Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 18, 2019 | |
Document Information [Line Items] | ||
Entity Registrant Name | HERON THERAPEUTICS, INC. /DE/ | |
Entity Central Index Key | 0000818033 | |
Trading Symbol | hrtx | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Common Stock, Shares Outstanding (in shares) | 79,069,527 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
ASSETS | ||
Cash and cash equivalents | $ 23,461 | $ 31,836 |
Short-term investments | 265,777 | 300,535 |
Accounts receivable, net | 74,007 | 64,652 |
Inventory | 31,421 | 39,032 |
Prepaid expenses and other current assets | 11,539 | 11,193 |
Total current assets | 406,205 | 447,248 |
Property and equipment, net | 16,267 | 14,677 |
Right-of-use lease assets | 13,068 | |
Other assets | 254 | 254 |
Total assets | 435,794 | 462,179 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Accounts payable | 10,811 | 16,863 |
Accrued clinical and manufacturing liabilities | 23,602 | 24,470 |
Accrued payroll and employee liabilities | 6,640 | 13,397 |
Other accrued liabilities | 44,351 | 32,715 |
Current lease liabilities | 2,032 | |
Convertible notes payable to related parties, net of discount | 4,821 | 4,574 |
Total current liabilities | 92,257 | 92,019 |
Non-current lease liabilities | 11,723 | |
Total liabilities | 103,980 | 92,019 |
Stockholders’ equity: | ||
Common stock | 789 | 782 |
Additional paid-in capital | 1,354,722 | 1,330,186 |
Accumulated other comprehensive income (loss) | 36 | (87) |
Accumulated deficit | (1,023,733) | (960,721) |
Total stockholders’ equity | 331,814 | 370,160 |
Total liabilities and stockholders’ equity | $ 435,794 | $ 462,179 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Net product sales | $ 31,602 | $ 11,567 |
Operating expenses: | ||
Cost of product sales | 14,962 | 3,133 |
Research and development | 42,972 | 39,561 |
General and administrative | 9,648 | 7,028 |
Sales and marketing | 28,720 | 13,835 |
Total operating expenses | 96,302 | 63,557 |
Loss from operations | (64,700) | (51,990) |
Other income (expense), net | 1,688 | (275) |
Net loss | (63,012) | (52,265) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on short-term investments | 123 | (32) |
Comprehensive loss | $ (62,889) | $ (52,297) |
Basic and diluted net loss per share (in dollars per share) | $ (0.80) | $ (0.81) |
Shares used in computing basic and diluted net loss per share (in shares) | 78,419 | 64,724 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ 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, 2017 | 64,609 | ||||
Balance at Dec. 31, 2017 | $ 646 | $ 913,955 | $ (10) | $ (783,455) | $ 131,136 |
Conversion benefit included in Convertible Notes issued | 96 | 96 | |||
Issuance of common stock on exercise of stock options (in shares) | 485 | ||||
Issuance of common stock on exercise of stock options | $ 4 | 4,198 | 4,202 | ||
Stock-based compensation expense | 7,701 | 7,701 | |||
Net loss | (52,265) | (52,265) | |||
Unrealized gain (loss) on short-term investments | (32) | (32) | |||
Comprehensive loss | (52,297) | ||||
Cumulative effect of adoption of new accounting standard at Dec. 31, 2017 | 1,573 | 1,573 | |||
Issuance of common stock in public offerings, net | (205) | (205) | |||
Balance (in shares) at Mar. 31, 2018 | 65,094 | ||||
Balance at Mar. 31, 2018 | $ 650 | 925,745 | (42) | (834,147) | 92,206 |
Balance (in shares) at Dec. 31, 2018 | 78,174 | ||||
Balance at Dec. 31, 2018 | $ 782 | 1,330,186 | (87) | (960,721) | 370,160 |
Conversion benefit included in Convertible Notes issued | 102 | $ 102 | |||
Issuance of common stock on exercise of stock options (in shares) | 732 | 732 | |||
Issuance of common stock on exercise of stock options | $ 7 | 6,532 | $ 6,539 | ||
Stock-based compensation expense | 17,902 | 17,902 | |||
Net loss | (63,012) | (63,012) | |||
Unrealized gain (loss) on short-term investments | 123 | 123 | |||
Comprehensive loss | (62,889) | ||||
Balance (in shares) at Mar. 31, 2019 | 78,906 | ||||
Balance at Mar. 31, 2019 | $ 789 | $ 1,354,722 | $ 36 | $ (1,023,733) | $ 331,814 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities: | ||
Net loss | $ (63,012,000) | $ (52,265,000) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Stock-based compensation expense | 17,902,000 | 7,701,000 |
Depreciation and amortization | 467,000 | 381,000 |
