Heron Therapeutics (HRTX) 10-Q 6 Nov 15 2015 Q3 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	9 Months Ended
	Sep. 30, 2015	Oct. 26, 2015
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	Accelerated Filer
Entity Current Reporting Status	Yes
Entity Voluntary Filers	No
Entity Well-known Seasoned Issuer	No
Entity Common Stock, Shares Outstanding (in shares)		35,970,990
Document Type	10-Q
Document Period End Date	Sep. 30, 2015
Document Fiscal Year Focus	2,015
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2015	Dec. 31, 2014
Current assets:
Cash and cash equivalents	$ 152,989	$ 72,675
Prepaid expenses and other current assets	2,006	1,057
Total current assets	154,995	73,732
Property and equipment, net	2,982	2,820
Other long-term assets	174	130
Total assets	158,151	76,682
Current liabilities:
Accounts payable	2,735	2,549
Accrued clinical liabilities	5,167	3,811
Accrued payroll and employee-related liabilities	3,389	2,731
Other accrued expenses	3,098	2,931
Convertible notes payable to related parties, net of discount	2,061	1,598
Total current liabilities	16,450	13,620
Stockholders’ equity:
Common stock	359	292
Additional paid-in capital	522,928	378,007
Accumulated deficit	(381,586)	(315,237)
Total stockholders’ equity	141,701	63,062
Total liabilities and stockholders’ equity	$ 158,151	$ 76,682

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Operating expenses:
Research and development	$ 14,241	$ 14,731	$ 44,920	$ 40,638
General and administrative	8,250	4,222	20,945	14,428
Total operating expenses	22,491	18,953	65,865	55,066
Loss from operations	(22,491)	(18,953)	(65,865)	(55,066)
Other expense, net	(181)	(241)	(484)	(677)
Net loss	$ (22,672)	$ (19,194)	$ (66,349)	$ (55,743)
Basic and diluted net loss per share (in dollars per share)	$ (0.63)	$ (0.66)	$ (2.07)	$ (2.17)
Shares used in computing basic and diluted net loss per share (in shares)	35,773	29,004	32,090	25,679

Condensed Consolidated Stateme4

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Operating activities:
Net loss	$ (66,349,000)	$ (55,743,000)
Adjustments to reconcile net loss to net cash used for operating activities:
Depreciation and amortization	498,000	389,000
Stock-based compensation expense	8,512,000	5,809,000
Amortization of Debt Discount (Premium)	463,000	$ 425,000
Gain on disposal of property and equipment	(118,000)
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(993,000)	$ (2,392,000)
Accounts payable	186,000	211,000
Accrued clinical liabilities	1,356,000	2,757,000
Accrued payroll and employee-related liabilities	658,000	35,000
Other accrued expenses	411,000	1,084,000
Net cash used for operating activities	(55,376,000)	(47,425,000)
Investing activities:
Purchases of property and equipment	(783,000)	$ (417,000)
Proceeds from sale of property and equipment	241,000
Net cash used for investing activities	(542,000)	$ (417,000)
Financing activities:
Proceeds from purchases under the Employee Stock Purchase Plan	118,000	19,000
Proceeds from stock option exercises	7,915,000	2,832,000
Net proceeds from sale of common stock and/or pre-funded warrants	128,199,000	58,916,000
Net cash provided by financing activities	136,232,000	61,767,000
Net increase in cash and cash equivalents	80,314,000	13,925,000
Cash and cash equivalents at beginning of period	72,675,000	72,287,000
Cash and cash equivalents at end of period	$ 152,989,000	$ 86,212,000

