Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Oct. 31, 2016 | |
Document Information [Line Items] | ||
Entity Registrant Name | BIOCRYST PHARMACEUTICALS INC | |
Entity Central Index Key | 882,796 | |
Trading Symbol | bcrx | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Voluntary Filers | No | |
Entity Well-known Seasoned Issuer | No | |
Entity Common Stock, Shares Outstanding (in shares) | 73,758,320 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets (Cu
Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Assets | ||
Cash and cash equivalents | $ 35,387 | $ 28,899 |
Restricted cash | 1,506 | 1,612 |
Investments | 17,434 | 22,664 |
Receivables from collaborations | 5,968 | 6,243 |
Inventory | 2,232 | 1,612 |
Prepaid expenses and other current assets | 2,007 | 2,674 |
Deferred collaboration expense | 98 | 90 |
Total current assets | 64,632 | 63,794 |
Investments | 14,371 | 47,683 |
Property and equipment, net | 10,095 | 5,149 |
Deferred collaboration expense | 214 | 265 |
Other assets | 2,190 | 5,468 |
Total assets | 91,502 | 122,359 |
Liabilities and Stockholders’ Equity | ||
Accounts payable | 2,760 | 9,307 |
Accrued expenses | 10,782 | 16,237 |
Interest payable | 7,563 | 6,746 |
Deferred collaboration revenue | 2,282 | 2,163 |
Non-recourse notes payable | 28,133 | 27,804 |
Total current liabilities | 51,520 | 62,257 |
Deferred collaboration revenue | 8,480 | 9,674 |
Deferred rent | 265 | 329 |
Foreign currency derivative | 1,904 | |
Lease financing obligation | 2,675 | 2,375 |
Senior credit facility | 22,665 | |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; shares authorized — 5,000; no shares issued and outstanding | ||
Common stock, $0.01 par value: shares authorized — 200,000; shares issued and outstanding — 73,758 in 2016 and 73,355 in 2015 | 738 | 734 |
Additional paid-in capital | 564,791 | 558,113 |
Accumulated other comprehensive income (loss) | 22 | (206) |
Accumulated deficit | (561,558) | (510,917) |
Total stockholders’ equity | 3,993 | 47,724 |
Total liabilities and stockholders’ equity | $ 91,502 | $ 122,359 |
Consolidated Balance Sheets (C3
Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
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) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 73,758,000 | 73,355,000 |
Common stock, shares outstanding (in shares) | 73,758,000 | 73,355,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenues | ||||
Product sales, net | $ 5,699 | $ 6,236 | ||
Royalty revenue | 3,501 | 126 | 6,020 | 1,776 |
Collaborative and other research and development | 4,262 | 5,162 | 11,350 | 35,643 |
Total revenues | 7,763 | 10,987 | 17,370 | 43,655 |
Expenses | ||||
Cost of products sold | 1,346 | 1,361 | ||
Research and development | 14,105 | 20,067 | 48,850 | 53,711 |
General and administrative | 2,756 | 2,731 | 8,692 | 10,326 |
Royalty | 143 | 5 | 247 | 507 |
Total operating expenses | 17,004 | 24,149 | 57,789 | 65,905 |
Loss from operations | (9,241) | (13,162) | (40,419) | (22,250) |
Interest and other income | 109 | 134 | 695 | 367 |
Interest expense | (1,465) | (1,241) | (4,356) | (3,862) |
(Loss) gain on foreign currency derivative | (931) | (352) | (6,561) | 861 |
Net loss | $ (11,528) | $ (14,621) | $ (50,641) | $ (24,884) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.16) | $ (0.20) | $ (0.69) | $ (0.34) |
Weighted average shares outstanding (in shares) | 73,734 | 73,262 | 73,677 | 72,752 |
Unrealized (loss) gain on available for sale investments | $ (24) | $ 91 | $ 228 | $ 129 |
Comprehensive loss | $ (11,552) | $ (14,530) | $ (50,413) | $ (24,755) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating activities | ||
Net loss | $ (50,641,000) | $ (24,884,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 311,000 | 137,000 |
Loss on disposal of property and equipment | 21,000 | |
Stock-based compensation expense | 6,478,000 | 7,773,000 |
Amortization of Debt Issuance Costs | 335,000 | 329,000 |
Amortization of premium/discount on investments | 499,000 | 459,000 |
Change in fair value of foreign currency derivative | 7,372,000 | 793,000 |
Changes in operating assets and liabilities: | ||
Receivables | 275,000 | 1,995,000 |
Inventory | (620,000) | 683,000 |
Prepaid expenses and other assets | 667,000 | 872,000 |
Deferred collaboration expense | 43,000 | (117,000) |
Accounts payable and accrued expenses | (12,066,000) | 12,582,000 |
Interest payable | 817,000 | (512,000) |
Deferred revenue | (1,075,000) | 1,602,000 |
Net cash (used in) provided by operating activities | (47,584,000) | 1,712,000 |
Investing activities | ||
Acquisitions of property and equipment | (5,278,000) | (1,076,000) |
Change in restricted cash | 106,000 | (1,472,000) |
Purchases of investments | (48,343,000) | |
Sales and maturities of investments | 38,272,000 | 35,874,000 |
Net cash provided by (used in) investing activities | 33,100,000 | (15,017,000) |
Financing activities | ||
Sale of common stock, net | 1,175,000 | |
Net proceeds from common stock issued under stock-based compensation plans | 204,000 | 4,217,000 |
Proceeds from senior credit facility | 22,658,000 | |
Payment of foreign currency derivative collateral | (2,190,000) | |
Increase in lease financing obligation | 300,000 | |
Net cash provided by financing activities | 20,972,000 | 5,392,000 |
Increase (decrease) in cash and cash equivalents | 6,488,000 | (7,913,000) |
Cash and cash equivalents at beginning of period | 28,899,000 | 54,540,000 |
Cash and cash equivalents at end of period | $ 35,387,000 | $ 46,627,000 |
Note 1 - Significant Accounting
Note 1 - Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 1 — Significant Accounting Policies The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a biotechnology company that designs, optimizes and develops novel small molecule drugs that block key enzymes involved in the pathogenesis of diseases. The Company focuses on the treatment of rare diseases in which significant unmet medical needs exist and align with its capabilities and expertise. The Company was incorporated in Delaware in 1986 and its headquarters is located in Durham, North Carolina. The Company integrates the disciplines of biology, crystallography, medicinal chemistry and computer modeling to discover and develop small molecule pharmaceuticals through the process known as structure-guided drug design. BioCryst has incurred losses and negative cash flows from operations since inception. Based on its current operating plans, the Company expects it has sufficient liquidity, with its existing cash, restricted cash and investments of $68,698, to continue its planned operations into 2018. The Company’s liquidity needs, and ability to address those needs, will largely be determined by the success of its product candidates and key development and regulatory events in the future. In order to continue its operations substantially beyond 2017 it will need to: (1) successfully secure or increase U.S. Government funding of its programs, including procurement contracts; (2) out-license rights to certain of its products or product candidates, pursuant to which the Company would receive cash milestones; (3) raise additional capital through equity or debt financings or from other sources; (4) obtain additional product candidate regulatory approvals, which would generate revenue and cash flow; (5) reduce spending on one or more research and development programs; and/or (6) restructure operations. The Company may issue securities, including common stock, preferred stock, depositary shares, stock purchase contracts, warrants and units, through private placement transactions or registered public offerings pursuant to its registration statement on Form S-3 initially filed with the Securities and Exchange Commission (“SEC”) on March 3, 2015. The Company will continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations. 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 financing transaction the Company completed on March 9, 2011. See Note 4, Royalty Monetization, for a further description of this transaction. MDCP was formed in connection with a $23,000 Senior Credit Facility the Company closed on September 23, 2016. See Note 5, Senior Credit Facility, for a further description of this transaction. All intercompany transactions and balances have been eliminated. The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and the instructions to Form 10-Q and do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Such 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 adjustments other than normal recurring adjustments. These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2015 and the notes thereto included in the Company’s 2015 Annual Report on Form 10-K. Interim operating results are not necessarily indicative of operating results for the full year. The balance sheet as of December 31, 2015 has been derived from the audited consolidated financial statements included in the Company’s most recent Annual Report on Form 10-K. Reclassifications During the first quarter of 2016, the Company adopted Accounting Standards Update No. 2015-03, Interest – Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs 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 months or less at the time of purchase. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. Restricted Cash Restricted cash as of September 30, 2016 reflects $101 in royalty revenue paid by Shionogi & Co., Ltd. (“Shionogi”) designated for interest on the PhaRMA Notes (defined in Note 4) and $1,405 the Company is required to maintain as collateral for a letter of credit associated with the lease execution and build-out of its new Birmingham research facilities. 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 consist of U.S. Government and government agency securities, money market and mutual fund investments, municipal and corporate notes and bonds, commercial paper and asset or mortgage-backed securities, among others. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of three years and requires an average portfolio maturity of no more than 18 months. Some of the securities the Company invests in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. Generally, the Company’s investments are not collateralized. The Company has not realized any significant losses from its investments. 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 be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are reflected in interest and other income in the Consolidated Statements of Comprehensive Loss and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term. At September 30, 2016, the Company believes that the cost of its investments is recoverable in all material respects. 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 in the fair value hierarchy as defined in U.S. GAAP. These valuations are based on observable direct and indirect inputs, primarily quoted prices of similar, but not identical, instruments in active markets or quoted prices for identical or similar instruments in markets that are not active. These fair values are obtained from independent pricing services which utilize Level 2 inputs. September 30, 2016 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 6,186 $ 15 $ 3 $ — $ 6,204 Corporate debt securities 7,187 24 5 (1 ) 7,215 Certificates of deposit 18,342 29 19 (4 ) 18,386 Total investments $ 31,715 $ 68 $ 27 $ (5 ) $ 31,805 December 31, 2015 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 26,557 $ 88 $ — $ (99 ) $ 26,546 Corporate debt securities 21,820 184 — (41 ) 21,963 Certificates of deposit 21,884 21 5 (72 ) 21,838 Total investments $ 70,261 $ 293 $ 5 $ (212 ) $ 70,347 The following table summarizes the scheduled maturity for the Company’s investments at September 30, 2016 and December 31, 2015. 