Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | Apr. 29, 2022 | |
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 | 2022 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
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 | 185,583,896 |
Consolidated Balance Sheets (Cu
Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Assets | ||
Cash and cash equivalents | $ 395,504 | $ 504,389 |
Restricted cash | 3,354 | 3,345 |
Investments | 47,964 | 3,212 |
Trade receivables | 36,415 | 29,413 |
Inventory | 16,144 | 15,791 |
Prepaid expenses and other current assets | 12,333 | 9,986 |
Total current assets | 511,714 | 566,136 |
Property and equipment, net | 8,799 | 8,714 |
Long-term investments | 0 | 6,829 |
Other assets | 7,207 | 6,472 |
Total assets | 527,720 | 588,151 |
Liabilities and Stockholders’ Deficit | ||
Accounts payable | 13,881 | 27,808 |
Accrued expenses | 63,584 | 72,670 |
Deferred revenue | 1,471 | 1,421 |
Lease financing obligation | 2,081 | 1,819 |
Total current liabilities | 81,017 | 103,718 |
Non-current operating lease liabilities | 6,457 | 5,962 |
Royalty financing obligations | 464,225 | 449,375 |
Secured term loan | 140,236 | 136,082 |
Stockholders’ equity: | ||
Preferred stock, $0.01 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 – 185,572 as of March 31, 2022 and 184,350 as of December 31, 2021 | 1,856 | 1,843 |
Additional paid-in capital | 1,115,443 | 1,098,498 |
Accumulated other comprehensive income | 186 | 177 |
Accumulated deficit | (1,281,700) | (1,207,504) |
Total stockholders’ deficit | (164,215) | (106,986) |
Total liabilities and stockholders’ deficit | $ 527,720 | $ 588,151 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
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) | 450,000,000 | 450,000,000 |
Common stock, shares issued (in shares) | 185,572,000 | 184,350,000 |
Common stock, shares outstanding (in shares) | 185,572,000 | 184,350,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenues: | ||
Revenues | $ 49,923 | $ 19,059 |
Expenses | ||
Cost of product sales | 236 | 5,923 |
Research and development | 65,360 | 42,435 |
Selling, general and administrative | 34,282 | 22,114 |
Royalty | 2 | (36) |
Total operating expenses | 99,880 | 70,436 |
Loss from operations | (49,957) | (51,377) |
Interest and other income | 54 | 26 |
Interest expense | (23,837) | (12,904) |
Foreign currency losses, net | (177) | (29) |
Loss before income taxes | (73,917) | (64,284) |
Income tax expense | 279 | 0 |
Net loss | (74,196) | (64,284) |
Foreign currency translation adjustment | 78 | 178 |
Unrealized (loss) gain on available for sale investments | (69) | 1 |
Comprehensive loss | $ (74,187) | $ (64,105) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.40) | $ (0.36) |
Weighted average shares outstanding (in shares) | 184,898 | 177,343 |
Product [Member] | ||
Revenues: | ||
Revenues | $ 49,546 | $ 17,871 |
Royalty [Member] | ||
Revenues: | ||
Revenues | 347 | (897) |
Collaborative and Other Research and Development [Member] | ||
Revenues: | ||
Revenues | $ 30 | $ 2,085 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (74,196) | $ (64,284) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 317 | 178 |
Stock-based compensation expense | 9,601 | 5,479 |
Non-cash interest expense on royalty financing obligations and secured term loan and amortization of debt issuance costs | 19,003 | 11,027 |
Amortization of premium/discount on investments | 30 | 14 |
Changes in operating assets and liabilities: | ||
Receivables | (7,048) | (261) |
Inventory | (354) | 1,927 |
Prepaid expenses and other assets | (2,320) | (9,850) |
Accounts payable and accrued expenses | (22,908) | (7,373) |
Interest payable | 0 | 1,877 |
Deferred revenue | 75 | 255 |
Net cash used in operating activities | (77,800) | (61,011) |
Cash flows from investing activities: | ||
Acquisitions of property and equipment | (406) | (99) |
Purchase of investments | (38,066) | 0 |
Sales and maturities of investments | 0 | 14,771 |
Realized gain on investments | 0 | 1 |
Net cash (used in) provided by investing activities | (38,472) | 14,673 |
Cash flows from financing activities: | ||
Net proceeds from common stock issued under stock-based compensation plans | 7,356 | 2,900 |
Net cash provided by financing activities | 7,356 | 2,900 |
Effect of exchange rate on cash, cash equivalents, and restricted cash | 40 | 0 |
Decrease in cash, cash equivalents and restricted cash | (108,876) | (43,438) |
Cash, cash equivalents and restricted cash at beginning of period | 507,734 | 274,348 |
Cash, cash equivalents and restricted cash at end of period | $ 398,858 | $ 230,910 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' 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, 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 | 2 | 721 | 723 | ||
Exercise of stock options, net | 6 | 2,171 | 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) |
Balance at Dec. 31, 2021 | 1,843 | 1,098,498 | 177 | (1,207,504) | (106,986) |
Net loss | (74,196) | (74,196) | |||
Other comprehensive income (loss) | 9 | 9 | |||
Employee stock purchase plan | 1 | 1,503 | 1,504 | ||
Exercise of stock options, net | 12 | 5,841 | 5,853 | ||
Stock-based compensation expense | 9,601 | 9,601 | |||
Balance at Mar. 31, 2022 | $ 1,856 | $ 1,115,443 | $ 186 | $ (1,281,700) | $ (164,215) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Deficit (Unaudited) (Parentheticals) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Common Stock [Member] | ||
Employee stock purchase plan sales, shares (in shares) | 115,000 | 193,000 |
Exercise of stock options, shares (in shares) | 593,000 | |
Employee stock purchase plan sales, shares (in shares) | 115,000 | 193,000 |
Exercise of stock options, shares (in shares) | 1,108 |
Note 1 - Significant Accounting
Note 1 - Significant Accounting Policies and Concentrations of Risk | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 1 Significant Accounting Policies and Concentrations of Risk The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a 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, The Company’s marketed products include oral, once-daily ORLADEYO® for the prevention of hereditary angioedema (“HAE”) attacks and RAPIVAB® (peramivir injection) for the treatment of acute uncomplicated influenza in the United States. ORLADEYO received regulatory approval in the United States in December 2020. 2021, Based on the Company’s expectations for revenue, operating expenses, and the additional $75 million available to the Company under its existing credit facility, the Company believes its financial resources available at March 31, 2022 12 2022 2022 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, 2021 2021 10 not December 31, 2021 10 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 and Factor D inhibitors royalty financing obligations 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 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. Product Sales, Net The Company’s principal sources of product sales are sales of ORLADEYO, which the Company began shipping to patients in December 2020, The Company recognizes revenue for sales when its customers obtain control of the product, which generally occurs upon delivery. For ORLADEYO, the Company classifies payments to its specialty pharmacy customer for certain services provided by its customer as selling, general and administrative expenses to the extent such services provided are determined to be distinct from the sale of its product. 