Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Jan. 31, 2019 | Jun. 30, 2018 | |
Document Information [Line Items] | |||
Entity Registrant Name | BIOCRYST PHARMACEUTICALS INC | ||
Entity Central Index Key | 0000882796 | ||
Trading Symbol | bcrx | ||
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 | Yes | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Common Stock, Shares Outstanding (in shares) | 110,176,627 | ||
Entity Public Float | $ 559,268,095 | ||
Entity Shell Company | false | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
ASSETS | ||
Cash and cash equivalents | $ 26,731 | $ 50,282 |
Restricted cash | 1,544 | 3,286 |
Investments | 77,736 | 64,115 |
Receivables from collaborations | 4,293 | 6,117 |
Inventory | 1,649 | |
Prepaid expenses and other current assets | 2,390 | 1,381 |
Deferred collaboration expense | 9 | 210 |
Total current assets | 114,352 | 125,391 |
Investments | 22,376 | 41,295 |
Property and equipment, net | 9,135 | 9,546 |
Other assets | 978 | 2,027 |
Total assets | 146,841 | 178,259 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Accounts payable | 7,769 | 6,337 |
Accrued expenses | 15,891 | 12,699 |
Interest payable | 11,848 | 12,095 |
Deferred collaboration revenue | 221 | 8,484 |
Lease financing obligation | 47 | 75 |
Senior credit facility | 4,580 | 6,464 |
Non-recourse notes payable | 29,121 | 28,682 |
Total current liabilities | 69,477 | 74,836 |
Deferred rent | 54 | 155 |
Lease financing obligation | 2,703 | 2,751 |
Senior credit facility | 25,372 | 16,750 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; shares authorized — 5,000; no shares outstanding | ||
Common stock, $0.01 par value; shares authorized — 200,000; shares issued and outstanding — 110,063 at December 31, 2018 and 98,411 at December 31, 2017 | 1,101 | 984 |
Additional paid-in capital | 780,400 | 714,869 |
Accumulated other comprehensive loss | (297) | (243) |
Accumulated deficit | (731,969) | (631,843) |
Total stockholders’ equity | 49,235 | 83,767 |
Total liabilities and stockholders’ equity | $ 146,841 | $ 178,259 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares shares in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000 | 5,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 200,000 | 200,000 |
Common stock, shares issued (in shares) | 110,063 | 98,411 |
Common stock, shares outstanding (in shares) | 110,063 | 98,411 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
Revenues | $ 20,653 | $ 25,186 | $ 26,353 |
Expenses | |||
Cost of products sold | 1,142 | 2,297 | |
Research and development | 84,888 | 66,962 | 61,008 |
Selling, general and administrative | 29,514 | 13,933 | 11,253 |
Royalty | 471 | 560 | 402 |
Total operating expenses | 114,873 | 82,597 | 74,960 |
Loss from operations | (94,220) | (57,411) | (48,607) |
Interest and other income | 2,252 | 1,015 | 793 |
Interest expense | (9,176) | (8,565) | (6,487) |
Loss on foreign currency derivative | (108) | (821) | (843) |
Net loss | (101,252) | (65,782) | (55,144) |
Unrealized (loss) gain on available for sale investments | (54) | (231) | 194 |
Net comprehensive loss | $ (101,306) | $ (66,013) | $ (54,950) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.98) | $ (0.78) | $ (0.75) |
Weighted average shares outstanding (in shares) | 103,185 | 84,451 | 73,699 |
Product [Member] | |||
Revenues: | |||
Revenues | $ 1,501 | $ 2,269 | |
Royalty [Member] | |||
Revenues: | |||
Revenues | 6,101 | 10,543 | 9,682 |
Collaborative and Other Research and Development [Member] | |||
Revenues: | |||
Revenues | $ 14,552 | $ 13,142 | $ 14,402 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities: | |||
Net loss | $ (101,252) | $ (65,782) | $ (55,144) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 770 | 704 | 483 |
Loss (gain) on disposal of property and equipment | 7 | (12) | 17 |
Stock-based compensation expense | 9,396 | 12,621 | 8,487 |
Amortization of debt issuance costs | 885 | 876 | 558 |
Amortization of premium/discount on investments | 110 | 157 | 523 |
Change in fair value of foreign currency derivative | 1,049 | 966 | (811) |
Changes in operating assets and liabilities: | |||
Receivables | 1,824 | 2,651 | (2,525) |
Inventory | (1,649) | 500 | 1,112 |
Prepaid expenses and other assets | (1,009) | 877 | 3,702 |
Deferred collaboration expense | 143 | 74 | 71 |
Accounts payable and accrued expenses | 4,487 | 3,842 | (10,524) |
Interest payable | (247) | 3,105 | 2,244 |
Deferred revenue | (7,079) | (1,722) | (1,631) |
Net cash used in operating activities: | (92,565) | (41,143) | (53,438) |
Investing activities: | |||
Acquisition of property and equipment | (366) | (328) | (5,277) |
Proceeds from sale of property and equipment | 12 | 4 | |
Purchases of investments | (62,614) | (107,787) | (14,106) |
Sales and maturities of investments | 67,748 | 43,461 | 42,652 |
Net cash provided by (used in) investing activities: | 4,768 | (64,642) | 23,273 |
Financing activities: | |||
Sale of common stock, net | 53,400 | 134,000 | |
Net proceeds from common stock issued under stock-based compensation plans | 2,852 | 1,581 | 317 |
Proceeds from senior credit facility | 10,353 | 22,658 | |
Payment of senior credit facility | (4,025) | ||
(Decrease) increase in lease financing obligation | (76) | 122 | 329 |
Net cash provided by financing activities: | 62,504 | 135,703 | 23,304 |
(Decrease) increase in cash, cash equivalents and restricted cash | (25,293) | 29,918 | (6,861) |
Cash, cash equivalents and restricted cash at beginning of year | 53,568 | 23,650 | 30,511 |
Cash, cash equivalents and restricted cash at end of year | $ 28,275 | $ 53,568 | $ 23,650 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2015 | $ 734 | $ 558,113 | $ (206) | $ (510,917) | $ 47,724 |
Net loss | (55,144) | (55,144) | |||
Other comprehensive income (loss) | 194 | 194 | |||
Exercise of stock options | 3 | (15) | (12) | ||
Employee stock purchase plan sales | 1 | 328 | 329 | ||
Stock-based compensation expense | 8,487 | 8,487 | |||
Balance at Dec. 31, 2016 | 738 | 566,913 | (12) | (566,061) | 1,578 |
Net loss | (65,782) | (65,782) | |||
Other comprehensive income (loss) | (231) | (231) | |||
Exercise of stock options | 6 | 1,230 | 1,236 | ||
Employee stock purchase plan sales | 1 | 344 | 345 | ||
Stock-based compensation expense | 12,621 | 12,621 | |||
Issuance of common stock | 239 | 133,761 | 134,000 | ||
Balance at Dec. 31, 2017 | 984 | 714,869 | (243) | (631,843) | 83,767 |
Net loss | (101,252) | (101,252) | |||
Other comprehensive income (loss) | (54) | (54) | |||
Exercise of stock options | 11 | 2,490 | 2,501 | ||
Employee stock purchase plan sales | 1 | 350 | 351 | ||
Stock-based compensation expense | 9,396 | 9,396 | |||
Issuance of common stock | 105 | 53,295 | 53,400 | ||
Impact to retained earnings from adoption of ASC 606 at Dec. 31, 2017 | 1,126 | 1,126 | |||
Balance at Dec. 31, 2018 | $ 1,101 | $ 780,400 | $ (297) | $ (731,969) | $ 49,235 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Deficit) (Parentheticals) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Common Stock [Member] | |||
Exercise of stock options, shares (in shares) | 1,106 | 351 | |
Employee stock purchase plan sales, shares (in shares) | 92 | 95 | 75 |
Issuance of common stock, shares (in shares) | 10,455 | 23,925 |
Note 1 - Significant Accounting
Note 1 - Significant Accounting Policies and Concentrations of Risk | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 1 The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a biotechnology company that discovers novel, oral, small-molecule medicines. The Company focuses on the treatment of rare diseases in which significant unmet medical needs exist and an enzyme plays the key role in the biological pathway of the disease. The Company was incorporated in Delaware in 1986 With the funds available at December 31, 2018, 2020. 2019 2019 2020. may 2020 1 2 3 4 5 one 6 may Basis of Presentation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, JPR Royalty Sub LLC (“Royalty Sub”) and MDCP, LLC (“MDCP”). Both subsidiaries were formed to facilitate financing transactions for the Company. Royalty Sub was formed in connection with a $30,000 March 9, 2011. 3, $23,000 September 23, 2016 July 20, 2018 February 6, 2019. 4 13 The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Such consolidated financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. There were no Cash and Cash Equivalents The Company generally considers cash equivalents to be all cash held in commercial checking accounts, certificates of deposit, money market accounts or investments in debt instruments with maturities of three Restricted Cash Restricted cash as of December 31, 2018 $131 3 $1,413 Investments The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may three no 18 may may not not not The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not three 12 12 December 31, 2018, The following tables summarize the fair value of the Company’s investments by type. The estimated fair values of the Company’s fixed income investments are classified as Level 2 not not 2 December 31, 2018 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 50,613 $ 176 $ 15 $ (131 ) $ 50,673 Corporate debt securities 45,793 254 4 (171 ) 45,880 Certificates of deposit 3,559 14 - (14 ) 3,559 Total investments $ 99,965 $ 444 $ 19 $ (316 ) $ 100,112 December 31, 2017 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 60,121 $ 177 $ - $ (122 ) $ 60,176 Corporate debt securities 34,021 203 - (108 ) 34,116 Certificates of deposit 11,099 32 1 (14 ) 11,118 Total investments $ 105,241 $ 412 $ 1 $ (244 ) $ 105,410 The following table summarizes the scheduled maturity for the Company’s investments at December 31, 2018 2017. 2018 2017 Maturing in one year or less $ 77,736 $ 64,115 Maturing after one year through two years 22,376 34,257 Maturing after two years - 7,038 Total investments $ 100,112 $ 105,410 Receivables from Collaborations Receivables from collaborations are recorded for amounts due to the Company related to reimbursable research and development costs from the U.S. Department of Health and Human Services, royalty receivables from Shionogi, Green Cross Corporation (“Green Cross”), Mundipharma International Holdings Limited (“Mundipharma”) and Seqirus UK Limited (“SUL”), and product sales to SUL. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. At December 31, 2018 December 31, 2017, December 31, 2018 Billed Unbilled Total U.S. Department of Health and Human Services $ - $ 1,525 $ 1,525 Shionogi & Co. Ltd. 854 - 854 Green Cross Corporation 876 28 904 Mundipharma International Holdings Limited 44 - 44 Seqirus UK Limited 940 26 966 Total receivables $ 2,714 $ 1,579 $ 4,293 December 31, 2017 Billed Unbilled Total U.S. Department of Health and Human Services $ 42 $ 2,020 $ 2,062 Shionogi & Co. Ltd. 1,600 - 1,600 Green Cross Corporation 1,388 28 1,416 Mundipharma International Holdings Limited 47 - 47 Seqirus UK Limited 825 167 992 Total receivables $ 3,902 $ 2,215 $ 6,117 Monthly invoices are submitted to the U.S. Department of Health and Human Services related to reimbursable research and development costs. The Company is also entitled to monthly reimbursement of indirect costs based on rates stipulated in the underlying contract. The Company’s calculations of its indirect cost rates are subject to audit by the U.S. Government. Receivables from Product Sales Receivables from product sales are recorded for amounts due to the Company related to sales of RAPIVAB. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. Inventory At December 31, 2018 December 31, 2017, first first Property and Equipment Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Computer equipment is depreciated over a life of three five seven not In accordance with U.S. GAAP, the Company periodically reviews its property and equipment for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not not Patents and Licenses The Company seeks patent protection on all internally developed processes and products. All patent related costs are expensed to selling, general and administrative expenses when incurred as recoverability of such expenditures is uncertain. Accrued Expenses The Company generally enters into contractual agreements with third not • fees paid to Clinical Research Organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; • fees paid to investigative sites in connection with clinical trials; • fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance and drug products; and • professional fees. The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may December 31, 2018 December 31, 2017, Accrued expenses were comprised of the following: December 31, 2018 2017 Compensation and benefits $ 4,659 $ 2,905 Development costs 7,564 6,683 Inventory 1,649 - Professional fees 118 729 Duties and taxes 51 148 Other 1,850 2,234 Total accrued expenses $ 15,891 $ 12,699 Income Taxes The liability method is used in the Company’s accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Accumulated Other Comprehensive Loss Accumulated other comprehensive loss is comprised of unrealized gains and losses on available-for-sale investments and is disclosed as a separate component of stockholders’ equity. Amounts reclassified from accumulated other comprehensive loss are recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. During 2018 2017, $2 $1, Revenue Recognition Transition Considerations In May 2014, No. 2014 09: Revenue from Contracts with Customers (Topic 606 606” 606 606 The Company adopted the provisions of ASC 606 January 1, 2018 not January 1, 2018. January 1, 2018 606, not 606. Adoption of ASC 606 606, 606, January 1, 2018. The following table summarizes the cumulative effect of the changes to the Company’s unaudited Consolidated Balance Sheet as of January 1, 2018 606: Balance at Adjustments due to Balance at Assets Deferred collaboration expense $ 210 $ (58 ) $ 152 Liabilities Deferred revenue $ 8,484 $ (1,184 ) $ 7,300 Equity Accumulated deficit $ (631,843 ) $ 1,126 $ (630,717 ) The following tables summarize the current period impacts of adopting ASC 606 December 31, 2018 As Reported Adjustments due to Balances without Assets Deferred collaboration expense $ 9 $ - $ 9 Liabilities Deferred revenue $ 221 $ - $ 221 Equity Accumulated deficit $ (731,969 ) $ - $ (731,969 ) For the Twelve Months Ended December 31, 2018 As Reported Adjustments due to Balances without Collaborative and other research and development revenue $ 14,552 $ 1,184 $ 15,736 Research and development expenses 84,888 58 84,946 Net loss (101,252 ) 1,126 (100,126 ) Basic and diluted net loss per share $ (0.98 ) $ 0.01 $ (0.97 ) Adoption of the standard had no Collaborative and Other Research and Development Arrangements and Royalties The Company recognizes revenue when it satisfies a performance obligation by transferring promised goods or services to a customer. Revenue is measured at the transaction price that is based on the amount of consideration that the Company expects to receive in exchange for transferring the promised goods or services to the customer. The transaction price includes estimates of variable consideration to the extent it is probable that a significant reversal of revenue recognized will not The Company has collaboration and license agreements with a number of third Revenue from license fees, royalty payments, milestone payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no Arrangements that involve the delivery of more than one not not may Milestone payments are recognized as licensing revenue upon the achievement of specified milestones if (i) the milestone is substantive in nature and the achievement of the milestone was not Reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the Consolidated Statements of Comprehensive Loss rather than as a reduction in expenses. Under the Company’s contracts with the Biomedical Advanced Research and Development Authority within the United States Department of Health and Human Services (”BARDA/HHS”) and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”), revenue is recognized as reimbursable direct and indirect costs are incurred. Under certain of the Company’s license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. Royalties are recognized at the later of when (i) the subsequent sale or usage occurs, or (ii) the performance obligation to which some or all of the sales-based or usage-based royalty has been satisfied. Product Sales The Company recognizes revenue for sales of RAPIVAB when the customer obtains control of the product, which generally occurs on the date of shipment to the Company’s specialty distributors, utilizing the Sell-In revenue recognition methodology. Product sales are recognized net of estimated allowances, discounts, sales returns, chargebacks and rebates. In the United States, prior to the Seqirus UK Limited (“SUL”) agreement, the Company sold RAPIVAB to specialty distributors, who in turn, sell to physician offices, hospitals and federal, state and commercial health care organizations. With the completion of the SUL worldwide license of RAPIVAB, SUL will be responsible for sales of RAPIVAB, other than U.S. Government stockpiling sales. With the completion of the SUL collaboration, all peramivir sales (i.e., RAPIVAB, ALPIVAB TM ® ® Sales deductions consist of statutory rebates to state Medicaid, Medicare and other government agencies and sales discounts (including trade discounts and distribution service fees). These deductions are recorded as reductions from revenue from RAPIVAB in the same period as the related sales with estimates of future utilization derived from historical experience adjusted to reflect known changes in the factors that impact such reserves. The Company recorded the following revenues for the years ended December 31: 2018 2017 2016 Product sales, net $ - $ 1,501 $ 2,269 Royalty revenue 6,101 10,543 9,682 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 2,552 4,608 12,449 Shionogi & Co. Ltd. - 1,184 1,184 Seqirus UK Limited 12,000 7,350 769 Total collaborative and other research and development revenues 14,552 13,142 14,402 Total revenues $ 20,653 $ 25,186 $ 26,353 Advertising The Company engages in very limited distribution and direct-response advertising when promoting RAPIVAB. Advertising and promotional costs are expensed as the costs are incurred. The Company did not 2018, 2017 2016. Research and Development Expenses The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third Additionally, the Company has license agreements with third Deferred collaboration expenses represent sub-license payments, paid to the Company’s academic partners upon receipt of consideration from various commercial partners, and other consideration paid to the Company’s academic partners for modification to existing license agreements. These deferred expenses would not Stock-Based Compensation All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in the Company’s Consolidated Statements of Comprehensive Loss based on their fair values. The fair value of stock option awards is estimated using the Black-Scholes option pricing model. The fair value of restricted stock unit awards is based on the grant date closing price of the common stock. Stock-based compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. In addition, we have outstanding performance-based stock options for which no Interest Expense and Deferred Financing Costs Interest expense for the years ended December 31, 2018, 2017 2016 $9,176, $8,565 $6,487, 3 4 $885, $876 $558 December 31, 2018, 2017 2016, Lease Financing Obligation Based on the terms of the lease agreement for the new research facility in Birmingham, Alabama, the Company had construction period risks during the construction period and the Company was deemed the owner of the building (for accounting purposes only) during the construction period, which ended in 2016. $1,589 December 31, 2015, not 20.5 no December 31, 2018, 2017 2016 $337, $299 $408, At December 31, 2018 2017, $2,703 $2,704, December 31, 2018 $3,890. Currency Hedge Agreement In connection with the issuance by Royalty Sub of the PhaRMA Notes, the Company entered into a Currency Hedge Agreement to hedge certain risks associated with changes in the value of the Japanese yen relative to the U.S. dollar. The Currency Hedge Agreement does not December 31, 2018, 2017 2016 $1,049, $1,787 $1,654, third not 2 $941, $966 $811 2018, 2017 2016, December 31, 2018 December 31, 2017, no Net Loss Per Share Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share is equivalent to basic net loss per share for all periods presented herein because common equivalent shares from unexercised stock options, outstanding warrants, and common shares expected to be issued under the Company’s employee stock purchase plan were anti-dilutive. The calculation of diluted earnings per share for the years ended December 31, 2018, 2017, 2016 not 2,274, 2,067 1,226 Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. The most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options, and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not Significant Customers and Other Risks Significant Customers Prior to the SUL Agreement, the Company relied primarily on three three 90% one Other than royalty revenues, the Company’s primary source of revenue that has an underlying cash flow stream is the reimbursement of galidesivir (formerly BCX4430 third Risks from Third Party Manufacturing and Distribution Concentration The Company relies on single source manufacturers for active pharmaceutical ingredient and finished drug product manufacturing of product candidates in development. Delays in the manufacture or distribution of any product could adversely impact the commercial revenue and future procurement stockpiling of the Company’s product candidates in development. Credit Risk Cash equivalents and investments are financial instruments which potentially subject the Company to concentration of risk to the extent recorded on the Consolidated Balance Sheets. The Company deposits excess cash with major financial institutions in the United States. Balances may 18 no |
Note 2 - Property and Equipment
Note 2 - Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 2 Property and equipment consisted of the following at December 31: 2018 2017 Furniture and fixtures $ 573 $ 566 Office equipment 152 146 Software 1,125 1,125 Laboratory equipment 3,329 2,984 Leased equipment 143 152 Leasehold improvements 8,413 8,405 Building 1,495 1,495 15,230 14,873 Less accumulated depreciation and amortization (6,095 ) (5,327 ) Property and equipment, net $ 9,135 $ 9,546 Depreciation and amortization expense for the years ended December 31, 2018, 2017 2016 $770, $704 $483, |
Note 3 - Royalty Monetization
Note 3 - Royalty Monetization | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Royalty Monetization [Text Block] | Note 3—Royalty Overview On March 9, 2011, $30,000 $22,691 $4,309 $3,000 September 2012 As part of the transaction, the Company entered into a purchase and sale agreement dated as of March 9, 2011 not Non-Recourse Notes Payable On March 9, 2011, $30,000 14.0% 2020 March 9, 2011 14% September 1st Royalty Sub’s obligations to pay principal and interest on the PhaRMA Notes are obligations solely of Royalty Sub and are without recourse to any other person, including the Company, except to the extent of the Company’s pledge of its equity interests in Royalty Sub in support of the PhaRMA Notes. The Company may, not may one In September 2014, September 3, 2013. September 2013 September 1, 2014, December 31, 2014 may may may not may no not December 31, 2018, The Indenture does not As of December 31, 2018, 50% $30,000. 2 The PhaRMA Notes are redeemable at the option of Royalty Sub at any time at a redemption price equal to the outstanding principal balance of the PhaRMA Notes being redeemed plus accrued and unpaid interest through the redemption date on the PhaRMA Notes being redeemed. Foreign Currency Hedge In connection with the issuance by Royalty Sub of the PhaRMA Notes, the Company entered into a Currency Hedge Agreement to hedge certain risks associated with changes in the value of the Japanese yen relative to the U.S. dollar. Under the Currency Hedge Agreement, the Company has the right to purchase dollars and sell yen at a rate of 100 may 2019 2020, $1,950 May 18 100 The Currency Hedge Agreement does not 2018, 2017 2016 $1,049, $1,787 $1,654, $941, $966 $811 2018, 2017 2016, December 31, 2018 2017, no not December 31, 2018, may $3,900. |