2016 2015 Maturing in one year or less $ 17,434 $ 22,664 Maturing after one year through two years 14,371 28,395 Maturing after two years — 19,288 Total investments $ 31,805 $ 70,347 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”) 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 September 30, 2016 and December 31, 2015, the Company had the following receivables. September 30, 2016 Billed Unbilled Total U.S. Department of Health and Human Services $ 83 $ 1,746 $ 1,829 Shionogi & Co. Ltd. 3,902 — 3,902 Green Cross Corporation 9 — 9 Seqirus UK Limited — 228 228 Total receivables $ 3,994 $ 1,974 $ 5,968 December 31, 2015 Billed Unbilled Total U.S. Department of Health and Human Services $ — $ 5,536 $ 5,536 Shionogi & Co. Ltd. 469 — 469 Seqirus UK Limited 210 28 238 Total receivables $ 679 $ 5,564 $ 6,243 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 September 30, 2016 and December 31, 2015, the Company’s inventory consisted primarily of RAPIVAB work in process. Inventory is stated at the lower of cost, determined under the first-in, first-out (“FIFO”) method, or market. The Company expenses costs related to the production of inventories as research and development expenses in the period incurred until such time it is believed that future economic benefit is expected to be recognized, which generally is reliant upon receipt of regulatory approval. Upon regulatory approval, the Company will capitalize subsequent costs related to the production of inventories. During 2014, in connection with the U.S. Food and Drug Administration (“FDA”) approval of RAPIVAB, the Company began capitalizing costs associated with the production of RAPIVAB inventories. The Company’s inventory consisted of the following at September 30, 2016 and December 31, 2015: 2016 2015 Work in process $ 2,232 $ 1,612 Inventories $ 2,232 $ 1,612 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 years. Laboratory equipment, office equipment, and software are depreciated over a life of five years. Furniture and fixtures are depreciated over a life of seven years. Leasehold improvements are amortized over their estimated useful lives or the expected lease term, whichever is less. Property consists of a leased building which did not meet the sale-leaseback criteria and is recorded at its fair value, less depreciation. The building is being depreciated over a period equal to the expected term of the related lease. 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 be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Property and equipment to be disposed of are reported at the lower of carrying amount or fair value less cost to sell. 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-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when it determines an obligation has been incurred, regardless of the timing of the invoice. This process involves reviewing open contracts and purchase orders, communicating with applicable Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued expenses include: • 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 our 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 result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. As of September 30, 2016 and December 31, 2015, the carrying value of accrued expenses approximates their fair value due to their short-term settlement. 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 Income (Loss) Accumulated other comprehensive income (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 income (loss) are recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. During the nine months ended September 30, 2016, realized gains of $11 were reclassified out of accumulated other comprehensive income (loss). During the nine months ended September 30, 2015, realized gains of $13 were reclassified out of accumulated other comprehensive income (loss). Revenue Recognition The Company recognizes revenues from collaborative and other research and development arrangements, royalties and product sales when realized or realizable and earned. Revenue is realized or realizable and earned when all of the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured. Collaborative and Other Research and Development Arrangements and Royalties Revenue from license fees, royalty payments, event payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no further continuing performance obligations or the Company has completed the performance obligations under the terms of the agreement. Fees received under licensing agreements that are related to future performance are deferred and recognized over an estimated period determined by management based on the terms of the agreement and the products licensed. Revisions to revenue or profit estimates as a result of changes in the estimated revenue period are recognized prospectively. Under certain of the Company’s license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. The Company recognizes royalty revenues when it can reliably estimate such amounts and collectability is reasonably assured. For arrangements that involve the delivery of more than one element, each product, service and/or right to use assets is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is based on whether the deliverable has “stand-alone value” to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value, (ii) third-party evidence of selling price (“TPE”) and (iii) best estimate of selling price (“BESP”). The BESP reflects our best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. In most cases the Company expects to use TPE or BESP for allocating consideration to each deliverable. The consideration allocated to each unit of accounting is recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. In June 2015, the Company entered into a License Agreement (the “SUL Agreement”) granting SUL and its affiliates worldwide rights, excluding Israel, Japan, Korea and Taiwan, to develop, manufacture and commercialize RAPIVAB. The SUL Agreement provides for various types of payments, including a non-refundable upfront fee, milestone payments, and future royalties. Analysis of the SUL Agreement identified three deliverables: (i) license rights, (ii) inventory and (iii) regulatory support to obtain Canadian and European Union (“EU”) marketing approvals. The Company received an upfront payment of $33,740 from SUL, of which $7,000 was determined to be contingent upon EU marketing approval and will be deferred until that time. Approximately $21,777 of the upfront payment was allocated to the license rights and recognized as revenue in the second quarter. Approximately $3,740 of the upfront payment was allocated to the pending sale of inventory and was recognized during the third quarter of 2015, when the inventory transfer was completed. Approximately $1,223 of the revenue from the SUL Agreement will be recognized over the expected period of involvement in these regulatory support activities. 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 reasonably assured at the inception of the agreement; and (ii) the fees are non-refundable. Any milestone payments received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. Under the terms of the SUL Agreement, the Company may receive up to $12,000 in additional payments related to the successful achievement of regulatory milestones, including marketing approval (i) by the FDA for a pediatric indication, (ii) by the EMA for an adult indication in the EU and (iii) by Health Products and Food Branch of Health Canada (“Health Canada”) for an adult indication in Canada. The Company evaluated each event based payment under the provisions of ASU 2010-17, Milestone Method of Revenue Recognition 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. Product Sales The Company recognizes revenue for sales of RAPIVAB when title and substantially all the risks and rewards of ownership have transferred to the customer, which generally occurs on the date of shipment from our specialty distributors, utilizing the Sell-Through revenue recognition methodology. Product sales are recognized when there is persuasive evidence that an arrangement exists, title has passed, the price is fixed and determinable, and collectability is reasonably assured. Product sales are recognized net of estimated allowances, discounts, sales returns, chargebacks and rebates. In the United States, and prior to the 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, RAPIACTA, and PERAMIFLU) will be made by the Company’s partners, except for U.S. Government stockpiling sales, and the Company will be reliant on these partners to generate sales. 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 utilizes data from external sources to help it estimate gross-to-net sales adjustments as they relate to the recognition of revenue for RAPIVAB sold. Externally sourced data includes, but is not limited to, information obtained from specialty distributors with respect to their inventory levels and their sell-through to customers, as well as information from third-party suppliers of market research data to the pharmaceutical industry. The Company accounts for these sales deductions in accordance with authoritative guidance on revenue recognition when consideration is given by a vendor to a customer. The Company has categorized and described more fully the following significant sales deductions, all of which involve estimates and judgments, which the Company considers to be critical accounting estimates, and require it to use information from external sources. Rebates and Chargebacks Statutory rebates to state Medicaid agencies and Medicare are based on statutory discounts to RAPIVAB’s selling price. As it can take up to nine months or more for information to be received on actual usage of RAPIVAB in Medicaid and other governmental programs, the Company maintains reserves for amounts payable under these programs relating to RAPIVAB sales. Chargebacks claimed by specialty distributors are based on the differentials between product acquisition prices paid by the specialty distributors and lower government contract pricing paid by eligible customers covered under federally qualified programs. The amount of the reserve for rebates and chargebacks is based on multiple qualitative and quantitative factors, including the historical and projected utilization levels, historical payment experience, changes in statutory laws and interpretations as well as contractual terms, product pricing (both normal selling prices and statutory or negotiated prices), changes in prescription demand patterns and utilization of the Company’s product through public benefit plans, and the levels of RAPIVAB inventory in the distribution channel. The Company acquires prescription utilization data from third-party suppliers of market research data to the pharmaceutical industry. The Company updates its estimates and assumptions each period and records any necessary adjustments to its reserves. Settlements of rebates and chargebacks typically occur within nine months from point of sale. To the extent actual rebates and chargebacks differ from the Company’s estimates, additional reserves may be required or reserves may need to be reversed, either of which would impact current period product revenue. Discounts and Sales Incentives Discounts and other sales incentives primarily consist of Inventory Management Agreement (“IMA”) fees. Per contractual agreements with the Company’s specialty distributors, the Company provides an IMA fee based on a percentage of their purchases of RAPIVAB. The IMA fee rates are set forth in individual contracts. The Company tracks sales to these distributors each period and accrues a liability relating to the unpaid portion of these fees by applying the contractual rates to such product sales. With the completion of the SUL collaboration, all peramivir sales (i.e., RAPIVAB, RAPIACTA, and PERAMIFLU) will be made by the Company’s partners, except for U.S. Government stockpiling sales, and the Company will be reliant on these partners to generate sales and to provide for discounts and sales incentives. Product Returns The Company does not record a product return allowance as it does not offer the ability to return goods once a bonafide shipment has been accepted by a specialty distributor. The Company recorded the following revenues for the three and nine months ended September 30, 2016 and 2015: Three Months Nine Months 2016 2015 2016 2015 Product sales, net $ — $ 5,699 $ — $ 6,236 Royalty revenue 3,501 126 6,020 1,776 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 3,813 4,582 9,846 12,788 Green Cross Corporation — 132 — 132 Shionogi (Japan) 296 296 888 888 Seqirus UK Limited 153 152 616 21,835 Total collaborative and other research and development revenues 4,262 5,162 11,350 35,643 Total revenues $ 7,763 $ 10,987 $ 17,370 $ 43,655 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. 