | |||||
Stock-based compensation expense | 30,538 | 30,538 | |||
Net loss | (197,484) | (197,484) | |||
Net unrealized gain on short-term investments | 7 | 7 | |||
Comprehensive loss | (197,477) | ||||
Issuance of common stock in public offerings, net (in shares) | 23,822,000 | ||||
Issuance of common stock in public offerings, net | $ 238 | 306,041 | 306,279 | ||
Issuance of warrants | 226 | 226 | |||
Balance (in shares) at Dec. 31, 2017 | 64,609,000 | ||||
Balance at Dec. 31, 2017 | $ 646 | 913,955 | (10) | (783,455) | 131,136 |
Conversion benefit included in Convertible Notes issued | 392 | 392 | |||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 72,000 | ||||
Issuance of common stock under Employee Stock Purchase Plan | $ 1 | 1,178 | $ 1,179 | ||
Issuance of common stock on exercise of stock options (in shares) | 1,530,000 | 1,529,509 | |||
Issuance of common stock on exercise of stock options | $ 15 | 18,286 | $ 18,301 | ||
Stock-based compensation expense | 33,367 | 33,367 | |||
Net loss | (178,840) | (178,840) | |||
Net unrealized gain on short-term investments | (77) | (77) | |||
Comprehensive loss | (178,917) | ||||
Issuance of common stock in public offerings, net (in shares) | 11,963,000 | ||||
Issuance of common stock in public offerings, net | $ 120 | 363,008 | 363,128 | ||
Balance (in shares) at Dec. 31, 2018 | 78,174,000 | ||||
Balance at Dec. 31, 2018 | $ 782 | 1,330,186 | (87) | (960,721) | 370,160 |
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 1,574 | $ 1,574 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities: | |||
Net loss | $ (178,840) | $ (197,484) | $ (173,143) |
Adjustments to reconcile net loss to net cash used for operating activities: | |||
Stock-based compensation expense | 33,367 | 30,538 | 25,956 |
Depreciation and amortization | 1,513 | 1,531 | 1,099 |
Amortization of debt discount | 890 | 773 | 689 |
(Accretion of discount) amortization of premium on short-term investments | (3,412) | (278) | 274 |
Impairment of property and equipment | 72 | ||
Loss on disposal of property and equipment | 29 | 39 | 9 |
Change in operating assets and liabilities: | |||
Accounts receivable | (22,778) | (39,914) | (1,960) |
Prepaid expenses and other assets | (7,482) | 3 | (338) |
Inventory | (29,122) | (4,768) | (5,340) |
Accounts payable | (1,906) | 11,955 | 3,514 |
Accrued clinical and manufacturing liabilities | (3,614) | 13,713 | 7,976 |
Accrued payroll and employee liabilities | 4,537 | 446 | 3,586 |
Deferred revenue | 1,664 | 1,099 | |
Other accrued liabilities | 14,941 | 11,482 | 2,482 |
Net cash used for operating activities | (191,805) | (170,300) | (134,097) |
Investing activities: | |||
Purchases of short-term investments | (497,104) | (121,570) | (43,318) |
Maturities of short-term investments | 227,700 | 131,783 | 61,329 |
Purchases of property and equipment | (9,171) | (2,553) | (3,135) |
Proceeds from the sale of property and equipment | 25 | 78 | |
Net cash (used for) provided by investing activities | (278,550) | 7,738 | 14,876 |
Financing activities: | |||
Net proceeds from sale of common stock and/or pre-funded warrants | 363,128 | 306,279 | |
Proceeds from purchases under the Employee Stock Purchase Plan | 1,179 | 989 | 771 |
Proceeds from stock option exercises | 18,301 | 11,463 | 6,684 |
Proceeds from issuance of promissory note payable to related party | 50,000 | ||
Repayment of promissory note payable to related party | (25,000) | (25,000) | |
Net cash provided by financing activities | 357,608 | 293,731 | 57,455 |
Net (decrease) increase in cash and cash equivalents | (112,747) | 131,169 | (61,766) |
Cash and cash equivalents at beginning of year | 144,583 | 13,414 | 75,180 |
Cash and cash equivalents at end of year | 31,836 | 144,583 | 13,414 |
Supplemental disclosure of cash flow information: | |||
Interest paid | 1,183 | 2,789 | 1,622 |
Cumulative effect of adoption of new accounting standard | $ 1,574 |
Note 1 - Organization and Busin
Note 1 - Organization and Business | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | 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 cancer or pain. On August 9, 2016, first 5 3 “5 HT3” ≥5 October 2016. On November 9, 2017, second 1 “NK1” NK1 80 January 2018. HTX- 011, 011 011 five 011 fourth 2017 second 2018. 011, April 30, 2019 not HTX- 034, 034 seven As of December 31, 2018, $332.4 December 31, 2018 one 10 |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 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. no no no 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, inventory and 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 Short-term investments consist of securities with contractual maturities of greater than three one 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 not third not not 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 December 31, 2018 not 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 may Our products are distributed in the U.S. through a limited number of specialty distributors and full line wholesalers (collectively, “Customers”) that resell our products to healthcare providers and hospitals, the end users. The following table includes the percentage of net product sales and accounts receivable balances for our three 10% Net Product Sales Accounts Receivable Year Ended December 31 , 2018 As of December 31 , 2018 Customer A 41.7 % 38.7 % Customer B 34.9 % 46.1 % Customer C 22.5 % 14.8 % Total 99.1 % 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 2 3 We offered extended payment terms to our Customers in connection with our product launches of SUSTOL and CINVANTI in October 2016 January 2018, January 2018, December 31, 2018, not As of December 31, 2018, not December 31, 2018, not Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first first may 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 five 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. Revenue Recognition In May 2014, No. 2014 09, Revenue from Contracts with Customers 606” 606 606 December 15, 2017, first 2018, 606 2018 606, $1.6 January 1, 2018. $2.9 $1.1 $0.2 5 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 not Research and Development Expense All costs of research and development are expensed in the period incurred. Research and development expense primarily consist 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 not 10 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 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 share 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 December 31 , 2018 2017 2016 Stock options outstanding 15,265 13,463 11,845 Warrants outstanding 640 620 600 Shares of common stock underlying Convertible Notes outstanding 8,473 7,983 7,521 Recent Accounting Pronouncements Recently Adopted In May 2017, No. 2017 09, Compensation – Stock Compensation: Scope of Modification Accounting 2017 09” 2017 09 718. first 2018, 2017 09, not Not In February 2016, No. 2016 02, Leases (Topic 842 2016 02” July 2018, No. 2018 11, Leases (Topic 842 No. 2018 10, Codification Improvements to Topic 842, 2016 02 842.” 842 not twelve twelve 842 December 15, 2018, 2016 02 January 1, 2019 842 842. In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13” 2018 13 December 15, 2019, 2018 13 first 2020, |
Note 3 - Fair Value Measurement
Note 3 - Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 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 Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements & Disclosures • Level 1 • Level 2 1 not • Level 3 no We measure 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 Quoted Prices in Significant Active Markets Other Significant Balance at for Identical Observable Unobservable December 31, Assets Inputs Inputs 2018 (Level 1) (Level 2) (Level 3) Money market funds $ 13,874 $ 13,874 $ — $ — U.S. treasury bills and government agency obligations 59,741 59,741 — — U.S. corporate debt securities 59,087 — 59,087 — Foreign corporate debt securities 5,046 — 5,046 — U.S. commercial paper 61,885 — 61,885 — Foreign commercial paper 123,861 — 123,861 — Total $ 323,494 $ 73,615 $ 249,879 $ — Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Active Markets Other Significant Balance at for Identical Observable Unobservable December 31 , Assets Inputs Inputs 2017 (Level 1) (Level 2) (Level 3) Money market funds $ 91,386 $ 91,386 $ — $ — U.S. corporate debt securities 17,520 — 17,520 — U.S. commercial paper 39,863 — 39,863 — Foreign commercial paper 19,854 — 19,854 — Total $ 168,623 $ 91,386 $ 77,237 $ — We have not three As of December 31, 2018, $9.1 three $300.5 three one December 31, 2017, $49.4 three $27.8 three one December 31, 2018 2017 Unrealized gains and losses associated with our investments are reported in accumulated other comprehensive loss. For the year ended December 31, 2018, $77,000 December 31, 2017 2016, $7,000 $23,000, Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We did not December 31, 2018, 2017 2016. |
Note 4 - Balance Sheet Details
