Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 26, 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 Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Common Stock, Shares Outstanding (in shares) | 78,019,031 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
ASSETS | ||
Cash and cash equivalents | $ 53,934 | $ 144,583 |
Short-term investments | 310,866 | 27,796 |
Accounts receivable, net | 53,633 | 41,874 |
Inventory | 31,412 | 10,108 |
Prepaid expenses and other current assets | 10,217 | 3,702 |
Total current assets | 460,062 | 228,063 |
Property and equipment, net | 10,581 | 5,981 |
Other assets | 253 | 263 |
Total assets | 470,896 | 234,307 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Accounts payable | 9,644 | 18,769 |
Accrued clinical liabilities | 14,281 | 26,920 |
Accrued payroll and employee liabilities | 8,457 | 8,860 |
Other accrued liabilities | 27,368 | 17,175 |
Deferred revenue | 2,763 | |
Promissory note payable to related party | 25,000 | |
Convertible notes payable to related parties, net of discount | 4,338 | 3,684 |
Total current liabilities | 64,088 | 103,171 |
Stockholders’ equity: | ||
Common stock | 780 | 646 |
Additional paid-in capital | 1,317,232 | 913,955 |
Accumulated other comprehensive loss | (42) | (10) |
Accumulated deficit | (911,162) | (783,455) |
Total stockholders’ equity | 406,808 | 131,136 |
Total liabilities and stockholders’ equity | $ 470,896 | $ 234,307 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenues: | ||||
Net product sales | $ 19,786 | $ 8,572 | $ 48,630 | $ 20,714 |
Operating expenses: | ||||
Cost of product sales | 7,576 | 1,051 | 15,940 | 3,250 |
Research and development | 30,421 | 28,844 | 100,141 | 90,825 |
General and administrative | 7,288 | 6,462 | 20,525 | 19,389 |
Sales and marketing | 16,281 | 13,529 | 44,647 | 39,918 |
Total operating expenses | 61,566 | 49,886 | 181,253 | 153,382 |
Loss from operations | (41,780) | (41,314) | (132,623) | (132,668) |
Other income (expense), net | 3,434 | (552) | 3,342 | (2,326) |
Net loss | (38,346) | (41,866) | (129,281) | (134,994) |
Other comprehensive income (loss): | ||||
Unrealized gains (losses) on short-term investments | (17) | 6 | (32) | 17 |
Comprehensive loss | $ (38,363) | $ (41,860) | $ (129,313) | $ (134,977) |
Basic and diluted net loss per share (in dollars per share) | $ (0.49) | $ (0.77) | $ (1.81) | $ (2.55) |
Shares used in computing basic and diluted net loss per share (in shares) | 77,811 | 54,176 | 71,544 | 52,846 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating activities: | ||
Net loss | $ (129,281) | $ (134,994) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Stock-based compensation expense | 23,572 | 23,647 |
Depreciation and amortization | 1,093 | 1,146 |
Amortization of debt discount | 654 | 570 |
(Gain) Loss on disposal of property and equipment | 3 | (7) |
Accretion of discount on short-term investments | (1,920) | (259) |
Change in operating assets and liabilities: | ||
Accounts receivable | (11,759) | (26,891) |
Prepaid expenses and other current assets | (6,505) | (849) |
Inventory | (21,502) | 171 |
Accounts payable | (9,125) | (1,477) |
Accrued clinical liabilities | (12,639) | 2,310 |
Accrued payroll and employee liabilities | (403) | (564) |
Deferred revenue | 4,461 | |
Other accrued liabilities | 9,494 | 9,585 |
Net cash used for operating activities | (158,318) | (123,151) |
Investing activities: | ||
Purchases of short-term investments | (400,382) | (93,776) |
Maturities and sales of short-term investments | 119,200 | 123,284 |
Purchases of property and equipment | (5,696) | (1,419) |
Proceeds from the sale of property and equipment | 13 | |
Net cash (used for) provided by investing activities | (286,878) | 28,102 |
Financing activities: | ||
Net proceeds from sale of common stock | 363,128 | 163,747 |
Repayment of promissory note payable to related party | (25,000) | (25,000) |
Proceeds from stock option exercises | 15,771 | 7,836 |
Proceeds from purchases under the Employee Stock Purchase Plan | 648 | 576 |
Net cash provided by financing activities | 354,547 | 147,159 |
Net (decrease) increase in cash and cash equivalents | (90,649) | 52,110 |
Cash and cash equivalents at beginning of year | 144,583 | 13,414 |
Cash and cash equivalents at end of period | 53,934 | 65,524 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 1,183 | 2,289 |
Cumulative effect of adoption of new accounting standard | $ 1,574 |
Note 1 - Business
Note 1 - Business | 9 Months Ended |
Sep. 30, 2018 | |