Amortization of debt discount | 247,000 | 210,000 |
Realized gain on short-term investments | (8,000) | 0 |
Accretion of discount on short-term investments | (1,357,000) | (211,000) |
Impairment on property and equipment | 27,000 | |
Loss on disposal of property and equipment | 52,000 | |
Change in operating assets and liabilities: | ||
Accounts receivable | (9,355,000) | 4,161,000 |
Prepaid expenses and other assets | (346,000) | (1,845,000) |
Inventory | 7,611,000 | (9,508,000) |
Accounts payable | (6,052,000) | (7,311,000) |
Accrued clinical and manufacturing liabilities | (868,000) | (1,986,000) |
Accrued payroll and employee liabilities | (6,757,000) | (3,612,000) |
Other accrued liabilities | 12,425,000 | 2,572,000 |
Net cash used for operating activities | (49,024,000) | (61,713,000) |
Investing activities: | ||
Purchases of short-term investments | (127,763,000) | (39,388,000) |
Maturities and sales of short-term investments | 164,009,000 | |
Purchases of property and equipment | (2,136,000) | (904,000) |
Net cash provided by (used for) investing activities | 34,110,000 | (40,292,000) |
Financing activities: | ||
Net proceeds from sale of common stock | (205,000) | |
Proceeds from stock option exercises | 6,539,000 | 4,202,000 |
Net cash provided by financing activities | 6,539,000 | 3,997,000 |
Net decrease in cash and cash equivalents | (8,375,000) | (98,008,000) |
Cash and cash equivalents at beginning of year | 31,836,000 | 144,583,000 |
Cash and cash equivalents at end of period | 23,461,000 | 46,575,000 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 500,000 | |
Cumulative effect of adoption of new accounting standard | $ 1,573,000 |
Note 1 - Business
Note 1 - Business | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | 1. We are 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 October 2016. On November 9, 2017, second 1 “NK1” NK1 80 January 2018. February 26, 2019, 30 2 HTX- 011, 011 011 five 011 fourth 2017 second 2018. 011 October 2018 December 2018. 011 April 30, 2019. not no April 2019, 011 011 first 2020. HTX- 034, 034 seven As of March 31, 2019 $289.2 March 31, 2019 one 10 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | 2 . Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information and with the instructions to Form 10 10 X. not three March 31, 2019 not may December 31, 2019. December 31, 2018 not 10 December 31, 2018, February 22, 2019. |
Note 3 - Accounting Policies
Note 3 - Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 3. Principles of Consolidation The accompanying unaudited condensed 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 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 the related reserves, accrued clinical liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates. Ca sh, Cash Equivalents and Short-t erm 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 a control agreement in accordance with our Senior Secured Convertible Notes (“Convertible Notes”) (see Note 8 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 Three Months March 31, 2019 As of March 31, 2019 Customer A 40.7 % 42.3 % Customer B 36.6 % 39.2 % Customer C 20.4 % 17.5 % Total 97.7 % 99.0 % 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, March 31, 2019, not As of March 31, 2019, not three March 31, 2019, not Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first first may Leases 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, We adopted ASC 842 January 1, 2019 No. 2018 11. not 12 842 no 7 We determine if an agreement is a lease or contains lease components at inception. Operating leases are recorded as lease liabilities with corresponding ROU lease assets on the condensed consolidated balance sheets. ROU lease assets represent our right to use the underlying assets over the lease term, and lease liabilities represent the present value of our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement based on the present value of lease payments over the lease term. As most of our leases do not Revenue Recognition In May 2014, No. 2014 09, Revenue from Contracts with Customers 606” 606 first 2018, 606 2018 606, $1.6 January 1, 2018. $2.9 $1.1 $0.2 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. 