Note 4 - Balance Sheet Details | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Supplemental Balance Sheet Disclosures [Text Block] | 4. Balance Sheet Details Short-Term Investments The following is a summary of our short-term investments (in thousands): December 31, 201 8 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. treasury bills and government agency obligations $ 59,747 $ — $ (6 ) $ 59,741 U.S. corporate debt 59,164 — (77 ) 59,087 Foreign corporate debt 5,041 5 — 5,046 U.S. commercial paper 52,800 — — 52,800 Foreign commercial paper 123,870 — (9 ) 123,861 Total $ 300,622 $ 5 $ (92 ) $ 300,535 December 31, 201 7 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. corporate debt securities $ 13,003 $ — $ (10 ) $ 12,993 U.S. commercial paper 4,929 — — 4,929 Foreign commercial paper 9,874 — — 9,874 Total $ 27,806 $ — $ (10 ) $ 27,796 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 December 31, 2018 2017. Inventory Inventory consists of the following (in thousands): December 31, 2018 2017 Raw materials $ 10,112 $ 2,754 Work in process 20,604 4,166 Finished goods 8,316 3,188 Total inventory $ 39,032 $ 10,108 As of December 31, 2018, $6.7 $32.3 December 31, 2017, $7.1 $3.0 Property and Equipment Property and equipment, net consists of the following (in thousands): December 31, 2018 2017 Scientific equipment $ 18,077 $ 9,742 Leasehold improvements 1,783 1,654 Computer equipment and software 1,190 1,420 Furniture, fixtures and office equipment 1,722 1,024 Property and equipment, gross 22,772 13,840 Less: accumulated depreciation and amortization (8,095 ) (7,859 ) Property and equipment, net $ 14,677 $ 5,981 Depreciation and amortization expense for the years ended December 31, 2018, 2017 2016 $1.5 $1.5 $1.1 December 31, 2018 2017, $10.3 $2.0 not Accrued Payroll and Employee Liabilities and Other Accrued Liabilities Accrued payroll and employee liabilities consist of the following (in thousands): December 31, 20 18 2017 Accrued employee salaries and benefits $ 2,330 $ 1,292 Accrued bonuses 9,139 5,044 Accrued vacation 1,928 1,438 Accrued expenses for realignment (see Note 7) — 1,086 Total accrued payroll and employee liabilities $ 13,397 $ 8,860 Other accrued liabilities consist of the following (in thousands): December 31, 2018 2017 Accrued product sales allowances $ 25,503 $ 9,319 Accrued consulting and professional fees 5,768 6,869 Deferred rent 780 651 Accrued accounts payable 224 148 Other accrued liabilities 440 188 Total other accrued liabilities $ 32,715 $ 17,175 |
Note 5 - Revenue Recognition
Note 5 - Revenue Recognition | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 5 . Revenue Recognition Product Sales SUSTOL is distributed in the U.S. through a limited number of Customers that resell SUSTOL to healthcare providers, the end users of SUSTOL. CINVANTI is distributed in the U.S. through a limited number of Customers that resell CINVANTI to healthcare providers and hospitals, the end users of CINVANTI. Adoption of Topic 606 On January 1, 2018, 606 not January 1, 2018. January 1, 2018 606, not 605, Revenue Recognition 605” 606, 606, 605 606 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, five The following table shows the reconciliation of assets and liabilities disclosed in our Annual Report on Form 10 December 31, 2017, 606 January 1, 2018 ( As Reported Under Topic 605 Effect of Change As Adjusted Under Topic 606 Inventory $ 10,108 $ (198 ) $ 9,910 Other accrued liabilities 17,175 991 18,166 Deferred revenue 2,763 (2,763 ) — Accumulated deficit (783,455 ) 1,574 (781,881 ) The following table shows the unaudited condensed consolidated financial statement line items as if revenue from contracts with customers had been accounted for under Topic 605 As Reported Under Topic 606 Effect of Change As Calculated Under Topic 605 Consolidated Balance Sheet as of December 31, 2018: Inventory $ 39,032 $ 2,181 $ 41,213 Other accrued liabilities 32,715 (7,195 ) 25,520 Deferred revenue — 14,010 14,010 Accumulated deficit (960,721 ) (4,634 ) (965,355 ) Consolidated Statement of Operations for the Year Ended December 31 , 2018 Net product sales $ 77,474 $ (5,043 ) $ 72,431 Cost of product sales 27,512 (1,983 ) 25,529 Loss from operations (183,937 ) (3,060 ) (186,997 ) Net loss (178,840 ) (3,060 ) (181,900 ) Basic and diluted net loss per share (2.44 ) (0.05 ) (2.49 ) Consolidated Statement of Cash Flows for the Year Ended December 31 , 2018 Net loss $ (178,840 ) $ (3,060 ) $ (181,900 ) Adjustments to reconcile net loss to net cash used in operating activities: Inventory (29,122 ) (1,983 ) (31,105 ) Other accrued liabilities 14,941 (6,204 ) 8,737 Deferred revenue — 11,247 11,247 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 ● Product Returns — We allow our Customers to return product for credit 12 may ● Distributor Fees — We offer contractually determined discounts to our Customers. These discounts are paid no two ● Group Purchasing Organization (“GPO”) Discounts and Rebates — We offer cash discounts to GPO members. These discounts are taken when the GPO members purchase SUSTOL or CINVANTI 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 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 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 sales allowance estimates could materially affect our results of operations and financial position. 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 condensed consolidated balance sheets (in thousands): Product Returns Distributor Fees Discounts, Rebates and Administrative Fees Total Balance at December 31, 2017 $ 521 $ 580 $ 8,218 $ 9,319 Provision 464 7,555 58,504 66,523 Payments/credits (38 ) (5,322 ) (44,979 ) (50,339 ) Balance at December 31, 2018 $ 947 $ 2,813 $ 21,743 $ 25,503 |
Note 6 - Commitments and Contin
Note 6 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 6 . Commitments and Contingencies Leases We lease 28,275 December 1, 2016 April 15, 2024. May 2018, 23,873 September 7, 2018 December 31, 2025. one 5 26,067 May 31, 2019. March 15, 2018, May 31, 2019. 1,898 June 30, 2019. December 31, 2018, $3.2 Annual future minimum lease payments as of December 31, 2018 Year ended December 31: 2019 $ 3,195 2020 2,722 2021 2,801 2022 2,883 2023 2,967 Thereafter 3,274 Total future minimum lease payments $ 17,842 Rent expense under all operating leases totaled $3.2 $3.1 $2.1 December 31, 2018, 2017 2016, Clinical Development Agreements We enter into agreements with clinical sites and clinical research organizations for the conduct of our clinical trials. We make payments to these sites and organizations based in part on the number of eligible patients enrolled and the length of their participation in the clinical trials. Under certain of these agreements, we may |
Note 7 - Realignment of Goals a
Note 7 - Realignment of Goals and Objectives and New Development Focus | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Restructuring and Related Activities Disclosure [Text Block] | 7. Following the approval of SUSTOL and consistent with our transition into a commercial-stage biotechnology company, we realigned our goals and objectives and refocused our development efforts to the area of postoperative pain management. On September 30, 2016, three one The total expense for these activities was $9.4 $5.5 $3.9 September 30, 2016 December 31, 2017. December 31, 2018, In March 2018, first 2018, $0.5 We have accounted for these expenses in accordance with ASC Topic 420, Exit or Disposal Cost Obligations |
Note 8 - Secured Notes to Relat
Note 8 - Secured Notes to Related Party | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | 8 . Secured Notes to Related Party Convertible Notes In April 2011, $4.5 no $4.3 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% May 2, 2021; may The Convertible Notes are convertible into shares of our common stock at a rate of 1,250 $1,000 no 9.99% not 61 As of December 31, 2018, In 2011, 3.5 July 29, 2011. 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 $1,000 10 December 31, 2018, $0.4 $0.4 December 31, 2018, 2017 2016, $0.4 three $0.9 $0.8 $0.7 As of December 31, 2018, $4.6 $6.8 $2.2 December 31, 2018, 8.5 Promissory Note In August 2016, $100.0 two 8% first $50.0 August 5, 2016. second $50.0 not no no no second no For the year ended December 31, 2018, $1.2 $2.8 2017. August 2018, $25.0 $0.2 December 31, 2018, no |
Note 9 - Stockholders' Equity