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. 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 HHS (”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. 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 of $1,924 as of both March 31, 2022 December 31, 2021 6 March 31, 2022 December 31, 2021, 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, 2022, Trade Receivables The majority of the Company’s trade receivables arise from product sales and primarily represent amounts due from its specialty pharmacy customer in the United States and other third 30 90 Receivables from collaborations are recorded for amounts due to the Company related to reimbursable research and development costs from the HHS, and royalty receivables from the Company’s partners, including Shionogi, Green Cross, and Torii. Monthly invoices are submitted to HHS 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. The Company does not one The Company provides reserves against trade receivables for estimated losses that may Inventory The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials, labor, manufacturing overhead and shipping and handling costs on a 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 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 Accrued Expenses The Company generally enters into contractual agreements with third not 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, 2022 December 31, 2021, 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 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 Selling, General and Administrative Expenses Selling, general and administrative expense is primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel. Additionally, selling, general and administrative expenses are comprised of market research, marketing, advertising and legal expenses, including patent costs, licenses and other general and administrative costs. Advertising expenses related to ORLADEYO were $3,984 three March 31, 2022 March 31, 2021, 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. Leases 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, 2022. 2016 02: Leases (Topic 842 Certain of the Company’s operating leases provide for renewal options, which can vary by lease. The right-of-use asset and lease liabilities on the Company’s Consolidated Balance Sheet represent payments over the lease term, which includes renewal options for certain real estate leases that we are likely to exercise. As part of the Company’s assessment of the lease term, the Company elected the hindsight practical expedient, which allows companies to use current knowledge and expectations when determining the likelihood to extend lease options. Certain operating leases include rent escalation provisions, which the Company recognizes as expense on a straight-line basis. Lease expense for leases with an initial term of twelve not The discount rate used in the calculation of the Company’s right-of-use asset and lease liability was determined based on the stated rate within each contract when available, or the Company’s collateralized borrowing rate from lending institutions. The Company has not no 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, 2022 March 31, 2021 6 7 6 three March 31, 2022 March 31, 2021, In December 2021, 6—Royalty Interest Expense and Royalty Financing Obligations The royalty financing obligations are eligible to be repaid based on royalties from net sales of ORLADEYO, BCX9930, 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. Beginning in fiscal year 2021, no Net Loss Per Share Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share is equivalent to basic net loss per share for all periods presented herein because common equivalent shares from unexercised stock options, warrants and common shares expected to be issued under the Company’s equity compensation plans were anti-dilutive. The calculation of diluted earnings per share for the three March 31, 2022 2021 not 28,699 Accumulated Other Comprehensive Income Accumulated other comprehensive income 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 income and recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. For the three March 31, 2021, three March 31, 2022. 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 United States. 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 a single specialty pharmacy for distribution of approved drug product in the United States. 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 12 The Company’s receivables from sales of ORLADEYO are primarily 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 There have been no three March 31, 2022, 1 10 December 31, 2021, |
Note 2 - Revenue
Note 2 - Revenue | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | Note 2 Revenue The Company recorded the following revenues for the three March 31, 2022 2021: Three Months Ended March 31, 2022 2021 Product sales, net: ORLADEYO $ 49,386 $ 10,938 RAPIVAB 160 113 Peramivir — 6,820 Total product sales, net 49,546 17,871 Royalty revenue 347 (897 ) Collaborative and other research and development revenues: U.S. Department of Health and Human Services 30 2,085 Total collaborative and other research and development revenues 30 2,085 Total revenues $ 49,923 $ 19,059 |
Note 3 - Investments
Note 3 - Investments | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Investments and Other Noncurrent Assets [Text Block] | Note 3 Investments 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, 2022 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 42,005 $ 98 $ 1 $ (42 ) $ 42,062 Corporate debt securities 4,272 19 — (32 ) 4,259 Certificates of deposit 1,648 3 — (8 ) 1,643 Total investments $ 47,925 $ 120 $ 1 $ (82 ) $ 47,964 December 31, 2021 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 4,043 $ 17 $ — $ (7 ) $ 4,053 Corporate debt securities 4,294 40 — (5 ) 4,329 Certificates of deposit 1,652 8 — (1 ) 1,659 Total investments $ 9,989 $ 65 $ — $ (13 ) $ 10,041 The following table summarizes the scheduled maturity for the Company’s investments at March 31, 2022 December 31, 2021: March 31, 2022 December 31, 2021 Maturing in one year or less $ 47,964 $ 3,212 Maturing after one year through two years — 6,829 Total investments $ 47,964 $ 10,041 |
Note 4 - Trade Receivables
Note 4 - Trade Receivables | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Trade Receivables [Text Block] | Note 4 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, 2022 December 31, 2021, March 31, 2022 December 31, 2021, March 31, 2022 December 31, 2021, Collaborations At March 31, 2022 December 31, 2021, March 31, 2022 Billed Unbilled Total U.S. Department of Health and Human Services $ 5 $ 1,600 $ 1,605 Royalty receivables from partners 327 — 327 Total receivables $ 332 $ 1,600 $ 1,932 December 31, 2021 Billed Unbilled Total U.S. Department of Health and Human Services $ 5 $ 1,670 $ 1,675 Royalty receivables from partners 305 — 305 Total receivables $ 310 $ 1,670 $ 1,980 As of both March 31, 2022 December 31, 2021, |