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 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, 2018 $ 947 $ 2,813 $ 21,743 $ 25,503 Provision 332 3,825 30,642 34,799 Payments/credits (3 ) (3,289 ) (22,945 ) (26,237 ) Balance at March 31, 2019 $ 1,276 $ 3,349 $ 29,440 $ 34,065 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 loss. Net L oss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, warrants and shares of common stock underlying Convertible Notes are considered to be common stock equivalents and are included in the calculation of diluted net loss per share only when their effect is dilutive. Because we have incurred a net loss for each of the periods presented in the unaudited condensed consolidated statements of operations and comprehensive loss, the following common stock equivalents were not March 31 , 2019 2018 Stock options outstanding 14,281 12,906 Warrants outstanding 640 640 Shares of common stock underlying Convertible Notes outstanding 8,600 8,103 Recent Accounting Pronouncements In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13” 2018 13 December 15, 2019, 2018 13 first 2020, In June 2016, No. 2016 13, Financial Instruments - Credit Losses (Topic 326 2016 13” 2016 13 December 15, 2019, 2016 13 first 2020, |
Note 4 - Fair Value Measurement
Note 4 - Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 4. 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 and Disclosures ● Level 1 ● Level 2 1 not ● Level 3 no We measure cash, cash equivalents and short-term investments at fair value on a recurring basis. The fair values of 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 March 31, Assets Inputs Inputs 201 9 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 23,461 $ 23,461 $ — $ — U.S. treasury bills and government agency obligations 89,283 89,283 — — U.S. corporate debt securities 51,310 — 51,310 — Foreign corporate debt securities 5,038 — 5,038 — U.S. commercial paper 50,176 — 50,176 — Foreign commercial paper 69,970 — 69,970 — Total $ 289,238 $ 112,744 $ 176,494 $ — 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 201 8 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 22,751 $ 22,751 $ — $ — 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 $ 332,371 $ 82,492 $ 249,879 $ — We have not three As of March 31, 2019, $265.8 three one December 31, 2018, $9.1 three $300.5 three one March 31, 2019 December 31, 2018 A company may not third not not Financial instruments, including cash, 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. Our Convertible Notes outstanding at March 31, 2019 not |
Note 5 - Short-term Investments
Note 5 - Short-term Investments | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] | 5. The following is a summary of our short-term investments (in thousands): March 31, 2019 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. treasury bills and government agency obligations $ 89,255 $ 28 $ — $ 89,283 U.S. corporate debt securities 51,311 — (1 ) 51,310 Foreign corporate debt securities 5,027 11 — 5,038 U.S. commercial paper 50,176 — — 50,176 Foreign commercial paper 69,972 — (2 ) 69,970 Total $ 265,741 $ 39 $ (3 ) $ 265,777 December 31, 2018 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 securities 59,164 — (77 ) 59,087 Foreign corporate debt securities 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 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 three March 31, 2019 2018. Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We recognized $8,000 three March 31, 2019. not three March 31, 2018. |
Note 6 - Inventory
Note 6 - Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 6. Inventory consists of the following (in thousands): March 31, 2019 Decemb er 31, 2018 Raw materials $ 9,379 $ 10,112 Work in process 14,770 20,604 Finished goods 7,272 8,316 Total inventory $ 31,421 $ 39,032 As of March 31, 2019, $4.2 $27.2 December 31, 2018, $6.7 $32.3 |
Note 7 - Leases
Note 7 - Leases | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 7. As of March 31, 2019, 81 two three On January 1, 2019, 842, $13.7 $14.5 81 not three March 31, 2019, $0.9 three March 31, 2019, $1.0 Future minimum lease payments under our operating leases are as follows (in thousands): Year Ending March 31, 2020 $ 2,941 2021 2,742 2022 2,821 2023 2,904 2024 2,988 Thereafter 2,514 Total future minimum lease payments $ 16,910 Less: discount (3,155 ) Total lease liabilities $ 13,755 |
