Significant Accounting Policies [Text Block] | Note 1 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 oral treatments for rare diseases in which significant unmet medical needs exist and that align with its capabilities and expertise. The Company was incorporated in Delaware in 1986 With the funds available at March 31, 2017, 2018. 2017 2017 may (1) (2) (3) (4) (5) one (6) may 3 March 3, 2015. Basis of Presentation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, JPR Royalty Sub LLC (“Royalty Sub”) and MDCP, LLC (“MDCP”). Both subsidiaries were formed to facilitate financing transactions for the Company. Royalty Sub was formed in connection with a $30,000 March 9, 2011. 4, $23,000 September 23, 2016. 5, The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and the instructions to Form 10 These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2016 2016 10 December 31, 2016 10 Cash and Cash Equivalents The Company generally considers cash equivalents to be all cash held in commercial checking accounts, certificates of deposit, money market accounts or investments in debt instruments with maturities of three Restricted Cash Restricted cash as of March 31, 2017 $1,391 4) $1,407 Investments The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may three 18 may may 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 three 12 12 March 31, 2017, The following tables summarize the fair value of the Company’s investments by type. The estimated fair values of the Company’s fixed income investments are classified as Level 2 2 March 31, 2017 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 7,312 $ 27 $ — $ (5 ) $ 7,334 Corporate debt securities 6,171 21 — (4 ) 6,188 Certificates of deposit 13,775 24 11 (5 ) 13,805 Total investments $ 27,258 $ 72 $ 11 $ (14 ) $ 27,327 December 31, 2016 Amortized Accrued Gross Gross Estimated Obligations of the U.S. Government and its agencies $ 20,266 $ 34 $ 2 $ (4 ) $ 20,298 Corporate debt securities 6,179 26 2 (8 ) 6,199 Certificates of deposit 14,962 17 7 (11 ) 14,975 Total investments $ 41,407 $ 77 $ 11 $ (23 ) $ 41,472 The following table summarizes the scheduled maturity for the Company’s investments at March 31, 2017 December 31, 2016. 2017 2016 Maturing in one year or less $ 23,524 $ 32,546 Maturing after one year through two years 3,803 8,926 Total investments $ 27,327 $ 41,472 Receivables from Collaborations Receivables from collaborations are recorded for amounts due to the Company related to reimbursable research and development costs from the U.S. Department of Health and Human Services, royalty receivables from Shionogi, Green Cross Corporation (“Green Cross”) and Seqirus UK Limited (“SUL”), and product sales to SUL. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. At March 31, 2017 December 31, 2016, March 31, 2017 Billed Unbilled Total U.S. Department of Health and Human Services $ 114 $ 2,186 $ 2,300 Shionogi & Co. Ltd. 5,834 — 5,834 Green Cross Corporation 382 — 382 Seqirus UK Limited 891 157 1,048 Total receivables $ 7,221 $ 2,343 $ 9,564 December 31, 2016 Billed Unbilled Total U.S. Department of Health and Human Services $ — $ 3,495 $ 3,495 Shionogi & Co. Ltd. 3,451 — 3,451 Green Cross Corporation 686 — 686 Seqirus UK Limited 957 179 1,136 Total receivables $ 5,094 $ 3,674 $ 8,768 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 March 31, 2017 December 31, 2016, first first During 2014, The Company’s inventory consisted of the following at March 31, 2017 December 31, 2016: 2017 2016 Work in process $ 655 $ 500 Inventories $ 655 $ 500 Property and Equipment Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Computer equipment is depreciated over a life of three five seven 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 Patents and Licenses The Company seeks patent protection on all internally developed processes and products. All patent related costs are expensed to general and administrative expenses when incurred as recoverability of such expenditures is uncertain. Accrued Expenses The Company generally enters into contractual agreements with third • fees paid to Contract Research Organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; • fees paid to investigative sites in connection with clinical trials; • fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance and drug products; and • professional fees. The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may March 31, 2017 December 31, 2016, 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. No reclassifications out of accumulated other comprehensive loss were recorded during the three March 31, 2017 March 31, 2016. 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 third may In June 2015, three $33,740 $7,000 $21,777 2015. $3,740 2015, $1,223 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 $10,000 2010 17, Milestone Method of Revenue Recognition first 2017, first 2016. 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 the Company’s specialty distributors, utilizing the Sell-Through revenue recognition methodology. Product sales are recognized when there is persuasive evidence that an arrangement exists, title has passed, the price is fixed and determinable, and collectability is reasonably assured. Product sales are recognized net of estimated allowances, discounts, sales returns, chargebacks and rebates. In the United States, and prior to the SUL Agreement, the Company sold RAPIVAB to specialty distributors, who in turn, sell to physician offices, hospitals and federal, state and commercial health care organizations. With the completion of the SUL worldwide license of RAPIVAB, SUL will be responsible for sales of RAPIVAB, other than U.S. Government stockpiling sales. With the completion of the SUL collaboration, all peramivir sales (i.e., RAPIVAB, RAPIACTA ® ® 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 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 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 nine may may Discounts and Sales Incentives Discounts and other sales incentives primarily consist of Inventory Management Agreement (“IMA”) fees. Per contractual agreements with the Company’s specialty distributors, the Company provides an IMA fee based on a percentage of their purchases of RAPIVAB. The IMA fee rates are set forth in individual contracts. The Company tracks sales to these distributors each period and accrues a liability relating to the unpaid portion of these