Note 9 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 9 . Stockholders’ Equity 2017 s In January 2017, 14.1 $12.20 $163.7 $8.8 In December 2017, 9.7 $15.50 $142.6 $7.4 2018 In April 2018, 6.9 $26.00 $168.7 $10.7 In June 2018, 5.1 $39.50 $194.4 $5.6 Public Offering Warrants In June 2014, 600,000 $0.01 June 30, 2021. December 31, 2017, 4,426 4,423 no December 31, 2018, 595,574 June 2014 Common Stock Reserved for Future Issuance Shares of our common stock reserved for future issuance as of December 31, 2018 Number of Shares Stock options outstanding 15,264,606 Stock options available for grant 1,354,280 Employee stock purchase plan 195,818 Warrants outstanding 640,164 Shares of common stock underlying Convertible Notes outstanding (see Note 8) 8,472,820 Total shares reserved for future issuance 25,927,688 Employee Stock Purchase Plan In 1997, December 2007, May 2009, June 2011, May 2014, May 2015, June 2016 June 2017, 5,000, 10,000, 25,000, 25,000, 100,000, 100,000 200,000 475,000 December 31, 2018. 10% 85% first six first May November. 71,499, 77,283, 54,932 2018, 2017 2016, 2018, 2017 2016 $16.48, $12.80 $14.03, December 31, 2018, 279,182 195,818 Stock Option Plans We currently have one December 2007, 2007 “2007 150,000 May 2010, June 2011, May 2014, May 2015, June 2016 June 2017, 2007 100,000, 4,500,000, 1,750,000, 4,300,000, 3,000,000 5,000,000 18,800,000 December 31, 2018. December 31, 2018, 1,354,280 2007 In 2014, 2013 2012, no ten four 8 The following table summarizes the stock option activity: Outstanding Options Weighted- Average Number of Exercise Shares Price Balance at December 31, 2015 8,434,988 $ 13.64 Granted 4,920,661 15.98 Exercised (798,363 ) 8.37 Cancelled (711,910 ) 22.43 Balance at December 31, 2016 11,845,376 14.44 Granted 4,300,621 16.17 Exercised (1,350,605 ) 8.49 Cancelled (1,332,429 ) 20.06 Balance at December 31, 2017 13,462,963 15.03 Granted 4,052,011 26.83 Exercised (1,529,509 ) 11.97 Cancelled (720,859 ) 17.98 Balance at December 31, 2018 15,264,606 18.33 For the year ended December 31, 2018, 667,338 $17.04 53,521 $29.71. As of December 31, 2018, 5.3 December 31, 2018 2017 $31.4 $9.9 December 31, 2018 2017, $75.7 $35.6 Years Ended December 31, 2018 2017 2016 Weighted- Weighted- Weighted- Average Average Average Exercise Exercise Exercise Options Price Options Price Options Price Exercisable at end of year 6,523,093 $ 14.83 5,446,586 $ 13.25 4,356,665 $ 11.66 Options vested or expected to vest 14,449,017 $ 18.11 12,854,571 $ 14.98 11,234,529 $ 14.32 Exercise prices and weighted-average remaining contractual lives for the options outstanding as of December 31, 2018 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 2,635,453 $5.20 – $9.05 3.03 $ 7.99 2,260,453 $ 8.12 2,531,622 $9.33 – $14.20 6.29 12.89 1,406,228 12.66 4,195,066 $14.25 – $17.00 7.78 16.60 1,512,260 16.54 845,157 $17.05 – $23.90 7.56 20.52 478,721 20.64 2,860,911 $24.97 – $24.97 8.94 24.97 — — 2,196,397 $25.06 – $39.25 7.42 30.85 865,431 29.71 15,264,606 $5.20 – $39.25 6.87 18.33 6,523,093 14.83 On December 31, 2018, 15,264,606 2007 Valuation and Expense Information The following table summarizes stock-based compensation expense related to stock-based payment awards granted pursuant to all of our equity compensation arrangements (in thousands): December 31, 2018 2017 2016 Research and development $ 13,689 $ 11,312 $ 11,316 General and administrative 9,630 9,469 7,402 Sales and marketing 10,048 9,757 7,238 Total stock-based compensation expense $ 33,367 $ 30,538 $ 25,956 As of December 31, 2018, $117.5 2.8 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, 2018 2017 2016 Risk-free interest rate 2.8 % 2.1 % 1.7 % Dividend yield — % — % — % Volatility 70.4 % 74.0 % 89.1 % Expected life (years) 6 6 6 ESPP: December 31, 2018 2017 2016 Risk-free interest rate 2.4 % 1.2 % 0.4 % Dividend yield — % — % — % Volatility 59.7 % 50.0 % 68.3 % Expected life (months) 6 6 6 The weighted-average fair value of options granted was $17.24, $10.61 $11.82 December 31, 2018, 2017 2016, The weighted-average fair value of shares purchased through the ESPP was $9.95, $4.51 $6.10 December 31, 2018, 2017 2016, 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 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 six |
Note 10 - Income Taxes
Note 10 - Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 10 . Income Taxes For the years ended December 31, 2018, 2017 2016, not 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, 2018 2017 2016 Tax at statutory federal rate $ (37,557 ) $ (67,145 ) $ (58,868 ) State tax, net of federal benefit (6,527 ) (6,203 ) 2,013 Research and development credits (4,775 ) (5,962 ) (4,206 ) Stock-based compensation expense (2,059 ) 3,151 2,694 Non-deductible compensation 901 — 1,864 Change in valuation allowance 50,834 3,241 55,173 Impact of the 2017 Tax Act — 74,361 — Other (817 ) (1,443 ) 1,330 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, 2018 2017 Deferred tax assets: Net operating loss carryforward $ 172,113 $ 134,659 Research and development credits 35,670 25,919 Stock-based compensation 11,905 8,633 Other 3,171 2,920 Total gross deferred tax assets 222,859 172,131 Valuation allowance (222,859 ) (172,131 ) Net deferred tax assets $ — $ — We have established a valuation allowance to offset net deferred tax assets as of December 31, 2018 2017 As of December 31, 2018, $715.3 $122.3 $824.9 $549.7 January 1, 2018, 2021 $165.6 80% 2028. As of December 31, 2018, $27.2 $13.3 2022. Internal Revenue Code (“IRC”) Section 382 383 50% three 382 383 382 383 2007, 2011, 2013. 382 383 2018. December 31, 2018. We file U.S. and state income tax returns with varying statutes of limitations. The tax years from 1999 2018 The Tax Cuts and Jobs Act ( “2017 December 2017. 2017 35% 21%, January 1, 2018, one December 31, 2017 21%, $74.3 not one not December 31, 2018. In December 2017, No. 118 118” 2017 118 not one 740. 118, 740 740 118, fourth 2018 no A reconciliation of our unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2018 2017 2016 Balance at beginning of year $ 120 $ 120 $ 120 Additions for tax positions of prior years — — — Additions based on tax positions related to current year 2,265 — — Balance at end of year $ 2,385 $ 120 $ 120 Due to our valuation allowance, the $2.4 not December 31, 2018, no not 12 |
Note 11 - Other Income (Expense
Note 11 - Other Income (Expense), Net | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Other Nonoperating Income and Expense [Text Block] | 1 1 . Other Income (Expense), Net In 2018, $1.9 16 1934. |
Note 12 - Employee Benefit Plan
Note 12 - Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Pension and Other Postretirement Benefits Disclosure [Text Block] | 1 2 . Employee Benefit Plan We have a defined contribution 401 three 50% 3% $8,250, $8,100 $7,950 December 31, 2018, 2017 2016, may December 31, 2018, 2017 2016, $0.7 $0.6 $0.6 No |
Note 13 - Summary of Quarterly
Note 13 - Summary of Quarterly Consolidated Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | 1 3 . Summary of Quarterly Consolidated Financial Data (U naudited) The following is a summary of the unaudited quarterly results of operations for the years ended December 31, 2018 2017: 2018 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 11,567 $ 17,277 $ 19,786 $ 28,844 Cost of product sales (3,133 ) (5,231 ) (7,576 ) (11,572 ) Gross Profit 8,434 12,046 12,210 17,272 Operating expenses: Research and development 39,561 30,159 30,421 39,891 General and administrative 7,028 6,209 7,288 8,738 Sales and marketing 13,835 14,531 16,281 19,957 Loss from operations (51,990 ) (38,853 ) (41,780 ) (51,314 ) Other income (expense), net (275 ) 183 3,434 1,755 Net loss $ (52,265 ) $ (38,670 ) $ (38,346 ) $ (49,559 ) Basic and diluted net loss per share $ (0.81 ) $ (0.54 ) $ (0.49 ) $ (0.63 ) 2017 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 3,632 $ 8,510 $ 8,572 $ 10,053 Cost of product sales (1,186 ) (1,013 ) (1,051 ) (1,338 ) Gross Profit 2,446 7,497 7,521 8,715 Operating expenses: Research and development 33,384 28,597 28,844 47,757 General and administrative 6,742 6,185 6,462 6,165 Sales and marketing 11,619 14,770 13,529 16,683 Loss from operations (49,299 ) (42,055 ) (41,314 ) (61,890 ) Other expense, net (1,030 ) (744 ) (552 ) (600 ) Net loss $ (50,329 ) $ (42,799 ) $ (41,866 ) $ (62,490 ) Basic and diluted net loss per share $ (1.00 ) $ (0.80 ) $ (0.77 ) $ (1.09 ) |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | 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. no no no |
Use of Estimates, Policy [Policy Text Block] | 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, inventory and 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 [Policy Text Block] | Cash, Cash Equivalents and Short-Term Investments Cash and cash equivalents consist of cash and highly liquid investments with contractual maturities of three Short-term investments consist of securities with contractual maturities of greater than three one 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 Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments A company may not third not not 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 December 31, 2018 not |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | 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 may Our products are distributed in the U.S. through a limited number of specialty distributors and full line wholesalers (collectively, “Customers”) that resell our products to healthcare providers and hospitals, the end users. The following table includes the percentage of net product sales and accounts receivable balances for our three 10% Net Product Sales Accounts Receivable Year Ended December 31 , 2018 As of December 31 , 2018 Customer A 41.7 % 38.7 % Customer B 34.9 % 46.1 % Customer C 22.5 % 14.8 % Total 99.1 % 99.6 % |