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. HTX- 011, 011 011 five 011 fourth 2017 second 2018. 011. As of September 30, 2018, $364.8 September 30, 2018 one 10 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 9 Months Ended |
Sep. 30, 2018 | |
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 nine September 30, 2018 not may December 31, 2018. December 31, 2017 not 10 December 31, 2017, February 27, 2018. |
Note 3 - Accounting Policies
Note 3 - Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 3 . Accounting Policies 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, 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 control agreements in accordance with our Senior Secured Convertible Notes (“Convertible Notes”) and our Subordinated Secured Promissory Note (“Promissory Note”) (see Note 10 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 Ended September 30, 2018 Nine Months Ended September 30, 2018 As of September 30, 2018 Customer A 23.2 % 42.6 % 45.4 % Customer B 44.1 % 30.6 % 36.1 % Customer C 32.0 % 26.4 % 18.3 % Total 99.3 % 99.6 % 99.8 % 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, September 30, 2018, not As of September 30, 2018, not three nine September 30, 2018, not Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first first may 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 7 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 for all periods presented. 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 As of September 30 , 2018 2017 Stock options outstanding 12,300 11,198 Warrants outstanding 640 620 Shares of common stock underlying Convertible Notes outstanding 8,348 7,865 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, In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13” 2018 13 December 15, 2019, 2018 13 first 2020, |
Note 4 - Fair Value Measurement
Note 4 - Fair Value Measurements | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30 , Assets Inputs Inputs 201 8 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 37,456 $ 37,456 $ — $ — U.S. treasury bills and government agency obligations 69,598 69,598 — — U.S. corporate debt securities 67,048 — 67,048 — Foreign corporate debt securities 6,993 — 6,993 — U.S. commercial paper 64,253 — 64,253 — Foreign commercial paper 119,452 — 119,452 — Total $ 364,800 $ 107,054 $ 257,746 $ — 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 7 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 95,142 $ 95,142 $ — $ — 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 $ 172,379 $ 95,142 $ 77,237 $ — We have not three As of September 30, 2018, $16.4 three $310.9 three one December 31, 2017, $49.4 three $27.8 three one September 30, 2018 December 31, 2017 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. |
Note 5 - Short-term Investments
Note 5 - Short-term Investments | 9 Months Ended |
Sep. 30, 2018 | |
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): September 30, 2018 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. treasury bills and government agency obligations $ 69,602 $ — $ (4 ) $ 69,598 U.S. corporate debt securities 67,084 — (36 ) 67,048 Foreign corporate debt securities 6,995 — (2 ) 6,993 U.S. commercial paper 55,261 — — 55,261 Foreign commercial paper 111,966 — — 111,966 Total $ 310,908 $ — $ (42 ) $ 310,866 D ecember 31, 2017 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 three nine September 30, 2018 2017. Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We did not three nine September 30, 2018 2017. |
Note 6 - Inventory
Note 6 - Inventory | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 6. Inventory consists of the following (in thousands): September 30, 2018 December 31, 2017 Raw materials $ 9,437 $ 2,754 Work in process 13,203 4,166 Finished goods 8,772 3,188 Total inventory $ 31,412 $ 10,108 Prior to FDA approval, $1.4 March 31, 2018, |
Note 7 - Revenue Recognition
Note 7 - Revenue Recognition | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 7 . 