Note 8 - Secured Notes to Relat
Note 8 - Secured Notes to Related Party | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | 8. 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 March 31, 2019, 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 three March 31, 2019, $0.1 $0.1 three March 31, 2019, 2018, $0.1 three March 31, 2019 2018, $0.2 As of March 31, 2019, $4.8 $6.9 $2.1 March 31, 2019, 8.6 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 three March 31, 2018, $0.5 August 2018, $25.0 $0.2 March 31, 2019, no |
Note 9 - Stockholders' Equity
Note 9 - Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 9. Common Stock Offering s In April 2018, 6.9 $26.00 $168.7 $10.7 In June 2018, 5.1 $39.50 $194.4 $5.6 Stock Option Activity The following table summarizes the stock option activity for the three March 31, 2019: Weighted- a verage Weighted- Remaining a verage Contractual Shares Exercise Term (in thousands) Price (Years) Balance at December 31, 2018 15,265 $ 18.33 6.87 Granted 253 $ 25.99 Exercised (732 ) $ 8.93 Expired and forfeited (505 ) $ 21.11 Balance at March 31, 2019 14,281 $ 18.85 7.19 For the three March 31, 2019, 732,000 $6.5 Stock-based Compensation 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): Three Months Ended March 31, 2019 2018 Research and development $ 5,324 $ 3,036 General and administrative 3,680 2,276 Sales and marketing 8,898 2,389 Total stock-based compensation expense $ 17,902 $ 7,701 As of March 31, 2019, $100.3 2.6 We estimated the fair value of each option grant on the grant date using the Black-Scholes option pricing model with the following weighted-average assumptions: March 31, 20 19 20 18 Risk-free interest rate 2.5 % 2.6 % Dividend yield 0.0 % 0.0 % Volatility 68.8 % 71.4 % Expected life (years) 6 6 We estimated the fair value of each purchase right granted under our 1997 no three March 31, 2019 2018. |
Note 10 - Income Taxes
Note 10 - Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 10 . Income Taxes Deferred income tax assets and liabilities are recognized for temporary differences between financial statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income tax assets, a full valuation allowance has been established. We continue to maintain a full valuation allowance against our deferred tax assets as of March 31, 2019. The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more likely than not not 10 December 31, 2018, February 22, 2019, three March 31, 2019. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The accompanying unaudited condensed 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 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 the related reserves, accrued clinical liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates. |
Cash, Cash Equivalents, and Short-Term Investments [Policy Text Block] | Ca sh, Cash Equivalents and Short-t erm 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 a control agreement in accordance with our Senior Secured Convertible Notes (“Convertible Notes”) (see Note 8 |
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 Three Months March 31, 2019 As of March 31, 2019 Customer A 40.7 % 42.3 % Customer B 36.6 % 39.2 % Customer C 20.4 % 17.5 % Total 97.7 % 99.0 % |
Receivable [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, March 31, 2019, not As of March 31, 2019, not three March 31, 2019, 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 |
Lessee, Leases [Policy Text Block] | Leases 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, We adopted ASC 842 January 1, 2019 No. 2018 11. not 12 842 no 7 We determine if an agreement is a lease or contains lease components at inception. Operating leases are recorded as lease liabilities with corresponding ROU lease assets on the condensed consolidated balance sheets. ROU lease assets represent our right to use the underlying assets over the lease term, and lease liabilities represent the present value of our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement based on the present value of lease payments over the lease term. As most of our leases do not |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition In May 2014, No. 2014 09, Revenue from Contracts with Customers 606” 606 first 2018, 606 2018 606, $1.6 January 1, 2018. $2.9 $1.1 $0.2 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. 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 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, 2018 $ 947 $ 2,813 $ 21,743 $ 25,503 Provision 332 3,825 30,642 34,799 Payments/credits (3 ) (3,289 ) (22,945 ) (26,237 ) Balance at March 31, 2019 $ 1,276 $ 3,349 $ 29,440 $ 34,065 |