Note 4 - Senior Credit Facility
Note 4 - Senior Credit Facility | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 4 On July 20, 2018, $30,000 July 20, 2018 ( September 23, 2016 not 0.5% 8%. July 2019 30 February 6, 2019, $100,000 13—Subsequent As of December 31, 2018, $30,000 10.3%. Principal Payments 2019 $ 5,000 2020 12,000 2021 12,000 2022 1,000 Total $ 30,000 The debt agreement contains two not |
Note 5 - Lease Obligations and
Note 5 - Lease Obligations and Other Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | Note 5 The Company has the following minimum payments under operating lease obligations that existed at December 31, 2018: 2019 $ 1,300 2020 934 2021 524 2022 491 2023 503 Thereafter 1,495 Total minimum payments $ 5,247 The obligations in the preceding table are primarily related to the Company’s leases for buildings in Birmingham, Alabama and Durham, North Carolina. As of December 31, 2018, June 30, 2020, December 31, 2020. October 31, 2026. $758, $617 $721 2018, 2017, 2016, Lease Financing Obligation Based on the terms of the lease agreement for the new research facility in Birmingham, Alabama, the Company had construction period risks during the construction period and the Company was deemed the owner of the building (for accounting purposes only) during the construction period, which ended in 2016. $1,589 December 31, 2015, not no At December 31, 2018 2017, $2,703 $2,704, $3,890. |
Note 6 - Stockholders' Equity
Note 6 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 6 Sales of Common Stock In March 2017, 6,061 $8.50 $47,750 In September 2017, 17,864 $5.15 $86,250 On November 8, 2017, $200,000 3 December 12, 2017 On August 6, 2018, 10,455 $5.50 30 $53,400 |
Note 7 - Stock-based Compensati
Note 7 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | Note 7 Stock Incentive Plan As of December 31, 2018, two September 2018 October 2018. March 2014 May 2014. $9,396 $9,223 $173 2018, $12,621 $12,421 $200 2017, $8,487 $8,340 $147 2016. The Company accounts for stock-based compensation in accordance with FASB authoritative guidance regarding share-based payments. Total stock-based compensation was allocated as follows: Year Ended December 31, 2018 2017 2016 Research and development $ 6,867 $ 9,602 $ 6,088 General and administrative 2,529 3,019 2,399 Total stock-based compensation expense $ 9,396 $ 12,621 $ 8,487 The Company grants stock option awards and restricted stock unit awards to its employees, directors, and consultants under the Incentive Plan. Under the Incentive Plan, stock option awards are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Commencing March 1, 2011, 25% four August 2013 December 2014, 1,032 1,250 December 31, 2018, 75% August 2013 three December 31, 2018, 30% December 2014 December 31, 2018, 25% August 2013 70% December 2014 no one 5 10 Related activity under the Incentive Plan is as follows: Awards Options Weighted Balance at December 31, 2015 16 10,671 $ 7.50 Plan amendment 3,800 - - Restricted stock awards granted (34 ) - - Restricted stock awards cancelled 22 - - Stock option awards granted (2,248 ) 2,248 3.20 Stock option awards exercised - (107 ) 2.63 Stock option awards cancelled 717 (717 ) 10.78 Balance at December 31, 2016 2,273 12,095 6.55 Plan amendment 1,000 - - Restricted stock awards granted (22 ) - - Restricted stock awards cancelled 12 - - Stock option awards granted (3,915 ) 3,915 5.33 Stock option awards exercised - (438 ) 3.50 Stock option awards cancelled 1,120 (1,120 ) 9.72 Balance at December 31, 2017 468 14,452 6.06 Plan amendment 4,400 - - Restricted stock awards granted (13 ) - - Restricted stock awards cancelled - - - Stock option awards granted (4,272 ) 4,272 7.15 Stock option awards exercised - (1,011 ) 2.92 Stock option awards cancelled 222 (222 ) 7.44 Balance at December 31, 2018 805 17,491 $ 6.49 As of December 31, 2018, 31 For stock option awards granted under the Incentive Plan during 2018, 2017 2016, 2018, 2017 2016 $4.92, $3.63 $2.17, 2018, 2017, 2016. not no not zero Weighted Average Assumptions for Stock Option Awards Granted under the Incentive Plan 2018 2017 2016 Expected Life 5.5 5.5 5.5 Expected Volatility 82 % 82 % 82 % Expected Dividend Yield 0.0 % 0.0 % 0.0 % Risk-Free Interest Rate 2.7 % 2.0 % 1.4 % The total intrinsic value of stock option awards exercised under the Incentive Plan was $4,504 2018, $1,964 2017 $339 2016. The following table summarizes, at December 31, 2018, 1 2 Outstanding Exercisable Range Number Weighted Average Remaining Life Weighted Average Exercise Price Number Weighted Average Exercise Price $ 0 to 3 1,266 4.1 $ 1.66 1,191 $ 1.58 3 to 6 7,778 6.8 4.69 3,937 4.50 6 to 9 4,768 8.7 7.06 883 6.85 9 to 12 2,980 6.5 10.90 1,711 10.96 12 to 15 604 6.0 12.29 403 12.35 15 to 18 95 6.5 15.39 71 15.39 $ 0 to 18 17,491 7.0 $ 6.49 8,196 $ 6.16 The weighted average remaining contractual life of stock option awards exercisable under the Incentive Plan at December 31, 2018 5.3 The aggregate intrinsic value of stock option awards outstanding and exercisable under the Incentive Plan at December 31, 2018 $22,891. The total fair value of the stock option awards vested under the Incentive Plan was $8,952 2018, $9,310 2017 $6,380 2016. As of December 31, 2018, 15,928. $6.43 7.0 The following table summarizes the changes in the number and weighted-average grant-date fair value of non-vested stock option awards during 2018: Non-Vested Weighted Average Balance December 31, 2017 7,202 $ 4.56 Stock option awards granted 4,272 4.92 Stock option awards vested (2,065 ) 4.33 Stock option awards forfeited (114 ) 4.12 Balance December 31, 2018 9,295 $ 4.78 As of December 31, 2018, $28,284 $10,423 2019, $7,779 2020, $5,791 2021 $4,291 2022. Employee Stock Purchase Plan The Company has reserved a total of 1,475 234 December 31, 2018. may 15% 85% 85% six No 3 may one six no may $25 one There were 92, 95 75 2018, 2017, 2016, $3.83, $3.61 $4.36, $173, $200 $147 2018, 2017, 2016, 2018, 2017, 2016, $1.89, $2.18 $1.95, |
Note 8 - Income Taxes
Note 8 - Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 8 The Company has incurred net losses since inception and, consequently, has not 2018, 2017, 2016 2018 2017 2016 Income tax benefit at federal statutory rate (21% for 2018 and 2017 and 35 % for 2016) $ (21,263 ) $ (23,024 ) $ (19,300 ) State and local income taxes net of federal tax benefit (2,547 ) (1,611 ) (1,173 ) Permanent items 503 910 1,057 Rate change (29 ) 71,155 1,080 Expiration of attribute carryforwards 2,183 918 559 Effect of ASU 2016-09 - (5,949 ) - Research and development tax credits (4,905 ) (1,977 ) (4,681 ) Orphan drug credit - 564 1,798 Other 18 1,639 822 Change in valuation allowance 26,040 (42,625 ) 19,838 Income tax expense $ - $ - $ - In December 2017, 21% 35%, January 1, 2018. 21%, $73,474 no December 31, 2018, No The Company adopted ASU 2016 09 March 31, 2017. $5,949 2016 09 no The Company recognizes the impact of a tax position in its financial statements if it is more likely than not no not 12 A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: 2018 2017 Balance at January 1, $ 4,750 $ 4,255 Additions to current period tax positions 1,226 495 Additions to prior period tax positions - - Reductions to prior period tax provisions - - Balance at December 31, $ 5,976 $ 4,750 The Company’s ability to utilize the net operating loss and tax credit carryforwards in the future may 382 1986, Significant components of the Company’s deferred tax assets and liabilities are as follows: 2018 2017 Deferred tax assets: Net federal and state operating losses $ 137,234 $ 117,787 Research and development credits 59,509 55,208 Deferred revenue - 1,854 Stock-based compensation 7,108 6,424 Other 5,258 2,046 Total deferred tax assets 209,109 183,319 Deferred tax liabilities: Fixed assets (418 ) (421 ) Foreign currency derivative (231 ) (478 ) Total deferred tax liabilities (649 ) (899 ) Valuation allowance (208,460 ) (182,420 ) Net deferred tax assets $ - $ - The majority of the Company’s deferred tax assets relate to net operating loss and research and development carryforwards that can only be realized if the Company is profitable in future periods. It is uncertain whether the Company will realize any tax benefit related to these carryforwards. Accordingly, the Company has provided a full valuation allowance against the net deferred tax assets due to uncertainties as to their ultimate realization. The valuation allowance will remain at the full amount of the deferred tax assets until it is more likely than not $26,040 2018, $42,625 2017 $19,837 2016. As of December 31, 2018, $569,314, $496,816, $65,485, 2019 2037. 2019, 2019 2019. Tax years 2015 2017 2015 no 2018, 2017 2016. |
Note 9 - Employee 401(k) Plan
Note 9 - Employee 401(k) Plan | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Pension and Other Postretirement Benefits Disclosure [Text Block] | Note 9 401 In January 1991, “401 401 may 401 may $724, $664 $504, 2018, 2017 2016, |
Note 10 - Collaborative and Oth
Note 10 - Collaborative and Other Research and Development Contracts | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | Note 10 National Institute of Allergy and Infectious Diseases (“NIAID/HHS”). September 2013, $5,000 1 December 31, 2018, $43,035. December 31, 2018, U.S. Department of Health and Human Services (“BARDA/HHS”). March 31, 2015, $16,265 $22,855 $39,120. December 31, 2018, $20,574 The contracts with NIAID/HHS and BARDA/HHS are cost-plus-fixed-fee contracts. That is, the Company is entitled to receive reimbursement for all costs incurred in accordance with the contract provisions that are related to the development of galidesivir plus a fixed fee, or profit. BARDA/HHS and NIAID/HHS will make periodic assessments of progress and the continuation of the contract is based on the Company’s performance, the timeliness and quality of deliverables, and other factors. The government has rights under certain contract clauses to terminate these contracts. These contracts are terminable by the government at any time for breach or without cause. Seqirus UK Limited (“SUL”). June 16, 2015, Pursuant to the SUL Agreement, RAPIVAB will be commercialized by CSL’s subsidiary, SUL, which specializes in influenza prevention through the supply of seasonal and pandemic vaccine to global markets. SUL will manufacture, commercialize and exercise decision-making authority with respect to the development and commercialization of RAPIVAB within the Territory and be responsible for all related costs, including sales and promotion. Under the terms of the SUL Agreement, the Company is responsible for fulfilling all post-marketing approval commitments in connection with the FDA's approval of the NDA, and upon fulfillment will transfer ownership of and financial responsibility for the NDA to SUL. Pursuant to rights to sell ALPIVAB in the EU, the Company was also responsible for regulatory filings and interactions with the European Medicines Agency (“EMA”). In accordance with the SUL Agreement, the Company and SUL formed a joint steering committee, composed of an equal number of representatives from each party, to oversee, review and coordinate the conduct and progress of the commercialization of RAPIVAB in the Territory and any additional development. In October 2017, Under the terms of the SUL Agreement, the Company has received an upfront payment of $33,740 $12,000. July 1 - June 30) ten The Company and SUL are engaged in a formal dispute resolution process, which has now entered arbitration proceedings. The dispute involves many items under the SUL Agreement including, but not no Shionogi & Co., Ltd. (“Shionogi”). February 2007, October 2008, In December 2017, no not not Green Cross Corporation (“Green Cross”). June 2006, one $250. Mundipharma International Holdings Limited (“Mundipharma”). February 2006, $10,000 On November 11, 2011, November 11, 2011, $15,000 Albert Einstein College of Medicine of Yeshiva University and Industrial Research, Ltd. (“AECOM” and “IRL” respectively). June 2000, $1,400 $4,000 one third $150 $500, may 60 In May 2010, one third not may February 1, 2006 On November 17, 2011, one On June 19, 2012, At its sole option and subject to certain agreed upon conditions, any future non-royalty payments due to be paid by the Company to AECOM/IRL under the license agreement may On January 6, 2014, The University of Alabama at Birmingham (“UAB”). third two 25 five three no |