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, and 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 U nder Topic 605 Effect of Change As Adjusted U nder Topic 606 Inventory $ 10,108 $ (198 ) $ 9,910 Other accrued liabilities 17,175 991 18,166 Deferred revenue 2,763 (2,763 ) — Retained earnings (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 R eported U nder Topic 606 Effect of Change As Revised Under Topic 605 Consolidated Balance Sheet as of September 30, 2018 Inventory $ 31,412 $ 1,954 $ 33,366 Other accrued liabilities 27,368 (4,628 ) 22,740 Deferred revenue — 10,524 10,524 Retained earnings (911,162 ) (3,942 ) (915,104 ) Consolidated Statement of Operations for the Three Months Ended September 30, 2018 Net product sales $ 19,786 $ 177 $ 19,963 Cost of product sales 7,576 (328 ) 7,248 Loss from operations (41,780 ) 505 (41,275 ) Net loss (38,346 ) 505 (37,841 ) Basic and diluted net loss per share (0.49 ) — (0.49 ) Consolidated Statement of Operations for the Nine Months Ended September 30, 2018 Net product sales $ 48,630 $ (4,124 ) $ 44,506 Cost of product sales 15,940 (1,756 ) 14,184 Loss from operations (132,623 ) (2,368 ) (134,991 ) Net loss (129,281 ) (2,368 ) (131,649 ) Basic and diluted net loss per share (1.81 ) (0.03 ) (1.84 ) Consolidated Statement of Cash Flows for the Nine Months Ended September 30, 2018 Net loss $ (129,281 ) $ (2,368 ) $ (131,649 ) Adjustments to reconcile net loss to net cash used in operating activities: Inventory (21,502 ) (1,756 ) (23,258 ) Other accrued liabilities 9,494 (3,637 ) (5,857 ) Deferred revenue — 7,761 7,761 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 GPO’s 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 for the nine September 30, 2018, Product Returns Distributor Fees Discounts, Rebates and Administrative Fees Total Balance at December 31, 2017 $ 521 $ 580 $ 8,218 $ 9,319 Provision 178 4,342 33,764 38,284 Payments/credits (18 ) (3,145 ) (25,619 ) (28,782 ) Balance at September 30, 2018 $ 681 $ 1,777 $ 16,363 $ 18,821 |
Note 8 - Leases
Note 8 - Leases | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Leases of Lessee Disclosure [Text Block] | 8. On May 8, 2018, AP3 SD1 October 18, 2016, March 15, 2017 4242 87 $0.9 first 12 $1.4 three $0.1 The following table shows the annual future minimum lease payments under all of our operating leases as of September 30, 2018 ( Period ending September 30: 2019 $ 3,335 2020 2,702 2021 2,781 2022 2,862 2023 2,946 Thereafter 4,026 Total future minimum lease payments $ 18,652 |
Note 9 - Realignment of Goals a
Note 9 - Realignment of Goals and Objectives and New Development Focus | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Restructuring and Related Activities Disclosure [Text Block] | 9. 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 $9.6 $5.7 $3.9 September 30, 2016 December 31, 2017. We expect to make the final payment resulting from the realignment of our goals and objectives and new development focus in the first 2019. September 30, 2018, $5.5 $5.7 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 10 - Secured Notes to Rela
Note 10 - Secured Notes to Related Party | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | 10. 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 a rate of 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 September 30, 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 nine September 30, 2018, $0.3 $0.3 three September 30, 2018 2017, $0.1 $0.2 nine September 30, 2018 2017, $0.3 $0.6 As of September 30, 2018, $4.3 $6.6 $2.3 September 30, 2018, 8.3 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 nine September 30, 2018, $0.2 $1.2 $0.5 $2.3 2017, August 2018, $25.0 $0.2 September 30, 2018, no |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 11. Common Stock Offering s In January 2017, 14.1 $12.20 $163.7 $8.8 In December 2017, 9.7 $15.50 $142.6 $7.4 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 nine September 30, 2018: Weighted- a verage Weighted- Remaining a verage Contractual Shares Exercise Term (in thousands) Price (Years) Balance at December 31, 2017 13,463 $ 15.03 8.01 Granted 725 $ 32.42 Exercised (1,332 ) $ 11.84 Expired and forfeited (556 ) $ 17.94 Balance at September 30, 2018 12,300 $ 16.27 7.50 For the nine September 30, 2018, 1,332,000 $15.8 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 September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 3,212 $ 2,595 $ 9,363 $ 8,758 General and administrative 2,366 2,419 6,950 7,345 Sales and marketing 2,472 2,462 7,259 7,544 Total stock-based compensation expense $ 8,050 $ 7,476 $ 23,572 $ 23,647 As of September 30, 2018, $73.8 2.5 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: September 30 , 20 18 20 17 Risk-free interest rate 2.8 % 2.0 % Dividend yield 0.0 % 0.0 % Volatility 70.5 % 80.2 % Expected life (years) 6 6 We estimated the fair value of each purchase right granted under our 1997 no three September 30, 2018 2017. |
Note 12 - Income Taxes
Note 12 - Income Taxes | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 1 2 . 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 September 30, 2018. 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 2017, 2016 09, $3.6 10 December 31, 2017, February 27, 2018, three nine September 30, 2018. |