Receivables, Policy [Policy Text Block] | 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 2 3 We offered extended payment terms to our Customers in connection with our product launches of SUSTOL and CINVANTI in October 2016 January 2018, January 2018, December 31, 2018, not As of December 31, 2018, not December 31, 2018, not |
Inventory, Policy [Policy Text Block] | Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first first may |
Property, Plant and Equipment, Policy [Policy Text Block] | 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 five |
Impairment or Disposal of Long-Lived Assets, Including Intangible Assets, Policy [Policy Text Block] | 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. |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition In May 2014, No. 2014 09, Revenue from Contracts with Customers 606” 606 606 December 15, 2017, first 2018, 606 2018 606, $1.6 January 1, 2018. $2.9 $1.1 $0.2 5 |
Clinical Trial Accruals [Policy Text Block] | 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 not |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expense All costs of research and development are expensed in the period incurred. Research and development expense primarily consist 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. |
Legal Costs, Policy [Policy Text Block] | 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. |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | 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 Issued in Equity Financings [Policy Text Block] | 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 Tax, Policy [Policy Text Block] | Income Taxes We recognize the impact of a tax position in our consolidated financial statements if the position is more likely than not not 10 |
Comprehensive Income, Policy [Policy Text Block] | 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 loss and represent the difference between our net loss and comprehensive net loss for all periods presented. |
Earnings Per Share, Policy [Policy Text Block] | 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 share 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 December 31 , 2018 2017 2016 Stock options outstanding 15,265 13,463 11,845 Warrants outstanding 640 620 600 Shares of common stock underlying Convertible Notes outstanding 8,473 7,983 7,521 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements Recently Adopted In May 2017, No. 2017 09, Compensation – Stock Compensation: Scope of Modification Accounting 2017 09” 2017 09 718. first 2018, 2017 09, not Not In February 2016, No. 2016 02, Leases (Topic 842 2016 02” July 2018, No. 2018 11, Leases (Topic 842 No. 2018 10, Codification Improvements to Topic 842, 2016 02 842.” 842 not twelve twelve 842 December 15, 2018, 2016 02 January 1, 2019 842 842. In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13” 2018 13 December 15, 2019, 2018 13 first 2020, |
Note 2 - Summary of Significa_2
Note 2 - Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedules of Concentration of Risk, by Risk Factor [Table Text Block] | Net Product Sales Accounts Receivable Year Ended December 31 , 2018 As of December 31 , 2018 Customer A 41.7 % 38.7 % Customer B 34.9 % 46.1 % Customer C 22.5 % 14.8 % Total 99.1 % 99.6 % |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31 , 2018 2017 2016 Stock options outstanding 15,265 13,463 11,845 Warrants outstanding 640 620 600 Shares of common stock underlying Convertible Notes outstanding 8,473 7,983 7,521 |
Note 3 - Fair Value Measureme_2
Note 3 - Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Active Markets Other Significant Balance at for Identical Observable Unobservable December 31, Assets Inputs Inputs 2018 (Level 1) (Level 2) (Level 3) Money market funds $ 13,874 $ 13,874 $ — $ — U.S. treasury bills and government agency obligations 59,741 59,741 — — U.S. corporate debt securities 59,087 — 59,087 — Foreign corporate debt securities 5,046 — 5,046 — U.S. commercial paper 61,885 — 61,885 — Foreign commercial paper 123,861 — 123,861 — Total $ 323,494 $ 73,615 $ 249,879 $ — Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Active Markets Other Significant Balance at for Identical Observable Unobservable December 31 , Assets Inputs Inputs 2017 (Level 1) (Level 2) (Level 3) Money market funds $ 91,386 $ 91,386 $ — $ — U.S. corporate debt securities 17,520 — 17,520 — U.S. commercial paper 39,863 — 39,863 — Foreign commercial paper 19,854 — 19,854 — Total $ 168,623 $ 91,386 $ 77,237 $ — |
Note 4 - Balance Sheet Details
Note 4 - Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Available-for-sale Securities [Table Text Block] | December 31, 201 8 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. treasury bills and government agency obligations $ 59,747 $ — $ (6 ) $ 59,741 U.S. corporate debt 59,164 — (77 ) 59,087 Foreign corporate debt 5,041 5 — 5,046 U.S. commercial paper 52,800 — — 52,800 Foreign commercial paper 123,870 — (9 ) 123,861 Total $ 300,622 $ 5 $ (92 ) $ 300,535 December 31, 201 7 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. corporate debt securities $ 13,003 $ — $ (10 ) $ 12,993 U.S. commercial paper 4,929 — — 4,929 Foreign commercial paper 9,874 — — 9,874 Total $ 27,806 $ — $ (10 ) $ 27,796 |
Schedule of Inventory, Current [Table Text Block] | December 31, 2018 2017 Raw materials $ 10,112 $ 2,754 Work in process 20,604 4,166 Finished goods 8,316 3,188 Total inventory $ 39,032 $ 10,108 |
Property, Plant and Equipment [Table Text Block] | December 31, 2018 2017 Scientific equipment $ 18,077 $ 9,742 Leasehold improvements 1,783 1,654 Computer equipment and software 1,190 1,420 Furniture, fixtures and office equipment 1,722 1,024 Property and equipment, gross 22,772 13,840 Less: accumulated depreciation and amortization (8,095 ) (7,859 ) Property and equipment, net $ 14,677 $ 5,981 |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 20 18 2017 Accrued employee salaries and benefits $ 2,330 $ 1,292 Accrued bonuses 9,139 5,044 Accrued vacation 1,928 1,438 Accrued expenses for realignment (see Note 7) — 1,086 Total accrued payroll and employee liabilities $ 13,397 $ 8,860 December 31, 2018 2017 Accrued product sales allowances $ 25,503 $ 9,319 Accrued consulting and professional fees 5,768 6,869 Deferred rent 780 651 Accrued accounts payable 224 148 Other accrued liabilities 440 188 Total other accrued liabilities $ 32,715 $ 17,175 |
Note 5 - Revenue Recognition (T
Note 5 - Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles [Table Text Block] | As Reported Under Topic 605 Effect of Change As Adjusted Under Topic 606 Inventory $ 10,108 $ (198 ) $ 9,910 Other accrued liabilities 17,175 991 18,166 Deferred revenue 2,763 (2,763 ) — Accumulated deficit (783,455 ) 1,574 (781,881 ) As Reported Under Topic 606 Effect of Change As Calculated Under Topic 605 Consolidated Balance Sheet as of December 31, 2018: Inventory $ 39,032 $ 2,181 $ 41,213 Other accrued liabilities 32,715 (7,195 ) 25,520 Deferred revenue — 14,010 14,010 Accumulated deficit (960,721 ) (4,634 ) (965,355 ) Consolidated Statement of Operations for the Year Ended December 31 , 2018 Net product sales $ 77,474 $ (5,043 ) $ 72,431 Cost of product sales 27,512 (1,983 ) 25,529 Loss from operations (183,937 ) (3,060 ) (186,997 ) Net loss (178,840 ) (3,060 ) (181,900 ) Basic and diluted net loss per share (2.44 ) (0.05 ) (2.49 ) Consolidated Statement of Cash Flows for the Year Ended December 31 , 2018 Net loss $ (178,840 ) $ (3,060 ) $ (181,900 ) Adjustments to reconcile net loss to net cash used in operating activities: Inventory (29,122 ) (1,983 ) (31,105 ) Other accrued liabilities 14,941 (6,204 ) 8,737 Deferred revenue — 11,247 11,247 |
Valuation Allowances and Reserves [Table Text Block] | Product Returns Distributor Fees Discounts, Rebates and Administrative Fees Total Balance at December 31, 2017 $ 521 $ 580 $ 8,218 $ 9,319 Provision 464 7,555 58,504 66,523 Payments/credits (38 ) (5,322 ) (44,979 ) (50,339 ) Balance at December 31, 2018 $ 947 $ 2,813 $ 21,743 $ 25,503 |
Note 6 - Commitments and Cont_2
Note 6 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Year ended December 31: 2019 $ 3,195 2020 2,722 2021 2,801 2022 2,883 2023 2,967 Thereafter 3,274 Total future minimum lease payments $ 17,842 |
Note 9 - Stockholders' Equity (
Note 9 - Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Common Stock Reserved for Future Issuance [Table Text Block] | Number of Shares Stock options outstanding 15,264,606 Stock options available for grant 1,354,280 Employee stock purchase plan 195,818 Warrants outstanding 640,164 Shares of common stock underlying Convertible Notes outstanding (see Note 8) 8,472,820 Total shares reserved for future issuance 25,927,688 |