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-party CROs. Costs for studies performed by CROs are accrued by the Company over the service periods specified in the contracts and estimates are adjusted, if required, based upon the Company’s on-going review of the level of services actually performed. Additionally, the Company has license agreements with third parties, such as Albert Einstein College of Medicine of Yeshiva University (“AECOM”), Industrial Research, Ltd. (“IRL”), and the University of Alabama at Birmingham (“UAB”), which require fees related to sublicense agreements or maintenance fees. The Company expenses sublicense payments as incurred unless they are related to revenues that have been deferred, in which case the expenses are deferred and recognized over the related revenue recognition period. The Company expenses maintenance payments as incurred. 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 our academic partners for modification to existing license agreements. These deferred expenses would not have been incurred without receipt of such payments or modifications from the Company’s commercial partners and are being expensed in proportion to the related revenue being recognized. The Company believes that this accounting treatment appropriately matches expenses with the associated revenue. 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 compensation expense is recognized until “performance” is deemed to have occurred. Interest Expense and Deferred Financing Costs Interest expense for the three months ended September 30, 2016 and 2015 was $1,465 and $1,241, respectively, and for the nine months ended September 30, 2016 and 2015 was $4,356 and $3,862, respectively, and primarily relates to the issuance of the PhaRMA Notes (defined in Note 4) and the Senior Credit Facility (defined in Note 5). Costs directly |
Note 2 - Stock-based Compensati
Note 2 - Stock-based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | Note 2 — Stock-Based Compensation As of September 30, 2016, the Company had two stock-based employee compensation plans, the Stock Incentive Plan (“Incentive Plan”) and the Employee Stock Purchase Plan (“ESPP”). The Incentive Plan was amended and restated in April 2016 and approved by the Company’s stockholders in May 2016. The ESPP was amended and restated in March 2014 and approved by the Company’s stockholders in May 2014. Stock-based compensation expense of $6,478 ($6,331 of expense related to the Incentive Plan and $147 of expense related to the ESPP) was recognized during the first nine months of 2016, while $7,773 ($7,553 of expense related to the Incentive Plan and $220 of expense related to the ESPP) was recognized during the first nine months of 2015. There was approximately $16,591 of total unrecognized compensation cost related to non-vested stock option awards and restricted stock unit awards granted by the Company as of September 30, 2016. That cost is expected to be recognized as follows: $1,889 during the remainder of 2016, $6,958 in 2017, $4,700 in 2018, $2,633 in 2019 and $411 in 2020. In addition, the Company has outstanding performance-based stock options for which no compensation expense is recognized until “performance” has occurred and the award vests. At the time of vesting, compensation expense will be recognized. Stock Incentive Plan 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. Since March 1, 2011, stock option awards granted to employees generally vest 25% each year until fully vested after four years. In August 2013 and December 2014, the Company issued 1,032 and 1,250 performance-based stock options, respectively. These awards vest upon successful completion of specific development milestones. As of September 30, 2016, 75% of the August 2013 grants have vested based upon achievement of three milestones: (1) successful completion of the OPuS-1 clinical trial, for which vesting occurred in the second quarter of 2014, (2) FDA approval of RAPIVAB for which vesting occurred in the fourth quarter of 2014, and (3) initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX7353 in healthy volunteers, for which vesting occurred in the second quarter of 2015. Thus, as of September 30, 2016, 25% of the August 2013 performance-based grants and 100% of the December 2014 performance-based grants remain unvested and no compensation expense has been recognized for these portions of the previously issued performance-based grants. Stock option awards granted to non-employee directors of the Company generally vest monthly over one year. All stock option awards have contractual terms of 5 to 10 years. The vesting exercise provisions of all awards granted under the Incentive Plan are subject to acceleration in the event of certain stockholder-approved transactions, or upon the occurrence of a change in control as defined in the Incentive Plan. Related activity under the Incentive Plan is as follows: Awards Options Weighted Balance December 31, 2015 16 10,671 $ 7.50 Plan amendment 3,800 — — Restricted stock unit awards granted (28 ) — — Restricted stock unit awards cancelled 15 — — Stock option awards granted (2,248 ) 2,248 3.20 Stock option awards exercised — (88 ) 2.23 Stock option awards cancelled 593 (593 ) 11.13 Balance September 30, 2016 2,148 12,238 $ 6.57 For stock option awards granted under the Incentive Plan during the first nine months of 2016 and 2015, the fair value was estimated on the date of grant using a Black-Scholes option pricing model and the assumptions noted in the table below. The weighted average grant date fair value per share of the awards granted during the first nine months of 2016 and 2015 was $2.17 and $8.15, respectively. The fair value of the stock option awards is amortized to expense over the vesting periods using a straight-line expense attribution method. The following table summarizes the key assumptions used by the Company to value the stock option awards granted during the first nine months of 2016 and 2015. The expected life is based on the average of the assumption that all outstanding stock option awards will be exercised at full vesting and the assumption that all outstanding stock option awards will be exercised at the midpoint of the current date (if already vested) or at full vesting (if not yet vested) and the full contractual term. The expected volatility represents the historical volatility on the Company’s publicly traded common stock. The Company has assumed no expected dividend yield, as dividends have never been paid to stock or option holders and will not be paid for the foreseeable future. The weighted average risk-free interest rate is the implied yield currently available on zero-coupon government issues with a remaining term equal to the expected term. Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors under the Incentive Plan 2016 2015 Expected Life in Years 5.5 5.5 Expected Volatility 82 % 83 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 1.4 % 1.5 % Employee Stock Purchase Plan The Company has reserved a total of 1,475 shares of common stock to be purchased under the ESPP, of which 422 shares remain available for purchase at September 30, 2016. Eligible employees may authorize up to 15% of their salary to purchase common stock at the lower of 85% of the beginning or 85% of the ending price during six-month purchase intervals. No more than 3 shares may be purchased by any one employee at the six-month purchase dates and no employee may purchase stock having a fair market value at the commencement date of $25 or more in any one calendar year. The Company issued 75 shares during the first nine months of 2016 under the ESPP. Compensation expense for shares purchased under the ESPP related to the purchase discount and the “look-back” option were determined using a Black-Scholes option pricing model. |
Note 3 - Collaborative and Othe
Note 3 - Collaborative and Other Research and Development Contracts | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | Note 3 — Collaborative and Other Research and Development Contracts U.S. Department of Health and Human Services (“BARDA/HHS”). National Institute of Allergy and Infectious Diseases (“NIAID/HHS”). The contracts with BARDA/HHS and NIAID/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”). 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. In December 2013, the Company submitted an NDA for RAPIVAB to the FDA. 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 potential rights to sell RAPIVAB in Canada and the EU, the Company is also responsible for regulatory filings and interactions with the Health Canada and the European Medicines Agency ("EMA") until marketing approval for RAPIVAB is obtained and assigned to SUL. In January 2016, the Company submitted a New Drug Submission (“NDS”) for RAPIVAB in Canada, seeking approval for treatment of acute uncomplicated influenza in adult patients. 