Note 13 - Other Income (Expense
Note 13 - Other Income (Expense), Net | 9 Months Ended |
Sep. 30, 2018 | |
Notes to Financial Statements | |
Other Nonoperating Income and Expense [Text Block] | 13. Other Income (Expense), Net In the third 2018, $1.9 16 1934. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
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, 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 control agreements in accordance with our Senior Secured Convertible Notes (“Convertible Notes”) and our Subordinated Secured Promissory Note (“Promissory Note”) (see Note 10 |
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 Ended September 30, 2018 Nine Months Ended September 30, 2018 As of September 30, 2018 Customer A 23.2 % 42.6 % 45.4 % Customer B 44.1 % 30.6 % 36.1 % Customer C 32.0 % 26.4 % 18.3 % Total 99.3 % 99.6 % 99.8 % |
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, September 30, 2018, not As of September 30, 2018, not three nine September 30, 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 |
Revenue Recognition, Policy [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 7 |
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 for all periods presented. |
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 As of September 30 , 2018 2017 Stock options outstanding 12,300 11,198 Warrants outstanding 640 620 Shares of common stock underlying Convertible Notes outstanding 8,348 7,865 |
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, In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13” 2018 13 December 15, 2019, 2018 13 first 2020, |
Note 3 - Accounting Policies (T
Note 3 - Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes Tables | |
Schedules of Concentration of Risk, by Risk Factor [Table Text Block] | Net Product Sales Accounts Receivable Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 As of September 30, 2018 Customer A 23.2 % 42.6 % 45.4 % Customer B 44.1 % 30.6 % 36.1 % Customer C 32.0 % 26.4 % 18.3 % Total 99.3 % 99.6 % 99.8 % |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | As of September 30 , 2018 2017 Stock options outstanding 12,300 11,198 Warrants outstanding 640 620 Shares of common stock underlying Convertible Notes outstanding 8,348 7,865 |
Note 4 - Fair Value Measureme_2
Note 4 - Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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 September 30 , Assets Inputs Inputs 201 8 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 37,456 $ 37,456 $ — $ — U.S. treasury bills and government agency obligations 69,598 69,598 — — U.S. corporate debt securities 67,048 — 67,048 — Foreign corporate debt securities 6,993 — 6,993 — U.S. commercial paper 64,253 — 64,253 — Foreign commercial paper 119,452 — 119,452 — Total $ 364,800 $ 107,054 $ 257,746 $ — 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 7 (Level 1) (Level 2) (Level 3) Cash and money market funds $ 95,142 $ 95,142 $ — $ — 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 $ 172,379 $ 95,142 $ 77,237 $ — |
Note 5 - Short-term Investmen_2
Note 5 - Short-term Investments (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes Tables | |
Debt Securities, Available-for-sale [Table Text Block] | September 30, 2018 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. treasury bills and government agency obligations $ 69,602 $ — $ (4 ) $ 69,598 U.S. corporate debt securities 67,084 — (36 ) 67,048 Foreign corporate debt securities 6,995 — (2 ) 6,993 U.S. commercial paper 55,261 — — 55,261 Foreign commercial paper 111,966 — — 111,966 Total $ 310,908 $ — $ (42 ) $ 310,866 D ecember 31, 2017 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 |
Note 6 - Inventory (Tables)
Note 6 - Inventory (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | September 30, 2018 December 31, 2017 Raw materials $ 9,437 $ 2,754 Work in process 13,203 4,166 Finished goods 8,772 3,188 Total inventory $ 31,412 $ 10,108 |
Note 7 - Revenue Recognition (T
