Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | Apr. 30, 2021 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0000882796 | |
Entity Registrant Name | BIOCRYST PHARMACEUTICALS INC | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2021 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
Document Transition Report | false | |
Entity File Number | 000-23186 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 62-1413174 | |
Entity Address, Address Line One | 4505 Emperor Blvd., Suite 200 | |
Entity Address, City or Town | Durham | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27703 | |
City Area Code | 919 | |
Local Phone Number | 859-1302 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | BCRX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 177,696,474 |
Consolidated Balance Sheets (Cu
Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Assets | ||
Cash and cash equivalents | $ 226,902 | $ 272,127 |
Restricted cash | 4,008 | 2,221 |
Investments | 13,454 | 28,239 |
Trade receivables | 18,386 | 8,646 |
Inventories | 5,113 | 7,039 |
Prepaid expenses and other current assets | 5,908 | 5,528 |
Total current assets | 273,771 | 323,800 |
Property and equipment, net | 7,035 | 7,113 |
Other assets | 3,625 | 3,802 |
Total assets | 284,431 | 334,715 |
Liabilities and Stockholders’ Equity | ||
Accounts payable | 13,529 | 18,713 |
Accrued expenses | 32,719 | 33,942 |
Interest payable | 23,547 | 21,670 |
Deferred collaboration revenue | 405 | 150 |
Lease financing obligation | 1,001 | 1,179 |
Non-recourse notes payable | 30,000 | 30,000 |
Total current liabilities | 101,201 | 105,654 |
Lease financing obligation | 3,883 | 3,871 |
Royalty financing obligation | 131,296 | 124,717 |
Secured term loan | 123,039 | 119,735 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; shares authorized - 5,000; no shares issued and outstanding | 0 | 0 |
Common stock, $0.01 par value: shares authorized - 450,000; shares issued and outstanding – 177,670 in 2021 and 176,883 in 2020 | 1,777 | 1,769 |
Additional paid-in capital | 1,010,779 | 1,002,408 |
Accumulated other comprehensive income | 182 | 3 |
Accumulated deficit | (1,087,726) | (1,023,442) |
Total stockholders’ equity | (74,988) | (19,262) |
Total liabilities and stockholders’ equity | $ 284,431 | $ 334,715 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares shares in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000 | 5,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 450,000 | 450,000 |
Common stock, shares issued (in shares) | 177,670 | 176,883 |
Common stock, shares outstanding (in shares) | 177,670 | 176,883 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenues: | ||
Revenues | $ 19,059 | $ 4,823 |
Expenses | ||
Cost of product sales | 5,923 | 0 |
Research and development | 42,435 | 29,867 |
Selling, general and administrative | 22,114 | 15,865 |
Royalty | (36) | 69 |
Total operating expenses | 70,436 | 45,801 |
Loss from operations | (51,377) | (40,978) |
Interest and other income | 26 | 6,446 |
Interest expense | (12,904) | (3,047) |
Loss on foreign currency | (29) | (20) |
Net loss | (64,284) | (37,599) |
Foreign currency translation adjustment | 178 | 0 |
Unrealized gain (loss) on available for sale investments | 1 | (25) |
Comprehensive loss | $ (64,105) | $ (37,624) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.36) | $ (0.24) |
Weighted average shares outstanding (in shares) | 177,343 | 154,156 |
Product [Member] | ||
Revenues: | ||
Revenues | $ 17,871 | $ 218 |
Royalty [Member] | ||
Revenues: | ||
Revenues | (897) | 1,945 |
Collaborative and Other Research and Development [Member] | ||
Revenues: | ||
Revenues | $ 2,085 | $ 2,660 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Net loss | $ (64,284) | $ (37,599) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 178 | 218 |
Stock-based compensation expense | 5,479 | 2,754 |
Non-cash interest expense on royalty financing obligation | 7,536 | 0 |
Non-cash paid in-kind interest on secured term loan | 3,549 | 0 |
Amortization of debt issuance costs | (58) | 341 |
Amortization of premium/discount on investments | 14 | 4 |
Change in fair value of foreign currency derivative | 0 | 20 |
Changes in operating assets and liabilities: | ||
Receivables | (261) | 16,504 |
Inventory | 1,927 | 0 |
Prepaid expenses and other assets | (9,850) | (847) |
Accounts payable, accrued expenses and other liabilities | (7,373) | (5,100) |
Interest payable | 1,877 | 1,477 |
Deferred revenue | 255 | (1,053) |
Net cash used in operating activities | (61,011) | (23,281) |
Investing activities | ||
Acquisitions of property and equipment | (99) | (116) |
Sales and maturities of investments | 14,771 | 10,840 |
Realized gain on investments | 1 | 0 |
Net cash provided by investing activities | 14,673 | 10,724 |
Financing activities | ||
Net proceeds from common stock issued under stock-based compensation plans | 2,900 | 266 |
Net cash provided by financing activities | 2,900 | 266 |
Decrease in cash, cash equivalents and restricted cash | (43,438) | (12,291) |
Cash, cash equivalents and restricted cash at beginning of period | 274,348 | 115,723 |
Cash, cash equivalents and restricted cash at end of period | $ 230,910 | $ 103,432 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2019 | $ 1,541 | $ 877,300 | $ 39 | $ (840,628) | $ 38,252 |
Net loss | (37,599) | (37,599) | |||
Other comprehensive income (loss) | 0 | 0 | (25) | 0 | (25) |
Exercise of stock options, net | 1 | 265 | 266 | ||
Stock-based compensation expense | 2,754 | 2,754 | |||
Balance at Mar. 31, 2020 | 1,542 | 880,319 | 14 | (878,227) | 3,648 |
Balance at Dec. 31, 2020 | 1,769 | 1,002,408 | 3 | (1,023,442) | (19,262) |
Net loss | (64,284) | (64,284) | |||
Other comprehensive income (loss) | 179 | 179 | |||
Employee stock purchase plan sales, net | 2 | 721 | 723 | ||
Exercise of stock options, net | 6 | 2,171 | 0 | 0 | 2,177 |
Stock-based compensation expense | 5,479 | 5,479 | |||
Balance at Mar. 31, 2021 | $ 1,777 | $ 1,010,779 | $ 182 | $ (1,087,726) | $ (74,988) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) (Parentheticals) shares in Thousands | 3 Months Ended |
Mar. 31, 2021shares | |
Employee stock purchase plan sales, shares (in shares) | 193 |
Exercise of stock options, shares (in shares) | 593 |
Note 1 - Significant Accounting
Note 1 - Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 1 The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a commercial-stage biotechnology company that discovers novel, oral, small-molecule medicines. The Company focuses on the treatment of rare diseases in which significant unmet medical needs exist and an enzyme plays the key role in the biological pathway of the disease. The Company was founded in 1986 1991, Based on the Company’s expectations for revenue, operating expenses, and its option to access an additional $75 million from its existing credit facility, the Company believes its financial resources available at March 31, 2021 2023. 2021 2021 may 1 2 3 4 5 one 6 may Basis of Presentation The consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany transactions and balances among the consolidated entities have been eliminated from the consolidated financial statements. 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 not no These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2020 2020 10 not December 31, 2020 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, 2021 December 31, 2020 2 Investments The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may three no may may not not not The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not three March 31, 2021, The following tables summarize the fair value of the Company’s investments by type. The estimated fair values of the Company’s fixed income investments are classified as Level 2 not not 2 March 31, 2021 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 10,675 $ 6 $ 3 $ - $ 10,684 Certificates of deposit 2,758 11 1 - 2,770 Total investments $ 13,433 $ 17 $ 4 $ - $ 13,454 December 31, 2020 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 24,986 $ 14 $ 3 $ (3 ) $ 25,000 Certificates of deposit 3,225 11 3 - 3,239 Total investments $ 28,211 $ 25 $ 6 $ (3 ) $ 28,239 The Company’s investments at March 31, 2021 December 31, 2020 one Trade Receivables Product Sales Receivables from product sales are recorded for amounts due to the Company related to sales of ORLADEYO™ and RAPIVAB®. At March 31, 2021 December 31, 2020, March 31, 2021 December 31, 2020, March 31, 2021 December 31, 2020, 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 Mundipharma International Holdings Limited (“Mundipharma”). These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date based on historical collection experience or specific circumstances, and no amounts were recorded at March 31, 2021 December 31, 2020. At March 31, 2021 December 31, 2020, March 31, 2021 Billed Unbilled Total U.S. Department of Health and Human Services $ 3,966 $ 3,514 $ 7,480 Shionogi & Co. Ltd. (190 ) 4 (186 ) Green Cross Corporation 1,157 21 1,178 Mundipharma International Holdings Limited 32 - 32 Total receivables $ 4,965 $ 3,539 $ 8,504 December 31, 2020 Billed Unbilled Total U.S. Department of Health and Human Services $ - $ 5,402 $ 5,402 Shionogi & Co. Ltd. 2,037 4 2,041 Green Cross Corporation 740 21 761 Mundipharma International Holdings Limited 39 - 39 Total receivables $ 2,816 $ 5,427 $ 8,243 Monthly invoices are submitted to the U.S. Department of Health and Human Services related to reimbursable research and development costs. The Company is also entitled to monthly reimbursement of indirect costs based on rates stipulated in the underlying contract. The Company’s calculations of its indirect cost rates are subject to audit by the U.S. Government. Inventory At March 31, 2021 December 31, 2020, first first The Company’s inventories are subject to expiration dating. The Company regularly evaluates the carrying value of its inventories and provides valuation reserves for any estimated obsolete, short-dated or unmarketable inventories. In addition, the Company may The Company’s inventories as of March 31, 2021 December 31, 2020, March 31, December, 31 2021 2020 Raw materials $ 101 $ 206 Work-in-process 5,012 2,555 Finished goods 270 4,548 Total Inventory $ 5,383 $ 7,309 Reserves (270 ) (270 ) Total Inventory, net $ 5,113 $ 7,039 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 capitalizes subsequent costs related to the production of inventories. 