Note 5 - Inventory
Note 5 - Inventory | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | Note 5 Inventory At March 31, 2022 December 31, 2021, The Company’s inventories consisted of the following: March 31, December 31, 2022 2021 Raw materials $ 5,269 $ 5,658 Work-in-process 10,434 9,669 Finished goods 694 709 Total Inventory $ 16,397 $ 16,036 Reserves (253 ) (245 ) Total Inventory, net $ 16,144 $ 15,791 |
Note 6 - Royalty Monetizations
Note 6 - Royalty Monetizations | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Royalty Monetization [Text Block] | Note 6 Royalty Monetizations RAPIACTA 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 may may not December 1, 2020, Non-Recourse Notes Payable Debt Extinguishment During 2021, September 1, 2014 December 1, 2020 no December 31, 2021. ORLADEYO and Factor D Inhibitors On December 7, 2020, 2019 “2020 “2020 2020 $350,000 $350,000 $550,000. $550,000. BCX9930. Under the 2020 $150,000 $150,000 $230,000 $230,000 On November 19, 2021, “2021 2020 $150,000 Under the 2021 $350,000 $350,000 $550,000. $550,000. $150,000 $150,000 $230,000 No $230,000 Under the 2021 BCX9930 $1.5 $1.5 $3.0 The royalties payable under the 2021 2020 Under the OMERS Royalty Purchase Agreement, commencing with the calendar quarter beginning October 1, 2023, $350,000 $350,000 $550,000 $550,000 2023 January 1, 2024, 2023 $350,000 $350,000 $550,000 $550,000 Under the OMERS Royalty Purchase Agreement, OMERS is also entitled to receive a tiered revenue share on ORLADEYO sublicense revenue or net sales by licensees in the Other Markets in an amount equal to: (i) 20.0% of the proceeds received by the Company for upfront license fees and development milestones for ORLADEYO in the Other Markets, (ii) 20.0% of proceeds received by the Company on annual net sales of up to $150,000 $150,000 $230,000 $230,000 Under the 2020 first 2021 October 1, 2021. October 1, 2023. no 2023. The transactions contemplated by each of the Royalty Purchase Agreements are referred to herein as the “Royalty Sales”. Under the Royalty Purchase Agreements, the Company has agreed to specified affirmative and negative covenants, including covenants regarding periodic reporting of information by the Company to RPI and OMERS, third 1 7 The cash consideration obtained pursuant to the Royalty Purchase Agreements is recorded in “Royalty financing obligations” on the Company’s consolidated balance sheet. The fair value for the royalty financing obligations at the time of the transactions was based on the Company’s estimates of future royalties expected to be paid to the counterparty over the life of the arrangement. The Company subsequently records the obligations at its carrying value using the effective interest method. In order to amortize the royalty financing obligations, the Company utilizes the prospective method to estimate the future royalties to be paid by the Company to the counterparty over the life of the arrangement. Under the prospective method, a new effective interest rate is determined based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. The Company periodically assesses the amount and timing of expected royalty payments using a combination of internal projections and forecasts from external sources. The estimates of future net product sales (and resulting royalty payments) are based on key assumptions including population, penetration, probability of success, and sales price, among others. To the extent such payments are greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the royalty financing obligations and the effective interest rate. The following table shows the activity within the Royalty financing obligations account (in thousands) as well as the effective interest rate as of March 31, 2022: 2020 RPI 2021 RPI OMERS Total Balance as of December 31, 2021 $ 147,224 $ 153,377 $ 148,774 $ 449,375 Deferred financing costs − (34 ) − (34 ) Non-cash Interest expense on Royalty financing obligations 10,165 6,327 3,157 19,649 Royalty revenues paid and payable (4,385 ) (380 ) − (4,765 ) Balance as of March 31, 2022 $ 153,004 $ 159,290 $ 151,931 $ 464,225 Effective interest rate 27.3 % 16.5 % 8.5 % Deferred issuance costs pursuant to the Royalty financing obligations, which consist primarily of advisory and legal fees, totaled $8,531 as of March 31, 2022. Concurrent with entering into the 2021 9 |
Note 7 - Debt
Note 7 - Debt | 3 Months Ended |
Mar. 31, 2022 | |
Credit Agreement [Member] | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 7 Debt Credit Agreement On December 7, 2020, 1 December 7, 2020 March 31, 2022. The Credit Agreement also provides for two may December 7, 2025. On November 19, 2021, 2021 not x 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 Sales), 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. As of March 31, 2022, three March 31, 2022 2021 March 31, 2022, 2 As of March 31, 2022, three March 31, 2022 2021, The Credit Agreement contains two not |
Note 8 - Lease Obligations
Note 8 - Lease Obligations | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 8 Lease Obligations 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, 2022. 2023 2026. Aggregate lease expense under operating leases was $594 and $452 for the three March 31, 2022 2021, All of the Company’s leases qualify as operating leases. The following table summarizes the presentation in the consolidated balance sheets of the Company’s operating leases: Balance Sheet Location As of March 31, 2022 As of December 31, 2021 Assets: Operating lease assets, net Other Assets $ 7,207 $ 6,472 Liabilities: Current operating lease liabilities Lease financing obligation current liabilities $ 2,081 $ 1,819 Non-current operating lease liabilities Lease financing obligation long-term liabilities 6,457 5,962 Total operating lease liabilities $ 8,538 $ 7,781 Operating lease assets are recorded net of accumulated amortization of $3,019 and $2,626 as of March 31, 2022 December 31, 2021, three March 31, 2022 2021, Maturities of operating lease liabilities as of March 31, 2022, 2022 (remaining) $ 1,820 2023 2,190 2024 1,641 2025 1,348 2026 617 Thereafter 6,734 Total lease payments 14,350 Less imputed interest (5,812 ) Total $ 8,538 |
Note 9 - Stockholders' Equity
Note 9 - Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 9 Stockholders Equity Sales of Common Stock On April 24, 2020, 3 May 14, 2020 On March 1, 2021, 3 On November 19, 2021 , 2021 20 November 17, 2021 , 2021 |
Note 10 - Stock-based Compensat
