Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Jan. 31, 2016 | Jun. 30, 2015 | |
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 | Yes | ||
Entity Common Stock, Shares Outstanding (in shares) | 73,576,471 | ||
Entity Public Float | $ 1,078,490,079 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Collaboration Receivables [Member] | ||
ASSETS | ||
Receivables | $ 6,243,000 | $ 3,849,000 |
Trade Accounts Receivable [Member] | ||
ASSETS | ||
Receivables | 5,641,000 | |
Deferred Collaborative Revenue [Member] | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Deferred revenue | $ 2,163,000 | 1,481,000 |
Deferred Product Sales [Member] | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Deferred revenue | 5,605,000 | |
Cash and cash equivalents | $ 28,899,000 | 54,540,000 |
Restricted cash | 1,612,000 | 150,000 |
Investments | 22,664,000 | 18,232,000 |
Inventory | 1,612,000 | 683,000 |
Prepaid expenses and other current assets | 4,870,000 | 6,172,000 |
Deferred collaboration expense | 90,000 | 76,000 |
Total current assets | 65,990,000 | 89,343,000 |
Investments | 47,683,000 | 41,116,000 |
Property and equipment, net | 5,149,000 | 207,000 |
Deferred collaboration expense | 265,000 | 177,000 |
Other assets | 5,468,000 | 6,031,000 |
Total assets | 124,555,000 | 136,874,000 |
Accounts payable | 9,307,000 | 2,849,000 |
Accrued expenses | 16,237,000 | 11,329,000 |
Interest payable | 6,746,000 | 6,029,000 |
Non-recourse notes payable | 30,000,000 | 30,000,000 |
Total current liabilities | 64,453,000 | 57,293,000 |
Deferred collaboration revenue | 9,674,000 | 3,552,000 |
Deferred rent | 329,000 | $ 394,000 |
Lease financing obligation | 2,375 | |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; shares authorized — 5,000; no shares outstanding | 0 | $ 0 |
Common stock, $0.01 par value; shares authorized — 200,000; shares issued and outstanding — 73,355 in 2015 and 71,955 in 2014 | 734,000 | 720,000 |
Additional paid-in capital | 558,113,000 | 542,943,000 |
Accumulated other comprehensive loss | (206,000) | (130,000) |
Accumulated deficit | (510,917,000) | (467,898,000) |
Total stockholders’ equity | 47,724,000 | 75,635,000 |
Total liabilities and stockholders’ equity | $ 124,555,000 | $ 136,874,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
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 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) | 73,355,000 | 71,955,000 |
Common stock, shares outstanding (in shares) | 73,355,000 | 71,955,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues | |||
Product sales, net | $ 6,291 | $ 33 | |
Royalty revenue | 2,386 | 3,025 | $ 2,562 |
Collaborative and other research and development | 39,580 | 10,550 | 14,769 |
Total revenues | 48,257 | 13,608 | $ 17,331 |
Expenses | |||
Cost of products sold | 1,368 | 1 | |
Research and development | 72,758 | 51,796 | $ 41,943 |
Selling, general and administrative | 13,047 | 7,461 | 6,007 |
Royalty | 528 | 121 | 98 |
Total operating expenses | 87,701 | 59,379 | 48,048 |
Loss from operations | (39,444) | (45,771) | (30,717) |
Interest and other income | 535 | 93 | 93 |
Interest expense | (5,200) | (4,998) | (4,778) |
Gain on foreign currency derivative | 1,090 | 5,487 | 5,294 |
Net loss | $ (43,019) | $ (45,189) | $ (30,108) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.59) | $ (0.68) | $ (0.55) |
Weighted average shares outstanding (in shares) | 72,901 | 66,773 | 55,216 |
Unrealized loss on available for sale investments | $ (76) | $ (134) | $ (23) |
Comprehensive loss | $ (43,095) | $ (45,323) | $ (30,131) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating activities: | |||
Net loss | $ (43,019,000) | $ (45,189,000) | $ (30,108,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation, Depletion and Amortization | $ 180,000 | 177,000 | 304,000 |
Loss (gain) on disposal of property and equipment | 27,000 | (47,000) | |
Stock-based compensation expense | $ 9,705,000 | 10,177,000 | 4,368,000 |
Amortization of Financing Costs | 439,000 | 439,000 | 439,000 |
Change in fair value of foreign currency derivative | 564,000 | (5,487,000) | (5,294,000) |
Changes in operating assets and liabilities: | |||
Receivables | 3,247,000 | (7,375,000) | $ 2,447,000 |
Inventory | (929,000) | (683,000) | |
Prepaid expenses and other assets | 1,207,000 | (1,943,000) | $ (620,000) |
Deferred collaboration expense | (102,000) | 59,000 | 5,133,000 |
Accounts payable and accrued expenses | 14,393,000 | 6,818,000 | (2,049,000) |
Deferred revenue | 1,199,000 | 4,429,000 | (1,103,000) |
Net cash used in operating activities: | (13,116,000) | (38,551,000) | (26,530,000) |
Investing activities: | |||
Acquisition of property and equipment | $ (5,122,000) | $ (106,000) | (30,000) |
Proceeds from sale of property and equipment | 50,000 | ||
Change in restricted cash | $ (1,462,000) | $ 1,000 | 157,000 |
Purchases of investments | (53,830,000) | (73,875,000) | (23,974,000) |
Sales and maturities of investments | 42,410,000 | 34,000,000 | 20,330,000 |
Net cash used in investing activities: | $ (18,004,000) | (39,980,000) | (3,467,000) |
Financing activities: | |||
Sale of common stock, net | 106,600,000 | 23,633,000 | |
Exercise of stock options | $ 5,124,000 | 4,997,000 | 1,333,000 |
Employee stock purchase plan sales | $ 355,000 | $ 310,000 | 124,000 |
Receipt of foreign currency derivative collateral | 5,180,000 | ||
Net cash provided by financing activities: | $ 5,479,000 | $ 111,907,000 | 30,270,000 |
(Decrease) increase in cash and cash equivalents | (25,641,000) | 33,376,000 | 273,000 |
Cash and cash equivalents at beginning of year | 54,540,000 | 21,164,000 | 20,891,000 |
Cash and cash equivalents at end of year | $ 28,899,000 | $ 54,540,000 | $ 21,164,000 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2012 | $ 509 | $ 391,611 | $ 27 | $ (392,601) | $ (454) |
Net loss | (30,108) | (30,108) | |||
Other comprehensive loss | (23) | (23) | |||
Exercise of stock options | 6 | 1,327 | 1,333 | ||
Employee stock purchase plan sales | 1 | 123 | 124 | ||
Issuance of common stock | 75 | 23,559 | 23,634 | ||
Stock-based compensation expense | 4,368 | 4,368 | |||
Balance at Dec. 31, 2013 | 591 | 420,988 | 4 | (422,709) | (1,126) |
Net loss | (45,189) | (45,189) | |||
Other comprehensive loss | (134) | (134) | |||
Exercise of stock options | 13 | 4,984 | 4,997 | ||
Employee stock purchase plan sales | 1 | 309 | 310 | ||
Issuance of common stock | 115 | 106,485 | 106,600 | ||
Stock-based compensation expense | 10,177 | 10,177 | |||
Balance at Dec. 31, 2014 | 720 | 542,943 | (130) | (467,898) | 75,635 |
Net loss | (43,019) | (43,019) | |||
Other comprehensive loss | (76) | (76) | |||
Exercise of stock options | 14 | 5,110 | 5,124 | ||
Employee stock purchase plan sales | 355 | 355 | |||
Stock-based compensation expense | 9,705 | 9,705 | |||
Balance at Dec. 31, 2015 | $ 734 | $ 558,113 | $ (206) | $ (510,917) | $ 47,724 |
Consolidated Statements of Sto7
Consolidated Statements of Stockholders' Equity (Parentheticals) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Common Stock [Member] | |||
Exercise of stock options, shares (in shares) | 1,359 | 1,314 | 348 |
Employee stock purchase plan sales, shares (in shares) | 41 | 49 | 89 |
Issuance of common stock, shares (in shares) | 11,500 | 7,547 | |
Exercise of stock options, shares (in shares) | 1,118 | 1,258 | 563 |
Issuance of common stock, shares (in shares) | 2,883 |
Note 1 - Significant Accounting
Note 1 - Significant Accounting Policies and Concentrations of Risk | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 1 — Significant Accounting Policies and Concentrations of Risk 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 $100,858, to continue its planned operations through mid-2017. 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 mid-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 through private placement transactions or registered public offerings pursuant to a registration statement filed with the SEC. Additionally, the Company retains the ability to offer for sale approximately $10,000 of securities, including common stock, preferred stock, depositary shares, stock purchase contracts, warrants and units from its effective shelf S-3 registration statement, which it filed with the Securities and Exchange Commission (“SEC”) on November 6, 2013. 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 Beginning in March 2011, the consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, JPR Royalty Sub LLC (“Royalty Sub”). Royalty Sub was formed in connection with a $30,000 financing transaction the Company completed on March 9, 2011. See Note 3, Royalty Monetization, 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”). Such consolidated financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. There were no adjustments other than normal recurring adjustments. Reclassifications Long term deferred rent as of December 31, 2014 has been reclassified to conform to the 2015 presentation. 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 December 31, 2015 reflects $150 the Company is required to maintain in an interest bearing certificate of deposit to serve as collateral for a corporate credit card program, $59 in royalty revenue paid by Shionogi & Co., Ltd. (“Shionogi”) designated for interest on the PhaRMA Notes (defined in Note 3) and $1,403 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 December 31, 2015, the Company believes that the costs of its investments are recoverable in all material respects. The following tables summarize the fair value of the Company’s investments by type. The estimated fair value 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. December 31, 2015 Amortized Accrued Gross Gross Estimated Obligations of 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 December 31, 2014 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 20,307 $ 22 $ — $ (23 ) $ 20,306 Corporate debt securities 27,152 151 5 (47 ) 27,261 Commercial paper 11,838 6 — (63 ) 11,781 Total investments $ 59,297 $ 179 $ 5 $ (133 ) $ 59,348 The following table summarizes the scheduled maturity for the Company’s investments at December 31, 2015 and 2014. 2015 2014 Maturing in one year or less $ 22,664 $ 18,232 Maturing after one year through two years 28,395 25,459 Maturing after two years 19,288 15,657 Total investments $ 70,347 $ 59,348 Receivable 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 and Seqirus UK Limited (“SUL”), and product sales to SUL. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. At December 31, 2015 and 2014, the Company had the following receivables. 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 December 31, 2014 Billed Unbilled Total U.S. Department of Health and Human Services $ — $ 2,778 $ 2,778 Shionogi & Co. Ltd. 1,071 — 1,071 Total receivables $ 1,071 $ 2,778 $ 3,849 Monthly invoices are submitted to the U.S. Department of Health and Human Services related to reimbursable research and development costs. The Company is also entitled to monthly reimbursement of indirect costs based on rates stipulated in the underlying contract. The Company’s calculations of its indirect cost rates are subject to audit by the U.S. Government. Receivables from Product Sales Receivables from product sales are recorded for amounts due to the Company related to sales of RAPIVAB. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. Inventory At December 31, 2015 and 2014, the Company’s inventory consisted of RAPIVAB finished goods inventory and 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 FDA approval of RAPIVAB, the Company began capitalizing costs associated with the production of RAPIVAB inventories. The Company’s inventory consisted of the following: As of December 31, 2015 2014 Work in process $ 1,612 $ 267 Finished goods — 416 Net inventories $ 1,612 $ 683 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 remaining 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 of ten years equal to the 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. Accrued expenses were comprised of the following: December 31, 2015 2014 Compensation and benefits $ 424 $ 2,105 Development costs 10,398 4,232 Inventory 549 397 Professional fees 242 238 Duties and taxes 102 75 Other 4,522 4,282 Total accrued expenses $ 16,237 $ 11,329 As of December 31, 2015 and 2014, 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 Loss Accumulated other comprehensive loss is comprised of unrealized gains and losses on available-for-sale investments and is disclosed as a separate component of stockholders’ equity. Amounts reclassified from accumulated other comprehensive loss are recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. During 2015, realized gains of $13 were reclassified out of accumulated other comprehensive loss. No reclassifications out of accumulated other comprehensive loss were recorded during 2014. 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 Seqirus UK Limited (“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, 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 primarily responsible for sales of RAPIVAB, other than U.S. Government stockpiling sales, and the Company’s commercial sales will be minimal. 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. 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 years ended December 31: 2015 2014 2013 Product sales, net $ 6,291 $ 33 $ — Royalty revenue 2,386 3,025 2,562 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 16,337 9,366 13,585 Green Cross Corporation 132 — — Shionogi (Japan) 1,184 1,184 1,184 Seqirus UK Limited 21,927 — — Total collaborative and other research and development revenues 39,580 10,550 14,769 Total revenues $ 48,257 $ 13,608 $ 17,331 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. Advertising and product promotion expenses were $103 and $290 for the years ended December 31, 2015 and 2014, respectively. 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” has occurred. Interest Expense and Deferred Financing Costs Interest expense for the years ended December 31, 2015, 2014 and 2013 was $5,200, $4,998 and $4,778, respectively, and relates to the issuance of the PhaRMA Notes. Costs directly associated with the issuance of the PhaRMA Notes have been capitalized and are included in other non-current assets on the Consolidated Balance Sheets. These costs are being amortized to interest expense over the term of the PhaRMA Notes using the effective interest rate method. Amortization of deferred financing costs included in interest expense was $439 for each of the years ended December 31, 2015, 2014 and 2013. 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 years ended December 31, 2015, 2014 and 2013 resulted in a loss of $564 and gains of $5,487 and $5,294, respectively. Mark to market adjustments are determined by a third party pricing model which 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. In addition, a realized currency exchang |
Note 2 - Furniture and Equipmen
Note 2 - Furniture and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 2 — Property and Equipment Property and equipment consisted of the following at December 31: 2015 2014 Furniture and fixtures $ 718 $ 542 Office equipment 1,122 1,115 Software 1,427 1,423 Laboratory equipment 6,004 5,786 Leased equipment 63 63 Leasehold improvements 5,610 5,303 Construction in progress 2,821 — Building 1,589 — 19,354 14,232 Less accumulated depreciation and amortization (14,205 ) (14,025 ) Property and equipment, net $ 5,149 $ 207 Depreciation and amortization expense for the years ended December 31, 2015, 2014 and 2013 was $180, $177 and $304, respectively. |
Note 3 - Royalty Monetization
Note 3 - Royalty Monetization | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Royalty Monetization [Text Block] | Note 3— 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, if approved for commercial sale, 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. In September 2013, Royalty Sub paid $1,844 of interest on the PhaRMA Notes from royalty payments received from RAPIACTA ® The Indenture does not contain any financial covenants. The Indenture includes customary representations and warranties of Royalty Sub, affirmative and negative covenants of Royalty Sub, Events of Default and related remedies, and provisions regarding the duties of the Trustee, indemnification of the Trustee, and other matters typical for indentures used in structured financings of this type. As of December 31, 2015, 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 2016 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 in 2015, 2014 and 2013 resulted in a loss of $564 and gains of $5,487 and $5,294 respectively. In addition, a realized currency exchange gain of $1,654 was recognized in 2015 related to the exercise of a U.S. dollar/Japanese yen currency option under our foreign currency hedge. The Company is also required to post collateral in connection with the mark to market adjustments based on defined thresholds. As of December 31, 2015 and 2014, no collateral was posted under the Currency Hedge Agreement. The Company will not be required at any time to post collateral exceeding the maximum premium payments remaining payable under the Currency Hedge Agreement. As of December 31, 2015, the maximum amount of hedge collateral the Company may be required to post is $9,750. |
Note 4 - Lease Obligations and
Note 4 - Lease Obligations and Other Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | Note 4 — Lease Obligations and Other Contingencies The Company has the following minimum payments under operating lease obligations that existed at December 31, 2015: 2016 $ 651 2017 871 2018 870 2019 820 2020 651 Thereafter 3,045 Total minimum payments $ 6,908 The obligations in the preceding table are primarily related to the Company’s leases for buildings in Birmingham, Alabama and Durham, North Carolina. The lease for the Company’s headquarters in Durham, North Carolina expires June 30, 2020. The lease for the existing facility in Birmingham, Alabama currently expires on June 30, 2016; however, in 2015, the Company leased an additional approximate 32,000 square feet in Birmingham to house its new research facility. The Company began construction on leasehold improvements for its new research facility in 2015 and this lease obligates the Company for $4,839 of lease payments into 2027. Rent expense for operating leases was $664, $633, and $526 in 2015, 2014, and 2013, respectively. 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 will 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, 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 and or construction in process. At December 31, 2015, the lease financing obligation balance was $2,375 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. |
Note 5 - Stockholders' Equity
Note 5 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 5 — Stockholders’ Equity Sales of Common Stock On March 3, 2015, the Company filed a $150,000 shelf registration statement on Form S-3 with the SEC. This shelf registration statement became effective upon filing and 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. The Company intends to file a post-effective amendment to this registration statement, which will allow for its use by the Company when declared effective by the SEC’s staff. On November 6, 2013, the Company filed a $125,000 shelf registration statement on Form S-3 with the SEC. This shelf registration statement was declared effective in November 2013 and allows us 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. On June 3, 2014, the Company issued 11,500 shares of common stock for gross proceeds of $115,000 under this $125,000 shelf registration statement. Net proceeds were approximately $107,800 after deducting underwriting discounts and offering expenses. The Company has $10,000 remaining under this shelf registration statement In August 2013, the Company completed a public offering of 4,600 shares of its common stock at a price of $4.40 per share, which included the underwriters’ over-allotment allocation of an additional 600 shares. Net proceeds were approximately $18,500 after deducting underwriting discounts and offering expenses. Shares of common stock in this offering were sold under the $70,000 shelf registration statement declared effective in July 2011. In June 2011, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with McNicoll, Lewis & Vlak (“MLV”) pursuant to which the Company was able to sell $70,000 in shares of its common stock at current market prices under a Form S-3 registration statement with MLV acting as the sales agent. During 2012, the Company sold an aggregate of 4,516 shares of common stock at an average per share price of $4.08 pursuant to the ATM Agreement for net proceeds of $17,805. During 2013, the Company sold an aggregate of 2,883 shares of common stock at an average per share price of $1.85 pursuant to the Agreement for net proceeds of $5,218. |