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 not not Patents and Licenses The Company seeks patent protection on all internally developed processes and products. All patent related costs are expensed to selling, general and administrative expenses when incurred as recoverability of such expenditures is uncertain. Accrued Expenses The Company generally enters into contractual agreements with third not ● fees paid to clinical research organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; ● fees paid to investigative sites in connection with clinical trials; ● fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance, drug products, and product candidates; 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, 2021 December 31, 2020, 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 cumulative foreign currency translation adjustments and unrealized gains and losses on available-for-sale investments and is disclosed as a separate component of stockholders’ equity. Realized gain and loss amounts on available-for-sale investments are reclassified from accumulated other comprehensive loss and recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. For the three March 31, 2021, three March 31, 2020. Revenue Recognition Pursuant to Accounting Standards Codification (“ASC”) Topic 606, 606 five At contract inception, the Company identifies the goods or services promised within each contract, assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. The Company recorded the following revenues for the three March 31, 2021 2020: Three Months Ended March 31, 2021 2020 Product sales, net: ORLADEYO $ 10,938 $ - Peramivir 6,820 218 RAPIVAB 113 - Total product sales, net 17,871 218 Royalty revenue (897 ) 1,945 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 2,085 1,607 Torii Pharmaceutical Co., Ltd. - 1,053 Total collaborative and other research and development revenues 2,085 2,660 Total revenues $ 19,059 $ 4,823 Product Sales, Net The Company’s principal sources of product sales are sales of ORLADEYO, which the Company began shipping to customers in December 2020, The Company sells ORLADEYO directly to patients through a single specialty pharmacy in the United States. Net revenue from sales of ORLADEYO is recorded at net selling price (transaction price), which includes estimates of variable consideration for which reserves are established for (i) estimated government rebates, such as Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (ii) estimated chargebacks, (iii) estimated costs of co-payment assistance programs and (iv) product returns. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable or as a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted for relevant factors, such as the Company’s current contractual and statutory requirements and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may not may Government and Managed Care Rebates third third third third third Chargebacks may Co-payment assistance and patient assistance programs may Product returns not Collaborative and Other Research and Development Arrangements and Royalties The Company has collaboration and license agreements with a number of third Revenue from license fees, royalty payments, milestone payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no Arrangements that involve the delivery of more than one not not may Milestone payments are recognized as licensing revenue upon the achievement of specified milestones if (i) the milestone is substantive in nature and the achievement of the milestone was not Reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the Consolidated Statements of Comprehensive Loss rather than as a reduction in expenses. Under the Company’s contracts with the Biomedical Advanced Research and Development Authority within the United States Department of Health and Human Services (”BARDA/HHS”) and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”), revenue is recognized as reimbursable direct and indirect costs are incurred. Under certain of the Company’s license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. Royalties are recognized at the later of when (i) the subsequent sale or usage occurs, or (ii) the performance obligation to which some or all of the sales-based or usage-based royalty has been satisfied. Cost of Product Sales Cost of product sales includes the cost of producing and distributing inventories that are related to product revenue during the respective period, including freight. In addition, shipping and handling costs for product shipments are recorded as incurred. Finally, cost of product sales may Advertising Advertising and promotional costs are expensed in “Selling, general and administrative” as the costs are incurred. Advertising expenses related to ORLADEYO were $1,404 for the three March 31, 2021. not Research and Development Expenses The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third Additionally, the Company has license agreements with third Deferred collaboration expenses represent sub-license payments, paid to the Company’s academic partners upon receipt of consideration from various commercial partners, and other consideration paid to the Company’s academic partners for modification to existing license agreements. These deferred expenses would not Stock-Based Compensation All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in the Company’s Consolidated Statements of Comprehensive Loss based on their fair values. The fair value of stock option awards is estimated using the Black-Scholes option pricing model. The fair value of restricted stock unit awards is based on the grant date closing price of the common stock. Stock-based compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. In addition, we have outstanding performance-based stock options for which no Interest Expense and Deferred Financing Costs Interest expense for the three March 31, 2021 March 31, 2020 3 2 4 three March 31, 2021 March 31, 2020, Interest Expense and Royalty Financing Obligation The royalty financing obligation is eligible to be repaid based on royalties from net sales of ORLADEYO. Interest expense is accrued using the effective interest rate method over the estimated period the related liability will be paid. This requires the Company to estimate the total amount of future royalty payments to be generated from product sales over the life of the agreement. The Company imputes interest on the carrying value of the royalty financing obligation and records interest expense using an imputed effective interest rate. The Company will reassess the expected royalty payments each reporting period and account for any changes through an adjustment to the effective interest rate on a prospective basis. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs require that the Company make estimates that could impact the carrying value of the liability, as well as the period over which associated issuance costs will be amortized. A significant increase or decrease in forecasted net sales could materially impact the liability balance, interest expense and the time period for repayment. Currency Hedge Agreement In connection with the issuance by JPR Royalty Sub LLC 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 final tranche of the options under the Currency Hedge Agreement expired in November 2020. not three March 31, 2020, 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, 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 three March 31, 2021 2020 not 12,196, Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. The most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options, the ORLADEYO royalty financing and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not Significant Customers and Other Risks Significant Customers The Company’s primary sources of revenue and cash flow are the sales of ORLADEYO to a specialty pharmacy, the reimbursement of galidesivir (formerly BCX4430 ORLADEYO is distributed through an arrangement with a single specialty pharmacy in the U.S. The specialty pharmacy subsequently sells ORLADEYO to its customers (pharmacy benefit managers, insurance companies, government programs and group purchasing organizations) and dispenses product to patients. The specialty pharmacy’s inability or unwillingness to continue these distribution activities could adversely impact the Company’s business, results of operations and financial condition. The Company relies on BARDA/HHS and NIAID/HHS to reimburse predominantly all of the development costs for its galidesivir program and stockpiling sales of RAPIVAB to HHS. Accordingly, reimbursement of these expenses represents a significant portion of the Company’s collaborative and other research and development revenues. Additionally, HHS is the primary customer for RABIVAB. The completion or termination of the NIAID/HHS and BARDA/HHS galidesivir contracts or the reduction or stoppage of purchases of RAPIVAB by HHS could adversely impact the Company’s business, results of operations and financial condition. Further, the Company’s drug development activities are performed by a limited group of 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 and on single source distributors for distribution of approved drug products. 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. Credit Risk Cash equivalents and investments are financial instruments that 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 The Company’s receivables from sales of ORLADEYO are due from one one The majority of the Company’s receivables from collaborations are due from the U.S. Government, for which there is no Recently Adopted Accounting Pronouncements In December 2019, No. 2019 12 740 2019 12 December 15, 2020. not The Company has reviewed other new accounting pronouncements that were issued as of March 31, 2021 not |