Share-based Compensation, Stock Options, Activity [Table Text Block] | Outstanding Options Weighted- Average Number of Exercise Shares Price Balance at December 31, 2015 8,434,988 $ 13.64 Granted 4,920,661 15.98 Exercised (798,363 ) 8.37 Cancelled (711,910 ) 22.43 Balance at December 31, 2016 11,845,376 14.44 Granted 4,300,621 16.17 Exercised (1,350,605 ) 8.49 Cancelled (1,332,429 ) 20.06 Balance at December 31, 2017 13,462,963 15.03 Granted 4,052,011 26.83 Exercised (1,529,509 ) 11.97 Cancelled (720,859 ) 17.98 Balance at December 31, 2018 15,264,606 18.33 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable [Table Text Block] | Years Ended December 31, 2018 2017 2016 Weighted- Weighted- Weighted- Average Average Average Exercise Exercise Exercise Options Price Options Price Options Price Exercisable at end of year 6,523,093 $ 14.83 5,446,586 $ 13.25 4,356,665 $ 11.66 Options vested or expected to vest 14,449,017 $ 18.11 12,854,571 $ 14.98 11,234,529 $ 14.32 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range [Table Text Block] | 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 2,635,453 $5.20 – $9.05 3.03 $ 7.99 2,260,453 $ 8.12 2,531,622 $9.33 – $14.20 6.29 12.89 1,406,228 12.66 4,195,066 $14.25 – $17.00 7.78 16.60 1,512,260 16.54 845,157 $17.05 – $23.90 7.56 20.52 478,721 20.64 2,860,911 $24.97 – $24.97 8.94 24.97 — — 2,196,397 $25.06 – $39.25 7.42 30.85 865,431 29.71 15,264,606 $5.20 – $39.25 6.87 18.33 6,523,093 14.83 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | December 31, 2018 2017 2016 Research and development $ 13,689 $ 11,312 $ 11,316 General and administrative 9,630 9,469 7,402 Sales and marketing 10,048 9,757 7,238 Total stock-based compensation expense $ 33,367 $ 30,538 $ 25,956 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | December 31, 2018 2017 2016 Risk-free interest rate 2.8 % 2.1 % 1.7 % Dividend yield — % — % — % Volatility 70.4 % 74.0 % 89.1 % Expected life (years) 6 6 6 December 31, 2018 2017 2016 Risk-free interest rate 2.4 % 1.2 % 0.4 % Dividend yield — % — % — % Volatility 59.7 % 50.0 % 68.3 % Expected life (months) 6 6 6 |
Note 10 - Income Taxes (Tables)
Note 10 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | December 31, 2018 2017 2016 Tax at statutory federal rate $ (37,557 ) $ (67,145 ) $ (58,868 ) State tax, net of federal benefit (6,527 ) (6,203 ) 2,013 Research and development credits (4,775 ) (5,962 ) (4,206 ) Stock-based compensation expense (2,059 ) 3,151 2,694 Non-deductible compensation 901 — 1,864 Change in valuation allowance 50,834 3,241 55,173 Impact of the 2017 Tax Act — 74,361 — Other (817 ) (1,443 ) 1,330 Provision for income taxes $ — $ — $ — |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, 2018 2017 Deferred tax assets: Net operating loss carryforward $ 172,113 $ 134,659 Research and development credits 35,670 25,919 Stock-based compensation 11,905 8,633 Other 3,171 2,920 Total gross deferred tax assets 222,859 172,131 Valuation allowance (222,859 ) (172,131 ) Net deferred tax assets $ — $ — |
Summary of Income Tax Contingencies [Table Text Block] | Year Ended December 31, 2018 2017 2016 Balance at beginning of year $ 120 $ 120 $ 120 Additions for tax positions of prior years — — — Additions based on tax positions related to current year 2,265 — — Balance at end of year $ 2,385 $ 120 $ 120 |
Note 13 - Summary of Quarterl_2
Note 13 - Summary of Quarterly Consolidated Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Quarterly Financial Information [Table Text Block] | 2018 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 11,567 $ 17,277 $ 19,786 $ 28,844 Cost of product sales (3,133 ) (5,231 ) (7,576 ) (11,572 ) Gross Profit 8,434 12,046 12,210 17,272 Operating expenses: Research and development 39,561 30,159 30,421 39,891 General and administrative 7,028 6,209 7,288 8,738 Sales and marketing 13,835 14,531 16,281 19,957 Loss from operations (51,990 ) (38,853 ) (41,780 ) (51,314 ) Other income (expense), net (275 ) 183 3,434 1,755 Net loss $ (52,265 ) $ (38,670 ) $ (38,346 ) $ (49,559 ) Basic and diluted net loss per share $ (0.81 ) $ (0.54 ) $ (0.49 ) $ (0.63 ) 2017 First Quarter Second Quarter Third Quarter Fourth Quarter (In thousands, except per share amounts) Revenues: Net product sales $ 3,632 $ 8,510 $ 8,572 $ 10,053 Cost of product sales (1,186 ) (1,013 ) (1,051 ) (1,338 ) Gross Profit 2,446 7,497 7,521 8,715 Operating expenses: Research and development 33,384 28,597 28,844 47,757 General and administrative 6,742 6,185 6,462 6,165 Sales and marketing 11,619 14,770 13,529 16,683 Loss from operations (49,299 ) (42,055 ) (41,314 ) (61,890 ) Other expense, net (1,030 ) (744 ) (552 ) (600 ) Net loss $ (50,329 ) $ (42,799 ) $ (41,866 ) $ (62,490 ) Basic and diluted net loss per share $ (1.00 ) $ (0.80 ) $ (0.77 ) $ (1.09 ) |
Note 1 - Organization and Bus_2
Note 1 - Organization and Business (Details Textual) $ in Millions | Dec. 31, 2018USD ($) |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 332.4 |
Note 2 - Summary of Significa_3
Note 2 - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | Jan. 01, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 1,574 | $ 1,574 | ||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 28,844 | $ 19,786 | $ 17,277 | $ 11,567 | $ 10,053 | $ 8,572 | $ 8,510 | $ 3,632 | 77,474 | $ 30,767 | $ 1,279 | |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Amount, Ending Balance | 25,503 | 9,319 | 25,503 | 9,319 | ||||||||
Cost of Goods and Services Sold, Total | 11,572 | $ 7,576 | $ 5,231 | $ 3,133 | $ 1,338 | $ 1,051 | $ 1,013 | $ 1,186 | 27,512 | $ 4,588 | $ 35 | |
Accounting Standards Update 2014-09 [Member] | ||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 2,900 | |||||||||||
Cost of Goods and Services Sold, Total | 200 | |||||||||||
Accounting Standards Update 2014-09 [Member] | Product Sales Allowance [Member] | ||||||||||||
SEC Schedule, 12-09, Valuation Allowances and Reserves, Amount, Ending Balance | 1,100 | |||||||||||
Retained Earnings [Member] | ||||||||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 1,574 | $ 1,574 | ||||||||||
Retained Earnings [Member] | Accounting Standards Update 2014-09 [Member] | ||||||||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 1,600 |
Note 2 - Summary of Significa_4
Note 2 - Summary of Significant Accounting Policies - Percentage of Net Product Sales and Accounts Receivable Balance (Details) - Customer Concentration Risk [Member] | 6 Months Ended | 12 Months Ended |
Dec. 31, 2018 | Dec. 31, 2018 | |
Sales Revenue, Net [Member] | ||
Concentration risk percentage | 99.10% | |
Sales Revenue, Net [Member] | Largest Customer [Member] | ||
Concentration risk percentage | 41.70% | |
Sales Revenue, Net [Member] | Second Largest Customer [Member] | ||
Concentration risk percentage | 34.90% | |
Sales Revenue, Net [Member] | Third Largest Customer [Member] | ||
Concentration risk percentage | 22.50% | |
Accounts Receivable [Member] | ||
Concentration risk percentage | 99.60% | |
Accounts Receivable [Member] | Largest Customer [Member] | ||
Concentration risk percentage | 38.70% | |
Accounts Receivable [Member] | Second Largest Customer [Member] | ||
Concentration risk percentage | 46.10% | |
Accounts Receivable [Member] | Third Largest Customer [Member] | ||
Concentration risk percentage | 14.80% |
Note 2 - Summary of Significa_5
Note 2 - Summary of Significant Accounting Policies - Securities Excluded From Calculation of Diluted Earnings Per Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Stock Option [Member] | |||
Shares excluded (in shares) | 15,265 | 13,463 | 11,845 |
Warrant [Member] | |||
Shares excluded (in shares) | 640 | 620 | 600 |
Convertible Debt Securities [Member] | |||
Shares excluded (in shares) | 8,473 | 7,983 | 7,521 |
Note 3 - Fair Value Measureme_3
Note 3 - Fair Value Measurements (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash Equivalents, at Carrying Value, Total | $ 9,100,000 | $ 49,400,000 | |
Available-for-sale Securities, Current, Total | 300,535,000 | 27,796,000 | |
Debt Securities, Available-for-sale, Realized Gain (Loss), Total | 77,000 | 7,000 | $ 23,000 |
Available-for-sale Securities, Gross Realized Gains | 0 | 0 | 0 |
Available-for-sale Securities, Gross Realized Losses | $ 0 | $ 0 | $ 0 |
Note 3 - Fair Value Measureme_4
Note 3 - Fair Value Measurements - Financial Assets Measured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Total | $ 323,494 | $ 168,623 |
Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 123,861 | 19,854 |
US Treasury Securities [Member] | ||
Available-for-sale securities | 59,741 | |
Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 59,087 | 17,520 |
United States Commercial Paper [Member] | ||
Available-for-sale securities | 61,885 | 39,863 |
Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 5,046 | |
Fair Value, Inputs, Level 1 [Member] | ||
Total | 73,615 | 91,386 |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | 59,741 | |
Fair Value, Inputs, Level 1 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 1 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 1 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 1 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 2 [Member] | ||
Total | 249,879 | 77,237 |
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 2 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 59,087 | 17,520 |
Fair Value, Inputs, Level 2 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | 61,885 | 39,863 |
Fair Value, Inputs, Level 2 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 5,046 | |