fees by applying the contractual rates to such product sales. With the completion of the SUL collaboration, all peramivir sales (i.e., RAPIVAB, RAPIACTA, and PERAMIFLU) will be made by the Company’s partners, except for U.S. Government stockpiling sales, and the Company will be reliant on these partners to generate sales and to provide for discounts and sales incentives. Product Returns The Company does not record a product return allowance as it does not offer the ability to return goods once a bona fide shipment has been accepted by a specialty distributor. The Company recorded the following revenues for the three March 31, 2017 2016: 2017 2016 Royalty revenue $ 6,321 $ 1,890 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 654 2,324 Shionogi & Co., Ltd. 296 296 Seqirus UK Limited 2,166 310 Total collaborative and other research and development revenues 3,116 2,930 Total revenues $ 9,437 $ 4,820 Advertising The Company engages in very limited distribution and direct-response advertising when promoting RAPIVAB. Advertising and promotional costs are expensed as the costs are incurred. Research and Development Expenses The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third Additionally, the Company has license agreements with third Deferred collaboration expenses represent sub-license payments, paid to the Company’s academic partners upon receipt of consideration from various commercial partners, and other consideration paid to the Company’s academic partners for modification to existing license agreements. These deferred expenses would not have been incurred without receipt of such payments or modifications from the Company’s commercial partners and are being expensed in proportion to the related revenue being recognized. The Company believes that this accounting treatment appropriately matches expenses with the associated revenue. Stock-Based Compensation All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in the Company’s Consolidated Statements of Comprehensive Loss based on their fair values. The fair value of stock option awards is estimated using the Black-Scholes option pricing model. The fair value of restricted stock unit awards is based on the grant date closing price of the common stock. Stock-based compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. In addition, we have outstanding performance-based stock options for which no compensation expense is recognized until “performance” is deemed to have occurred. Interest Expense and Deferred Financing Costs Interest expense for the three March 31, 2017 2016 $2,020 $1,338, 4) 5). $220 $110 three March 31, 2017 2016, Lease Financing Obligation Based on the terms of the lease agreement for the new research facility in Birmingham, Alabama, the Company had construction period risks during the construction period and the Company was deemed the owner of the building (for accounting purposes only) during the construction period. Accordingly, the Company recorded an asset of $1,589 December 31, 2015, 2016, 20.5 three March 31, 2017 2016 $80 $132, At each of March 31, 2017 December 31, 2016, $2,704 March 31, 2017 $4,662. 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 three March 31, 2017 2016 $1,543 $2,753, third 2 March 31, 2017 December 31, 2016, Net Loss Per Share Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share is equivalent to basic net loss per share for all periods presented herein because common equivalent shares from unexercised stock options and common shares expected to be issued under the Company’s employee stock purchase plan were anti-dilutive. The calculation of diluted earnings per share for the three March 31, 2017 2016 2,762 1,330, 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. Significant Customers and Other Risks Significant Customers Prior to the SUL Agreement, the Company relied primarily on three three 90% one Other than royalty revenues, the Company’s primary source of revenue that has an underlying cash flow stream is the reimbursement of RAPIVAB and galidesivir (formerly BCX4430) June 30, 2014 third Risks from Third Party Manufacturing and Distribution Concentration The Company relies on single source manufacturers for active pharmaceutical ingredient and finished drug product manufacturing of product candidates in development. Delays in the manufacture or distribution of any product could adversely impact the commercial revenue and future procurement stockpiling of the Company’s product candidates in development. Credit Risk Cash equivalents and investments are financial instruments which potentially subject the Company to concentration of risk to the extent recorded on the Consolidated Balance Sheets. The Company deposits excess cash with major financial institutions in the United States. Balances may 18 Going Concern The Company’s liquidity needs will be largely determined by the success of operations in regards to the progression of its product candidates in the future. The Company’s plans to alleviate the doubt of its going concern, which are probable of effectively being implemented and mitigating these conditions, primarily include its ability to control the timing and spending on its research and development programs and raising additional funds through equity financings. The Company also may (1) (2) (3) (4) (5) one (6) may 3 March 3, 2015. Recent Accounting Pronouncements In November 2016 2016 18: Statement of Cash Flows (Topic 230): 2016 18”). December 15, 2017, In August 2016, 2016 15: Statement of Cash Flows (Topic 230): 2016 15”). one 2016 15 December 15, 2017, In March 2016, 2016 09: Compensation - Stock Compensation (Topic 718): 2016 09”). ASU 2016 09 2016 09, January 1, 2017, 2016 09. January 1, 2017 March 31, 2017 The Company elected not to change its policy on accounting for forfeitures and continues to estimate the total number of awards for which the requisite service period will not be rendered. The Company adopted ASU 2016 09 January 1, 2017. 2016 09 In February 2016, 2016 02: Leases (Topic 842) 2016 02”). 12 2016 02 2019, In January 2016, 2016 01: Financial Instruments - Overall (Subtopic 825 10): 2016 01”). 2016 01 2018, In July 2015, 2015 11: Inventory (Topic 330): 2015 11”), 2015 11 first first first 2015 11 December 15, 2016. 2015 11 January 1, 2017. In May 2014, 2014 09: Revenue from Contracts with Customers (Topic 606) 2014 09”), 2014 09 July 2015, one January 1, 2018; January 1, 2017. 2017. January 1, 2018. |