Note 2 - Royalty Monetizations
Note 2 - Royalty Monetizations | 3 Months Ended |
Mar. 31, 2021 | |
Notes to Financial Statements | |
Royalty Monetization [Text Block] | Note 2 Royalty Monetizations RAPIACTA Royalty Monetization Overview On March 9, 2011, September 2012 As part of the transaction, the Company entered into a purchase and sale agreement dated as of March 9, 2011 not Non-Recourse Notes Payable On March 9, 2011, December 1, 2020 ( March 9, 2011 ( September 1st Royalty Sub’s obligations to pay principal and interest on the PhaRMA Notes are obligations solely of Royalty Sub and are without recourse to any other person, including the Company, except to the extent of the Company’s pledge of its equity interests in Royalty Sub in support of the PhaRMA Notes. The Company may, not may one In September 2014, September 3, 2013. September 2013 September 1, 2014, December 31, 2014 December 1, 2020, March 31, 2021, no may may not not March 31, 2021, The Indenture does not As of March 31, 2021, 3 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 had the right to purchase dollars and sell yen at a rate of 100 yen per dollar. The Currency Hedge Agreement did not November 2020. ORLADEYO Royalty Monetization On December 7, 2020, 2019 $350,000 $350,000 $550,000. $550,000. BCX9930. Under the Royalty Purchase Agreement, RPI is also entitled to receive a tiered revenue share on ORLADEYO sublicense revenue or net sales by licensees outside of the Key Territories (the “Other Markets”) equal to: (i) 20% of the proceeds received by the Company for upfront license fees and development milestones for ORLADEYO in the Other Markets; (ii) 20% of proceeds received on annual net sales of up to $150,000 $150,000 $230,000 $230,000 No may The Company will be required to make royalty payments of amounts owed to RPI each calendar quarter following the first Under the Royalty Purchase Agreement, the Company has agreed to specified affirmative and negative covenants, including covenants regarding periodic reporting of information by the Company to RPI, third 1 3 The cash consideration of $125,000 obtained pursuant to the Royalty Purchase Agreement is recorded in “Royalty financing obligation” on the Company’s consolidated balance sheet as of December 31, 2020. 3 March 31, 2021. March 31, 2021 three March 31, 2021, March 31, 2021, |
Note 3 - Credit Agreement
Note 3 - Credit Agreement | 3 Months Ended |
Mar. 31, 2021 | |
Senior Credit Facility [Member] | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 4 Senior Credit Facility On February 5, 2019, three first second third second third The Second Amended and Restated Senior Credit Facility had a variable interest rate of LIBOR (which was not June 2020 For the three March 31, 2020, December 2020, |
Credit Agreement [Member] | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 3 Credit Agreement On December 7, 2020, 1 December 7, 2020 The Credit Agreement also provides for two may December 7, 2025. The Credit Agreement provides for quarterly interest-only payments until the maturity date, with the unpaid principal amount of the outstanding Term Loans due and payable on the maturity date. For each of the first eight December 7, 2020, three no no Subject to certain exceptions, the Company is required to make mandatory prepayments of the Term Loans with the proceeds of certain asset sales, certain ORLADEYO out-licensing or royalty monetization transactions (excluding the Royalty Sale), extraordinary receipts, debt issuances, or upon a change of control of the Company and specified other events, subject to certain exceptions. The Company may second 1 2 second second third third fourth fourth The Credit Agreement also contains representations and warranties and affirmative and negative covenants customary for financings of this type, as well as customary events of default. Certain of the customary negative covenants limit the ability of the Company and certain of its subsidiaries to, among other things, grant liens, make investments, incur additional indebtedness, engage in mergers, acquisitions, and similar transactions, dispose of assets, license certain property, distribute dividends, make certain restricted payments, change the nature of the Company's business, engage in transactions with affiliates and insiders, prepay other indebtedness, or engage in sale and leaseback transactions, subject to certain exceptions. Additionally, as of the last day of each fiscal quarter (a “Test Date”), beginning with the first may not four one not A failure to comply with the covenants in the Credit Agreement could permit the Lenders under the Credit Agreement to declare the outstanding principal as well as accrued interest and fees, to be immediately due and payable. The Company's obligations under the Credit Agreement are secured by a security interest in, subject to certain exceptions, substantially all of the Company's assets. The Credit Agreement provides for quarterly interest-only payments until the maturity date, with the unpaid principal amount of the outstanding Term Loans due and payable on the maturity date of December 7, 2025. first three March 31, 2021, March 31, 2021, March 31, 2021, The Credit Agreement contains two not |
Note 4 - Senior Credit Facility
Note 4 - Senior Credit Facility | 3 Months Ended |
Mar. 31, 2021 | |
Senior Credit Facility [Member] | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 4 Senior Credit Facility On February 5, 2019, three first second third second third The Second Amended and Restated Senior Credit Facility had a variable interest rate of LIBOR (which was not June 2020 For the three March 31, 2020, December 2020, |
Note 5 - Lease Obligations and
Note 5 - Lease Obligations and Other Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Notes to Financial Statements | |
Leases of Lessor Disclosure [Text Block] | Note 5 Lease Obligations and Other Contingencies The Company leases certain assets under operating leases, which primarily consisted of real estate leases, laboratory equipment leases and office equipment leases as of March 31, 2020. 2016 02: Leases (Topic 842 2023 2026. The Company has not no Aggregate lease expense under operating leases was $452 and $448 for the three March 31, 2021 2020, twelve not three March 31, 2021 2020, Future lease payments for assets under operating leases as of March 31, 2021, Remaining Maturities of Lease Liabilities Year Ending December 31, Operating Leases 2021 $ 902 2022 805 2023 666 2024 584 2025 582 Thereafter 7,327 Total lease payments 10,866 Less imputed interest 5,982 Total $ 4,884 The Company’s current lease liability as of March 31, 2021 December 31, 2020 March 31, 2021 December 31, 2020 March 31, 2021 December 31, 2020, March 31, 2021 December 31, 2020, |
Note 6 - Stockholders' Equity
Note 6 - Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 6 Stockholders Equity Sales of Common Stock On April 24, 2020, 3 May 14, 2020 $500,000 On June 1, 2020, one March 31, 2021. On March 1, 2021, 3 |
Note 7 - Stock-based Compensati
Note 7 - Stock-based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | Note 7 Stock-Based Compensation As of March 31, 2021, three March 2020 May 12, 2020. April 24, 2019 February 2020 July 2020. March 2020 May 12, 2020. April 2021 May 25, 2021. Stock-based compensation expense of $5,479 ($4,554 of expense related to the Incentive Plan, $598 of expense related to the Inducement Plan, and $327 of expense related to the ESPP) was recognized during the three March 31, 2021, three March 31, 2020. There was approximately $59,329 of total unrecognized compensation expense related to non-vested stock option awards granted by the Company as of March 31, 2021. 