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. Under the terms of the SUL Agreement, the Company received an upfront payment of $33,740, and may receive up to $12,000 in additional milestone payments related to the successful achievement of regulatory milestones, including marketing approval (i) by the FDA for a pediatric indication, (ii) by the EMA for an adult indication in the EU and (iii) by Health Canada for an adult indication in Canada. The Company is also entitled under the SUL Agreement to receive tiered royalties at a percentage rate beginning in the mid-teens contingent upon meeting minimum thresholds of net sales, as well as a low-thirties percentage of the gross profit from government stockpiling purchases made outside the U.S. Specifically, the Company receives tiered royalties at a percentage rate in the mid-teens to low-forties on net sales in the U.S. during a Contract Year (defined as July 1 - June 30) and tiered royalties at a percentage rate in the mid-teens to mid-twenties on net sales in the Territory, other than in the U.S., during a Calendar Year, each subject to certain downward adjustments for circumstance or events impacting the overall market opportunity. SUL's royalty payment obligations commence on the date of the SUL Agreement and expire, on a country-by-country basis, upon the later of (i) the expiration of legal exclusivity in such country and (ii) ten years from the date of the SUL Agreement. The Company developed RAPIVAB under a license from UAB and will owe sublicense payments to them on any future milestone payments and/or royalties received by the Company from SUL. Shionogi & Co., Ltd. (“Shionogi”). Green Cross Corporation (“Green Cross”). Mundipharma International Holdings Limited (“Mundipharma”). Albert Einstein College of Medicine of Yeshiva University and Industrial Research, Ltd. (“AECOM” and “IRL” respectively). In May 2010, the Company amended the licensee agreement through which the Company obtained worldwide exclusive rights to develop and ultimately distribute any product candidates that might arise from research on a series of PNP inhibitors, including forodesine and ulodesine. Under the terms of the amendment, the Licensors agreed to accept a reduction of one-half in the percentage of future payments received from third-party sub licensees of the licensed PNP inhibitors that must be paid to the Licensors. This reduction does not apply to (i) any milestone payments the Company may receive in the future under its license agreement dated February 1, 2006 with Mundipharma and (ii) royalties received from its sub licensees in connection with the sale of licensed products, for which the original payment rate will remain in effect. The rate of royalty payments to the Licensors based on net sales of any resulting product made by the Company remains unchanged. On June 19, 2012, the Company further amended its agreements with AECOM/IRL whereby the parties clarified the definition of the field with respect to PNP inhibition and AECOM/IRL agreed to exclusive worldwide license of galidesivir to BioCryst for any antiviral use. The University of Alabama at Birmingham (“UAB”). |
Note 4 - Royalty Monetization
Note 4 - Royalty Monetization | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Royalty Monetization [Text Block] | Note 4 — Royalty Monetization Overview On March 9, 2011, the Company completed a $30,000 financing transaction to monetize certain future royalty and milestone payments under the Shionogi Agreement, pursuant to which Shionogi licensed from the Company the rights to market RAPIACTA in Japan and Taiwan. The Company received net proceeds of $22,691 from the transaction after transaction costs of $4,309 and the establishment of a $3,000 interest reserve account by Royalty Sub, available to help cover interest shortfalls in the future. All of the interest reserve account has been fully utilized with the September 2012 interest payment. As part of the transaction, the Company entered into a purchase and sale agreement dated as of March 9, 2011 with Royalty Sub, whereby the Company transferred to Royalty Sub, among other things, (i) its rights to receive certain royalty and milestone payments from Shionogi arising under the Shionogi Agreement, and (ii) the right to receive payments under a Japanese yen/US dollar foreign currency hedge arrangement (as further described below, the “Currency Hedge Agreement”) put into place by the Company in connection with the transaction. Royalty payments will be paid by Shionogi in Japanese yen and milestone payments will paid in U.S. dollars. The Company’s collaboration with Shionogi was not impacted as a result of this transaction. Non-Recourse Notes Payable On March 9, 2011, Royalty Sub completed a private placement to institutional investors of $30,000 in aggregate principal amount of its PhaRMA Senior Secured 14.0% Notes due 2020 (the “PhaRMA Notes”). The PhaRMA Notes were issued by Royalty Sub under an Indenture, dated as of March 9, 2011 (the “Indenture”), by and between Royalty Sub and U.S. Bank National Association, as Trustee. Principal and interest on the PhaRMA Notes issued are payable from, and are secured by, the rights to royalty and milestone payments under the Shionogi Agreement transferred by the Company to Royalty Sub and payments, if any, made to Royalty Sub under the Currency Hedge Agreement. The PhaRMA Notes bear interest at 14% per annum, payable annually in arrears on September 1st of each year. The Company remains entitled to receive any royalties and milestone payments related to sales of peramivir by Shionogi following repayment of the PhaRMA Notes. 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, but is not obligated to, make capital contributions to a capital account that may be used to redeem, or on up to one occasion pay any interest shortfall on, the PhaRMA Notes. On September 1, 2014, Royalty Sub was unable to pay the full amount of interest payable to avoid an event of default. Accordingly, the PhaRMA Notes and related accrued interest have been classified as current liabilities on the balance sheet. As a result of the event of default under the PhaRMA Notes, the holders of the PhaRMA Notes may pursue acceleration of the PhaRMA Notes, may foreclose on the collateral securing the PhaRMA Notes and the equity interest in Royalty Sub and exercise other remedies available to them under the Indenture in respect of the PhaRMA Notes. In such event, the Company may not realize the benefit of future royalty payments that might otherwise accrue to it following repayment of the PhaRMA Notes and it might otherwise be adversely affected. Due to the non-recourse nature of the PhaRMA Notes, in the event of any potential acceleration or foreclosure, the primary impact to the Company would be the loss of future royalty payments from Shionogi and legal costs associated with retiring the PhaRMA Notes. In addition, the Company may incur costs associated with liquidating the related Currency Hedge Agreement, which would no longer be required in the event of foreclosure, or if the PhaRMA Notes cease to be outstanding. As the PhaRMA Notes are the obligation of Royalty Sub and non-recourse to the Company, the event of default of the PhaRMA Notes is not expected to have a significant impact on the Company’s future results of operations or cash flows. As of September 30, 2016, the PhaRMA Notes remain in default. As of September 30, 2016, the aggregate fair value of the PhaRMA Notes was estimated to be approximately 50% of its carrying value of $30,000. The estimated fair value of the PhaRMA Notes is classified as Level 2 in the fair value hierarchy as defined in U.S. GAAP. 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 yen per dollar for which the Company may be required to pay a premium in each year from 2017 through 2020, provided the Currency Hedge Agreement remains in effect. A payment of $1,950 will be required if, on May 18 of the relevant year, the U.S. dollar is worth 100 yen or less as determined in accordance with the Currency Hedge Agreement. The Currency Hedge Agreement does not qualify for hedge accounting treatment; therefore, mark-to-market adjustments are recognized in the Company’s Consolidated Statement of Comprehensive Loss. Cumulative mark-to-market adjustments for the nine months ended September 30, 2016 and 2015 resulted in losses of $7,372 and $793, respectively. The Company is also required to post collateral in connection with the mark-to-market adjustments based on defined thresholds. As of September 30, 2016, $2,190 of hedge collateral was posted under the Currency Hedge Agreement. The Company will not be required to post collateral exceeding the maximum premium payments remaining payable under the Currency Hedge Agreement. As of September 30, 2016, the maximum amount of hedge collateral the Company may be required to post is $7,800. |
Note 5 - Credit Facility
Note 5 - Credit Facility | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 5 — Senior Credit Facility On September 23, 2016, the Company closed a $23,000 Senior Credit Facility with an affiliate of MidCap Financial Services, LLC (“MidCap”), as administrative agent (the “Senior Credit Facility”). The Senior Credit Facility was fully funded at closing and bears a variable interest rate of LIBOR (which shall not be less than 0.5%) plus 8%. The Senior Credit Facility includes an interest-only payment period through fiscal 2017 and scheduled monthly principal and interest payments for the subsequent 40 months. The Company has the option to repay the Senior Credit Facility at any time prior to the scheduled principal repayment date subject to prepayment fees. Final payment of the Senior Credit Facility is subject to a final payment fee equal to 5% of the principal funded under the Senior Credit Facility. As of September 30, 2016, the Company had borrowings of $23,000 under the Senior Credit Facility bearing an interest rate of 8.5%. The carrying amount of the debt approximates its fair value based on prevailing interest rates as of the balance sheet date. Scheduled principal repayments of the Senior Credit Facility are as follows: Principal Payments 2017 $ — 2018 6,900 2019 6,900 2020 6,900 2021 2,300 Total $ 23,000 The debt agreement contains two provisions that if deemed probable would create the recognition of an embedded feature; however, at this time we do not believe either provision is probable. |
Note 6 - Stockholders' Equity
Note 6 - Stockholders' Equity | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 6 — Stockholders’ Equity On March 3, 2015, the Company filed a $150,000 shelf registration statement on Form S-3 with the SEC. This shelf registration statement, as amended by a post-effective amendment filed on February 26, 2016 and declared effective on April 18, 2016, allows the Company to sell securities, including common stock, preferred stock, depository shares, stock purchase contracts, warrants and units, from time to time at prices and on terms to be determined at the time of sale. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Description of Company [Policy Text Block] | The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a biotechnology company that designs, optimizes and develops novel small molecule drugs that block key enzymes involved in the pathogenesis of diseases. The Company focuses on the treatment of rare diseases in which significant unmet medical needs exist and align with its capabilities and expertise. The Company was incorporated in Delaware in 1986 and its headquarters is located in Durham, North Carolina. The Company integrates the disciplines of biology, crystallography, medicinal chemistry and computer modeling to discover and develop small molecule pharmaceuticals through the process known as structure-guided drug design. BioCryst has incurred losses and negative cash flows from operations since inception. Based on its current operating plans, the Company expects it has sufficient liquidity, with its existing cash, restricted cash and investments of $68,698, to continue its planned operations into 2018. The Company’s liquidity needs, and ability to address those needs, will largely be determined by the success of its product candidates and key development and regulatory events in the future. In order to continue its operations substantially beyond 2017 it will need to: (1) successfully secure or increase U.S. Government funding of its programs, including procurement contracts; (2) out-license rights to certain of its products or product candidates, pursuant to which the Company would receive cash milestones; (3) raise additional capital through equity or debt financings or from other sources; (4) obtain additional product candidate regulatory approvals, which would generate revenue and cash flow; (5) reduce spending on one or more research and development programs; and/or (6) restructure operations. The Company may issue securities, including common stock, preferred stock, depositary shares, stock purchase contracts, warrants and units, through private placement transactions or registered public offerings pursuant to its registration statement on Form S-3 initially filed with the Securities and Exchange Commission (“SEC”) on March 3, 2015. The Company will continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations. |