Fair Value, Inputs, Level 2 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 123,861 | 19,854 |
Fair Value, Inputs, Level 3 [Member] | ||
Total | ||
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 3 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 3 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 3 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 3 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | ||
Money Market Funds [Member] | ||
Available-for-sale securities | 13,874 | 91,386 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities | 13,874 | 91,386 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities | ||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities |
Note 4 - Balance Sheet Detail_2
Note 4 - Balance Sheet Details (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 | |
Other-than-temporary Impairment Loss, Debt Securities, Available-for-sale, Total | $ 0 | $ 0 | ||
Inventory, Net, Total | 39,032 | 10,108 | $ 9,910 | |
Depreciation, Total | 1,500 | 1,500 | $ 1,100 | |
Construction in Progress, Gross | 10,300 | 2,000 | ||
SUSTOL [Member] | ||||
Inventory, Net, Total | 6,700 | 7,100 | ||
CINVANTI [Member] | ||||
Inventory, Net, Total | $ 32,300 | $ 3,000 |
Note 4 - Balance Sheet Detail_3
Note 4 - Balance Sheet Details - Available-for-sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Available-for-sale securities, amortized cost | $ 300,622 | $ 27,806 |
Available-for-sale securities, gross unrealized gains | 5 | |
Available-for-sale securities, gross unrealized losses | (92) | (10) |
Available-for-sale securities, current | 300,535 | 27,796 |
US Treasury Securities [Member] | ||
Available-for-sale securities, amortized cost | 59,747 | |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (6) | |
Available-for-sale securities, current | 59,741 | |
Debt Security, Corporate, US [Member] | ||
Available-for-sale securities, amortized cost | 59,164 | 13,003 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (77) | (10) |
Available-for-sale securities, current | 59,087 | 12,993 |
United States Commercial Paper [Member] | ||
Available-for-sale securities, amortized cost | 52,800 | 4,929 |
Available-for-sale securities, gross unrealized losses | ||
Available-for-sale securities, current | 52,800 | 4,929 |
Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities, amortized cost | 5,041 | |
Available-for-sale securities, gross unrealized gains | 5 | |
Available-for-sale securities, gross unrealized losses | ||
Available-for-sale securities, current | 5,046 | |
Foreign Commercial Paper [Member] | ||
Available-for-sale securities, amortized cost | 123,870 | 9,874 |
Available-for-sale securities, gross unrealized losses | (9) | |
Available-for-sale securities, current | $ 123,861 | $ 9,874 |
Note 4 - Balance Sheet Detail_4
Note 4 - Balance Sheet Details - Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Raw materials | $ 10,112 | $ 2,754 | |
Work in process | 20,604 | 4,166 | |
Finished goods | 8,316 | 3,188 | |
Total inventory | $ 39,032 | $ 9,910 | $ 10,108 |
Note 4 - Balance Sheet Detail_5
Note 4 - Balance Sheet Details - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property and equipment, gross | $ 22,772 | $ 13,840 |
Less: accumulated depreciation and amortization | (8,095) | (7,859) |
Property and equipment, gross | 14,677 | 5,981 |
Equipment [Member] | ||
Property and equipment, gross | 18,077 | 9,742 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 1,783 | 1,654 |
Computer Equipment [Member] | ||
Property and equipment, gross | 1,190 | 1,420 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | $ 1,722 | $ 1,024 |
Note 4 - Balance Sheet Detail_6
Note 4 - Balance Sheet Details - Accrued Payroll, Employee Liabilities, and Other Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Accrued employee salaries and benefits | $ 2,330 | $ 1,292 | |
Accrued bonuses | 9,139 | 5,044 | |
Accrued vacation | 1,928 | 1,438 | |
Accrued expenses for realignment (see Note 7) | 1,086 | ||
Total accrued payroll and employee liabilities | 13,397 | 8,860 | |
Accrued product sales allowances | 25,503 | 9,319 | |
Accrued consulting and professional fees | 5,768 | 6,869 | |
Deferred rent | 780 | 651 | |
Accrued accounts payable | 224 | 148 | |
Other accrued liabilities | 440 | 188 | |
Total other accrued liabilities | $ 32,715 | $ 18,166 | $ 17,175 |
Note 5 - Revenue Recognition -
Note 5 - Revenue Recognition - Adoption of Topic 606 (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Inventory | $ 9,910 | $ 39,032 | $ 10,108 | $ 39,032 | $ 10,108 | |||||||
Other accrued liabilities | 18,166 | 32,715 | 17,175 | 32,715 | 17,175 | |||||||
Deferred revenue | 2,763 | 2,763 | ||||||||||
Accumulated deficit | (781,881) | (960,721) | (783,455) | (960,721) | (783,455) | |||||||
Other accrued liabilities | 18,166 | 32,715 | 17,175 | 32,715 | 17,175 | |||||||
Accumulated deficit | (781,881) | (960,721) | (783,455) | (960,721) | (783,455) | |||||||
Net product sales | 28,844 | $ 19,786 | $ 17,277 | $ 11,567 | 10,053 | $ 8,572 | $ 8,510 | $ 3,632 | 77,474 | 30,767 | $ 1,279 | |
Cost of product sales | 11,572 | 7,576 | 5,231 | 3,133 | 1,338 | 1,051 | 1,013 | 1,186 | 27,512 | 4,588 | 35 | |
Loss from operations | (183,937) | (194,558) | (170,915) | |||||||||
Net loss | $ (49,559) | $ (38,346) | $ (38,670) | $ (52,265) | $ (62,490) | $ (41,866) | $ (42,799) | $ (50,329) | $ (178,840) | $ (197,484) | $ (173,143) | |
Basic and diluted net loss per share (in dollars per share) | $ (0.63) | $ (0.49) | $ (0.54) | $ (0.81) | $ (1.09) | $ (0.77) | $ (0.80) | $ (1) | $ (2.44) | $ (3.65) | $ (4.56) | |
Inventory | $ (29,122) | $ (4,768) | $ (5,340) | |||||||||
Other accrued liabilities | 14,941 | 11,482 | 2,482 | |||||||||
Deferred revenue | $ 1,664 | $ 1,099 | ||||||||||
Calculated under Revenue Guidance in Effect before Topic 606 [Member] | ||||||||||||
Inventory | $ 41,213 | 41,213 | ||||||||||
Other accrued liabilities | 25,520 | 25,520 | ||||||||||
Deferred revenue | 14,010 | 14,010 | ||||||||||
Accumulated deficit | (965,355) | (965,355) | ||||||||||
Other accrued liabilities | 25,520 | 25,520 | ||||||||||
Accumulated deficit | (965,355) | (965,355) | ||||||||||
Net product sales | 72,431 | |||||||||||
Cost of product sales | 25,529 | |||||||||||
Loss from operations | (186,997) | |||||||||||
Net loss | $ (181,900) | |||||||||||
Basic and diluted net loss per share (in dollars per share) | $ (2.49) | |||||||||||
Inventory | $ (31,105) | |||||||||||
Other accrued liabilities | 8,737 | |||||||||||
Deferred revenue | 11,247 | |||||||||||
Accounting Standards Update 2014-09 [Member] | ||||||||||||
Inventory | (198) | |||||||||||
Other accrued liabilities | 991 | |||||||||||
Deferred revenue | (2,763) | |||||||||||
Accumulated deficit | 1,574 | |||||||||||
Other accrued liabilities | 991 | |||||||||||
Accumulated deficit | 1,574 | |||||||||||
Net product sales | 2,900 | |||||||||||
Cost of product sales | $ 200 | |||||||||||
Accounting Standards Update 2014-09 [Member] | Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ||||||||||||
Inventory | 2,181 | 2,181 | ||||||||||
Other accrued liabilities | (7,195) | (7,195) | ||||||||||
Deferred revenue | 14,010 | 14,010 | ||||||||||
Accumulated deficit | (4,634) | (4,634) | ||||||||||
Other accrued liabilities | (7,195) | (7,195) | ||||||||||
Accumulated deficit | $ (4,634) | (4,634) | ||||||||||
Net product sales | (5,043) | |||||||||||
Cost of product sales | (1,983) | |||||||||||
Loss from operations | (3,060) | |||||||||||
Net loss | $ (3,060) | |||||||||||
Basic and diluted net loss per share (in dollars per share) | $ (0.05) | |||||||||||
Inventory | $ (1,983) | |||||||||||
Other accrued liabilities | (6,204) | |||||||||||
Deferred revenue | $ 11,247 |
Note 5 - Revenue Recognition _2
Note 5 - Revenue Recognition - Summary of Product Sales Allowance (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Balance | $ 9,319 |
Provision | 66,523 |
Payments/credits | (50,339) |
Balance | 25,503 |
Allowance for Sales Returns 1 [Member] | |
Balance | 521 |
Provision | 464 |
Payments/credits | (38) |
Balance | 947 |
Allowance for Distributor Fees [Member] | |
Balance | 580 |
Provision | 7,555 |
Payments/credits | (5,322) |
Balance | 2,813 |
Allowance for Rebates and Chargebacks [Member] | |
Balance | 8,218 |
Provision | 58,504 |
Payments/credits | (44,979) |
Balance | $ 21,743 |
Note 6 - Commitments and Cont_3
Note 6 - Commitments and Contingencies (Details Textual) $ in Millions | 12 Months Ended | |||
Dec. 31, 2018USD ($)ft² | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | May 31, 2018ft² | |
Operating Leases, Rent Expense, Total | $ | $ 3.2 | $ 3.1 | $ 2.1 | |
San Diego [Member] | ||||
Area of Real Estate Property | 28,275 | 23,873 | ||
Lessee, Operating Lease, Renewal Term | 5 years | |||
Redwood City [Member] | ||||
Area of Real Estate Property | 26,067 | |||
Jersey City [Member] | ||||
Area of Real Estate Property | 1,898 |
Note 6 - Commitments and Cont_4
Note 6 - Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
2,019 | $ 3,195 |
2,020 | 2,722 |
2,021 | 2,801 |
2,022 | 2,883 |
2,023 | 2,967 |
Thereafter | 3,274 |
Total future minimum lease payments | $ 17,842 |