2021, 2022, 2023, 2024 2025. no Stock Incentive Plan The Company grants stock option awards and restricted stock unit awards to its employees, directors, and consultants under the Incentive Plan. Under the Incentive Plan, stock option awards are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Stock option awards and restricted stock units granted to employees generally vest 25% each year until fully vested after four In August 2013, December 2014 December 2019, March 31, 2021, August 2013, December 2014 December 2019 2020, two August 2013 December 2019 Stock option awards granted to non-employee directors of the Company generally vest over one Related activity under the Incentive Plan is as follows: Weighted Average Awards Options Exercise Available Outstanding Price Balance December 31, 2020 4,592 24,885 $ 6.52 Restricted stock unit awards granted (100 ) - - Stock option awards granted (1,074 ) 1,074 10.06 Stock option awards exercised - (586 ) 3.97 Stock option awards cancelled 39 (39 ) 8.15 Balance March 31, 2021 3,457 25,334 $ 6.72 For stock option awards granted under the Incentive Plan during the first three 2021 2020, first three 2021 2020 Inducement Equity Incentive Plan The Company has the ability to grant stock option awards to newly-hired employees as inducements material to each employee entering employment with the Company. Stock option awards granted to newly hired employees are granted with an exercise price equal to the market price of the Company’s stock at the date of grant and generally vest 25% each year until fully vested after four Related activity under the Inducement Plan is as follows: Weighted Average Awards Options Exercise Available Outstanding Price Balance December 31, 2020 229 4,171 $ 3.88 Stock option awards granted (138 ) 138 8.52 Stock option awards exercised - (7 ) 3.63 Stock option awards cancelled 27 (27 ) 2.44 Balance March 31, 2021 118 4,275 $ 4.04 For stock option awards granted under the Inducement Plan during the first three 2021 2020, first three 2021 2020 The following table summarizes the key assumptions used by the Company to value the stock option awards granted under the Incentive Plan and the Inducement Plan during the first three 2021 2020, not not zero Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors under the Plans 2021 2020 Expected Life in Years 5.5 5.5 Expected Volatility 84.2 % 83.5 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 0.8 % 0.8 % Employee Stock Purchase Plan ( ESPP ) The Company has reserved a total of 4,475 shares of common stock to be purchased under the ESPP, of which 2,679 shares remain available for purchase as of March 31, 2021. may six No may one six no may one first three 2021 |
Note 8 - Collaborative and Othe
Note 8 - Collaborative and Other Research and Development Contracts | 3 Months Ended |
Mar. 31, 2021 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | Note 8 Collaborative and Other Research and Development Contracts National Institute of Allergy and Infectious Diseases ( NIAID/HHS ) September 2013, March 31, 2021, August 2020 August 2020, Biomedical Advanced Research and Development Authority ( BARDA/HHS ) March 2015, March 31, 2021, The contracts with NIAID/HHS and BARDA/HHS are cost-plus-fixed-fee contracts. That is, the Company is entitled to receive reimbursement for all costs incurred in accordance with the contract provisions that are related to the development of galidesivir plus a fixed fee, or profit. BARDA/HHS and NIAID/HHS will make periodic assessments of progress, and the continuation of the contract is based on the Company’s performance, the timeliness and quality of deliverables, and other factors. The government has rights under certain contract clauses to terminate these contracts. These contracts are terminable by the government at any time for breach or without cause. U.S. Department of Health and Human Services ( HHS ) September 2018, 50,000 five 10,000 September 2019, 10,000 20,000 2019. September 3, 2020, 10,000 2021. three March 31, 2021 10,000 Torii Pharmaceutical Co., Ltd. ( Torii ) November 5, 2019, Under the Torii Agreement, the Company received an upfront, non-refundable payment of $22,000. The Japanese National Health Insurance System’s (“NHI”) approval of the addition of ORLADEYO to the NHI drug price list in April 2021 In addition, under the Torii Agreement, the Company is entitled to receive tiered royalty payments, ranging from 20% to 40% of annual net sales of ORLADEYO in Japan during each calendar year. Torii’s royalty payment obligations are subject to customary reductions in certain circumstances, but may not first tenth first The Company identified performance obligations related to (i) the license to develop and commercialize ORLADEYO, (ii) regulatory approval support and (iii) reimbursement pricing approval support. These were each determined to be distinct from the other performance obligations. The Company allocated the $22,000 606. three March 31, 2020, $ 1,053 $22,000 2020, $22,000 Seqirus UK Limited ( SUL ). June 16, 2015, On March 4, 2020, August 1, 2020 November 1, 2020, 30 three March 31, 2020. Shionogi & Co., Ltd. ( Shionogi ). February 2007, October 2008, In December 2017, no Green Cross Corporation ( Green Cross ). June 2006, one Mundipharma International Holdings Limited ( Mundipharma ). February 2006, Albert Einstein College of Medicine of Yeshiva University and Industrial Research, Ltd. ( AECOM and IRL, respectively). June 2000, third The University of Alabama at Birmingham ( UAB ). third two five three no |
Note 9 - Subsequent Event
Note 9 - Subsequent Event | 3 Months Ended |
Mar. 31, 2021 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 9 Subsequent Event In January 2021, 12 April 14, 2021, April 21, 2021. second 2021.Torii April 23, 2021. 8, |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Description of Company [Policy Text Block] | The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a commercial-stage biotechnology company that discovers novel, oral, small-molecule medicines. The Company focuses on the treatment of rare diseases in which significant unmet medical needs exist and an enzyme plays the key role in the biological pathway of the disease. The Company was founded in 1986 1991, Based on the Company’s expectations for revenue, operating expenses, and its option to access an additional $75 million from its existing credit facility, the Company believes its financial resources available at March 31, 2021 2023. 2021 2021 may 1 2 3 4 5 one 6 may |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany transactions and balances among the consolidated entities have been eliminated from the consolidated financial statements. 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 not no These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2020 2020 10 not December 31, 2020 10 |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company generally considers cash equivalents to be all cash held in commercial checking accounts, certificates of deposit, money market accounts or investments in debt instruments with maturities of three |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash Restricted cash as of March 31, 2021 December 31, 2020 2 |
Investment, Policy [Policy Text Block] | Investments The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may three no may may not not not The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not three March 31, 2021, The following tables summarize the fair value of the Company’s investments by type. The estimated fair values of the Company’s fixed income investments are classified as Level 2 not not 2 March 31, 2021 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 10,675 $ 6 $ 3 $ - $ 10,684 Certificates of deposit 2,758 11 1 - 2,770 Total investments $ 13,433 $ 17 $ 4 $ - $ 13,454 December 31, 2020 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 24,986 $ 14 $ 3 $ (3 ) $ 25,000 Certificates of deposit 3,225 11 3 - 3,239 Total investments $ 28,211 $ 25 $ 6 $ (3 ) $ 28,239 The Company’s investments at March 31, 2021 December 31, 2020 one |
Receivable [Policy Text Block] | Trade Receivables Product Sales Receivables from product sales are recorded for amounts due to the Company related to sales of ORLADEYO™ and RAPIVAB®. At March 31, 2021 December 31, 2020, March 31, 2021 December 31, 2020, March 31, 2021 December 31, 2020, 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 Mundipharma International Holdings Limited (“Mundipharma”). These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date based on historical collection experience or specific circumstances, and no amounts were recorded at March 31, 2021 December 31, 2020. At March 31, 2021 December 31, 2020, March 31, 2021 Billed Unbilled Total U.S. Department of Health and Human Services $ 3,966 $ 3,514 $ 7,480 Shionogi & Co. Ltd. (190 ) 4 (186 ) Green Cross Corporation 1,157 21 1,178 Mundipharma International Holdings Limited 32 - 32 Total receivables $ 4,965 $ 3,539 $ 8,504 December 31, 2020 Billed Unbilled Total U.S. Department of Health and Human Services $ - $ 5,402 $ 5,402 Shionogi & Co. Ltd. 2,037 4 2,041 Green Cross Corporation 740 21 761 Mundipharma International Holdings Limited 39 - 39 Total receivables $ 2,816 $ 5,427 $ 8,243 Monthly invoices are submitted to the U.S. Department of Health and Human Services related to reimbursable research and development costs. The Company is also entitled to monthly reimbursement of indirect costs based on rates stipulated in the underlying contract. The Company’s calculations of its indirect cost rates are subject to audit by the U.S. Government. |
Inventory, Policy [Policy Text Block] | Inventory At March 31, 2021 December 31, 2020, first first The Company’s inventories are subject to expiration dating. The Company regularly evaluates the carrying value of its inventories and provides valuation reserves for any estimated obsolete, short-dated or unmarketable inventories. In addition, the Company may The Company’s inventories as of March 31, 2021 December 31, 2020, March 31, December, 31 2021 2020 Raw materials $ 101 $ 206 Work-in-process 5,012 2,555 Finished goods 270 4,548 Total Inventory $ 5,383 $ 7,309 Reserves (270 ) (270 ) Total Inventory, net $ 5,113 $ 7,039 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 capitalizes subsequent costs related to the production of inventories. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Computer equipment is depreciated over a life of three five seven In accordance with U.S. GAAP, the Company periodically reviews its property and equipment for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not not |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Patents and Licenses The Company seeks patent protection on all internally developed processes and products. All patent related costs are expensed to selling, general and administrative expenses when incurred as recoverability of such expenditures is uncertain. |