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 financing transaction the Company completed on March 9, 2011. See Note 4, Royalty Monetization, for a further description of this transaction. MDCP was formed in connection with a $23,000 Senior Credit Facility the Company closed on September 23, 2016. See Note 5, Senior Credit Facility, for a further description of this transaction. All intercompany transactions and balances have been eliminated. The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and the instructions to Form 10-Q and do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Such 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 adjustments other than normal recurring adjustments. These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2015 and the notes thereto included in the Company’s 2015 Annual Report on Form 10-K. Interim operating results are not necessarily indicative of operating results for the full year. The balance sheet as of December 31, 2015 has been derived from the audited consolidated financial statements included in the Company’s most recent Annual Report on Form 10-K. |
Reclassification, Policy [Policy Text Block] | Reclassifications During the first quarter of 2016, the Company adopted Accounting Standards Update No. 2015-03, Interest – Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs |
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 months or less at the time of purchase. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash Restricted cash as of September 30, 2016 reflects $101 in royalty revenue paid by Shionogi & Co., Ltd. (“Shionogi”) designated for interest on the PhaRMA Notes (defined in Note 4) and $1,405 the Company is required to maintain as collateral for a letter of credit associated with the lease execution and build-out of its new Birmingham research facilities. |
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 consist of U.S. Government and government agency securities, money market and mutual fund investments, municipal and corporate notes and bonds, commercial paper and asset or mortgage-backed securities, among others. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of three years and requires an average portfolio maturity of no more than 18 months. Some of the securities the Company invests in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. Generally, the Company’s investments are not collateralized. The Company has not realized any significant losses from its investments. 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 be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are reflected in interest and other income in the Consolidated Statements of Comprehensive Loss and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term. At September 30, 2016, the Company believes that the cost of its investments is recoverable in all material respects. 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 in the fair value hierarchy as defined in U.S. GAAP. These valuations are based on observable direct and indirect inputs, primarily quoted prices of similar, but not identical, instruments in active markets or quoted prices for identical or similar instruments in markets that are not active. These fair values are obtained from independent pricing services which utilize Level 2 inputs. September 30, 2016 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 6,186 $ 15 $ 3 $ — $ 6,204 Corporate debt securities 7,187 24 5 (1 ) 7,215 Certificates of deposit 18,342 29 19 (4 ) 18,386 Total investments $ 31,715 $ 68 $ 27 $ (5 ) $ 31,805 December 31, 2015 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 26,557 $ 88 $ — $ (99 ) $ 26,546 Corporate debt securities 21,820 184 — (41 ) 21,963 Certificates of deposit 21,884 21 5 (72 ) 21,838 Total investments $ 70,261 $ 293 $ 5 $ (212 ) $ 70,347 The following table summarizes the scheduled maturity for the Company’s investments at September 30, 2016 and December 31, 2015. 2016 2015 Maturing in one year or less $ 17,434 $ 22,664 Maturing after one year through two years 14,371 28,395 Maturing after two years — 19,288 Total investments $ 31,805 $ 70,347 |
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”) 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 September 30, 2016 and December 31, 2015, the Company had the following receivables. September 30, 2016 Billed Unbilled Total U.S. Department of Health and Human Services $ 83 $ 1,746 $ 1,829 Shionogi & Co. Ltd. 3,902 — 3,902 Green Cross Corporation 9 — 9 Seqirus UK Limited — 228 228 Total receivables $ 3,994 $ 1,974 $ 5,968 December 31, 2015 Billed Unbilled Total U.S. Department of Health and Human Services $ — $ 5,536 $ 5,536 Shionogi & Co. Ltd. 469 — 469 Seqirus UK Limited 210 28 238 Total receivables $ 679 $ 5,564 $ 6,243 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 September 30, 2016 and December 31, 2015, the Company’s inventory consisted primarily of RAPIVAB work in process. Inventory is stated at the lower of cost, determined under the first-in, first-out (“FIFO”) method, or market. The Company expenses costs related to the production of inventories as research and development expenses in the period incurred until such time it is believed that future economic benefit is expected to be recognized, which generally is reliant upon receipt of regulatory approval. Upon regulatory approval, the Company will capitalize subsequent costs related to the production of inventories. During 2014, in connection with the U.S. Food and Drug Administration (“FDA”) approval of RAPIVAB, the Company began capitalizing costs associated with the production of RAPIVAB inventories. The Company’s inventory consisted of the following at September 30, 2016 and December 31, 2015: 2016 2015 Work in process $ 2,232 $ 1,612 Inventories $ 2,232 $ 1,612 |
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 years. Laboratory equipment, office equipment, and software are depreciated over a life of five years. Furniture and fixtures are depreciated over a life of seven years. Leasehold improvements are amortized over their estimated useful lives or the expected lease term, whichever is less. Property consists of a leased building which did not meet the sale-leaseback criteria and is recorded at its fair value, less depreciation. The building is being depreciated over a period equal to the expected term of the related lease. 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 be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Property and equipment to be disposed of are reported at the lower of carrying amount or fair value less cost to sell. |
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-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when it determines an obligation has been incurred, regardless of the timing of the invoice. This process involves reviewing open contracts and purchase orders, communicating with applicable Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued expenses include: • 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 our 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 result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. As of September 30, 2016 and December 31, 2015, the carrying value of accrued expenses approximates their fair value due to their short-term settlement. |
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 Income (Loss) Accumulated other comprehensive income (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 income (loss) are recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. During the nine months ended September 30, 2016, realized gains of $11 were reclassified out of accumulated other comprehensive income (loss). During the nine months ended September 30, 2015, realized gains of $13 were reclassified out of accumulated other comprehensive income (loss). |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition The Company recognizes revenues from collaborative and other research and development arrangements, royalties and product sales when realized or realizable and earned. Revenue is realized or realizable and earned when all of the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured. Collaborative and Other Research and Development Arrangements and Royalties Revenue from license fees, royalty payments, event payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no further continuing performance obligations or the Company has completed the performance obligations under the terms of the agreement. Fees received under licensing agreements that are related to future performance are deferred and recognized over an estimated period determined by management based on the terms of the agreement and the products licensed. Revisions to revenue or profit estimates as a result of changes in the estimated revenue period are recognized prospectively. Under certain of the Company’s license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. The Company recognizes royalty revenues when it can reliably estimate such amounts and collectability is reasonably assured. For arrangements that involve the delivery of more than one element, each product, service and/or right to use assets is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is based on whether the deliverable has “stand-alone value” to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value, (ii) third-party evidence of selling price (“TPE”) and (iii) best estimate of selling price (“BESP”). The BESP reflects our best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. In most cases the Company expects to use TPE or BESP for allocating consideration to each deliverable. The consideration allocated to each unit of accounting is recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. In June 2015, the Company entered into a License Agreement (the “SUL Agreement”) granting SUL and its affiliates worldwide rights, excluding Israel, Japan, Korea and Taiwan, to develop, manufacture and commercialize RAPIVAB. The SUL Agreement provides for various types of payments, including a non-refundable upfront fee, milestone payments, and future royalties. Analysis of the SUL Agreement identified three deliverables: (i) license rights, (ii) inventory and (iii) regulatory support to obtain Canadian and European Union (“EU”) marketing approvals. The Company received an upfront payment of $33,740 from SUL, of which $7,000 was determined to be contingent upon EU marketing approval and will be deferred until that time. Approximately $21,777 of the upfront payment was allocated to the license rights and recognized as revenue in the second quarter. Approximately $3,740 of the upfront payment was allocated to the pending sale of inventory and was recognized during the third quarter of 2015, when the inventory transfer was completed. Approximately $1,223 of the revenue from the SUL Agreement will be recognized over the expected period of involvement in these regulatory support activities. 