Note 7 - Realignment of Goals_2
Note 7 - Realignment of Goals and Objectives and New Development Focus (Details Textual) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2018 | |
Restructuring and Related Cost, Expected Cost, Total | $ 9.4 | |
Restructuring Plan [Member] | General and Administrative Expense [Member] | ||
Restructuring Charges, Total | $ 0.5 | |
Restructuring Plan [Member] | Employee Severance [Member] | ||
Restructuring and Related Cost, Expected Cost, Total | 5.5 | |
Restructuring Plan [Member] | Accelerated Non-Cash Stock Option Expense [Member] | ||
Restructuring and Related Cost, Expected Cost, Total | $ 3.9 |
Note 8 - Secured Notes to Rel_2
Note 8 - Secured Notes to Related Party (Details Textual) - USD ($) | Aug. 05, 2016 | Aug. 02, 2016 | Jul. 29, 2011 | Aug. 31, 2018 | Aug. 31, 2016 | Apr. 30, 2011 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Convertible Debt Issuable in Connection with Private Placement | $ 4,500,000 | ||||||||
Proceeds from Convertible Debt | $ 4,300,000 | ||||||||
Amortization of Debt Discount (Premium) | $ 890,000 | $ 773,000 | $ 689,000 | ||||||
Convertible Notes Payable, Related Parties, Current | 4,574,000 | 3,684,000 | |||||||
Interest Expense, Total | 2,672,000 | 3,937,000 | 2,664,000 | ||||||
Repayments of Long-term Debt, Total | 25,000,000 | 25,000,000 | |||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | 1,183,000 | 2,789,000 | 1,622,000 | ||||||
Convertible Debt [Member] | |||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.00% | ||||||||
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 | 61 days | ||||||||
Common Shares Registered for Resale in Connection with Convertible Notes | 3,500,000 | ||||||||
Debt Instrument, Term | 10 years | ||||||||
Paid-in-Kind Interest | 400,000 | ||||||||
Debt Instrument, Increase (Decrease), Other, Net | 400,000 | ||||||||
Amortization of Debt Discount (Premium) | 900,000 | 800,000 | 700,000 | ||||||
Debt Instrument, Face Amount | 6,800,000 | ||||||||
Debt Instrument, Unamortized Discount, Total | $ 2,200,000 | ||||||||
Debt Instrument, Convertible, Number Shares of Equity Insturments | 8,500,000 | ||||||||
Interest Expense, Debt, Excluding Amortization | $ 400,000 | 400,000 | $ 400,000 | ||||||
Convertible Debt [Member] | Common Stock [Member] | |||||||||
Debt Instrument Conversion Ratio Shares | 1,250 | ||||||||
Term Loan [Member] | Tang Capital [Member] | |||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | ||||||||
Debt Instrument, Term | 2 years | ||||||||
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 | 0 | ||||||||
Debt Instrument, Convertible, Beneficial Conversion Feature | $ 0 | ||||||||
Interest Expense, Total | 1,200,000 | $ 2,800,000 | |||||||
Repayments of Long-term Debt, Total | $ 25,000,000 | ||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | $ 200,000 | ||||||||
Long-term Debt, Total | $ 0 |
Note 9 - Stockholders' Equity_2
Note 9 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |||||||||||||||
Jun. 30, 2018 | Apr. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Jan. 31, 2017 | Jun. 30, 2016 | May 31, 2015 | May 30, 2015 | May 31, 2014 | Jun. 30, 2011 | May 31, 2010 | May 31, 2009 | Dec. 31, 2007 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jun. 30, 2014 | |
Proceeds from Issuance of Common Stock | $ 194.4 | $ 168.7 | $ 142.6 | $ 163.7 | |||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 640,164 | ||||||||||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ 11.97 | $ 8.49 | $ 8.37 | ||||||||||||||
Common Stock, Shares, Issued, Total | 64,609,000 | 78,174,000 | 64,609,000 | ||||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 25,927,688 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,354,280 | ||||||||||||||||
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, Forfeitures in Period | 667,338 | ||||||||||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Forfeitures in Period, Weighted Average Exercise Price | $ 17.04 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period | 53,521 | ||||||||||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Expirations in Period, Weighted Average Exercise Price | $ 29.71 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 5 years 109 days | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 31.4 | $ 9.9 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 35.6 | $ 75.7 | $ 35.6 | ||||||||||||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Number of Outstanding Options, Ending Balance | 15,264,606 | ||||||||||||||||
Employee Stock Purchase Plan [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 200,000 | 100,000 | 100,000 | 25,000 | 25,000 | 10,000 | 5,000 | 475,000 | |||||||||
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 | 71,499 | 77,283 | 54,932 | ||||||||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ 16.48 | $ 12.80 | $ 14.03 | ||||||||||||||
Common Stock, Shares, Issued, Total | 279,182 | ||||||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 195,818 | ||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 117.5 | ||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 292 days | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 17.24 | 10.61 | 11.82 | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Per Share Weighted-average Fair Value Price of Shares Purchased | $ 4.51 | $ 9.95 | $ 4.51 | $ 6.10 | |||||||||||||
Equity Incentive Plan 2007 [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 5,000,000 | 3,000,000 | 4,300,000 | 1,750,000 | 4,500,000 | 100,000 | 18,800,000 | ||||||||||
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 Shares Available for Grant | 1,354,280 | ||||||||||||||||
Pre-funded Warrants[Member] | |||||||||||||||||
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, Exercised During Period | 4,426 | ||||||||||||||||
Class of Warrant or Right, Outstanding | 595,574 | ||||||||||||||||
Common Stock [Member] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 5,100,000 | 6,900,000 | 9,700,000 | 14,100,000 | 11,963,000 | 23,822,000 | |||||||||||
Share Price | $ 39.50 | $ 26 | $ 15.50 | $ 12.20 | $ 15.50 | ||||||||||||
Payments of Stock Issuance Costs | $ 5.6 | $ 10.7 | $ 7.4 | $ 8.8 | |||||||||||||
Stock Issued During Period, Shares, Warrants Exercised | 4,000 | 2,396,000 | |||||||||||||||
Common Stock [Member] | Pre-funded Warrants[Member] | |||||||||||||||||
Stock Issued During Period, Shares, Warrants Exercised | 4,423 |
Note 9 - Stockholders' Equity -
Note 9 - Stockholders' Equity - Common Stock Reserved for Future Issuance (Details) - shares | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Stock options outstanding (in shares) | 15,264,606 | 13,462,963 | 11,845,376 | 8,434,988 |
Stock options available for grant (in shares) | 1,354,280 | |||
Employee stock purchase plan (in shares) | 195,818 | |||
Warrants outstanding (in shares) | 640,164 | |||
Shares of common stock underlying Convertible Notes outstanding (see Note 8) (in shares) | 8,472,820 | |||
Total shares reserved for future issuance (in shares) | 25,927,688 |
Note 9 - Stockholders' Equity_3
Note 9 - Stockholders' Equity - Stock Option Activity (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Number of shares outstanding (in shares) | 13,462,963 | 11,845,376 | 8,434,988 |
Number of shares outstanding, weighted average exercise price (in dollars per share) | $ 15.03 | $ 14.44 | $ 13.64 |
Number of shares granted (in shares) | 4,052,011 | 4,300,621 | 4,920,661 |
Number of shares granted, weighted average exercise price (in dollars per share) | $ 26.83 | $ 16.17 | $ 15.98 |
Number of shares exercised (in shares) | (1,529,509) | (1,350,605) | (798,363) |
Number of shares exercised, weighted average exercise price (in dollars per share) | $ 11.97 | $ 8.49 | $ 8.37 |
Number of shares cancelled (in shares) | (720,859) | (1,332,429) | (711,910) |
Number of shares cancelled, weighted average exercise price (in dollars per share) | $ 17.98 | $ 20.06 | $ 22.43 |
Number of shares outstanding (in shares) | 15,264,606 | 13,462,963 | 11,845,376 |
Number of shares outstanding, weighted average exercise price (in dollars per share) | $ 18.33 | $ 15.03 | $ 14.44 |
Note 9 - Stockholders' Equity_4
Note 9 - Stockholders' Equity - Options Exercisable, Vested or Expected to Vest (Details) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Options exercisable at end of year (in shares) | 6,523,093 | 5,446,586 | 4,356,665 |
Options exercisable at end of year, weighted average exercise price (in dollars per share) | $ 14.83 | $ 13.25 | $ 11.66 |
Options vested or expected to vest (in shares) | 14,449,017 | 12,854,571 | 11,234,529 |
Options vested or expected to vest, weighted average exercise price (in dollars per share) | $ 18.11 | $ 14.98 | $ 14.32 |
Note 9 - Stockholders' Equity_5
Note 9 - Stockholders' Equity - Exercise Price Range (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Options Outstanding (in shares) | shares | 15,264,606 |
Exercise Price Range 1 [Member] | |
Options Outstanding (in shares) | shares | 2,635,453 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 5.20 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 9.05 |