Note 10 - Stock-based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | Note 10 Stock-Based Compensation As of March 31, 2022, three April 1, 2021 May 25, 2021. April 18, 2022 June 7, 2022. July 23, 2021. April 1, 2021 May 25, 2021. Stock-based compensation expense of $9,601 ($8,078 of expense related to the Incentive Plan, $1,225 of expense related to the Inducement Plan, and $298 of expense related to the ESPP) was recognized during the three March 31, 2022, three March 31, 2021. There was approximately $109,635 of total unrecognized compensation expense related to non-vested stock option and restricted stock unit awards granted by the Company as of March 31, 2022. March 31, 2022, 2022, 2023, 2024, 2025 2026. no Stock Incentive Plan The Company grants stock option awards, restricted stock and restricted stock units to its employees, directors, and consultants under the Incentive Plan. Under the Incentive Plan, stock option awards are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Commencing March 1, 2011, four In December 2014, March 31, 2022, In January 2022, 2022, first second third three Stock option awards granted to non-employee directors of the Company generally vest over one first 36 three Related activity under the Incentive Plan is as follows: Weighted Average Awards Options Exercise Available Outstanding Price Balance December 31, 2021 3,651 28,685 $ 7.90 Restricted stock unit awards granted (391 ) — — Restricted stock unit awards cancelled 40 — — Stock option awards granted (109 ) 109 16.49 Stock option awards exercised — (1,033 ) 5.83 Stock option awards cancelled 369 (369 ) 11.22 Balance March 31, 2022 3,560 27,392 $ 7.96 For stock option awards granted under the Incentive Plan during the first three 2022 2021, first three 2022 2021 first three 2022 Inducement Equity Incentive Plan The Company has the ability to grant stock option and restricted stock unit awards to newly-hired employees as inducements material to each employee entering employment with the Company. Awards granted to newly hired employees 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, 2021 900 4,408 $ 6.20 Restricted stock unit awards granted (134 ) — — Stock option awards granted (566 ) 566 16.10 Stock option awards exercised — (51 ) 3.22 Stock option awards cancelled 58 (58 ) 6.29 Balance March 31, 2022 258 4,865 $ 7.42 For stock option awards granted under the Inducement Plan during the first three 2022 2021, first three 2022 2021 first three 2022 No first three 2021. The following table summarizes the key assumptions used by the Company to value the stock option awards granted under all plans during the first three 2022 2021, not not zero Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors under the Plans 2022 2021 Expected Life in Years 5.5 5.5 Expected Volatility 84.1 % 84.2 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 1.9 % 0.8 % Employee Stock Purchase Plan The Company has reserved a total of 7,975 shares of common stock to be purchased under the ESPP, of which 5,937 shares remain available for purchase as of March 31, 2022. may six No may one six no may one three March 31, 2022, 2021, |
Note 11- Collaborative and Othe
Note 11- Collaborative and Other Relationships | 3 Months Ended |
Mar. 31, 2022 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | Note 11 Collaborative and Other Relationships National Institute of Allergy and Infectious Diseases September 2013, September 15, 2021, In August 2020, Biomedical Advanced Research and Development Authority March 2015, March 31, 2022, March 31, 2022. 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 contracts 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 September 2018, five March 31, 2022, 29,980 50,000 Torii Pharmaceutical Co., Ltd. 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 May 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 April 23, 2021. 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. Shionogi & Co., Ltd. February 2007, October 2008, Green Cross Corporation. June 2006, Albert Einstein College of Medicine of Yeshiva University and Industrial Research, Ltd. June 2000, third The University of Alabama at Birmingham. third two five three no |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
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, The Company’s marketed products include oral, once-daily ORLADEYO® for the prevention of hereditary angioedema (“HAE”) attacks and RAPIVAB® (peramivir injection) for the treatment of acute uncomplicated influenza in the United States. ORLADEYO received regulatory approval in the United States in December 2020. 2021, Based on the Company’s expectations for revenue, operating expenses, and the additional $75 million available to the Company under its existing credit facility, the Company believes its financial resources available at March 31, 2022 12 2022 2022 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, 2021 2021 10 not December 31, 2021 10 |
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 and Factor D inhibitors royalty financing obligations 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 |
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. Product Sales, Net The Company’s principal sources of product sales are sales of ORLADEYO, which the Company began shipping to patients in December 2020, The Company recognizes revenue for sales when its customers obtain control of the product, which generally occurs upon delivery. For ORLADEYO, the Company classifies payments to its specialty pharmacy customer for certain services provided by its customer as selling, general and administrative expenses to the extent such services provided are determined to be distinct from the sale of its product. 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. 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 HHS (”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. |
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 of $1,924 as of both March 31, 2022 December 31, 2021 6 March 31, 2022 December 31, 2021, |
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, 2022, |
Receivable [Policy Text Block] | Trade Receivables The majority of the Company’s trade receivables arise from product sales and primarily represent amounts due from its specialty pharmacy customer in the United States and other third 30 90 Receivables from collaborations are recorded for amounts due to the Company related to reimbursable research and development costs from the HHS, and royalty receivables from the Company’s partners, including Shionogi, Green Cross, and Torii. Monthly invoices are submitted to HHS 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. The Company does not one The Company provides reserves against trade receivables for estimated losses that may |
Inventory, Policy [Policy Text Block] | Inventory The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials, labor, manufacturing overhead and shipping and handling costs on a 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 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 |
Accrued Expenses [Policy Text Block] | Accrued Expenses The Company generally enters into contractual agreements with third not 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, 2022 December 31, 2021, |
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 |
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 |
Selling, General and Administrative Expenses, Policy [Policy Text Block] | Selling, General and Administrative Expenses Selling, general and administrative expense is primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel. Additionally, selling, general and administrative expenses are comprised of market research, marketing, advertising and legal expenses, including patent costs, licenses and other general and administrative costs. Advertising expenses related to ORLADEYO were $3,984 three March 31, 2022 March 31, 2021, 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. |