Accrued Expenses [Policy Text Block] | Accrued Expenses The Company generally enters into contractual agreements with third not ● fees paid to clinical research organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; ● fees paid to investigative sites in connection with clinical trials; ● fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance, drug products, and product candidates; 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, 2021 December 31, 2020, |
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 cumulative foreign currency translation adjustments and unrealized gains and losses on available-for-sale investments and is disclosed as a separate component of stockholders’ equity. Realized gain and loss amounts on available-for-sale investments are reclassified from accumulated other comprehensive loss and recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. For the three March 31, 2021, three March 31, 2020. |
Revenue [Policy Text Block] | Revenue Recognition Pursuant to Accounting Standards Codification (“ASC”) Topic 606, 606 five At contract inception, the Company identifies the goods or services promised within each contract, assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. The Company recorded the following revenues for the three March 31, 2021 2020: Three Months Ended March 31, 2021 2020 Product sales, net: ORLADEYO $ 10,938 $ - Peramivir 6,820 218 RAPIVAB 113 - Total product sales, net 17,871 218 Royalty revenue (897 ) 1,945 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 2,085 1,607 Torii Pharmaceutical Co., Ltd. - 1,053 Total collaborative and other research and development revenues 2,085 2,660 Total revenues $ 19,059 $ 4,823 Product Sales, Net The Company’s principal sources of product sales are sales of ORLADEYO, which the Company began shipping to customers in December 2020, The Company sells ORLADEYO directly to patients through a single specialty pharmacy in the United States. Net revenue from sales of ORLADEYO is recorded at net selling price (transaction price), which includes estimates of variable consideration for which reserves are established for (i) estimated government rebates, such as Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (ii) estimated chargebacks, (iii) estimated costs of co-payment assistance programs and (iv) product returns. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable or as a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted for relevant factors, such as the Company’s current contractual and statutory requirements and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may not may Government and Managed Care Rebates third third third third third Chargebacks may Co-payment assistance and patient assistance programs may Product returns not Collaborative and Other Research and Development Arrangements and Royalties The Company has collaboration and license agreements with a number of third Revenue from license fees, royalty payments, milestone payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no Arrangements that involve the delivery of more than one not not may Milestone payments are recognized as licensing revenue upon the achievement of specified milestones if (i) the milestone is substantive in nature and the achievement of the milestone was not Reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the Consolidated Statements of Comprehensive Loss rather than as a reduction in expenses. Under the Company’s contracts with the Biomedical Advanced Research and Development Authority within the United States Department of Health and Human Services (”BARDA/HHS”) and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”), revenue is recognized as reimbursable direct and indirect costs are incurred. Under certain of the Company’s license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. Royalties are recognized at the later of when (i) the subsequent sale or usage occurs, or (ii) the performance obligation to which some or all of the sales-based or usage-based royalty has been satisfied. |
Cost of Goods and Service [Policy Text Block] | Cost of Product Sales Cost of product sales includes the cost of producing and distributing inventories that are related to product revenue during the respective period, including freight. In addition, shipping and handling costs for product shipments are recorded as incurred. Finally, cost of product sales may Advertising Advertising and promotional costs are expensed in “Selling, general and administrative” as the costs are incurred. Advertising expenses related to ORLADEYO were $1,404 for the three March 31, 2021. not |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third Additionally, the Company has license agreements with third Deferred collaboration expenses represent sub-license payments, paid to the Company’s academic partners upon receipt of consideration from various commercial partners, and other consideration paid to the Company’s academic partners for modification to existing license agreements. These deferred expenses would not |
Share-based Payment Arrangement [Policy Text Block] | Stock-Based Compensation All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in the Company’s Consolidated Statements of Comprehensive Loss based on their fair values. The fair value of stock option awards is estimated using the Black-Scholes option pricing model. The fair value of restricted stock unit awards is based on the grant date closing price of the common stock. Stock-based compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. In addition, we have outstanding performance-based stock options for which no |
Interest Expense and Deferred Financing Costs [Policy Text Block] | Interest Expense and Deferred Financing Costs Interest expense for the three March 31, 2021 March 31, 2020 3 2 4 three March 31, 2021 March 31, 2020, |
Interest Expense and Royalty Financing Obligation [Policy Text Block] | Interest Expense and Royalty Financing Obligation The royalty financing obligation is eligible to be repaid based on royalties from net sales of ORLADEYO. Interest expense is accrued using the effective interest rate method over the estimated period the related liability will be paid. This requires the Company to estimate the total amount of future royalty payments to be generated from product sales over the life of the agreement. The Company imputes interest on the carrying value of the royalty financing obligation and records interest expense using an imputed effective interest rate. The Company will reassess the expected royalty payments each reporting period and account for any changes through an adjustment to the effective interest rate on a prospective basis. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs require that the Company make estimates that could impact the carrying value of the liability, as well as the period over which associated issuance costs will be amortized. A significant increase or decrease in forecasted net sales could materially impact the liability balance, interest expense and the time period for repayment. |
Currency Hedge Agreement [Policy Text Block] | Currency Hedge Agreement In connection with the issuance by JPR Royalty Sub LLC 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 final tranche of the options under the Currency Hedge Agreement expired in November 2020. not three March 31, 2020, |
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, 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 three March 31, 2021 2020 not 12,196, |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. The most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options, the ORLADEYO royalty financing and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not |
Concentration of Market Risk [Policy Text Block] | Significant Customers and Other Risks Significant Customers The Company’s primary sources of revenue and cash flow are the sales of ORLADEYO to a specialty pharmacy, the reimbursement of galidesivir (formerly BCX4430 ORLADEYO is distributed through an arrangement with a single specialty pharmacy in the U.S. The specialty pharmacy subsequently sells ORLADEYO to its customers (pharmacy benefit managers, insurance companies, government programs and group purchasing organizations) and dispenses product to patients. The specialty pharmacy’s inability or unwillingness to continue these distribution activities could adversely impact the Company’s business, results of operations and financial condition. The Company relies on BARDA/HHS and NIAID/HHS to reimburse predominantly all of the development costs for its galidesivir program and stockpiling sales of RAPIVAB to HHS. Accordingly, reimbursement of these expenses represents a significant portion of the Company’s collaborative and other research and development revenues. Additionally, HHS is the primary customer for RABIVAB. The completion or termination of the NIAID/HHS and BARDA/HHS galidesivir contracts or the reduction or stoppage of purchases of RAPIVAB by HHS could adversely impact the Company’s business, results of operations and financial condition. Further, the Company’s drug development activities are performed by a limited group of 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 and on single source distributors for distribution of approved drug products. 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. Credit Risk Cash equivalents and investments are financial instruments that 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 The Company’s receivables from sales of ORLADEYO are due from one one The majority of the Company’s receivables from collaborations are due from the U.S. Government, for which there is no |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Pronouncements In December 2019, No. 2019 12 740 2019 12 December 15, 2020. not The Company has reviewed other new accounting pronouncements that were issued as of March 31, 2021 not |