Note 6 - Stock-Based Compensati
Note 6 - Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | Note 6 — Stock-Based Compensation Stock Incentive Plan As of December 31, 2015, the Company had two stock-based employee compensation plans, the Stock Incentive Plan (“Incentive Plan”) and the Employee Stock Purchase Plan (“ESPP”), both which were amended and restated in March 2014 and approved by the Company’s stockholders in May 2014. Stock-based compensation expense of $9,705 ($9,485 of expense related to the Incentive Plan, $220 of expense related to the ESPP) was recognized during 2015, while $10,177 ($9,963 of expense related to the Incentive Plan, $214 of expense related to the ESPP) was recognized during 2014, and $4,368 ($4,253 of expense related to the Incentive Plan, $115 of expense related to the ESPP) was recognized during 2013. The Company accounts for stock-based compensation in accordance with FASB authoritative guidance regarding share-based payments. Total stock-based compensation was allocated as follows: Year Ended December 31, 2015 2014 2013 Research and development $ 7,580 $ 8,906 $ 3,664 General and administrative 2,125 1,271 704 Total stock-based compensation expense $ 9,705 $ 10,177 $ 4,368 The Company grants stock option awards and restricted stock unit awards to its employees, directors, and consultants under the Incentive Plan. Under the Incentive Plan, stock option awards are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Commencing March 1, 2011, stock option awards granted to employees generally vest 25% each year until fully vested after four years. In January 2013, the Company made retention grants of stock option awards and restricted stock units. These awards vest 50% each year until fully vested after two 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 December 31, 2015, 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 December 31, 2015, 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 at December 31, 2012 2,815 8,073 $ 6.09 Restricted stock awards granted (310 ) — — Restricted stock awards cancelled 53 — — Stock option awards granted (3,277 ) 3,277 3.05 Stock option awards exercised — (563 ) 2.37 Stock option awards cancelled 1,801 (1,801 ) 7.22 Balance at December 31, 2013 1,082 8,986 4.99 Plan amendment 3,750 — — Restricted stock awards granted (593 ) — — Restricted stock awards cancelled — — — Stock option awards granted (1,965 ) 1,965 10.99 Stock option awards exercised — (1,258 ) 4.78 Stock option awards cancelled 88 (88 ) 8.83 Balance at December 31, 2014 2,362 9,605 6.21 Restricted stock awards granted (163 ) — — Restricted stock awards cancelled 1 — — Stock option awards granted (2,217 ) 2,217 11.52 Stock option awards exercised — (1,118 ) 4.36 Stock option awards cancelled 33 (33 ) 9.87 Balance at December 31, 2015 16 10,671 $ 7.50 For stock option awards granted under the Incentive Plan during 2015, 2014 and 2013, 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 of these awards granted during 2015, 2014 and 2013 was $7.72, $8.02, and $1.28, 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 explanations describe the assumptions used by the Company to value the stock option awards granted during 2015, 2014, and 2013. 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 volatility over the most recent period corresponding with the expected life. The Company has assumed no expected dividend yield, as dividends have never been paid to stockholders and will not be 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 under the Incentive Plan 2015 2014 2013 Expected Life 5.5 5.5 4.7 Expected Volatility 81 % 87 % 84 % Expected Dividend Yield 0.0 % 0.0 % 0.0 % Risk-Free Interest Rate 1.6 % 1.6 % 0.7 % The total intrinsic value of stock option awards exercised under the Incentive Plan was $10,117 during 2015, $8,522 during 2014, $738 and during 2013. The intrinsic value represents the total proceeds (fair market value at the date of exercise, less the exercise price, times the number of stock option awards exercised) received by all individuals who exercised stock option awards during the period. The following table summarizes, at December 31, 2015, by price range: (1) for stock option awards outstanding under the Incentive Plan, the number of stock option awards outstanding, their weighted average remaining life and their weighted average exercise price; and (2) for stock option awards exercisable under the Plan, the number of stock option awards exercisable and their weighted average exercise price: Outstanding Exercisable Range Number Weighted Weighted Number Weighted $ 0 to 3 1,826 6.4 $ 1.51 1,322 $ 1.55 3 to 6 2,792 6.1 4.63 2,329 4.53 6 to 9 1,153 4.5 7.10 1,070 7.13 9 to 12 3,728 8.1 11.07 714 11.45 12 to 15 1,077 6.4 12.44 374 12.65 15 to 18 95 9.5 15.39 — — $ 0 to 18 10,671 6.7 $ 7.50 5,809 $ 5.70 The weighted average remaining contractual life of stock option awards exercisable under the Incentive Plan at December 31, 2015 was 5.0 years. The aggregate intrinsic value of stock option awards outstanding and exercisable under the Incentive Plan at December 31, 2015 was $28,511. The aggregate intrinsic value represents the value (the period’s closing market price, less the exercise price, times the number of in-the-money stock option awards) that would have been received by all stock option award holders under the Incentive Plan had they exercised their stock option awards at the end of the year. The total fair value of the stock option awards vested under the Incentive Plan was $4,492 during 2015, $2,844 during 2014, and $3,483 during 2013. As of December 31, 2015, the number of stock option awards vested and expected to vest under the Incentive Plan is 9,633. The weighted average exercise price of these stock option awards is $7.51 and their weighted average remaining contractual life is 6.6 years. The following table summarizes the changes in the number and weighted-average grant-date fair value of non-vested stock option awards during 2015: Non-Vested Weighted Average Balance December 31, 2014 4,385 $ 4.27 Stock option awards granted 2,217 7.72 Stock option awards vested (1,711 ) 2.63 Stock option awards forfeited (28 ) 6.39 Balance December 31, 2015 4,863 $ 6.40 As of December 31, 2015, there was approximately $18,607 of total unrecognized compensation cost related to non-vested employee stock option awards and restricted stock units granted by the Company. That cost is expected to be recognized as follows: $7,023 in 2016, $6,010 in 2017, $3,891 in 2018, and $1,683 in 2019. 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 497 shares remain available for purchase at December 31, 2015. 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. There were 41, 49 and 89 shares of common stock purchased under the ESPP in 2015, 2014, and 2013, respectively, at a weighted average price per share of $8.65, $6.29, and $1.39, respectively. Expense of $220, $214, and $115, related to the ESPP was recognized during 2015, 2014, and 2013, respectively. 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. The weighted average grant date fair values of shares granted under the ESPP during 2015, 2014, and 2013, were $4.93, $4.41, and $1.27, respectively. |
Note 7 - Income Taxes
Note 7 - Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 7 — Income Taxes The Company has incurred net losses since inception and, consequently, has not recorded any U.S. Federal and state income tax expense or benefit. The differences between the Company’s effective tax rate and the statutory tax rate in 2015, 2014, and 2013 are as follows: 2015 2014 2013 Income tax benefit at federal statutory rate (35%) $ (15,057 ) $ (15,816 ) $ (10,538 ) State and local income taxes net of federal tax benefit (819 ) (1,286 ) (839 ) Permanent items 560 258 738 Rate change 1,012 22 1,892 Expiration of attribute carryforwards 330 373 242 Research and development tax credits (10,454 ) (748 ) (1,206 ) Orphan drug credit 4,307 — — Other (218 ) (115 ) 1,144 Change in valuation allowance 20,339 17,312 8,567 Income tax expense $ — $ — $ — The Company recognizes the impact of a tax position in its financial statements if it is more likely than not that the position will be sustained on audit based on the technical merits of the position. The Company has concluded that it has an uncertain tax position pertaining to its research and development and orphan drug credit carryforwards. The Company has established these credits based on information and calculations it believes are appropriate and the best estimate of the underlying credit. Any changes to the Company’s unrecognized tax benefits are offset by an adjustment to the valuation allowance and there would be no impact on the Company’s financial statements. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: 2015 2014 Balance at January 1, $ 472 $ 284 Additions to current period tax positions 2,616 176 Additions to prior period tax positions — 12 Reductions to prior period tax provisions (3 ) — Balance at December 31, $ 3,085 $ 472 The Company’s ability to utilize the net operating loss and tax credit carryforwards in the future may be subject to substantial restrictions in the event of past or future ownership changes as defined in Section 382 of the Internal Revenue Code of 1986, as amended and similar state tax law. Significant components of the Company’s deferred tax assets and liabilities are as follows: 2015 2014 Deferred tax assets: Net federal and state operating losses $ 142,836 $ 135,922 Research and development credits 48,551 38,096 Fixed assets 1,054 1,073 Deferred revenue 4,240 3,798 Stock-based compensation 8,605 7,086 Other 2,590 1,178 Total deferred tax assets 207,876 187,153 Deferred tax liabilities: Foreign currency derivative (2,668 ) (2,285 ) Total deferred tax liabilities (2,668 ) (2,285 ) Valuation allowance (205,208 ) (184,868 ) Net deferred tax assets $ — $ — The majority of the Company’s deferred tax assets relate to net operating loss and research and development carryforwards that can only be realized if the Company is profitable in future periods. It is uncertain whether the Company will realize any tax benefit related to these carryforwards. Accordingly, the Company has provided a full valuation allowance against the net deferred tax assets due to uncertainties as to their ultimate realization. The valuation allowance will remain at the full amount of the deferred tax assets until it is more likely than not that the related tax benefits will be realized. The Company’s valuation allowance increased by $20,339 in 2015, $17,312 in 2014, and $8,567 in 2013. As of December 31, 2015, the Company had federal operating loss carryforwards of $386,219, state operating loss carryforwards of $373,454, and research and development and orphan drug credit carryforwards of $48,551, which will expire at various dates from 2016 through 2035. The federal losses begin to expire in 2018, the state losses begin to expire in 2016 and the research and development contracts begin to expire in 2018. The Company’s federal and state operating loss carryforwards include $15,655 of excess tax benefits related to a deduction from the exercise of stock options. The tax benefit of these deductions has not been recognized in deferred tax assets. If utilized, the benefits from these deductions will be recorded as adjustments to additional paid-in capital. Tax years 2012-2014 remain open to examination by the major taxing jurisdictions to which the Company is subject. Additionally, years prior to 2012 are also open to examination to the extent of loss and credit carryforwards from those years. The Company recognizes interest and penalties accrued related to unrecognized tax benefits as components of its income tax provision. However, there were no provisions or accruals for interest and penalties in 2015, 2014, and 2013. |
Note 8 - Employee 401(k) Plan
Note 8 - Employee 401(k) Plan | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Pension and Other Postretirement Benefits Disclosure [Text Block] | Note 8 — Employee 401(k) Plan In January 1991, the Company adopted an employee retirement plan (“401(k) Plan”) under Section 401(k) of the Internal Revenue Code covering all employees. Employee contributions may be made to the 401(k) Plan up to limits established by the Internal Revenue Service. Company matching contributions may be made at the discretion of the Board of Directors. The Company made matching contributions of $366, $361, and $313, in 2015, 2014, and 2013, respectively. |
Note 9 - Collaborative and Othe
Note 9 - Collaborative and Other Research and Development Contracts | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | Note 9 — Collaborative and Other Research and Development Contracts U.S. Department of Health and Human Services (“BARDA/HHS”). On March 31, 2015, the Company announced that the Biomedical Research and Development Authority within the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response awarded BioCryst a contract for the continued development of BCX4430 as a potential treatment for diseases caused by RNA pathogens, including filoviruses. This BARDA/HHS contract includes a base contract of $13,314 to support BCX4430 drug manufacturing, as well as $22,855 in additional development options that can be exercised by the government, bringing the potential value of the contract to $36,169. As of September 30, 2015, a total of $16,300 has been awarded under exercised options within this contract. 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 contracts provisions that are related to the development of peramivir and BCX4430 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 a New Drug Application ("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 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 "Royalty Term"). 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”). The Company deferred revenue recognition of the $10,000 up-front payment that was received from Mundipharma in February 2006 because the Company was involved in the continued development of forodesine. Amortization of this revenue commenced in February 2006 and was initially scheduled to end in October 2017, which is the date of expiration for the last-to-expire patent covered by the agreement. The Company also deferred revenue recognition of a $5,000 payment received from Mundipharma in connection with the initiation of a clinical trial in 2007. Amortization of this deferred revenue commenced in 2007 and was initially scheduled to end in October 2017. Under its agreement with AECOM/IRL, the Company paid sublicense payments related to these upfront cash payments received from Mundipharma. Expense recognition of these sublicense payments was deferred and recognized under the same term as the related deferred revenue. On November 11, 2011, the Company entered into the Amended and Restated License and Development Agreement (the “Amended and Restated Agreement”) with Mundipharma, amending and restating the Original Agreement. Under the terms of the Amended and Restated Agreement, Mundipharma obtained worldwide rights to forodesine. Commencing on November 11, 2011, Mundipharma controls the development and commercialization of forodesine and assumes all future development and commercialization costs. The Amended and Restated Agreement provides for the possibility of future event payments totaling $15,000 for achieving specified regulatory events for certain indications and tiered royalties ranging from mid to high single-digit percentages of net product sales in each country where forodesine is sold by Mundipharma. These royalties are subject to downward adjustments based on the then-existing patent coverage and/or the availability of generic compounds in each country. The Amended and Restated Agreement is a multiple element arrangement for accounting purposes, in which the Company is required to deliver to Mundipharma both the worldwide rights to forodesine in the field of oncology and the transfer of product data and know-how to permit Mundipharma to develop and commercialize forodesine (the “Knowledge Transfer”). The Company accounted for these elements as a combined unit of accounting as they do not have stand-alone value to Mundipharma. The worldwide license rights were granted to Mundipharma on November 11, 2011 and the Knowledge Transfer was completed during the first quarter of 2012. 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. In consideration for these modifications in 2010, the Company issued to the Licensors shares of its common stock with an aggregate value of $5,911 and paid the Licensors $90 in cash. Additionally, at the Company’s sole option and subject to certain agreed upon conditions, any future non-royalty payments due to be paid by it to the Licensors under the license agreement may be made either in cash, in shares of its common stock, or in a combination of cash and shares. On November 17, 2011, the Company further amended its agreements with the Licensors whereby the Licensors agreed to accept a reduction of one-half in the percentage of Net Proceeds (as defined) received by the Company under its Amended and Restated Agreement with Mundipharma that will be paid to AECOM/IRL. 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 BCX4430 to BioCryst for any antiviral use. At its sole option and subject to certain agreed upon conditions, any future non-royalty payments due to be paid by the Company to AECOM/IRL under the license agreement may be made either in cash, in shares of the Company’s common stock, or in a combination of cash and shares. On January 6, 2014, the Carbohydrate Chemistry Research Team from Callaghan Innovation Research Limited, formerly Industrial Research Limited, transferred to Victoria University of Wellington (“VUW”) to establish the Ferrier Research Institute. The intellectual property rights relating to this research team, and the contracts relating to that intellectual property were transferred to a wholly owned subsidiary of VUW, including the contracts to which BioCryst is a party. The parties executed novation agreements in order to effectuate the transfer. Except for a substitution of parties, the terms and conditions of the contracts are substantially the same The University of Alabama at Birmingham (“UAB”). |
Note 10 - Quarterly Financial I
Note 10 - Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | Note 10 — Quarterly Financial Information (Unaudited) First Second Third Fourth 2015 Quarters Revenues $ 6,826 $ 25,842 $ 10,987 $ 4,602 Net (Loss) Income (15,164 ) 4,901 (14,621 ) (18,135 ) Basic net (loss) income per share (0.21 ) 0.07 (0.20 ) (0.25 ) Diluted net (loss) income per share (0.21 ) 0.06 (0.20 ) (0.25 ) 2014 Quarters Revenues $ 3,458 $ 1,466 $ 3,238 $ 5,446 Net Loss (10,137 ) (14,649 ) (8,731 ) (11,672 ) Basic and diluted net loss per share (0.17 ) (0.23 ) (0.12 ) (0.16 ) |
Note 11 - Recent Accounting Pro
Note 11 - Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
New Accounting Pronouncements and Changes in Accounting Principles [Text Block] | Note 11 — Recent Accounting Pronouncements In November 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-17, Balance Sheet Classification of Deferred Taxes In April 2015, the FASB issued ASU No.2015-03, Simplifying the Presentation of Debt Issuance Costs In August 2014, the FASB issued ASU 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 ASU 2014-09 – Revenue from Contracts with Customers |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
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 $100,858, to continue its planned operations through mid-2017. 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 mid-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 through private placement transactions or registered public offerings pursuant to a registration statement filed with the SEC. Additionally, the Company retains the ability to offer for sale approximately $10,000 of securities, including common stock, preferred stock, depositary shares, stock purchase contracts, warrants and units from its effective shelf S-3 registration statement, which it filed with the Securities and Exchange Commission (“SEC”) on November 6, 2013. The Company will continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations. |