Note 11 - Quarterly Financial I
Note 11 - Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | Note 11 First Second Third Fourth 2018 Quarters Revenues $ 3,976 $ 12,494 $ 1,454 $ 2,729 Net Loss (25,777 ) (18,446 ) (29,597 ) (27,432 ) Basic and diluted net loss per share (0.26 ) (0.19 ) (0.28 ) (0.25 ) 2017 Quarters Revenues $ 9,437 $ 3,099 $ 8,760 $ 3,890 Net Loss (14,219 ) (16,886 ) (15,134 ) (19,543 ) Basic and diluted net loss per share (0.19 ) (0.21 ) (0.18 ) (0.20 ) |
Note 12 - Recent Accounting Pro
Note 12 - Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
New Accounting Pronouncements and Changes in Accounting Principles [Text Block] | Note 12 In June 2018, 2018 07: Compensation - Stock Compensation: Improvements to Nonemployee Share-based Payment Accounting 2018 07” . 718 718 718 not 1 2 606, December 15, 2018, no 606. 2018 07 July 1, 2018. 2018 07 not In November 2016, 2016 18: Statement of Cash Flows (Topic 230 2016 18” December 15, 2017, 2016 18 January 1, 2018 2016 18 not In August 2016, No. 2016 15: Statement of Cash Flows (Topic 230 2016 15” one December 15, 2017, 2016 15 January 1, 2018. 2016 15 not In February 2016, No. 2016 02: Leases (Topic 842 2016 02” 12 2016 02 2019, July 2018, 2018 11 $3,000 $6,000 January 1, 2019; not In January 2016, No. 2016 01: Financial Instruments - Overall (Subtopic 825 10 2016 01” December 15, 2017, 2016 01 January 1, 2018. 2016 01 not |
Note 13 - Subsequent Event
Note 13 - Subsequent Event | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 13 Second Amended and Restated Credit Facility On February 6, 2019, $100,000 three February 6, 2019, three first $50,000 $30,000 second $30,000, third $20,000, second third July 20, 2018. not 0.5% 8%. June 2020 30 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Description of Company [Policy Text Block] | The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a biotechnology company that discovers novel, oral, small-molecule medicines. The Company focuses on the treatment of rare diseases in which significant unmet medical needs exist and an enzyme plays the key role in the biological pathway of the disease. The Company was incorporated in Delaware in 1986 With the funds available at December 31, 2018, 2020. 2019 2019 2020. may 2020 1 2 3 4 5 one 6 may |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, JPR Royalty Sub LLC (“Royalty Sub”) and MDCP, LLC (“MDCP”). Both subsidiaries were formed to facilitate financing transactions for the Company. Royalty Sub was formed in connection with a $30,000 March 9, 2011. 3, $23,000 September 23, 2016 July 20, 2018 February 6, 2019. 4 13 The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Such consolidated financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. There were no |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company generally considers cash equivalents to be all cash held in commercial checking accounts, certificates of deposit, money market accounts or investments in debt instruments with maturities of three |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash Restricted cash as of December 31, 2018 $131 3 $1,413 |
Investment, Policy [Policy Text Block] | Investments The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may three no 18 may may not not not The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not three 12 12 December 31, 2018, The following tables summarize the fair value of the Company’s investments by type. The estimated fair values of the Company’s fixed income investments are classified as Level 2 not not 2 December 31, 2018 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 50,613 $ 176 $ 15 $ (131 ) $ 50,673 Corporate debt securities 45,793 254 4 (171 ) 45,880 Certificates of deposit 3,559 14 - (14 ) 3,559 Total investments $ 99,965 $ 444 $ 19 $ (316 ) $ 100,112 December 31, 2017 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 60,121 $ 177 $ - $ (122 ) $ 60,176 Corporate debt securities 34,021 203 - (108 ) 34,116 Certificates of deposit 11,099 32 1 (14 ) 11,118 Total investments $ 105,241 $ 412 $ 1 $ (244 ) $ 105,410 The following table summarizes the scheduled maturity for the Company’s investments at December 31, 2018 2017. 2018 2017 Maturing in one year or less $ 77,736 $ 64,115 Maturing after one year through two years 22,376 34,257 Maturing after two years - 7,038 Total investments $ 100,112 $ 105,410 |
Receivables, Policy [Policy Text Block] | Receivables from Collaborations Receivables from collaborations are recorded for amounts due to the Company related to reimbursable research and development costs from the U.S. Department of Health and Human Services, royalty receivables from Shionogi, Green Cross Corporation (“Green Cross”), Mundipharma International Holdings Limited (“Mundipharma”) and Seqirus UK Limited (“SUL”), and product sales to SUL. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. At December 31, 2018 December 31, 2017, December 31, 2018 Billed Unbilled Total U.S. Department of Health and Human Services $ - $ 1,525 $ 1,525 Shionogi & Co. Ltd. 854 - 854 Green Cross Corporation 876 28 904 Mundipharma International Holdings Limited 44 - 44 Seqirus UK Limited 940 26 966 Total receivables $ 2,714 $ 1,579 $ 4,293 December 31, 2017 Billed Unbilled Total U.S. Department of Health and Human Services $ 42 $ 2,020 $ 2,062 Shionogi & Co. Ltd. 1,600 - 1,600 Green Cross Corporation 1,388 28 1,416 Mundipharma International Holdings Limited 47 - 47 Seqirus UK Limited 825 167 992 Total receivables $ 3,902 $ 2,215 $ 6,117 Monthly invoices are submitted to the U.S. Department of Health and Human Services related to reimbursable research and development costs. The Company is also entitled to monthly reimbursement of indirect costs based on rates stipulated in the underlying contract. The Company’s calculations of its indirect cost rates are subject to audit by the U.S. Government. Receivables from Product Sales Receivables from product sales are recorded for amounts due to the Company related to sales of RAPIVAB. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. |
Inventory, Policy [Policy Text Block] | Inventory At December 31, 2018 December 31, 2017, first first |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Computer equipment is depreciated over a life of three five seven not In accordance with U.S. GAAP, the Company periodically reviews its property and equipment for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not not |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Patents and Licenses The Company seeks patent protection on all internally developed processes and products. All patent related costs are expensed to selling, general and administrative expenses when incurred as recoverability of such expenditures is uncertain. |
Accrued Expenses [Policy Text Block] | Accrued Expenses The Company generally enters into contractual agreements with third not • fees paid to Clinical Research Organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; • fees paid to investigative sites in connection with clinical trials; • fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance and drug products; and • professional fees. The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may December 31, 2018 December 31, 2017, Accrued expenses were comprised of the following: December 31, 2018 2017 Compensation and benefits $ 4,659 $ 2,905 Development costs 7,564 6,683 Inventory 1,649 - Professional fees 118 729 Duties and taxes 51 148 Other 1,850 2,234 Total accrued expenses $ 15,891 $ 12,699 |
Income Tax, Policy [Policy Text Block] | Income Taxes The liability method is used in the Company’s accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. |
Comprehensive Income, Policy [Policy Text Block] | Accumulated Other Comprehensive Loss Accumulated other comprehensive loss is comprised of unrealized gains and losses on available-for-sale investments and is disclosed as a separate component of stockholders’ equity. Amounts reclassified from accumulated other comprehensive loss are recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. During 2018 2017, $2 $1, |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition Transition Considerations In May 2014, No. 2014 09: Revenue from Contracts with Customers (Topic 606 606” 606 606 The Company adopted the provisions of ASC 606 January 1, 2018 not January 1, 2018. January 1, 2018 606, not 606. Adoption of ASC 606 606, 606, January 1, 2018. The following table summarizes the cumulative effect of the changes to the Company’s unaudited Consolidated Balance Sheet as of January 1, 2018 606: Balance at Adjustments due to Balance at Assets Deferred collaboration expense $ 210 $ (58 ) $ 152 Liabilities Deferred revenue $ 8,484 $ (1,184 ) $ 7,300 Equity Accumulated deficit $ (631,843 ) $ 1,126 $ (630,717 ) The following tables summarize the current period impacts of adopting ASC 606 December 31, 2018 As Reported Adjustments due to Balances without Assets Deferred collaboration expense $ 9 $ - $ 9 Liabilities Deferred revenue $ 221 $ - $ 221 Equity Accumulated deficit $ (731,969 ) $ - $ (731,969 ) For the Twelve Months Ended December 31, 2018 As Reported Adjustments due to Balances without Collaborative and other research and development revenue $ 14,552 $ 1,184 $ 15,736 Research and development expenses 84,888 58 84,946 Net loss (101,252 ) 1,126 (100,126 ) Basic and diluted net loss per share $ (0.98 ) $ 0.01 $ (0.97 ) Adoption of the standard had no Collaborative and Other Research and Development Arrangements and Royalties The Company recognizes revenue when it satisfies a performance obligation by transferring promised goods or services to a customer. Revenue is measured at the transaction price that is based on the amount of consideration that the Company expects to receive in exchange for transferring the promised goods or services to the customer. The transaction price includes estimates of variable consideration to the extent it is probable that a significant reversal of revenue recognized will not The Company has collaboration and license agreements with a number of third Revenue from license fees, royalty payments, milestone payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no Arrangements that involve the delivery of more than one not not may Milestone payments are recognized as licensing revenue upon the achievement of specified milestones if (i) the milestone is substantive in nature and the achievement of the milestone was not Reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the Consolidated Statements of Comprehensive Loss rather than as a reduction in expenses. Under the Company’s contracts with the Biomedical Advanced Research and Development Authority within the United States Department of Health and Human Services (”BARDA/HHS”) and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”), revenue is recognized as reimbursable direct and indirect costs are incurred. Under certain of the Company’s license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. Royalties are recognized at the later of when (i) the subsequent sale or usage occurs, or (ii) the performance obligation to which some or all of the sales-based or usage-based royalty has been