Note 1 - Significant Accounti_2
Note 1 - Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Notes Tables | |
Debt Securities, Available-for-sale [Table Text Block] | March 31, 2021 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 10,675 $ 6 $ 3 $ - $ 10,684 Certificates of deposit 2,758 11 1 - 2,770 Total investments $ 13,433 $ 17 $ 4 $ - $ 13,454 December 31, 2020 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 24,986 $ 14 $ 3 $ (3 ) $ 25,000 Certificates of deposit 3,225 11 3 - 3,239 Total investments $ 28,211 $ 25 $ 6 $ (3 ) $ 28,239 |
Schedule of Receivables from Collaborations [Table Text Block] | March 31, 2021 Billed Unbilled Total U.S. Department of Health and Human Services $ 3,966 $ 3,514 $ 7,480 Shionogi & Co. Ltd. (190 ) 4 (186 ) Green Cross Corporation 1,157 21 1,178 Mundipharma International Holdings Limited 32 - 32 Total receivables $ 4,965 $ 3,539 $ 8,504 December 31, 2020 Billed Unbilled Total U.S. Department of Health and Human Services $ - $ 5,402 $ 5,402 Shionogi & Co. Ltd. 2,037 4 2,041 Green Cross Corporation 740 21 761 Mundipharma International Holdings Limited 39 - 39 Total receivables $ 2,816 $ 5,427 $ 8,243 |
Schedule of Inventory, Current [Table Text Block] | March 31, December, 31 2021 2020 Raw materials $ 101 $ 206 Work-in-process 5,012 2,555 Finished goods 270 4,548 Total Inventory $ 5,383 $ 7,309 Reserves (270 ) (270 ) Total Inventory, net $ 5,113 $ 7,039 |
Disaggregation of Revenue [Table Text Block] | Three Months Ended March 31, 2021 2020 Product sales, net: ORLADEYO $ 10,938 $ - Peramivir 6,820 218 RAPIVAB 113 - Total product sales, net 17,871 218 Royalty revenue (897 ) 1,945 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 2,085 1,607 Torii Pharmaceutical Co., Ltd. - 1,053 Total collaborative and other research and development revenues 2,085 2,660 Total revenues $ 19,059 $ 4,823 |
Note 5 - Lease Obligations an_2
Note 5 - Lease Obligations and Other Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Notes Tables | |
Lessee, Lease, Liability, Maturity [Table Text Block] | Remaining Maturities of Lease Liabilities Year Ending December 31, Operating Leases 2021 $ 902 2022 805 2023 666 2024 584 2025 582 Thereafter 7,327 Total lease payments 10,866 Less imputed interest 5,982 Total $ 4,884 |
Note 7 - Stock-based Compensa_2
Note 7 - Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Notes Tables | |
Share-based Payment Arrangement, Activity [Table Text Block] | Weighted Average Awards Options Exercise Available Outstanding Price Balance December 31, 2020 4,592 24,885 $ 6.52 Restricted stock unit awards granted (100 ) - - Stock option awards granted (1,074 ) 1,074 10.06 Stock option awards exercised - (586 ) 3.97 Stock option awards cancelled 39 (39 ) 8.15 Balance March 31, 2021 3,457 25,334 $ 6.72 Weighted Average Awards Options Exercise Available Outstanding Price Balance December 31, 2020 229 4,171 $ 3.88 Stock option awards granted (138 ) 138 8.52 Stock option awards exercised - (7 ) 3.63 Stock option awards cancelled 27 (27 ) 2.44 Balance March 31, 2021 118 4,275 $ 4.04 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2021 2020 Expected Life in Years 5.5 5.5 Expected Volatility 84.2 % 83.5 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 0.8 % 0.8 % |
Note 1 - Significant Accounti_3
Note 1 - Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Restricted Cash and Cash Equivalents, Current, Total | $ 4,008 | $ 2,221 | |
Reclassification from Accumulated Other Comprehensive Income, Current Period, before Tax | 1 | $ 0 | |
Advertising Expense | 1,404 | ||
Interest Expense, Debt, Total | 12,904 | 3,047 | |
Amortization of Debt Financing Costs and Original Issue Discounts | $ (58) | $ 341 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 23,741 | 12,196 | |
Foreign Exchange Contract [Member] | Not Designated as Hedging Instrument [Member] | |||
Derivative, Loss on Derivative | $ 20 | ||
Computer Equipment [Member] | |||
Property, Plant and Equipment, Useful Life (Year) | 3 years | ||
Laboratory Equipment, Office Equipment and Software [Member] | |||
Property, Plant and Equipment, Useful Life (Year) | 5 years | ||
Furniture and Fixtures [Member] | |||
Property, Plant and Equipment, Useful Life (Year) | 7 years | ||
Trade Accounts Receivable [Member] | |||
Accounts Receivable, after Allowance for Credit Loss, Total | $ 0 | 0 | |
Accounts Receivable, Allowance for Credit Loss, Ending Balance | 0 | ||
Collaboration Receivables [Member] | |||
Accounts Receivable, Allowance for Credit Loss, Ending Balance | 0 | ||
ORLADEYO [Member] | Trade Accounts Receivable [Member] | |||
Accounts Receivable, after Allowance for Credit Loss, Total | 9,882 | 149 | |
RAPIVAB [Member] | Trade Accounts Receivable [Member] | |||
Accounts Receivable, after Allowance for Credit Loss, Total | $ 0 | 254 | |
Maximum [Member] | |||
Maturity Period of High Quality Marketable Securities (Year) | 3 years | ||
Average Maturity Period of High Quality Marketable Securities (Month) | 18 months | ||
Maturity Period of Short Term Investment (Month) | 12 months | ||
Average Maturity for Portfolio Investments (Month) | 18 months | ||
Minimum [Member] | |||
Long-term Investment Maturity, Minimum (Month) | 12 months | ||
Royalty Receivable [Member] | |||
Restricted Cash and Cash Equivalents, Current, Total | $ 2,587 | 796 | |
Collateral for Credit [Member] | |||
Restricted Cash and Cash Equivalents, Current, Total | 1,421 | $ 1,425 | |
Senior Credit Facility [Member] | MidCap Financial Services, LLC [Member] | |||
Line of Credit Facility, Remaining Borrowing Capacity | $ 75,000 | ||
Interest Expense, Debt, Total | $ 1,454 |
Note 1 - Significant Accounti_4
Note 1 - Significant Accounting Policies - Fair Value of the Company's Investments by Type (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Amortized Cost | $ 13,433 | $ 28,211 |
Accrued Interest | 17 | 25 |
Gross Unrealized Gains | 4 | 6 |
Gross Unrealized Losses | 0 | (3) |
Estimated Fair Value | 13,454 | 28,239 |
US Government Agencies Debt Securities [Member] | ||
Amortized Cost | 10,675 | 24,986 |
Accrued Interest | 6 | 14 |
Gross Unrealized Gains | 3 | 3 |
Gross Unrealized Losses | 0 | (3) |
Estimated Fair Value | 10,684 | 25,000 |
Certificates of Deposit [Member] | ||
Amortized Cost | 2,758 | 3,225 |
Accrued Interest | 11 | 11 |
Gross Unrealized Gains | 1 | 3 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | $ 2,770 | $ 3,239 |
Note 1 - Significant Accounti_5
Note 1 - Significant Accounting Policies - Summary of Receivables (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Receivables | $ 8,504 | $ 8,243 |
Billed Revenues [Member] | ||
Receivables | 4,965 | 2,816 |
Unbilled Revenues [Member] | ||
Receivables | 3,539 | 5,427 |
US Department of Health and Human Services [Member] | ||
Receivables | 7,480 | 5,402 |
US Department of Health and Human Services [Member] | Billed Revenues [Member] | ||
Receivables | 3,966 | 0 |
US Department of Health and Human Services [Member] | Unbilled Revenues [Member] | ||
Receivables | 3,514 | 5,402 |
Shionogi and Co. Ltd [Member] | ||
Receivables | 2,041 | |
Receivables (payables) | (186) | |
Shionogi and Co. Ltd [Member] | Billed Revenues [Member] | ||
Receivables | 2,037 | |
Receivables (payables) | (190) | |
Shionogi and Co. Ltd [Member] | Unbilled Revenues [Member] | ||
Receivables | 4 | |
Receivables (payables) | 4 | |
Green Cross Corporation [Member] | ||
Receivables | 1,178 | 761 |
Green Cross Corporation [Member] | Billed Revenues [Member] | ||
Receivables | 1,157 | 740 |
Green Cross Corporation [Member] | Unbilled Revenues [Member] | ||
Receivables | 21 | 21 |
Mundipharma International Holdings Limited [Member] | ||
Receivables | 32 | 39 |
Mundipharma International Holdings Limited [Member] | Billed Revenues [Member] | ||
Receivables | 32 | 39 |
Mundipharma International Holdings Limited [Member] | Unbilled Revenues [Member] | ||
Receivables | $ 0 | $ 0 |
Note 1 - Significant Accounti_6
Note 1 - Significant Accounting Policies - Summary of Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Raw materials | $ 101 | $ 206 |
Work-in-process | 5,012 | 2,555 |
Finished goods | 270 | 4,548 |
Total Inventory | 5,383 | 7,309 |
Reserves | (270) | (270) |
Total Inventory, net | $ 5,113 | $ 7,039 |
Note 1 - Significant Accounti_7
Note 1 - Significant Accounting Policies - Summary of Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2019 | |
Revenues | $ 19,059 | $ 4,823 | |
Torii Pharmaceutical Co. [Member] | |||
Revenues | 1,053 | $ 20,101 | |
Product [Member] | |||
Revenues | 17,871 | 218 | |
Product [Member] | ORLADEYO [Member] | |||
Revenues | 10,938 | 0 | |
Product [Member] | PERAMIVIR [Member] | |||
Revenues | 6,820 | 218 | |
Product [Member] | RAPIVAB [Member] | |||
Revenues | 113 | 0 | |
Royalty [Member] | |||
Revenues | (897) | 1,945 | |
Collaborative and Other Research and Development [Member] | |||
Revenues | 2,085 | 2,660 | |
Collaborative and Other Research and Development [Member] | US Department of Health and Human Services [Member] | |||
Revenues | 2,085 | 1,607 | |
Collaborative and Other Research and Development [Member] | Torii Pharmaceutical Co. [Member] | |||
Revenues | $ 0 | $ 1,053 |
Note 2 - Royalty Monetizations
Note 2 - Royalty Monetizations (Details Textual) $ in Thousands | Dec. 07, 2020USD ($) | Mar. 09, 2011USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 01, 2020USD ($) | Nov. 30, 2020¥ / $ |
Future Royalties Payable | $ 131,296 | $ 124,717 | ||||
RPI 2019 Intermediate Finance Trust [Member] | ||||||
Future Royalties Payable | $ 125,000 | |||||
Accrued Royalties | 957 | |||||