Consolidation, Policy [Policy Text Block] | Basis of Presentation Beginning in March 2011, the consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, JPR Royalty Sub LLC (“Royalty Sub”). Royalty Sub was formed in connection with a $30,000 financing transaction the Company completed on March 9, 2011. See Note 3, Royalty Monetization, 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”). Such consolidated financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. There were no adjustments other than normal recurring adjustments. |
Reclassification, Policy [Policy Text Block] | Reclassifications Long term deferred rent as of December 31, 2014 has been reclassified to conform to the 2015 presentation. |
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 December 31, 2015 reflects $150 the Company is required to maintain in an interest bearing certificate of deposit to serve as collateral for a corporate credit card program, $59 in royalty revenue paid by Shionogi & Co., Ltd. (“Shionogi”) designated for interest on the PhaRMA Notes (defined in Note 3) and $1,403 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 December 31, 2015, the Company believes that the costs of its investments are recoverable in all material respects. The following tables summarize the fair value of the Company’s investments by type. The estimated fair value 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. December 31, 2015 Amortized Accrued Gross Gross Estimated Obligations of 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 December 31, 2014 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 20,307 $ 22 $ — $ (23 ) $ 20,306 Corporate debt securities 27,152 151 5 (47 ) 27,261 Commercial paper 11,838 6 — (63 ) 11,781 Total investments $ 59,297 $ 179 $ 5 $ (133 ) $ 59,348 The following table summarizes the scheduled maturity for the Company’s investments at December 31, 2015 and 2014. 2015 2014 Maturing in one year or less $ 22,664 $ 18,232 Maturing after one year through two years 28,395 25,459 Maturing after two years 19,288 15,657 Total investments $ 70,347 $ 59,348 |
Receivables, Policy [Policy Text Block] | Receivable 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 and Seqirus UK Limited (“SUL”), and product sales to SUL. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. At December 31, 2015 and 2014, the Company had the following receivables. 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 December 31, 2014 Billed Unbilled Total U.S. Department of Health and Human Services $ — $ 2,778 $ 2,778 Shionogi & Co. Ltd. 1,071 — 1,071 Total receivables $ 1,071 $ 2,778 $ 3,849 Monthly invoices are submitted to the U.S. Department of Health and Human Services related to reimbursable research and development costs. The Company is also entitled to monthly reimbursement of indirect costs based on rates stipulated in the underlying contract. The Company’s calculations of its indirect cost rates are subject to audit by the U.S. Government. Receivables from Product Sales Receivables from product sales are recorded for amounts due to the Company related to sales of RAPIVAB. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. |
Inventory, Policy [Policy Text Block] | Inventory At December 31, 2015 and 2014, the Company’s inventory consisted of RAPIVAB finished goods inventory and 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 FDA approval of RAPIVAB, the Company began capitalizing costs associated with the production of RAPIVAB inventories. The Company’s inventory consisted of the following: As of December 31, 2015 2014 Work in process $ 1,612 $ 267 Finished goods — 416 Net inventories $ 1,612 $ 683 |
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 remaining 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 of ten years equal to the 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. Accrued expenses were comprised of the following: December 31, 2015 2014 Compensation and benefits $ 424 $ 2,105 Development costs 10,398 4,232 Inventory 549 397 Professional fees 242 238 Duties and taxes 102 75 Other 4,522 4,282 Total accrued expenses $ 16,237 $ 11,329 As of December 31, 2015 and 2014, 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 Loss Accumulated other comprehensive loss is comprised of unrealized gains and losses on available-for-sale investments and is disclosed as a separate component of stockholders’ equity. Amounts reclassified from accumulated other comprehensive loss are recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. During 2015, realized gains of $13 were reclassified out of accumulated other comprehensive loss. No reclassifications out of accumulated other comprehensive loss were recorded during 2014. |
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 Seqirus UK Limited (“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, 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 primarily responsible for sales of RAPIVAB, other than U.S. Government stockpiling sales, and the Company’s commercial sales will be minimal. 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. 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 years ended December 31: 2015 2014 2013 Product sales, net $ 6,291 $ 33 $ — Royalty revenue 2,386 3,025 2,562 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 16,337 9,366 13,585 Green Cross Corporation 132 — — Shionogi (Japan) 1,184 1,184 1,184 Seqirus UK Limited 21,927 — — Total collaborative and other research and development revenues 39,580 10,550 14,769 Total revenues $ 48,257 $ 13,608 $ 17,331 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. Advertising and product promotion expenses were $103 and $290 for the years ended December 31, 2015 and 2014, respectively. |
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” has occurred. |
Interest Expense and Deferred Financing Costs [Policy Text Block] | Interest Expense and Deferred Financing Costs Interest expense for the years ended December 31, 2015, 2014 and 2013 was $5,200, $4,998 and $4,778, respectively, and relates to the issuance of the PhaRMA Notes. Costs directly associated with the issuance of the PhaRMA Notes have been capitalized and are included in other non-current assets on the Consolidated Balance Sheets. These costs are being amortized to interest expense over the term of the PhaRMA Notes using the effective interest rate method. Amortization of deferred financing costs included in interest expense was $439 for each of the years ended December 31, 2015, 2014 and 2013. |
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 years ended December 31, 2015, 2014 and 2013 resulted in a loss of $564 and gains of $5,487 and $5,294, respectively. Mark to market adjustments are determined by a third party pricing model which 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. In addition, a realized currency exchange gain of $1,654 was recognized in 2015 related to the exercise of a U.S. dollar/Japanese yen currency option under our foreign currency hedge. The Company is also required to post collateral in connection with the mark to market adjustments based on defined thresholds. As of December 31, 2015 and December 31, 2014, no hedge collateral was posted under the agreement. |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Share Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share is equivalent to basic net loss per share for all periods presented herein because common equivalent shares from unexercised stock options, outstanding warrants, and common shares expected to be issued under the Company’s employee stock purchase plan were anti-dilutive. The calculation of diluted earnings per share for the years ended December 31, 2015, 2014, and 2013 does not include 3,524, 3,991 and 1,430 respectively, of 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 to date 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 BCX4430 development expenses earned under cost-plus-fixed-fee contracts with BARDA/HHS and NIAID/HHS, respectively. The Company relies on BARDA/HHS and NIAID/HHS to reimburse predominantly all of the development costs for its RAPIVAB and BCX4430 programs. 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 BCX4430 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 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. 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. |
Note 1 - Significant Accounti20
Note 1 - Significant Accounting Policies and Concentrations of Risk (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Available-for-sale Securities [Table Text Block] | December 31, 2015 Amortized Accrued Gross Gross Estimated Obligations of 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 December 31, 2014 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 20,307 $ 22 $ — $ (23 ) $ 20,306 Corporate debt securities 27,152 151 5 (47 ) 27,261 Commercial paper 11,838 6 — (63 ) 11,781 Total investments $ 59,297 $ 179 $ 5 $ (133 ) $ 59,348 |
Available For Sale Securities Debt Maturities Fair Value [Table Text Block] | 2015 2014 Maturing in one year or less $ 22,664 $ 18,232 Maturing after one year through two years 28,395 25,459 Maturing after two years 19,288 15,657 Total investments $ 70,347 $ 59,348 |
Schedule of Receivables from Collaborations [Table Text Block] | 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 December 31, 2014 Billed Unbilled Total U.S. Department of Health and Human Services $ — $ 2,778 $ 2,778 Shionogi & Co. Ltd. 1,071 — 1,071 Total receivables $ 1,071 $ 2,778 $ 3,849 |
Schedule of Inventory, Current [Table Text Block] | As of December 31, 2015 2014 Work in process $ 1,612 $ 267 Finished goods — 416 Net inventories $ 1,612 $ 683 |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2015 2014 Compensation and benefits $ 424 $ 2,105 Development costs 10,398 4,232 Inventory 549 397 Professional fees 242 238 Duties and taxes 102 75 Other 4,522 4,282 Total accrued expenses $ 16,237 $ 11,329 |
Schedule of Revenues from Collaborations [Table Text Block] | 2015 2014 2013 Product sales, net $ 6,291 $ 33 $ — Royalty revenue 2,386 3,025 2,562 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 16,337 9,366 13,585 Green Cross Corporation 132 — — Shionogi (Japan) 1,184 1,184 1,184 Seqirus UK Limited 21,927 — — Total collaborative and other research and development revenues 39,580 10,550 14,769 Total revenues $ 48,257 $ 13,608 $ 17,331 |