Note 1 - Business

Note 1 - Business	9 Months Ended
	Sep. 30, 2015
Notes to Financial Statements
Business Description and Basis of Presentation [Text Block]	1. Business Overview Heron Therapeutics, Inc. is a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents. Our goal is to build on therapeutics with well-known pharmacology by improving their tolerability and efficacy as well as broadening their potential field of use. We are currently developing four pharmaceutical products for patients suffering from cancer or pain. SUSTOL ® is being developed for the prevention of both acute and delayed chemotherapy induced nausea and vomiting. (“CINV”) associated with moderately emetogenic chemotherapy or highly emetogenic chemotherapy. Our New Drug Application for SUSTOL is pending review with the U.S. Food and Drug Administration (“FDA”), and has been assigned a Prescription Drug User Fee Act goal date of January 17, 2016. HTX-019, also being developed for the prevention of CINV, has the potential to become the first polysorbate 80-free, intravenous formulation of aprepitant, a neurokinin-1 receptor antagonist. HTX-011, a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam, is being developed for the prevention of post-operative pain. HTX-003, a long-acting formulation of buprenorphine, is being developed for the management of chronic pain and opioid addiction. All of our product candidates utilize our innovative science and technology platforms, including our proprietary Biochronomer® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a period of days to weeks with a single injection. Liquidity We have incurred significant operating losses and negative cash flows from operations, and we had an accumulated deficit of $381.6 million as of September 30, 2015. As of September 30, 2015, we had cash and cash equivalents on hand of $153.0 million. We believe that our current cash and working capital are sufficient to fund operations through 2016 based on our current operating plans, including building a commercial infrastructure to support a potential commercial launch of SUSTOL and continuing to pursue our current clinical development programs. In the event we were to pursue clinical product development in other areas, potentially acquire other strategic assets, or if SUSTOL is not approved or the degree of commercial success of SUSTOL is less than expected, we would need to raise additional capital. If we are unable to obtain sufficient financing on acceptable terms or otherwise, we may be required to reduce or defer our activities. Our capital requirements going forward will depend on numerous factors, including but not limited to: the scope, rate of progress, results and costs of preclinical testing and clinical trials; an approval decision by the FDA with respect to SUSTOL; the timing of and costs associated with the commercial launch of SUSTOL, if approved; the degree of commercial success of SUSTOL; the number and characteristics of product development programs we pursue and the pace of each program, including the timing of clinical trials; the time, cost and outcome involved in seeking other regulatory approvals; scientific progress in our research and development programs; the magnitude and scope of our research and development programs; our ability to establish and maintain strategic collaborations or partnerships for research, development, clinical testing, manufacturing and marketing of our product candidates; the cost and timing of establishing sales, manufacturing, marketing and distribution capabilities if we commercialize products independently; the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop; and general market conditions. We may not be able to raise sufficient additional capital when we need it on favorable terms, or at all. The sale of additional equity in the future may be dilutive to our stockholders. If we are unable to obtain adequate funds on reasonable terms, we may be required to curtail operations significantly or to obtain funds by entering into financing, supply or collaboration agreements on unattractive terms.

Note 2 - Basis of Presentation

Note 2 - Basis of Presentation	9 Months Ended
	Sep. 30, 2015
Notes to Financial Statements
Basis of Accounting [Text Block]	2 . B asis 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-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2015 are not necessarily indicative of the results that may be expected for other quarters or the year ending December 31, 2015. The condensed balance sheet at December 31, 2014 has been derived from the audited financial statements as of that date, but does not include all of the information and disclosures required by GAAP. For more complete financial information, these unaudited condensed consolidated financial statements and the notes thereto should be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2015 .