satisfied. Product Sales The Company recognizes revenue for sales of RAPIVAB when the customer obtains control of the product, which generally occurs on the date of shipment to the Company’s specialty distributors, utilizing the Sell-In revenue recognition methodology. Product sales are recognized net of estimated allowances, discounts, sales returns, chargebacks and rebates. In the United States, prior to the Seqirus UK Limited (“SUL”) agreement, the Company sold RAPIVAB to specialty distributors, who in turn, sell to physician offices, hospitals and federal, state and commercial health care organizations. With the completion of the SUL worldwide license of RAPIVAB, SUL will be responsible for sales of RAPIVAB, other than U.S. Government stockpiling sales. With the completion of the SUL collaboration, all peramivir sales (i.e., RAPIVAB, ALPIVAB TM ® ® Sales deductions consist of statutory rebates to state Medicaid, Medicare and other government agencies and sales discounts (including trade discounts and distribution service fees). These deductions are recorded as reductions from revenue from RAPIVAB in the same period as the related sales with estimates of future utilization derived from historical experience adjusted to reflect known changes in the factors that impact such reserves. The Company recorded the following revenues for the years ended December 31: 2018 2017 2016 Product sales, net $ - $ 1,501 $ 2,269 Royalty revenue 6,101 10,543 9,682 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 2,552 4,608 12,449 Shionogi & Co. Ltd. - 1,184 1,184 Seqirus UK Limited 12,000 7,350 769 Total collaborative and other research and development revenues 14,552 13,142 14,402 Total revenues $ 20,653 $ 25,186 $ 26,353 Advertising The Company engages in very limited distribution and direct-response advertising when promoting RAPIVAB. Advertising and promotional costs are expensed as the costs are incurred. The Company did not 2018, 2017 2016. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third Additionally, the Company has license agreements with third Deferred collaboration expenses represent sub-license payments, paid to the Company’s academic partners upon receipt of consideration from various commercial partners, and other consideration paid to the Company’s academic partners for modification to existing license agreements. These deferred expenses would not |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in the Company’s Consolidated Statements of Comprehensive Loss based on their fair values. The fair value of stock option awards is estimated using the Black-Scholes option pricing model. The fair value of restricted stock unit awards is based on the grant date closing price of the common stock. Stock-based compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. In addition, we have outstanding performance-based stock options for which no |
Interest Expense and Deferred Financing Costs [Policy Text Block] | Interest Expense and Deferred Financing Costs Interest expense for the years ended December 31, 2018, 2017 2016 $9,176, $8,565 $6,487, 3 4 $885, $876 $558 December 31, 2018, 2017 2016, |
Lessee, Leases [Policy Text Block] | Lease Financing Obligation Based on the terms of the lease agreement for the new research facility in Birmingham, Alabama, the Company had construction period risks during the construction period and the Company was deemed the owner of the building (for accounting purposes only) during the construction period, which ended in 2016. $1,589 December 31, 2015, not 20.5 no December 31, 2018, 2017 2016 $337, $299 $408, At December 31, 2018 2017, $2,703 $2,704, December 31, 2018 $3,890. |
Currency Hedge Agreement [Policy Text Block] | Currency Hedge Agreement In connection with the issuance by Royalty Sub of the PhaRMA Notes, the Company entered into a Currency Hedge Agreement to hedge certain risks associated with changes in the value of the Japanese yen relative to the U.S. dollar. The Currency Hedge Agreement does not December 31, 2018, 2017 2016 $1,049, $1,787 $1,654, third not 2 $941, $966 $811 2018, 2017 2016, December 31, 2018 December 31, 2017, no |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Share Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share is equivalent to basic net loss per share for all periods presented herein because common equivalent shares from unexercised stock options, outstanding warrants, and common shares expected to be issued under the Company’s employee stock purchase plan were anti-dilutive. The calculation of diluted earnings per share for the years ended December 31, 2018, 2017, 2016 not 2,274, 2,067 1,226 |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. The most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options, and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not |
Concentration of Market Risk [Policy Text Block] | Significant Customers and Other Risks Significant Customers Prior to the SUL Agreement, the Company relied primarily on three three 90% one Other than royalty revenues, the Company’s primary source of revenue that has an underlying cash flow stream is the reimbursement of galidesivir (formerly BCX4430 third Risks from Third Party Manufacturing and Distribution Concentration The Company relies on single source manufacturers for active pharmaceutical ingredient and finished drug product manufacturing of product candidates in development. Delays in the manufacture or distribution of any product could adversely impact the commercial revenue and future procurement stockpiling of the Company’s product candidates in development. Credit Risk Cash equivalents and investments are financial instruments which potentially subject the Company to concentration of risk to the extent recorded on the Consolidated Balance Sheets. The Company deposits excess cash with major financial institutions in the United States. Balances may 18 no |
Note 1 - Significant Accounti_2
Note 1 - Significant Accounting Policies and Concentrations of Risk (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Debt Securities, Available-for-sale [Table Text Block] | December 31, 2018 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 50,613 $ 176 $ 15 $ (131 ) $ 50,673 Corporate debt securities 45,793 254 4 (171 ) 45,880 Certificates of deposit 3,559 14 - (14 ) 3,559 Total investments $ 99,965 $ 444 $ 19 $ (316 ) $ 100,112 December 31, 2017 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 60,121 $ 177 $ - $ (122 ) $ 60,176 Corporate debt securities 34,021 203 - (108 ) 34,116 Certificates of deposit 11,099 32 1 (14 ) 11,118 Total investments $ 105,241 $ 412 $ 1 $ (244 ) $ 105,410 |
Available For Sale Securities Debt Maturities Fair Value [Table Text Block] | 2018 2017 Maturing in one year or less $ 77,736 $ 64,115 Maturing after one year through two years 22,376 34,257 Maturing after two years - 7,038 Total investments $ 100,112 $ 105,410 |
Schedule of Receivables from Collaborations [Table Text Block] | December 31, 2018 Billed Unbilled Total U.S. Department of Health and Human Services $ - $ 1,525 $ 1,525 Shionogi & Co. Ltd. 854 - 854 Green Cross Corporation 876 28 904 Mundipharma International Holdings Limited 44 - 44 Seqirus UK Limited 940 26 966 Total receivables $ 2,714 $ 1,579 $ 4,293 December 31, 2017 Billed Unbilled Total U.S. Department of Health and Human Services $ 42 $ 2,020 $ 2,062 Shionogi & Co. Ltd. 1,600 - 1,600 Green Cross Corporation 1,388 28 1,416 Mundipharma International Holdings Limited 47 - 47 Seqirus UK Limited 825 167 992 Total receivables $ 3,902 $ 2,215 $ 6,117 |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2018 2017 Compensation and benefits $ 4,659 $ 2,905 Development costs 7,564 6,683 Inventory 1,649 - Professional fees 118 729 Duties and taxes 51 148 Other 1,850 2,234 Total accrued expenses $ 15,891 $ 12,699 |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles [Table Text Block] | Balance at Adjustments due to Balance at Assets Deferred collaboration expense $ 210 $ (58 ) $ 152 Liabilities Deferred revenue $ 8,484 $ (1,184 ) $ 7,300 Equity Accumulated deficit $ (631,843 ) $ 1,126 $ (630,717 ) December 31, 2018 As Reported Adjustments due to Balances without Assets Deferred collaboration expense $ 9 $ - $ 9 Liabilities Deferred revenue $ 221 $ - $ 221 Equity Accumulated deficit $ (731,969 ) $ - $ (731,969 ) For the Twelve Months Ended December 31, 2018 As Reported Adjustments due to Balances without Collaborative and other research and development revenue $ 14,552 $ 1,184 $ 15,736 Research and development expenses 84,888 58 84,946 Net loss (101,252 ) 1,126 (100,126 ) Basic and diluted net loss per share $ (0.98 ) $ 0.01 $ (0.97 ) |
Disaggregation of Revenue [Table Text Block] | 2018 2017 2016 Product sales, net $ - $ 1,501 $ 2,269 Royalty revenue 6,101 10,543 9,682 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 2,552 4,608 12,449 Shionogi & Co. Ltd. - 1,184 1,184 Seqirus UK Limited 12,000 7,350 769 Total collaborative and other research and development revenues 14,552 13,142 14,402 Total revenues $ 20,653 $ 25,186 $ 26,353 |
Note 2 - Property and Equipme_2
Note 2 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | 2018 2017 Furniture and fixtures $ 573 $ 566 Office equipment 152 146 Software 1,125 1,125 Laboratory equipment 3,329 2,984 Leased equipment 143 152 Leasehold improvements 8,413 8,405 Building 1,495 1,495 15,230 14,873 Less accumulated depreciation and amortization (6,095 ) (5,327 ) Property and equipment, net $ 9,135 $ 9,546 |
Note 4 - Senior Credit Facili_2
Note 4 - Senior Credit Facility (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Maturities of Long-term Debt [Table Text Block] | Principal Payments 2019 $ 5,000 2020 12,000 2021 12,000 2022 1,000 Total $ 30,000 |
Note 5 - Lease Obligations an_2
Note 5 - Lease Obligations and Other Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | 2019 $ 1,300 2020 934 2021 524 2022 491 2023 503 Thereafter 1,495 Total minimum payments $ 5,247 |
Note 7 - Stock-based Compensa_2
Note 7 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Year Ended December 31, 2018 2017 2016 Research and development $ 6,867 $ 9,602 $ 6,088 General and administrative 2,529 3,019 2,399 Total stock-based compensation expense $ 9,396 $ 12,621 $ 8,487 |
Share-based Compensation, Activity [Table Text Block] | Awards Options Weighted Balance at December 31, 2015 16 10,671 $ 7.50 Plan amendment 3,800 - - Restricted stock awards granted (34 ) - - Restricted stock awards cancelled 22 - - Stock option awards granted (2,248 ) 2,248 3.20 Stock option awards exercised - (107 ) 2.63 Stock option awards cancelled 717 (717 ) 10.78 Balance at December 31, 2016 2,273 12,095 6.55 Plan amendment 1,000 - - Restricted stock awards granted (22 ) - - Restricted stock awards cancelled 12 - - Stock option awards granted (3,915 ) 3,915 5.33 Stock option awards exercised - (438 ) 3.50 Stock option awards cancelled 1,120 (1,120 ) 9.72 Balance at December 31, 2017 468 14,452 6.06 Plan amendment 4,400 - - Restricted stock awards granted (13 ) - - Restricted stock awards cancelled - - - Stock option awards granted (4,272 ) 4,272 7.15 Stock option awards exercised - (1,011 ) 2.92 Stock option awards cancelled 222 (222 ) 7.44 Balance at December 31, 2018 805 17,491 $ 6.49 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2018 2017 2016 Expected Life 5.5 5.5 5.5 Expected Volatility 82 % 82 % 82 % Expected Dividend Yield 0.0 % 0.0 % 0.0 % Risk-Free Interest Rate 2.7 % 2.0 % 1.4 % |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable [Table Text Block] | Outstanding Exercisable Range Number Weighted Average Remaining Life Weighted Average Exercise Price Number Weighted Average Exercise Price $ 0 to 3 1,266 4.1 $ 1.66 1,191 $ 1.58 3 to 6 7,778 6.8 4.69 3,937 4.50 6 to 9 4,768 8.7 7.06 883 6.85 9 to 12 2,980 6.5 10.90 1,711 10.96 12 to 15 604 6.0 12.29 403 12.35 15 to 18 95 6.5 15.39 71 15.39 $ 0 to 18 17,491 7.0 $ 6.49 8,196 $ 6.16 |