Lessee, Leases [Policy Text Block] | Leases 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, 2022. 2016 02: Leases (Topic 842 Certain of the Company’s operating leases provide for renewal options, which can vary by lease. The right-of-use asset and lease liabilities on the Company’s Consolidated Balance Sheet represent payments over the lease term, which includes renewal options for certain real estate leases that we are likely to exercise. As part of the Company’s assessment of the lease term, the Company elected the hindsight practical expedient, which allows companies to use current knowledge and expectations when determining the likelihood to extend lease options. Certain operating leases include rent escalation provisions, which the Company recognizes as expense on a straight-line basis. Lease expense for leases with an initial term of twelve not The discount rate used in the calculation of the Company’s right-of-use asset and lease liability was determined based on the stated rate within each contract when available, or the Company’s collateralized borrowing rate from lending institutions. The Company has not no |
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, 2022 March 31, 2021 6 7 6 three March 31, 2022 March 31, 2021, In December 2021, 6—Royalty |
Interest Expense and Royalty Financing Obligation [Policy Text Block] | Interest Expense and Royalty Financing Obligations The royalty financing obligations are eligible to be repaid based on royalties from net sales of ORLADEYO, BCX9930, |
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. Beginning in fiscal year 2021, no |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Share Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share is equivalent to basic net loss per share for all periods presented herein because common equivalent shares from unexercised stock options, warrants and common shares expected to be issued under the Company’s equity compensation plans were anti-dilutive. The calculation of diluted earnings per share for the three March 31, 2022 2021 not 28,699 |
Comprehensive Income, Policy [Policy Text Block] | Accumulated Other Comprehensive Income Accumulated other comprehensive income 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 income and recorded as interest and other income on the Consolidated Statements of Comprehensive Loss. For the three March 31, 2021, three March 31, 2022. |
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 United States. 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 a single specialty pharmacy for distribution of approved drug product in the United States. 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 12 The Company’s receivables from sales of ORLADEYO are primarily 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 There have been no three March 31, 2022, 1 10 December 31, 2021, |
Note 2 - Revenue (Tables)
Note 2 - Revenue (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Three Months Ended March 31, 2022 2021 Product sales, net: ORLADEYO $ 49,386 $ 10,938 RAPIVAB 160 113 Peramivir — 6,820 Total product sales, net 49,546 17,871 Royalty revenue 347 (897 ) Collaborative and other research and development revenues: U.S. Department of Health and Human Services 30 2,085 Total collaborative and other research and development revenues 30 2,085 Total revenues $ 49,923 $ 19,059 |
Note 3 - Investments (Tables)
Note 3 - Investments (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Notes Tables | |
Debt Securities, Available-for-Sale [Table Text Block] | March 31, 2022 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 42,005 $ 98 $ 1 $ (42 ) $ 42,062 Corporate debt securities 4,272 19 — (32 ) 4,259 Certificates of deposit 1,648 3 — (8 ) 1,643 Total investments $ 47,925 $ 120 $ 1 $ (82 ) $ 47,964 December 31, 2021 Gross Gross Amortized Accrued Unrealized Unrealized Estimated Cost Interest Gains Losses Fair Value Obligations of U.S. Government and its agencies $ 4,043 $ 17 $ — $ (7 ) $ 4,053 Corporate debt securities 4,294 40 — (5 ) 4,329 Certificates of deposit 1,652 8 — (1 ) 1,659 Total investments $ 9,989 $ 65 $ — $ (13 ) $ 10,041 |
Debt Securities, Held-to-Maturity [Table Text Block] | March 31, 2022 December 31, 2021 Maturing in one year or less $ 47,964 $ 3,212 Maturing after one year through two years — 6,829 Total investments $ 47,964 $ 10,041 |
Note 4 - Trade Receivables (Tab
Note 4 - Trade Receivables (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Notes Tables | |
Schedule of Receivables from Collaborations [Table Text Block] | March 31, 2022 Billed Unbilled Total U.S. Department of Health and Human Services $ 5 $ 1,600 $ 1,605 Royalty receivables from partners 327 — 327 Total receivables $ 332 $ 1,600 $ 1,932 December 31, 2021 Billed Unbilled Total U.S. Department of Health and Human Services $ 5 $ 1,670 $ 1,675 Royalty receivables from partners 305 — 305 Total receivables $ 310 $ 1,670 $ 1,980 |
Note 5 - Inventory (Tables)
Note 5 - Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | March 31, December 31, 2022 2021 Raw materials $ 5,269 $ 5,658 Work-in-process 10,434 9,669 Finished goods 694 709 Total Inventory $ 16,397 $ 16,036 Reserves (253 ) (245 ) Total Inventory, net $ 16,144 $ 15,791 |
Note 6 - Royalty Monetizations
Note 6 - Royalty Monetizations (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Notes Tables | |
Royalty Financing Obligations [Table Text Block] | 2020 RPI 2021 RPI OMERS Total Balance as of December 31, 2021 $ 147,224 $ 153,377 $ 148,774 $ 449,375 Deferred financing costs − (34 ) − (34 ) Non-cash Interest expense on Royalty financing obligations 10,165 6,327 3,157 19,649 Royalty revenues paid and payable (4,385 ) (380 ) − (4,765 ) Balance as of March 31, 2022 $ 153,004 $ 159,290 $ 151,931 $ 464,225 Effective interest rate 27.3 % 16.5 % 8.5 % |
Note 8 - Lease Obligations (Tab
Note 8 - Lease Obligations (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Notes Tables | |
Lessee, Operating Lease, Assets and Liabilities [Table Text Block] | Balance Sheet Location As of March 31, 2022 As of December 31, 2021 Assets: Operating lease assets, net Other Assets $ 7,207 $ 6,472 Liabilities: Current operating lease liabilities Lease financing obligation current liabilities $ 2,081 $ 1,819 Non-current operating lease liabilities Lease financing obligation long-term liabilities 6,457 5,962 Total operating lease liabilities $ 8,538 $ 7,781 |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | 2022 (remaining) $ 1,820 2023 2,190 2024 1,641 2025 1,348 2026 617 Thereafter 6,734 Total lease payments 14,350 Less imputed interest (5,812 ) Total $ 8,538 |
Note 10 - Stock-based Compens_2