Note 3 - Accounting Policies

Note 3 - Accounting Policies	9 Months Ended
	Sep. 30, 2015
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. Heron Therapeutics B.V. has no operations and no material assets or liabilities and there have been no significant transactions related to Heron Therapeutics B.V. since its inception. 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 critical accounting policies that involve significant judgment and estimates include accrued clinical liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities from purchase date of three months or less. Our bank accounts have been placed under a control agreement in accordance with our Senior Secured Convertible Notes (“Convertible Notes”). Earnings Per Share Basic earnings per share (“EPS”) is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of common share equivalents. Diluted EPS is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, warrants and common stock underlying Convertible Notes are considered to be common stock equivalents and are only included in the calculation of diluted EPS when their effect is dilutive. Because we have incurred a net loss for all periods presented in the condensed consolidated statements of operations, outstanding stock options, warrants and common stock underlying Convertible Notes are not included in the computation of net loss per share because their effect would be anti-dilutive. The following table includes the number of outstanding stock options, warrants and common stock underlying Convertible Notes not included in the computation as of the dates shown below (in thousands): As of September 30, 2015 2014 Stock options outstanding 6,960 6,456 Warrants outstanding 3,565 4,108 Common stock underlying convertible notes outstanding 6,982 6,578 Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Our comprehensive net loss for all periods presented was comprised solely of our net loss, and there were no other changes in equity from non-owner sources. Recent Accounting Pronouncements In January 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015- 01 , Income Statement—Extraordinary and Unusual Items (Subtopic 225-20) The amendments in ASU 2015-01 are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. A reporting entity may apply the amendments prospectively. A reporting entity also may apply the amendments retrospectively to all prior periods presented in the financial statements. We adopted the provisions of ASU 2015-01 in the first quarter of 2015, which did not have a material impact on our results of operations or financial condition. In August 2014, FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40) , including interim periods, (3) provide principles for considering the mitigating effect of management’s plans, (4) require certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans, (5) require an express statement and other disclosures when substantial doubt is not alleviated, and (6) require an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). The amendments in ASU 2014-15 are effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early adoption is permitted. We plan to adopt the provisions of ASU 2014-15 in 2016. We do not expect the adoption of this ASU to have a material impact on our results of operations or financial condition. In June 2014, FASB issued ASU No. 2014-12, Compensation – Stock Compensation (Topic 718)

Note 4 - Convertible Notes to R

Note 4 - Convertible Notes to Related Parties	9 Months Ended
	Sep. 30, 2015
Notes to Financial Statements
Debt Disclosure [Text Block]	4. Convertible Notes to Related Parties In April 2011, we entered into a Securities Purchase Agreement for a private placement of up to $4.5 million in Convertible Notes. We received a total of $4.3 million, net of issuance costs, from the issuance of these Convertible Notes. The Convertible Notes are secured by substantially all of our assets, including placing our bank accounts under a control agreement. The Convertible Notes bear interest at 6% per annum, payable quarterly in cash or in additional principal amount of Convertible Notes, at the election of the purchasers. The Convertible Notes mature on May 2, 2021, however, the holders of the Convertible Notes may require prepayment of the Convertible Notes at any time, at each holder’s option. The Convertible Notes are convertible into shares of our common stock at a rate of 1,250 shares for every $1,000 of principal and accrued interest due under the Convertible Notes. There is no right to convert the Convertible Notes to the extent that, after giving effect to such conversion, the holder would beneficially own in excess of 9.99% of our outstanding common stock. Each holder of the Convertible Notes can increase or decrease this beneficial ownership conversion limit by written notice to us, which will not be effective until 61 days after delivery of the notice. As of September 30, 2015, we were in compliance with all covenants under the Convertible Notes. Upon the occurrence of an event of default under the Convertible Notes, the holders of the Convertible Notes have the right to require us to redeem all or a portion of their Convertible Notes. We filed a registration statement with the SEC to register for resale 3.5 million shares underlying the Convertible Notes. The registration statement was declared effective on July 29, 2011. The Convertible Note holders have agreed to waive their right to require us to maintain the effectiveness of the registration statement and to register the additional shares underlying the Convertible Notes until they provide notice otherwise. The Convertible Notes contain an embedded conversion feature that was in-the-money on the issuance dates. Based on an effective fixed conversion rate of 1,250 shares for every $1,000 of principal and accrued interest due under the Convertible Notes, the total conversion benefit at issuance exceeded the loan proceeds. Therefore, a debt discount was recorded in an amount equal to the face value of the Convertible Notes on the issuance dates and we began amortizing the resultant debt discount over the respective 10-year term of the Convertible Notes. During the nine months ended September 30, 2015, accrued interest of approximately $244,000 was paid-in-kind and rolled into the Convertible Note principal balance, which resulted in an additional debt discount of approximately $244,000. For the three months ended September 30, 2015 and 2014, interest expense relating to the stated rate was approximately $84,000 and $79,000, respectively, and interest expense relating to the amortization of the debt discount was approximately $158,000 and $145,000, respectively. For the nine months ended September 30, 2015 and 2014, interest expense relating to the stated rate was approximately $248,000 and $233,000, respectively, and interest expense relating to the amortization of the debt discount was approximately $463,000 and $425,000, respectively. As of September 30, 2015, the carrying value of the Convertible Notes was approximately $2,061,000, which is comprised of the $5,586,000 principal amount of the Convertible Notes outstanding, less debt discount of $3,525,000. If the $5,586,000 principal amount of Convertible Notes is converted, we would issue 6,981,833 shares of our common stock.