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 reasonably assured at the inception of the agreement; and (ii) the fees are non-refundable. Any milestone payments received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. Under the terms of the SUL Agreement, the Company may receive up to $12,000 in additional payments related to the successful achievement of regulatory milestones, including marketing approval (i) by the FDA for a pediatric indication, (ii) by the EMA for an adult indication in the EU and (iii) by Health Products and Food Branch of Health Canada (“Health Canada”) for an adult indication in Canada. The Company evaluated each event based payment under the provisions of ASU 2010-17, Milestone Method of Revenue Recognition 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. Product Sales The Company recognizes revenue for sales of RAPIVAB when title and substantially all the risks and rewards of ownership have transferred to the customer, which generally occurs on the date of shipment from our specialty distributors, utilizing the Sell-Through revenue recognition methodology. Product sales are recognized when there is persuasive evidence that an arrangement exists, title has passed, the price is fixed and determinable, and collectability is reasonably assured. Product sales are recognized net of estimated allowances, discounts, sales returns, chargebacks and rebates. In the United States, and prior to the 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, RAPIACTA, and PERAMIFLU) will be made by the Company’s partners, except for U.S. Government stockpiling sales, and the Company will be reliant on these partners to generate sales. 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 utilizes data from external sources to help it estimate gross-to-net sales adjustments as they relate to the recognition of revenue for RAPIVAB sold. Externally sourced data includes, but is not limited to, information obtained from specialty distributors with respect to their inventory levels and their sell-through to customers, as well as information from third-party suppliers of market research data to the pharmaceutical industry. The Company accounts for these sales deductions in accordance with authoritative guidance on revenue recognition when consideration is given by a vendor to a customer. The Company has categorized and described more fully the following significant sales deductions, all of which involve estimates and judgments, which the Company considers to be critical accounting estimates, and require it to use information from external sources. Rebates and Chargebacks Statutory rebates to state Medicaid agencies and Medicare are based on statutory discounts to RAPIVAB’s selling price. As it can take up to nine months or more for information to be received on actual usage of RAPIVAB in Medicaid and other governmental programs, the Company maintains reserves for amounts payable under these programs relating to RAPIVAB sales. Chargebacks claimed by specialty distributors are based on the differentials between product acquisition prices paid by the specialty distributors and lower government contract pricing paid by eligible customers covered under federally qualified programs. The amount of the reserve for rebates and chargebacks is based on multiple qualitative and quantitative factors, including the historical and projected utilization levels, historical payment experience, changes in statutory laws and interpretations as well as contractual terms, product pricing (both normal selling prices and statutory or negotiated prices), changes in prescription demand patterns and utilization of the Company’s product through public benefit plans, and the levels of RAPIVAB inventory in the distribution channel. The Company acquires prescription utilization data from third-party suppliers of market research data to the pharmaceutical industry. The Company updates its estimates and assumptions each period and records any necessary adjustments to its reserves. Settlements of rebates and chargebacks typically occur within nine months from point of sale. To the extent actual rebates and chargebacks differ from the Company’s estimates, additional reserves may be required or reserves may need to be reversed, either of which would impact current period product revenue. Discounts and Sales Incentives Discounts and other sales incentives primarily consist of Inventory Management Agreement (“IMA”) fees. Per contractual agreements with the Company’s specialty distributors, the Company provides an IMA fee based on a percentage of their purchases of RAPIVAB. The IMA fee rates are set forth in individual contracts. The Company tracks sales to these distributors each period and accrues a liability relating to the unpaid portion of these fees by applying the contractual rates to such product sales. With the completion of the SUL collaboration, all peramivir sales (i.e., RAPIVAB, RAPIACTA, and PERAMIFLU) will be made by the Company’s partners, except for U.S. Government stockpiling sales, and the Company will be reliant on these partners to generate sales and to provide for discounts and sales incentives. Product Returns The Company does not record a product return allowance as it does not offer the ability to return goods once a bonafide shipment has been accepted by a specialty distributor. The Company recorded the following revenues for the three and nine months ended September 30, 2016 and 2015: Three Months Nine Months 2016 2015 2016 2015 Product sales, net $ — $ 5,699 $ — $ 6,236 Royalty revenue 3,501 126 6,020 1,776 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 3,813 4,582 9,846 12,788 Green Cross Corporation — 132 — 132 Shionogi (Japan) 296 296 888 888 Seqirus UK Limited 153 152 616 21,835 Total collaborative and other research and development revenues 4,262 5,162 11,350 35,643 Total revenues $ 7,763 $ 10,987 $ 17,370 $ 43,655 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. |
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-party CROs. Costs for studies performed by CROs are accrued by the Company over the service periods specified in the contracts and estimates are adjusted, if required, based upon the Company’s on-going review of the level of services actually performed. Additionally, the Company has license agreements with third parties, such as Albert Einstein College of Medicine of Yeshiva University (“AECOM”), Industrial Research, Ltd. (“IRL”), and the University of Alabama at Birmingham (“UAB”), which require fees related to sublicense agreements or maintenance fees. The Company expenses sublicense payments as incurred unless they are related to revenues that have been deferred, in which case the expenses are deferred and recognized over the related revenue recognition period. The Company expenses maintenance payments as incurred. 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 our academic partners for modification to existing license agreements. These deferred expenses would not have been incurred without receipt of such payments or modifications from the Company’s commercial partners and are being expensed in proportion to the related revenue being recognized. The Company believes that this accounting treatment appropriately matches expenses with the associated revenue. |
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 compensation expense is recognized until “performance” is deemed to have occurred. |
Interest Expense and Deferred Financing Costs [Policy Text Block] | Interest Expense and Deferred Financing Costs Interest expense for the three months ended September 30, 2016 and 2015 was $1,465 and $1,241, respectively, and for the nine months ended September 30, 2016 and 2015 was $4,356 and $3,862, respectively, and primarily relates to the issuance of the PhaRMA Notes (defined in Note 4) and the Senior Credit Facility (defined in Note 5). Costs directly associated with the issuance of the PhaRMA Notes and the Senior Credit Facility have been capitalized and are netted against the non-recourse notes payable and Senior Credit Facility on the Consolidated Balance Sheets. These costs are being amortized to interest expense over the term of the PhaRMA Notes and the Senior Credit Facility using the effective interest rate method. Amortization of deferred financing costs included in interest expense was $116 and $110 for each of the three months ended September 30, 2016 and 2015, respectively. Amortization of deferred financing costs included in interest expense was $335 and $329 for each of the nine months ended September 30, 2016 and 2015, respectively. |
Lease, Policy [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. Accordingly, the Company recorded an asset of $1,589, representing the Company’s leased portion of the building and recorded a corresponding liability. Upon completion of leasehold improvement construction, the Company did not meet the sale-leaseback criteria for de-recognition of the building asset and liability. Therefore, the lease is accounted for as a financing obligation. The asset will be depreciated over the expected duration of the lease of 20.5 years, and rental payments will be treated as principal and interest payments on the lease financing obligation liability. The underlying accounting for this transaction has no impact on cash flows associated with the underlying lease or construction in process. Interest expense for the three and nine months ended September 30, 2016 includes $86 and $300, respectively, related to the lease financing obligation. At September 30, 2016, the lease financing obligation balance was $2,675 and was recorded as a long term liability on the consolidated balance sheets. The remaining future minimum payments under the lease financing obligation are $4,839. |
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 qualify for hedge accounting treatment; therefore, mark-to-market adjustments are recognized in the Company’s Consolidated Statements of Comprehensive Loss. Cumulative mark-to-market adjustments for the nine months ended September 30, 2016 and 2015 resulted in losses of $7,372 and $793, respectively. Mark-to-market adjustments are determined by a third party pricing model that uses quoted prices in markets that are not actively traded and for which significant inputs are observable directly or indirectly, representing Level 2 in the fair value hierarchy as defined by U.S. GAAP. The Company is also required to post collateral in connection with the mark-to-market adjustments based on thresholds defined in the Currency Hedge Agreement. In addition, the Company realized currency exchange gains of $811 and $1,654 during the first nine months of 2016 and 2015, respectively, associated with the exercise of a U.S. dollar/Japanese yen currency option under the Currency Hedge Agreement. As of September 30, 2016, $2,190 of hedge collateral was posted under the agreement. No hedge collateral was posted as of December 31, 2015. |