Note 7 - Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes Tables | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles [Table Text Block] | As Reported U nder Topic 605 Effect of Change As Adjusted U nder Topic 606 Inventory $ 10,108 $ (198 ) $ 9,910 Other accrued liabilities 17,175 991 18,166 Deferred revenue 2,763 (2,763 ) — Retained earnings (783,455 ) 1,574 (781,881 ) As R eported U nder Topic 606 Effect of Change As Revised Under Topic 605 Consolidated Balance Sheet as of September 30, 2018 Inventory $ 31,412 $ 1,954 $ 33,366 Other accrued liabilities 27,368 (4,628 ) 22,740 Deferred revenue — 10,524 10,524 Retained earnings (911,162 ) (3,942 ) (915,104 ) Consolidated Statement of Operations for the Three Months Ended September 30, 2018 Net product sales $ 19,786 $ 177 $ 19,963 Cost of product sales 7,576 (328 ) 7,248 Loss from operations (41,780 ) 505 (41,275 ) Net loss (38,346 ) 505 (37,841 ) Basic and diluted net loss per share (0.49 ) — (0.49 ) Consolidated Statement of Operations for the Nine Months Ended September 30, 2018 Net product sales $ 48,630 $ (4,124 ) $ 44,506 Cost of product sales 15,940 (1,756 ) 14,184 Loss from operations (132,623 ) (2,368 ) (134,991 ) Net loss (129,281 ) (2,368 ) (131,649 ) Basic and diluted net loss per share (1.81 ) (0.03 ) (1.84 ) Consolidated Statement of Cash Flows for the Nine Months Ended September 30, 2018 Net loss $ (129,281 ) $ (2,368 ) $ (131,649 ) Adjustments to reconcile net loss to net cash used in operating activities: Inventory (21,502 ) (1,756 ) (23,258 ) Other accrued liabilities 9,494 (3,637 ) (5,857 ) Deferred revenue — 7,761 7,761 |
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 178 4,342 33,764 38,284 Payments/credits (18 ) (3,145 ) (25,619 ) (28,782 ) Balance at September 30, 2018 $ 681 $ 1,777 $ 16,363 $ 18,821 |
Note 8 - Leases (Tables)
Note 8 - Leases (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Period ending September 30: 2019 $ 3,335 2020 2,702 2021 2,781 2022 2,862 2023 2,946 Thereafter 4,026 Total future minimum lease payments $ 18,652 |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes Tables | |
Share-based Compensation, Stock Options, Activity [Table Text Block] | Weighted- a verage Weighted- Remaining a verage Contractual Shares Exercise Term (in thousands) Price (Years) Balance at December 31, 2017 13,463 $ 15.03 8.01 Granted 725 $ 32.42 Exercised (1,332 ) $ 11.84 Expired and forfeited (556 ) $ 17.94 Balance at September 30, 2018 12,300 $ 16.27 7.50 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 3,212 $ 2,595 $ 9,363 $ 8,758 General and administrative 2,366 2,419 6,950 7,345 Sales and marketing 2,472 2,462 7,259 7,544 Total stock-based compensation expense $ 8,050 $ 7,476 $ 23,572 $ 23,647 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | September 30 , 20 18 20 17 Risk-free interest rate 2.8 % 2.0 % Dividend yield 0.0 % 0.0 % Volatility 70.5 % 80.2 % Expected life (years) 6 6 |
Note 1 - Business (Details Text
Note 1 - Business (Details Textual) $ in Millions | Sep. 30, 2018USD ($) |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 364.8 |
Note 3 - Accounting Policies (D
Note 3 - Accounting Policies (Details Textual) - USD ($) $ in Thousands | Jan. 01, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Revenue from Contract with Customer, Including Assessed Tax | $ 19,786 | $ 8,572 | $ 48,630 | $ 20,714 | ||
SEC Schedule, 12-09, Valuation Allowances and Reserves, Amount, Ending Balance | 18,821 | 18,821 | $ 9,319 | |||
Cost of Goods and Services Sold, Total | $ 7,576 | $ 1,051 | $ 15,940 | $ 3,250 | ||
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] | 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 | 9 Months Ended |
Sep. 30, 2018 | Sep. 30, 2018 | |
Sales Revenue, Net [Member] | ||
Concentration risk percentage | 99.30% | 99.60% |
Sales Revenue, Net [Member] | Largest Customer [Member] | ||
Concentration risk percentage | 23.20% | 42.60% |
Sales Revenue, Net [Member] | Second Largest Customer [Member] | ||
Concentration risk percentage | 44.10% | 30.60% |
Sales Revenue, Net [Member] | Third Largest Customer [Member] | ||
Concentration risk percentage | 32.00% | 26.40% |
Accounts Receivable [Member] | ||
Concentration risk percentage | 99.80% | |
Accounts Receivable [Member] | Largest Customer [Member] | ||
Concentration risk percentage | 45.40% | |
Accounts Receivable [Member] | Second Largest Customer [Member] | ||
Concentration risk percentage | 36.10% | |
Accounts Receivable [Member] | Third Largest Customer [Member] | ||
Concentration risk percentage | 18.30% |
Note 3 - Accounting Policies _2
Note 3 - Accounting Policies - Securities Excluded From Calculation of Diluted Earnings Per Share (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Employee Stock Option [Member] | ||
Shares excluded (in shares) | 12,300 | 11,198 |
Warrant [Member] | ||
Shares excluded (in shares) | 640 | 620 |
Convertible Debt Securities [Member] | ||
Shares excluded (in shares) | 8,348 | 7,865 |
Note 4 - Fair Value Measureme_3