Share-based Compensation, Stock Options, Activity [Table Text Block] | Non-Vested Weighted Average Balance December 31, 2017 7,202 $ 4.56 Stock option awards granted 4,272 4.92 Stock option awards vested (2,065 ) 4.33 Stock option awards forfeited (114 ) 4.12 Balance December 31, 2018 9,295 $ 4.78 |
Note 8 - Income Taxes (Tables)
Note 8 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | 2018 2017 2016 Income tax benefit at federal statutory rate (21% for 2018 and 2017 and 35 % for 2016) $ (21,263 ) $ (23,024 ) $ (19,300 ) State and local income taxes net of federal tax benefit (2,547 ) (1,611 ) (1,173 ) Permanent items 503 910 1,057 Rate change (29 ) 71,155 1,080 Expiration of attribute carryforwards 2,183 918 559 Effect of ASU 2016-09 - (5,949 ) - Research and development tax credits (4,905 ) (1,977 ) (4,681 ) Orphan drug credit - 564 1,798 Other 18 1,639 822 Change in valuation allowance 26,040 (42,625 ) 19,838 Income tax expense $ - $ - $ - |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | 2018 2017 Balance at January 1, $ 4,750 $ 4,255 Additions to current period tax positions 1,226 495 Additions to prior period tax positions - - Reductions to prior period tax provisions - - Balance at December 31, $ 5,976 $ 4,750 |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | 2018 2017 Deferred tax assets: Net federal and state operating losses $ 137,234 $ 117,787 Research and development credits 59,509 55,208 Deferred revenue - 1,854 Stock-based compensation 7,108 6,424 Other 5,258 2,046 Total deferred tax assets 209,109 183,319 Deferred tax liabilities: Fixed assets (418 ) (421 ) Foreign currency derivative (231 ) (478 ) Total deferred tax liabilities (649 ) (899 ) Valuation allowance (208,460 ) (182,420 ) Net deferred tax assets $ - $ - |
Note 11 - Quarterly Financial_2
Note 11 - Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Quarterly Financial Information [Table Text Block] | First Second Third Fourth 2018 Quarters Revenues $ 3,976 $ 12,494 $ 1,454 $ 2,729 Net Loss (25,777 ) (18,446 ) (29,597 ) (27,432 ) Basic and diluted net loss per share (0.26 ) (0.19 ) (0.28 ) (0.25 ) 2017 Quarters Revenues $ 9,437 $ 3,099 $ 8,760 $ 3,890 Net Loss (14,219 ) (16,886 ) (15,134 ) (19,543 ) Basic and diluted net loss per share (0.19 ) (0.21 ) (0.18 ) (0.20 ) |
Note 1 - Significant Accounti_3
Note 1 - Significant Accounting Policies and Concentrations of Risk (Details Textual) shares in Thousands, $ in Thousands | 12 Months Ended | ||||||
Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($)shares | Jul. 20, 2018USD ($) | Sep. 23, 2016USD ($) | Dec. 31, 2015USD ($) | Mar. 09, 2011USD ($) | |
Long-term Line of Credit, Total | $ 25,372 | $ 16,750 | |||||
Restricted Cash and Cash Equivalents, Current, Total | 1,544 | 3,286 | |||||
Loss on Sale of Investments | 0 | ||||||
Reclassification from Accumulated Other Comprehensive Income, Current Period, before Tax | 2 | 1 | |||||
Interest Expense, Debt, Total | 9,176 | 8,565 | $ 6,487 | ||||
Amortization of Debt Issuance Costs | 885 | 876 | 558 | ||||
Property, Plant and Equipment, Gross, Ending Balance | 15,230 | 14,873 | |||||
Interest Expense, Total | 9,176 | 8,565 | $ 6,487 | ||||
Lease Financing Obligation, Net of Current | $ 2,703 | $ 2,751 | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares | 2,274 | 2,067 | 1,226 | ||||
RAPIVAB [Member] | Customer Concentration Risk [Member] | Sales Revenue, Product Line [Member] | |||||||
Number of Major Customers | 3 | ||||||
RAPIVAB [Member] | Customer Concentration Risk [Member] | Sales Revenue, Product Line [Member] | Three Customers [Member] | |||||||
Concentration Risk, Percentage | 90.00% | ||||||
Foreign Exchange Contract [Member] | Not Designated as Hedging Instrument [Member] | |||||||
Derivative, Loss on Derivative | $ 1,049 | $ 1,787 | $ 1,654 | ||||
Derivative, Gain on Derivative | 941 | 966 | 811 | ||||
Currency Hedge Agreement [Member] | |||||||
Collateral Already Posted, Aggregate Fair Value | 0 | 0 | |||||
Birmingham Research Facility [Member] | |||||||
Interest Expense, Total | 337 | 299 | $ 408 | ||||
Lease Financing Obligation, Net of Current | 2,703 | 2,704 | |||||
Capital Leases, Future Minimum Payments Due, Total | $ 3,890 | ||||||
Computer Equipment [Member] | |||||||
Property, Plant and Equipment, Useful Life | 3 years | ||||||
Laboratory Equipment, Office Equipment and Software [Member] | |||||||
Property, Plant and Equipment, Useful Life | 5 years | ||||||
Furniture and Fixtures [Member] | |||||||
Property, Plant and Equipment, Useful Life | 7 years | ||||||
Property, Plant and Equipment, Gross, Ending Balance | $ 573 | 566 | |||||
Leasehold Improvements [Member] | |||||||
Property, Plant and Equipment, Gross, Ending Balance | $ 8,413 | $ 8,405 | |||||
Leasehold Improvements [Member] | Birmingham Research Facility [Member] | |||||||
Property, Plant and Equipment, Useful Life | 20 years 182 days | ||||||
Property, Plant and Equipment, Gross, Ending Balance | $ 1,589 | ||||||
Maximum [Member] | |||||||
Maturity Period of High Quality Marketable Securities | 3 years | ||||||
Average Maturity Period of High Quality Marketable Securities | 1 year 180 days | ||||||
Maturity Period of Short Term Investment | 1 year | ||||||
Average Maturity for Portfolio Investments | 1 year 180 days | ||||||
Minimum [Member] | |||||||
Maturity Period of Short Term Investment | 90 days | ||||||
Long-term Investment Maturity, Minimum | 1 year | ||||||
Designated for Interest on Notes [Member] | |||||||
Restricted Cash and Cash Equivalents, Current, Total | $ 131 | ||||||
Collateral for Credit [Member] | |||||||
Restricted Cash and Cash Equivalents, Current, Total | 1,413 | ||||||
Senior Credit Facility [Member] | MidCap Financial Services, LLC [Member] | |||||||
Long-term Line of Credit, Total | $ 30,000 | $ 30,000 | $ 23,000 | ||||
JPR Royalty Sub LLC [Member] | |||||||
Revenue Recognition Royalty and Milestone Revenue Recognized | $ 30,000 |
Note 1 - Significant Accounti_4
Note 1 - Significant Accounting Policies and Concentrations of Risk - Fair Value of the Company's Investments by Type (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Amortized Cost | $ 99,965 | $ 105,241 |
Accrued Interest | 444 | 412 |
Gross Unrealized Gains | 19 | 1 |
Gross Unrealized Losses | (316) | (244) |
Estimated Fair Value | 100,112 | 105,410 |
US Government Agencies Debt Securities [Member] | ||
Amortized Cost | 50,613 | 60,121 |
Accrued Interest | 176 | 177 |
Gross Unrealized Gains | 15 | |
Gross Unrealized Losses | (131) | (122) |
Estimated Fair Value | 50,673 | 60,176 |
Corporate Debt Securities [Member] | ||
Amortized Cost | 45,793 | 34,021 |
Accrued Interest | 254 | 203 |
Gross Unrealized Gains | 4 | |
Gross Unrealized Losses | (171) | (108) |
Estimated Fair Value | 45,880 | 34,116 |
Certificates of Deposit [Member] | ||
Amortized Cost | 3,559 | 11,099 |
Accrued Interest | 14 | 32 |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (14) | (14) |
Estimated Fair Value | $ 3,559 | $ 11,118 |
Note 1 - Significant Accounti_5
Note 1 - Significant Accounting Policies and Concentrations of Risk - Scheduled Maturity for the Company's Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Maturing in one year or less | $ 77,736 | $ 64,115 |
Maturing after one year through two years | 22,376 | 34,257 |
Maturing after two years | 7,038 | |
Total investments | $ 100,112 | $ 105,410 |
Note 1 - Significant Accounti_6
Note 1 - Significant Accounting Policies and Concentrations of Risk- Summary of Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Receivables | $ 4,293 | $ 6,117 |
Billed Revenues [Member] | ||
Receivables | 2,714 | 3,902 |
Unbilled Revenues [Member] | ||
Receivables | 1,579 | 2,215 |
US Department of Health and Human Services [Member] | ||
Receivables | 1,525 | 2,062 |
US Department of Health and Human Services [Member] | Billed Revenues [Member] | ||
Receivables | 42 | |
US Department of Health and Human Services [Member] | Unbilled Revenues [Member] | ||
Receivables | 1,525 | 2,020 |
Shionogi and Co. Ltd [Member] | ||
Receivables | 854 | 1,600 |
Shionogi and Co. Ltd [Member] | Billed Revenues [Member] | ||
Receivables | 854 | 1,600 |
Shionogi and Co. Ltd [Member] | Unbilled Revenues [Member] | ||
Receivables | ||
Green Cross Corporation [Member] | ||
Receivables | 904 | 1,416 |
Green Cross Corporation [Member] | Billed Revenues [Member] | ||
Receivables | 876 | 1,388 |
Green Cross Corporation [Member] | Unbilled Revenues [Member] | ||
Receivables | 28 | 28 |
Mundipharma International Holdings Limited [Member] | ||
Receivables | 44 | 47 |
Mundipharma International Holdings Limited [Member] | Billed Revenues [Member] | ||
Receivables | 44 | 47 |
Mundipharma International Holdings Limited [Member] | Unbilled Revenues [Member] | ||
Receivables | ||
Seqirus UK Limited [Member] | ||
Receivables | 966 | 992 |
Seqirus UK Limited [Member] | Billed Revenues [Member] | ||
Receivables | 940 | 825 |
Seqirus UK Limited [Member] | Unbilled Revenues [Member] | ||
Receivables | $ 26 | $ 167 |
Note 1 - Significant Accounti_7
Note 1 - Significant Accounting Policies and Concentrations of Risk - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Compensation and benefits | $ 4,659 | $ 2,905 |
Development costs | 7,564 | 6,683 |
Inventory | 1,649 | |
Professional fees | 118 | 729 |
Duties and taxes | 51 | 148 |
Other | 1,850 | 2,234 |
Total accrued expenses | $ 15,891 | $ 12,699 |
Note 1 - Significant Accounti_8
Note 1 - Significant Accounting Policies and Concentrations of Risk - Cumulative Effective Adopted Accounting Pronouncement (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 | |
Deferred collaboration expense | $ 9 | $ 210 | $ 9 | $ 210 | $ 152 | |||||||
Deferred revenue | 221 | 8,484 | 221 | 8,484 | 7,300 | |||||||
Accumulated deficit | (731,969) | (631,843) | (731,969) | (631,843) | (630,717) | |||||||
Revenues | 2,729 | $ 1,454 | $ 12,494 | $ 3,976 | 3,890 | $ 8,760 | $ 3,099 | $ 9,437 | 20,653 | 25,186 | $ 26,353 | |
Research and development | 84,888 | 66,962 | 61,008 | |||||||||
Net loss | $ (27,432) | $ (29,597) | $ (18,446) | $ (25,777) | $ (19,543) | $ (15,134) | $ (16,886) | $ (14,219) | $ (101,252) | $ (65,782) | $ (55,144) | |
Basic and diluted net loss per common share (in dollars per share) | $ (0.25) | $ (0.28) | $ (0.19) | $ (0.26) | $ (0.20) | $ (0.18) | $ (0.21) | $ (0.19) | $ (0.98) | $ (0.78) | $ (0.75) | |
Accounting Standards Update 2014-09 [Member] | ||||||||||||
Deferred collaboration expense | (58) | |||||||||||
Deferred revenue | (1,184) | |||||||||||
Accumulated deficit | $ 1,126 | |||||||||||
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ||||||||||||
Deferred collaboration expense | ||||||||||||
Deferred revenue | ||||||||||||
Accumulated deficit | ||||||||||||
Research and development | 58 | |||||||||||
Net loss | $ 1,126 | |||||||||||
Basic and diluted net loss per common share (in dollars per share) | $ 0.01 | |||||||||||
Calculated under Revenue Guidance in Effect before Topic 606 [Member] | ||||||||||||
Deferred collaboration expense | 9 | $ 9 | ||||||||||
Deferred revenue | 221 | 221 | ||||||||||
Accumulated deficit | $ (731,969) | (731,969) | ||||||||||
Research and development | 84,946 | |||||||||||
Net loss | $ (100,126) | |||||||||||
Basic and diluted net loss per common share (in dollars per share) | $ (0.97) | |||||||||||
Collaborative and Other Research and Development [Member] | ||||||||||||
Revenues | $ 14,552 | $ 13,142 | $ 14,402 | |||||||||
Collaborative and Other Research and Development [Member] | Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ||||||||||||
Revenues | 1,184 | |||||||||||
Collaborative and Other Research and Development [Member] | Calculated under Revenue Guidance in Effect before Topic 606 [Member] | ||||||||||||
Revenues | $ 15,736 |
Note 1 - Significant Accounti_9
Note 1 - Significant Accounting Policies and Concentrations of Risk - Summary of Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues | $ 2,729 | $ 1,454 | $ 12,494 | $ 3,976 | $ 3,890 | $ 8,760 | $ 3,099 | $ 9,437 | $ 20,653 | $ 25,186 | $ 26,353 |
Product [Member] | |||||||||||
Revenues | 1,501 | 2,269 | |||||||||
Royalty [Member] | |||||||||||