Note 5 - Stockholders' Equity

Note 5 - Stockholders' Equity	9 Months Ended
	Sep. 30, 2015
Notes to Financial Statements
Stockholders' Equity Note Disclosure [Text Block]	5. Stockholders’ Equity 2013 Common Stock Offering In November 2013, we sold approximately 7.7 million shares of our common stock at a public offering price of $8.00 per share. We received total net proceeds of approximately $57.8 million (net of approximately $3.9 million in issuance costs). 2014 Common Stock Offering In June 2014, we sold approximately 4.8 million shares of our common stock at a public offering price of $11.75 per share. In addition, as a component of the offering, we sold 600,000 pre-funded warrants to purchase shares of our common stock at a public offering price of $11.74 per share. The pre-funded warrants have an exercise price of $0.01 per share and expire on June 30, 2021. We received total net proceeds of approximately $58.9 million (net of approximately $4.0 million in issuance costs) from the sale of the common stock and the pre-funded warrants. 201 5 Common Stock Offering In June 2015, we sold approximately 5.5 million shares of our common stock at a public offering price of approximately $24.75 per share. We received total net proceeds of approximately $128.2 million (net of approximately $8.4 million in issuance costs) from the sale of the common stock. Private Placement Warrants In June 2011, we sold shares of common stock and warrants to purchase common stock in a private placement. A total of 4.0 million warrants to purchase common stock at an exercise price of $3.60 per share were issued as part of this private placement. The warrants were immediately exercisable and expire on July 1, 2016. The warrants may be exercised for cash only, or, if a registration statement is not then effective and available for the resale of the shares of common stock issuable upon exercise of the warrants, by surrender of such warrant, or a portion of such warrant, by way of cashless exercise. There is no right to exercise the warrants to the extent that, after giving effect to such exercise the holder would beneficially own in excess of 9.99% of our outstanding shares of common stock or such other limit as may be designated by any particular purchaser. Each holder of the warrants can amend or waive the foregoing limitation by written notice to us, with such waiver taking effect only upon the expiration of a 61-day notice period. During the nine months ended September 30, 2015, warrant holders exercised 343,813 warrants under the cashless exercise provision in each holder’s warrant, which resulted in the net issuance of 285,713 shares of common stock and no net cash proceeds to us. During the nine months ended September 30, 2014, warrant holders exercised 460,706 warrants under the cashless exercise provision in the warrant agreement, which resulted in the net issuance of 303,614 shares of common stock and no net cash proceeds to us. As of September 30, 2015, 2,965,477 warrants from the June 2011 Private Placement remain outstanding. Stock Option Exercises For the nine months ended September 30, 2015, 882,579 shares of common stock were issued pursuant to the exercise of stock options, resulting in proceeds to us of approximately $7,915,000. For the nine months ended September 30, 2014, option holders exercised 719,092 stock options, a portion of which were exercised under the cashless exercise provision of our 2007 Amended and Restated Equity Incentive Plan, resulting in the net issuance of 550,496 shares of common stock and cash proceeds to us of approximately $2,832,000. 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 for the three and nine months ended September 30, 2015 and 2014 (in thousands): Three Months Ended September 30 , Nine Months Ended September 30 , 2015 2014 2015 2014 Research and development $ 927 $ 715 $ 2,652 $ 2,423 General and administrative 1,894 1,045 5,860 3,386 Stock-based compensation expense included in operating expenses $ 2,821 $ 1,760 $ 8,512 $ 5,809 Impact on basic and diluted net loss per share $ 0.08 $ 0.06 $ 0.27 $ 0.23 As of September 30, 2015, there was $31,150,000 of total unrecognized compensation cost related to non-vested, stock-based payment awards granted under all of our equity compensation plans and all non-plan option grants. Total unrecognized compensation cost will be adjusted for future changes in estimated forfeitures. We expect to recognize this compensation cost over a weighted-average period of 2.0 years. 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 15 20 14 Risk-free interest rate 1.7 % 2.0 % Dividend yield 0.0 % 0.0 % Volatility 90.7 % 102.9 % Expected life (years) 6 6 We estimate the fair value of each purchase right granted under the ESPP at the beginning of each new offering period using the Black-Scholes option valuation model. There were no new offering periods for the quarters ended September 30, 2015 and 2014. The following table summarizes the stock option activity for the nine months ended September 30, 2015: Weighted- Average Weighted- Remaining Average Contractual Shares Exercise Term (in thousands) Price (Years) Balance at January 1, 2015 7,918 $ 8.69 7.92 Granted 375 $ 29.26 Exercised (883 ) $ 8.97 Expired and forfeited (450 ) $ 11.02 Balance at September 30, 2015 6,960 $ 9.61 7.90