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 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 three months ended September 30, 2016 and 2015 does not include 1,291 and 3,821, respectively, of such potential common shares, as their impact would be anti-dilutive. The calculation of diluted earnings per share for the nine months ended September 30, 2016 and 2015 does not include 1,190 and 3,673, respectively, of such potential common shares, as their impact would be anti-dilutive. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements. Actual results could differ from those estimates. |
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 specialty distributors to purchase and supply the majority of RAPIVAB. These three pharmaceutical specialty distributors accounted for greater than 90% of all RAPIVAB product sales and accounted for predominantly all of the Company’s outstanding receivables from product sales. The loss of one or more of these specialty distributors as a customer could negatively impact the commercialization of RAPIVAB. However, the Company will utilize these specialty distributors on a limited basis subsequent to the SUL collaboration as SUL, and other peramivir collaboration partners, will be responsible for commercial sales on a worldwide basis. In addition, in connection with the SUL collaboration, all peramivir sales (i.e., RAPIVAB, RAPIACTA, and PERAMIFLU) will be made by the Company’s partners and the Company will be reliant on these partners to generate sales and remit cash to satisfy receivables. The Company’s primary source of revenue that has an underlying cash flow stream is the reimbursement of RAPIVAB and galidesivir (formerly BCX4430) development expenses earned under cost-plus-fixed-fee contracts with BARDA/HHS and NIAID/HHS. The Company relies on BARDA/HHS and NIAID/HHS to reimburse predominantly all of the development costs for its galidesivir program. Accordingly, reimbursement of these expenses represents a significant portion of the Company’s collaborative and other research and development revenues. The completion (as with the June 30, 2014 BARDA/HHS peramivir development contract) or termination of the NIAID/HHS and BARDA/HHS galidesivir contracts could negatively impact the Company’s future Consolidated Statements of Comprehensive Loss and Cash Flows. In addition, the Company also recognizes royalty revenue from the net sales of RAPIACTA by Shionogi; however, the underlying cash flow from these royalty payments, except for Japanese government stockpiling sales, goes directly to pay the interest, and then the principal, on the Company’s non-recourse notes payable. Payment of the interest and the ultimate repayment of principal of these notes will be entirely funded by future royalty payments derived from net sales of RAPIACTA. Further, the Company’s drug development activities are performed by a limited group of third party vendors. If any of these vendors were unable to perform their services, this could significantly impact the Company’s ability to complete its drug development activities. 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 RAPIVAB, as well as for its other product candidates in development. Delays in the manufacture or distribution of any product could adversely impact the commercial revenue and future procurement stockpiling of RAPIVAB or 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 exceed the amount of insurance provided on such deposits. The Company believes it has established guidelines for investment of its excess cash relative to diversification and maturities that maintain safety and liquidity. To minimize the exposure due to adverse shifts in interest rates, the Company maintains a portfolio of investments with an average maturity of approximately 18 months or less. Other than product sale and collaborative partner receivables discussed above, the majority of the Company’s receivables from collaborations are due from the U.S. Government, for which there is no assumed credit risk. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In August 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2016-15: Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments In March 2016, the FASB issued Accounting Standards Update No. 2016-09: Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting In February 2016, the FASB issued Accounting Standards Update No. 2016-02: Leases (Topic 842) In January 2016, the FASB issued Accounting Standards Update No. 2016-01: Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities In July 2015, the FASB issued Accounting Standards Update No. 2015-11: Inventory (Topic 330): Simplifying the Measurement of Inventory In August 2014, the FASB issued Accounting Standards Update No. 2014-15: Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , In May 2014, the FASB issued Standards Update No. 2014-09: Revenue from Contracts with Customers (Topic 606) |
Note 1 - Significant Accounti13
Note 1 - Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Available-for-sale Securities [Table Text Block] | September 30, 2016 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 6,186 $ 15 $ 3 $ — $ 6,204 Corporate debt securities 7,187 24 5 (1 ) 7,215 Certificates of deposit 18,342 29 19 (4 ) 18,386 Total investments $ 31,715 $ 68 $ 27 $ (5 ) $ 31,805 December 31, 2015 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 26,557 $ 88 $ — $ (99 ) $ 26,546 Corporate debt securities 21,820 184 — (41 ) 21,963 Certificates of deposit 21,884 21 5 (72 ) 21,838 Total investments $ 70,261 $ 293 $ 5 $ (212 ) $ 70,347 |
Available For Sale Securities Debt Maturities Fair Value [Table Text Block] | 2016 2015 Maturing in one year or less $ 17,434 $ 22,664 Maturing after one year through two years 14,371 28,395 Maturing after two years — 19,288 Total investments $ 31,805 $ 70,347 |
Schedule of Receivables from Collaborations [Table Text Block] | September 30, 2016 Billed Unbilled Total U.S. Department of Health and Human Services $ 83 $ 1,746 $ 1,829 Shionogi & Co. Ltd. 3,902 — 3,902 Green Cross Corporation 9 — 9 Seqirus UK Limited — 228 228 Total receivables $ 3,994 $ 1,974 $ 5,968 December 31, 2015 Billed Unbilled Total U.S. Department of Health and Human Services $ — $ 5,536 $ 5,536 Shionogi & Co. Ltd. 469 — 469 Seqirus UK Limited 210 28 238 Total receivables $ 679 $ 5,564 $ 6,243 |
Schedule of Inventory, Current [Table Text Block] | 2016 2015 Work in process $ 2,232 $ 1,612 Inventories $ 2,232 $ 1,612 |
Schedule of Revenues from Collaborations [Table Text Block] | Three Months Nine Months 2016 2015 2016 2015 Product sales, net $ — $ 5,699 $ — $ 6,236 Royalty revenue 3,501 126 6,020 1,776 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 3,813 4,582 9,846 12,788 Green Cross Corporation — 132 — 132 Shionogi (Japan) 296 296 888 888 Seqirus UK Limited 153 152 616 21,835 Total collaborative and other research and development revenues 4,262 5,162 11,350 35,643 Total revenues $ 7,763 $ 10,987 $ 17,370 $ 43,655 |
Note 2 - Stock-based Compensa14
Note 2 - Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Schedule of Share-based Compensation, Activity [Table Text Block] | Awards Options Weighted Balance December 31, 2015 16 10,671 $ 7.50 Plan amendment 3,800 — — Restricted stock unit awards granted (28 ) — — Restricted stock unit awards cancelled 15 — — Stock option awards granted (2,248 ) 2,248 3.20 Stock option awards exercised — (88 ) 2.23 Stock option awards cancelled 593 (593 ) 11.13 Balance September 30, 2016 2,148 12,238 $ 6.57 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2016 2015 Expected Life in Years 5.5 5.5 Expected Volatility 82 % 83 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 1.4 % 1.5 % |
Note 5 - Credit Facility (Table
Note 5 - Credit Facility (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Schedule of Maturities of Long-term Debt [Table Text Block] | Principal Payments 2017 $ — 2018 6,900 2019 6,900 2020 6,900 2021 2,300 Total $ 23,000 |
Note 1 - Significant Accounti16
Note 1 - Significant Accounting Policies (Details Textual) shares in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Jun. 30, 2015USD ($) | Sep. 30, 2016USD ($)shares | Mar. 31, 2016USD ($) | Sep. 30, 2015USD ($)shares | Sep. 30, 2016USD ($)shares | Sep. 30, 2015USD ($)shares | Sep. 26, 2016USD ($) | Sep. 23, 2016USD ($) | Dec. 31, 2015USD ($) | Mar. 09, 2011USD ($) | |
Customer Concentration Risk [Member] | Sales Revenue, Product Line [Member] | RAPIVAB [Member] | Three Customers [Member] | ||||||||||
Concentration Risk, Percentage | 90.00% | |||||||||
Customer Concentration Risk [Member] | Sales Revenue, Product Line [Member] | RAPIVAB [Member] | ||||||||||
Number of Major Customers | 3 | |||||||||
RAPIVAB [Member] | Agreement [Member] | CSL [Member] | Contingent upon EU Marketing Approval [Member] | ||||||||||
Proceeds from License Fees Received | $ 7,000,000 | |||||||||
RAPIVAB [Member] | Agreement [Member] | CSL [Member] | Regulatory Support Revenue for Canadian and EU Marketing Approvals, Portion Recognized Ratably Over Expected Period of Involvement [Member] | ||||||||||
Deferred Revenue, Additions | 1,223,000 | |||||||||
RAPIVAB [Member] | Agreement [Member] | CSL [Member] | ||||||||||
Proceeds from License Fees Received | 33,740,000 | |||||||||
Revenues | 21,777,000 | |||||||||
Milestone Payment Maximum | 12,000,000 | |||||||||
JPR Royalty Sub LLC [Member] | ||||||||||
Revenue Recognition Royalty and Milestone Revenue Recognized | $ 30,000,000 | |||||||||
Senior Credit Facility [Member] | MidCap Financial Services, LLC [Member] | ||||||||||
Long-term Line of Credit | $ 23,000,000 | $ 23,000,000 | $ 23,000,000 | $ 23,000,000 | ||||||
Debt Issuance Costs Reclassifed from Other Current Assets [Member] | December 31, 2015 [Member] | ||||||||||
Prior Period Reclassification Adjustment | $ 2,196,000 | |||||||||
Royalty Receivable [Member] | ||||||||||
Restricted Cash and Cash Equivalents, Current | 101,000 | 101,000 | ||||||||
Collateral for Credit [Member] | ||||||||||
Restricted Cash and Cash Equivalents, Current | 1,405,000 | $ 1,405,000 | ||||||||
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 | |||||||||
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 | |||||||||
Leasehold Improvements [Member] | Birmingham Research Facility [Member] | ||||||||||
Property, Plant and Equipment, Useful Life | 20 years 182 days | |||||||||
Property, Plant and Equipment, Gross | 1,589,000 | $ 1,589,000 | ||||||||
Lease Financing Obligation, Net of Current | 2,675,000 | 2,675,000 | ||||||||
Foreign Exchange Contract [Member] | Not Designated as Hedging Instrument [Member] | ||||||||||
Deferred Revenue, Additions | $ 3,740,000 | |||||||||
Derivative, Loss on Derivative | 7,372,000 | $ 793,000 | ||||||||
Derivative, Gain on Derivative | 811,000 | 1,654,000 | ||||||||
Currency Hedge Agreement [Member] | ||||||||||
Collateral Already Posted, Aggregate Fair Value | 2,190,000 | 2,190,000 | $ 0 | |||||||
PhaRMA Notes Member] | ||||||||||
Interest Expense | 1,465,000 | $ 1,241,000 | 4,356,000 | 3,862,000 | ||||||
Birmingham Research Facility [Member] | ||||||||||
Interest Expense | 86,000 | 300,000 | ||||||||
Capital Leases, Future Minimum Payments Due | 4,839,000 | 4,839,000 | ||||||||
Investments and Cash | 68,698,000 | 68,698,000 | ||||||||
Loss on Sale of Investments | 0 | |||||||||
Long-term Line of Credit | 22,665,000 | $ 22,665,000 | ||||||||
Maturity of Investments | 3 years | |||||||||
Restricted Cash and Cash Equivalents, Current | 1,506,000 | $ 1,506,000 | 1,612,000 | |||||||