RPI 2019 Intermediate Finance Trust [Member] | ORLADEYO [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Sublicense Revenue in Other Markets | 20.00% | |||||
RPI 2019 Intermediate Finance Trust [Member] | ORLADEYO [Member] | Annual Net Sales Under $350,000 [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Key Territories | 8.75% | |||||
RPI 2019 Intermediate Finance Trust [Member] | ORLADEYO [Member] | Annual Net Sales Between $350,000 and $550,000 [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Key Territories | 2.75% | |||||
RPI 2019 Intermediate Finance Trust [Member] | ORLADEYO [Member] | Annual Net Sales Over $550,000 [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Key Territories | 0.00% | |||||
RPI 2019 Intermediate Finance Trust [Member] | ORLADEYO [Member] | Annual Net Sales Under $150,000 [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Other Markets | 20.00% | |||||
RPI 2019 Intermediate Finance Trust [Member] | ORLADEYO [Member] | Annual Net Sales Between $150,000 and $230,000 [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Other Markets | 10.00% | |||||
RPI 2019 Intermediate Finance Trust [Member] | ORLADEYO [Member] | Annual Net Sales Over $230,000 [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Other Markets | 0.00% | |||||
RPI 2019 Intermediate Finance Trust [Member] | BCX9930 [Member] | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Global Annual Net Sales | 1.00% | |||||
RPI 2019 Intermediate Finance Trust [Member] | Future Royalties Payable [Member] | ||||||
Proceeds from Issuance of Debt | $ 125,000 | |||||
Debt Issuance Costs, Net, Total | $ 2,370 | |||||
Debt Instrument, Interest Rate, Effective Percentage | 24.00% | |||||
Royalty Financing Obligation Interest Accretion | $ 7,536 | |||||
PhaRMA Notes Member] | Currency Hedge Agreement [Member] | ||||||
Derivative, Forward Exchange Rate (in JPY per USD) | ¥ / $ | 100 | |||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | ||||||
Private Placement of Senior Secured Notes | $ 30,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 14.00% | |||||
Secured Debt, Total | $ 30,000 | |||||
Interest Payable | $ 22,244 | |||||
Percentage of Carrying Amount in Excess of Fair Value | 3.00% | |||||
JPR Royalty Sub LLC [Member] | PhaRMA Notes Member] | Fair Value, Inputs, Level 2 [Member] | ||||||
Notes Payable, Fair Value Disclosure | $ 30,000 | |||||
JPR Royalty Sub LLC [Member] | Royalty Monetization [Member] | ||||||
Debt Instrument, Face Amount | $ 30,000 | |||||
Proceeds from Issuance of Secured Debt | 22,691 | |||||
Transaction Costs | 4,309 | |||||
Interest Reserve | $ 3,000 |
Note 3 - Credit Agreement (Deta
Note 3 - Credit Agreement (Details Textual) - USD ($) $ in Thousands | Dec. 07, 2020 | Feb. 05, 2019 | Mar. 31, 2021 | Dec. 31, 2020 |
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | ||||
Debt Instrument, Face Amount | $ 100,000 | |||
Repayments of Lines of Credit | $ 43,298 | |||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | London Interbank Offered Rate (LIBOR) [Member] | ||||
Debt Instrument, Basis Spread on Variable Rate | 8.00% | |||
Credit Agreement [Member] | Athyrium [Member] | ||||
Debt Instrument, Face Amount | $ 200,000 | |||
Debt Instrument, LIBOR Floor | 1.75% | |||
Debt Instrument, LIBOR Cap | 3.50% | |||
Debt Instrument, Exit Fee, Percentage of Principal | 2.00% | |||
Debt Instrument, Commitment Fee Percentage | 1.00% | |||
Debt Instrument, Interest Rate, Effective Percentage | 12.17% | |||
Paid-in-Kind Interest on Secured Term Loan | $ 3,549 | |||
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net, Total | 8,010 | |||
Long-term Debt, Including Paid-in-Kind Interest | $ 128,549 | |||
Credit Agreement [Member] | Athyrium [Member] | Prior to the Second Anniversary [Member] | ||||
Debt Instrument, Prepayment Fee, Percentage of Principal Voluntary Payments | 102.00% | |||
Debt Instrument, Prepayment Fee, Percentage of Accrued Interest | 0.50% | |||
Credit Agreement [Member] | Athyrium [Member] | Between the Second and Third Anniversaries [Member] | ||||
Debt Instrument, Prepayment Fee, Percentage of Principal Voluntary Payments | 2.00% | |||
Credit Agreement [Member] | Athyrium [Member] | Between the Third and Fourth Anniversaries [Member] | ||||
Debt Instrument, Prepayment Fee, Percentage of Principal Voluntary Payments | 1.00% | |||
Credit Agreement [Member] | Athyrium [Member] | After Fourth Anniversary [Member] | ||||
Debt Instrument, Prepayment Fee, Percentage of Principal Voluntary Payments | 0.00% | |||
Credit Agreement [Member] | Athyrium [Member] | Term Loan A Drawn [Member] | ||||
Debt Instrument, Covenant, Minimum Unrestricted Cash and Cash Equivalents | $ 15,000 | |||
Credit Agreement [Member] | Athyrium [Member] | Term Loan A and B Drawn [Member] | ||||
Debt Instrument, Covenant, Minimum Unrestricted Cash and Cash Equivalents | 20,000 | |||
Credit Agreement [Member] | Athyrium [Member] | Term Loans A, B and C Drawn [Member] | ||||
Debt Instrument, Covenant, Minimum Unrestricted Cash and Cash Equivalents | 15,000 | |||
Credit Agreement [Member] | Athyrium [Member] | Term Loans A, B and C Drawn and Cure Right Exercised [Member] | ||||
Debt Instrument, Covenant, Minimum Unrestricted Cash and Cash Equivalents | $ 20,000 | |||
Credit Agreement [Member] | Athyrium [Member] | London Interbank Offered Rate (LIBOR) [Member] | ||||
Debt Instrument, Basis Spread on Variable Rate | 8.25% | |||
Credit Agreement [Member] | Athyrium [Member] | London Interbank Offered Rate (LIBOR) [Member] | PIK Interest Payment is Made [Member] | ||||
Debt Instrument, Basis Spread on Variable Rate | 10.25% | |||
Credit Agreement [Member] | Athyrium [Member] | Term A Loan [Member] | ||||
Proceeds from Issuance of Long-term Debt, Total | $ 125,000 | |||
Credit Agreement [Member] | Athyrium [Member] | Term B Loan [Member] | ||||
Debt Instrument, Face Amount | 25,000 | |||
Credit Agreement [Member] | Athyrium [Member] | Term C Loan [Member] | ||||
Debt Instrument, Face Amount | $ 50,000 |
Note 4 - Senior Credit Facili_2
Note 4 - Senior Credit Facility (Details Textual) - USD ($) $ in Thousands | Feb. 05, 2019 | Dec. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 |
Interest Expense, Debt, Total | $ 12,904 | $ 3,047 | ||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | ||||
Debt Instrument, Face Amount | $ 100,000 | |||
Debt Instrument, Minimum LIBOR | 0.50% | |||
Debt Instrument, Term (Month) | 30 months | |||
Interest Expense, Debt, Total | $ 1,454 | |||
Extinguishment of Debt, Amount | $ 40,000 | |||
Payment for Debt Extinguishment or Debt Prepayment Cost | 3,298 | |||
Write off of Deferred Debt Issuance Cost | $ 1,211 | |||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | London Interbank Offered Rate (LIBOR) [Member] | ||||
Debt Instrument, Basis Spread on Variable Rate | 8.00% | |||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | Secured Credit Facility, First Tranche [Member] | ||||
Debt Instrument, Face Amount | $ 50,000 | |||
Repayments of Long-term Debt, Total | 30,000 | |||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | Secured Credit Facility, Second Tranche [Member] | ||||
Debt Instrument, Face Amount | 30,000 | |||
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | Secured Credit Facility, Third Tranche [Member] | ||||
Debt Instrument, Face Amount | $ 20,000 |
Note 5 - Lease Obligations an_3
Note 5 - Lease Obligations and Other Contingencies (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Operating Lease, Weighted Average Remaining Lease Term (Year) | 13 years 4 months 24 days | ||
Operating Lease, Weighted Average Discount Rate, Percent | 12.80% | ||
Operating Lease, Expense | $ 452 | $ 448 | |
Operating Lease, Payments | 440 | $ 408 | |
Operating Lease, Right-of-Use Asset, Accumulated Amortization | 2,940 | $ 2,641 | |
Accrued Liabilities, Current [Member] | |||
Operating Lease, Liability, Current | 1,001 | 1,179 | |
Other Noncurrent Liabilities [Member] | |||
Operating Lease, Liability, Noncurrent | 3,883 | 3,871 | |
Other Noncurrent Assets [Member] | |||
Operating Lease, Right-of-Use Asset | $ 3,625 | $ 3,802 | |
Minimum [Member] | |||
Lessee, Operating Lease, Term of Contract (Year) | 1 year | ||
Maximum [Member] | |||
Lessee, Operating Lease, Term of Contract (Year) | 5 years |
Note 5 - Lease Obligations an_4
Note 5 - Lease Obligations and Other Contingencies - Remaining Maturities of Lease Liabilities (Details) $ in Thousands | Mar. 31, 2021USD ($) |
2021 | $ 902 |
2022 | 805 |
2023 | 666 |
2024 | 584 |
2025 | 582 |
Thereafter | 7,327 |
Total lease payments | 10,866 |
Less imputed interest | 5,982 |
Accrued Liabilities, Current and Other Noncurrent Liabilities [Member] | |
Total | $ 4,884 |
Note 6 - Stockholders' Equity (
Note 6 - Stockholders' Equity (Details Textual) $ / shares in Units, $ in Thousands | Jun. 01, 2020USD ($)$ / sharesshares |
Stock Issued During Period, Shares, New Issues (in shares) | shares | 22,044 |
Shares Issued, Price Per Share (in dollars per share) | $ 4.50 |
Proceeds from Issuance or Sale of Equity, Total | $ | $ 108,096 |
Warrants Issued in Public Offering [Member] | |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 3,511 |
Class of Warrant or Right, Warrants Issued, Price Per Warrant (in dollars per share) | $ 4.49 |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.01 |
Note 7 - Stock-based Compensa_3
Note 7 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2014 | Aug. 31, 2013 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expense | $ 5,479 | $ 2,754 | ||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | 59,329 | |||||