Note 2 - Furniture and Equipm21
Note 2 - Furniture and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | 2015 2014 Furniture and fixtures $ 718 $ 542 Office equipment 1,122 1,115 Software 1,427 1,423 Laboratory equipment 6,004 5,786 Leased equipment 63 63 Leasehold improvements 5,610 5,303 Construction in progress 2,821 — Building 1,589 — 19,354 14,232 Less accumulated depreciation and amortization (14,205 ) (14,025 ) Property and equipment, net $ 5,149 $ 207 |
Note 4 - Lease Obligations an22
Note 4 - Lease Obligations and Other Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | 2016 $ 651 2017 871 2018 870 2019 820 2020 651 Thereafter 3,045 Total minimum payments $ 6,908 |
Note 6 - Stock-Based Compensa23
Note 6 - Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Year Ended December 31, 2015 2014 2013 Research and development $ 7,580 $ 8,906 $ 3,664 General and administrative 2,125 1,271 704 Total stock-based compensation expense $ 9,705 $ 10,177 $ 4,368 |
Schedule of Share-based Compensation, Activity [Table Text Block] | Awards Options Weighted Balance at December 31, 2012 2,815 8,073 $ 6.09 Restricted stock awards granted (310 ) — — Restricted stock awards cancelled 53 — — Stock option awards granted (3,277 ) 3,277 3.05 Stock option awards exercised — (563 ) 2.37 Stock option awards cancelled 1,801 (1,801 ) 7.22 Balance at December 31, 2013 1,082 8,986 4.99 Plan amendment 3,750 — — Restricted stock awards granted (593 ) — — Restricted stock awards cancelled — — — Stock option awards granted (1,965 ) 1,965 10.99 Stock option awards exercised — (1,258 ) 4.78 Stock option awards cancelled 88 (88 ) 8.83 Balance at December 31, 2014 2,362 9,605 6.21 Restricted stock awards granted (163 ) — — Restricted stock awards cancelled 1 — — Stock option awards granted (2,217 ) 2,217 11.52 Stock option awards exercised — (1,118 ) 4.36 Stock option awards cancelled 33 (33 ) 9.87 Balance at December 31, 2015 16 10,671 $ 7.50 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2015 2014 2013 Expected Life 5.5 5.5 4.7 Expected Volatility 81 % 87 % 84 % Expected Dividend Yield 0.0 % 0.0 % 0.0 % Risk-Free Interest Rate 1.6 % 1.6 % 0.7 % |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable [Table Text Block] | Outstanding Exercisable Range Number Weighted Weighted Number Weighted $ 0 to 3 1,826 6.4 $ 1.51 1,322 $ 1.55 3 to 6 2,792 6.1 4.63 2,329 4.53 6 to 9 1,153 4.5 7.10 1,070 7.13 9 to 12 3,728 8.1 11.07 714 11.45 12 to 15 1,077 6.4 12.44 374 12.65 15 to 18 95 9.5 15.39 — — $ 0 to 18 10,671 6.7 $ 7.50 5,809 $ 5.70 |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | Non-Vested Weighted Average Balance December 31, 2014 4,385 $ 4.27 Stock option awards granted 2,217 7.72 Stock option awards vested (1,711 ) 2.63 Stock option awards forfeited (28 ) 6.39 Balance December 31, 2015 4,863 $ 6.40 |
Note 7 - Income Taxes (Tables)
Note 7 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | 2015 2014 2013 Income tax benefit at federal statutory rate (35%) $ (15,057 ) $ (15,816 ) $ (10,538 ) State and local income taxes net of federal tax benefit (819 ) (1,286 ) (839 ) Permanent items 560 258 738 Rate change 1,012 22 1,892 Expiration of attribute carryforwards 330 373 242 Research and development tax credits (10,454 ) (748 ) (1,206 ) Orphan drug credit 4,307 — — Other (218 ) (115 ) 1,144 Change in valuation allowance 20,339 17,312 8,567 Income tax expense $ — $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | 2015 2014 Balance at January 1, $ 472 $ 284 Additions to current period tax positions 2,616 176 Additions to prior period tax positions — 12 Reductions to prior period tax provisions (3 ) — Balance at December 31, $ 3,085 $ 472 |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | 2015 2014 Deferred tax assets: Net federal and state operating losses $ 142,836 $ 135,922 Research and development credits 48,551 38,096 Fixed assets 1,054 1,073 Deferred revenue 4,240 3,798 Stock-based compensation 8,605 7,086 Other 2,590 1,178 Total deferred tax assets 207,876 187,153 Deferred tax liabilities: Foreign currency derivative (2,668 ) (2,285 ) Total deferred tax liabilities (2,668 ) (2,285 ) Valuation allowance (205,208 ) (184,868 ) Net deferred tax assets $ — $ — |
Note 10 - Quarterly Financial25
Note 10 - Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Quarterly Financial Information [Table Text Block] | First Second Third Fourth 2015 Quarters Revenues $ 6,826 $ 25,842 $ 10,987 $ 4,602 Net (Loss) Income (15,164 ) 4,901 (14,621 ) (18,135 ) Basic net (loss) income per share (0.21 ) 0.07 (0.20 ) (0.25 ) Diluted net (loss) income per share (0.21 ) 0.06 (0.20 ) (0.25 ) 2014 Quarters Revenues $ 3,458 $ 1,466 $ 3,238 $ 5,446 Net Loss (10,137 ) (14,649 ) (8,731 ) (11,672 ) Basic and diluted net loss per share (0.17 ) (0.23 ) (0.12 ) (0.16 ) |
Note 1 - Significant Accounti26
Note 1 - Significant Accounting Policies and Concentrations of Risk (Details Textual) - USD ($) shares in Thousands | Nov. 06, 2013 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Mar. 09, 2011 |
Currency Hedge Agreement [Member] | ||||||
Collateral Already Posted, Aggregate Fair Value | $ 0 | $ 0 | ||||
Foreign Exchange Contract [Member] | Not Designated as Hedging Instrument [Member] | ||||||
Derivative, Loss on Derivative | 564,000 | |||||
Derivative, Gain on Derivative | $ 1,654,000 | 5,487,000 | $ 5,294,000 | |||
JPR Royalty Sub LLC [Member] | ||||||
Revenue Recognition Royalty and Milestone Revenue Recognized | $ 30,000,000 | |||||
Maximum [Member] | ||||||
Maturity of Investments | 3 years | |||||
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 | |||||
Certificates of Deposit [Member] | ||||||
Restricted Cash and Cash Equivalents, Current | $ 150,000 | |||||
Royalty Receivable [Member] | ||||||
Restricted Cash and Cash Equivalents, Current | 59,000 | |||||
Collateral for Credit [Member] | ||||||
Restricted Cash and Cash Equivalents | $ 1,403,000 | |||||
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 | |||||
Building [Member] | ||||||
Property, Plant and Equipment, Useful Life | 10 years | |||||
Agreement [Member] | CSL [Member] | RAPIVABMember | Contingent upon EU Marketing Approval [Member] | ||||||
Proceeds from License Fees Received | $ 7,000,000 | |||||
Agreement [Member] | CSL [Member] | RAPIVABMember | Revenue from Sale of Inventory to be Recognized When the Inventory Transfer Is Complete [Member] | ||||||
Deferred Revenue, Additions | 3,740,000 | |||||
Agreement [Member] | CSL [Member] | RAPIVABMember | Regulatory Support Revenue for Canadian and EU Marketing Approvals, Portion Recognized Ratably Over Expected Period of Involvement [Member] | ||||||
Deferred Revenue, Additions | 1,223,000 | |||||
Agreement [Member] | CSL [Member] | RAPIVABMember | ||||||
Proceeds from License Fees Received | 33,740,000 | |||||
Revenues | 21,777,000 | |||||
Milestone Payment Maximum | $ 12,000,000 | |||||
RAPIVABMember | Customer Concentration Risk [Member] | Sales Revenue, Product Line [Member] | ||||||
Concentration Risk, Percentage | 90.00% | |||||
PhaRMA Notes Member] | ||||||
Interest Expense | $ 5,200,000 | 4,998,000 | 4,778,000 | |||
Reclassification from Accumulated Other Comprehensive Income, Current Period, before Tax | 13,000 | 0 | ||||
Amortization of Financing Costs | 439,000 | 439,000 | 439,000 | |||
Investments and Cash | 100,858,000 | |||||
Securities Offered | $ 10,000,000 | |||||
Restricted Cash and Cash Equivalents, Current | 1,612,000 | 150,000 | ||||
Revenues | 48,257,000 | 13,608,000 | 17,331,000 | |||
Advertising Expense | 103,000 | 290,000 | ||||
Interest Expense | $ 5,200,000 | $ 4,998,000 | $ 4,778,000 | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,524 | 3,991 | 1,430 |
Note 1 - Fair Value of the Comp
Note 1 - Fair Value of the Company's Investments by Type (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
US Government Agencies Debt Securities [Member] | ||
Amortized Cost | $ 26,557 | $ 20,307 |
Accrued Interest | $ 88 | $ 22 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | $ (99) | $ (23) |
Estimated Fair Value | 26,546 | 20,306 |
Corporate Debt Securities [Member] | ||
Amortized Cost | 21,820 | 27,152 |
Accrued Interest | $ 184 | 151 |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | $ (41) | (47) |
Estimated Fair Value | 21,963 | 27,261 |
Certificates of Deposit [Member] | ||
Amortized Cost | 21,884 | |
Accrued Interest | 21 | |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | (72) | |
Estimated Fair Value | 21,838 | |
Commercial Paper [Member] | ||
Amortized Cost | 11,838 | |
Accrued Interest | $ 6 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | $ (63) | |
Estimated Fair Value | 11,781 | |
Amortized Cost | 70,261 | 59,297 |
Accrued Interest | 293 | 179 |
Gross Unrealized Gains | 5 | 5 |
Gross Unrealized Losses | (212) | (133) |
Estimated Fair Value | $ 70,347 | $ 59,348 |
Note 1 - Scheduled Maturity for
Note 1 - Scheduled Maturity for the Company's Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Maturing in one year or less | $ 22,664 | $ 18,232 |
Maturing after one year through two years | 28,395 | 25,459 |
Maturing after two years | 19,288 | 15,657 |
Total investments | $ 70,347 | $ 59,348 |
Note 1 - Summary of Receivables
Note 1 - Summary of Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
US Department of Health and Human Services [Member] | Billed Revenues [Member] | ||
Receivables | ||
US Department of Health and Human Services [Member] | Unbilled Revenues [Member] | ||
Receivables | $ 5,536 | $ 2,778 |
US Department of Health and Human Services [Member] | ||
Receivables | 5,536 | 2,778 |
Shionogi and Co. Ltd [Member] | Billed Revenues [Member] | ||
Receivables | $ 469 | $ 1,071 |
Shionogi and Co. Ltd [Member] | Unbilled Revenues [Member] | ||
Receivables | ||
Shionogi and Co. Ltd [Member] | ||
Receivables | $ 469 | $ 1,071 |
CSL Limited [Member | Billed Revenues [Member] | ||
Receivables | 210 | |
CSL Limited [Member | Unbilled Revenues [Member] | ||
Receivables | 28 | |
CSL Limited [Member | ||
Receivables | 238 | |
Billed Revenues [Member] | ||
Receivables | 679 | 1,071 |
Unbilled Revenues [Member] | ||
Receivables | 5,564 | 2,778 |
Receivables | $ 6,243 | $ 3,849 |
Note 1 - Inventory (Details)
Note 1 - Inventory (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Work in process | $ 1,612,000 | $ 267,000 |