Note 4 - Fair Value Measurements (Details Textual) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Cash Equivalents, at Carrying Value, Total | $ 16,400 | $ 49,400 |
Available-for-sale Securities, Current, Total | $ 310,866 | $ 27,796 |
Note 4 - Fair Value Measureme_4
Note 4 - Fair Value Measurements - Financial Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Available-for-sale securities | $ 310,866 | $ 27,796 |
US Treasury Securities [Member] | ||
Available-for-sale securities | 69,598 | |
Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 67,048 | 12,993 |
United States Commercial Paper [Member] | ||
Available-for-sale securities | 55,261 | 4,929 |
Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 6,993 | |
Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 111,966 | 9,874 |
Fair Value, Measurements, Recurring [Member] | ||
Total | 364,800 | 172,379 |
Fair Value, Measurements, Recurring [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 119,452 | 19,854 |
Fair Value, Measurements, Recurring [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | 69,598 | |
Fair Value, Measurements, Recurring [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 67,048 | 17,520 |
Fair Value, Measurements, Recurring [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | 64,253 | 39,863 |
Fair Value, Measurements, Recurring [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 6,993 | |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Total | 107,054 | 95,142 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | 69,598 | |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Total | 257,746 | 77,237 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | 67,048 | 17,520 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | 64,253 | 39,863 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | 6,993 | |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | 119,452 | 19,854 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Debt Security, Corporate, US [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | United States Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Foreign Commercial Paper [Member] | ||
Available-for-sale securities | ||
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash and money market funds | 37,456 | 95,142 |
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and money market funds | 37,456 | 95,142 |
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and money market funds | ||
Fair Value, Measurements, 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 ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Other-than-temporary Impairment Loss, Debt Securities, Available-for-sale, Total | $ 0 | $ 0 | $ 0 | $ 0 |
Debt Securities, Available-for-sale, Realized Gain (Loss), Total | $ 0 | $ 0 | $ 0 | $ 0 |
Note 5 - Short-term Investmen_4
Note 5 - Short-term Investments - Summary of Short-term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Available-for-sale securities, amortized cost | $ 310,908 | $ 27,806 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (42) | (10) |
Available-for-sale securities | 310,866 | 27,796 |
US Treasury Securities [Member] | ||
Available-for-sale securities, amortized cost | 69,602 | |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (4) | |
Available-for-sale securities | 69,598 | |
Debt Security, Corporate, US [Member] | ||
Available-for-sale securities, amortized cost | 67,084 | 13,003 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (36) | (10) |
Available-for-sale securities | 67,048 | 12,993 |
United States Commercial Paper [Member] | ||
Available-for-sale securities, amortized cost | 55,261 | 4,929 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | ||
Available-for-sale securities | 55,261 | 4,929 |
Debt Security, Corporate, Non-US [Member] | ||
Available-for-sale securities, amortized cost | 6,995 | |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | (2) | |
Available-for-sale securities | 6,993 | |
Foreign Commercial Paper [Member] | ||
Available-for-sale securities, amortized cost | 111,966 | 9,874 |
Available-for-sale securities, gross unrealized gains | ||
Available-for-sale securities, gross unrealized losses | ||
Available-for-sale securities | $ 111,966 | $ 9,874 |
Note 6 - Inventory (Details Tex
Note 6 - Inventory (Details Textual) $ in Millions | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Research and Development Expense [Member] | CINVANTI [Member] | |
Manufacturing Costs | $ 1.4 |
Note 6 - Inventory - Inventory
Note 6 - Inventory - Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Raw materials | $ 9,437 | $ 2,754 | |