Note 6 - Income Taxes

Note 6 - Income Taxes	9 Months Ended
	Sep. 30, 2015
Notes to Financial Statements
Income Tax Disclosure [Text Block]	6. 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, 2015. 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 to be sustained upon audit by the relevant tax authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. There have been no material changes in our unrecognized tax benefits since December 31, 2014 and, as such, disclosures included in our 2014 Annual Report on Form 10-K for the year ended December 31, 2014 continue to be relevant for the period ended September 30, 2015.

Significant Accounting Policies

Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2015
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. Heron Therapeutics B.V. has no operations and no material assets or liabilities and there have been no significant transactions related to Heron Therapeutics B.V. since its inception.
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 critical accounting policies that involve significant judgment and estimates include accrued clinical liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates.
Cash and Cash Equivalents, Policy [Policy Text Block]	Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities from purchase date of three months or less. Our bank accounts have been placed under a control agreement in accordance with our Senior Secured Convertible Notes (“Convertible Notes”).
Earnings Per Share, Policy [Policy Text Block]	Earnings Per Share Basic earnings per share (“EPS”) is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of common share equivalents. Diluted EPS is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, warrants and common stock underlying Convertible Notes are considered to be common stock equivalents and are only included in the calculation of diluted EPS when their effect is dilutive. Because we have incurred a net loss for all periods presented in the condensed consolidated statements of operations, outstanding stock options, warrants and common stock underlying Convertible Notes are not included in the computation of net loss per share because their effect would be anti-dilutive. The following table includes the number of outstanding stock options, warrants and common stock underlying Convertible Notes not included in the computation as of the dates shown below (in thousands): As of September 30, 2015 2014 Stock options outstanding 6,960 6,456 Warrants outstanding 3,565 4,108 Common stock underlying convertible notes outstanding 6,982 6,578
Comprehensive Income, Policy [Policy Text Block]	Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Our comprehensive net loss for all periods presented was comprised solely of our net loss, and there were no other changes in equity from non-owner sources.
New Accounting Pronouncements, Policy [Policy Text Block]	Recent Accounting Pronouncements In January 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015- 01 , Income Statement—Extraordinary and Unusual Items (Subtopic 225-20) The amendments in ASU 2015-01 are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. A reporting entity may apply the amendments prospectively. A reporting entity also may apply the amendments retrospectively to all prior periods presented in the financial statements. We adopted the provisions of ASU 2015-01 in the first quarter of 2015, which did not have a material impact on our results of operations or financial condition. In August 2014, FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40) , including interim periods, (3) provide principles for considering the mitigating effect of management’s plans, (4) require certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans, (5) require an express statement and other disclosures when substantial doubt is not alleviated, and (6) require an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). The amendments in ASU 2014-15 are effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early adoption is permitted. We plan to adopt the provisions of ASU 2014-15 in 2016. We do not expect the adoption of this ASU to have a material impact on our results of operations or financial condition. In June 2014, FASB issued ASU No. 2014-12, Compensation – Stock Compensation (Topic 718)