Finished goods | 416,000 | |
Net inventories | $ 1,612,000 | $ 683,000 |
Note 1 - Accrued Expenses (Deta
Note 1 - Accrued Expenses (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Development Cost [Member] | ||
Development costs | $ 10,398,000 | $ 4,232,000 |
Compensation and benefits | 424,000 | 2,105,000 |
Inventory | 549,000 | 397,000 |
Professional fees | 242,000 | 238,000 |
Duties and taxes | 102,000 | 75,000 |
Other | 4,522,000 | 4,282,000 |
Total accrued expenses | $ 16,237,000 | $ 11,329,000 |
Note 1 - Summary of Revenues (D
Note 1 - Summary of Revenues (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
US Department of Health and Human Services [Member] | |||
Collaborative and other research and development revenues: | |||
Collaborative and other research and development revenues | $ 16,337 | $ 9,366 | $ 13,585 |
Green Cross Corporation [Member] | |||
Collaborative and other research and development revenues: | |||
Collaborative and other research and development revenues | 132 | ||
Shionogi and Co. Ltd [Member] | |||
Collaborative and other research and development revenues: | |||
Collaborative and other research and development revenues | 1,184 | $ 1,184 | $ 1,184 |
CSL [Member] | |||
Collaborative and other research and development revenues: | |||
Collaborative and other research and development revenues | 21,927 | ||
Product sales, net | 6,291 | $ 33 | |
Royalty revenue | 2,386 | 3,025 | $ 2,562 |
Collaborative and other research and development revenues | 39,580 | 10,550 | 14,769 |
Revenues | $ 48,257 | $ 13,608 | $ 17,331 |
Note 2 - Furniture and Equipm33
Note 2 - Furniture and Equipment (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Depreciation, Depletion and Amortization | $ 180 | $ 177 | $ 304 |
Note 2 - Furniture and Equipm34
Note 2 - Furniture and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment, Gross | $ 718 | $ 542 |
Office Equipment [Member] | ||
Property, Plant and Equipment, Gross | 1,122 | 1,115 |
Software Development [Member] | ||
Property, Plant and Equipment, Gross | 1,427 | 1,423 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment, Gross | 6,004 | 5,786 |
Leased Equipment [Member] | ||
Property, Plant and Equipment, Gross | 63 | 63 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross | 5,610 | $ 5,303 |
Construction in Progress [Member] | ||
Property, Plant and Equipment, Gross | 2,821 | |
Building [Member] | ||
Property, Plant and Equipment, Gross | 1,589 | |
Property, Plant and Equipment, Gross | 19,354 | $ 14,232 |
Less accumulated depreciation and amortization | (14,205) | (14,025) |
Property and equipment, net | $ 5,149 | $ 207 |
Note 3 - Royalty Monetization (
Note 3 - Royalty Monetization (Details Textual) | Mar. 09, 2011USD ($) | Aug. 31, 2014USD ($) | Jun. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Sep. 30, 2013USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2014JPY (¥) | Sep. 30, 2014USD ($) | Sep. 03, 2013USD ($) |
PhaRMA Notes Member] | JPR Royalty Sub LLC [Member] | Currency Hedge Agreement [Member] | ||||||||||||
Collateral Already Posted, Aggregate Fair Value | $ 0 | $ 0 | ||||||||||
Maximum Amount of Collateral Required to Post | $ 9,750,000 | |||||||||||
PhaRMA Notes Member] | JPR Royalty Sub LLC [Member] | Shortfall 2013 [Member] | ||||||||||||
Interest Payable | $ 222,000 | |||||||||||
PhaRMA Notes Member] | JPR Royalty Sub LLC [Member] | Fair Value, Inputs, Level 2 [Member] | ||||||||||||
Notes Payable, Fair Value Disclosure | $ 30,000,000 | |||||||||||
PhaRMA Notes Member] | JPR Royalty Sub LLC [Member] | ||||||||||||
Private Placement of Senior Secured Notes | $ 30,000,000 | |||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 14.00% | 14.00% | ||||||||||
Interest Paid | $ 70,000 | $ 1,882,000 | $ 446,000 | $ 1,844,000 | ||||||||
Interest Payable | $ 2,356,000 | |||||||||||
PhaRMA Notes Member] | Currency Hedge Agreement [Member] | Japan, Yen [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 | |||||||||||
PhaRMA Notes Member] | JPR Royalty Sub LLC [Member] | ||||||||||||
Percentage of Carrying Amount in Excess of Fair Value | 50.00% | |||||||||||
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 | |||||||||||
Currency Hedge Agreement [Member] | ||||||||||||
Collateral Already Posted, Aggregate Fair Value | $ 0 | 0 | ||||||||||
Foreign Exchange Contract [Member] | Not Designated as Hedging Instrument [Member] | ||||||||||||
Derivative, Loss on Derivative | 564,000 | |||||||||||
Derivative, Gain on Derivative | $ 1,654,000 | $ 5,487,000 | $ 5,294,000 | |||||||||
JPR Royalty Sub LLC [Member] | ||||||||||||
Revenue Recognition Royalty and Milestone Revenue Recognized | $ 30,000,000 |
Note 4 - Lease Obligations an36
Note 4 - Lease Obligations and Other Contingencies (Details Textual) | 12 Months Ended | ||
Dec. 31, 2015USD ($)ft² | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Birmingham Research Facility [Member] | Leasehold Improvements [Member] | |||
Property, Plant and Equipment, Gross | $ 1,589,000 | ||
Birmingham Research Facility [Member] | Long Term Liabilities [Member] | |||
Lease Financing Obligation, Net of Current | 2,375,000 | ||
Birmingham Research Facility [Member] | |||
Operating Leases, Future Minimum Payments Due | 4,839,000 | ||
Leasehold Improvements [Member] | |||
Property, Plant and Equipment, Gross | $ 5,610,000 | $ 5,303,000 | |
Area of Real Estate Property | ft² | 32,000 | ||
Operating Leases, Future Minimum Payments Due | 6,908,000 | ||
Operating Leases, Rent Expense, Net | $ 664,000 | 633,000 | $ 526,000 |
Property, Plant and Equipment, Gross | 19,354,000 | $ 14,232,000 | |
Lease Financing Obligation, Net of Current | $ 2,375 |
Note 4 - Minimum Payments under
Note 4 - Minimum Payments under Operating Lease Obligations (Details) $ in Thousands | Dec. 31, 2014USD ($) |
2,016 | $ 651 |
2,017 | 871 |
2,018 | 870 |
2,019 | 820 |
2,020 | 651 |
Thereafter | 3,045 |
Total minimum payments | $ 6,908 |
Note 5 - Stockholders' Equity (
Note 5 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, shares in Thousands | Jun. 03, 2014 | Aug. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Mar. 03, 2015 | Jun. 30, 2014 | Nov. 06, 2013 | Jul. 13, 2011 |
Maximum Aggregate Offering Price | $ 150,000,000 | $ 125,000,000 | ||||||||
Issuance of common stock, shares (in shares) | 11,500 | 4,600 | 2,883 | 4,516 | ||||||
Proceeds from Issuance of Common Stock | $ 115,000,000 | $ 18,500,000 | $ 106,600,000 | $ 23,633,000 | $ 17,805,000 | |||||
Proceeds from Issuance or Sale of Equity | $ 107,800,000 | |||||||||
Remaining Aggregate Offering Price | $ 10,000,000 | |||||||||
Share Price | $ 4.40 | $ 1.85 | $ 4.08 | |||||||
Stock Issued During Period Shares for over Allotment Option Exercised by Underwriter | 600 | |||||||||
Common Stock to be Issued, Value | $ 70,000,000 | |||||||||
Common Stock, Value, Issued | $ 734,000 | $ 720,000 | $ 70,000,000 | |||||||
Proceeds from Issuance of Shares under Incentive and Share-based Compensation Plans, Including Stock Options | $ 5,218,000 |
Note 6 - Stock-Based Compensa39
Note 6 - Stock-Based Compensation (Details Textual) $ / shares in Units, shares in Thousands | 1 Months Ended | 12 Months Ended | |||
Aug. 31, 2013shares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | Dec. 31, 2013USD ($)$ / sharesshares | Dec. 31, 2012shares | |
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] | Stock Options and Restricted Stock [Member] | Vest 50% Each Year Until Fully Vested [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 50.00% | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 2 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 | 1,032 | 1,250 | |||
Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 0 | ||||
Allocated Share-based Compensation Expense | $ 9,485,000 | $ 9,963,000 | $ 4,253,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 5 years | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 7.72 | $ 8.02 | $ 1.28 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 10,117,000 | $ 8,522,000 | $ 738,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | 28,511,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 4,492,000 | 2,844,000 | 3,483,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | shares | 9,633 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ / shares | $ 7.51 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 6 years 219 days | ||||
Employee Stock Purchase Plan [Member] | |||||
Allocated Share-based Compensation Expense | $ 220,000 | $ 214,000 | $ 115,000 | ||
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 | 497 | ||||
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 | $ 25,000 | ||||
Employee stock purchase plan sales, shares (in shares) | shares | 41 | 49 | 89 | ||
Employee Stock Ownership Plan (ESOP), Weighted Average Purchase Price of Shares Purchased | $ / shares | $ 8.65 | $ 6.29 | $ 1.39 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 4.93 | $ 4.41 | $ 1.27 | ||
Number of Stock-based Compensation Plans | 2 | ||||
Allocated Share-based Compensation Expense | $ 9,705,000 | $ 10,177,000 | $ 4,368,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 2,217 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 7.72 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 18,607,000 | ||||
Employee Service Share-based Compensation Nonvested Awards Compensation Cost Expected to be Recognized For Remainder of Fiscal Year | 7,023,000 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Two | 6,010,000 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Three | 3,891,000 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Four | $ 1,683,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | shares | 16 | 2,362 | 1,082 | 2,815 |
Note 6 - Stock-based Compensa40
Note 6 - Stock-based Compensation Allocation (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Research and Development Expense [Member] | |||
Allocated Share-based Compensation Expense | $ 7,580,000 | $ 8,906,000 | $ 3,664,000 |
General and Administrative Expense [Member] | |||
Allocated Share-based Compensation Expense | 2,125,000 | 1,271,000 | 704,000 |
Allocated Share-based Compensation Expense | $ 9,705,000 | $ 10,177,000 | $ 4,368,000 |
Note 6 - Stock Incentive Plan A