Revenues | 6,101 | 10,543 | 9,682 | ||||||||
Collaborative and Other Research and Development [Member] | |||||||||||
Revenues | 14,552 | 13,142 | 14,402 | ||||||||
Collaborative and Other Research and Development [Member] | US Department of Health and Human Services [Member] | |||||||||||
Revenues | 2,552 | 4,608 | 12,449 | ||||||||
Collaborative and Other Research and Development [Member] | Shionogi and Co. Ltd [Member] | |||||||||||
Revenues | 1,184 | 1,184 | |||||||||
Collaborative and Other Research and Development [Member] | Seqirus UK Limited [Member] | |||||||||||
Revenues | $ 12,000 | $ 7,350 | $ 769 |
Note 2 - Property and Equipme_3
Note 2 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Depreciation, Depletion and Amortization, Total | $ 770 | $ 704 | $ 483 |
Note 2 - Property and Equipme_4
Note 2 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property and equipment | $ 15,230 | $ 14,873 |
Less accumulated depreciation and amortization | (6,095) | (5,327) |
Property and equipment, net | 9,135 | 9,546 |
Furniture and Fixtures [Member] | ||
Property and equipment | 573 | 566 |
Office Equipment [Member] | ||
Property and equipment | 152 | 146 |
Software Development [Member] | ||
Property and equipment | 1,125 | 1,125 |
Laboratory Equipment [Member] | ||
Property and equipment | 3,329 | 2,984 |
Leased Equipment [Member] | ||
Property and equipment | 143 | 152 |
Leasehold Improvements [Member] | ||
Property and equipment | 8,413 | 8,405 |
Building [Member] | ||
Property and equipment | $ 1,495 | $ 1,495 |
Note 3 - Royalty Monetization (
Note 3 - Royalty Monetization (Details Textual) $ in Thousands | May 18, 2016USD ($) | Mar. 09, 2011USD ($) | Dec. 31, 2018USD ($)¥ / $ | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Currency Hedge Agreement [Member] | |||||
Collateral Already Posted, Aggregate Fair Value | $ 0 | $ 0 | |||
Foreign Exchange Contract [Member] | Not Designated as Hedging Instrument [Member] | |||||
Derivative, Loss on Derivative | 1,049 | 1,787 | $ 1,654 | ||
Derivative, Gain on Derivative | $ 941 | 966 | $ 811 | ||
PhaRMA Notes Member] | Currency Hedge Agreement [Member] | |||||
Payments for (Proceeds from) Hedge, Investing Activities, Total | $ 1,950 | ||||
Required Foreign Currency Hedge Per Dollar | 100 | ||||
PhaRMA Notes Member] | Japan, Yen | Currency Hedge Agreement [Member] | |||||
Derivative, Forward Exchange Rate | ¥ / $ | 100 | ||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | |||||
Private Placement of Senior Secured Notes | $ 30,000 | ||||
Debt Instrument, Interest Rate, Stated Percentage | 14.00% | ||||
Percentage of Carrying Amount in Excess of Fair Value | 50.00% | ||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | Currency Hedge Agreement [Member] | |||||
Collateral Already Posted, Aggregate Fair Value | $ 0 | $ 0 | |||
Maximum Amount of Collateral Required to Post | 3,900 | ||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | Fair Value, Inputs, Level 2 [Member] | |||||
Notes Payable, Fair Value Disclosure | $ 30,000 | ||||
JPR Royalty Sub LLC [Member] | Royalty Monetization [Member] | |||||
Debt Instrument, Face Amount | $ 30,000 | ||||
Proceeds from Issuance of Secured Debt | 22,691 | ||||
Transaction Costs | 4,309 | ||||
Interest Reserve | $ 3,000 |
Note 4 - Senior Credit Facili_3
Note 4 - Senior Credit Facility (Details Textual) - USD ($) $ in Thousands | Feb. 06, 2019 | Jul. 20, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 23, 2016 |
Long-term Line of Credit, Total | $ 25,372 | $ 16,750 | |||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | Subsequent Event [Member] | |||||
Debt Instrument, Minimum LIBOR | 0.50% | ||||
Debt Instrument, Face Amount | $ 100,000 | ||||
MidCap Financial Services, LLC [Member] | London Interbank Offered Rate (LIBOR) [Member] | Senior Credit Facility [Member] | Subsequent Event [Member] | |||||
Debt Instrument, Basis Spread on Variable Rate | 8.00% | ||||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | |||||
Long-term Line of Credit, Total | $ 30,000 | $ 30,000 | $ 23,000 | ||
Debt Instrument, Minimum LIBOR | 0.50% | ||||
Debt Instrument, Term | 2 years 180 days | ||||
Line of Credit Facility, Interest Rate at Period End | 10.30% | ||||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | London Interbank Offered Rate (LIBOR) [Member] | |||||
Debt Instrument, Basis Spread on Variable Rate | 8.00% |
Note 4 - Senior Credit Facili_4
Note 4 - Senior Credit Facility - Scheduled Principal Repayments of the Credit Facility (Details) $ in Millions | Dec. 31, 2018USD ($) |
2019 | $ 5 |
2020 | 12 |
2021 | 12 |
2022 | 1 |
Total | $ 30 |
Note 5 - Lease Obligations an_3
Note 5 - Lease Obligations and Other Contingencies (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating Leases, Rent Expense, Net, Total | $ 758 | $ 617 | $ 721 | |
Property, Plant and Equipment, Gross, Ending Balance | 15,230 | 14,873 | ||
Lease Financing Obligation, Net of Current | 2,703 | 2,751 | ||
Operating Leases, Future Minimum Payments Due, Total | 5,247 | |||
Birmingham Research Facility [Member] | ||||
Lease Financing Obligation, Net of Current | 2,703 | 2,704 | ||
Operating Leases, Future Minimum Payments Due, Total | 3,890 | |||
Birmingham Research Facility [Member] | Long Term Liabilities [Member] | ||||
Lease Financing Obligation, Net of Current | 2,703 | 2,704 | ||
Leasehold Improvements [Member] | ||||
Property, Plant and Equipment, Gross, Ending Balance | $ 8,413 | $ 8,405 | ||
Leasehold Improvements [Member] | Birmingham Research Facility [Member] | ||||
Property, Plant and Equipment, Gross, Ending Balance | $ 1,589 |
Note 5 - Lease Obligations an_4
Note 5 - Lease Obligations and Other Contingencies - Minimum Payments under Operating Lease Obligations (Details) $ in Thousands | Dec. 31, 2018USD ($) |
2019 | $ 1,300 |
2020 | 934 |
2021 | 524 |
2022 | 491 |
2023 | 503 |
Thereafter | 1,495 |
Total minimum payments | $ 5,247 |
Note 6 - Stockholders' Equity (
Note 6 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Aug. 06, 2018 | Sep. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Nov. 08, 2017 |
Stock Issued During Period, Shares, New Issues | 10,455 | 17,864 | 6,061 | ||||
Shares Issued, Price Per Share | $ 5.50 | $ 5.15 | $ 8.50 | ||||
Proceeds from Issuance of Common Stock | $ 53,400 | $ 86,250 | $ 47,750 | $ 53,400 | $ 134,000 | ||
Maximum Aggregate Offering Price | $ 200,000 |
Note 7 - Stock-based Compensa_3
Note 7 - Stock-based Compensation (Details Textual) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Aug. 31, 2013shares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2014shares | Dec. 31, 2015shares | |
Number of Stock-based Compensation Plans | 2 | |||||
Allocated Share-based Compensation Expense, Total | $ 9,396 | $ 12,621 | $ 8,487 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 4,272 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 4.92 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ 22,891 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | shares | 15,928 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ / shares | $ 6.43 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 7 years | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 28,284 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Next Year | 10,423 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Two | 7,779 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Three | 5,791 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Four | 4,291 | |||||
Incentive Plan [Member] | ||||||
Allocated Share-based Compensation Expense, Total | $ 9,223 | $ 12,421 | $ 8,340 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 5 years 109 days | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 4.92 | $ 3.63 | $ 2.17 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% | 0.00% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 4,504 | $ 1,964 | $ 339 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 8,952 | $ 9,310 | $ 6,380 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | shares | 805 | 468 | 2,273 | 16 | ||
Incentive Plan [Member] | Employee Stock Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||
Incentive Plan [Member] | Employee Stock Option [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 5 years | |||||
Incentive Plan [Member] | Employee Stock Option [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 10 years | |||||
Incentive Plan [Member] | Employee Stock Option [Member] | Non-employee Directors [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, First Vesting Period After Grant Date | 1 year | |||||
Incentive Plan [Member] | Employee Stock Option [Member] | Vest 25% Each Year Until Fully Vested [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||||
Incentive Plan [Member] | Performance Shares [Member] | ||||||
Allocated Share-based Compensation Expense, Total | $ 0 | |||||
Incentive Plan [Member] | Performance Shares [Member] | Vest Upon Successful Completion of Specific Development Milestones [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 1,032 | 1,250 | ||||
Incentive Plan [Member] | Performance Shares [Member] | Vest Upon Successful Completion of Specific Development Milestones [Member] | August 2013 [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 75.00% | |||||
Share-based Compensation Arrangement by Shar-based Payment Award, Awards Unvested, Percentage | 25.00% | |||||
Incentive Plan [Member] | Performance Shares [Member] | Vest Upon Successful Completion of Specific Development Milestones [Member] | December 2014 [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 30.00% | |||||
Share-based Compensation Arrangement by Shar-based Payment Award, Awards Unvested, Percentage | 70.00% | |||||
Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding, Number, Ending Balance | shares | 31 | |||||
Employee Stock Purchase Plan [Member] | ||||||
Allocated Share-based Compensation Expense, Total | $ 173 | $ 200 | $ 147 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | shares | 1,475 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | shares | 234 | |||||
Percentage of Salary to Purchase Common Stock, Maximum | 15.00% | |||||
Percentage of Common Stock Shares, Beginning | 85.00% | |||||
Percentage of Common Stock Shares, Ending | 85.00% | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Maximum Number of Shares Per Employee | shares | 3 | |||||
Shar-based Compensation Arrangement by Shar-based Payment Award, Maximum Number of Shares Per Employee, Amount | $ 25 | |||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | shares | 92 | 95 | 75 | |||
Employee Stock Ownership Plan (ESOP), Weighted Average Purchase Price of Shares Purchased | $ / shares | $ 3.83 | $ 3.61 | $ 4.36 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 1.89 | $ 2.18 | $ 1.95 |
Note 7 - Stock-Based Compensa_4
Note 7 - Stock-Based Compensation - Stock-based Compensation Allocation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Allocated Share-based Compensation Expense, Total | $ 9,396 | $ 12,621 | $ 8,487 |
Research and Development Expense [Member] | |||
Allocated Share-based Compensation Expense, Total | 6,867 | 9,602 | 6,088 |
General and Administrative Expense [Member] | |||
Allocated Share-based Compensation Expense, Total | $ 2,529 | $ 3,019 | $ 2,399 |
Note 7 - Stock-based Compensa_5
Note 7 - Stock-based Compensation - Stock Incentive Plan Activities (Details) - Incentive Plan [Member] - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Awards available, beginning balance (in shares) | 468 | 2,273 | 16 |
Options outstanding, beginning balance (in shares) | 14,452 | 12,095 | 10,671 |
Weighted average exercise price, beginning balance (in dollars per share) | $ 7.50 | ||
Awards available, plan amendment (in shares) | 4,400 | 1,000 | 3,800 |
Awards available, Restricted stock awards granted (in shares) | (13) | (22) | (34) |
Awards available, Restricted stock awards cancelled (in shares) | 12 | 22 | |
Awards available, stock option awards granted (in shares) | (4,272) | (3,915) | (2,248) |