Note 10 - Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Activity [Table Text Block] | Weighted Average Awards Options Exercise Available Outstanding Price Balance December 31, 2021 3,651 28,685 $ 7.90 Restricted stock unit awards granted (391 ) — — Restricted stock unit awards cancelled 40 — — Stock option awards granted (109 ) 109 16.49 Stock option awards exercised — (1,033 ) 5.83 Stock option awards cancelled 369 (369 ) 11.22 Balance March 31, 2022 3,560 27,392 $ 7.96 Weighted Average Awards Options Exercise Available Outstanding Price Balance December 31, 2021 900 4,408 $ 6.20 Restricted stock unit awards granted (134 ) — — Stock option awards granted (566 ) 566 16.10 Stock option awards exercised — (51 ) 3.22 Stock option awards cancelled 58 (58 ) 6.29 Balance March 31, 2022 258 4,865 $ 7.42 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2022 2021 Expected Life in Years 5.5 5.5 Expected Volatility 84.1 % 84.2 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 1.9 % 0.8 % |
Note 1 - Significant Accounti_2
Note 1 - Significant Accounting Policies and Concentrations of Risk (Details Textual) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Restricted Cash and Cash Equivalents, Current, Total | $ 3,354 | $ 3,345 | |
Advertising Expense | 3,984 | $ 1,404 | |
Interest Expense, Debt, Total | 23,837 | 12,904 | |
Amortization of Debt Financing Costs and Original Issue Discounts | $ 167 | $ 58 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 28,699 | 23,741 | |
Reclassification from Accumulated Other Comprehensive Income, Current Period, before Tax | $ 0 | $ (1) | |
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 | ||
Maximum [Member] | |||
Maturity Period of High Quality Marketable Securities (Year) | 3 years | ||
Average Maturity Period of High Quality Marketable Securities (Month) | 12 months | ||
Maturity Period of Short Term Investment (Month) | 12 months | ||
Minimum [Member] | |||
Long-term Investment Maturity, Minimum (Year) | 12 years | ||
Royalty Receivable [Member] | |||
Restricted Cash and Cash Equivalents, Current, Total | $ 1,924 | 1,924 | |
Collateral for Credit [Member] | |||
Restricted Cash and Cash Equivalents, Current, Total | 1,430 | $ 1,421 | |
Senior Credit Facility [Member] | MidCap Financial Services, LLC [Member] | |||
Line of Credit Facility, Remaining Borrowing Capacity | $ 75,000 |
Note 2 - Revenue - Summary of R
Note 2 - Revenue - Summary of Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenues | $ 49,923 | $ 19,059 |
Product [Member] | ||
Revenues | 49,546 | 17,871 |
Product [Member] | ORLADEYO [Member] | ||
Revenues | 49,386 | 10,938 |
Product [Member] | RAPIVAB [Member] | ||
Revenues | 160 | 113 |
Product [Member] | PERAMIVIR [Member] | ||
Revenues | 0 | 6,820 |
Royalty [Member] | ||
Revenues | 347 | (897) |
Collaborative and Other Research and Development [Member] | ||
Revenues | 30 | 2,085 |
Collaborative and Other Research and Development [Member] | US Department of Health and Human Services [Member] | ||
Revenues | $ 30 | $ 2,085 |
Note 3 - Investments- Fair Valu
Note 3 - Investments- Fair Value of the Company's Investments by Type (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Amortized Cost | $ 47,925 | $ 9,989 |
Accrued Interest | 120 | 65 |
Gross Unrealized Gains | 1 | 0 |
Gross Unrealized Losses | (82) | (13) |
Total investments | 47,964 | 10,041 |
US Government Agencies Debt Securities [Member] | ||
Amortized Cost | 42,005 | 4,043 |
Accrued Interest | 98 | 17 |
Gross Unrealized Gains | 1 | 0 |
Gross Unrealized Losses | (42) | (7) |
Total investments | 42,062 | 4,053 |
Corporate Debt Securities [Member] | ||
Amortized Cost | 4,272 | 4,294 |
Accrued Interest | 19 | 40 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (32) | (5) |
Total investments | 4,259 | 4,329 |
Certificates of Deposit [Member] | ||
Amortized Cost | 1,648 | 1,652 |
Accrued Interest | 3 | 8 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (8) | |
Total investments | $ 1,643 | $ 1,659 |
Note 3 - Investment - Schedule
Note 3 - Investment - Schedule of Maturity of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Maturing in one year or less | $ 47,964 | $ 3,212 |
Maturing after one year through two years | 0 | 6,829 |
Total investments | $ 47,964 | $ 10,041 |
Note 4 - Trade Receivables (Det
Note 4 - Trade Receivables (Details Textual) - Trade Accounts Receivable [Member] - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Accounts Receivable, after Allowance for Credit Loss, Total | $ 0 | $ 0 |
ORLADEYO [Member] | ||
Accounts Receivable, after Allowance for Credit Loss, Total | 34,405 | 27,384 |
RAPIVAB [Member] | ||
Accounts Receivable, after Allowance for Credit Loss, Total | 78 | 49 |
Green Cross Corporation [Member] | ||
Accounts Receivable, after Allowance for Credit Loss, Total | $ 701 | $ 701 |
Note 4 - Trade Receivables - Su
Note 4 - Trade Receivables - Summary of Receivables (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Total receivables | $ 1,932 | $ 1,980 |
Billed Revenues [Member] | ||
Total receivables | 332 | 310 |
Unbilled Revenues [Member] | ||
Total receivables | 1,600 | 1,670 |
US Department of Health and Human Services [Member] | ||
Total receivables | 1,605 | 1,675 |
US Department of Health and Human Services [Member] | Billed Revenues [Member] | ||
Total receivables | 5 | 5 |
US Department of Health and Human Services [Member] | Unbilled Revenues [Member] | ||
Total receivables | 1,600 | 1,670 |
Royalty Receivables from Partners [Member] | ||
Receivables | 327 | 305 |
Royalty Receivables from Partners [Member] | Billed Revenues [Member] | ||
Receivables | $ 327 | 305 |
Royalty Receivables from Partners [Member] | Unbilled Revenues [Member] | ||
Receivables | $ 0 |
Note 5 - Inventory - Summary of
Note 5 - Inventory - Summary of Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Raw materials | $ 5,269 | $ 5,658 |
Work-in-process | 10,434 | 9,669 |
Finished goods | 694 | 709 |
Total Inventory | 16,397 | 16,036 |
Reserves | (253) | (245) |
Total Inventory, net | $ 16,144 | $ 15,791 |
Note 6 - Royalty Monetization_2
Note 6 - Royalty Monetizations (Details Textual) - USD ($) $ in Thousands | Nov. 19, 2021 | Dec. 07, 2020 | Mar. 09, 2011 | Dec. 31, 2021 | Mar. 31, 2022 | Jun. 30, 2021 | Dec. 01, 2020 |
Debt Issuance Costs, Net, Total | $ 34 | ||||||
RPI 2019 Intermediate Finance Trust [Member] | |||||||
Shares Issued, Common Stock, Premium | 4,269 | ||||||
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% | ||||||
Royalty Purchase Agreement, Royalties, Maximum Tiered Profit Share Percentage on Permitted Sales in Other Markets | 3.00% | ||||||
RPI 2019 Intermediate Finance Trust [Member] | BCX9930 [Member] | Annual Net Sales Over $3 Billions [Member] | |||||||
Royalty Purchase Agreement, Royalties, Annual Net Sales Payment Threshold | $ 3,000,000 | ||||||
RPI 2019 Intermediate Finance Trust [Member] | Future Royalties Payable [Member] | |||||||
Proceeds from Issuance of Debt | $ 125,000 | ||||||
Debt Issuance Costs, Net, Total | $ 8,531 | ||||||
RPI 2021 and 2020 Intermediate Finance Trust [Member] | Future Royalties Payable [Member] | |||||||
Proceeds from Issuance of Debt | $ 150,000 | ||||||
The 2021 RPI Royalty Purchase Agreement [Member] | Annual Net Sales Under $350,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Key Territories | 0.75% | ||||||
The 2021 RPI Royalty Purchase Agreement [Member] | Annual Net Sales Between $350,000 and $550,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Key Territories | 1.75% | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Other Markets | 0.00% | ||||||