Reclassification from Accumulated Other Comprehensive Income, Current Period, before Tax | 11,000 | 13,000 | ||||||||
Revenues | 7,763,000 | 10,987,000 | 17,370,000 | 43,655,000 | ||||||
Interest Expense | 1,465,000 | 1,241,000 | 4,356,000 | 3,862,000 | ||||||
Amortization of Debt Issuance Costs | 116,000 | $ 110,000 | 335,000 | $ 329,000 | ||||||
Lease Financing Obligation, Net of Current | $ 2,675,000 | $ 2,675,000 | $ 2,375,000 | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares | 1,291 | 3,821 | 1,190 | 3,673 |
Note 1 - Significant Accounti17
Note 1 - Significant Accounting Policies - Fair Value of the Company's Investments by Type (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
US Government Agencies Debt Securities [Member] | ||
Amortized Cost | $ 6,186 | $ 26,557 |
Accrued Interest | 15 | 88 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | (99) | |
Estimated Fair Value | 6,204 | 26,546 |
Corporate Debt Securities [Member] | ||
Amortized Cost | 7,187 | 21,820 |
Accrued Interest | 24 | 184 |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | (1) | (41) |
Estimated Fair Value | 7,215 | 21,963 |
Certificates of Deposit [Member] | ||
Amortized Cost | 18,342 | 21,884 |
Accrued Interest | 29 | 21 |
Gross Unrealized Gains | 19 | 5 |
Gross Unrealized Losses | (4) | (72) |
Estimated Fair Value | 18,386 | 21,838 |
Amortized Cost | 31,715 | 70,261 |
Accrued Interest | 68 | 293 |
Gross Unrealized Gains | 27 | 5 |
Gross Unrealized Losses | (5) | (212) |
Estimated Fair Value | $ 31,805 | $ 70,347 |
Note 1 - Significant Accounti18
Note 1 - Significant Accounting Policies - Scheduled Maturity for the Company's Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Maturing in one year or less | $ 17,434 | $ 22,664 |
Maturing after one year through two years | 14,371 | 28,395 |
Maturing after two years | 19,288 | |
Total investments | $ 31,805 | $ 70,347 |
Note 1 - Significant Accounti19
Note 1 - Significant Accounting Policies - Summary of Receivables (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
US Department of Health and Human Services [Member] | Billed Revenues [Member] | ||
Receivables | $ 83 | |
US Department of Health and Human Services [Member] | Unbilled Revenues [Member] | ||
Receivables | 1,746 | 5,536 |
US Department of Health and Human Services [Member] | ||
Receivables | 1,829 | 5,536 |
Shionogi and Co. Ltd [Member] | Billed Revenues [Member] | ||
Receivables | 3,902 | 469 |
Shionogi and Co. Ltd [Member] | Unbilled Revenues [Member] | ||
Receivables | ||
Shionogi and Co. Ltd [Member] | ||
Receivables | 3,902 | 469 |
Green Cross Corporation [Member] | Billed Revenues [Member] | ||
Receivables | 9 | |
Green Cross Corporation [Member] | Unbilled Revenues [Member] | ||
Receivables | ||
Green Cross Corporation [Member] | ||
Receivables | 9 | |
Seqirus UK Limited [Member] | Billed Revenues [Member] | ||
Receivables | 210 | |
Seqirus UK Limited [Member] | Unbilled Revenues [Member] | ||
Receivables | 228 | 28 |
Seqirus UK Limited [Member] | ||
Receivables | 228 | 238 |
Billed Revenues [Member] | ||
Receivables | 3,994 | 679 |
Unbilled Revenues [Member] | ||
Receivables | 1,974 | 5,564 |
Receivables | $ 5,968 | $ 6,243 |
Note 1 - Significant Accounti20
Note 1 - Significant Accounting Policies - Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Work in process | $ 2,232 | $ 1,612 |
Inventories | $ 2,232 | $ 1,612 |
Note 1 - Significant Accounti21
Note 1 - Significant Accounting Policies - Summary of Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
US Department of Health and Human Services [Member] | ||||
Collaborative and other research and development revenues | $ 3,813 | $ 4,582 | $ 9,846 | $ 12,788 |
Green Cross Corporation [Member] | ||||
Collaborative and other research and development revenues | 132 | 132 | ||
Shionogi and Co. Ltd [Member] | ||||
Collaborative and other research and development revenues | 296 | 296 | 888 | 888 |
Seqirus UK Limited [Member] | ||||
Collaborative and other research and development revenues | 153 | 152 | 616 | 21,835 |
Product sales, net | 5,699 | 6,236 | ||
Royalty revenue | 3,501 | 126 | 6,020 | 1,776 |
Collaborative and other research and development revenues | 4,262 | 5,162 | 11,350 | 35,643 |
Revenues | $ 7,763 | $ 10,987 | $ 17,370 | $ 43,655 |
Note 2 - Stock-based Compensa22
Note 2 - Stock-based Compensation (Details Textual) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 9 Months Ended | |||
Dec. 31, 2014shares | Aug. 31, 2013shares | Sep. 30, 2016USD ($)$ / sharesshares | Sep. 30, 2015USD ($)$ / shares | Dec. 31, 2015shares | |
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] | 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] | 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] | 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% | ||||
Number of Milestones Achieved | 3 | ||||
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 Shar-based Payment Award, Awards Unvested, Percentage | 100.00% | ||||
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 | 1,250 | 1,032 | |||
Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% | |||
Allocated Share-based Compensation Expense | $ 6,331 | $ 7,553 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 2.17 | $ 8.15 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | shares | 2,148 | 16 | |||
Employee Stock Purchase Plan [Member] | |||||
Allocated Share-based Compensation Expense | $ 147 | $ 220 | |||
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 | 422 | ||||
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 | 75 | ||||
Number of Stock-based Compensation Plans | 2 | ||||
Allocated Share-based Compensation Expense | $ 6,478 | $ 7,773 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | 16,591 | ||||
Employee Service Share-based Compensation Nonvested Awards Compensation Cost Expected to be Recognized For Remainder of Fiscal Year | 1,889 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Two | 6,958 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Three | 4,700 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Four | 2,633 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Five | $ 411 |
Note 2 - Stock-based Compensa23
Note 2 - Stock-based Compensation - Stock Incentive Plan Activities (Details) - Incentive Plan [Member] shares in Thousands | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Restricted Stock Units (RSUs) [Member] | |
Restricted stock unit awards granted (in shares) | (28) |
Restricted stock unit awards cancelled (in shares) | 15 |
Awards Available (in shares) | 16 |
Options Outstanding (in shares) | 10,671 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 7.50 |
Plan amendment (in shares) | 3,800 |
Stock option awards granted (in shares) | (2,248) |
Stock option awards granted (in shares) | 2,248 |
Stock option awards granted (in dollars per share) | $ / shares | $ 3.20 |
Stock option awards exercised (in shares) | (88) |
Stock option awards exercised (in dollars per share) | $ / shares | $ 2.23 |
Stock option awards cancelled (in shares) | 593 |
Stock option awards cancelled (in shares) | (593) |
Stock option awards cancelled (in dollars per share) | $ / shares | $ 11.13 |
Awards Available (in shares) | 2,148 |
Options Outstanding (in shares) | 12,238 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 6.57 |
Note 2 - Stock-based Compensa24
Note 2 - Stock-based Compensation - Weighted Average Assumptions (Details) - Incentive Plan [Member] | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Expected Life in Years | 5 years 182 days | 5 years 182 days |
Expected Volatility | 82.00% | 83.00% |
Expected Dividend Yield | 0.00% | 0.00% |
Risk-Free Interest Rate | 1.40% | 1.50% |
Note 3 - Collaborative and Ot25
Note 3 - Collaborative and Other Research and Development Contracts (Details Textual) - USD ($) $ in Thousands | Jun. 16, 2015 | Sep. 30, 2013 | Feb. 28, 2006 | Jun. 30, 2000 | Sep. 30, 2016 | Sep. 30, 2016 | Mar. 31, 2015 |
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 | ||||||
Mundipharma [Member] | |||||||
Upfront Payments Receivable Amount | $ 10,000 | ||||||
AECOM and IRL [Member] | |||||||
Milestone Payment Maximum | $ 4,000 | ||||||
Milestone Payment Minimum | 1,400 | ||||||
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] | |||||||
Proceeds from awards for Research and Development Contracts | $ 5,000 | ||||||
Expected Receivable From Awards for Research and Development Contracts | $ 39,477 | ||||||
UAB [Member] | |||||||
Period of Agreement | 25 years | ||||||
Renewable Period of Agreement | 5 years | ||||||
CSL Limited [Member | |||||||
Proceeds from License Fees Received | $ 33,740 | ||||||
Milestone Payment Maximum | $ 12,000 | ||||||
Royalty Term | 10 years |
Note 4 - Royalty Monetization (
Note 4 - Royalty Monetization (Details Textual) | May 18, 2016USD ($) | Mar. 09, 2011USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | May 18, 2016JPY (¥) | Dec. 31, 2015USD ($) |
JPR Royalty Sub LLC [Member] | Royalty Monetization [Member] | ||||||
Revenue Recognition Royalty and Milestone Revenue Recognized | $ 30,000,000 | |||||
Revenue Recognition Royalty And Milestone Revenue Recognized, Net | 22,691,000 | |||||
Transaction Costs | 4,309,000 | |||||
Interest Reserve | 3,000,000 | |||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | Fair Value, Inputs, Level 2 [Member] | ||||||
Notes Payable, Fair Value Disclosure | $ 30,000,000 | |||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | Currency Hedge Agreement [Member] | ||||||
Collateral Already Posted, Aggregate Fair Value | 2,190,000 | |||||
Maximum Amount of Collateral Required to Post | $ 7,800,000 | |||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | ||||||
Private Placement of Senior Secured Notes | $ 30,000,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 14.00% | |||||
Percentage of Carrying Amount in Excess of Fair Value | 50.00% | |||||
PhaRMA Notes Member] | Japan, Yen | Currency Hedge Agreement [Member] | ||||||
Derivative, Forward Exchange Rate | 100 | |||||
PhaRMA Notes Member] | Currency Hedge Agreement [Member] | ||||||
Payments for (Proceeds from) Hedge, Investing Activities | $ 1,950,000 | |||||
Required Foreign Currency Hedge Per Dollar | ¥ | ¥ 100 | |||||
Currency Hedge Agreement [Member] | ||||||
Collateral Already Posted, Aggregate Fair Value | $ 2,190,000 | $ 0 | ||||
Foreign Exchange Contract [Member] | Not Designated as Hedging Instrument [Member] | ||||||
Derivative, Loss on Derivative | $ 7,372,000 | $ 793,000 |
Note 5 - Credit Facility (Detai
Note 5 - Credit Facility (Details Textual) - USD ($) | Sep. 23, 2016 | Sep. 30, 2016 | Sep. 26, 2016 | Dec. 31, 2015 |
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | ||||
Long-term Line of Credit | $ 23,000,000 | $ 23,000,000 | $ 23,000,000 | |
Debt Instrument, Basis Spread on Variable Rate | 8.00% | |||
Debt Instrument, Final Payment Fee, Percentage | 5.00% | |||
Line of Credit Facility, Interest Rate at Period End | 8.50% | |||
Line of Credit Facility, Fair Value of Amount Outstanding | $ 2,000 | |||
Long-term Line of Credit | $ 22,665,000 |
Note 5 - Credit Facility - Sche
Note 5 - Credit Facility - Scheduled Principal Repayments of the Credit Facility (Details) - Senior Credit Facility [Member] $ in Millions | Sep. 30, 2016USD ($) |
2,017 | |
2,018 | 6.9 |
2,019 | 6.9 |
2,020 | 6.9 |
2,021 | 2.3 |
Total | $ 23 |
Note 6 - Stockholders' Equity (
Note 6 - Stockholders' Equity (Details Textual) $ in Millions | Mar. 03, 2015USD ($) |
Maximum Aggregate Offering Price | $ 150 |