Weighted- Average Remaining Contractual Life (Year) | 3 years 10 days |
Weighted- Average Exercise Price (in dollars per share) | $ 7.99 |
Options Exercisable (in shares) | shares | 2,260,453 |
Weighted- Average Exercise Price of Options Exercisable (in dollars per share) | $ 8.12 |
Exercise Price Range 2 [Member] | |
Options Outstanding (in shares) | shares | 2,531,622 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 9.33 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 14.20 |
Weighted- Average Remaining Contractual Life (Year) | 6 years 105 days |
Weighted- Average Exercise Price (in dollars per share) | $ 12.89 |
Options Exercisable (in shares) | shares | 1,406,228 |
Weighted- Average Exercise Price of Options Exercisable (in dollars per share) | $ 12.66 |
Exercise Price Range 3 [Member] | |
Options Outstanding (in shares) | shares | 4,195,066 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 14.25 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 17 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 284 days |
Weighted- Average Exercise Price (in dollars per share) | $ 16.60 |
Options Exercisable (in shares) | shares | 1,512,260 |
Weighted- Average Exercise Price of Options Exercisable (in dollars per share) | $ 16.54 |
Exercise Price Range 4 [Member] | |
Options Outstanding (in shares) | shares | 845,157 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 17.05 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 23.90 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 204 days |
Weighted- Average Exercise Price (in dollars per share) | $ 20.52 |
Options Exercisable (in shares) | shares | 478,721 |
Weighted- Average Exercise Price of Options Exercisable (in dollars per share) | $ 20.64 |
Exercise Price Range 5 [Member] | |
Options Outstanding (in shares) | shares | 2,860,911 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 24.97 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 24.97 |
Weighted- Average Remaining Contractual Life (Year) | 8 years 343 days |
Weighted- Average Exercise Price (in dollars per share) | $ 24.97 |
Options Exercisable (in shares) | shares | |
Weighted- Average Exercise Price of Options Exercisable (in dollars per share) | |
Exercise Price Range 6 [Member] | |
Options Outstanding (in shares) | shares | 2,196,397 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 25.06 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 39.25 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 153 days |
Weighted- Average Exercise Price (in dollars per share) | $ 30.85 |
Options Exercisable (in shares) | shares | 865,431 |
Weighted- Average Exercise Price of Options Exercisable (in dollars per share) | $ 29.71 |
Exercise Price Range 7 [Member] | |
Options Outstanding (in shares) | shares | 15,264,606 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 5.20 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 39.25 |
Weighted- Average Remaining Contractual Life (Year) | 6 years 317 days |
Weighted- Average Exercise Price (in dollars per share) | $ 18.33 |
Options Exercisable (in shares) | shares | 6,523,093 |
Weighted- Average Exercise Price of Options Exercisable (in dollars per share) | $ 14.83 |
Note 9 - Stockholders' Equity_6
Note 9 - Stockholders' Equity - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock-based compensation expense | $ 33,367 | $ 30,538 | $ 25,956 |
Research and Development Expense [Member] | |||
Stock-based compensation expense | 13,689 | 11,312 | 11,316 |
General and Administrative Expense [Member] | |||
Stock-based compensation expense | 9,630 | 9,469 | 7,402 |
Selling and Marketing Expense [Member] | |||
Stock-based compensation expense | $ 10,048 | $ 9,757 | $ 7,238 |
Note 9 - Stockholders' Equity_7
Note 9 - Stockholders' Equity - Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Stock Option [Member] | |||
Risk-free interest rate | 2.80% | 2.10% | 1.70% |
Dividend yield | |||
Volatility | 70.40% | 74.00% | 89.10% |
Expected life (Year) | 6 years | 6 years | 6 years |
Employee Stock Purchase Plan [Member] | |||
Risk-free interest rate | 2.40% | 1.20% | 0.40% |
Dividend yield | |||
Volatility | 59.70% | 50.00% | 68.30% |
Expected life (Year) | 180 days | 180 days | 180 days |
Note 10 - Income Taxes (Details
Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Expense (Benefit), Total | $ 0 | $ 0 | $ 0 | |
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 35,670 | $ 25,919 | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 35.00% | ||
Adjustment of Deferred Tax (Asset) Liability, Revaluation Based On New Tax Rate | $ 74,300 | |||
Unrecognized Tax Benefits, Ending Balance | $ 2,385 | 120 | $ 120 | $ 120 |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | 0 | 0 | ||
Deferred Tax Assets Revaluated [Member] | ||||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ (74,300) | |||
Domestic Tax Authority [Member] | ||||
Operating Loss Carryforwards, Total | 715,300 | |||
Expiring Operating Loss Carryforwards | 549,700 | |||
Indefinite Operating Loss Carryforwards | 165,600 | |||
Deferred Tax Assets, Tax Credit Carryforwards, Research | 27,200 | |||
State and Local Jurisdiction [Member] | ||||
Deferred Tax Assets, Tax Credit Carryforwards, Research | 13,300 | |||
State and Local Jurisdiction [Member] | California Franchise Tax Board [Member] | ||||
Operating Loss Carryforwards, Total | 122,300 | |||
State and Local Jurisdiction [Member] | Other State Jurisdiction [Member] | ||||
Operating Loss Carryforwards, Total | $ 824,900 |
Note 10 - Income Taxes - Provis
Note 10 - Income Taxes - Provisions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Tax at statutory federal rate | $ (37,557) | $ (67,145) | $ (58,868) |
State tax, net of federal benefit | (6,527) | (6,203) | 2,013 |
Research and development credits | (4,775) | (5,962) | (4,206) |
Stock-based compensation expense | (2,059) | 3,151 | 2,694 |
Non-deductible compensation | 901 | 1,864 | |
Change in valuation allowance | 50,834 | 3,241 | 55,173 |
Impact of the 2017 Tax Act | 74,361 | ||
Other | (817) | (1,443) | 1,330 |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Note 10 - Income Taxes - Compon
Note 10 - Income Taxes - Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Net operating loss carryforward | $ 172,113 | $ 134,659 |
Research and development credits | 35,670 | 25,919 |
Stock-based compensation | 11,905 | 8,633 |
Other | 3,171 | 2,920 |
Total gross deferred tax assets | 222,859 | 172,131 |
Valuation allowance | (222,859) | (172,131) |
Net deferred tax assets |
Note 10 - Income Taxes - Unreco
Note 10 - Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Balance at beginning of year | $ 120 | $ 120 | $ 120 |
Additions for tax positions of prior years | |||
Additions based on tax positions related to current year | 2,265 | ||
Balance at end of year | $ 2,385 | $ 120 | $ 120 |
Note 11 - Other Income (Expen_2
Note 11 - Other Income (Expense), Net (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Other Nonoperating Income (Expense), Total | $ 1,804 | $ (38) | $ (9) |
Disgorgement of Short-Swing Profits from the Sale of Common Stock [Member] | |||
Other Nonoperating Income (Expense), Total | $ 1,900 |
Note 12 - Employee Benefit Pl_2
Note 12 - Employee Benefit Plan (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
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 | $ 8,250 | $ 8,100 | $ 7,950 |
Defined Contribution Plan, Cost | $ 700,000 | $ 600,000 | $ 600,000 |
Maximum [Member] | |||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 3.00% | 3.00% | 3.00% |
Note 13 - Summary of Quarterl_3
Note 13 - Summary of Quarterly Consolidated Financial Data (Unaudited) - Summary Quarterly Results of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||||||||||
Net product sales | $ 28,844 | $ 19,786 | $ 17,277 | $ 11,567 | $ 10,053 | $ 8,572 | $ 8,510 | $ 3,632 | $ 77,474 | $ 30,767 | $ 1,279 |
Cost of product sales | (11,572) | (7,576) | (5,231) | (3,133) | (1,338) | (1,051) | (1,013) | (1,186) | (27,512) | (4,588) | (35) |
Gross Profit | 17,272 | 12,210 | 12,046 | 8,434 | 8,715 | 7,521 | 7,497 | 2,446 | |||
Operating expenses: | |||||||||||
Research and development | 39,891 | 30,421 | 30,159 | 39,561 | 47,757 | 28,844 | 28,597 | 33,384 | 140,032 | 138,582 | 103,125 |
General and administrative | 8,738 | 7,288 | 6,209 | 7,028 | 6,165 | 6,462 | 6,185 | 6,742 | 29,263 | 25,554 | 21,366 |
Sales and marketing | 19,957 | 16,281 | 14,531 | 13,835 | 16,683 | 13,529 | 14,770 | 11,619 | 64,604 | 56,601 | 47,668 |
Loss from operations | (51,314) | (41,780) | (38,853) | (51,990) | (61,890) | (41,314) | (42,055) | (49,299) | |||
Other income (expense), net | 1,755 | 3,434 | 183 | (275) | (600) | (552) | (744) | (1,030) | 5,097 | (2,926) | (2,228) |
Net loss | $ (49,559) | $ (38,346) | $ (38,670) | $ (52,265) | $ (62,490) | $ (41,866) | $ (42,799) | $ (50,329) | $ (178,840) | $ (197,484) | $ (173,143) |
Basic and diluted net loss per share (in dollars per share) | $ (0.63) | $ (0.49) | $ (0.54) | $ (0.81) | $ (1.09) | $ (0.77) | $ (0.80) | $ (1) | $ (2.44) | $ (3.65) | $ (4.56) |