The 2021 RPI Royalty Purchase Agreement [Member] | Annual Net Sales Under $150,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Sublicense Revenue in Other Markets | 3.00% | ||||||
The 2021 RPI Royalty Purchase Agreement [Member] | Annual Net Sales Between $150,000 and $230,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Sublicense Revenue in Other Markets | 2.00% | ||||||
The 2021 RPI Royalty Purchase Agreement [Member] | BCX9930 [Member] | Annual Net Sales Under $1.5 Billion [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Key Territories | 3.00% | ||||||
The 2021 RPI Royalty Purchase Agreement [Member] | BCX9930 [Member] | Annual Net Sales Between $1.5 and $3 Billions [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Key Territories | 2.00% | ||||||
The 2021 RPI Royalty Purchase Agreement [Member] | BCX9930 [Member] | Annual Net Sales Over $3 Billions [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Other Markets | 0.00% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Sublicense Revenue in Other Markets | 20.00% | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales in Other Markets | 10.00% | ||||||
Royalty Purchase Agreement, Royalties, Purchase Price, Amount | $ 150,000 | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Minimum [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Purchase Price | 142.50% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Maximum [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Purchase Price | 155.00% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Annual Net Sales Under $350,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales | 7.50% | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales, Based on Reduction in Sales | 10.00% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Annual Net Sales Between $350,000 and $550,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales | 6.00% | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales, Based on Reduction in Sales | 3.00% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Annual Net Sales Over $550,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales | 0.00% | ||||||
Royalty Purchase Agreement, Royalties, Percentage of Annual Net Sales, Based on Reduction in Sales | 0.00% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Annual Net Sales Under $150,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Sublicense Revenue in Other Markets | 20.00% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Annual Net Sales Between $150,000 and $230,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Sublicense Revenue in Other Markets | 10.00% | ||||||
OMERS Capital Markets [Member] | ORLADEYO [Member] | Annual Net Sales Over $230,000 [Member] | |||||||
Royalty Purchase Agreement, Royalties, Percentage of Sublicense Revenue in Other Markets | 0.00% | ||||||
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 | $ 20,614 | ||||||
Gain (Loss) on Extinguishment of Debt, Total | $ 25,838 | ||||||
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 6 - Royalty Monetization_3
Note 6 - Royalty Monetizations - Schedule of Royalty Financing Obligations (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Balance | $ 449,375 |
Deferred financing costs | (34) |
Non-cash Interest expense on Royalty financing obligations | 19,649 |
Royalty revenues paid and payable | (4,765) |
Balance | 464,225 |
2020 RPI Royalty Agreement [Member] | |
Balance | 147,224 |
Non-cash Interest expense on Royalty financing obligations | 10,165 |
Royalty revenues paid and payable | (4,385) |
Balance | $ 153,004 |
Effective interest rate | 27.30% |
2021 RPI Royalty Agreement [Member] | |
Deferred financing costs | $ (34) |
Non-cash Interest expense on Royalty financing obligations | 6,327 |
Royalty revenues paid and payable | (380) |
Balance | $ 159,290 |
Effective interest rate | 16.50% |
OMERS Royalty Agreement [Member] | |
Non-cash Interest expense on Royalty financing obligations | $ 3,157 |
Balance | $ 151,931 |
Effective interest rate | 8.50% |
Note 7 - Debt (Details Textual)
Note 7 - Debt (Details Textual) - USD ($) $ in Thousands | Dec. 07, 2020 | Mar. 31, 2022 | Mar. 31, 2021 |
MidCap Financial Services, LLC [Member] | Senior Credit Facility [Member] | |||
Repayments of Lines of Credit | $ 43,298 | ||
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% | ||
Long-term Debt, Gross | $ 125,000 | ||
Paid-in-Kind Interest | 4,321 | $ 3,549 | |
Long-Term Debt, Total | $ 146,386 | ||
Debt Instrument, Interest Rate, Effective Percentage | 12.17% | ||
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 | ||
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net, Total | $ 8,651 | ||
Amortization of Debt Issuance Costs | $ 167 | $ 58 | |
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 8 - Lease Obligations (Det
Note 8 - Lease Obligations (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Operating Lease, Weighted Average Remaining Lease Term (Year) | 8 years | ||
Operating Lease, Weighted Average Discount Rate, Percent | 10.36% | ||
Operating Lease, Expense | $ 594 | $ 452 | |
Operating Lease, Right-of-Use Asset, Accumulated Amortization | 3,019 | $ 2,626 | |
Operating Lease, Payments | $ 574 | $ 440 | |
Minimum [Member] | |||
Lessee, Operating Lease, Term of Contract (Year) | 1 year | ||
Maximum [Member] | |||
Lessee, Operating Lease, Term of Contract (Year) | 5 years |
Note 8 - Lease Obligations -Bal
Note 8 - Lease Obligations -Balance Sheets of the Company's Operating Leases (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Liabilities: | ||
Current operating lease liabilities | $ 2,081 | $ 1,819 |
Non-current operating lease liabilities | 6,457 | 5,962 |
Total operating lease liabilities | 8,538 | 7,781 |
Other Assets [Member] | ||
Assets: | ||
Operating lease assets, net | $ 7,207 | $ 6,472 |
Note 8 - Lease Obligations - Ma
Note 8 - Lease Obligations - Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
2022 (remaining) | $ 1,820 | |
2023 | 2,190 | |
2024 | 1,641 | |
2025 | 1,348 | |
2026 | 617 | |
Thereafter | 6,734 | |
Total lease payments | 14,350 | |
Less imputed interest | (5,812) | |
Total | 8,538 | $ 7,781 |
Accrued Liabilities, Current and Other Noncurrent Liabilities [Member] | ||
Total | $ 8,538 |
Note 9 - Stockholders' Equity (
Note 9 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Nov. 19, 2021 | Nov. 17, 2021 | Apr. 24, 2020 |
Maximum Aggregate Offering Price | $ 500,000 | ||
Common Stock Purchase Agreement with RPI [Member] | |||
Stock Issued During Period, Shares, New Issues (in shares) | 3,846,154 | ||
Proceeds from Issuance of Common Stock | $ 50,000 | ||
Shares Issued, Price Per Share (in dollars per share) | $ 13 | $ 13 | |
Shares Issued, Price Per Share, Premium (in dollars per share) | 1.11 | ||
Shares Issued, Price Per Share, Closing Price (in dollars per share) | $ 11.89 | ||
Shares Issued, Common Stock, Premium | $ 4,269 |
Note 10 - Stock-based Compens_3
Note 10 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Jan. 31, 2022 | Dec. 31, 2014 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Expense | $ 9,601 | $ 5,479 | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | 109,635 | ||||