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 loss. |
Earnings Per Share, Policy [Policy Text Block] | Net L oss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, warrants and shares of common stock underlying Convertible Notes are considered to be common stock equivalents and are included in the calculation of diluted net loss per share only when their effect is dilutive. Because we have incurred a net loss for each of the periods presented in the unaudited condensed consolidated statements of operations and comprehensive loss, the following common stock equivalents were not March 31 , 2019 2018 Stock options outstanding 14,281 12,906 Warrants outstanding 640 640 Shares of common stock underlying Convertible Notes outstanding 8,600 8,103 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13” 2018 13 December 15, 2019, 2018 13 first 2020, In June 2016, No. 2016 13, Financial Instruments - Credit Losses (Topic 326 2016 13” 2016 13 December 15, 2019, 2016 13 first 2020, |
Note 3 - Accounting Policies (T
Note 3 - Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Notes Tables | |
Schedules of Concentration of Risk, by Risk Factor [Table Text Block] | Net Product Sales Accounts Receivable Three Months March 31, 2019 As of March 31, 2019 Customer A 40.7 % 42.3 % Customer B 36.6 % 39.2 % Customer C 20.4 % 17.5 % Total 97.7 % 99.0 % |
Valuation Allowances and Reserves [Table Text Block] | Product Returns Distributor Fees Discounts, Rebates and Administrative Fees Total Balance at December 31, 2018 $ 947 $ 2,813 $ 21,743 $ 25,503 Provision 332 3,825 30,642 34,799 Payments/credits (3 ) (3,289 ) (22,945 ) (26,237 ) Balance at March 31, 2019 $ 1,276 $ 3,349 $ 29,440 $ 34,065 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | March 31 , 2019 2018 Stock options outstanding 14,281 12,906 Warrants outstanding 640 640 Shares of common stock underlying Convertible Notes outstanding 8,600 8,103 |
Note 4 - Fair Value Measureme_2
Note 4 - Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, Assets Inputs Inputs 201 9 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 23,461 $ 23,461 $ — $ — U.S. treasury bills and government agency obligations 89,283 89,283 — — U.S. corporate debt securities 51,310 — 51,310 — Foreign corporate debt securities 5,038 — 5,038 — U.S. commercial paper 50,176 — 50,176 — Foreign commercial paper 69,970 — 69,970 — Total $ 289,238 $ 112,744 $ 176,494 $ — 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 201 8 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 22,751 $ 22,751 $ — $ — 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 $ 332,371 $ 82,492 $ 249,879 $ — |
Note 5 - Short-term Investmen_2
Note 5 - Short-term Investments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Notes Tables | |
Debt Securities, Available-for-sale [Table Text Block] | March 31, 2019 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. treasury bills and government agency obligations $ 89,255 $ 28 $ — $ 89,283 U.S. corporate debt securities 51,311 — (1 ) 51,310 Foreign corporate debt securities 5,027 11 — 5,038 U.S. commercial paper 50,176 — — 50,176 Foreign commercial paper 69,972 — (2 ) 69,970 Total $ 265,741 $ 39 $ (3 ) $ 265,777 December 31, 2018 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 securities 59,164 — (77 ) 59,087 Foreign corporate debt securities 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 |
Note 6 - Inventory (Tables)
Note 6 - Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | March 31, 2019 Decemb er 31, 2018 Raw materials $ 9,379 $ 10,112 Work in process 14,770 20,604 Finished goods 7,272 8,316 Total inventory $ 31,421 $ 39,032 |
Note 7 - Leases (Tables)
Note 7 - Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Notes Tables | |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Year Ending March 31, 2020 $ 2,941 2021 2,742 2022 2,821 2023 2,904 2024 2,988 Thereafter 2,514 Total future minimum lease payments $ 16,910 Less: discount (3,155 ) Total lease liabilities $ 13,755 |
Note 9 - Stockholders' Equity (