Work in process | 13,203 | 4,166 | |
Finished goods | 8,772 | 3,188 | |
Total inventory | $ 31,412 | $ 9,910 | $ 10,108 |
Note 7 - Revenue Recognition -
Note 7 - Revenue Recognition - Adoption of Topic 606 (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Inventory | $ 9,910 | $ 31,412 | $ 31,412 | $ 10,108 | ||
Other accrued liabilities | 18,166 | 27,368 | 27,368 | 17,175 | ||
Deferred revenue | 2,763 | |||||
Retained earnings | (781,881) | (911,162) | (911,162) | $ (783,455) | ||
Net product sales | 19,786 | $ 8,572 | 48,630 | $ 20,714 | ||
Cost of product sales | 7,576 | 1,051 | 15,940 | 3,250 | ||
Loss from operations | (41,780) | (41,314) | (132,623) | (132,668) | ||
Net loss | $ (38,346) | $ (41,866) | $ (129,281) | $ (134,994) | ||
Basic and diluted net loss per share (in dollars per share) | $ (0.49) | $ (0.77) | $ (1.81) | $ (2.55) | ||
Inventory | $ (21,502) | $ 171 | ||||
Other accrued liabilities | 9,494 | 9,585 | ||||
Deferred revenue | $ 4,461 | |||||
Calculated under Revenue Guidance in Effect before Topic 606 [Member] | ||||||
Inventory | $ 33,366 | 33,366 | ||||
Other accrued liabilities | 22,740 | 22,740 | ||||
Deferred revenue | 10,524 | 10,524 | ||||
Retained earnings | (915,104) | (915,104) | ||||
Net product sales | 19,963 | 44,506 | ||||
Cost of product sales | 7,248 | 14,184 | ||||
Loss from operations | (41,275) | (134,991) | ||||
Net loss | $ (37,841) | $ (131,649) | ||||
Basic and diluted net loss per share (in dollars per share) | $ (0.49) | $ (1.84) | ||||
Inventory | $ (23,258) | |||||
Other accrued liabilities | (5,857) | |||||
Deferred revenue | 7,761 | |||||
Accounting Standards Update 2014-09 [Member] | ||||||
Inventory | (198) | |||||
Other accrued liabilities | 991 | |||||
Deferred revenue | (2,763) | |||||
Retained earnings | 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 | $ 1,954 | 1,954 | ||||
Other accrued liabilities | (4,628) | (4,628) | ||||
Deferred revenue | 10,524 | 10,524 | ||||
Retained earnings | (3,942) | (3,942) | ||||
Net product sales | 177 | (4,124) | ||||
Cost of product sales | (328) | (1,756) | ||||
Loss from operations | 505 | (2,368) | ||||
Net loss | $ 505 | $ (2,368) | ||||
Basic and diluted net loss per share (in dollars per share) | $ (0.03) | |||||
Inventory | $ (1,756) | |||||
Other accrued liabilities | (3,637) | |||||
Deferred revenue | $ 7,761 |
Note 7 - Revenue Recognition _2
Note 7 - Revenue Recognition - Summary of Product Sales Allowance (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Balance | $ 9,319 |
Provision | 38,284 |
Payments/credits | (28,782) |
Balance | 18,821 |
Allowance for Sales Returns 1 [Member] | |
Balance | 521 |
Provision | 178 |
Payments/credits | (18) |
Balance | 681 |
Allowance for Distributor Fees [Member] | |
Balance | 580 |
Provision | 4,342 |
Payments/credits | (3,145) |
Balance | 1,777 |
Allowance for Rebates and Chargebacks [Member] | |
Balance | 8,218 |
Provision | 33,764 |
Payments/credits | (25,619) |
Balance | $ 16,363 |
Note 8 - Leases (Details Textua
Note 8 - Leases (Details Textual) - Lease Amendment to Lease for Additional Office Space in Campus Point Court, San Diego, California [Member] $ in Millions | May 08, 2018USD ($) |
Lessee, Operating Lease, Liability, Annual Payments, Due Next Twelve Months | $ 0.9 |
Lessee, Operating Lease, Liability, Annual Payments Due in Final Three Months of Agreement | 1.4 |
Payments for Security Deposit | $ 0.1 |
Note 8 - Leases - Future Minimu
Note 8 - Leases - Future Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2018USD ($) |
2,019 | $ 3,335 |
2,020 | 2,702 |
2,021 | 2,781 |
2,022 | 2,862 |
2,023 | 2,946 |
Thereafter | 4,026 |
Total future minimum lease payments | $ 18,652 |
Note 9 - Realignment of Goals_2
Note 9 - Realignment of Goals and Objectives and New Development Focus (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | |
Restructuring and Related Cost, Expected Cost, Total | $ 9.6 | ||
Restructuring Plan [Member] | |||
Payments for Restructuring | $ 5.5 | ||
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 | $ 5.7 | 5.7 | |
Restructuring Plan [Member] | Accelerated Non-Cash Stock Option Expense [Member] | |||
Restructuring and Related Cost, Expected Cost, Total | $ 3.9 |
Note 10 - Secured Notes to Re_2
Note 10 - Secured Notes to Related Party (Details Textual) - USD ($) | Aug. 07, 2018 | Aug. 05, 2016 | Aug. 02, 2016 | Jul. 29, 2011 | Apr. 30, 2011 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Convertible Debt Issuable in Connection with Private Placement | $ 4,500,000 | |||||||||