Note 3 - Accounting Policies (T

Note 3 - Accounting Policies (Tables)	9 Months Ended
	Sep. 30, 2015
Notes Tables
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]	As of September 30, 2015 2014 Stock options outstanding 6,960 6,456 Warrants outstanding 3,565 4,108 Common stock underlying convertible notes outstanding 6,982 6,578

Note 5 - Stockholders' Equity (

Note 5 - Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2015
Notes Tables
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 , 2015 2014 2015 2014 Research and development $ 927 $ 715 $ 2,652 $ 2,423 General and administrative 1,894 1,045 5,860 3,386 Stock-based compensation expense included in operating expenses $ 2,821 $ 1,760 $ 8,512 $ 5,809 Impact on basic and diluted net loss per share $ 0.08 $ 0.06 $ 0.27 $ 0.23
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]	September 30, 20 15 20 14 Risk-free interest rate 1.7 % 2.0 % Dividend yield 0.0 % 0.0 % Volatility 90.7 % 102.9 % Expected life (years) 6 6
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block]	Weighted- Average Weighted- Remaining Average Contractual Shares Exercise Term (in thousands) Price (Years) Balance at January 1, 2015 7,918 $ 8.69 7.92 Granted 375 $ 29.26 Exercised (883 ) $ 8.97 Expired and forfeited (450 ) $ 11.02 Balance at September 30, 2015 6,960 $ 9.61 7.90

Note 1 - Business (Details Text

Note 1 - Business (Details Textual) - USD ($) $ in Thousands	Sep. 30, 2015	Dec. 31, 2014	Sep. 30, 2014	Dec. 31, 2013
Retained Earnings (Accumulated Deficit)	$ (381,586)	$ (315,237)
Cash and Cash Equivalents, at Carrying Value	$ 152,989	$ 72,675	$ 86,212	$ 72,287

Note 3 - Accounting Policies -

Note 3 - Accounting Policies - Equity Excluded From Calculation of Diluted Earnings Per Share (Details) - shares shares in Thousands	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Employee Stock Option [Member]
Shares excluded (in shares)	6,960	6,456
Warrant [Member]
Shares excluded (in shares)	3,565	4,108
Convertible Debt Securities [Member]
Shares excluded (in shares)	6,982	6,578

Note 4 - Convertible Notes to16

Note 4 - Convertible Notes to Related Parties (Details Textual)	Jul. 29, 2011shares	Apr. 30, 2011USD ($)shares	Sep. 30, 2015USD ($)	Sep. 30, 2014USD ($)	Sep. 30, 2015USD ($)	Sep. 30, 2014USD ($)	Dec. 31, 2014USD ($)
Convertible Debt Securities [Member] | Common Stock [Member]
Debt Instrument, Term					10 years
Debt Instrument Conversion Ratio Shares | shares		1,250
Convertible Debt Securities [Member] | In Case of Debt Conversion [Member]
Debt Instrument, Face Amount			$ 5,586,000		$ 5,586,000
Debt Instrument, Convertible, Number of Equity Instruments					6,981,833
Convertible Debt Securities [Member]
Debt Instrument, Maturity Date		May 2, 2021
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
Paid-in-Kind Interest					$ 244,000
Convertible Notes Payable, Related Parties, Current			2,061,000		2,061,000
Debt Instrument, Face Amount			5,586,000		5,586,000
Debt Instrument, Unamortized Discount			3,525,000		3,525,000
Convertible Debt Issuable in Connection with Private Placement		$ 4,500,000
Proceeds from Convertible Debt		$ 4,300,000
Common Shares Registered for Resale in Connection with Convertible Notes | shares	3,500,000
Debt Instrument, Increase (Decrease) in Unamortized Discount					244,000
Interest Expense, Debt, Excluding Amortization			84,000	$ 79,000	248,000	$ 233,000
Amortization of Debt Discount (Premium)			158,000	$ 145,000	463,000	$ 425,000
Convertible Notes Payable, Related Parties, Current			$ 2,061,000		$ 2,061,000		$ 1,598,000