Options outstanding, stock option awards granted (in shares) | 4,272 | 3,915 | 2,248 |
Weighted average exercise price, stock option awards granted (in dollars per share) | $ 7.15 | $ 5.33 | $ 3.20 |
Options outstanding, stock option awards exercised (in shares) | (1,011) | (438) | (107) |
Weighted average exercise price, stock option awards exercised (in dollars per share) | $ 2.92 | $ 3.50 | $ 2.63 |
Awards available, stock option awards cancelled (in shares) | 222 | 1,120 | 717 |
Options outstanding, stock option awards cancelled (in shares) | (222) | (1,120) | (717) |
Weighted average exercise price, stock option awards cancelled (in dollars per share) | $ 7.44 | $ 9.72 | $ 10.78 |
Awards available, ending balance (in shares) | 805 | 468 | 2,273 |
Options outstanding, ending balance (in shares) | 17,491 | 14,452 | 12,095 |
Weighted average exercise price, ending balance (in dollars per share) | $ 6.49 | $ 6.06 | $ 6.55 |
Note 7 - Stock-based Compensa_6
Note 7 - Stock-based Compensation - Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors Under the Incentive Plan (Details) - Incentive Plan [Member] | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Expected Life (Year) | 5 years 182 days | 5 years 182 days | 5 years 182 days |
Expected Volatility | 82.00% | 82.00% | 82.00% |
Expected Dividend Yield | 0.00% | 0.00% | 0.00% |
Risk-Free Interest Rate | 2.70% | 2.00% | 1.40% |
Note 7 - Share-Based Compensati
Note 7 - Share-Based Compensation - Number of Stock Option Awards Exercisable and their Weighted Average Exercise Price (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Lower Exercise Price Range (in dollars per share) | $ 0 |
Upper Exercise Price Range (in dollars per share) | $ 18 |
Outstanding Number (in shares) | shares | 17,491 |
Outstanding Weighted Average Remaining Life (Year) | 7 years |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ 6.49 |
Exercisable Number (in shares) | shares | 8,196 |
Exercisable Weighted Average Exercise Price (in dollars per share) | $ 6.16 |
Exercise Price Range 01 [Member] | |
Lower Exercise Price Range (in dollars per share) | 0 |
Upper Exercise Price Range (in dollars per share) | $ 3 |
Outstanding Number (in shares) | shares | 1,266 |
Outstanding Weighted Average Remaining Life (Year) | 4 years 36 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ 1.66 |
Exercisable Number (in shares) | shares | 1,191 |
Exercisable Weighted Average Exercise Price (in dollars per share) | $ 1.58 |
Exercise Price Range 02 [Member] | |
Lower Exercise Price Range (in dollars per share) | 3 |
Upper Exercise Price Range (in dollars per share) | $ 6 |
Outstanding Number (in shares) | shares | 7,778 |
Outstanding Weighted Average Remaining Life (Year) | 6 years 292 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ 4.69 |
Exercisable Number (in shares) | shares | 3,937 |
Exercisable Weighted Average Exercise Price (in dollars per share) | $ 4.50 |
Exercise Price Range 03 [Member] | |
Lower Exercise Price Range (in dollars per share) | 6 |
Upper Exercise Price Range (in dollars per share) | $ 9 |
Outstanding Number (in shares) | shares | 4,768 |
Outstanding Weighted Average Remaining Life (Year) | 8 years 255 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ 7.06 |
Exercisable Number (in shares) | shares | 883 |
Exercisable Weighted Average Exercise Price (in dollars per share) | $ 6.85 |
Exercise Price Range 04 [Member] | |
Lower Exercise Price Range (in dollars per share) | 9 |
Upper Exercise Price Range (in dollars per share) | $ 12 |
Outstanding Number (in shares) | shares | 2,980 |
Outstanding Weighted Average Remaining Life (Year) | 6 years 182 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ 10.90 |
Exercisable Number (in shares) | shares | 1,711 |
Exercisable Weighted Average Exercise Price (in dollars per share) | $ 10.96 |
Exercise Price Range 05 [Member] | |
Lower Exercise Price Range (in dollars per share) | 12 |
Upper Exercise Price Range (in dollars per share) | $ 15 |
Outstanding Number (in shares) | shares | 604 |
Outstanding Weighted Average Remaining Life (Year) | 6 years |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ 12.29 |
Exercisable Number (in shares) | shares | 403 |
Exercisable Weighted Average Exercise Price (in dollars per share) | $ 12.35 |
Exercise Price Range 06 [Member] | |
Lower Exercise Price Range (in dollars per share) | 15 |
Upper Exercise Price Range (in dollars per share) | $ 18 |
Outstanding Number (in shares) | shares | 95 |
Outstanding Weighted Average Remaining Life (Year) | 6 years 182 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ 15.39 |
Exercisable Number (in shares) | shares | 71 |
Exercisable Weighted Average Exercise Price (in dollars per share) | $ 15.39 |
Note 7 - Share-Based Compensa_2
Note 7 - Share-Based Compensation - Changes in the Number and Weighted-Average Grant-Date Fair Value (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Non-vested stock option awards (in shares) | shares | 7,202 |
Weighted average grant-date fair value (in dollars per share) | $ / shares | $ 4.56 |
Stock option awards granted (in shares) | shares | 4,272 |
Stock option awards granted (in dollars per share) | $ / shares | $ 4.92 |
Stock option awards vested (in shares) | shares | (2,065) |
Stock option awards vested (in dollars per share) | $ / shares | $ 4.33 |
Stock option awards forfeited (in shares) | shares | (114) |
Stock option awards forfeited (in dollars per share) | $ / shares | $ 4.12 |
Balance December 31, 2018 (in shares) | shares | 9,295 |
Balance December 31, 2018 (in dollars per share) | $ / shares | $ 4.78 |
Note 8 - Income Taxes (Details
Note 8 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 35.00% | 35.00% | |
Income Tax Expense (Benefit), Continuing Operations, Adjustment of Deferred Tax (Asset) Liability | $ 73,474 | |||
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Amount | $ 26,040 | $ (42,625) | $ 19,838 | |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | 0 | 0 | 0 | $ 0 |
Research Tax Credit Carryforward [Member] | ||||
Tax Credit Carryforward, Amount | 65,485 | |||
Domestic Tax Authority [Member] | ||||
Operating Loss Carryforwards, Total | 569,314 | |||
State and Local Jurisdiction [Member] | ||||
Operating Loss Carryforwards, Total | $ 496,816 | |||
Accounting Standards Update 2016-09 [Member] | ||||
Deferred Tax Assets, Operating Loss Carryforwards, Total | $ 5,949,000 | $ 5,949,000 |
Note 8 - Income Taxes - Differe
Note 8 - Income Taxes - Differences Between the Company's Effective Tax Rate and the Statutory Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income tax benefit at federal statutory rate (21% for 2018 and 2017 and 35 % for 2016) | $ (21,263) | $ (23,024) | $ (19,300) |
State and local income taxes net of federal tax benefit | (2,547) | (1,611) | (1,173) |
Permanent items | 503 | 910 | 1,057 |
Rate change | (29) | 71,155 | 1,080 |
Expiration of attribute carryforwards | 2,183 | 918 | 559 |
Effect of ASU 2016-09 | (5,949) | ||
Research and development tax credits | (4,905) | (1,977) | (4,681) |
Orphan drug credit | 564 | 1,798 | |
Other | 18 | 1,639 | 822 |
Change in valuation allowance | 26,040 | (42,625) | 19,838 |
Income tax expense | $ 0 | $ 0 | $ 0 |
Note 8 - Income Taxes - Diffe_2
Note 8 - Income Taxes - Differences Between the Company's Effective Tax Rate and the Statutory Tax Rate (Details) (Parentheticals) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income tax benefit at federal statutory rate, percentage | 21.00% | 35.00% | 35.00% |
Note 8 - Income Taxes - Reconci
Note 8 - Income Taxes - Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Balance | $ 4,750 | $ 4,255 |
Additions to current period tax positions | 1,226 | 495 |
Additions to prior period tax positions | ||
Reductions to prior period tax provisions | ||
Balance | $ 5,976 | $ 4,750 |
Note 8 - Income Taxes - Compone
Note 8 - Income Taxes - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Net federal and state operating losses | $ 137,234 | $ 117,787 |
Research and development credits | 59,509 | 55,208 |
Deferred revenue | 1,854 | |
Stock-based compensation | 7,108 | 6,424 |
Other | 5,258 | 2,046 |
Total deferred tax assets | 209,109 | 183,319 |
Fixed assets | (418) | (421) |
Foreign currency derivative | (231) | (478) |
Total deferred tax liabilities | (649) | (899) |
Valuation allowance | (208,460) | (182,420) |
Net deferred tax assets |
Note 9 - Employee 401(k) Plan (
Note 9 - Employee 401(k) Plan (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 724 | $ 664 | $ 504 |
Note 10 - Collaborative and O_2
Note 10 - Collaborative and Other Research and Development Contracts (Details Textual) - USD ($) $ in Thousands | Jun. 16, 2015 | Feb. 28, 2006 | Jan. 31, 2007 | Jun. 30, 2006 | Jun. 30, 2000 | Sep. 30, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2018 | Mar. 31, 2015 | Nov. 11, 2011 |
CSL Limited [Member | |||||||||||
Milestone Payment Received | $ 12,000 | ||||||||||
Royalty Term | 10 years | ||||||||||
Base Contract [Member] | |||||||||||
Government Contract Receivable | $ 16,265 | ||||||||||
Additional Development Options [Member] | |||||||||||
Government Contract Receivable | 22,855 | ||||||||||
ASPRBARDA Contract [Member] | |||||||||||
Government Contract Receivable | $ 39,120 | ||||||||||
Proceeds from awards for Research and Development Contracts | $ 20,574 | ||||||||||
Green Cross Corporation [Member] | |||||||||||
Proceeds from License Fees Received | $ 250 | ||||||||||
Mundipharma [Member] | |||||||||||
Upfront Payments Receivable Amount | $ 10,000 | ||||||||||
Potential Milestone Payments Receivable | $ 15,000 | ||||||||||
AECOM and IRL [Member] | |||||||||||
Milestone Payment Minimum | $ 1,400 | ||||||||||
Milestone Payment Maximum | 4,000 | ||||||||||
Annual License Fee Minimum | 150 | ||||||||||
Annual License Fee Maximum | $ 500 | ||||||||||
Advance Notice Period for Termination of Agreement | 60 days | ||||||||||
National Institute of Allergy and Infectious Diseases [Member] | |||||||||||
Collaborative Agreement Contract Value | $ 5,000 | ||||||||||
Expected Receivable From Awards for Research and Development Contracts | $ 43,035 | ||||||||||
UAB [Member] | |||||||||||
Period of Agreement | 25 years | ||||||||||
Renewable Period of Agreement | 5 years |
Note 11 - Quarterly Financial_3
Note 11 - Quarterly Financial Information (Unaudited) - Schedule of Quarterly Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues | $ 2,729 | $ 1,454 | $ 12,494 | $ 3,976 | $ 3,890 | $ 8,760 | $ 3,099 | $ 9,437 | $ 20,653 | $ 25,186 | $ 26,353 |
Net Loss | $ (27,432) | $ (29,597) | $ (18,446) | $ (25,777) | $ (19,543) | $ (15,134) | $ (16,886) | $ (14,219) | $ (101,252) | $ (65,782) | $ (55,144) |
Basic and diluted net loss per share (in dollars per share) | $ (0.25) | $ (0.28) | $ (0.19) | $ (0.26) | $ (0.20) | $ (0.18) | $ (0.21) | $ (0.19) | $ (0.98) | $ (0.78) | $ (0.75) |
Note 12 - Recent Accounting P_2
Note 12 - Recent Accounting Pronouncements (Details Textual) - Accounting Standards Update 2016-02 [Member] - Subsequent Event [Member] $ in Millions | Jan. 01, 2019USD ($) |
Minimum [Member] | |
Operating Lease, Right-of-Use Asset | $ 3 |
Operating Lease, Liability, Total | 3 |
Maximum [Member] | |
Operating Lease, Right-of-Use Asset | 6 |
Operating Lease, Liability, Total | $ 5 |
Note 13 - Subsequent Event (Det
Note 13 - Subsequent Event (Details Textual) - MidCap Financial Services, LLC [Member] - Subsequent Event [Member] $ in Millions | Feb. 06, 2019USD ($) |
Senior Credit Facility [Member] | |
Debt Instrument, Face Amount | $ 100 |
Repayments of Long-term Debt, Total | $ 30 |
Debt Instrument, Minimum LIBOR | 0.50% |
Senior Credit Facility [Member] | London Interbank Offered Rate (LIBOR) [Member] | |
Debt Instrument, Basis Spread on Variable Rate | 8.00% |
Secured Credit Facility, First Tranche [Member] | |
Debt Instrument, Face Amount | $ 50 |
Secured Credit Facility, Second Tranche [Member] | |
Debt Instrument, Face Amount | 30 |
Secured Credit Facility, Third Tranche [Member] | |
Debt Instrument, Face Amount | $ 20 |