Employee Service Share-based Compensation Nonvested Awards Compensation Cost Expected to be Recognized For Remainder of Fiscal Year | 14,490 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Next Year | 18,299 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Two | 14,511 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Three | 11,612 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Four | $ 417 | |||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in shares) | 193 | |||||
Incentive Plan [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 4,554 | $ 2,437 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 3,457 | 4,592 | ||||
Incentive Plan [Member] | Share-based Payment Arrangement, Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 6.87 | $ 1.87 | ||||
Incentive Plan [Member] | Share-based Payment Arrangement, Option [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term (Year) | 10 years | |||||
Incentive Plan [Member] | Share-based Payment Arrangement, 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 (Year) | 4 years | |||||
Incentive Plan [Member] | Performance Shares [Member] | August 2013 [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 1,768 | |||||
Incentive Plan [Member] | Performance Shares [Member] | December 2019 [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 684 | |||||
Incentive Plan [Member] | Performance Shares [Member] | Vest Upon Successful Completion of Specific Development Milestones [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 100.00% | 85.00% | 100.00% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) | 315 | 1,250 | 1,032 | |||
Inducement Plan [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 598 | $ 198 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 4 years | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 118 | 229 | ||||
Inducement Plan [Member] | Vest 25% Each Year Until Fully Vested [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | |||||
Inducement Plan [Member] | Share-based Payment Arrangement, Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 5.86 | $ 1.77 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||
Employee Stock Purchase Plan [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 327 | $ 119 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 4,475 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 2,679 | |||||
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 (in shares) | 3 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Maximum Number of Shares Per Employee, Amount | $ 25 | |||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in shares) | 193 |
Note 7 - Stock-based Compensa_4
Note 7 - Stock-based Compensation - Stock Plan Activities (Details) shares in Thousands | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Options outstanding, stock option awards exercised (in shares) | (593) |
Incentive Plan [Member] | |
Awards available, beginning balance (in shares) | 4,592 |
Options outstanding, beginning balance (in shares) | 24,885 |
Weighted average exercise price, beginning balance (in dollars per share) | $ / shares | $ 6.52 |
Awards available, Restricted stock awards granted (in shares) | (100) |
Awards available, stock option awards granted (in shares) | (1,074) |
Options outstanding, stock option awards granted (in shares) | 1,074 |
Weighted average exercise price, stock option awards granted (in dollars per share) | $ / shares | $ 10.06 |
Options outstanding, stock option awards exercised (in shares) | (586) |
Weighted average exercise price, stock option awards exercised (in dollars per share) | $ / shares | $ 3.97 |
Awards available, stock option awards cancelled (in shares) | 39 |
Options outstanding, stock option awards cancelled (in shares) | (39) |
Weighted average exercise price, stock option awards cancelled (in dollars per share) | $ / shares | $ 8.15 |
Awards available, ending balance (in shares) | 3,457 |
Options outstanding, ending balance (in shares) | 25,334 |
Weighted average exercise price, ending balance (in dollars per share) | $ / shares | $ 6.72 |
Inducement Plan [Member] | |
Awards available, beginning balance (in shares) | 229 |
Options outstanding, beginning balance (in shares) | 4,171 |
Weighted average exercise price, beginning balance (in dollars per share) | $ / shares | $ 3.88 |
Awards available, stock option awards granted (in shares) | (138) |
Options outstanding, stock option awards granted (in shares) | 138 |
Weighted average exercise price, stock option awards granted (in dollars per share) | $ / shares | $ 8.52 |
Options outstanding, stock option awards exercised (in shares) | (7) |
Weighted average exercise price, stock option awards exercised (in dollars per share) | $ / shares | $ 3.63 |
Awards available, stock option awards cancelled (in shares) | 27 |
Options outstanding, stock option awards cancelled (in shares) | (27) |
Weighted average exercise price, stock option awards cancelled (in dollars per share) | $ / shares | $ 2.44 |
Awards available, ending balance (in shares) | 118 |
Options outstanding, ending balance (in shares) | 4,275 |
Weighted average exercise price, ending balance (in dollars per share) | $ / shares | $ 4.04 |
Note 7 - Stock-based Compensa_5
Note 7 - Stock-based Compensation - Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors Under the Plans (Details) - Incentive Plan and Inducement Plan [Member] | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Expected Life (Year) | 5 years 6 months | 5 years 6 months |
Expected Volatility | 84.20% | 83.50% |
Expected Dividend Yield | 0.00% | 0.00% |
Risk-Free Interest Rate | 0.80% | 0.80% |
Note 8 - Collaborative and Ot_2
Note 8 - Collaborative and Other Research and Development Contracts (Details Textual) - USD ($) $ in Thousands | Sep. 03, 2020 | Mar. 04, 2020 | Nov. 05, 2019 | Sep. 06, 2018 | Jun. 16, 2015 | Aug. 31, 2020 | Jun. 30, 2006 | Jun. 30, 2000 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2021 | Mar. 31, 2021 | Mar. 31, 2015 | Feb. 28, 2006 |
Revenue from Contract with Customer, Including Assessed Tax | $ 19,059 | $ 4,823 | |||||||||||||
Arbitration Proceedings of SUL Agreement [Member] | |||||||||||||||
Litigation Settlement, Amount Awarded from Other Party | $ 5,000 | ||||||||||||||
Arbitration Proceedings of SUL Agreement [Member] | Other Income [Member] | |||||||||||||||
Gain (Loss) Related to Litigation Settlement, Total | 6,138 | ||||||||||||||
Arbitration Proceedings of SUL Agreement [Member] | Selling, General and Administrative Expenses [Member] | |||||||||||||||
Legal Fees | 4,668 | ||||||||||||||
US Department of Health and Human Services [Member] | |||||||||||||||
Collaborative Agreement Contract Value | $ 34,660 | ||||||||||||||
Contract Term (Year) | 5 years | ||||||||||||||
Proceeds from Collaborators | $ 6,932 | 0 | $ 13,864 | ||||||||||||
Torii Pharmaceutical Co. [Member] | |||||||||||||||
Upfront Payments Receivable Amount | $ 22,000 | ||||||||||||||
Potential Milestone Payments Receivable if Regulatory Approval Before December 31, 2021 | $ 15,000 | ||||||||||||||
Maximum Customary Reduction on Royalty Rate | 50.00% | ||||||||||||||
Royalty Payments Receivable, Expiration Term From First Commercial (Year) | 10 years | ||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,053 | $ 20,101 | |||||||||||||
Torii Pharmaceutical Co. [Member] | Minimum [Member] | |||||||||||||||
Royalty Rate if Maintains Sakigake Designation | 20.00% | ||||||||||||||
Torii Pharmaceutical Co. [Member] | Maximum [Member] | |||||||||||||||
Royalty Rate if Maintains Sakigake Designation | 40.00% | ||||||||||||||
CSL Limited [Member | |||||||||||||||
Proceeds from License Fees Received | $ 33,740 | ||||||||||||||
Milestone Payment Received | $ 12,000 | ||||||||||||||
Base Contract [Member] | |||||||||||||||
Government Contract Receivable | $ 16,265 | ||||||||||||||
Additional Development Options [Member] | |||||||||||||||
Government Contract Receivable | 22,855 | ||||||||||||||
ASPRBARDA Contract [Member] | |||||||||||||||
Government Contract Receivable | $ 39,120 | ||||||||||||||
Proceeds from awards for Research and Development Contracts | $ 20,574 | ||||||||||||||
Green Cross Corporation [Member] | |||||||||||||||
Proceeds from License Fees Received | $ 250 | ||||||||||||||
Mundipharma [Member] | |||||||||||||||
Potential Milestone Payments Receivable | $ 15,000 | ||||||||||||||
AECOM and IRL [Member] | |||||||||||||||
Milestone Payment Minimum | $ 1,400 | ||||||||||||||
Milestone Payment Maximum | 4,000 | ||||||||||||||
Annual License Fee Minimum | 150 | ||||||||||||||
Annual License Fee Maximum | $ 500 | ||||||||||||||
National Institute of Allergy and Infectious Diseases [Member] | |||||||||||||||
Expected Receivable From Awards for Research and Development Contracts | $ 2,897 | $ 45,931 | |||||||||||||
Collaborative Agreement Contract, Covenant, Maximum Amount of Funding | 43,908 | ||||||||||||||
Collaborative Agreement Contract Value | $ 6,326 | ||||||||||||||
UAB [Member] | |||||||||||||||
Period of Agreement (Year) | 25 years | ||||||||||||||
Renewable Period of Agreement (Year) | 5 years |
Note 9 - Subsequent Event (Deta
Note 9 - Subsequent Event (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2019 | Nov. 05, 2019 | |
Revenue from Contract with Customer, Including Assessed Tax | $ 19,059 | $ 4,823 | |||
Torii Pharmaceutical Co. [Member] | |||||
Potential Milestone Payments Receivable if Regulatory Approval Before December 31, 2021 | $ 15,000 | ||||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,053 | $ 20,101 | |||
Torii Pharmaceutical Co. [Member] | Minimum [Member] | |||||
Royalty Rate if Maintains Sakigake Designation | 20.00% | ||||
Torii Pharmaceutical Co. [Member] | Maximum [Member] | |||||
Royalty Rate if Maintains Sakigake Designation | 40.00% | ||||
Torii Pharmaceutical Co. [Member] | Forecast [Member] | |||||
Revenue from Contract with Customer, Including Assessed Tax | $ 15,000 |