Proceeds from Convertible Debt | $ 4,300,000 | |||||||||
Amortization of Debt Discount (Premium) | $ 654,000 | $ 570,000 | ||||||||
Convertible Notes Payable, Related Parties, Current | $ 4,338,000 | 4,338,000 | $ 3,684,000 | |||||||
Repayments of Long-term Debt, Total | 25,000,000 | 25,000,000 | ||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | 1,183,000 | 2,289,000 | ||||||||
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 | 300,000 | |||||||||
Debt Instrument, Increase (Decrease), Other, Net | 300,000 | |||||||||
Interest Expense, Debt, Excluding Amortization | 100,000 | $ 100,000 | 300,000 | 300,000 | ||||||
Amortization of Debt Discount (Premium) | 200,000 | 200,000 | 600,000 | 600,000 | ||||||
Debt Instrument, Face Amount | 6,600,000 | 6,600,000 | ||||||||
Debt Instrument, Unamortized Discount, Total | 2,300,000 | $ 2,300,000 | ||||||||
Debt Instrument, Convertible, Number Shares of Equity Insturments | 8,300,000 | |||||||||
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 | 200,000 | $ 500,000 | $ 1,200,000 | $ 2,300,000 | ||||||
Repayments of Long-term Debt, Total | $ 25,000,000 | |||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | $ 200,000 | |||||||||
Long-term Debt, Total | $ 0 | $ 0 |
Note 11 - Stockholders' Equit_2
Note 11 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Jun. 30, 2018 | Apr. 30, 2018 | Dec. 31, 2017 | Jan. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Proceeds from Issuance of Common Stock | $ 194,400 | $ 168,700 | $ 142,600 | $ 163,700 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Net | 1,332,000 | |||||
Proceeds from Stock Options Exercised | $ 15,771 | $ 7,836 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 73,800 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 182 days | |||||
Common Stock [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 5,100,000 | 6,900,000 | 9,700,000 | 14,100,000 | ||
Share Price | $ 39.50 | $ 26 | $ 15.50 | $ 12.20 | ||
Payments of Stock Issuance Costs | $ 5,600 | $ 10,700 | $ 7,400 | $ 8,800 |
Note 11 - Stockholders' Equit_3
Note 11 - Stockholders' Equity - Stock Option Activity (Details) - $ / shares shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Number of shares outstanding (in shares) | 13,463 | |
Number of shares outstanding, weighted average exercise price (in dollars per share) | $ 15.03 | |
Number of shares outstanding, weighted average remaining contractual term (Year) | 7 years 182 days | 8 years 3 days |
Number of shares granted (in shares) | 725 | |
Number of shares granted, weighted average exercise price (in dollars per share) | $ 32.42 | |
Number of shares exercised (in shares) | (1,332) | |
Number of shares exercised, weighted average exercise price (in dollars per share) | $ 11.84 | |
Expired and forfeited (in shares) | (556) | |
Number of shares expired and forfeited, weighted average exercise price (in dollars per share) | $ 17.94 | |
Number of shares outstanding (in shares) | 12,300 | 13,463 |
Number of shares outstanding, weighted average exercise price (in dollars per share) | $ 16.27 | $ 15.03 |
Note 11 - Stockholders' Equit_4
Note 11 - Stockholders' Equity - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Stock-based compensation expense | $ 8,050 | $ 7,476 | $ 23,572 | $ 23,647 |
Research and Development Expense [Member] | ||||
Stock-based compensation expense | 3,212 | 2,595 | 9,363 | 8,758 |
General and Administrative Expense [Member] | ||||
Stock-based compensation expense | 2,366 | 2,419 | 6,950 | 7,345 |
Selling and Marketing Expense [Member] | ||||
Stock-based compensation expense | $ 2,472 | $ 2,462 | $ 7,259 | $ 7,544 |
Note 11 - Stockholders' Equit_5
Note 11 - Stockholders' Equity - Valuation Assumptions (Details) - Employee Stock Option [Member] | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Risk-free interest rate | 2.80% | 2.00% |
Dividend yield | 0.00% | 0.00% |
Volatility | 70.50% | 80.20% |
Expected life (Year) | 6 years | 6 years |
Note 12 - Income Taxes (Details
Note 12 - Income Taxes (Details Textual) $ in Millions | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Accounting Standards Update 2014-09 [Member] | |
Unrecognized Tax Benefits, Period Increase (Decrease), Total | $ (3.6) |
Note 13 - Other Income (Expen_2
Note 13 - Other Income (Expense), Net (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Other Nonoperating Income (Expense), Total | $ 3,434 | $ (552) | $ 3,342 | $ (2,326) |
Disgorgement of Short-Swing Profits from the Sale of Common Stock [Member] | ||||
Other Nonoperating Income (Expense), Total | $ 1,900 |