Note 5 - Stockholders' Equity17

Note 5 - Stockholders' Equity (Details Textual) - USD ($)	1 Months Ended				6 Months Ended	9 Months Ended
	Jun. 30, 2015	Jun. 30, 2014	Nov. 30, 2013	Jun. 30, 2011	Jun. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Private Placement 2011 [Member] | Common Stock [Member]
Stock Issued During Period, Shares, New Issues						285,713	303,614
Private Placement 2011 [Member] | Warrant [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Exercised						343,813	460,706
Private Placement 2011 [Member]
Proceeds from Warrant Exercises					$ 0	$ 0
Class of Warrant or Right, Number of Securities Called by Warrants or Rights				4,000,000
Class of Warrant or Right, Exercise Price of Warrants or Rights				$ 3.60
Beneficial Ownership after Conversion				9.99%
Notice Period Associated with Beneficial Ownership Percentage Limitation Convertible Notes				61 days
Class of Warrant or Right, Outstanding						2,965,477
Jefferies, LLC [Member] | Common Stock [Member]
Stock Issued During Period, Shares, New Issues			7,700,000
Sale of Stock, Price Per Share			$ 8
Proceeds from Issuance of Common Stock			$ 57,800,000
Payments of Stock Issuance Costs			$ 3,900,000
Common Stock [Member]
Stock Issued During Period, Shares, New Issues	5,500,000	4,800,000
Sale of Stock, Price Per Share	$ 24.75	$ 11.75			$ 11.75
Payments of Stock Issuance Costs	$ 8,400,000
Proceeds from Issuance or Sale of Equity	$ 128,200,000
Common Stock and Prefunded Warrants [Member]
Payments of Stock Issuance Costs		$ 4,000,000
Proceeds from Issuance or Sale of Equity		$ 58,900,000
Pre-funded Warrants[Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights		600,000			600,000
Share Price		$ 11.74			$ 11.74
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 0.01			$ 0.01
Proceeds from Issuance or Sale of Equity						$ 128,199,000	$ 58,916,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Net						882,579	550,496
Proceeds from Stock Options Exercised						$ 7,915,000	$ 2,832,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period						883,000	719,092
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized						$ 31,150,000
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition						2 years

Note 5 - Stockholders' Equity -

Note 5 - Stockholders' Equity - Allocation of the Recognized Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Research and Development Expense [Member]
Share-based compensation expense	$ 927	$ 715	$ 2,652	$ 2,423
General and Administrative Expense [Member]
Share-based compensation expense	1,894	1,045	5,860	3,386
Share-based compensation expense	$ 2,821	$ 1,760	$ 8,512	$ 5,809
Impact on basic and diluted net loss per share (in dollars per share)	$ 0.08	$ 0.06	$ 0.27	$ 0.23

Note 5 - Stockholders' Equity19

Note 5 - Stockholders' Equity - Option Valuation Assumptions (Details) - Employee Stock Option [Member]	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Risk-free interest rate	1.70%	2.00%
Dividend yield	0.00%	0.00%
Volatility	90.70%	102.90%
Expected life (years)	6 years	6 years

Note 5 - Stockholders' Equity20

Note 5 - Stockholders' Equity - Option Summary (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2015	Dec. 31, 2014
Balance at January 1, 2015 (in shares)	6,960,000	7,918,000
Balance at January 1, 2015 (in dollars per share)	$ 9.61	$ 8.69
Balance at January 1, 2015	7 years 328 days	7 years 335 days
Granted (in shares)	375,000
Granted (in dollars per share)	$ 29.26
Exercised (in shares)	(883,000)
Exercised (in dollars per share)	$ 8.97
Expired and forfeited (in shares)	(450,000)
Expired and forfeited (in dollars per share)	$ 11.02