Note 9 - Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Notes Tables | |
Share-based Payment Arrangement, Option, Activity [Table Text Block] | Weighted- a verage Weighted- Remaining a verage Contractual Shares Exercise Term (in thousands) Price (Years) Balance at December 31, 2018 15,265 $ 18.33 6.87 Granted 253 $ 25.99 Exercised (732 ) $ 8.93 Expired and forfeited (505 ) $ 21.11 Balance at March 31, 2019 14,281 $ 18.85 7.19 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended March 31, 2019 2018 Research and development $ 5,324 $ 3,036 General and administrative 3,680 2,276 Sales and marketing 8,898 2,389 Total stock-based compensation expense $ 17,902 $ 7,701 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | March 31, 20 19 20 18 Risk-free interest rate 2.5 % 2.6 % Dividend yield 0.0 % 0.0 % Volatility 68.8 % 71.4 % Expected life (years) 6 6 |
Note 1 - Business (Details Text
Note 1 - Business (Details Textual) $ in Millions | Mar. 31, 2019USD ($) |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 289.2 |
Note 3 - Accounting Policies (D
Note 3 - Accounting Policies (Details Textual) - USD ($) $ in Thousands | Jan. 01, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 1,573 | ||||
Revenue from Contract with Customer, Including Assessed Tax | $ 31,602 | $ 11,567 | |||
SEC Schedule, 12-09, Valuation Allowances and Reserves, Amount, Ending Balance | 34,065 | $ 25,503 | |||
Cost of Goods and Services Sold, Total | $ 14,962 | $ 3,133 | |||
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 | $ 1,573 | ||||
Retained Earnings [Member] | Accounting Standards Update 2014-09 [Member] | |||||
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 1,600 |
Note 3 - Accounting Policies -
Note 3 - Accounting Policies - Percentage of Net Product Sales and Accounts Receivable Balance (Details) - Customer Concentration Risk [Member] | 3 Months Ended |
Mar. 31, 2019 | |
Revenue Benchmark [Member] | |
Concentration risk percentage | 97.70% |
Revenue Benchmark [Member] | Largest Customer [Member] | |
Concentration risk percentage | 40.70% |
Revenue Benchmark [Member] | Second Largest Customer [Member] | |
Concentration risk percentage | 36.60% |
Revenue Benchmark [Member] | Third Largest Customer [Member] | |
Concentration risk percentage | 20.40% |
Accounts Receivable [Member] | |
Concentration risk percentage | 99.00% |
Accounts Receivable [Member] | Largest Customer [Member] | |
Concentration risk percentage | 42.30% |
Accounts Receivable [Member] | Second Largest Customer [Member] | |
Concentration risk percentage | 39.20% |
Accounts Receivable [Member] | Third Largest Customer [Member] | |
Concentration risk percentage | 17.50% |
Note 3 - Accounting Policies _2
Note 3 - Accounting Policies - Summary of Product Sales Allowance (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Balance | $ 25,503 |
Provision | 34,799 |
Payments/credits | (26,237) |
Balance | 34,065 |
Allowance for Sales Returns 1 [Member] | |
Balance | 947 |
Provision | 332 |
Payments/credits | (3) |
Balance | 1,276 |
Allowance for Distributor Fees [Member] | |
Balance | 2,813 |
Provision | 3,825 |
Payments/credits | (3,289) |
Balance | 3,349 |
Allowance for Rebates and Chargebacks [Member] | |
Balance | 21,743 |
Provision | 30,642 |
Payments/credits | (22,945) |
Balance | $ 29,440 |
Note 3 - Accounting Policies _3
Note 3 - Accounting Policies - Securities Excluded From Calculation of Diluted Earnings Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Payment Arrangement, Option [Member] | ||
Shares excluded (in shares) | 14,281 | 12,906 |
Warrant [Member] | ||
Shares excluded (in shares) | 640 | 640 |
Convertible Debt Securities [Member] | ||
Shares excluded (in shares) | 8,600 | 8,103 |
Note 4 - Fair Value Measureme_3
Note 4 - Fair Value Measurements (Details Textual) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Cash Equivalents, at Carrying Value, Total | $ 265,800 | $ 9,100 |
Available-for-sale Securities, Current, Total | $ 265,777 | $ 300,535 |
Note 4 - Fair Value Measureme_4
Note 4 - Fair Value Measurements - Financial Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Available-for-sale securities | $ 265,777 | $ 300,535 |
US Treasury Securities [Member] | ||
Available-for-sale securities | 89,283 | 59,741 |
Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 51,310 | 59,087 |
Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 5,038 | 5,046 |
United States Commercial Paper [Member] | ||
Available-for-sale securities | 50,176 | 52,800 |
Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 69,970 | 123,861 |
Fair Value, Recurring [Member] | ||
Total | 289,238 | 332,371 |
Fair Value, Recurring [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 69,970 | 123,861 |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | 89,283 | 59,741 |
Fair Value, Recurring [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 51,310 | 59,087 |
Fair Value, Recurring [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 5,038 | 5,046 |
Fair Value, Recurring [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | 50,176 | 61,885 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Total | 112,744 | 82,492 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | 89,283 | 59,741 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Total | 176,494 | 249,879 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 51,310 | 59,087 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 5,038 | 5,046 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | 50,176 | 61,885 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 69,970 | 123,861 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Recurring [Member] | Money Market Funds [Member] | ||
Cash and money market funds | 23,461 | 22,751 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and money market funds | 23,461 | 22,751 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and money market funds | ||
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and money market funds |
Note 5 - Short-term Investmen_3
Note 5 - Short-term Investments (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Other-than-temporary Impairment Loss, Debt Securities, Available-for-sale, Total | $ 0 | $ 0 |
Debt Securities, Available-for-sale, Realized Gain (Loss), Total | $ 8,000 | $ 0 |
Note 5 - Short-term Investmen_4
Note 5 - Short-term Investments - Summary of Short-term Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Available-for-sale securities, amortized cost | $ 265,741 | $ 300,622 |
Available-for-sale securities, gross unrealized gains | 39 | 5 |
Available-for-sale securities, gross unrealized losses | (3) | (92) |
Available-for-sale securities | 265,777 | 300,535 |
US Treasury Securities [Member] | ||
Available-for-sale securities, amortized cost | 89,255 | 59,747 |
Available-for-sale securities, gross unrealized gains | 28 | |
Available-for-sale securities, gross unrealized losses | (6) | |
Available-for-sale securities | 89,283 | 59,741 |
Debt Security, Corporate, US [Member] | ||
Available-for-sale securities, amortized cost | 51,311 | 59,164 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (1) | (77) |
Available-for-sale securities | 51,310 | 59,087 |
Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities, amortized cost | 5,027 | 5,041 |
Available-for-sale securities, gross unrealized gains | 11 | 5 |
Available-for-sale securities, gross unrealized losses | ||
Available-for-sale securities | 5,038 | 5,046 |
United States Commercial Paper [Member] | ||
Available-for-sale securities, amortized cost | 50,176 | 52,800 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | ||
Available-for-sale securities | 50,176 | 52,800 |
Foreign Commercial Paper [Member] | ||
Available-for-sale securities, amortized cost | 69,972 | 123,870 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (2) | (9) |
Available-for-sale securities | $ 69,970 | $ 123,861 |
Note 6 - Inventory (Details Tex
Note 6 - Inventory (Details Textual) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory, Net, Total | $ 31,421 | $ 39,032 |
SUSTOL [Member] | ||
Inventory, Net, Total | 4,200 | 6,700 |
CINVANTI [Member] | ||
Inventory, Net, Total | $ 27,200 | $ 32,300 |
Note 6 - Inventory - Inventory
Note 6 - Inventory - Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Raw materials | $ 9,379 | $ 10,112 |
Work in process | 14,770 | 20,604 |
Finished goods | 7,272 | 8,316 |
Total inventory | $ 31,421 | $ 39,032 |
Note 7 - Leases (Details Textua
Note 7 - Leases (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | |
Operating Lease, Right-of-Use Asset | $ 13,068 | ||
Operating Lease, Liability, Total | $ 13,755 | ||