Employee Service Share-based Compensation Nonvested Awards Compensation Cost Expected to be Recognized For Remainder of Fiscal Year | 28,801 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Next Year | 33,073 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Two | 30,267 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Three | 17,094 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Expected to be Recognized Year Four | $ 400 | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in shares) | 115 | 193 | |||
Share-Based Payment Arrangement, Option [Member] | Non-employee Directors [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 1 year | ||||
Incentive Plan [Member] | |||||
Share-Based Payment Arrangement, Expense | $ 8,078 | $ 4,554 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 3,560 | 3,651 | |||
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) | $ 11.48 | $ 6.87 | |||
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] | Share-Based Payment Arrangement, Option [Member] | Thirty-six Equal Monthly Installments [Member] | Non-employee Directors [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 3 years | ||||
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 | 85.00% | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) | 1,250 | ||||
Incentive Plan [Member] | Performance-based Restricted Stock Units [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 3 years | ||||
Incentive Plan [Member] | Performance-based Restricted Stock Units [Member] | Vest 25% Each Year Until Fully Vested [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | ||||
Incentive Plan [Member] | Performance-based Restricted Stock Units [Member] | Vest Upon Successful Completion of Specific Development Milestones [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) | 221 | ||||
Incentive Plan [Member] | Performance-based Restricted Stock Units [Member] | Share-Based Payment Arrangement, Tranche One [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 50.00% | ||||
Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 15.49 | ||||
Inducement Plan [Member] | |||||
Share-Based Payment Arrangement, Expense | $ 1,225 | $ 598 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 4 years | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 11.14 | $ 5.86 | |||
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) | 258 | 900 | |||
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, Fair Value Assumptions, Expected Dividend Rate | 0.00% | ||||
Inducement Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 16.27 | ||||
Employee Stock Purchase Plan [Member] | |||||
Share-Based Payment Arrangement, Expense | $ 298 | $ 327 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 7,975 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 5,937 | ||||
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 |
Note 10 - Stock-based Compens_4
Note 10 - Stock-based Compensation - Stock Plan Activities (Details) | 3 Months Ended |
Mar. 31, 2022$ / sharesshares | |
Options outstanding, stock option awards exercised (in shares) | (1,108) |
Incentive Plan [Member] | |
Awards available, beginning balance (in shares) | 3,651,000 |
Options outstanding, beginning balance (in shares) | 28,685,000 |
Weighted average exercise price, beginning balance (in dollars per share) | $ / shares | $ 7.90 |
Awards available, Restricted stock awards granted (in shares) | (391,000) |
Awards available, Restricted stock unit awards cancelled (in shares) | 40,000 |
Awards available, stock option awards granted (in shares) | (109,000) |
Options outstanding, stock option awards granted (in shares) | 109,000 |
Weighted average exercise price, stock option awards granted (in dollars per share) | $ / shares | $ 16.49 |
Options outstanding, stock option awards exercised (in shares) | (1,033,000) |
Weighted average exercise price, stock option awards exercised (in dollars per share) | $ / shares | $ 5.83 |
Awards available, stock option awards cancelled (in shares) | 369,000 |
Options outstanding, stock option awards cancelled (in shares) | (369,000) |
Weighted average exercise price, stock option awards cancelled (in dollars per share) | $ / shares | $ 11.22 |
Awards available, ending balance (in shares) | 3,560,000 |
Options outstanding, ending balance (in shares) | 27,392,000 |
Weighted average exercise price, ending balance (in dollars per share) | $ / shares | $ 7.96 |
Inducement Plan [Member] | |
Awards available, beginning balance (in shares) | 900,000 |
Options outstanding, beginning balance (in shares) | 4,408,000 |
Weighted average exercise price, beginning balance (in dollars per share) | $ / shares | $ 6.20 |
Awards available, Restricted stock awards granted (in shares) | (134,000) |
Awards available, stock option awards granted (in shares) | (566,000) |
Options outstanding, stock option awards granted (in shares) | 566,000 |
Weighted average exercise price, stock option awards granted (in dollars per share) | $ / shares | $ 16.10 |
Options outstanding, stock option awards exercised (in shares) | (51,000) |
Weighted average exercise price, stock option awards exercised (in dollars per share) | $ / shares | $ 3.22 |
Awards available, stock option awards cancelled (in shares) | 58,000 |
Options outstanding, stock option awards cancelled (in shares) | (58,000) |
Weighted average exercise price, stock option awards cancelled (in dollars per share) | $ / shares | $ 6.29 |
Awards available, ending balance (in shares) | 258,000 |
Options outstanding, ending balance (in shares) | 4,865,000 |
Weighted average exercise price, ending balance (in dollars per share) | $ / shares | $ 7.42 |
Note 10 - Stock-based Compens_5
Note 10 - 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 | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Expected Life (Year) | 5 years 6 months | 5 years 6 months |
Expected Volatility | 84.10% | 84.20% |
Expected Dividend Yield | 0.00% | 0.00% |
Risk-Free Interest Rate | 1.90% | 0.80% |
Note 11- Collaborative and Ot_2
Note 11- Collaborative and Other Relationships (Details Textual) $ in Thousands | Sep. 15, 2021USD ($) | Nov. 05, 2019USD ($) | Sep. 06, 2018USD ($) | Sep. 30, 2013USD ($) | Aug. 31, 2020USD ($) | Jun. 30, 2000USD ($) | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Mar. 31, 2015USD ($) |
Revenue from Contract with Customer, Including Assessed Tax | $ 49,923 | $ 19,059 | |||||||
US Department of Health and Human Services [Member] | |||||||||
Collaborative Agreement Contract Value | $ 34,660 | ||||||||
Contract Term (Year) | 5 years | ||||||||
US Department of Health and Human Services [Member] | RAPIVAB [Member] | |||||||||
Maximum Number of Products, Doses | 50,000 | ||||||||
Proceeds from Collaborators | 20,782 | ||||||||
Torii Pharmaceutical Co. [Member] | |||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 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 | ||||||||
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% | ||||||||
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 | ||||||||
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 | $ 47,315 | $ 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 |