Note 6 - Stock Incentive Plan Activities (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Awards Available (in shares) | 2,362 | 1,082 | 2,815 |
Options Outstanding (in shares) | 9,605 | 8,986 | 8,073 |
Weighted Average Exercise Price (in dollars per share) | $ 6.09 | ||
Restricted stock awards granted (in shares) | (163) | (593) | (310) |
Restricted stock awards cancelled (in shares) | 1 | 53 | |
Stock option awards granted (in shares) | (2,217) | (1,965) | (3,277) |
Stock option awards granted (in shares) | 2,217 | 1,965 | 3,277 |
Stock option awards granted (in dollars per share) | $ 11.52 | $ 10.99 | $ 3.05 |
Stock option awards exercised (in shares) | (1,118) | (1,258) | (563) |
Stock option awards exercised (in dollars per share) | $ 4.36 | $ 4.78 | $ 2.37 |
Stock option awards cancelled (in shares) | 33 | 88 | 1,801 |
Stock option awards cancelled (in shares) | (33) | (88) | (1,801) |
Stock option awards cancelled (in dollars per share) | $ 9.87 | $ 8.83 | $ 7.22 |
Awards Available (in shares) | 16 | 2,362 | 1,082 |
Options Outstanding (in shares) | 10,671 | 9,605 | 8,986 |
Weighted Average Exercise Price (in dollars per share) | $ 7.50 | $ 6.21 | $ 4.99 |
Plan amendment (in shares) | 3,750 |
Note 6 - Weighted Average Assum
Note 6 - Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors under the Incentive Plan (Details) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Expected Life | 5 years 182 days | 5 years 182 days | 4 years 255 days |
Expected Volatility | 81.00% | 87.00% | 84.00% |
Expected Dividend Yield | 0.00% | 0.00% | 0.00% |
Risk-Free Interest Rate | 1.60% | 1.60% | 0.70% |
Note 6 - Number of Stock Option
Note 6 - Number of Stock Option Awards Exercisable and their Weighted Average Exercise Price (Details) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Exercise Price Range 01 [Member] | |
Upper Exercise Price Range (in dollars per share) | $ / shares | $ 1,826 |
Outstanding Number (in shares) | shares | 6,400 |
Outstanding Weighted Average Remaining Life | 1 year 186 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 1,322 |
Exercisable Number (in shares) | shares | 1,550 |
Exercise Price Range 02 [Member] | |
Upper Exercise Price Range (in dollars per share) | $ / shares | $ 2,792 |
Outstanding Number (in shares) | shares | 6,100 |
Outstanding Weighted Average Remaining Life | 4 years 229 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 2,329 |
Exercisable Number (in shares) | shares | 4,530 |
Exercise Price Range 03 [Member] | |
Upper Exercise Price Range (in dollars per share) | $ / shares | $ 1,153 |
Outstanding Number (in shares) | shares | 4,500 |
Outstanding Weighted Average Remaining Life | 7 years 36 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 1,070 |
Exercisable Number (in shares) | shares | 7,130 |
Exercise Price Range 04 [Member] | |
Upper Exercise Price Range (in dollars per share) | $ / shares | $ 3,728 |
Outstanding Number (in shares) | shares | 8,100 |
Outstanding Weighted Average Remaining Life | 11 years 25 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 714 |
Exercisable Number (in shares) | shares | 11,450 |
Exercise Price Range 05 [Member] | |
Upper Exercise Price Range (in dollars per share) | $ / shares | $ 1,077 |
Outstanding Number (in shares) | shares | 6,400 |
Outstanding Weighted Average Remaining Life | 12 years 160 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 374 |
Exercisable Number (in shares) | shares | 12,650 |
Exercise Price Range 06 [Member] | |
Upper Exercise Price Range (in dollars per share) | $ / shares | $ 95 |
Outstanding Number (in shares) | shares | 9,500 |
Outstanding Weighted Average Remaining Life | 15 years 142 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ / shares | |
Exercisable Number (in shares) | shares | |
Upper Exercise Price Range (in dollars per share) | $ / shares | $ 10,671 |
Outstanding Number (in shares) | shares | 6,700 |
Outstanding Weighted Average Remaining Life | 7 years 182 days |
Outstanding Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 5,809 |
Exercisable Number (in shares) | shares | 5,700 |
Note 6 - Changes in the Number
Note 6 - Changes in the Number and Weighted-Average Grant-Date Fair Value (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Non-vested stock option awards (in shares) | shares | 4,385 |
Weighted average grant-date fair value (in dollars per share) | $ / shares | $ 4.27 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 2,217 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 7.72 |
Stock option awards vested (in shares) | shares | (1,711) |
Stock option awards vested (in dollars per share) | $ / shares | $ 2.63 |
Stock option awards forfeited (in shares) | shares | (28) |
Stock option awards forfeited (in dollars per share) | $ / shares | $ 6.39 |
Non-vested stock option awards (in shares) | shares | 4,863 |
Weighted average grant-date fair value (in dollars per share) | $ / shares | $ 6.40 |
Note 7 - Income Taxes (Details
Note 7 - Income Taxes (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards | $ 386,219,000 | ||
State and Local Jurisdiction [Member] | |||
Operating Loss Carryforwards | 373,454,000 | ||
Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | 48,551,000 | ||
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued | 0 | $ 0 | $ 0 |
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Amount | 20,339,000 | $ 17,312,000 | $ 8,567,000 |
Employee Service Share-based Compensation, Tax Benefit Realized from Exercise of Stock Options | $ 15,655,000 |
Note 7 - Differences Between th
Note 7 - Differences Between the Company's Effective Tax Rate and the Statutory Tax Rate (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income tax benefit at federal statutory rate (35%) | $ (15,057,000) | $ (15,816,000) | $ (10,538,000) |
State and local income taxes net of federal tax benefit | (819,000) | (1,286,000) | (839,000) |
Permanent items | 560,000 | 258,000 | 738,000 |
Rate change | 1,012,000 | 22,000 | 1,892,000 |
Expiration of attribute carryforwards | 330,000 | 373,000 | 242,000 |
Research and development tax credits | (10,454,000) | $ (748,000) | $ (1,206,000) |
Orphan drug credit | 4,307,000 | ||
Other | (218,000) | $ (115,000) | $ 1,144,000 |
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Amount | $ 20,339,000 | $ 17,312,000 | $ 8,567,000 |
Income tax expense |
Note 7 - Differences Between 47
Note 7 - Differences Between the Company's Effective Tax Rate and the Statutory Tax Rate (Details) (Parentheticals) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income tax benefit at federal statutory rate | 35.00% | 35.00% | 35.00% |
Note 7 - Reconciliation of Begi
Note 7 - Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Balance at | $ 472 | $ 284 |
Additions to current period tax positions | $ 2,616 | 176 |
Additions to prior period tax positions | 12 | |
Balance at | $ 3,085 | $ 472 |
Note 7 - Components of Deferred
Note 7 - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Net federal and state operating losses | $ 142,836 | $ 135,922 |
Research and development credits | 48,551 | 38,096 |
Fixed assets | 1,054 | 1,073 |
Deferred revenue | 4,240 | 3,798 |
Stock-based compensation | 8,605 | 7,086 |
Other | 2,590 | 1,178 |
Total deferred tax assets | 207,876 | 187,153 |
Foreign currency derivative | (2,668) | (2,285) |
Total deferred tax liabilities | (2,668) | (2,285) |
Valuation allowance | $ (205,208) | $ (184,868) |
Net deferred tax assets |
Note 8 - Employee 401(k) Plan (
Note 8 - Employee 401(k) Plan (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 366 | $ 361 | $ 313 |
Note 9 - Collaborative and Ot51
Note 9 - Collaborative and Other Research and Development Contracts (Details Textual) - USD ($) $ in Thousands | Jun. 16, 2015 | Sep. 30, 2013 | Feb. 24, 2011 | May. 31, 2010 | Sep. 30, 2009 | Jan. 31, 2007 | Jun. 30, 2006 | Feb. 28, 2006 | Sep. 30, 2015 | Dec. 31, 2015 | Feb. 24, 2011 | Mar. 31, 2015 | Nov. 11, 2011 | Dec. 31, 2007 |
US Department of Health and Human Services [Member] | ||||||||||||||
Collaborative Agreement Contract Value | $ 102,661 | |||||||||||||
Collaborative Agreement Additional Contract Value | $ 55,000 | $ 77,191 | ||||||||||||
Collaborative Agreement Adjusted Contract Value | $ 234,852 | |||||||||||||
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 | $ 34,002 | |||||||||||||
Collaborative Agreement Period of Contract | 5 years | |||||||||||||
Collaboration Agreement Additional Payments Received | $ 29,875 | |||||||||||||
UAB [Member] | ||||||||||||||
Period of Agreement | 25 years | |||||||||||||
Renewable Period of Agreement | 5 years | |||||||||||||
Base Contract [Member] | ||||||||||||||
Government Contract Receivable | $ 13,314 | |||||||||||||
Additional Development Options [Member] | ||||||||||||||
Government Contract Receivable | 22,855 | |||||||||||||
ASPRBARDA Contract [Member] | ||||||||||||||
Government Contract Receivable | $ 36,169 | |||||||||||||
Proceeds from awards for Research and Development Contracts | $ 16,300 | |||||||||||||
Green Cross Corporation [Member] | ||||||||||||||
Proceeds from License Fees Received | $ 250 | |||||||||||||
Mundipharma [Member] | Upfront Payment [Member] | ||||||||||||||
Deferred Revenue | $ 10,000 | |||||||||||||
Mundipharma [Member] | Clinical Trial 2007 [Member] | ||||||||||||||
Deferred Revenue | $ 5,000 | |||||||||||||
Mundipharma [Member] | ||||||||||||||
Upfront Payments Receivable Amount | $ 10,000 | |||||||||||||
Potential Milestone Payments Receivable | $ 15,000 | |||||||||||||
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 | |||||||||||||
Stock Issued During Period, Value, for Modification of License Agreement | $ 5,911 | |||||||||||||
Payments for Modification of License Agreement | $ 90 | |||||||||||||
CSL Limited [Member | ||||||||||||||
Proceeds from License Fees Received | $ 33,740 | |||||||||||||
Milestone Payment Maximum | $ 12,000 | |||||||||||||
Royalty Term | 10 years |
Note 10 - Quarterly Financial52
Note 10 - Quarterly Financial Information (Unaudited) (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | |
Revenues | $ 4,602 | $ 10,987 | $ 25,842 | $ 6,826 |
Net loss | $ (18,135) | $ (14,621) | $ 4,901 | $ (15,164) |
Basic net (loss) income per share (in dollars per share) | $ (0.25) | $ (0.20) | $ 0.07 | $ (0.21) |
Diluted net (loss) income per share (in dollars per share) | $ (0.25) | $ (0.20) | $ 0.06 | $ (0.21) |