Operating Lease, Weighted Average Remaining Lease Term | 6 years 270 days | ||
Operating Lease, Expense | $ 900 | ||
Operating Lease, Payments | $ 1,000 | ||
Accounting Standards Update 2016-02 [Member] | |||
Operating Lease, Right-of-Use Asset | $ 13,700 | ||
Operating Lease, Liability, Total | $ 14,500 | ||
Minimum [Member] | |||
Lessee, Operating Lease, Term of Contract | 60 days |
Note 7 - Leases - Future Minimu
Note 7 - Leases - Future Minimum Lease Payments (Details) $ in Thousands | Mar. 31, 2019USD ($) |
2020 | $ 2,941 |
2021 | 2,742 |
2022 | 2,821 |
2023 | 2,904 |
2024 | 2,988 |
Thereafter | 2,514 |
Total future minimum lease payments | 16,910 |
Less: discount | (3,155) |
Total lease liabilities | $ 13,755 |
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 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 |
Convertible Debt Issuable in Connection with Private Placement | $ 4,500,000 | ||||||||
Proceeds from Convertible Debt | $ 4,300,000 | ||||||||
Amortization of Debt Discount (Premium) | $ 247,000 | $ 210,000 | |||||||
Convertible Notes Payable, Related Parties, Current | 4,821,000 | $ 4,574,000 | |||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | 500,000 | ||||||||
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 | 100,000 | ||||||||
Debt Instrument, Increase (Decrease), Other, Net | 100,000 | ||||||||
Interest Expense, Debt, Excluding Amortization | 100,000 | 100,000 | |||||||
Amortization of Debt Discount (Premium) | 200,000 | 200,000 | |||||||
Debt Instrument, Face Amount | 6,900,000 | ||||||||
Debt Instrument, Unamortized Discount, Total | $ 2,100,000 | ||||||||
Debt Instrument, Convertible, Number Shares of Equity Insturments | 8,600,000 | ||||||||
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 | $ 500,000 | ||||||||
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 Thousands | 1 Months Ended | 3 Months Ended | ||
Jun. 30, 2018 | Apr. 30, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Proceeds from Issuance of Common Stock | $ 194,400 | $ 168,700 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Net | 732,000 | |||
Proceeds from Stock Options Exercised | $ 6,539 | $ 4,202 | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 100,300 | |||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 219 days | |||
Common Stock [Member] | ||||
Stock Issued During Period, Shares, New Issues | 5,100,000 | 6,900,000 | ||
Share Price | $ 39.50 | $ 26 | ||
Payments of Stock Issuance Costs | $ 5,600 | $ 10,700 |
Note 9 - Stockholders' Equity -
Note 9 - Stockholders' Equity - Stock Option Activity (Details) - $ / shares shares in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Number of shares outstanding (in shares) | 15,265 | |
Number of shares outstanding, weighted average exercise price (in dollars per share) | $ 18.33 | |
Number of shares outstanding, weighted average remaining contractual term (Year) | 7 years 69 days | 6 years 317 days |
Number of shares granted (in shares) | 253 | |
Number of shares granted, weighted average exercise price (in dollars per share) | $ 25.99 | |
Number of shares exercised (in shares) | (732) | |
Number of shares exercised, weighted average exercise price (in dollars per share) | $ 8.93 | |
Expired and forfeited (in shares) | (505) | |
Number of shares expired and forfeited, weighted average exercise price (in dollars per share) | $ 21.11 | |
Number of shares outstanding (in shares) | 14,281 | 15,265 |
Number of shares outstanding, weighted average exercise price (in dollars per share) | $ 18.85 | $ 18.33 |
Note 9 - Stockholders' Equity_3
Note 9 - Stockholders' Equity - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Stock-based compensation expense | $ 17,902 | $ 7,701 |
Research and Development Expense [Member] | ||
Stock-based compensation expense | 5,324 | 3,036 |
General and Administrative Expense [Member] | ||
Stock-based compensation expense | 3,680 | 2,276 |
Selling and Marketing Expense [Member] | ||
Stock-based compensation expense | $ 8,898 | $ 2,389 |
Note 9 - Stockholders' Equity_4
Note 9 - Stockholders' Equity - Valuation Assumptions (Details) - Share-based Payment Arrangement, Option [Member] | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Risk-free interest rate | 2.50% | 2.60% |
Dividend yield | 0.00% | 0.00% |
Volatility | 68.80% | 71.40% |
Expected life (Year) | 6 years | 6 years |